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.
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
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.
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.
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.
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
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.
If you haven’t yet registered there are still a few weeks left before our compliance seminars taking place in Long Island this April. For more information, agendas, pricing and link to register, visit our seminars webpage. We invite you to join us for these two-day information-rich events.
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.
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.
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.
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.
EAS is honored to be an instructor for two FDLI events this month. First, Gisela Leon will present on general requirements of labeling at the Intro to Food Law and Regulation on March 24-25, and Allen Sayler will provide a recall recap, looking at FDA enforcement actions in the past year on March 26 at the Food Enforcement and Compliance conference. Both events will be held in Washington, D.C.
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.
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.
Angel Suarez was interviewed on GMPs and Food Code 2017 Guidelines in an article published in Food Safety Strategies. In the food area, the GMPs ensure that ingredients, products and packaging materials are prepared, presented and handled safely and that food products are prepared in a suitable environment. Employee training is a must.
“The Food Code continues to be a model for adoption by states to safeguard public health and ensure that food offered to the consumer is not adulterated and a cause for illness outbreaks. It continues to be the best advice offered to the retail and food service industry addressing the safety and protection of food with the objective for reduction of the risk of foodborne illnesses caused by retail food and restaurant establishments, thus protecting consumers and industry from potentially devastating health consequences and financial losses.
“The Food Code 2017 contains several amendments and clarifications for the food service industry. These changes were made throughout the document for internal consistency, to correct some errors in the 2013 Code… Bare hand contact with ready-to-eat (RTE) food products is to be avoid under any circumstance to provide needed safeguards: It is important the employee be trained and practice thorough handwashing in order to avoid contamination of the food or food serving places, dishes and eating utensils, as outlined in the Code… Overconfidence on the use of gloves must also be addressed as a contaminated glove and transfer foodborne pathogens as easily as any bare hand.” Read more at Food Safety Strategies.
There are numerous compliance requirements for companies seeking to install new or relocate equipment or utilities within a GMP production facility including a systematic process for designing utility change control procedures. Read more in an article written by EAS Independent Consultant, Greg Weilersbacher, published in Tablets and Capsules.
EAS Independent Consultants Penny Vyskocil and P.C. Vasavada, Ph.D. were interviewed for an article on warehousing, FSMA benchmarks, and full scope inspections in an article published in Food Safety Strategies. As of October 2019, FDA had “conducted over 516 domestic and 150 foreign full scope inspections,” explained Vasavada. Ensure your warehousing facilities are ready when FDA knocks on your door.
EAS Independent Advisor for Food Law and Regulation, Steve Armstrong, along with Senior Director for Food Consulting Services, Allen Sayler, are invited speakers to the March 26, 2020 FDLI Food Enforcement and Compliance Conference taking place in Washington, D.C. Armstrong will speak on “Criminal and Civil Trends and Priorities for Foods and Dietary Supplements” and Sayler will conclude the day with a “Recall Recap” that includes key trends and takeaways.
As connected devices move further into mainstream, designers and manufacturers of both the devices themselves and the software that supports them must ensure due diligence, effectiveness, as well as regulatory compliance protecting the end user’s data. Industry, FDA and customer confidence must be addressed early and often to create an on-going dialogue of how data is being protected. Read more in this EAS authored article published in MedTech Intelligence.
Allen Sayler is an invited speaker at the Oregon Dairy Industries Annual Conference where he will explore lessons learned from 2019 dairy recalls as well present a session on extending the shelf life of cold-filled beverages, April 14-15, 2020 in Salem, OR.
EAS is pleased to again join the faculty at the AHPA Hemp-CBD Supplement Congress, this time April 14-15, 2020 in Portland, OR to discuss GMP requirements. As the marketplace and opportunities for hemp and CBD products expands, ensuring product are manufactured with full GMP compliance is imperative for product safety.
Dietary Supplements, no matter the ingredients, dosage form or health indictor, must be tested against specifications to ensure safety and meet label claims, and those specifications must be reviewed using fit-for-purpose assays. Read more in Natural Products Insider, where Tara Lin Couch, Ph.D., Senior Director for Dietary Supplement and Tobacco Services, was interviewed about these fundamental requirement, for dietary supplement GMPs.
CTP has stressed that the PMTA submission is an opportunity to tell the FDA a story about why a product should get market authorization. If the current May 12, 2020 deadline for submission remains in place, CTP indicated its intent to expedite the review of all applications and complete them within one-year. In order to accomplish this goal, CTP emphasized to the industry the importance of filing a complete application. Read a summary of the meeting in FDLI Update magazine.
Steve Armstrong, Independent Advisor for Food Law and Regulation, was interviewed for an article published in Food Engineering Magazine on how product claims affect food production processes. Savvy consumers are looking for specific attributes in the products they consume. Making those claims can severely restrict production methods. Says Armstrong, “fundamental issues with marketing claims are ensuring that the process-oriented marketing claim is truthful, non-misleading and adequately substantiated… Resolving these issues is essential for every marketing claim, and process labeling claims present special challenges.”
From Big Data, to Real World Evidence to Value Proposition and Reimbursements, regulators and sponsors must guide new pharma product development and promotion to be consistent with product labeling as the regulatory approval environment becomes more complex. Read on in ISPE’s iSpeak blog written by EAS independent consultant, John Harbell.
