Sousan Sheldon, Ph.D.

Sousan Sheldon, Ph.D. is a former FDA International Policy Analyst for medical devices and pharmaceuticals with expertise in Asia, the Middle East and Canada. She is an expert in regulatory pathways for INDs, NDAs, ANDAs, 510(k)s, IDEs, De Novo, HDE, PMAs, and other regulatory submissions and has extensive knowledge in the development of medical devices, medical devices containing antimicrobial agents, combination products, companion diagnostic products, and applications for Clinical Laboratory Improvement Amendment waivers. She has a doctoral degree in Microbiology/Immunology from the University of North Texas.

Maged Sharaf, Ph.D.

Dr. Maged Sharaf works with EAS clients in the area of dietary supplement products, particularly those containing botanical ingredients. He brings over 30 years of experience working closely with the industry and the FDA regarding dietary supplement sciences and regulations and is experienced in investigations, 21 CFR 111 audits, food and dietary supplement label compliance review, marketing material reviews for FDA and FTC compliance, claim substantiation, dietary ingredient review and specifications development. He has a Ph.D. in Pharmaceutical Sciences from School of Pharmacy, University of Pittsburgh.

Meet EAS Issue of the Month Author – Robert Post, Ph.D.

Dr. Robert Post is a former food industry executive, White House and regulatory agency executive, and university instructor with expertise in food science and nutrition. His roles in the food industry have included leading nutrition and regulatory affairs; corporate health and wellness programs; and food and health communications to support marketing and customers/sales. He has also directed legislative affairs, food ingredient specifications and approvals, food product design and innovation, food labeling and nutrition labeling strategies, and brand communications strategies. In the Federal sector, Rob directed the agencies that set the Dietary Guidelines for Americans, created MyPlate(.gov), and the national nutrition evidence library, supporting the White House as a key nutrition advisor. Prior to consulting Rob was the Senior Director for Chobani Health and Wellness and Regulatory Affairs. He also served as the Executive Director for Center for Nutrition Policy and Promotion in the U.S. Department of Agriculture.

Dietary Supplement Serious Adverse Events – Traceability Compliance in the Era of COVID-19

In the wake of COVID-19 pandemic, a number of enforcement discretion measures have been put in place by FDA, one of which pertains to the reporting of Serious Adverse Events (SAE) for dietary supplements which, in accordance to the Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2006, require dietary supplement firms to submit all SAE accusations to the FDA within 15 business days of receipt of the complaint. Join EAS Independent Consultant, Tamika Cathey for a complimentary webinar covering SAEs and Traceability considerations on April 16, 2020, at 1 pm eastern.

New Dates for Food and Dietary Supplement Compliance Seminars in Long Island

Due to travel restrictions and out of an abundance of caution, EAS has rescheduled the upcoming compliance seminars in Long Island and extended the early-bird discount. New dates are:

  • Food Labeling Seminar: July 21-22, 2020
  • Dietary Supplement GMP Seminar: July 21-22, 2020
  • Dietary Supplement Labeling Seminar: July 23-24, 2020

Learn more by visiting our Seminars page on the EAS website and don’t forget to use earlybird at checkout to receive 10% off of your registration.

EAS Webinar – Fast Tracking Anti-Microbial Agents – FDA Accelerated Programs – April 22, 2020

Developers of antimicrobial agents may seek an accelerated FDA review of their products and gain an additional 5 years of market exclusivity by qualifying under the Limited Population Pathway for Antimicrobial and Antifungal Drugs. Learn more about these important FDA pathways that facilitate fast track product reviews from EAS Consulting Group’s independent consultant, Sousan Sheldon, MT-ASCP, Ph.D. a former Supervisory Review Officer, Senior Scientific Policy Advisor and Senior Policy Analyst at the FDA. Learn from her insights and avoid critical missteps that raise red flags and require time consuming revisions. Register here.

EAS Consultants Present Webinars on GRAS and NDI Opportunities for the CBD Industry

CBD: Future Regulatory Pathways to Market in the US – with Frost Brown Todd, LLP – April 30, 2020

Independent Consultant, Tom Jonaitis, will join attorneys from Frost Brown Todd, LLP for a webinar on regulatory pathways to market CBD in the U.S. The webinar will discuss CBD’s current legal status, legislative efforts to define a legal pathway for the use of CBD in foods, beverages and dietary supplements and likely FDA requirements once the regulatory path is defined. The discussion will include new dietary ingredient (NDI) notifications for dietary supplements and food additive petitions or self-GRAS, as well as proper and sophisticated safety data, and strategic advantages and disadvantages of each. Register via Frost Brown Todd’s website directly.

GRAS? CBD’s Uphill Battle to Answer FDA’s Safety Concerns – An IFT Live Webcast – May 20, 2020

Independent Consultants Robin Guy and attorney Marc Ullman of Rivkin Radler will present a webinar for the Institute for Food Technologists (IFT) on CBD’s Uphill Battle to Answer FDA’s Safety Concerns. What questions will FDA need answered and how should studies be designed to consider conditions of intended use? Explore the regulatory and legal landscape of CBD containing products, with a dive into how the CBD industry can begin addressing FDA safety concerns through toxicology in support of filing a successful GRAS submission. What questions will FDA need answered to satisfy their concerns for this very challenging ingredient? What types of studies must be designed, and how to provide an evaluation of safety under the conditions of its intended use? If you are operating in the CBD space, it is imperative to understand the requirements of GRAS as well as how to develop a roadmap to successful FDA submission. Join EAS and IFT on May 20, 2020 at 11am eastern.

EAS Complimentary Lock-Out Tag-Out Employee Safety Webinar Moved to April 9

Due to the critical nature of employee safety, particularly as manufacturing facilities attempt to maintain or increase production levels with reduced capacity and/staggered shifts, the EAS complimentary LOTO webinar which covers OSHA employee safety standards is moving up to April 9, 2020. Learn to identify sources of energy hazards, identify and develop equipment-specific procedural steps for LOTO as well as the roles and responsibilities during LOTO procedures. Register for the LOTO webinar on the EAS website.

Dietary Supplement Serious Adverse Events – Traceability Compliance in the Era of COVID-19

April 16, 2020, 1 pm eastern

Presented by Tamika Cathey, EAS Independent Consultant

In the wake of COVID-19 pandemic, a number of enforcement discretion measures have been put in place by FDA, one of which pertains to the reporting of Serious Adverse Events (SAE) for dietary supplements which, in accordance to the Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2006, require dietary supplement firms to submit all SAE accusations to the FDA within 15 business days of receipt of the complaint.

However, in light of COVID-19 that may result in increased employee absenteeism and other situations that limit company resources, the FDA is temporarily allowing for the “storage” of SAEs at the dietary supplement firm and then reporting those to the FDA within six months after normal operations are resumed.  This enforcement discretion is discussed in the recently issued FDA Guidance for Industry, Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic.

Having a robust complaint handling system that allows for the identification, traceability, investigation, “storage” and submission of SAEs at a later date is, therefore a must. Learn factors that make for a GMP compliant complaint handling system including what must be included in SOPs, what documentation is required, how to conduct the investigation, how to develop a retention system and more.

Though COVID-19 is altering some normal day to day operations, firms cannot lose sight of their obligations under FDA to protect the consumer.

About the Presenter

Tamika Cathey consults with an international client base on regulations pertaining to safety and quality of pharmaceuticals and dietary supplements. She evaluates client compliance readiness by conducting audits, risk assessments and mock FDA/GMP investigations and works to design improvement programs based on findings. Tamika has a B.S. in Biology from Greensboro College in North Carolina. Prior to consulting she held positions such as Associate Director, Regulatory Affairs for Charles River Laboratories, and Consumer Safety Officer at FDA’s Atlanta District. She is a certified auditor with the Natural Products Association and holds FDA Level II certifications for the Clinical Bioresearch Monitoring Auditor and Drug Auditor Program.

Terms and Conditions

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EAS Client Update – FDA Submits Request to Extend PMTA Deadline

FDA has filed a motion with the United States District Court for the District of Maryland requesting a 120-day extension of the premarket application deadline (currently set for May 12, 2020) for many e-cigarettes, cigars and other tobacco products.

The extension is sought solely because of the coronavirus outbreak and the challenges posed during these extraordinary circumstances. If granted, the 120-day extension would move the deadline to Sept. 9, 2020. However, until a court decision is made, the May 12, 2020 deadline remains in effect.

EAS Consulting Group is closely monitoring these and other FDA initiatives. Please contact us with any questions or if we can be of assistance in the preparation and filing of your PMTAs.

If the court grants this extension, FDA intends to revise its January 2020 enforcement priorities guidance to be consistent with the new deadline, including continued enforcement discretion for a period of up to one year from the date an application was submitted (up to Sept. 9, 2021 if the 120-day extension is granted) or unless a negative action is taken by FDA during that time.

Thanks and take care,

Tara Couch

Tara Lin Couch, Ph.D.
EAS Senior Director of Dietary Supplement and Tobacco Services
571-447-5510 tcouch@easconsultinggroup.com

Practical Approaches to FSMA (PCQI, Supply chain, FSVP) in the Era of COVID-19

April 8, 2020, at 1 pm eastern

Presented by Julie Litz, EAS Independent Consultant, and Allen Sayler, Senior Director, Food Consulting Services

A global pandemic does not negate our responsibility and requirement to maintain Food Safety in food production plants and adhere to FSMA policies set forth by the FDA.  In fact, in an era of reduced workforce, supply chains may be disrupted, critical contracted services such as cleaning and pest control may unavailable and you may not be able to get critical supplies.

Join EAS independent consultant, Julie Litz, and Senior Director for Food Consulting Services, Allen Sayler for a look at practical steps you can take to ensure your FSMA obligations are being met in this challenging time. From PCQI to FSVP, any policy and personnel changes must meet the CFR 117 cGMP requirements. Keep your employees and your customers safe.

