On April 7, 2014, the Natural Resources Defense Council (NRDC) issued its latest report on GRAS self-determinations, entitled Generally Recognized as Secret: Chemicals Added to Food in the United States. We previously reported on NRDC’s and the Pew Charitable Trust’s prior criticism of the GRAS provision here and here. The new article reports on a study of GRAS ingredients that NRDC concluded were marketed in the U.S. based on GRAS self-determinations that were either never submitted to FDA or were the subject of GRAS Notifications to FDA that subsequently were withdrawn. NRDC claims to have identified “275 chemicals from 56 companies that appear to be marketed for use in food based on undisclosed GRAS safety determinations.” The report categorizes the GRAS exemption as “the loophole that has swallowed the law.” NRDC concludes that “[t]he system is broken and plagued with conflicts of interest,” that a food ingredient cannot be GRAS “if its identity, chemical composition and safety determination are not publicly disclosed,” and that a legislative change to GRAS authorizations is necessary.
In a coordinated effort, the Center for Science in the Public Interest (CSPI) issued an alert to its members, alleging that GRAS self- determinations are a “frightening problem” and asking their supporters to join its “campaign to strengthen FDA’s role on food safety and let them know how shocked and disappointed you are that they have fallen down on the job and put you at risk.”
As an initial matter, we note that there is nothing improper with a company making a GRAS determination and marketing its product based on that determination. See FDA, Proposed Rule, Substances Generally Recognized as Safe, 62 Fed Reg 18938, 41 (April 17, 1997) (“a manufacturer may market a substance that the manufacturer determines is GRAS without informing the agency …”). Under Section 201(s) of the Federal Food, Drug and Cosmetic Act (FFDCA), 21 USC 321(s), an ingredient that is generally recognized as safe is not a “food additive” and is not subject to the food additive pre-market review requirements.
The NRDC article overlooks several facts that render their conclusions questionable. Specifically:
- The identities of GRAS food ingredients are not unknown;
- A GRAS determination must be based on “the same quantity and quality of scientific evidence as is required to obtain approval of a food additive regulation for the ingredient,” 21 CFR 170.30(b); and
- Foods containing ingredients based on improper GRAS determinations are “adulterated” and subject to FDA enforcement actions.
Several times in the report NRDC claims that the chemical identity of some GRAS ingredients are not “publicly disclosed.” [NRDC suggests that the acronym GRAS should stand for “Generally Recognized as Secret.] However, FDA regulations require that all ingredients in a processed food (except for processing aids and other incidental additives) be listed on the label in the ingredient declaration. 21 CFR 101.4(a)(1). Since the GRAS ingredients will be listed on the label, they are not secret. Further, since a GRAS determination must be based on published data, 21 CFR 170.30(b), the public is able to review the safety data and make their own determinations as to the safety of the ingredient.
NRDC also implies that substances deemed to be GRAS are less safe than substances cleared through a food additive petition or GRAS Notification. However, as noted above, FDA regulations require the same evidence for GRAS determinations that are required for food additive petitions. In addition, FDA requires that this information be published, usually in a peer-reviewed journal, before the GRAS determination is made. Thus, the data used to support a GRAS determination has undergone an independent evaluation and been found to be suitable for publication before a proper GRAS determination is made.
In the article, NRDC contends that FDA needs more authority to regulate GRAS ingredients. However, the article never discusses FDA’s current authority and how FDA has acted in the past to control the use of ingredients that may not be GRAS. Under the FFDCA, a food ingredient that is neither GRAS nor used in accordance with an applicable regulation is an unapproved food additive and is deemed to be unsafe under FFDCA §409(a)(2), 21 USC §348(a)(2). Any food that contains an unsafe food additive is considered to be adulterated under FFDCA §402(a)(2)(c)(i), 21 USC §342(a)(2)(c)(i) and may not be introduced into interstate commerce. FFDCA §301(a), 21 USC §331(a).
Over the past few years, FDA has issued Warning Letters to companies it believes are marketing food containing ingredients that are not GRAS. For example, FDA issued letters to 30 companies on November 13, 2009, asking them to provide data supporting their determinations that caffeine is GRAS for use in alcoholic beverages. The agency followed up with Warning Letters to 4 companies supplying caffeinated alcoholic beverages on November 17, 2010, questioning the GRAS status of caffeine as an ingredient in their products (see here and here). FDA’s actions in this matter were highly effective and all of the caffeinated alcoholic beverages have now been removed from the marketplace. In situations where a food poses a more immediate public health concern, FDA has authority to seize adulterated foods, FFDCA §304(a), 21 USC §334(a).
In coordination with the NRDC article, CSPI issued an alert alleging that GRAS self determinations are a “frightening problem.” The alert included an “infographic” that it claims exposes “the spaghetti-tangle of FDA’s failure to ensure the safety of food additives.” CSPI asked their supporters to share its material through social media. The infographic suggests that suppliers can ignore FDA questions regarding GRAS determinations and use the product in food without adequate safety data. This ignores the fact that, as explained above, FDA has significant authority to prevent such use.
The CSPI infographic also fails to address the primary reason many companies choose to pursue a GRAS self-determination rather than submit a food additive petition or GRAS Notification. Under the FFDCA, FDA is required to respond to a food additive petition within 180 days. FFDCA §409(c)(2), 21 USC §348(c)(2). However, in practice, the review period for most food additive petitions is 3 years or more. For many companies, the delay incurred by the food additive petition process is unfeasible.
Neither NRDC nor CSPI make a persuasive argument that reform of the GRAS process is needed to protect consumer safety. Without a clear and significant threat to public health, it appears unlikely that Congress will enact the changes to the FFDCA that would be needed to significantly restrict the ability of companies to make GRAS determinations.