You might think your routine food safety protocol is doing the job, keeping your food and guests safe. This webinar, presented by Charles Otto and hosted by the National Restaurant Association, will show you how your system really stacks up and if it’s as preventative as it should be. You’ll learn how to use self-assessment results to design a system of policies that head off risks. You’ll hear effective ways to train employees and establish an ongoing verification process to ensure the system is being followed. Click here to register for this January 28, 2020 webinar.
Senior Directors Allen Sayler and Tara Lin Couch, Ph.D. presented a webinar on dietary supplements and FSMA. Now available on-demand, this webinar is a must to understand where dietary supplement GMPs (21 CFR 111) and food’s FSMA (21 CFR 117) intersect so that your firm can ensure compliance.
FDA CTP’s Public Meeting on PTMAs updated stakeholders on a variety of issues pertaining Premarket Tobacco Product Applications for Deemed Products, including items such as scientific content ensuring applications and information contained are Appropriate for the Protection of Public Health (APPH). FDA reviews chemistry, microbiology, toxicology and more and applicants must ensure establishments referenced in a PMTA submission are “inspection ready” at the time of submission. In addition to chemistry, microbiology and toxicology, FDA will observe the manufacturing process for the proposed APPH product ensuring compliance with FDA-regulated facility Current Good Manufacturing Practice (cGMP) inspection per sections 902 and 906(e)(1) of the FD&C Act. Learn more in FDLI’s Update where Tara Couch, Ph.D., Senior Director for Dietary Supplements and Tobacco Products, co-authored a meeting summary.
The preparation of a DMF to support a variety of pharmaceutical applications to FDA is lengthy and cumbersome to develop and produce. But just what documentation and how much detail is required of a DMF and where do companies commonly run into issues during the FDA review of their dossiers? Join EAS Consulting Group independent consultant and expert in DMF preparations, Priya Jambhekar, for a complimentary webinar and overview of the details DMFs should contain and tips for getting it right. Register today.
Food Quality and Safety Magazine published an article written by EAS Independent Consultant Robert Kapp Safety Data Sheets (SDS) covering their importance and utilization in manufacturing operations. SDS, are a critical component, required by law, containing all the basic information about a chemical or product which will help to ensure the user’s safety and health all stages of its manufacture, storage, use, and disposal.
FDA has stated all color additives are synthetic, so “natural colors” in cosmetic products must be an inherent color of an ingredient, not added for coloring, says John and Catherine Bailey, EAS Independent Consultants and experts on cosmetics. Their article on natural claims was published in the Natural Products Insider.
Gabe Miller, independent consultant and expert in equipment sanitation, published an article in Natural Products Insider on equipment sanitation and the need for co-packers to be aware of how this can impact their business – and liability. “Food processing equipment requires proper design, operation and sanitary maintenance to minimize the risk of contamination from microbial, chemical and physical hazards,” he says.
Senior Director for Dietary Supplement and Tobacco Services, Tara Lin Couch, Ph.D., was interviewed for a Natural Products Insider podcast on how important paper audits are to a contract lab qualification. Couch spoke at the SupplySide West show on this subject in a session titled: Trust in Testing: Contract Labs for Safe, Compliant Supplements.
FDA announced the release of the next chapter, in draft, of the Guidance for Industry “Hazard Analysis and Risk-Based Preventive Controls for Human Food” on recall plans. This newest chapter will assist the food industry establish and implement a written recall plan as required by 21 CFR 117.139.
The Preventive Control Human Food (PCHF) requirements specify that processors must establish a written recall plan for food that requires a preventive control (21 CFR 117.139(a)). The PCHF requirements also specify that the written recall plan must include procedures that describe the steps to be taken, and assign responsibility for taking those steps, to perform the following actions as appropriate to the facility (21 CFR 117.139(b)).
Written comments on the draft guidance are due by February 4, 2020.
Medical device manufacturers have a new tool available to demonstrate substantial equivalence through FDA’s 510(k) Safety and Performance measures. In a recently released Final Guidance, the Agency, as part of their effort towards stimulating innovation and reducing administrative burdens, all while keeping a keen eye on safety, is adding to their arsenal of abbreviated device submissions available for products based on previously approved predicates. Read more about FDA’s latest initiative in an EAS authored blog published by ISPE and contact Bryan Coleman, Senior Director for Pharmaceuticals and Medical Devices, to learn more about EAS services to support Medical Device manufacturers and their development of innovative new products.
Allen Sayler was interviewed for an article published in Food Safety Strategies on preventing and testing for pathogens and allergens in the food industry including LIMs software and blockchain technologies and internal audits. With an increasing number of food recalls, staying vigilant with all components of FSMA is key.
EAS Independent Consultant, Ramakrishnan “Rama” Narasimhan published an article in Food Safety Magazine on the Safe Food for Canadians Act, including areas where it is similar to FDA’s FSMA. Did you know EAS offers food safety services for Canadian firms and has a number of Canadian independent consultants who assist? Contact Allen Sayler, Senior Director for Food Consulting Services, for more information.