About the Presenters

Julie Litz

Julie Litz’s career as a quality director has covered Food, Dietary supplement and Animal Feed industries. She has extensive experience in setting up food safety plans for manufacturing facilities and transitioning a facility from food regulation compliance (CFR 117) to Dietary Supplement regulation compliance (CFR 111). She is HACCP certified and PCQI certified in both Human Food, and Animal Feed. In addition, she has conducted audits at foreign facilities and worked with companies on FSVP compliance. She has also conducted biotechnology research in academic and commercial settings. She has extensive knowledge in validation and verification procedures, clinical trials, IACUC requirements for animal protocols, animal experimentation and expert understanding of biotechnology techniques.

Allen Sayler

Allen Sayler is the Senior Director for Food Consulting Services at EAS with expertise in the areas of food processing, particularly in the area of dairy processing, infant formula, bakery products, food additives, botanical products and food packaging as well as GSFI Third-Party Certification programs such as Safe Quality Foods (SQF).

Terms and Conditions

By submitting this form you will be joining the nearly 20,000 who receive the monthly EASeNews regulatory newsletter. Please note EAS never shares your information and you may unsubscribe at any time.

Drug and Device Corner for March 2020

Please see the end of our monthly segment for COVID-19 specific information.

The FDA issued a requirement for a stronger boxed warning about serious mental health side effects for the asthma and allergy drug montelukast. The FDA took this action after a review of available information led the agency to reevaluate the benefits and risks of montelukast use. Please review the FDA website for all relevant information.

On March 2, 2020, the FDA published their newest Product-Specific Guidances for Generic Drug Development. This batch of 43 PSGs includes: 33 new and 10 revised PSGs; PSGs for generic products for important treatments for diseases such as Amyotrophic Lateral Sclerosis (ALS), Diabetes, Human Immunodeficiency Virus (HIV), Lung cancer, and Melanoma. 38 of the PSGs are for products with no approved ANDAs (including 14 for complex products) and 16 PSGs are for complex products (10 new and 6 revised). 12 of these PSGs were developed based on research data generated by the Generic Drug User Fee Amendments (GDUFA) Science and Research program.

FDA’s Center for Drug Evaluation and Research embarked on an initiative to modernize the New Drugs Regulatory Program. Included in this program is the reorganization of the New Drugs Regulatory Program. The agency created a website publishing the Applications affected by the reorganization.

The FDA has launched FDA-Track, agency performance dashboards to offer a more concise, interactive, and visual presentation of some of the data reports in FDA’s annual performance reports. Specific to the generic drug approval process, you can review the FDA-Track; PDUFA Performance website.

The Regulatory Education for Industry (REdI) Generic Drugs Forum will be held virtually only this year on April 15 & 16 from 8 am to 4 pm EDT.

The FDA published a news release regarding Potential Cybersecurity Vulnerabilities in Certain Medical Devices with Bluetooth Low Energy. The agency is asking medical device manufacturers to communicate to health care providers and patients which medical devices could be affected by SweynTooth and ways to reduce associated risk. Please see the website for more specific information.

CVM Broadcast message #42: CVM is updating its Electronic Submission System (ESS) to assist stakeholders when submitting their Manage Forms (Form FDA 3538) through FDA ESG. This update will modify the Submission Type list of values for CVM. 1] Submission Type “Electronic Submissions” will be changed to “Manage Form”. Stakeholders should use this folder when submitting Manage Form submissions to CVM. 2] Submission Type “eSubmitter” should be used for any eSubmitter submission to CVM and 3] Submission Type “Adverse Events Reports” should be used for any electronic adverse event report submission to CVM.

Guidance Document updates on the FDA website:

All Divisions:

Restricted Delivery Systems: Flow Restrictors for Oral Liquid Drug Products Guidance for Industry

This guidance provides recommendations regarding the use of restricted delivery systems, to limit unintentional ingestion of oral liquid drug products by children. The recommendations in this guidance apply broadly to oral liquid drug and biological products. Accordingly, this guidance is intended for manufacturers of oral liquid drug and biological products.

CDER:

Competitive Generic Therapies

This guidance provides a description of the process that applicants should follow to request designation of a drug as a CGT and the criteria for designating a drug as a CGT. It also includes information on the actions FDA may take to expedite the development and review of ANDAs for drugs designated as CGTs.

Type 2 Diabetes Mellitus: Evaluating the Safety of New Drugs for Improving Glycemic Control

The purpose of this guidance is to provide the Food and Drug Administration’s current recommendations regarding the overall evaluation of safety for the development of drugs and biologics indicated for improvement of glycemic control in patients with type 2 diabetes mellitus.

Contact Dermatitis From Topical Drug Products for Cutaneous Application: Human Safety Assessment

The purpose of this guidance is to provide FDA’s current thinking about local safety assessment for the risk of contact dermatitis (irritant, allergic, and photoallergic) during development of new drug products intended for topical application to the skin.

Safety Testing of Drug Metabolites

This guidance provides recommendations to industry on when and how to identify and characterize drug metabolites whose nonclinical toxicity needs to be evaluated.

CDER & CBER:

Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices

This guidance describes recommendations for device manufacturers seeking to submit information through a CLIA waiver application to FDA to support a determination whether the device meets CLIA statutory criteria for waiver described above.

Slowly Progressive, Low-Prevalence Rare Diseases with Substrate Deposition That Results from Single Enzyme Defects: Providing Evidence of Effectiveness for Replacement or Corrective Therapies

This document provides guidance to sponsors on the evidence necessary to demonstrate the effectiveness of investigational new drugs or new drug uses intended for slowly progressive, low-prevalence rare diseases that are associated with substrate deposition and are caused by single enzyme defects. This guidance applies only to those low-prevalence rare diseases with well-characterized pathophysiology, and in which changes in substrate deposition can be readily measured in relevant tissue or tissues.

Providing Regulatory Submissions in Alternate Electronic Format

This guidance provides recommendations on an alternate electronic format for submissions covered under an exemption from or a waiver of the requirements of section 745A(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Q3D(R1) ELEMENTAL IMPURITIES

There are three parts of this guidance: 1] The evaluation of the toxicity data for potential elemental impurities; 2] The establishment of a permitted daily exposure (PDE) for each element of toxicological concern and 3] The application of a risk-based approach to control elemental impurities in drug products.

Inclusion of Older Adults in Cancer Clinical Trials

This guidance provides recommendations regarding the inclusion of older adult patients in clinical trials of drugs for the treatment of cancer. For the purpose of this guidance, older adults are those aged 65 years and older.

The “Deemed to be a License” Provision of the BPCI Act: Questions and Answers

This guidance is intended to provide answers to common questions about FDA’s implementation of the “transition” provision of the Biologics Price Competition and Innovation Act of 2009 under which an application for a biological product approved under section 505 of the Federal Food, Drug, and Cosmetic Act as of March 23, 2020, will be deemed to be a license for the biological product under section 351 of the Public Health Service Act on March 23, 2020 (the transition date).

CDRH:

Product Labeling for Laparoscopic Power Morcellators

This draft guidance contains recommendations concerning the content and format for certain labeling information for laparoscopic power morcellators (LPMs). The recommendations in this draft guidance reflect the state of the science and available technology regarding use of LPMs and are being made in light of scientific information that suggests that the use of these devices contributes to the dissemination and upstaging of an occult uterine malignancy in women undergoing laparoscopic gynecologic surgery for presumed fibroids.

Recommendations for Dual 510(k) and CLIA Waiver by Application Studies

The purpose of this guidance is to assist manufacturers in using the Dual 510(k) and Clinical Laboratory Improvement Amendments (CLIA) Waiver by Application pathway.

510(k) Third Party Review Program

The objectives of this guidance are: 1] To describe the factors FDA will use in determining device type eligibility for review by 3P510k Review Organizations; 2] To outline FDA’s process for the recognition, re-recognition, suspension, and withdrawal of recognition for 3P510k Review Organizations and 3] To ensure consistent quality of work among 3P510k Review Organizations through the Medical Device User Fee Amendments (MDUFA) IV commitments authorized under FDARA7 to eliminate the need for routine, substantive re-review by FDA.

Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery

FDA has developed this guidance document to assist industry in preparing premarket notification (510(k)) submissions for electrosurgical devices intended for use in general surgery. These devices are designed to cut and/or remove tissue and control bleeding through the use of high-frequency electrical current. For the purpose of this guidance, electrosurgical devices may also be called radiofrequency (RF) devices or high-frequency (HF) devices.

Soft (Hydrophilic) Daily Wear Contact Lenses – Performance Criteria for Safety and Performance Based Pathway

This draft guidance provides performance criteria for soft (hydrophilic) daily wear contact lenses in support of the Safety and Performance Based Pathway. Under this framework, submitters planning to submit a 510(k) using the Safety and Performance Based Pathway for soft (hydrophilic) contact lenses will have the option to use the performance criteria proposed in this draft guidance to support substantial equivalence, rather than a direct comparison of the performance of the subject device to that of a predicate device.

Bone Anchors – Premarket Notification (510(k)) Submissions

This guidance document provides recommendations for 510(k) submissions for bone anchor (suture anchor) devices. These devices are indicated for attachment of soft tissue to bone. This final guidance clarifies and provides current thinking on the recommended content for a bone anchor 510(k) submission, including performance testing recommendations and device description.

CBER:

Biological Product Deviation Reporting for Blood and Plasma Establishments

FDA is providing blood or plasma establishments, with revised recommendations related to biological product deviation (BPD) reporting. This guidance document is intended to assist blood and plasma establishments in determining when a report is required, who submits the report, what information to submit in the report, the timeframe for reporting, and how to submit the report.

