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  • We reported on a November 14, 2019 citizen petition submitted to FDA by the Consumer Healthcare Products Associated (CHPA) requesting that the agency issue regulations to establish a clear pathway for the use of cannabidiol (CBD) in dietary supplements.  After public hearings and the first of two Congressionally mandated reports from FDA, discussed here, however, the market for FDA-regulated food and dietary supplement products that contain CBD continues to grow rapidly while a regulatory pathway for lawfully marketing such products still is not in place in the U.S.
  • Undeterred by FDA’s inaction on the CHPA petition, the Council for Responsible Nutrition (CRN) filed a similar citizen petition on June 16, 2020 urging FDA to regulate hemp-derived CBD as a dietary ingredient.  The petition distinguishes “full spectrum” hemp extracts from CBD isolates, which CRN argues is the substance that has been approved for use in a drug and is therefore prohibited from use in a food or a dietary supplement.  Regarding the petition’s focus only on dietary supplements, a CRN spokesperson told Food Navigator that FDA’s report to Congress indicates that FDA’s safety concerns may be limited to food uses of CBD, although CBD-infused beverage brands maintain that both categories can be safely accommodated under the current regulatory framework.  CRN recognizes that its petition could languish with FDA and told Food Navigator that the organization is focusing mainly on legislative initiatives to bypass FDA altogether.
  • A June 17, 2020 letter from the consumer organizations, Consumer Federation of America (CFA), Center for Science in the Public Interest (CSPI), Consumer Reports, and Public Health institute, urged lawmakers not to push FDA to act on CBD before it has adequate data or to by-pass FDA.
  • In the wake of rapidly increasing sales, FDA has continued to maintain that dietary supplements containing hemp-derived cannabidiol (CBD) are illegal under the Federal Food, Drug & Cosmetic Act. FDA officials have previously stated that the agency is exploring additional regulatory pathways available to hemp products containing CBD, but predicted that completing a potential rulemaking proceeding could span 3 to 5 years even under the best of circumstances.
  • Amidst Congressional pressure for FDA to act quickly in establishing a regulatory framework for CBD and outside efforts urging Congress to pass legislation that would make CBD derived from hemp a legal dietary ingredient, the Consumer Healthcare Products Associated (CHPA) submitted a citizen petition to FDA requesting that the agency issue regulations to establish a clear pathway for the use of CBD in dietary supplement manufacturers. CHPA expressed a preference for an interim final rule as opposed to full notice and comment rulemaking but asked that if notice and comment rulemaking was used that FDA issue guidance or an enforcement discretion position at the same time.
  • Under CHPA’s proposal, FDA should require manufacturers of CBD-containing dietary supplements to submit a new dietary ingredient notification (NDIN) for CBD and comply with other applicable laws, including using appropriate labeling and claims, adhering to GMPs, and reporting serious adverse events. The petition notes that requiring NDINs would provide FDA with much-needed data on CBD that could help inform FDA’s broader regulatory framework for CBD products. CHPA’s petition is consistent with the approach that we believe FDA is considering as it evaluates whether CBD can be authorized for use in dietary supplements.
  • FDA’s regulation on nutrition labeling of dietary supplements requires that dietary ingredients for which a Reference Daily Intake (RDI) or Daily Reference Value (DRV) has not been established must be listed inside the Supplement Facts label along with their quantitative amount by weight per serving in metric units, as described in 21 CFR 101.36(b)(3).  For microbial ingredients in probiotic products, the weight of the cellular mass (which can include dead and injured cells) does not necessarily correlate with the number of viable microorganisms in the product.
  • In finalizing its May 2016 amendment of the labeling regulations for conventional foods and dietary supplements, FDA declined a request to “permit the use of additional units of measure for dietary ingredients to allow for use of more appropriate units of measure when metric weight is not the most accurate way to express the quantity of the dietary ingredient,” and cited the need for more time to evaluate the matter.  FDA subsequently received a citizen petition from the International Probiotics Association (IPA) requesting that the permitted unit for reporting live microbials be changed from weight to colony forming units (CFUs) in the regulation.
  • As reported here, FDA’s September 2018 draft guidance (Policy Regarding Quantitative Labeling of Dietary Supplements Containing Live Microbials) reflected FDA’s decision to delay acting on IPA’s petition, and announced conditions under which the agency would in the interim exercise enforcement discretion for the declaration of the quantity of live microbials in CFUs in addition to weight.  FDA received 1,958 comments on the draft guidance before the comment period closed on November 6, 2018.  The Consumer Healthcare Products Association (CHPA), Council for Responsible Nutrition (CRN), and other stakeholder groups argue that requiring companies to list both the quantitative amount as weight (in mg) and as CFUs will present information on product labels in a way that is potentially misleading and will likely result in consumer confusion.  IPA further asserts that labeling only CFUs complies with the law because the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 343(q)) requires labeling to include the quantity of a nutrient but does not prescribe any specific unit of measure.
  • Since comments on IPA’s petition reflect wide – but not unanimous – industry support for mandatory listing of CFUs for microbial ingredients, and new methods for quantifying live microbes – including flow cytometry – are still in the research phase, we are convinced that FDA will not promulgate a regulation on listing CFUs at this juncture and is also very unlikely to revise its current enforcement policy to drop the requirement for listing the weight of microbial ingredients.