Kathy Knutson, Ph.D.

Kathy Knutson Ph.D.

Kathy Knutson, Ph.D. is a microbiologist and certified lead instructor for Preventive Controls for Qualified Individuals through the Food Safety Preventive Controls Alliance. She consults with companies in meeting FSMA requirements, including manufacturers in the cannabis industry as she educates on issues surrounding cannabis infused food products for sale in states with medical and recreational use legislation. Kathy has a Ph.D. in Food Science from the University of Minnesota and prior to consulting worked as a Food Safety Educator and Proficiency Program Coordinator with the Northland Laboratories.

Robert Kapp, Ph.D.

Robert Kapp Ph.D.

Robert Kapp, Ph.D. has over 30 years’ experience as a toxicologist involved with the management, development, and safety of new and existing products in a broad spectrum of industries including preclinical program study design, study reports, occupational and industrial toxicology and evaluating clinical and product safety data. Dr. Kapp assists EAS clients with writing critical position papers, GRAS notifications, 510(k) submissions, US EPA Premarketing Notifications, toxicology profiles, Safety Data Sheets and labels in the US and in global markets. Prior to consulting Dr. Kapp worked as Director, Toxicology Laboratory at Exxon Biomedical Sciences, Inc. He has a Ph.D. in toxicology from George Washington University.

Robin Guy

Robin Guy

Robin Guy is a board certified toxicologist and quality assurance consultant with more than thirty years of experience including nineteen years in industry (pharmaceutical toxicology & food ingredient safety assessment) and over sixteen years as an independent consultant. She is an expert in nonclinical toxicology, regulatory and Good Laboratory Practices (GLPs), designing/coordinating toxicology studies and programs, preparing regulatory submissions, including GRAS Notices, upgrading labs to GLP quality, and developing and presenting professional training courses worldwide. Prior to becoming a consultant, she served for eleven years with The NutraSweet Company/Monsanto, and for eight years with G.D. Searle & Co.

FDA Inspections Webinar with Recent Trends in Observations

Webinar Laptop View

EAS has posted our latest webinar to the On-Demand webinars page. Presented by Sophia Lily, Preparing for FDA Inspections, is free to view on-demand – along with numerous other webinars presented by our consultants on a variety of topics. EAS regulatory webinars provide timely and relevant content to help your firm take actionable steps to understanding FDA requirements.

Preparing for FDA Inspections, a Look at Recent Observations and Trends

Presenter: Sophia Lily, EAS Independent Consultant

Foreign companies exporting FDA regulated products to the United States can at any time expect an FDA announcement of facility inspection. Looking at the complete safety package from record keeping and retention, to specifications and testing to employee training, FDA ensures foreign firms operate with the same safety standards required of companies operating within the U.S.

A look at trends of inspection findings of foreign manufacturers provides insight into industry challenges concerns garnering FDA’s increased focus.

Learn more about how FDA conducts foreign facility inspections as well as recent inspection trends. Understanding how gaps may be addressed before FDA knocks on your door will lead to a safer consumer product as well as a smoother inspection process.

About the Presenter

Sophia Lily has over 25 years of experience in the regulated pharmaceutical, nutraceutical and food industry Quality Control, Quality Assurance. Based in India, she is experienced in handling inspections, validations, vendor audits and training. She routinely works with, including training, personnel in a range of GMP topics including Data Integrity. With expertise including GMP compliance, gap analysis and remediation and development of roadmaps to compliance, she has successfully implemented effective quality management systems for many companies both small and large.

Ron Levine Expands EAS Services Offering with Creation of Expert Witness Training and Consulting on Complex Commercial Matters

Ron Levine

Ron Levine, EAS Independent Consultant and General Counsel of Herrick, Feinstein LLP will lead EAS’ newest training initiative with a comprehensive look at how to be an effective and sought-after Expert Witness.