Do you know which of the seven major FSMA regulations were designed to support the Food Safety Modernization Act (FSMA)? Join EAS Consulting Group’s FSMA and Dietary Supplement experts Tara Lin Couch, Ph.D., Senior Director for Dietary Supplement and Tobacco Services and Allen Sayler, Senior Director for Food Consulting Services for an overview of the FSMA regulation and a deeper dive into those aspects which specifically apply to dietary supplements. Learn the crucial steps to compliance, including what must be included in a food safety plan, required qualifications the Preventive Controls Qualified Individual and what is needed to develop an FSVP. This complimentary EAS webinar will take place on December 4, 2019, at 1 pm eastern. Register here.
Neha Mookuparambil, a recent EAS intern focusing on pharmaceutical studies at Georgetown University published an article of FDA’s perspective on continuous manufacturing in FDLI Update, the bi-monthly magazine of the Food Drug Law Institute. EAS has partnered with Georgetown for a number of years hosting
Independent Consultant Mehrdad Tajkarimi, Ph.D. wrote about next-generation sequencing technology as it applies to detect plant and animal species in food adulteration cases for MeatingPlace magazine. NGS produces more variable and more in-depth genome sequencing datasets to find food-related genes for verification of the actual food’s content, ingredients, sourcing and labels for the prevention of Food Fraud. Learn more at MeatingPlace (Complimentary login required).
Independent Consultant and infant formula expert, Robbie Burns, Ph.D., published an article in Natural Products Insider on regulatory considerations for the development of infant formula for sale in the U.S. In addition to this article you may wish to review more on infant formula regulatory challenges in our recent webinar, now available on-demand.
Independent Consultant Bruce Elsner discussed considerations of Own Label Distributors for the assurance of GMP compliance and certificates of analysis in Natural Products Insider. Dietary supplement companies that contract out some or all their operations often fail to consider how little they know about the operations of those providing the contracted services and thus may be taking significant risks, he says.
The requirement to comply with FSMA is well understood for food manufacturers, and there are no exceptions for warehousing facilities. FDA inspections of facilities that receive, store and distribute human or animal food can occur at any time and firms must be prepared for such an inspection 24 hours a day. Jerry Heaps discusses ways warehousing facilities can and should stay on top of FSMA requirements in Food Safety Strategies.
EAS Independent Consultant Heather Fairman authored two recent articles for Natural Products Insider. First, Supply Chain Transparency on the demand by consumers and regulators for supply chain transparency from farm to fork. Next, Quality Assurance for manufacturers of nutrition bars. In addition to consulting for EAS, Heather is a technical advisor for the Small Island Developing States (SIDS) DOCK Island Women Open Network (IWON, sidsdock.org), an intergovernmental organization.
Tamika Cathey was a guest columnist for Ask the Expert in Tablets and Capsules Solid Dose Digest where she responded to the question of creating a dietary supplement specification program that meets FDA expectations. In June 2007, the FDA published 21 CFR Part 111, which established cGMP requirements for dietary supplements. Since then, manufacturers have struggled to understand and comply with these requirements regarding specifications development.
EAS regulatory intern Neha Mookuparambil authored a blog for ISPE iSpeak on FDA’s Proposed Approach to Improve Efficiencies for the Advancement of Pharma Manufacturing through Continuous Manufacturing. The FDA has been pushing for advanced manufacturing processes in the pharmaceutical industry. The efficiency, consistency, reliability and ease with adoption of CM could provide for cost benefits and timely supply of drugs.
EAS independent consultant, Kaiser Aziz discussed FDA’s Quality Risk Management Approach to New Drug Applications in Drug Development and Delivery. Risk management is one of the most important tools in new drug applications to assess the risk level of a drug product and promotes quality through increased efficiency and knowledge transfer, he says.
EAS Senior Director for Food Consulting Services, Allen Sayler, was interviewed for an article published in Food Processing Magazine on the regulatory state of the food industry under the Trump administration. Published during Scott Gottlieb’s tenure as FDA commissioner, Sayler discussed how Gottleib appeared to have the full confidence of the Trump administration. EAS continues to monitor Agency updates under the acting commissioner, Norman Sharpless.
Independent Consultant, Jay Mansour, discussed the movement away from substantial equivalence in favor of performance testing for the 510(k) application process in a recent MedTech Intelligence. “Expanding on the Abbreviated 510(k) Program for demonstrating substantial equivalence for 510(k) premarket submissions, FDA is identifying certain “well understood” medical devices that may be cleared based on performance criteria,” he says.
Senior Director for Pharmaceutical and Medical Device Consulting Services, Bryan Coleman, wrote a blog for the ISPE’s iSpeak on opportunities ahead for the pharma industry as the Agency works to streamline processes for improved innovations.
Senior Advisor for Dietary Supplements, Tim Stewart, discussed GMPs in Natural Products Insider. FDA has been asking for additional information beyond GMPs in recent inspections, inquiring on botanical forms and safety. Stewart discusses compliance challenges and best practices. In addition, Tim contributed to the Insider’s recent Botanicals Digital Magazine.
Tara Lin Couch was interviewed for a Natural Products Insider podcast on her reflections of 25 years of DSHEA. Recorded at SupplySide East, she discusses how the dietary supplement industry, pre-DSHEA, was the “wild, wild west” and that 21 CFR 111, Current Good Manufacturing Practices, completely changed the way the dietary supplement industry operates, with “current” processes adapting as technology advances.