CVM:

CVM GFI #264 Standardized Medicated Feed Assay Limits

This guidance recommends a standardized set of assay limits for medicated feeds. If you have any questions or concerns please email CVMDCU@fda.hhs.gov

CVM GFI #108 Registering with CVM’s Electronic Submission System

This guidance provides general standards which should be used to register with the Center for Veterinary Medicine (CVM or the Center) Electronic Submission System (ESS).

COVID-19 Specific information

The FDA has established a Coronavirus Disease 2019 (COVID-19) webpage for their most up to date information.

In response to the current medical health crisis, the FDA has issued three guidance documents regarding the manufacture of alcohol-based hand sanitizer products. Two of these guidance documents communicate the agency’s policy for the temporary manufacture of certain alcohol-based hand sanitizer products. The third describes the agency’s policy for entities that wish to produce alcohol for incorporation into alcohol-based hand sanitizers. These guidance documents will only be in effect for the duration of the public health emergency declared by the Secretary of Health and Human Services (HHS) on January 31, 2020.

Guidance for Industry: Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19)

The Food and Drug Administration (FDA or Agency) plays a critical role in protecting the United States from emerging infectious diseases, such as the Coronavirus Disease 2019 (COVID-19) pandemic. FDA is committed to providing timely guidance to support continuity and response efforts to this pandemic.

Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency

Due to the Coronavirus Disease 2019 (COVID-19) pandemic, the Food and Drug Administration (FDA or Agency) has received a number of queries concerning compounding of alcohol-based hand sanitizers. The Agency is issuing this guidance to communicate its policy for the temporary compounding of certain alcohol-based hand sanitizer products by pharmacists in State-licensed pharmacies or Federal facilities and registered outsourcing facilities (referred to collectively in this guidance as compounders) for the duration of the public health emergency declared by the Secretary of Health and Human Services (HHS) on January 31, 2020.

Temporary Policy for Manufacture of Alcohol for Incorporation Into Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19)

This guidance is being issued to address the Coronavirus Disease 2019 (COVID-19) public health emergency. This is being implemented without prior public comment because FDA has determined that prior public participation for this guidance is not feasible or appropriate. This guidance document is being implemented immediately, but it remains subject to comment in accordance with the Agency’s good guidance practices.

FDA is issuing this guidance in response to a number of queries from entities that are not currently registered drug manufacturers that would like to produce alcohol for incorporation into alcohol-based hand sanitizers. This policy does not extend to other types of active ingredients for incorporation into alcohol-based hand sanitizers, such as isopropyl alcohol. The Agency is issuing this guidance to communicate its policy for the temporary manufacture of ethanol products by firms that manufacture alcohol for incorporation into alcohol-based hand sanitizer products under the circumstances described in this guidance (alcohol production firms) for the duration of the public health emergency declared by the Secretary of Health and Human Services (HHS) on January 31, 2020. At such time when the public health emergency is over, as declared by the Secretary, FDA intends to discontinue this enforcement discretion policy and withdraw this guidance

Further COVID-19 specific Guidance Documents:

Enforcement Policy for Ventilators and Accessories and Other Respiratory Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency

FDA is issuing this guidance to provide a policy to help expand the availability of ventilators as well as other respiratory devices and their accessories during this pandemic. This policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the Department of Health and Human Services (HHS), including any renewals made by the Secretary in accordance with section 319(a)(2) of the PHS Act.

Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease-2019 (COVID-19 ) Public Health Emergency

FDA is issuing this guidance to provide a policy to help expand the availability and capability of non-invasive remote monitoring devices to facilitate patient monitoring while reducing patient and healthcare provider contact and exposure to COVID-19 during this pandemic. This policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the Department of Health and Human Services (HHS), including any renewals made by the Secretary in accordance with section 319(a)(2) of the PHS Act.

Policy for Certain REMS Requirements During the COVID-19 Public Health Emergency Guidance for Industry and Health Care Professionals

FDA is issuing this guidance to communicate its temporary policy for certain risk evaluation and mitigation strategies (REMS) requirements for the duration of the public health emergency (PHE) declared by the Secretary of Health and Human Services (HHS) on January 31, 2020. The policy outlined in the guidance will be in effect only for the duration of the public health emergency.

Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency

The Food and Drug Administration (FDA or Agency) is issuing this guidance to provide a policy to help accelerate the availability of novel coronavirus (COVID-19) diagnostic tests developed by laboratories and commercial manufacturers during the public health emergency.

Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic

This guidance provides recommendations to industry regarding postmarketing adverse event reporting for drugs, biologics, medical devices, combination products, and dietary supplements during a pandemic. FDA anticipates that during a pandemic, industry and FDA workforces may be reduced because of high employee absenteeism while reporting of adverse events related to widespread use of medical products indicated for the treatment or prevention of the pathogen causing the pandemic may increase. The extent of these possible changes is unknown. This guidance discusses FDA’s intended approach to enforcement of adverse event reporting requirements for medical products and dietary supplements during a pandemic.

FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic

The Food and Drug Administration (FDA or Agency) plays a critical role in protecting the United States from threats including emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic. FDA is committed to providing timely guidance to support continuity and response efforts to this pandemic.

CVM GFI# 269 Enforcement Policy Regarding Federal VCPR Requirements to Facilitate Veterinary Telemedicine During the COVID-19 Outbreak

FDA is aware that during the COVID-19 outbreak some States are modifying their requirements for veterinary telemedicine, including State requirements regarding the veterinarian-client-patient relationship (VCPR). Given that the Federal VCPR definition requires animal examination and/or medically appropriate and timely visits to the premises where the animal(s) are kept, the Federal VCPR definition cannot be met solely through telemedicine. To further facilitate veterinarians’ ability to utilize telemedicine to address animal health needs during the COVID-19 outbreak, FDA intends to temporarily suspend enforcement of a portion of the Federal VCPR requirements. Specifically, FDA generally intends not to enforce the animal examination and premises visit VCPR requirements relevant to FDA regulations governing Extralabel Drug Use in Animals (21 CFR part 530) and Veterinary Feed Directive Drugs (21 CFR 558.6). Given the temporary nature of this policy, we plan to reassess it periodically and provide revision or withdrawal of this guidance as necessary.

COVID-19 specific FDA announcements / websites:

85 FR 16949 Process for Making Available Guidance Documents Related to Coronavirus Disease 2019

Emergency Use Authorizations

FAQs on Diagnostic Testing for SARS-CoV-2

Coronavirus (COVID-19) Update:  FDA allows expanded use of devices to monitor patients’ vital signs remotely

Letter to Industry on COVID-19 (Medical Device Establishments)

CSMS #42124872 -Information for Filing Personal Protective Equipment and Medical Devices During COVID-19 Coronavirus (COVID-19) Update: FDA takes action to increase U.S. supplies through instructions for PPE and device manufacturers.

Investigational COVID-19 Convalescent Plasma – Emergency INDs

Did You Know – COVID-19: GMP for Hand Sanitizers

FDA announced final guidance for the temporary manufacture of certain alcohol-based hand sanitizer products for the duration of the on-going COVID-19 health emergency.

Because of the increased demand for these OTC drug products, FDA will temporarily suspend enforcement actions against firms that prepare alcohol-based hand sanitizers for consumer use and for use as health care personnel hand rubs for the duration of the public health emergency, provided certain stipulations are met:

  • The hand sanitizer is manufactured using only United States Pharmacopoeia (USP) grade ingredients consistent with World Health Organization (WHO) recommendations as described in the guidance document, and in the correct amounts.
  • No other active or inactive ingredients are included.
  • Conditions for manufacture must meet FDA Good Manufacturing Practices (GMP) standards, including sanitary conditions and documented analysis for verification of alcohol content in samples of the finished drug product before each batch is released.
  • Appropriate labeling as referenced in the monograph and guidance document.
  • The manufacturer must have a mechanism to accept adverse event reports (AER) and must submit those reports to FDA.
  • Firms manufacturing these products must register their facility and list their products in the FDA Drug Registration and Listing System (DRLS).

Bryan Coleman, EAS Senior Director for Pharmaceuticals and Medical Devices, reminds all manufacturers and distributors of hand sanitizers that FDA has not relaxed or suspended any GMP manufacturing requirements for these or any other products:

  • A firm operates at its own risk if it exceeds the limits of the GMPs and/or does not perform required tasks as prescribed (such as validation, change of ingredient suppliers, etc.)
  • Change control to set the definitive time frames and additional control measures must be used should a firm wish to change batch size, introduce new ingredient suppliers or packaging components, without undergoing qualification/validations/pre-assessment studies for an OTC monograph formula. (These should reference the President’s National Emergency Declaration and firms must commit to ceasing such “changed operations” immediately upon closure of the National Emergency Declaration and/or upon pursuing the prospective validation/qualification of the changes according to GMP requirements.)
  • Detailed record keeping is essential, including for any non-routine production activities.
  • Firms could be cited for having introduced into interstate commerce a product which has not been fully subjected to the GMP requirements and is therefore potentially adulterated/misbranded and subject to FDA enforcement discretion.
  • While FDA has temporarily reduced its domestic inspections to high priority/critical operations only, the Agency still has the right and capability to perform inspections at its will.

EAS is ready to help navigate how to document, properly plan for and execute such deviations and change controls. With detailed knowledge of FDA requirements and GMP methods, enlisting the advice of a competent expert can help to reduce your regulatory risk in these trying times. EAS staff can also assist with your establishment registration and drug listing process. For assistance in these matters, contact Bryan Coleman directly.

Building Food Product Development and Business Through Health and Wellness Branding and Messaging

By Robert C. Post, PhD., MEd., MSc.