Ron Levine has over 40 years of experience advising consumer products companies in complex commercial matters. He offers a wealth of services to EAS clients including

  • Litigation research including relevant records and subpoena requests
  • Research on outcomes of litigations involving similar claims
  • Due diligence assessments including claim history of a target company, risk management policies and procedures
  • Preparing for FDA inspections from the perspective of record production and management
  • Preparing and editing reports to federal agencies and other entities

Ron’s latest projects include helping Expert Witnesses strengthen their understanding of the role, expectations and skills required for being an effective expert witness. With topics including 

  • Understanding the discovery process and the role of the expert
  • The engagement process of becoming an expert
  • How experts are utilized in investigations, trials, and arbitrations
  • Projecting expertise as part of written reports and oral testimony 
  • The business of being an expert witness 

Ron is a pragmatic advisor who helps clients anticipate, minimize and resolve the financial and reputational damage arising from claims and potential claims, Ron specializes in crisis management, for food and beverage manufacturers, where he advises on class action litigations and investigations, including labeling, FSMA, advertising claims, product recalls, FDA regulations, new technologies such as 3-D printing and block chain and many others.

Additionally, Ron has developed EAS’s newest seminar on how to become and strengthen skills as an expert witness. This seminar, in Alexandria, VA and offered remotely will be November 6m 2019. For more details see EAS in Action.

Risks to OLDs Discussed in Natural Products Insider

Natural Products Insider

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.

Warehousing Compliance and FSMA Reviewed in Food Safety Strategies

Food Safety Strategies

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.

Register for EAS Webinar on FDA Inspections in India

Independent Consultant, Sophia Lily, is expert of pharmaceuticals who is based in India will present a webinar on how to prepare for FDA facility inspections, including a look at recent FDA observations and trends. Understanding how gaps may be addressed before FDA knocks on your door will lead to a safer consumer product as well as a smoother inspection process. Join Sophia Lily on July 24 at — eastern and — Indian Standard Time. This webinar is conveniently timed for our overseas audiences. Register today!

EAS Offers Dairy 101 at Process Expo

Process Expo

EAS will bring its popular Dairy Processing 101 seminar to the Process Expo in Chicago, October 8-11, 2019. This full day event covering an overview of the US dairy industry will include the impact of dairy farm practices on the quality and composition of raw milk; how raw milk and dairy product prices are established; an appreciation of government requirements for dairy plants including FSMA’S PCHF regulation; exposure to milk chemistry and microbiology (including dairy cultures); an in-depth overview of dairy processing technologies related to milk beverages, cheese, yogurt, ice cream, as well as hands-on practical knowledge of dairy laboratory testing systems and capabilities. Registrations are being taken by Process Expo.

EAS to Offer Training on Expert Witness Preparations

As highly regulated industries are subject to more claims and litigations, and with growing agency challenges to ingredients, processes and branding, the target company’s regulatory compliance is often a key issue in presenting a successful defense. An expert witness’ opinion, report and testimony will play an essential role in mounting the response. Join EAS Consulting Group’s Independent Consultant and General Counsel at Herrick Feinstein LLP, Ronald J. Levine, for a one-day seminar on the role, expectations and skills for being an effective expert witness. Serving as an expert can be a part-time or full-time career. Whether you are just starting as an expert, or are looking to improve your skills, this seminar is meant to help to arm you for the important role you will be playing. We will also be discussing how to craft your resume and promote yourself with an aim of increasing opportunities to serve as an expert. [Add hyperlink when ready]

Next Dietary Supplement GMP Refresher Training in Andover, MA

EAS’ next Dietary Supplement GMP Refresher Training takes place August 13, 2019 in Andover, MA. Taught by Independent Consultant Tamika Cathey, this one-day intensive training is designed and priced so that firms can outsource their GMP training requirements to EAS. Conveniently located around the country, following the August training in Massachusetts, the fall GMP Refresher training will take place in Long Island November 12, 2019. Visit the EAS website for more information on the August 13 GMP Refresher training in Andover and the November 12 GMP Refresher training in Long Island.

