HPM’s Food, Beverage & Supplement Wrap Up: September 2020

October 8, 2020By Karin F.R. Moore & Ricardo Carvajal & Riëtte van Laack

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:

Upcoming Events: