The announcement also made it clear that regulating cultured meat – which involves producing meat from growing animal cells outside an animal – falls squarely within the FDA's remit, despite calls for USDA to create new regulations governing clean meat.
In a statement about the meeting, to be held on July 12 at FDA’s Center for Food Safety and Applied Nutrition HQ in Maryland, the agency explained: “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, 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 and applicable statutory and regulatory food safety and food labeling requirements.”
As to the mechanisms available, it said: “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.”
Attorney: FDA, not the USDA, will have primary jurisdiction over cultured meat
Rebecca Cross, an attorney formerly with Davis, Wright, Tremaine LLP and now with Outermost House, an incubator for plant-based and cell-cultured food companies launching later this year, told FoodNavigator-USA that she saw two key takeaways:
"One, that FDA, not the USDA, will have primary jurisdiction over cultured meat — at both pre-market and post-market stages.
"Two, that the FDA sees no need for new regulations to oversee cultured meat — either pre-market or post-market. The agency explains that cultured meat, while innovative, uses technologies that the FDA already regulates and, once scaled-up, will be processed using traditional food manufacturing processes that it regulates under FSMA. The regulatory pathway will, therefore, be through an existing FDA program, which may be as a food additive, through GRAS designation or something else."
Good Food Institute: It makes sense for FDA to regulate clean meat
The Good Food Institute - which works with companies in the cultured and plant-based meat space – also welcomed the FDA’s announcement, said director of policy Jessica Almy, who noted that the FDA has experience with new technologies and production methods that are most closely analogous to clean meat, which comes with significantly reduced risk of microbial contamination.
“It makes sense for FDA to regulate clean meat. FDA regulates food. Both the Federal Meat Inspection Act and the Poultry Products Inspection Act are intended to give USDA the authority to regulate the slaughter of animals. Because there is no slaughterhouse involved in clean meat production, it is not clear how these laws would apply to clean meat.”
She added: “We are heartened to see that FDA is engaged in thinking through how clean meat can come to market under the existing regulatory framework.”
Eric Schulze, VP of product and regulation at clean meat co Memphis Meats, said he looked forward to participating in the meeting on July 12: "Memphis Meats believes that stakeholders across government, including FDA and USDA, and the meat and poultry industries should work together to clarify how the existing regulatory framework applies to clean/cultured meat, while supporting innovation."
Josh Tetrick, cofounder and CEO at JUST Inc (formerly Hampton Creek) - which is also developing a clean meat platform - added: “The leaders of the national and global meat industry want to feed the world animal protein in a sustainable way. That’s a shared interest that should be celebrated. And I’m grateful to see the FDA bringing all us together to talk about making it happen.”
“[At] the July 12 meeting, we will share our initial thinking for how we intend to appropriately apply our existing regulatory tools and policies to this novel area of technology. The forum will also provide an opportunity to discuss with stakeholders potential benefits and challenges of developing and regulating these products.
“While the primary focus of the meeting is food safety… we also want to have a dialogue around other areas of interest related to foods produced through animal cell culture technology, such as labeling.”
FDA commissioner Dr Scott Gottlieb
Questions the FDA wants to address
Ahead of the meeting – which will also include some discussion about naming conventions for cell-cultured meat, poultry and fish – the subject of much debate in light of a petition from the US Cattlemen’s Association – the FDA has issued some questions for public comment, including:
- What considerations specific to animal cell culture technology would be appropriate to include in evaluation of food produced by this method of manufacture?
- What kinds of variations in manufacturing methods would be relevant to safety for foods produced by animal cell culture technology?
- 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?
Who’s who in the global clean meat market?
While no cultured meat products are on the market yet, a handful of players from Mosameat in the Netherlands, Future Meat Technologies and SuperMeat in Israel, Memphis Meats, Finless Foods, Wild Type, BlueNalu and Just Inc in the US, and Integriculture in Japan are looking to introduce them over the next five years, prompting some lawmakers to question whether a new regulatory framework is required.
Culturing animal cells to make meat might be a novel approach to food production, Memphis Meats CEO and co-founder Uma Valeti MD told FoodNavigator-USA in a recent call, but the resulting products are “compositionally and nutritionally substantially equivalent to existing meat products on the market,” meaning existing regulatory frameworks can accommodate them.
Read more from Dr Valeti about the go-to-market strategy HERE.