EAS Presents cGMP Workshop at AHPA Hemp-CBD Supplement Congress

AHPA Logo

EAS Senior Director for Dietary Supplements and Tobacco Services, Tara Lin Couch, Ph.D. will present a workshop on cGMPs for dietary supplements along with attorney Marc Ullman of Rivken Radler, LLP at the upcoming American Herbal Products Association Hemp-CBD Supplement Congress in Denver, August 14-15, 2019. This event, focused on the challenges and opportunities of marketing hemp and CBD in dietary supplement products, will provide critical information for companies navigating the rapidly evolving legal, regulatory and financial landscapes to manufacture and market dietary supplement products with hemp or hemp-derived ingredients like CBD. For more information and to register visit the AHPA webpage.

How Does USDA Labeling Differ From FDA Food Labeling?

By Susan Glenn

Each month EAS experts answer one question sent in by readers. This month’s answer regarding USDA labeling is provided by Susan Glenn. Susan is an expert in matters pertaining to USDA and FDA regulations of the food industry with a particular focus on labeling, product standards and requirements. To ask your question of our experts, contact us.

Question: How does USDA labeling differ from FDA food labeling?

Glenn: Though both food products, USDA labeling is uniquely different from FDA labeling. While covering the full scope of regulations would require more time than can be answered simply here, (EAS does offer an in-house one-day USDA labeling compliance seminar), here are some brief facts to help you understand the differences.

USDA does not require an allergen statement at the end of the ingredient statement.

USDA requires all ingredients be listed by their common and usual name. Adding the allergen statement is voluntary but, if used, must follow all of the requirements of the Food Allergen Labeling and Consumer Protection Act (FALCPA).

USDA does not require the type size of the ingredient statement and address line to be 1/16”. 9 CFR 317.2(b) states “Any word, statement, or other information required by this part to appear on the label must be prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.” For poultry, the reference is 9 CFR 318.116.

The New Nutrition Facts Panel formats for FDA are not required for USDA. On January 19, 2017 USDA published a proposed rule to revise the nutrition facts panel format and certain reference amounts customarily consumed (RACC) to be consistent with FDA nutrition facts panel formats and certain RACC changes. By the end of July 2017, USDA announced the purposed rule was placed on the inactive list of rules and could be re-introduced “at a later time.” Meat and Poultry companies have the option to use the new FDA formats but must adhere to all of the FDA regulations pertaining to the formats and RACCS.

There are many additional differences between USDA and FDA regulated products, with labeling a big concern and one which can be confusing if the nuances between USDA and FDA labeling and not well understood. For more information on USDA labeling contact EAS.

June 2019 Drug and Device Corner

As part of the FDA’s ongoing efforts in their goal of more ANDA approvals in order to increase access to high-quality lower cost generic drugs, the agency began on 18 June 2019 to publish additional data in the existing Paragraph IV Patent Certifications list. The FDA hopes to assist ANDA applicants in their business decisions to pursue generic drug development. The list will now include, on a prospective basis, the following information:

  • Number of potential first applicants
  • 180-day decision status
  • Date of first “first applicant” approval
  • Date of first commercial marketing
  • Expiration date of last qualifying patent

For further information, please see the FDA’s Patent Certifications and Suitability Petitions website.

The FDA has posted a website regarding products containing cannabis or cannabis-derived compounds, and particularly cannabidiol (CBD), articulating their current position and 4 specific points they are working to learn more about. The webpage includes a link to a public docket the FDA is using to gather information and data. The docket is available for comment until 16 July 2019. The agency has consistently stated, however, that it believes that CBD is not a legal ingredient in a food or a dietary supplement because it has been investigated as a Investigational New Drug (IND) and has been approved for use in the drug Epidiolex.

Effective 17 June 2019, the FDA is making pre-assigned ANDA number requests available via the CDER NextGen Portal.

