HP&M’s Food, Beverage & Supplement Wrap Up: October 2020

Welcome to the latest edition of HP&M’s monthly wrap up of food, beverage and supplement news, including regulations, guidances, events, and whatever else is catching our eye.

Food & Beverage

• Are your cows happy? Check out Karin’s blog post on corporate social responsibility claims.
• Is it a Sugar? Riëtte and Ricardo wrote about FDA’s request for information pertinent to nutrition labeling of sugars that don’t act like traditional sugars.
• Cell-Based Meat and Seafood Labeling: The North American Meat Institute and the Alliance for Meat, Poultry and Seafood Innovation joined forces to back a mandatory labeling requirement for cell-based meat and poultry products. Meanwhile, FDA published a constituent updateand Federal Register notice asking for comment by March 8, 2021 on a number of questions pertaining to labeling of “foods comprised of or containing cultured seafood cells.”  More details can be found in Ricardo’s blog post on the notice.
• Some processes preclude a “100% natural” claim. The National Advertising Review Board recommended that GSK discontinue a “100% natural” claim for a product consisting solely of wheat dextrin because consumers “would likely conclude that the manufacturing exceeded minimal processing” compatible with that claim. The panel held out the possibility that a qualified use of “natural” might be supportable.
• Gluten Free Alcoholic Beverages: TTB has updated its guidance on gluten content statements for wines, distilled spirits, and malt beverages in response to the August 2020 FDA final rule on verifying “gluten-free” labeling claims for fermented or hydrolyzed foods.
• The Incredible, Edible Egg: The HAACP and sanitation SOPs for egg producers final rule was just published in the Federal Register.
• Take Me to the Pilot: The FDA is launching a voluntary pilot program to evaluate alignment of private third-party food safety audit standards with the food safety requirements in Preventive Controls for Human Food and the Produce Safety rules.
• Ingredient safety assessments under fire: A late September 2020 citizen petition asks FDA to enforce the FDC Act requirement regarding the cumulative effect of food substances as part of safety assessment. See Riëtte’s blog post for more details.
• Boring but important: FDA is issuing guidance establishing a U.S. Agent Voluntary Identification System (VIS) for food facility registration, which is intended to be used in conjunction with the food facility registration database to streamline and expedite the U.S. agent verification process.
• Also boring but important: Don’t forget to renew your food establishment registration.

Supplements

• DMAA out. The Supreme Court rejected a request to review a case involving the legality of DMAA (1,3-dimethylamylamine), a once-prevalent ingredient marketed in sports supplements, leaving in place a 2019 ruling by the 11^th Circuit – which you can read about in our blog posting on that ruling.
• Branched chain amino acids? Natural Products Association Petitions FDA on Nutrition Facts and Supplement Facts Labeling Regulations Pertaining to Caloric Values.
• Challenge to DEA’s Clarification of the Farm Bill: Should intermediates containing in excess of 0.3% THC that have been derived from hemp be regulated as controlled substances by DEA? Not if plaintiffs in these lawsuits

Some Things We Are Monitoring:

• 2020-2025 Dietary Guidelines: Expected by year end.
• A hemp case where HIA and RE Botanicals filed a lawsuit against the DEA in the D.D.C., seeking a declaration that the definition of hemp in Section 1639o, includes “intermediate hemp material” (IHM) and “waste hemp material” (WHM) and that the THC in IHM and WHM is not a controlled substance. You can read about that litigation in our colleagues’ blog posting.
• Supreme Court oral arguments on December 1 on the application of the Alien Tort Statute to ethical sourcing claims in Nestlé v. Doe I and Cargill v. Doe I.
• Interesting perspectives on the possible direction of the FTC’s consumer protection mission under a Biden administration, particularly when it comes to consumer redress and civil penalties.

Upcoming Events:

• FDA public meeting on ‘‘CBD and Other Cannabinoids: Sex and Gender Differences in Use and Responses.” November 19, 2020
• FDA public meetings on the proposed rule for “Requirements for Additional Traceability Records for Certain Foods.” November 6, 2020, November 18, 2020, and December 2, 2020.
• The Center for Research on Ingredient Safety at Michigan State University will host a virtual CBD Science Symposium on November 11-12. Ricardo will present a primer on key issues in the regulation of hemp-derived CBD.