Food companies are striving to be a force for good and today many are developing products to accelerate wellness. That’s because consumers are prioritizing health consciousness as part of their everyday food choices, according to the IFIC Foundation 2019 Food and Health Survey. Price, taste and convenience are no longer the reigning factors. And, for many consumers, a food label alone is not sufficient to convey the information they seek to make a choice. Consumers are weighing a new set of factors and choosing food and beverage products that promote their health and wellness. To that end, food manufacturers must ensure that their business functions and product messaging convey integrity of brand, promotes transparency, and are messaged beyond the label to be appealing.

According to consumer survey research (Deloitte Food Value Equation Survey 2015, Deloitte Analysis; Center for Food Integrity, A Clear View of Transparency and How it Builds Trust, 2015), consumers are weighing lifestyle nutrition benefits at every life stage as part of their food decisions. Naturality and the simplicity of production methods, product formulations, and ingredient sourcing are also important factors. Additionally, the actions of a food company in making positive social impact are important – not only wellness programming for employees but also how companies support community wellness with sustainability practices, environmental stewardship, and fair trade. All of these efforts must be reflected in a transparent food philosophy to earn consumers’ trust in a brand and a food-focused wellness company.

With consumer values driving today’s food and beverage marketplace, more and more, modern food companies are recognizing the importance of establishing a brand identity that embraces health and wellness – products for the marketplace, programs for employees, and programs for the communities they operate in. When every aspect of a company is empowered with the know-how for helping consumers, customers, and employees make health-conscious, good lifestyle choices decisions, it just makes good business sense.

What is health and wellness? It’s an active process of becoming aware of and making choices that support a healthy and fulfilling life. Food companies can support a consumer’s ability to make positive choices by building a health and wellness focus into their corporate structure and enterprise values.  By addressing at least three dimensions, such as nutritional and physical wellbeing, social wellbeing, and environmental wellbeing, companies can support the trend towards sustainable and healthy food choices while building their customer base as a trusted entity providing positive choices.

Why is building a wellness focus important? According to a recent Forbes article entitled Emerging Brands Grabbing Share Of The Retail Wellness Market, consumer packaged goods (CPG) companies are faltering as they fail to meet consumers’ growing demand for healthier foods. Reporting that this demand for healthier options hindered growth in the past year, new research from the FMI Foundation also recently advised that, as consumer focus on health and wellness deepens, their understanding of the concept is also evolving and diversifying based on their life-stage and unique health circumstances – creating new and necessary marketing opportunities for retailers and brands that can offer more personalized solutions.

How can you build wellness into your brand? Building a wellness focus into your brand makes good sense. Not only is wellness a major platform of the future of food, it is an expectation of today’s consumer. But, developing a strategy that best positions your product against competitors is complicated. Further, companies must understand consumer demands and develop a responsive brand purpose and products that align with it. Products must fill a need and be conveyed in a market strategy that showcases the products’ science-supported benefits in a compelling and meaningful way. Simply put, consumers want to know “what’s in it for me”…literally.

Product development should adopt a multi-sector approach that combines knowledge of the food industry; the federal regulatory environment and policy landscape, including public health and trade; and mining research and tracking trends. These experiences must be combined with an understanding of how to integrate health and wellness into a brand, enterprise mission and business plans, while creating a culture of health and wellness within the company and in the communities in which it operates and does business.

The FoodTrition Solutions Wellness Works© concept builds the capabilities that food companies need to meet consumer wellness-seeking trends by linking the best research on health and wellness benefits to support product and process innovation, corporate communications, employee programs, and community outreach. As the owner of FoodTrition Solutions, LLC, and an independent consultant with EAS, I use my 25-plus-years of multi-sector experience as a leader in the food industry, academia, and federal regulatory and public health policy agencies, to help food companies define and promote health and wellness within a company’s culture.

The FoodTrition Solutions Wellness Works© means establishing a corporate food philosophy that guides the work of R&D, product innovation, and marketing, with criteria and standards that promote creativity for product and process innovation to result in better-for-you products that differentiate the brand in the marketplace. It involves designing a corporate Wellness Works guidebook with the guardrails tailored to assure conformance with regulatory requirements for labeling, marketing and advertising, ingredient and packaging sourcing and procurement, and food safety. Adopting this wellness focus requires establishing access to and analysis of food, nutrition and health research on health benefits for your products, which link to product and process innovation, and corporate employee wellness program needs. Finally, a wellness brand is benefited by forming and maintaining an external health and wellness expert advisory council. Such a council helps a company assess health and consumer behavior trends, adapt complex research to the individualized needs of the organization and the communities served, and act as liaisons for building networks with health and healthcare communities. These are essential components for assuring a food-focused wellness path to marketplace success. FoodTrition Solutions Wellness Works© brings a food company’s wellness story to life.

As your company works to meet consumer demand through the development of health and wellness focused products and business structure, remember doing good is a northstar goal. Another goal is doing good under the regulatory construct of FDA, USDA, and aligning with Federal dietary guidance. Choosing a consultant with demonstratable knowledge and skills to help your company develop a holistic and creative approach to your wellness-focused brand will allow you to place your efforts where you wish – ensuring the integrity of your vision is fulfilled.

Additional Reading:

(http://www.sjsu.edu/wellness/dimensions_defined/; https://www.indstate.edu/human-resources/wellness/eight-dimensions). (https://www.forbes.com/sites/pamdanziger/2018/02/20/emerging-brands-grabbing-share-of-the-retail-wellness-market/#79006aa54173). (https://www.foodnavigator-usa.com/Article/2019/01/23/Consumers-evolving-understanding-of-wellness-creates-marketing-opportunities-for-retailers-brands).

Maribel Colon

Maribel Colon assists EAS clients with pharmaceutical, medical device and biotechnology consulting services including continuous improvement, quality management, technology transfer, auditing, risk assessment, new product setup and development, and overall quality and process improvements.  She is experienced with cGMPs, including 21CFR Parts: 11, 58, 210, 211, 820, 4; ISO 14971, 13485, 17025 and ICH GCP, Q7, Q8, Q9, Q10. She is a former Director of Quality Assurance and Regulatory Compliance with VEQTOR and former Senior Quality Engineer with GE Healthcare.

James Goldman

James Goldman is a certified packaging expert focusing on package development, supply chain, and production equipment and has deep knowledge of design, manufacture and distribution. Goldman is a glass container expert applying knowledge to reduction of bottle weight, decrease in bottle breakage, and improvement in bottle production efficiency. He is a former Senior Manager, Supply Chain Optimization with the Coca-Cola Company and has an M.B.A. from George State University.

Maged Sharaf, Ph.D.

Dr. Maged Sharaf works with EAS clients in the area of dietary supplement products, particularly those containing botanical ingredients. He brings over 30 years of experience working closely with the industry and the FDA regarding dietary supplement sciences and regulations and is experienced in dietary supplement investigations, 21 CFR 111 audits, food and dietary supplement label compliance review, marketing material reviews for FDA and FTC compliance, claim substantiation, dietary ingredient review and specifications development, and training services. He has a Ph.D. in Pharmaceutical Sciences from School of Pharmacy, University of Pittsburgh.

Susan Sheldon, Ph.D.

Sousan Sheldon, Ph.D. is a former FDA International Policy Analyst for medical devices and pharmaceuticals with expertise in Asia, the Middle East and Canada. She is an expert in regulatory pathways for INDs, NDAs, ANDAs, 510(k)s, IDEs, De Novo, HDE, PMAs, and other regulatory submissions and has extensive knowledge in the development of medical devices, medical devices containing antimicrobial agents, combination products, companion diagnostic products, and applications for Clinical Laboratory Improvement Amendment waivers. She has a doctoral degree in Microbiology/Immunology from the University of North Texas.

EAS – Continuity in Unprecedented Times!

Dear EAS clients,

Given the unprecedented challenges that we are all facing, I want you to know that our thoughts and prayers go out to you, your families and employees. We are all learning how to work in new but effective ways, while protecting our neighbors and communities. With the increasing urgency and uncertainty of COVID-19, we at EAS are first and foremost committed to the safety of our employees, consultants, and clients. Please be assured that we are doing everything in our power to minimize the exposure and spread of this virus.

To that end, EAS has made workplace adjustments that allow us to protect the health of our personnel, while continuing to provide the reliable expertise and consulting services you have come to expect. EAS is fully operational and all EAS staff members are working from home with the same tools and capabilities as they have in our offices. Therefore, you may continue to reach us, as you always have, through our EAS phone numbers and email addresses.

Our team continues to closely monitor the unfolding COVID-19 information from the FDA and USDA to ensure all new requirements related to the virus are well understood and provided to our clients in a timely manner.

Though we have temporarily cancelled all non-critical business travel, we remain available to assist you remotely with all your ongoing regulatory consulting needs. Whether it is providing desk audits, SOP reviews, training, labeling review and development, submission support or simply augmenting or supporting your internal regulatory and quality teams, we are committed and available to you and your employees during this crisis.

Thank you for your understanding as we work together during these challenging times. We are honored that you have placed your trust in EAS, and our entire team is committed to ensuring you have access to the resources and expertise needed to meet your ongoing regulatory and compliance requirements.

As Coretta Scott King said, “The greatness of a community is most accurately measured by the compassionate actions of its members.” I think this is important to remember, because only together can we successfully navigate these challenging times.

Sincerely,

Dean R. Cirotta Signature

Dean R. Cirotta
President
EAS Consulting Group
571-447-5502
dcirotta@easconsultinggroup.com

Action From EAS

EAS highly values our professional relationship with our clients and given that it is difficult to predict the impact of the COVID-19 virus we want to take this opportunity to let you know of the risk reduction measures we have taken to protect our staff, consultants and you.

  • All foreign travel is suspended
  • Domestic travel is limited to business-critical trips.
  • We are asking clients to reschedule on-site visits for later in the spring or early summer.
  • We are proactively monitoring employee health
  • We are limiting in-person meetings between staff, consultants and clients.
  • We are utilizing recommended sanitizing and cleaning procedures.