Labeling expert, Gisela Leon, discussed supplement facts panel requirements in a recent Tablets and Capsules Spotlight on Nutraceuticals. If you would like more detailed information on requirements, Leon has written a handbook covering the specifics. This can be purchased directly from EAS on our Products page.
Independent Consultant Ronald Levine authored an article on the very serious subject of product recalls published in the Natural Products Insider illustrated through a fictitious conversation between a hypothetical company’s CEO and their attorney as they plan for a recall response.
EAS Independent Advisor for OTC Drugs and Labeling, Susan Crane, published a blog discussing the future of Homeopathy on the International Society of Pharmaceutical Engineering (ISPE) blog page iSpeak. FDA and FTC are taking a more proactive approach to homeopathic drugs indicating that they will be held to the same standard as other products with regard to claims.
Charlotte Peyton, a noted expert in cannabis, has published an article in a recent Cannabis Industry Journal. She discusses FDA’s stance with Hemp, CBD versus Isolates, and good manufacturing practice considerations. You may also wish to view the recent 2018 Farm Bill and the Cannabis Industry webinar presented by Attorney Marc Ullman, Of Counsel with Rivkin Radler and Tara Lin Couch, PhD, Senior Director of Dietary Supplement and Tobacco Services. This webinar is available on-demand on the EAS website.
Steve Armstrong, EAS Independent Advisor for Food Law and Regulation, is co-author of an article published in the March 2019 Food Drug Law Institute Update Magazine covering FDA’s recent decision to delist six synthetic ingredients as required by the Delaney Clause, a 60-year-old provision of the Food, Drug, and Cosmetic Act (FDCA) which states, in plain language that FDA may not approve any food additive—even one that is safe—if it is “found to induce cancer” in laboratory animals. Steve hypothesizes as to whether it is time to repeal the Delaney Clause.
Thomas Dunn has authored an article for Natural Products Insider on sustainable packaging for natural foods. Packaging for natural food products must protect food quality and safety while also connoting clean labels and sustainability, he says.
EAS Independent Consultant April Kates was interviewed for a recently published article on Food Labeling published in Supermarket Perimeter. EAS is very pleased to have such a strong team of labeling consultants who are often called upon for sharing their expertise.
EAS Independent Consultant, Norma Skolnik and Advisor for OTC Drugs and Labeling, Susan Crane, has co-written an article on the OTC Drug Safety, Innovation, and Reform Act. Recently published in Solid Dose Digest, the article includes a proposed review and overhaul of the OTC Monograph process, eliminating inefficiencies and allows for better response times to safety concerns. Learn more in Solid Dose Digest and join Susan in Part 2 of her Five-part webinar series on OTC Monographs. Part 1 – an Overview of the OTC Monograph system, is available On-Demand now. Part 2 on OTC Labeling and Listing Requirements takes place on February 27, 2019.
EAS independent consultant, Steve Cammarn, is presenting a webinar on considerations for Developing Vitamin, Mineral and Supplement Products for Commercial and Compliance Success. Join EAS February 7, 2019, at 1 pm Eastern where Dr. Cammarn will share principles and techniques for a phased-approach of the development of vitamin, mineral, and supplements products incorporating product design, process development, supply chain establishment, and qualification. Dr. Cammarn weaves together the scientific principles as well as the overarching regulatory requirements that must be met for commercial and compliance success. Join us!
Independent Consultant Thomas Dunn discusses packaging trends in an article for Natural Products Insider. Packaging is an important component of overall product design as it protects, preserves, escorts and describes the products consumed. As consumers demand more sustainable packaging, companies are working hard to meet that demand with innovative and cost-effective products.
Senior Director for Dietary Supplement and Tobacco Services, Tara Lin Couch, Ph.D. was interviewed for an article in Natural Products Insider on Own Label Distributors and challenges of industry to establish product specifications. According to FDA data, in fiscal year 2018, about 24 percent of the FDA Form 483 inspection reports cited firms for failing to establish specifications of finished dietary supplements. This issue is clearly a challenge for the industry and one in which OLDs should be well-versed and ensure compliance.
Independent Consultant Mehrdad Tajkarimi has published part two of his three-part series in Food Safety Magazine on designing food safety training programs to meet FSMA compliance expectations. Food safety training is critical, not only in meeting FDA
EAS published a blog on the International Society of Pharmaceutical Engineers’ iSpeak blog on how GMPs and data integrity align for safer products and swifter approvals. FDA has noted that in recent years, findings from pharma facility inspections show increasing challenges with meeting data integrity requirements, which has led to regulatory actions including warning letters, import alerts, and consent decrees.
The December American Herbal Products Association (AHPA) Report (subscription required) included an EAS authored article on steps to develop fully compliant Standard Operating Procedures. Though the development and detail of each SOP is at the discretion of individual companies, they should provide a thorough manual that enables each employee to understand their roles and responsibilities and how to perform and document them with regard to the cGMPs. As current practices evolve, so too should SOPs as they are designed to be living documents, representing best practices and required procedures.
EAS authored an article in MedTech Intelligence on FDA’s efforts at encouraging innovation while keeping a close eye on safety as part of a medical device regulatory overhaul. FDA is working to retire outdated predicates for 510(k) submissions as well as improve their post-market surveillance system through a multi-collaborative effort called National Evaluation System for Health Technology (NEST).