Guidance Document updates on the FDA website

CDER

CDER & CBER

CDRH

CDRH & CBER

  • Testing for Biotin Interference in In Vitro Diagnostic Devices
    This guidance is intended to help device developers and clinicians understand how FDA recommends biotin interference testing be performed, and how the results of the testing should be communicated to end-users, including clinical laboratories and clinicians.

CVM

Did you know? EAS Consulting Group Offers Preparatory Assessments Against VQIP Requirements for Firms

The Voluntary Qualified Import Program (VQIP) enables qualified importers of food and food products into the U.S. an expedited review and entry. However, meeting the stringent requirements of the VQIP program requires a thorough demonstration of documented safety of foreign suppliers of human and animal foods as well as an unblemished history of imports.

FDA uses its Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting (PREDICT) import screening tool to recognize shipments of food that are part of an approved VQIP application. The technical application requirements to achieve VQIP status can be time-consuming and complicated, but the end result is a smoother facilitation of imports. Many firms find VQIP to be of benefit to their operations and that of their customers in the US. In some cases, firms wishing to apply for VQIP seek an independent third-party certification of assurance of compliant practices.

EAS Consulting Group offers preparatory assessments against VQIP requirements for firms seeking approval into the program directly or through third-party certifications. EAS ensures that all processes and procedures are compliant with the rigorous safety requirements and identifies any gaps which must be addressed, ultimately better positioning firms when seeking FDA recognition into the VQIP program.

Contact EAS today for a desk assessment of SOPs and review of safety documentation, including that of suppliers, or bring EAS consultants in-house for a mock third-party certification audit prior to undergoing the official inspection. Thorough preparation for VQIP recognition will make for a smoother inspection process and ultimate certification, saving your business time and money by getting your products to the consumer in an expedited manner. For more information contact EAS today. You may also wish to view our recent on-demand webinar on VQIP requirements or search VQIP in the search bar of the EAS website to learn more about the program and our services.

Meet New Consultants for July 2019

Rama Narasimhan

Ramakrishnan Narasimhan (aka ‘Rama’) is a versatile, knowledgeable and competent professional with over 35 years of management experience in the manufacturing sectors pertaining to food, pharmaceutical and dietary supplement industries. He has wide ranging experience in designing, developing, guiding and auditing customized and standard product safety and quality system standards. His ‘think outside the box’ approach to solving complicated technical issues and problems enables novel solutions for clients. He is a frequent invited speaker in the area of product safety (food, pharmaceutical and dietary supplements) in international and domestic conferences.

Rama Narasimhan

Angel Suarez

Angel Suarez is a former Supervisor Consumer Safety Officer with the Food & Drug Administration. In this role he had responsibility of import enforcement in areas of seafood and Low-Acid Canned Food (LACF) as well as foreign inspections, warning letters, detentions, import alerts, import bulletins, and sample collections. He is the co-author of numerous publications including portions of the National Shellfish Sanitation Program’s Shellfish Equipment Construction Guide and the National Shellfish Sanitation Program’s Guide for the Control of Molluscan Shellfish Annotated Manual. In addition, he has developed training courses including FDA Certified Better Process Control School, Inspection and Sampling of Abnormal Food Metal Containers and the FDA Shellfish Officer Standardization Course. Angel has a B.S. with a major in Biology and minor in Chemistry and Physics from the Inter American University.

Angel Suarez

Meet July 2019 Issue of the Month Author

Robert Kapp, Ph.D. has over 30 years’ experience as a toxicologist involved with the management, development, and safety of new and existing products in a broad spectrum of industries including preclinical program study design, study reports, occupational and industrial toxicology and evaluating clinical and product safety data. Dr. Kapp assists EAS clients with writing critical position papers, GRAS notifications, 510(k) submissions, US EPA Premarketing Notifications, toxicology profiles, Safety Data Sheets and labels in the US and in global markets. Prior to consulting Dr. Kapp worked as Director, Toxicology Laboratory at Exxon Biomedical Sciences, Inc. He has a Ph.D. in toxicology from George Washington University.