However, during this period of uncertainty, I want you to be assured that EAS remains available to provide you with remote (via teleconference or videoconference) consulting services, such as:

  • FDA Consulting
  • Training
  • Webinars
  • Document writing and review
  • Desk audits
  • Regulatory support
  • Label review
  • FDA submissions

Thank you for your understanding during these unprecedented times. Please know that EAS will continue to support you and your regulatory consulting needs and provide you with all our available resources as your trusted FDA consulting partner.

If you have any questions or require assistance please do not hesitate to contact me or our staff.

Best Regards,

Dean R. Cirotta Signature
Dean R. Cirotta
President
EAS Consulting Group
571-447-5502
dcirotta@easconsultinggroup.com

Couch Interviewed in Insider Article on COVID-19 Threats to Contract Manufacturing

Senior Director, Tara Couch, Ph.D. was interviewed for an article in Natural Products Insider on COVID-19’s threats to the dietary supplement contract manufacturing relationship. COVID-19 fears, risk of massive recalls and misunderstanding of GMPs underscore the importance of transparency between supplement brands and their contract manufacturers.

ABH recall and COVID-19 threat to contract manufacturing relationships

Question: How do concerns over COVID-19 affect contract manufacturing in 2020?

Tara Lin Couch, Ph.D., senior director of dietary supplement and tobacco services, EAS Consulting Group LLC: Raw materials (dietary ingredients and components) must have an established specification and testing must be performed to determine whether those specifications have been met upon the receipt of every shipment of the material per cGMPs [current good manufacturing practices] 21 CFR (Code of Federal Regulations) 111.70 and 111.75. Qualified suppliers are preferred suppliers to reduce both testing costs and timelines. A significant disruption in the delivery of materials from qualified suppliers, as is now the case due to COVID-19, presents a serious issue to a contract manufacturer. Alternative suppliers will have to be identified and employed, at least temporarily, and full testing to the entirety of the specification parameters must be performed. If the disruption persists, contract manufacturers will have to assess whether a qualification of the alternative supplier is beneficial. Read More in Natural Products Insider

Fast Tracking Antimicrobial Agents – FDA’s Accelerated Programs

April 22, 2020, at 1 pm eastern

Presented by Sousan Sheldon, MT-ASCP, Ph.D. Independent Consultant

Developers of antimicrobial agents may seek an accelerated FDA review of their products under the accelerated programs such as Fast Track Designation, Breakthrough Therapy Designation, Accelerated Approval, or Priority Review and gain additional 5 years of market exclusivity by qualifying under the Limited Population Pathway for Antimicrobial and Antifungal Drugs While these submissions do not lessen the development period and regulatory requirements for approvals, these accelerated programs can help drug firms get their product to market more quickly and maintain exclusivity for additional 5 years under the GAIN Act

Learn more about these important FDA pathways that facilitate fast track product reviews from EAS Consulting Group’s independent consultant, Sousan Sheldon, MT-ASCP, Ph.D. a former Supervisory Review Officer, Senior Scientific Policy Advisor and Senior Policy Analyst at the FDA. Learn from her insights and avoid critical missteps that raise red flags and require time consuming revisions.

About the Presenter

Sousan Sheldon, Ph.D. is a former FDA International Policy Analyst for medical devices and pharmaceuticals with expertise in Asia, the Middle East and Canada. She is an expert in regulatory pathways for INDs, NDAs, ANDAs, 510(k)s, IDEs, De Novo, HDE, PMAs, and other regulatory submissions and has extensive knowledge in the development of medical devices, medical devices containing antimicrobial agents, combination products, companion diagnostic products, and applications for Clinical Laboratory Improvement Amendment waivers. She has a doctoral degree in Microbiology/Immunology from the University of North Texas.

Terms and Conditions

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Revised Serious Adverse Event Reporting During COVID-19 Pandemic

Hello,

I hope this finds all of you and all of your family well. As your trusted FDA regulatory partner, EAS Consulting Group strives to keep your company informed of current activities at the Agency that may impact your business. Given the Coronavirus Disease 2019 (COVID-19) outbreak, the FDA has been working hard to fulfill its responsibility of protecting the public health and ensuring the safety of our nation’s food supply.

In accordance to the Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2006, dietary supplement manufacturers, packers, or distributors must submit all complaints with the accusation of a Serious Adverse Event (SAE) to the FDA via the electronic MedWatch Form 3500A available on the FDA website within 15 business days of receipt of the complaint.

However, given the COVID-19 outbreak today the FDA issued a new Guidance for Industry, Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic, that replaces the 2012 Guidance for Industry Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic to update and clarify that the guidance applies to all pandemics.

The guidance discusses the FDA’s intended approach to enforcement of SAE reporting requirements for medical products and dietary supplements during a pandemic, acknowledging that both industry and FDA workforces may be reduced because of high employee absenteeism and other limited resources. During this pandemic, as much compliance and continuity with company complaint processes and SAE reporting requirements should be maintained as possible, with those related to product safety taking highest priority. However, if necessary SAEs can be “stored” and reported to the FDA within the six (6) months after the restoration of normal activities. It is important that the declaration of the pandemic issued by the World Health Organization (March 11th, 2020 for COVID-19) and the situation of high absenteeism or other factors that is/are preventing normal SAE requirements be well documented.

After the pandemic is resolved and a pre-pandemic state has been restored, it is expected that firms will resume fulfilling all reporting requirements on time as well as submit reports that were stored because of pandemic-related high employee absenteeism.

Please let me know if EAS Consulting Group can be of any assistance during this time.

Take Care,

Tara Couch

Tara Lin Couch, Ph.D.
EAS Senior Director of Dietary Supplement and Tobacco Services
571-447-5510 tcouch@easconsultinggroup.com

FDA CTP Announces Partial Stop Work Order at the State Level

FDA has announced an immediate partial stop work order to state contracted entities for activities such as compliance checks and vape shop inspections in light of the COVID-19 outbreak and in keeping with the White House Coronavirus Task Force and cross-government guidance.

While this stoppage does not apply to those carrying out non-portable activities, such as certain lab activities or the monitoring of imported products, FDA has indicated it will continue to adjust its approach to a number of activities, including facility inspections for all FDA-regulated products such as food, animal feed, drugs, biological products, devices and tobacco.

According to Mitch Zeller, CTP Director at FDA, while inspections will cease immediately, administrative work can continue for two weeks, and the entire situation will be reevaluated over the coming four weeks.

Though inspections are being temporarily halted, it goes without saying that all FDA regulated industries must remain vigilant in ensuring compliance requirements continue to be met. Now is not the time to lose our focus on the safety and legality of our products.

If EAS can be of assistance with any questions related to your current compliance status or how to strengthen operations to better meet FDA expectations, please do not hesitate to contact me.

Thanks and take care,

Tara Couch

Tara Lin Couch, Ph.D.
EAS Senior Director of Dietary Supplement and Tobacco Services
571-447-5510 tcouch@easconsultinggroup.com

New FDA Guidance on Hand Sanitizer Manufacturing for COVID-19 Response

On March 20, 2020 FDA issued a new guidance on the manufacture of alcohol-based hand sanitizers. This guidance indicates that the FDA is going to use enforcement discretion and allow non-traditional drug firms to make alcohol-based hand sanitizers provided they can meet the following minimum requirements:

  • The hand sanitizer must be made from alcohol (USP or FCC grade) and be formulated in accordance with the designated 80% denatured alcohol-aqueous v/v solution for ethanol or 75% v/v/ for isopropyl alcohol solution.
  • Other ingredients in the overall formulation beyond the alcohol API) are limited to: Glycerol (1.45% v/v), Hydrogen Peroxide (0.125% v/v) and the balance is composed of sterile distilled water or boiled cold water [to be used to QS to volume].
  • No other active ingredients can be added, used or substituted.
  • A batch record for the production of each batch needs to be generated and maintained in enough detail to determine that it was formulated properly, traces raw materials by lot number and captures weights/volume measures and any calculations.
  • The manufacturing facility and equipment need to be sanitary, maintained and fit for the intended use.
  • Finished product testing needs to be conducted using a method appropriate to determine the alcohol content of each batch prior to release.
  • The FDA approved hand sanitizer label and drug facts panel is used (as referenced in the FDA Guidance – Appendix A, B, C, D).
  • The manufacturing facility must register with FDA CDER and drug list the hand sanitizer products in the DRLS (Drug Registration and Listing System).
  • There must be a means of receiving and accepting adverse event reports (AER) for reporting under the FDA’s MedWatch process. (Often these AERs come in initially as a general product complaint so a means of performing assessment a triage of complaints is likely a necessary tool as well.)

Please note that this guidance and the exceptions outlined will only remain in effect as long as the Department of Health and Human Services emergency declaration (of 31 January 2020) remains in effect.

For more information on GMP requirements for OTCs and an overview of FDA enforcement actions I encourage you to view this complimentary on-demand webinar.

Please let me know if you need any assistance or help with registration, listing or setting up for the limited GMP requirements to meet the intent of this guidance.

EAS Memo on FDA Hand Sanitizer Manufacturing Guidnace for COVID-19 Response.

Bryan Coleman

Bryan Coleman
Senior Director for Pharmaceutical and Device Consulting Services
bcoleman@easconsultinggroup.com
571-447-5504

Update on FDA’s Temporary Suspension of FSVP Onsite Audit Requirements

Given the current COVID-19 outbreak that has resulted in numerous travel bans and restrictions all over the world, it is important to note FDA’s temporary enforcement suspension of FSVP supplier verification on-site audit requirements for receiving facilities and importers under FSMA, provided other supplier verification methods are used instead.

My colleague Allen Sayler and I recently co-wrote an article on FSVP requirements published in Food Safety Magazine that discusses the FSMA rule for importing dietary supplements.

