Welcome to the inaugural edition of Hyman, Phelps & McNamara, P.C.’s monthly wrap up of food, beverage and supplement news, including regulations, guidances, events, and whatever else is catching our eye. (Yes, we know that beverages and dietary supplements are “food” within the meaning of the FFDCA, but our international readers might not be aware of that nuance in U.S. law – so please just roll with the title.)
Food & Beverage
- FSMA Traceability: The FDA has proposed a new rule for FSMA traceability as part of the New Era of Smarter Food Safety initiative. Our initial analysis is forthcoming.
- Pesticides: FDA issued its annual Pesticide Residue Monitoring Program Report for FY 2018. The Pesticide Residue Monitoring Program is administered by the FDA to ensure that FDA-regulated foods in U.S. commerce comply with the pesticide tolerances, or maximum residue levels, set by the U.S. Environmental Protection Agency (EPA).
- Strengthening Organic Enforcement: USDA has proposed a rule intended to strengthen organic control systems, improve farm to market traceability, and provide robust enforcement of the USDA organic regulations. Comment period closes at 11:59 pm Eastern on October 5, 2020.
- Domestic Hemp Production Program: USDA’s AMS is providing an additional thirty (30) days for public comments on the interim final rule that established the Program. The comment period will be open from September 8, 2020 to October 8, 2020.
- Nutrition Facts Label: On September 18, 2020, FDA announced additional flexibility for manufacturers with less than $10 million in annual food sales who need to comply with updated Nutrition and Supplement Facts label requirements by January 1, 2021. Although the compliance date will remain in place, FDA announced they will not focus on enforcement actions during 2021 for these smaller food manufacturers.
- Sometimes Denigration is OK: But it has to be truthful, accurate, and narrowly drawn – a fine needle to thread. In a challenge brought by Clif Bar & Company, NAD concluded in part that Kind, LLC’s depiction of two bars in a commercial had a reasonable basis and was not “falsely denigrating.”
- Enforcement: DOJ announced “the largest-ever criminal penalty following a conviction in a food safety case” – a cool $17.25 million levied against Blue Bell Creameries. See our summary here.
- Bioengineered Animals: FDA posted a helpful webinar for product developers to help them understand the agency’s expectations for data submitted in support of a new animal drug application. (In the U.S., animals that have undergone intentional genomic alteration are subject to regulation as new animal drugs, even if they are only intended for food use.)
- CRN’s Board voted unanimously to reaffirm that participation in the Supplement OWL is a requirement of association membership for companies that market eligible finished products.
- Pharmaceutical ingredients found in cognitive enhancement supplements: Merits of the study aside, one possible consequence is increased scrutiny of the quality of products marketed in this category. Hat tip to CRN.
Some Things We Are Monitoring:
- 2020-2025 Dietary Guidelines: Expected by year end.
- A Petition from the Harvard Law School’s Animal Law and Policy Clinic (discussed in our FDALawBlog) regarding the naming of cell-based or cultured meat and poultry products requesting that the FSIS establish a labeling approach for cell-based meat and poultry that “does not overly restrict speech and that respects the First Amendment.”
- Supreme Court oral arguments on December 1 on the application of the Alien Tort Statute to ethical sourcing claims in Nestlé Doe I and Cargill v. Doe I.
- Lawsuits challenging FDA’s GRAS notice regulation and the agency’s oversight of bioengineered animals, and one challenging USDA’s BE labeling rule – all of which grind on, and on, and on…
- OEHHA’s proposed rulemaking to provide an exception for some exposures to listed chemicals in cooked or heat-processed foods – comments are due by October 21.
- FDLI Annual Conference: Exploring Advanced Topics in Food & Drug Law, October 6-8, 2020, where HPM’s Karin Moore will lead a lunchtime table discussion about Corporate Social Responsibility claims.
- CRN Day of Science and Annual Conference, October 13-16, where HPM’s Ricardo Carvajal will participate in a panel discussion on what the industry really needs from FDA.
- Consumer Brands Association Fall Food Labeling Workshop, October 19-23, 2020
- FDA public meeting on ‘‘CBD and Other Cannabinoids: Sex and Gender Differences in Use and Responses.” November 19, 2020