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  1. 1. Novel Food Ingredients: Challenges and Opportunities in Regulating an Emerging Industry David J. Glass, Ph.D. D. Glass Associates, Inc. December 9, 2019
  2. 2. Overview • Regulation of foods and food ingredients in the U.S. • Food Additives • GRAS Substances • Dietary Supplements • Case Studies reflecting some current regulatory issues • GMO Plants • Cell-Based and Plant-Based Meats • Animal Food Ingredients • Dietary Supplements
  4. 4. U.S. Regulation of Foods • Introduction of new “foods” in the U.S. does not require prior approval, as long as the food is not adulterated. • The U.S. Department of Agriculture (USDA) has authority over meats (beef, pork, etc.), poultry and catfish: facility registration, inspections, etc. • Food and Drug Administration (FDA) has authority over all other food products under the Food, Drug and Cosmetic Act. • Center for Food Safety and Nutrition (CFSAN): human food ingredients • Center for Veterinary Medicine (CVM): animal food ingredients (and drugs) • Food production must follow Good Manufacturing Practice, be in conformance with the Food Safety Modernization Act (FSMA), and production facilities must be registered and inspected.
  5. 5. U.S. Regulation of Food Additives • New ingredients intended for use in food or feed might require FDA approval as food additives. • Definition under the Act: “any substance the intended use of which results or may reasonably be expected to result -- directly or indirectly -- in its becoming a component or otherwise affecting the characteristics of any food.” • Different types of additives have somewhat different regulatory requirements, but all require FDA approval of a Food Additive Petition. • Direct food additive • Indirect food additive • Food contact substance • Color additives
  6. 6. GRAS Substances • Substances are not considered to be food additives if “that are generally recognized, among experts qualified by scientific training and experience to evaluate their safety, as having been adequately shown through scientific procedures (or, in the case of a substance used in food prior to January 1, 1958, through either scientific procedures or through experience based on common use in food) to be safe under the conditions of their intended use.” • GRAS status applies to a given use of a substance, not to substances per se. • GRAS determinations must be based on publicly available data. • The law allows a company to determine GRAS status itself, generally based on review by a panel of qualified experts. • FDA now maintains a policy for agency review of company GRAS determinations, through submission of GRAS Notices.
  7. 7. FDA GRAS Notice Program • August 2016, FDA issued a Final Rule that formalized a notification procedure under which an applicant may notify FDA of a conclusion that a substance is GRAS under the conditions of its intended use. • The rule formalized an interim process in place since 1997 for human foods; 2010 for animal foods. • The 2016 regulations specify the format and data requirements for GRAS Notices; FDA must review and respond to the applicant within 180 days. • FDA decides if Notice supports GRAS status: FDA “No Questions” letter is the equivalent of approval. • Human GRAS program has been very effective, Animal GRAS program somewhat less so.
  8. 8. Animal Food Data Requirements GRAS Notice • Part 1: Signed statements and certification • Part 2: The identity, method of manufacture, specifications, and physical or technical effect of the notified substance • Part 3: Dietary exposure • Part 4: Self-limiting levels of use • Part 5: Evidence of a substantial history of consumption of the substance for food use prior to January 1, 1958, • Part 6: A narrative that provides the basis for the GRAS conclusion • Part 7: A list of the data and information that the applicant discusses in the narrative of the GRAS notice Food Additive Petition • Identity and composition of the additive including manufacturing methods and controls • Intended use, use level, and labeling • Data establishing the intended effect (physical, nutritional, or other technical effect) • Analytical methods • Safety evaluation (target animal and human food) • Proposed tolerances for the food additive • Proposed regulation • Environmental assessment
  9. 9. Dietary Supplements • New regulatory class created by the Dietary Supplement Health and Education Act of 1994 (known as “DSHEA”). • Key components of the definition of “Dietary Supplement”: • a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients: a vitamin; a mineral; an herb or other botanical; an amino acid; a dietary substance for use by man to supplement the diet by increasing the total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of the above. • is intended for ingestion, and is not represented for use as a conventional food or as a sole item of a meal or the diet; and is labeled as a dietary supplement . • does not include an article that is approved as a new drug, antibiotic or biologic, or which has been authorized for investigation as a new drug, antibiotic, or biological. • FDA regulates claims made in labeling and packaging; Federal Trade Commission regulates claims made in advertising.
  10. 10. Dietary Supplements • Any dietary ingredient that was not sold commercially in the U.S. as of October 15, 1994 is considered a new dietary ingredient (NDI). • FDA approval is not needed before a product can be placed on the market, but manufacturers and distributors must make sure that all claims and information on the product label and in other labeling are truthful and not misleading. • Manufacturers and distributors of NDIs are required to notify FDA at least 75 days before beginning commercial introduction by filing an NDI notification form. • Product is free to be marketed at expiration of 75-day period, although FDA frequently notifies applicants that it has questions about specific products. • FDA directs much of its enforcement efforts at dietary supplements that are marketed with unsupported health claims.
  12. 12. Food use of transgenic (GMO) plants
  13. 13. • Allows for FDA review of proposed food use of transgenic (GMO) plants. • Process: • Initial consultations. • Submission of company’s safety and nutritional assessment. • Review by Biotechnology Evaluation Team with members from FDA CFSAN and CVM. • FDA may request a meeting, or submission of more data. FDA Voluntary Consultation for GMO Crops
  14. 14. • FDA may conclude: • No further questions • The product requires review as a food additive • There are other regulatory issues (e.g. labeling requirements) to be addressed. • FDA has reviewed > 180 cases to date. • Average time to decision has been increasing over time, but is approximately 20-24 months. FDA Voluntary Consultation for GMO Crops
  15. 15. Labeling of GMO Foods • Uniform standards for labeling “bioengineered” foods. • Proposed rule 2018, finalized December 21, 2018. • Voluntary compliance 2020-2021, mandatory compliance January 1, 2022. • Definition is broader than originally proposed, not limited to GMO plants: • (i) A food that contains genetic material that has been modified through in vitro recombinant deoxyribonucleic acid (rDNA) techniques and for which the modification could not otherwise be obtained through conventional breeding or found in nature; provided that • (ii) Such a food does not contain modified genetic material if the genetic material is not detectable pursuant to § 66.9.