When the 1994 Dietary Supplement Health and Education Act (DSHEA) created a legal class of foods, called “dietary supplements,” it carved out many unique regulatory requirements and exemptions. Since the passing of the Food Safety Modernization Act (FSMA) in 2011, dietary supplement firms have the added confusing task of identifying which FSMA rules apply, and what impact, if any, this has to their current dietary supplement quality system designed to meet 21 CFR 111, Current Good Manufacturing Practice (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, as well as all other applicable statutory requirements. This can be even more challenging when a firm imports dietary supplements or ingredients.

There are seven major rules that have been issued by the FDA to support the enforcement of FSMA:

  • Current Good Manufacturing Practice (cGMP), Hazard Analysis, and Risk-Based Preventative Controls for Human and Animal Food (HARPC)
  • Foreign Supplier Verification Program (FSVP) Rule
  • Intentional Adulteration Rule
  • Product Safety Rule (Fruits and Vegetables)
  • Sanitary Transportation Rule
  • Standard for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption
  • Voluntary Accredited Third-Party Certification Program

The cGMP and HARPC requirements for foods are dictated in 21 CFR 117, but firms that are in compliance with dietary supplement cGMPs in 21 CFR 111 are exempt from Subparts C – HARPC and Subpart G – Supply Chain Program of 21 CFR 117. In addition, since both 21 CFR 111 and 21 CFR 117 define the cGMP requirements for the sourcing, manufacturing, packaging, holding and distribution of foods, a dietary supplement firm that is in compliance with 21 CFR 111 will already have a quality system in place to address the 21 CFR 117 requirements as well. It is also very important to note that 21 CFR 111 has very rigorous and specific quality and testing requirements for raw materials, in-process materials, packaging components and labels, and finished products; detailed requirements for manufacturing, packaging, and labeling operations; and extensive responsibilities that must be conducted by a Quality Unit.

Whenever a dietary supplement product or ingredient (raw material) is imported from a foreign supplier, the FSMA Foreign Supplier Verification Program (FSVP) rule applies, and many of the raw materials used for the manufacture of dietary supplements are sourced from foreign suppliers. This is NOT covered under 21 CFR 111. However, a Supplier Qualification Program consistent with 21 CFR 111.75(a)(2)(ii) that incorporates the requirements for FSVP is the optimal way to ensure compliance with this FSMA requirement. This Supplier Qualification Program should be a multi-step process which includes the use of a Supplier Qualification Questionnaire, often referred to as the “Paper” or “Documentation” audit; an on-site facility audit of the supplier; and confirmation testing to ensure that the material meets the quality requirements for identity, purity, strength, composition, and the lack of potential contaminants as dictated on the Raw Material Specification. The extent of testing necessary is dependent on the type of material being qualified as well as the responses on the questionnaire and results of the on-site audit. Periodic requalification of the supplier is also required and is based upon a number of factors such as the frequency of material quality issues.

With the global pandemic of COVID-19, for now, the performance of an on-site facility audit of the supplier may not be physically possible and is certainly, not recommended due to the need to exercise “social distancing” to limit the spread of the virus. The Food and Drug Administration (FDA) has acknowledged this challenge and released the attached Guidance for Industry, Temporary Policy Regarding Preventive Controls and FSVP Food Supplier Verification Onsite Audit Requirements During the COVID-19 Public Health Emergency.

I hope this information is beneficial, as everyone works to ensure continued compliance to all of the FDA regulatory requirements for dietary supplement finished products while also taking all appropriate and necessary precautions for the health and wellbeing of every employee, the community, the nation, and the World.

Thanks and Take Care,

Tara Couch

Tara Lin Couch, Ph.D.
EAS Senior Director of Dietary Supplement and Tobacco Services
571-447-5510 tcouch@easconsultinggroup.com

EAS Takeaways from FDA Briefing to Stakeholders in the Wake of COVID-19

If you missed FDA’s briefing to food stakeholders on how the COVID-19 Pandemic is affecting the food industry, here are top-line takeaways on immediate impacts to your business. Additionally, attached is a more detailed summary of the meeting.

Should you need any assistance or have any questions on steps your company should take in response to the FDA recommendations, please don’t hesitate to contact

Allen Sayler
Senior Director, Food Consulting Services
asayler@easconsultinggroup.com
571-447-5509

Tara Lin Couch, Ph.D.
Senior Director, Dietary Supplement Services
tcouch@easconsultinggroup.com
571-447-5510

  1. There has been NO evidence of the transmission of the Coronavirus from food or food packaging.
  2. Food products do not have to be placed on-hold or recalled if an employee at a food facility is diagnosed with COVID-19.
  3. Personal hygiene as well as facility, equipment, and utensil cleaning and sanitization procedures that are required in GMPs are expected to still be appropriate amid this crisis.
  4. The FDA will be exercising enforcement discretion regarding the requirements for on-site supplier facility audits needed to comply with the Foreign Supplier Verification Program (FSVP) Rule under the Food Safety Modernization Act (FDA). This policy is provided in the new FDA Guidance for Industry, Temporary Policy Regarding Preventive Controls and FSVP Food Supplier Verification Onsite Audit Requirements During the COVID-19 Public Health Emergency, to communicate FDA’s intention to temporarily not enforce FSVP supplier verification on-site audit requirements for receiving facilities and importers under FSMA in response to the global pandemic of COVID-19.
  5. Routine foreign inspections were postponed earlier this month and only “mission-critical” inspections will be conducted as deemed necessary.
  6. Now routine domestic inspections will also be postponed and only “mission-critical” inspections will be conducted as necessary in cases where there is Class I Recall, a foodborne outbreak, or COVID-19 related situation.
  7. Ensuring a continuous supply of safe food is a critical factor for the US and the FDA and Department of Homeland Security are working together to ensure that is the case. Food facilities involved in this supply, are therefore not subject to the quarantine and shelter in place orders and any issues with this should be addressed to the latter and FEMA.

Sayler and Couch Discuss Importing Challenges for Dietary Supplements Under FSMA and FSVP

EAS Senior Directors Allen Sayler and Tara Couch, Ph.D. discussed importing challenges of dietary supplements, particularly in light of the Foreign Supplier Verification Program in Food Safety Magazine. Dietary supplement firms must comply with GMPs set forth in 21 CFR 111 Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, as well as all other applicable statutory requirements. This can be even more challenging when a firm imports dietary supplements or ingredients which are also subject to FSMA and FSVP.

“When the 1994 Dietary Supplement Health and Education Act (DSHEA) created a legal class of foods, called “dietary supplements,” it carved out many unique regulatory requirements and exemptions. Since the passing of the Food Safety Modernization Act (FSMA) in 2011, dietary supplement firms have the added confusing task of identifying which FSMA rules apply, and what impact, if any, this has to their current dietary supplement quality system designed to meet 21 CFR 111, Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, as well as all other applicable statutory requirements. This can be even more challenging when a firm imports dietary supplements or ingredients.

“The For example, CGMP and Hazard Analysis, and Risk-Based Preventative Controls for Human and Animal Food (HARPC) requirements for foods are dictated in 21 C.F.R. 117, but firms that are in compliance with dietary supplement CGMPs in 21 C.F.R. 111 are exempt from Subparts C – HARPC and Subpart G – Supply Chain Program of 21 C.F.R. 117. In addition, since both 21 C.F.R. 111 and 21 C.F.R. 117 define the CGMP requirements for the sourcing, manufacturing, packaging, holding, and distribution of foods, a dietary supplement firm that is in compliance with 21 C.F.R. 111 will already have a quality system in place to address the 21 C.F.R. 117 requirements as well. It is also very important to note that 21 C.F.R. 111 has very rigorous and specific quality and testing requirements for raw materials, in-process materials, packaging components and labels, and finished products; detailed requirements for manufacturing, packaging, and labeling operations; and extensive responsibilities that must be conducted by a quality unit….” Read more in Food Safety Magazine.

Nico van Belzen, Ph.D.

Dr. Nico van Belzen is an advocate of food safety and nutrition. Formerly, Dr. van Belzen held managing director positions at the International Dairy Federation (IDF) and the European branch of the International Life Sciences Institute (ILSI) which he represented towards FAO, WHO, Codex, EFSA and other intergovernmental organizations. He has also held R&D management positions at DMV International where he was involved in product development, biochemical and physical analyses of food ingredients and pharmaceutical excipients, marketing support, business development and due diligence.

February 2020 Drug and Device Corner

The FDA has published a revision to Manual of Policies and Procedures 5240.3, Prioritization of the Review of Original ANDAs, Amendments, and Supplements. This update is designed to efficiently allocate limited agency resources to areas where priority review is most likely to meaningfully increase generic drug access and ensure fairness to applicants. Details can be found on the FDA webpage. Additionally, the agency has a prerecorded webinar describing the revisions.

The FDA published a Guidance Document, Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications, which describes how sponsors and applicants must organize the content that they submit to the Agency electronically for all submission types under section 745A(a) of the FD&C Act. Of note, this guidance also describes the addition of exemptions and waivers from complying with eCTD requirements. Exempted from the eCTD Requirements are all Type III DMF submissions. Although these specific submissions will be exempt from filing in eCTD format as described in this guidance, FDA still encourages applicants to send submissions in an alternative electronic format (e.g., PDF files following the CTD structure). See the Guidance Document for further exemptions and waivers.

Below noted CDER Product-Specific Guidances have been withdrawn as of 22 January 2020:

Active IngredientType of GuidanceRoute & Dosage FormRLD
Butenafine HydrochlorideDraftTopical dream21408
LevonorgestrelDraftIUD203159
SelexipagDraftOral Tablet207947

The Agency has launched The Compilation of Center for Drug Evaluation and Research (CDER) New Molecular Entity (NME) Drug and New Biologic Approvals, a new resource designed to assist external and agency researchers collecting historical information about FDA’s drug approvals. This .csv file with curated data regarding drug products approved by CDER since 1985, will be available on the agency’s website.