Senior Director for Dietary Supplement and Tobacco Services, Tara Lin Couch, Ph.D. participated in a discussion with other industry leaders on best practices for contract laboratories in a recent Natural Products Insider. Contract labs are often enlisted to certify that products are fully and validly tested, and the relationship with these labs can sometimes be complicated by a lack of provided material and product matrix information to ensure that appropriate, scientifically valid test methodologies are used. Couch and her industry colleagues share thoughts on how to convey expectations and develop agreements.
Senior Director for Dietary Supplement and Tobacco Services, Tara Lin Couch, Ph.D., has written an article for Natural Products Insider on the intersection of OLD and Quality Systems. “The development and implementation of essential own label distributor quality systems and programs will go a long way to ensure GMP compliance in a contract manufacturer partnership,” she says.
In addition, for those who missed or would like to review the very informative webinar presented by Bruce Elsner, also on OLD responsibilities, it is now available on-demand on the EAS website along with many other complimentary webinars covering a wide range of regulatory topics.
Senior Director for Food Consulting Services, Allen Sayler, published an article in Dairy Foods Magazine on FDA’s PMO (Produce Milk Ordinance) new Appendix T, which mirrors FSMA in many ways in that it requires preventive controls for those hazards not already covered in the PMO. This new requirement may well be the dairy industry’s most significant new regulatory challenge for 2019. “One of the major challenges many firms face is the establishment of acceptable written food safety programs and maintenance of required records that demonstrate compliance with Appendix T. The failure of a Grade “A” dairy plant to meet any of these requirements will result in either loss of its Grade “A” designation or a request for the state to remove its Grade “A” designation.”
James Evans expanded on his September 2018 issue of the month article on MRAs in an article published in Tablets and Capsules magazine. He discusses MRAs in-depth, as well as Field Action Reports, Med-Watch Reports, and Drug Quality Sampling and Testing as methods of monitoring the U.S. drug product supply chain.
Beth Crozier-Dodson published an article in Meating Place discussing top tips for proactive pathogen control in poultry processing. “One of the most significant aspects of any poultry food safety plan is the implementation of pathogen control measures at each critical control point identified in the processing plant. Those who do this in a proactive manner will be able to reduce the risk of microbial contamination that could prompt a costly recall.”
Senior Director for Dietary Supplement and Tobacco Services, Tara Lin Couch, Ph.D. discussed challenges facing Own Label Distributors in the Natural Products Insider. Although a firm may contract certain dietary supplement manufacturing operations, it cannot contract out ultimate responsibility for compliance with GMP requirements.
Independent Advisor for Food Law and Regulation, Steve Armstrong, JD, has written an article on the Good Food Movement for Natural Products Insider. “Consumers are increasingly looking for foods with clean labels,” he says. Unfortunately, there is no regulatory definition to guide the terms “clean label” and “good foods”.
Carl Custer wrote about the challenges of Listeria, Salmonella, extraneous materials and worse in an article published in Food Safety Magazine. Carl also shared some of his experiences at problem-solving both while at FSIS and working with clients as a consultant, observing plant practices as “third-eye” in order to solve food safety problems.
Senior Director for Pharmaceuticals and Medical Devices, Bryan J. Coleman discussed innovations and the regulatory landscape in an AdvaMed MedTech blog. Bryan shared his thoughts as FDA continues to harmonize and leverage existing regulatory approaches in increasingly more creative ways that allow the industry to grow and flex along with innovation. Still based in sound science and documented evidence, FDA expects sponsor and contract manufacturers to tighten controls over raw materials and component quality equal to internal design and production. Now more than ever companies must plan and prepare for meeting quality requirements and ensure quality measures are weaving design, supporting technologies, supply chain and feedback mechanisms into one cohesive program.
EAS Independent Consultant Heather Fairman discussed Own Label Distributor audits of contract manufacturers as well as steps for ensuring their compliance in the Natural Products Insider. “Own label distributors performing contract supplier and/or contract manufacturer audits often have critical blind spots that may result in products not meeting specifications or their quality and safety expectations,” she says.
Senior Director Tara Lin Couch, Ph.D. shared Own Label Distributor (OLD) responsibilities in a recent article published in Technoscienze – AgroFOOD Industry HI Tech. Regardless of whether an OLD is domestic or international, the FDA is clear that the OLD is responsible for compliance with the regulatory requirements in 21 CFR 111, she says. “The development of critical OLD processes should include procedures such as qualification of OLD contractors; demonstration that the quality unit is fulfilling obligations of finished product specifications; a complaint system for evaluating all reported consumer concerns for the identification and reporting of Serious Adverse Events (SAEs) to FDA; and change control processes to ensure revisions are tracked and monitored.”
Norma Skolnik discussed Adverse Events Reporting (AER) requirements for the dietary supplement industry in Natural Products Insider. The requirements as well as the Guidance for Industry: Questions & Answers Regarding Adverse Event Reporting and Recordkeeping for Dietary Supplements as required by the Dietary Supplement & Nonprescription Drug Consumer Protection Act,” published in 2007 cover SAE reporting for manufacturers and OLDs as well as FDA notification to companies when FDA receives an SAE involving one of their products.