  16. 16. Regulation of Cell- and Plant-Based Meats
  17. 17. Regulation of Cell- and Plant-Based Meats • 2018 saw increased attention to the companies developing and beginning to sell nontraditional fish and meat products (e.g. derived from plants or from cell culture). • This attention spilled over to the regulatory sphere, as stakeholders debated agency jurisdiction and the appropriate oversight scheme. • October 2018: FDA, USDA hold public meetings, open docket for public comments. • November 2018: FDA and USDA announce intent to develop joint regulatory framework. • March 2019: FDA and USDA Memorandum of Understanding.
  18. 18. Regulation of Cell- and Plant-Based Meats: FDA/USDA Memorandum of Understanding • MOU announced March 7, 2019. • MOU applies only to meat and poultry products: FDA to retain authority over cell-based fish production (other than catfish). • FDA would oversee activities relating to cell collection, and proliferation, e.g. cell banks, cell culturing facilities. • USDA would oversee processing, packaging and labeling of cell-based meat products, including facility and product inspection. • MOU identified areas where the agencies would work together. • Framework would rely on existing regulations, but agencies will review the possible need for new rules.
  19. 19. Regulation of Cell- and Plant-Based Meats: Current Status • Intense interest from consumer, environmental groups and industry trade associations. • Debate over appropriate labeling: should cell-based meats be labeled as ”meat” or somehow identified differently? • Approvals to date: Impossible Meats: soy leghemoglobin from genetically modified microorganism: FDA “no questions” letter July 2018.
  20. 20. Regulation of New Animal Food Ingredients
  21. 21. • Although overseen by FDA CVM there are several options for approval of new animal food (feed) ingredients: • GRAS Self-determination • GRAS Self-determination, notification to FDA • FDA Food Additive Petition • AAFCO New Ingredient Definition • Different pathways all generally require the same types of data. • The same group at FDA CVM conducts the technical review under all the pathways. Regulation of New Animal Food Ingredients
  22. 22. • AAFCO established a process to add approved new ingredient definitions to their Official Publication. • Applicants submit dossier to AAFCO Investigator, for review by FDA CVM. • New definitions approved by Ingredient Definition Committee and full AAFCO membership. • Program operates under an MOU with FDA CVM. AAFCO New Ingredient Definition Process AAFCO: Association of American Feed Control Officials
  23. 23. AAFCO Process is manageable but time-consuming 12-18 mos 3-6 mos 6 mos 12 mos minimum Submission CVM Review CVM Letter AAFCO Ingredients Definition Cmte Vote Good case scenario: 36 months from submission to publication Biannual meeting cycle Annual publication cycle CVM & AAFCO MOU: The 2 organizations work together under a Memorandum of Understanding that currently expires Sept 2017 Publication in the “next” Official Publication AAFCO General Membership Vote Slide courtesy of Kevin Wenger, Mascoma/Lallemand, used with permission
  24. 24. Pros Cons GRAS Self-determination Does not require agency review Not recognized by many states, Canada GRAS Notification through FDA When successful, GRAS status clearly established Program has not worked well, but FDA track record is improving Food Additive Petition through FDA If approved, legal status clear at FDA and AAFCO Time-consuming, requires rulemaking AAFCO Ingredient Definition Iterative review process, approval clears marketing in all states Long timeframes, dependent upon AAFCO meeting schedule, CVM review is low priority Regulation of New Animal Food Ingredients: Pros and Cons of Different Strategies
  25. 25. Dietary Supplements
  26. 26. Dietary Supplements: Most products do not meet FDA standards “Each of these issues has contributed to a situation where FDA finds approximately 75 percent of the NDI notifications it receives fail to satisfy the “reasonable expectation of safety" standard. While this is an alarming failure rate, companies that take the time to understand why others have failed and what those who have succeeded have in common stand a good chance of having their NDI notification filed by FDA without substantive objection.” “It is important to remember that the NDI Notification process is just that: a premarket notification of intent to sell. Seventy-five days after a notification is submitted, the statutory requirement has been satisfied, even if FDA has substantive questions concerning safety. Whether it is wise to go to market when FDA has such questions is another question.” Source: “Negotiating the New Dietary Ingredient Notification Process”, Marc Ullman, September 2014. process.
  27. 27. Dietary Supplements: FDA enforcement of CBD products • FDA has issued numerous warning letters to manufacturers or distributors of CBD products. • CBD products cannot be dietary supplements because CBD is an approved drug. • FDA concerns over unwarranted health claims made for such products. • FDA has also determined that many products do not contain the stated concentrations of CBD. Source: events/public-health-focus/fda-regulation- cannabis-and-cannabis-derived-products- including-cannabidiol-cbd.
  29. 29. Recommendations for the Future • Inter-agency cooperation, coordination is crucial. • Regulations must be science-based and focus on real risks. • Regulations must provide clear roadmap for industry while affording sufficient oversight to protect the public. • Must ensure sufficient outreach and involvement of the public, producer trade associations and other organizations, NGOs and public interest groups. • Government decisions must be transparent and accessible to the public.
  30. 30. David J. Glass, Ph.D. D. Glass Associates, Inc. 124 Bird Street Needham, MA 02492 USA Phone 617-653-9945 Thank you very much.