Robert Kapp Ph.D.

What are SDSs?

By Robert Kapp, Ph.D.

Safety Data Sheets (SDSs) (formerly known as Material Data Sheets (MSDSs) contain basic information about a chemical or product needed to insure the safety and health of the user at all stages of its manufacture, storage, use, and disposal.

Interestingly, SDSs have a long and involved history, extending back into time – ultimately resulting in the present-day format. There are records indicating that MSDS-like documents were used 4000 years ago to describe pharmaceutical use in Egypt. A thousand year later, the Greeks recorded not only their own observations, but also some of their early experimental work on similar documents. Skipping ahead another millennium, chemical data sheets were continuously being developed by chemists at avante garde chemical companies as a way of transmitting various data to fellow chemists: melting/freezing/flash points, viscosity, density. As the industry became more enlightened in the last 100 years or so, the chemists began adding additional items, such as reactions and fire hazards. While health/safety and toxicological data had been developing over the past few 1000 years, it was only recently included on these data sheets as the next logical step in an all-inclusive document.

The US Federal Government got involved in the mid-1960s and developed its original Form LSB-00S-4 to meet the needs of maritime workers, added safety and hazard information for the first time to a chemical safety sheet. It was published and became law on August 23, 1968 in 33 FR 12008 as amendments to 29 CFR parts 1501, 1502 and 1503. Over the ensuing few years, there was pressure on Congress to extend benefits of the Longshoreman’s Act, plus additional safety and health coverages, to all of the nation’s industrial workers. With the passage of Public Law 91-596, on December 29, 1970, OSHA was established within the Department of Labor.

Initially, the formatting for these MSDS’s was fluid and varied considerably from company to company and from country to country. The EU standardized the format into what is now the 16-section document. Nevertheless, the quality, type of information and specifics of the MSDSs remained chaotic and in the minds of regulators, need some consistency. There was an effort to coordinate these vastly different documents by the US Government: The Hazard Communication Standard (HCS) (29 CFR 1910.1200(g)), was revised in 2012, requiring that the chemical manufacturer, distributor, or importer provide Safety Data Sheets (SDSs) (formerly MSDSs or Material Safety Data Sheets) for each hazardous chemical to downstream users to communicate information on these hazards.

The information contained in the SDS is largely the same as the familiar MSDS, except now the SDSs are required to be presented in a consistent user-friendly, 16-section format. When one creates an SDS, he/she must be aware that the proper labeling and warnings are included for the area (country) the product will be sold – the place that regulates the product.

Sections 1 through 8 contain general information about the chemical, identification, hazards, composition, safe handling practices, and emergency control measures (e.g., firefighting). This information should be helpful to those that need to get the information quickly. Sections 9 through 11 and 16 contain other technical and scientific information, such as physical and chemical properties, stability and reactivity information, toxicological information, exposure control information, and other information including the date of preparation or last revision. The SDS must also state that no applicable information was found when the preparer does not find relevant information for any required element.

The basic toxicological information is placed methodically in Section 11. While the specific format is not set, the acute data is a generally good place to start. Toxicological data such as the oral and dermal LD50s (Dose at which 50% of the animals exposed would be expected to succumb – this is a calculated formulaic number from a limited number of animals) as well as the inhalation LC50s (Concentration of a chemical at which 50% of the animals exposed would be expected to succumb). Basic information on skin, mucous membrane, respiratory and eye irritation as well as any repeated dose information would also be inserted in this section. Any cancer listings from IARC, EPA, NTP, ACGIH, NIOSH or OSHA would be included here. Any repeated dose studies that generate the no observed adverse effect level (NOAEL) should be briefly included here. Some companies insist on a toxicological profile of the chemical in this section, while others put minimal information.

