Welcome to the latest 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.
Food & Beverage
- Transition: As of this writing, Janet Woodcock is Acting Commissioner of Food and Drugs; Norris Cochran is Acting Secretary of Health & Human Services; and Tom Vilsack was just confirmed as Secretary of Agriculture (again!).
- 3D printed ribeye? An Israeli company unveiled what is being described as a “3-D printed rib-eye” made with “3-D bioprinting technology.” The company claims to have been in discussions with USDA and FDA for the past two and a half years.
- Food Supply Chain Focus at the WH. The President signed an Executive Order to help create more resilient and secure supply chains for critical and essential goods, and agricultural commodities and food production are a key sector that will be the focus of a year-long review.
- Keep those essential workers safe! FDA published a new web page with information to help employees in the food and ag sector communicate about COVID-19 vaccines in their workplace.
- Prop 65: OEHHA announced a (virtual) public hearing on March 11, 2021, at 10:00 a.m. and extended the time for submitting comments to the proposed rule regarding short form warnings to March 29 to accommodate the hearing.
- Baby food report. The House Subcommittee on Economic and Consumer Policy, Committee on Oversight and Reform released a report alleging “dangerous” levels of heavy metals in baby foods. Shortly thereafter, FDA published a response in the form of a Constituent Update in which the agency assured the public that “FDA regulations and monitoring help to ensure the safety of baby foods sold or manufactured in the United States.”
- US Food Supply is Safe! FDA and USDA issued a statement that food and food packaging have not been linked to spread of COVID-19.
- Costs of Foodborne Illness: USDA published a report on the cost of foodborne illnesses; the report is a bit short on conclusions but the cost continues to increase. This is not particularly surprising since last year CDC reported a continued increase in incidence of foodborne diseases.
- Speaking of Pathogens in Food: Center for Science in the Public Interest together with several other public interest organizations and individuals submitted a petition to FSIS/USDA requesting that FSIS engage in rulemaking to 1) establish enforceable finished product standards for Salmonella types of greatest public health concern and Campylobacter and 2) require poultry establishments to identify and control food safety risks within their supply chain. FSIS opened a docket on regulations.gov for comments which must be submitted by April 6, 2021.
- Organic wild caught fish? NOP just announced a town hall meeting regarding wild caught fish.
- More transition. Steven Tave is leaving the Office of Dietary Supplement Programs and moving to the Office of Regulatory Affairs at FDA. Cara Welch will be acting director of ODSP starting March 15.
- Warning Letters. FDA issued warning letters to 10 companies for selling dietary supplements that claim to treat depression and other mental health disorders.
- Criminal Sentencing. A former dietary supplement company executive was sentenced to prison for his role in fraudulently selling popular workout supplements that caused liver damage. A number of executives have already been sentenced in this ongoing fraud investigation.
- Nanotech-related claim requires substantiation. NAD recommended discontinuation of a claim touting a nanotech oral delivery system for glutathione as the first effective alternative to injections. NAD found the supporting in vitro and in vivo pilot studies did not constitute a reasonable basis for the claim.
More on Cannabis
- Just under the wire: We wrote last month about USDA finalizing the framework for the Establishment of a Domestic Hemp Production Program, which takes effect on March 22. Our colleague Larry Houck provides more insight.
- The deadline for submission of comments on labeling of cell-cultured seafood products is coming up on March 8.
- The American Conference Institute’s popular “FDA Boot Camp” – now in its 36th iteration – is scheduled to take place (virtually, of course) March 24-25, 2021, and is co-chaired by HPM’s own Kurt Karst.
- Riëtte van Laack will be discussing “Nutrient Content, Health and Other Claims” at FDLI’s Introduction to Food Law and Regulation, March 16-18.