Cell-Based Meats: Regulatory Issues Facing an Emerging Field

Although a bit off-point from the original scope of this blog (biofuels and bio-based chemicals), I’ve lately been spending some time with the emerging field of cell-based meats, which has in recent months caught the attention of federal regulators here in the U.S. This field, more formally known as “foods produced using animal cell culture” or also as “cellular agriculture,” involves R&D aimed at producing edible substitutes for common human foods through cell culture, rather than through the farming and/or slaughter of live food animals (one early summary of the field can be found here). There are a growing number of companies in the U.S. and elsewhere, as well as numerous academic groups, that are working on such technologies, with the goal of creating beef, pork, poultry or fish products grown from tissue culture. Also under development are products such as egg substitutes comprised of microbially-produced proteins, as well as the “Impossible Burger” where a yeast-produced plant heme protein gives veggie burgers the taste and feel of beef hamburgers.

Although there have been low-key internal discussions within regulatory agencies and individual one-on-one discussions between companies and regulators about the appropriate regulatory pathways for such products, recent events in the first half of 2018 have brought this issue to the forefront. These have included a petition filed in February 2018 by the U.S. Cattleman’s Association asking the U.S. Department of Agriculture (USDA) to block cell-cultured meat products from being labeled as “meat” or “beef” (similar to the unrelated, recently-successful effort to prevent soy- or nut-based products from being labeled as “milk”), a Congressional briefing on the subject of cellular agriculture in June 2018, and a public meeting held by FDA on July 12, 2018 to discuss scientific issues relating to safety and regulatory oversight over such products (see below). Also, although not directly related to the use of tissue culture to produce meat substitute products, in July 2018, the FDA informed Impossible Foods, Inc. that the Agency had no objections to the company’s finding that its microbially-produced soy leghemoglobin was Generally Recognized as Safe for use with its plant-based Impossible Burgers.

FDA’s interest in regulating these products is notable because historically, the regulation of meat products in the U.S. has been under the auspices of the USDA, through the inspection and labeling authorities of its Food Safety and Inspection Service (FSIS). Indeed, the battle lines are beginning to be drawn between those favoring FDA’s having the lead role through its traditional responsibility for reviewing the safety and efficacy of new food additives and ingredients, and those who would prefer to see jurisdiction for meat and poultry to remain with the USDA (cell-based fish products, however, would be on the sidelines of any jurisdictional battle, because USDA has no regulatory or inspection role for any fish products other than, through a legislative quirk, catfish). FDA says that it has been in discussions with USDA about coordination to avoid any possible regulatory overlap, although there are signs that each agency may be pursuing its own plans for regulatory programs.

It was with this backdrop that FDA held its public meeting on July 12, 2018. The stated goal of the session was to “provide the public the opportunity to provide comments related to the production of foods using animal cell culture technology”. The June 18, 2018 Federal Register Notice announcing the meeting listed four topics on which public comments were invited:

  • FDA has evaluated a variety of foods produced by cell culture, including microbial (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. 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?

I was not able to attend the meeting myself, and so I can’t summarize the meeting and the nature of the public comments delivered orally at the session. There are several excellent summaries available online, such as reports on the websites of the Food and Drug Law Institute, the Good Food Institute and Ag Funder News. In the public meeting, FDA officials laid out the scientific issues it anticipates being raised by products in this category. In addition to hearing public comments from industry, public interest groups and others, the meeting featured a panel of stakeholders from industry, academia, and the non-profit sector offering their perspective on these issues and the nature of the regulatory regime that might emerge.

Following the meeting, FDA is soliciting public comments through September 25, 2018, which can be submitted online at regulations.gov, or in writing to FDA’s Rockville, MD address.

In follow-up posts, I have offered my thoughts about the scientific questions FDA has posed, and the regulatory and jurisdictional issues that should be addressed to enable the adoption of a rational, science-based regulatory scheme that utilizes all the applicable resources of federal regulatory agencies to assure the public that cell-based foods are safe, without creating an undue burden on the innovative companies developing these products.

D. Glass Associates, Inc. is a consulting company specializing in government and regulatory affairs support for renewable fuels, industrial biotechnology and related field. David Glass, Ph.D. is a veteran of over thirty years in the biotechnology industry, with expertise in industrial biotechnology regulatory affairs, U.S. and international renewable fuels regulation, patents, technology licensing, and market and technology assessments. More information on D. Glass Associates’ regulatory affairs consulting capabilities, and copies of some of Dr. Glass’s prior presentations on biofuels and biotechnology regulation, are available at www.slideshare.net/djglass99 and at www.dglassassociates.com. The views expressed in this blog are those of Dr. Glass and D. Glass Associates and do not represent the views of any other organization with which Dr. Glass is affiliated.