Independent Advisor for FSMA, Charles Breen has co-authored an article with Stacey Stevens, Senior Vice President of FoodMinds, a food PR firm with which EAS has a collaborative partnership on responding to a food safety emergency. The article, published in Food Quality and Safety magazine discusses the many issues of responding to an emergency and how to focus messaging on that response.
Senior Director for Dietary Supplements, Dr. Tara Lin Couch was interviewed for a Natural Products Insider podcast on contract manufacturing partnerships. Dr. Couch is one of two EAS presenters for the upcoming SupplySide West trade show taking place in Las Vegas. Stay tuned for more information on EAS presentations by Dr. Couch and EAS Independent Consultant Heather Fairman.
Independent Consultant Mehrdad Tajkarimi and Senior Director Allen Sayler co-wrote an article for Natural Products Insider discussing Cause, Effect and Impact of RTE Operations on complying with FDA’s draft Listeria guidance. Food manufacturers are expected to operate within an entirely new scheme of “design out” of potential entry and harborage of Listeria, develop “hygienic zoning”, enhance monitoring and record keeping for cleaning and sanitizing a food processing facility and more. As FDA inspectors use draft FDA guidance for Control of Listeria Monocytogenes in Ready to Eat Foods during routine and targeted investigations, these new criteria, as well as others found in the guidance, will become the new benchmark of safety against Listeria in RTE operations.
EAS authored an article discussing options for dietary supplement ingredient submissions – New Dietary Ingredient (NDIs) and Generally Recognized as Safe (GRAS) on August 8, 2018, of the AHPA Report (AHPA membership required to view). Botanical chemicals may be isolated and also sold as dietary supplements, and in some cases, FDA’s interpretation of botanical and plant parts would qualify them for an NDI submission. In some cases, GRAS is a more appropriate submission for this unique category of botanicals. EAS can discuss your particular situation and help you to determine the right path for your product.
Senior Director for Food Consulting Services, Allen Sayler, has written an article for Food Safety Tech on FDA Fast-Track Unified and Listing Systems (FURLS) program and whether it is expediting or impeding access to overseas markets. “The FDA recently released a notification that their FURLS system has been updated to include an Export Listing Module (ELM),” he says. This allows U.S. food manufacturers to electronically submit, and for FDA to receive and process requests for inclusion on the export lists for FDA-regulated food products and present these lists to countries that require them, whether a company is participating in this program or is looking for new markets outside the U.S.
Mehrdad Tajkarimi discusses the importance of food safety training as a solution to FSMA challenges in Part One of a three-part series for Food Safety Magazine. “There are several challenges ahead for proper food safety training at all levels,” he says. “These challenges include, but are not limited to, numbers of training hours, type, content, and facilitation procedures.” The types and applications of training have dramatic impacts on food safety management systems, improvements in FSMA compliance, and employee productivity.
Robert Lavieri authored a guest column in Food Safety News on the important and often overlooked “human element” to food safety planning and programs. Companies spend much time and effort designing and cross-checking procedures to protect against food safety issues, but the human element or employee training and assurance of appropriate training to the job function is equally important. Make sure you “test, verify and regularly evaluate and hold accountable the human elements as you do your equipment i.e. Process Control, Automatic Sampling, CIP, Calibrations, etc,” he says.
EAS offers a wealth of regulatory consulting capabilities in all FDA commodity areas, as well as USDA and some state regulatory services as they pertain to food and dietary supplement products. EAS is creating short clips that discuss our capabilities and is posting them on our website. We invite you to learn more about our Product Development and Labeling services, FSMA, food and dietary supplement labeling as well as food additive services through these videos. We’ll be adding additional so stay tuned.
Karen Dixon discusses critical points for helping tobacco firms prepare for FDA Inspections in this month’s issue of the Tobacco Reporter, including FDA’s inspection authority and how companies should prepare internally, including a having a detailed inspection plan in place. It is important to note that FDA inspections are not always preannounced, so companies in all industries are encouraged to have written and detailed SOPs as well as ready access to critical information that would be pertinent and requested as part of FDA’s inspection.
EAS Independent Consultant Steve DeMuri authored an article in Natural Products Insider on Probiotic health benefits of natural foods and supplements. With many reported health benefits currently being studied, “Probiotics are here to stay and now is the time for companies to conduct new product development to incorporate probiotics into the “tinkering process” that is part of all food technology and product development efforts,” he says.
EAS Independent Advisor Elizabeth “Betty” Campbell and Independent Consultant, April Kates have co-written an article on how to keep “clean label” claims legal for Natural Products Insider. “Marketing a clean label can be a great way to for brands to connect to consumers,” they say, “but they need to ensure their statements don’t run afoul of a legal claim.”
The U.K.’s departure from the EU sparks uncertainty in future trade agreements with the United States, which may not be finalized until after Brexit occurs, says Heather Fairman in a recent article for Natural Products Insider. “For U.S. supplement companies that currently are actively exporting/importing products to the U.K., a watchful eye should be kept on the Brexit transition.”
Senior Director for Dietary Supplements and Tobacco Services, Tara Lin Couch, Ph.D. has published an article in Tablets and Capsules magazine on the importance of quality agreements for dietary supplement manufacturers. “The dietary supplement industry, like the pharmaceutical and food industries, relies heavily on contractors and subcontractors. However, no matter who does what along the supply chain, the product owner is ultimately responsible for GMP compliance,” she says.