The FDA is requesting voluntary withdrawal of bacitracin for injection from the market. In April 2019, the Antimicrobial Drugs Advisory Committee met and discussed the safety and effectiveness of bacitracin for injection. The advisory committee voted almost unanimously, with one abstention, that the risks outweigh the benefits for the drug’s only approved indication. Based on FDA’s review of currently available data, FDA believes that the potential problems associated with bacitracin for injection are sufficiently serious to remove the drug from the market. This requested voluntary withdrawal does not impact approved topical or ophthalmic drugs that contain bacitracin.

The FDA is hosting a Public Meeting regarding Communications about the Safety of Medical Devices. During this public meeting the FDA hopes to hear from all stakeholders, including patients and caregivers, healthcare providers, regulated industry, and media. The FDA is looking for feedback on how the agency can improve their safety communications to assure stakeholders receive the information they need in a timely, clear, and consistent manner. A preliminary agenda has been published. Details can be found on the website for participation.

CVM Broadcast #39 notice was issued 7 February 2020. The OSC DER eSubmitter Program will soon require digital signatures on electronic submissions to be registered with the CVM Electronic Submission System (ESS). We expect this requirement to be implemented as early as mid-March 2020. If you have questions, please contact CVM at cvmesubmitter@fda.hhs.gov.

CVM Broadcast #40 notice was issued 13 February 2020. CVM is updating their CVM Submission Type list of values in response to feedback from stakeholders when submitting Manage Forms to CVM. This change will occur on February 22, 2020 in FDA ESG Pre-Production and February 29, 2020 for FDA ESG Production. This update will modify the Submission Type list of values for CVM: 1] Submission Type “Electronic_Submissions” will be changed to “Manage_Form”. Stakeholders should use this folder when submitting Manage Form submissions to CVM. 2] Submission Type “eSubmitter” should be used for any eSubmitter submission to CVM 3] Submission Type “Adverse_Events_Reports” should be used for any electronic adverse event report submission to CVM.

Guidance Document updates on the FDA website

CDER

Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims – This guidance is intended to assist applicants in developing labeling for cardiovascular outcome claims for drugs that are indicated to treat hypertension.

CDER & CBER

Promotional Labeling and Advertising Reference and Biosimilar Products Questions and Answers – This guidance addresses questions firms may have when developing FDA-regulated promotional labeling and advertisements (promotional materials), for prescription reference products licensed under 351(a) of the Public Health Service Act (PHS Act) (42 U.S.C. 262(a))

Mucopolysaccharidosis Type III (Sanfilippo Syndrome): Developing Drugs for Treatment – The purpose of this guidance is to provide recommendations to sponsors regarding eligibility criteria, trial design considerations, and efficacy endpoints to enhance clinical trial data quality and foster greater efficiency in development programs for drugs to treat mucopolysaccharidosis type III (MPS III; also called Sanfilippo syndrome).

Biosimilars and Interchangeable Biosimilars: Licensure for Fewer Than All Conditions of Use for Which the Reference Product Has Been Licensed – This guidance provides recommendations to applicants seeking licensure under section 351(k) of the Public Health Service (PHS) Act of a proposed biosimilar or proposed interchangeable biosimilar for fewer than all of the reference product’s licensed conditions of use.

Specifications for Preparing and Submitting Electronic ICSRs and ICSR Attachments – This document provides current specifications for submitting individual case safety reports (ICSRs) and ICSR attachments in electronic form.

CDRH

Arthroscopy Pump Tubing Sets Intended for (510(k)) Submissions – This draft guidance document provides recommendations for 510(k) submissions for arthroscopy pump tubing sets intended for multiple patient use. These devices are designed to deliver irrigation fluid to the surgical site, such as knee, shoulder, hip, elbow, ankle, and wrist joint cavities, during arthroscopic procedures.

Peripheral Vascular Atherectomy Devices – Premarket Notification [510(k)] Submissions – This guidance document provides recommendations for 510(k) submissions for peripheral vascular atherectomy devices. The recommendations reflect current review practices and are intended to promote consistency and facilitate efficient review of peripheral vascular atherectomy submissions.

CBER

Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations – This guidance provides FDA’s current thinking on determining sameness of human gene therapy products under FDA’s orphan drug regulations for the purpose of orphan-drug designation and orphan-drug exclusivity.

Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up – FDA is providing sponsors of retroviral vector-based human gene therapy products, recommendations regarding the testing for RCR during the manufacture of retroviral vector based gene therapy products, and during follow-up monitoring of patients who have received retroviral vector-based gene therapy products.

Long Term Follow-up After Administration of Human Gene Therapy Products – FDA is providing sponsors who are developing a human gene therapy product (GT Product), recommendations regarding the design of long term follow-up studies (LTFU observations) for the collection of data on delayed adverse events following administration of a GT product.

Human Gene Therapy for Retinal Disorders – This guidance provides recommendations to sponsors developing human gene therapy (GT) products for retinal disorders affecting adult and pediatric patients.

Human Gene Therapy for Rare Diseases – This guidance provides recommendations to sponsors developing human gene therapy (GT) products intended to treat a rare disease in adult and/or pediatric patients regarding the manufacturing, preclinical, and clinical trial design issues for all phases of the clinical development program.

Human Gene Therapy for Hemophilia – This guidance provides recommendations to sponsors developing human gene therapy (GT) products for the treatment of hemophilia including clinical trial design and related development of coagulation factor VIII (hemophilia A) and IX (hemophilia B) activity assays, including how to address discrepancies in factor VIII and factor IX activity assays.

Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs) – FDA is providing sponsors of human gene therapy Investigational New Drug Applications (INDs), recommendations regarding chemistry, manufacturing, and control (CMC) information submitted in an IND.

Recommendations to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Components – FDA is issuing this guidance document to provide blood establishments that collect blood and blood components, with revised recommendations intended to reduce the possible risk of transmission of Creutzfeldt-Jakob disease (CJD) and variant Creutzfeldt-Jakob disease (vCJD) by blood and blood components.

Use of Serological Tests to Reduce the Risk of Transfusion-Transmitted Human T-Lymphotropic Virus Types I and II (HTLV-I/II) – We, FDA, are providing you, blood collection establishments, with recommendations regarding the use of serological tests to reduce the risk of transmission of human T-lymphotropic virus type I (HTLV-I) and type II (HTLV-II), collectively referred to as HTLV-I/II, by blood and blood components. These recommendations apply to the collection of Whole blood and blood components, except Source Plasma.

CVM

CVM GFI #108 Registering with CVM’s Electronic Submission System – This guidance provides general standards which should be used to register with the Center for Veterinary Medicine (CVM or the Center) Electronic Submission System (ESS).

CVM GFI #191 Changes to Approved NADAs – New NADAs vs. Category II Supplemental NADAs – This guidance is intended to assist sponsors who wish to apply for approval of changes to approved new animal drugs that require FDA to reevaluate safety and/or effectiveness data.

Draft Guidance for comment purposes only

Nonclinical Safety Evaluation of the Immunotoxic Potential of Drugs and Biologics – The purpose of this guidance is to assist sponsors in their nonclinical evaluation of the immunotoxic potential of drugs and biologics by supplementing the recommendations on nonclinical immune system assessments provided across the following guidance documents: 1] International Council for Harmonisation (ICH) guidances for industry, 2] S8 Immunotoxicity Studies for Human Pharmaceuticals (April 2006), 3] M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals (January 2010), 4] S6(R1) Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals (May 2012) and 5] S5(R3) Detection of Toxicity to Reproduction for Human Pharmaceuticals (November 2017)

Knutson Interviewed on Allergen Controls and Training

Food Safety Strategies

EAS independent consultant Kathy Knutson, Ph.D. discussed the importance of allergen controls and employee training in an article published in Food Safety Strategies. “Allergen management training… must be at the same intensity [as that of training]… on the management of pathogens,” she says. EAS offers a robust review of allergen and pathogen management as well as capabilities to develop customized in-house training programs that enable your employees to gain the skills they need in your own facilities.  

Therapeutic Nutrition: Potential and Challenges for Novel New Products

David Cockram, Independent Consultant, EAS Consulting Group, LLC

We live in exciting times, with new discoveries being announced daily about the relationships between nutrition, diet, health, and disease. So much so that it’s often hard to keep track of whether this food or food component is currently something we should be eating more or less of at the moment (think eggs or caffeine). At the same time, these discoveries create opportunities for new nutritional products to help maintain health, optimize physical performance, avoid disease, slow progression of a chronic condition, or manage an existing condition. A food or food ingredient that prevents or treats a disease sounds like a great commercial opportunity, right? How about omega 3s, CLAs, plant proteins, probiotics, prebiotics, individual amino acids, tropical plants and their fruits and seeds, “pre-digested” fats and carbohydrates?

From a regulatory standpoint, however, food products making therapeutic claims are very challenging. While most countries allow foods to make claims about their value in maintaining normal nutritional status and function, opportunities to make claims about disease risk reduction generally are either prohibited or permitted only in the context of approved health claims (claims about the relationship between the potential reduction in the risk of developing a disease and nutrition). Going a step further and making claims about treating or preventing an existing disease or condition, even where the evidence is clear that the claim is truthful and not misleading, is permitted only under very limited circumstances for foods. For products where the intended use is for therapeutic purposes, medical foods are a very limited category of foods that can make claims for dietary management of a disease or condition (but not that they prevent, treat, or cure anything). Developing a product positioning, adequate substantiation, and claim language that is both compliant but also commercially compelling is challenging but not impossible.

