FDA to USDA: Slow Your Roll On Cell Cultured Meat

This assertion ostensibly is responding to a Congressional proposal that would require these products to be regulated by USDA’s Food Safety and Inspection Service.

In a Federal Register Notice published on June 18, 2018, FDA announced that it would convene a public meeting on July 12, 2018 titled, “Foods Produced Using Animal Cell Culture Technology.” In its meeting announcement, FDA acknowledged that technological advances and consumer interest are spurring development of commercial-scale production of foods that are intended to resemble traditional meat, poultry, and seafood, but are manufactured using, generally, a small amount of cells from the type of animal the food is intended to resemble.

However, the most noteworthy component of the meeting announcement is FDA asserting its jurisdiction over the developing technology.

“Just as we have been in the past with respect to rapidly evolving areas of technological innovation in food, FDA will be involved in the regulation of foods generated by animal cell culture technology in light of our broad statutory authority and our extensive expertise and experience in relevant scientific areas,” FDA declared.

In his statement announcing the meeting, Commissioner Gottlieb asserted that, under the Federal Food, Drug, and Cosmetic Act, FDA has jurisdiction over “food,” which includes “articles used for food” and “articles used for components of any such article.” Thus, as a starting point, he maintained, “both substances used in the manufacture of these products of animal cell culture technology and the products themselves that will be used for food are subject to FDA’s jurisdiction.”

FDA further explained that the agency currently evaluates microbial, algal, and fungal cells generated by large-scale culture and used as direct food ingredients, administers safety assessment programs for a broad array of food ingredients and foods derived from genetically engineered plants. FDA also reasoned that it manages safety issues associated with animal cell culture technology in therapeutic settings, and manages risks associated with the processing, manufacture, and packaging of food incorporating seafood tissues.

USDA Response: No, You Slow Your Roll

As reported in The Hagstrom Report, A USDA spokesperson pushed back on FDA’s statement, asserting, “FDA’s claim of jurisdiction over food — and anything used in food — is so overly broad that it implies that USDA doesn’t have a role. According to federal law, meat and poultry inspections are the sole purview of USDA, so we expect any product marketed as ‘meat’ to be USDA’s responsibility. We look forward to working with FDA as we engage the public on this issue.”

What Happens Now?

This issue likely will need to be resolved by Congress at some point, and FDA’s jurisdictional assertion on this issue complicates the prospects of any legislative proposal moving through Congress. While there is a provision included in the FY 2019 House Agriculture Appropriations bill that would provide FSIS with the authority to regulate lab-grown meat products, the prospects of this provision remaining in the bill as it moves through the legislative process is uncertain.

Additionally, FDA’s announcement could allow time for agency defenders in Congress, and other stakeholder groups who support FDA’s position, to enter the debate. This could have the effect of blunting the advocacy efforts of the livestock groups that support having jurisdiction over these products at USDA-FSIS.

Potential FDA Meeting Topics

In the Federal Register Notice announcing the meeting, FDA suggested that attendees provide information on the following topics:

• FDA has evaluated a variety of foods produced by cell culture, including microbial (e.g., probiotics), algal (e.g., spirulina), and fungal products (e.g., mycoprotein). What considerations specific to animal cell culture technology would be appropriate to include in evaluation of food produced by this method of manufacture?
• FDA has issued guidance on how to assess the effects of significant manufacturing process changes on the safety of a food ingredient. (See “Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes, Including Emerging Technologies, on the Safety and Regulatory Status of Food Ingredients and Food Contact Substances, Including Food Ingredients that Are Color Additives.”) What kinds of variations in manufacturing methods would be relevant to safety for foods produced by animal cell culture technology?
• FDA has a variety of pre- and postmarket programs for evaluating the safety of substances used in the production and manufacture of foods, including, for example, food additive and color additive regulations and preventive control requirements. What kinds of substances would be used in the manufacture of foods produced using animal cell culture technology and what considerations would be appropriate in evaluating the safety of these uses?
• Are the hazards associated with production of foods using animal cell culture technology different from those associated with traditional food production/processing (such as, for example, insanitary conditions, improper temperature controls, or control of contaminants)? Is there a need for unique control measures to address the hazards associated with production of foods using animal cell culture technology?