Independent Consultant Celia Schebella discusses tips for designing a cannabis edible in the state of California that meets customer expectations and regulatory requirements in Cannabis Industry Journal. Designing a cannabis food product with GMPs, local regulations, ingredient sourcing and scalability in mind can help companies succeed, she says.
Independent Advisor for Food Law and Regulation, Steve Armstrong, has authored an article for Natural Products Insider on buying a 21st-century food company and mergers and acquisitions. “A health and nutrition startup should resolve any potential issues with its quality control, labeling and advertising practices before it is acquired,” he says.
EAS offers a number of services to attorneys working in the area of due diligence and mergers and acquisitions. For more information on these services please review our Food and Drug Attorney Services Sheet.
As you may be aware, Congress is currently working on legislation to update the Over-the-Counter (OTC) monograph system. This legislation, the Over-the-Counter Drug Safety, Innovation, and Reform Act, has bipartisan support in Congress as well as the backing of the FDA, industry and other public health organizations. As such, it is expected to pass and be signed into law by the President before the mid-term elections in November.
Due to the significant changes ahead, EAS has decided to postpone the webinar “The OTC Monograph System – Past, Present, and Future originally scheduled for July, and will instead monitor this legislation and present the webinar after the passage of the bill. This will enable us to provide you with better information on how to market your OTC products going forward.
EAS Senior Director for Dietary Supplement and Tobacco Services, Tara Lin Couch, Ph.D., along with attorney Marc Ullman from Rivkin Radler, and EAS Independent Advisor for Quality and Compliance, Robert Fish, held a Dietary Supplement Short Course, consisting of four hours of regulatory content, recently. It is now available to view as an on-demand webinar on the EAS website. This video is $99 to view for non-EAS clients and free to view for EAS clients.
The GMP short course is a great tool for those seeking a broader overview of GMPs, as it covers the basics of working in a GMP environment including personal hygiene, sanitation, the use of Standard Operating Procedures (SOPs), and Good Documentation Practices (GDPs) and addresses the top 5 observations cited in FDA Warning Letters since 2010. To access the short course, click here. EAS clients may use discount code [clientwebinar], non-EAS clients will be billed upon viewing.
EAS authored an article for MedTech Intelligence on FDA’s new approach to the regulatory pathway for De Novo medical device classification which simplifies the approval process for the class I or class II devices for which there is no one-to-one precedent or predicate. De Novo applications are appropriate in cases where it appears that the device meets the statutory standards for classification into Class I or Class II under section 513(a)(1) of the Food Drug & Cosmetic Act, and when the sponsor has determined that the device does not fall within any existing classification regulation.
EAS offers a number of services to the medical device industry. For more information, click here.
EAS Independent Consultant and FSPCA recognized lead instructor, Jenifer Kane, will co-instruct two FSPCA courses with Independent Consultant and trainer Susan Moyers, Ph.D. on the intricacies of Preventive Controls for Human Food as well as the Foreign Supplier Verification Program. Both courses will take place in early October in Alexandria, VA.
The Current Good Manufacturing Practice, Hazard Analysis, and Risk-based Preventive Controls for Human Food regulation (referred to as the Preventive Controls for Human Food Regulation) is intended to ensure safe manufacturing/processing, packing and holding of food products for human consumption in the U.S. and requires that certain activities must be completed by a “preventive controls qualified individual” who has “successfully completed training in the development and application of risk-based preventive controls”. This course meets FDA’s requirement. Join EAS October 1-3, 2018 in Alexandria for this 2.5 intensive training. Earlybird discounts are available through August 14, 2018.
Next, the “Foreign Supplier Verification Program (FSVP)” requires importers to verify that their foreign suppliers of food, food ingredients and food additives imported into the US market are compliant with all parts of the FSMA and its “Preventive Controls for Human Foods (PCHF) and “Preventive Controls for Animal Feeds (PCAF”) regulations. EAS’ two-day intensive FSVP Compliance Seminar will explain in detail FSVP rules, risk exposure by importers as well as US-based food processors using foreign sources of foods, food ingredients, and food additives. Join us October 3-4, 2018 for this 1.5-day training. Earlybird rates are in effect through August 14, 2018.
Gabe Miller, an expert in Food Safety Programs has written an article for the Cannabis Industry Journal on how solid food safety programs can help make cannabis products safer and save businesses a lot of time and money.
Gabe spoke at the upcoming University of Madison Cleaning and Sanitation Short Course on sanitary equipment design on May 1. Gabe is a specialist in troubleshooting food safety and quality problems and has extensive experience in evaluating electrical, mechanical and equipment systems. He is a 3-A Sanitary Standards Inc. Certified Conformance Evaluator (CCE) who works with food processing equipment design and engineering companies to advance hygienic design.
Independent Consultant, Heather Fairman has published two articles recently. One in Food Processing Magazine focuses on the positive impact of workplace safety programs on corporate culture. Next, she wrote about five “golden rules” for co-packers to stay competitive and profitable for Natural Products Insider. In addition to being a gifted writer and expert consultant on quality control and quality assurance issues, Heather serves as a Technical Advisor for the SIDS DOCK Island Women Open Network (IWON), an intergovernmental organization of Small Island Developing States (SIDS), which has all the rights and privileges of a United Nations organization comprised of 32 countries and who are embarking on developing a raw material market for the herbal supply-chain.
