FDA Releases Public Inventory of Unapproved Food Additives and Lists of Select Chemicals in the Food Supply under FDA Review

The FDA’s Center for Food Safety and Applied Nutrition announced on July 12, 2023, that it has released a public inventory of food ingredients it believes are unsafe for use in food because they are unapproved food additives that do not qualify as GRAS (generally recognized as safe) for their intended uses. FDA also released lists of chemicals in the food supply, including food ingredients, food contact substances, and contaminants, that are currently under review by the agency. In addition, as part of its Conversations With Experts on Food Topics series, FDA released a Q&A session noting, among other things, that it intends to take a more systematic, proactive approach to post-market ingredient safety activities and is requesting additional funding from Congress for the agency’s post-market review framework. While FDA has previously expressed concerns regarding the safety of each of the substances currently identified in the public inventory as well as the lists through, for example, enforcement or public communications, this marks the first time FDA has compiled a public inventory of substances it has concluded are not GRAS as well as lists of chemicals in the food supply subject to FDA review. These actions as well as FDA’s post-market compliance plans signal increased focus on and scrutiny of unsafe food additives and chemicals of concern in the food supply.

Under the Federal Food, Drug, and Cosmetic Act (FDCA), any substance that is reasonably expected to become a component of food must be authorized by FDA for use as a food additive, unless use of the substance is generally recognized as safe (GRAS) by qualified experts or otherwise meets another exclusion from the food additive definition such as the exclusion for dietary ingredients, which are subject to different premarket requirements. As part of its on-going compliance activities, if FDA finds that a substance used in the food supply is an unapproved food additive, the agency may document its findings in a memo and take enforcement action.

These post-market determinations are now available in a searchable public inventory that identifies the names(s) of the substance and, for most of the identified substances, provides a copy of FDA’s scientific memo assessing the safety of the substance. The inventory also provides links to related FDA documents issued since 2004, such as warning letters, consumer updates, and other agency communications.

The current inventory, which is not meant to be exhaustive, identifies 12 substances for which FDA has concluded their intended uses are not GRAS, including CBD, THC, melatonin, and caffeinated alcoholic beverages. Notably, the inventory provides two FDA scientific memos in which the agency articulates its rationale for finding that CBD is an unlawful food additive. More specifically, in memos from 2019 and 2022, FDA maintains that CBD does not qualify as GRAS primarily because animal studies suggest that orally consumed CBD has the potential to cause damage to the male reproductive system and to the liver as well drug metabolism interactions—concerns previously made public by the agency.

FDA explains that it reviews the safety of exposure to chemicals in the food supply in response to stakeholder requests or its own initiative when review is warranted based on scientific evidence. The agency released two lists of such substances, which are not intended to be exhaustive: (1) a list of select food ingredients and food contact substances that FDA is re-reviewing; (2) a list of select environmental or process contaminants that are currently under FDA review.

The list of select food ingredients and food contact substances consists of chemicals that FDA has previously reviewed—such as short-chain PFAS, BPA, and phthalates—but is currently reassessing in light of the latest available information. The list of contaminants reflects chemicals that are of significant interest to a range of stakeholders and includes contaminants, such as arsenic, lead, and other heavy metals, that FDA is focused on through programs like its Closer to Zero initiative as well as other chemicals such as PFAS.

FDA also released a conversation with Acting Director of FDA’s Office of Food Additive Safety, Kristi Muldoon-Jacobs, that included a discussion of the agency’s post-market food safety activities. Muldoon-Jacobs signaled that FDA plans to take a more systematic, proactive approach to post-market food safety assessment that will be science-based, prioritize ingredients and food contact substances based on potential for public health risk, and will provide an opportunity for stakeholder input and engagement. FDA plans to detect signals through routine surveillance and will assess risk using toxicology data, exposure modeling, and potentially new methods designed to assess safety without the use of animal models. FDA has requested additional financial resources to help fund these post-market safety activities as part of President Biden’s fiscal year 2024 budget.

Taken together, these actions indicate that FDA may soon ramp up its post-market safety monitoring and enforcement activities. This could include increased and more extensive enforcement against substances FDA has already identified as unlawful, and an expansion of the food substances and contaminants that come under FDA’s scrutiny. In addition, these FDA actions could lead to increased attention from state regulators and legislators as well as potential consumer litigation. Covington will continue to monitor FDA’s activities related to the safety of food ingredients, food contact substances, and contaminants to provide up-to-date information and insights.

If you have any questions concerning the material discussed in this client alert, please contact the members of our Food, Drugs, and Devices practice.