There are other sections which will depend upon the toxicology section. For instance, Section 3 is the Hazard Identification and usually deals with the safe handling of the material by the user. This also includes things other than toxicity (e.g. flammability, vapor, etc.) but it is the application of the toxicological data to direct how the user must handle the product. If there are serious issues in handling the product, this has to be pointed out here. Sometimes potential health effects are detailed in this section. If this is global/EU, then those warning pictograms go in this section.

Section 4 is first aid. There are stock phrases that go in here based upon the toxicological profile of the material. Section 5 is Fire Fighting measures and can also relate back to the toxicology section if there’s some serious chemical reactions with the product.

Section 12 is ecological information. This is very important for EU. They put more emphasis on this than we have historically here in the US. The EU regulators want to know the potential ecotoxicity to fish, daphnia, algae and if the product biodegrades and/or bio-accumulates which can produce long-term harm to the environment.

The relevant regulatory information including exemptions, what agency takes precedence, rules to follow in the country that product is in, Toxic Substances Control Act (TSCA) – 1976 Public Law 94-469) listing, etc., should be in Section 15.

To summarize, many companies put a considerable amount of information on their SDSs while others – not so much. As a rule of thumb, the data should be as complete as possible with what is at hand with toxicological statements evaluated by a certified toxicologist. One should never speculate or overstate the effect of the product. As in all things scientific – be truthful and accurate.

FDA Strengthens Commitment to Defining High-Risk Foods, FSMA Enforcement

Dear readers,

Welcome to the July edition of EAS-e-News, the free newsletter for industries regulated by FDA. FDA took an important step this month when it agreed to settle a lawsuit filed by the Center for Science and commit to defining a designated list of “high-risk” foods as well as a proposed rule for high-risk food record keeping requirements by September 8, 2020. Additionally, the final rule will be established no later than November 7, 2022. Originally, Congress mandated that FDA designate high-risk foods by January 2012 and propose recordkeeping requirements for facilities that handle those foods by January 2013, so this renewed effort is welcomed as an important protection against food-borne illnesses which sickens countless annually.

I am pleased to say that EAS is an invited training partner for two upcoming events. First, Tara Lin Couch, Ph.D., Senior Director for Dietary Supplements and Tobacco Services will present a workshop on dietary supplement GMPs along with long-time training partner Marc Ullman, Of Counsel at Rivkin Radler, at the upcoming AHPA Hemp-CBD Congress taking place in Denver, August 14-15, 2019. Additionally, EAS will bring its popular Dairy Processing 101 seminar to the Process Expo in Chicago, October 8-11, 2019. More information on both of these seminars can be found in the EAS in Action section of this issue.

Additionally, EAS is announcing a new training seminar that we are very excited about. Coming on November 6, 2019, EAS Independent Consultant and General Counsel at Herrick Feinstein, Ronald Levine, will instruct a full-day event in Alexandria, VA on how to become, and strengthen skills, in the important service of providing Expert Witness services for FDA litigation, arbitration and mediation matters. EAS has over 30 consultants who serve in the capacity of Expert Witness. This important and critical component, as part of a comprehensive legal team, has become a critical factor in the demonstration of compliance expectations.

We invite you to join EAS at the International Association of Food Protection Annual Meeting, July 21-24, 2019 in Louisville, KY. EAS will be exhibiting at booth #319 and additionally independent consultant PC Vasavada will be speaking as part of an esteemed panel, along with Senior Director Allen Sayler, on FSMA compliance and FDA enforcement. You may wish to also view our recent webinar, Understanding the Food Fraud Puzzle, available on-demand on the EAS website.

I am pleased to welcome two new independent consultants, Rama Narasimhan and Angel Suarez. I am always impressed with the caliber of independent consultants who choose to work with EAS for the benefit of our clients. I invite you to learn more about both in the Who’s Who section of this issue.

I hope you enjoy this issue and please feel free to share with friends and colleagues who may also have interest.

Sincerely,

EAS Signature Ed

Ed