The U.S. Food and Drug Administration has issued a final rule to extend the compliance dates for updating Nutrition Facts and Supplement Facts labels, from July 26, 2018, to January 1, 2020, for manufacturers with $10 million or more in annual food sales. Manufacturers with less than $10 million in annual food sales will receive an extra year to comply – until January 1, 2021. The agency published a proposed rule to extend the compliance date in September 2017, and this rule finalizes that extension. This approximately 18-month extension will provide sufficient time to transition to the new version of the Nutrition Facts label.
The FDA released inflation-adjusted values for six FSMA regulations covering 2016-2017. These values are particularly noteworthy for smaller businesses that may not be covered, may receive an exemption, or have later compliance dates based on their sales being less than the indicated value. In addition, certain businesses subject to the Preventive Controls for Human Food, Preventive Controls for Animal Food, Produce Safety, Foreign Supplier Verification Programs, Sanitary Transportation and Intentional Adulteration Regulations should also refer to the updated values to determine whether they meet the cut-off value for the applicable regulation. Contact Allen Sayler, Senior Director for Food Consulting Services for assistance with FSMA questions at 571-447-5509 or firstname.lastname@example.org
Independent Advisor for Labeling and Claims, Betty Campbell and Senior Director for Food Consulting Services, Allen Sayer have co-written an article on how FDA interprets and enforces regulations of Medical Foods in Food Safety Magazine. This narrow product category sees a lot of confusion within the industry as to what constitutes a medical food, how it can be labeled and its ingredient requirements.
Independent Advisor for Food Law and Regulation, Steve Armstrong discussed how FSMA implementation has impacted food safety systems during its first year of enforcement in the prestigious FDLI Update. Mr. Armstrong is the former Chief Law Counsel for Campbell Soup Company and works with EAS client on product development issues.
EAS Independent Consultant, Rudy Westervelt, discussed fulfilling quality assurance potential and generating a net profit in a recent article published in Dairy Foods Magazine. Quality assurance could — and should — drive revenue by providing information that allows plant leadership to control costs, improve operational efficiencies and maximize finished product output, he says. Westervelt specializes in problem-solving related to dairy food quality, loss reduction, employee safety results, throughput and cost control.
EAS Independent Consultant Heather Fairman contributed to a Q&A in Natural Products Insider on Successfully Choosing and Maintaining a Contract Manufacturing Partnership. Heather was part of a panel of experts that discussed contract manufacturing aspects that brand owners should evaluate in a potential contract manufacturer, what should be outlined in an agreement and what ongoing quality assurance (QA) checks a brand owner should conduct during the partnership.
EAS Independent Consultant, Rob Carper, has written an article on how audits are an integral part of the food safety system for Food Quality and Safety Magazine. “Food safety plans must be monitored and verified throughout the year, making sure the entire written food safety program is being supported with detailed records at the right frequency, capturing operational data,” Carper says. Also, he says, annual audits protect the company and the consumer by ensuring products are manufactured using adequate Food Safety Fundamentals (prerequisite programs and other requirements); Food Safety Plans, such as HACCP; and Quality Plans (a requirement for SQF Level 3 certification).
Product development is a competitive challenge whereby companies attempt to best posture themselves as an attractive option to consumers, an effective competitor against similar products on retail shelves and do so in a manner that meets FDA, USDA and FTC requirements. EAS’ strategic product development and labeling service help companies with all of these challenges and more, providing a comprehensive and holistic approach to product development from ideation to commercialization. A successful product is about more than designing the right label, it must take into account marketing objectives as well as the current regulatory, compliance, and enforcement environments. EAS is proud of this service and the many companies for which we have provided proactive solutions.
We invite you to view a short video on this Strategic Product Development and Labeling service as well as our Industry Service Sheets detailing some of the many challenges within product development and how a partnership with EAS experts would be of benefit.
For those seeking a broader overview of GMPs, EAS is offering a new two-part online short course which will cover the basics of working in a GMP environment including personal hygiene, sanitation, the use of Standard Operating Procedures (SOPs), and Good Documentation Practices (GDPs). It will also address the top 5 observations cited in FDA Warning Letters since 2010.
This Short Course, based on the 21 CFR 111, Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, provides a great initial training for personnel unfamiliar with GMPs and can serve as a refresher and annual GMP training requirement.
Each session runs 2.5 hours in length and the dates are February 22nd and March 1st from 1:00-3:30 pm ET and is FREE to EAS clients. Registration is $99 for both sessions for non-clients. Click here for more information and to register.
The prestigious FDLI Update November/December 2017 Student Corner included an article written by EAS Regulatory Intern and recent Georgetown University graduate, Rahul. The article, The Value of FDA Pre-Submission Meetings & Enhancements under PDUFA VI, discusses how pharma companies can manage risks through proper communication with FDA throughout the drug development process.
Natural Products Insider posted an infographic on considerations for validating a contract laboratory with materials compiled from a number of 2017 Supplyside West Presentations, including that of EAS Senior Director for Dietary Supplements and Tobacco Services, Tara Lin Couch, Ph.D.