By: Robert W. George and Kael K. Bowling
A June 15, 2018 notice from Commissioner Scott Gottlieb, M.D. suggests that the Food and Drug Administration may have won the first round of a debate about who should regulate meat and poultry products grown in laboratories rather than on farms. In its notice, FDA touts its prior experience evaluating new areas of food innovation and schedules a public meeting in Washington, D.C. for July 12, 2018 to start the dialogue about how to regulate “cultured meat products” made from cells collected from animals that are multiplied using non-traditional food technologies.
FDA is seeking input on the safety of this emerging category of foods, but the most controversial topic on the agenda for this meeting relates to how these products will be labeled. Current definitions and standards applied to meat and poultry products under the Federal Meat Inspection Act, 21 U.S.C. § 601 et seq., and the Poultry Products Inspection Act, 21 U.S.C. § 451 et seq., arguably are limited to foods produced from the carcasses of animals harvested at processing plants.
Manufacturers of cultured meat products looking to position their products as simply “better” versions of products that consumers already trust and enjoy are likely to push for the right to use words like “meat,” “beef” or “poultry” on their labels. Farmers and food companies producing food products from conventionally-raised animals are opposed to labeling terminology that equates meats from animal cells cultured in labs to their more traditional products. And, for now, it appears that the arbiter of this dispute will be FDA.
News that FDA, rather than United States Department of Agriculture, is conducting the initial public meeting likely surprised and disappointed groups aligned with traditional animal agriculture. The US Cattleman Association previously submitted a petition asking USDA to prohibit the use of the terms such as “meat” and “beef” on labels for cultured products. Farm groups similarly sought to include language attempting to delegate regulatory oversight over cultured products to USDA in a recent spending bill which Congress failed to pass. Whether FDA will be less protective of traditional animal agriculture’s interests than USDA remains to be seen.
Despite their disappointment in FDA’s selection as the regulator of choice, farm groups should be comforted by the current administration’s plans to provide early regulatory guidance on these issues. This approach could avoid the chaotic and litigious emergence of alternative milk products experienced by those in the dairy industry over the past two decades. Federal regulators were not proactive in regulating those new products and generally ignored stakeholder requests to develop new standards of identity for plant-based alternatives to milk (e.g., soy milk and almond milk). The uncertainty produced litigation between trade associations, openings for class action lawsuits and confusion among consumers — all of which persists to this day.
Commissioner Gottlieb’s notice suggests that FDA is seeking to avoid a costly repeat of these counter-productive dynamics for cultured meat products. Rather than lament the assignment of this task to FDA, as opposed to USDA, now is the time for stakeholders to engage, and the July 12, 2018 public meeting is their first opportunity to do so. The issues raised in FDA’s notice are legally and technically complex. If your company or association would like assistance in the development of messages or strategies related to the upcoming July 12, 2018 public meeting, our firm would be pleased to assist you.
The information provided above is created the Attorneys Robert W. George and Kael K. Bowling of Friday, Eldredge & Clark, LLP. Robert’s focus consists of a multifaceted business litigation practice in both federal and state courts and includes defending clients against environmental and toxic tort claims, as well as commercial disputes or involving fraud, theft or unfair competition. Kael is an associate in the firm’s Commercial Litigation and Regulation Practice Group. His practice includes serving as litigation counsel to financial institutions, insurance companies, and other business entities in connection with a broad range of subject matters.
This is not a substitute for legal advice and should be considered for general guidance only. For more information or if you have further questions, please contact one of our attorneys.