What can be done to assure success from a regulatory standpoint? Some pieces of the puzzle are clear, such as assuring that the finished product is safe and effective for its intended use, all components are permissible food ingredients, and packaging materials are acceptable for use. Design a product using solid science to support the intended benefits. Where products are intended for a multinational launch, early consideration of all country’s regulatory requirements (permitted ingredients, claims, packaging, substantiation standards, data needed for approval of novel ingredients, and review timelines) is critical. Fortunately, the basic data package is pretty standard across countries; however, formatting, review timelines, and fine points of data submissions vary widely so regulatory considerations must be a high priority throughout the formulation and product development process.

Other parts of the compliance puzzle, particularly in the area of product claims tend to be grayer and potentially subject to different interpretations. What a marketer may view as an awesome claim about their new food product may to a regulator be a violative drug claim that garners enforcement action for the company. Product claims must be substantiated using soundly designed and statistically-powered studies that clearly support the express and implied product benefits and label claims. Such studies in humans can be challenging to conduct and interpret for a number of reasons (e.g., all humans need to eat so careful attention to trial design is needed to detect the incremental effect of a product or nutrient beyond the baseline diet, free will and other causes of non-adherence to study protocols, etc.). To overcome the challenges of studying humans, preclinical designs are frequently used as partial substantiation for claims. However, increasingly regulatory bodies are unwilling to accept preclinical data as a sole source for substantiation for benefit claims in humans. Sometimes a premarket consultation with regulatory agency staff such as that provided by EAS can provide helpful guidance…but it can also yield challenging feedback that can only be ignored at great risk.

An infrequently discussed issue is the risk tolerance of the company around product positioning and claims. Where on the spectrum of risk does your company fall? It can range from ‘get a warning letter from a regulatory agency and you are fired’ to ‘if we don’t get an occasional warning letter then you’re obviously not pushing the envelope enough’. Keep in mind that agency enforcement action is enormously time-consuming and disruptive to the company and can quickly derail any product development, marketing and launch effort. This knowledge, along with an understanding of Agency expectations and historical enforcement activities will go a long way to helping a product development and marketing professional appropriately calibrate product claims and claim substantiation.

In the end, careful planning and early discussion between product development, clinical science, labeling and marketing staff are needed to assure that the product meets all needs including regulatory, as cost- and time-efficiently as possible. An experienced regulatory professional must have a seat at the table throughout the process to help the organization balance commercial objectives and desires with Agency expectations and EAS Consulting Group with over 150 Independent Consultants under contract has expertise in all of these areas.

Jim Goldman

Jim Goldman, CPP, is a certified packaging expert with a consistent history of achievement in developing packaging, supply chain, and production equipment for the Consumer Products industry. He is an innovative business partner with the ability to create a vision for change and the roadmap to introduce new products and processes efficiently. His broad packaging technical knowledge includes deep experience in glass containers including fracture analysis. Jim is frequently asked to service as an expert witness in legal matters.

EAS Exhibiting at Society of Toxicology Annual Meeting

EAS director, Cathryn Sacra, and independent consultant, Tom Jonaitis, will represent EAS at the Society of Toxicology Annual Meeting taking place in Anaheim, March 15-19, 2020. On hand to discuss EAS toxicology capabilities pertaining to GRAS and NDI submissions, EAS offers this comprehensive technical service to all companies seeking FDA support for novel ingredients. Please stop by the EAS booth #761 while at SOT or make an appointment to speak with Cathryn and Tom directly.

Cesar Matto

Cesar Matto assists clients with pharma GMP compliance. He is experienced in all forms of solid dosages, ensuring positive outcomes, through the creation and implementation of successful transitions in development projects through clinical manufacturing, regulatory approval, conformance and commercial manufacturing. Additionally, he has a history of successful implementation of GMP remediation activities. 

Did you Know? Requirements for Animal Food/Feed Manufacturers Include Preventive Controls

Preventive Controls for Animal Food/Feed is a requirement for all manufacturers of animal food/feeds. EAS expert, Jerry Poley, who assists clients with food safety audits including requirements for HACCP, FAMI QS, FPA Safe, PAACO (Professional Animal Auditor Certification Organization) as well as evaluation of nutrition, composition, safety, quality, regulatory issues and training programs explains:

Poley: The Preventive Controls for Animal Food (PCAF) regulation is found in Title 21 of the Code of Federal Regulations part 507 (21 CFR part 507). The PCAF regulation applies to all facilities that manufacture, process, pack or hold animal food for consumption in the United States (21 CFR 507.5(a)). Enforcement dates have passed so all animal food companies need to be in compliance with the PCAF Rule, although so far, FDA has not taken a strong enforcement stance against any company producing an animal food unless there was evidence the food caused an illness in the animal consuming it or to the human animal owner, i.e. imported processed pig ears for dogs. All animal food manufacturing facilities, foreign or domestic must be registered with FDA and for foreign manufacturing facilities, have a “US Agent” (a service which EAS provides). This is different than the US Agent used for US Customs and Border Protection.

Animal food is defined in Title 21 of the Code of Federal Regulations (21 CFR 507.3) as food for animals other than man and includes pet food, animal feed, raw materials and ingredients. Hummingbird food, for example, is one area of confusion for the animal food industry because it is primarily sugar in water. However, hummingbird food is considered animal food and is regulated as such. Therefore, if it is intended for consumption by animals in the US, it would be subject to the PCAF regulation.

In addition to the PCAF regulation, the US importer of any animal food would be subject to the requirements of the Foreign Supplier Verification Program (FSVP) regulation, which requires that there be an FSVP “Importer’s Office”, geographically located in the US and a written animal food safety and risk assessment program is developed and available at the FSVP Importer’s Office for review and inspection by FDA.

Depending on certain factors regarding the Canadian manufacturing facility, such as size and if the facility is a personal residence, different registration and regulations will apply.

For more PCAF information see FDA’s fact sheet. For more information on EAS capabilities in foods click here. Companies importing animal or human foods into the US may wish to view our complimentary on-demand regulatory webinars, including topics such as requirements for a Qualified Individual, the role of a US Agent, FSVP requirements (offered both in English and Spanish) and more. View our on-demand webinars page here.

Unfamiliar with Detection Methods for Food Fraud? Join our Webinar

The challenge of detecting Food Fraud has never been greater nor the economic loss to food manufacturers, importers, retailers and consumers. If you haven’t already registered it is not too late to join EAS Independent Consultant Dr. Mehrdad Tajkarimi on March 4, 2020 at 1pm eastern for a deep dive into the latest and greatest technologies in food fraud detection and their applications.

FDA’s Nutrition Strategy Discussed in Food Safety Tech

Food Safety Tech

April Kates shared insights into the multi-pronged approach of FDA’s Nutrition Innovation Strategy which includes modernizing food labeling, including food standards, health claims policy, ingredient labeling requirements as well as continuing forward with the implementation of the updated nutrition facts label, menu labeling, and reducing sodium in processed food products.

Coming Soon – a New and Improved Website for EAS!

The benefits of EAS being a part of the Certified Group of companies are really starting to gain momentum and our clients are beginning to take advantage of the synergies between EAS, Certified Laboratories, Labstat and Labs-Mart. EAS is now assisting Certified clients with regulatory consulting services, labeling and more, while EAS clients are enjoying the benefits of having access to best in class laboratory testing solutions.

With expanded offerings also comes an opportunity to improve our services and look – you’ll soon find the EAS website updated and enhanced to reflect our membership in the Certified Group of companies and to provide easier navigation and quicker access to the critical information EAS is known for providing: Reliable Regulatory Content.

Our new website will allow you to more easily find the information you need, such as articles written by EAS independent consultants and staff, complimentary on-demand webinars that offer deeper dives into important current compliance issues and of course, detailed information about EAS services and capabilities in regulatory consulting, training and auditing.

We are very excited for you to see our new website and look forward to continuing to be your trusted partner for FDA regulatory solutions. As we develop the new website, we will continue to provide pertinent updates and information through our email and LinkedIn channels. We anticipate an early April launch of our new website so If you aren’t already linked with EAS please take the opportunity do so and stay tuned for our new and exciting website!

Tim Kapsala

Tim Kapsala works with EAS pharmaceutical clients to identify compliance gaps and deficiencies through audits and mock-FDA inspections, preparing reports documenting significant observations and providing recommendations to be used in remediation activities. Additionally, he performs mock FDA pre-approval audits prior to NDA and ANDA submissions, with audit capabilities including APIs, OTCs, pre-filled syringe biosimilars, due diligence, internal audit evaluation, pre-inspection readiness, distributor/vendor qualification, contract laboratory, contract manufacturer, and more.

EAS Webinar on OSHA Requirements for Lockout-Tagout and Enhancing Employee Safety

EAS Consulting Group

Is your manufacturing floor a safe work environment? Do you abide by OSHA controls commonly known as Lockout-Tagout? Employees can be seriously or fatally injured when machinery they clean, service or maintain unexpectedly energizes, starts up, or releases stored energy. Join EAS independent consultant, Jon Anderson for this complimentary webinar on OSHA’s Lockout-Tagout on April 16, 2020 at 1pm eastern.

Peyton Discusses Hemp/CBD Regulatory Efforts

Charlotte Peyton discussed recent regulatory and business changes in the hemp industry in Natural Products Insider. Regulators are working to get a handle on the unbridled hemp and CBD markets, while finished product brands are seeking out strategies for testing and the supply chain. If this is your business, EAS can help.

Meet 2020 March Issue of the Month Author

David Cockram

David Cockram assists EAS clients in the areas of GRAS, Infant Formula and NDI study design through the execution and support of safety submissions for novel foods, dietary ingredients and nutritional products. He recently retired as Senior Director of Global Regulatory Science and Innovation at Abbott Nutrition. David holds a PhD from The Ohio State University in Nutrition. He is an author or inventor of 25 scientific papers, book chapters, webinars, and patents.