Letter on proposed changes to GRAS regulations

There is a bill before the Senate Committee on Health, Education, Labor, and Pensions that would drastically alter the path to market for new food ingredients.  As an observer of FDA, I expect that this bill will have ramifications for the dietary supplement industry and the New Dietary Ingredient Notification process.  Here is the text of the letter I sent to the committee members and the sponsoring senators:

Re: Comments on S.4316, Ensuring Safe and Toxic-Free Foods Act of 2022

Honorable Senators Murray, Burr, Markey, Blumenthal, and Warren,

This letter serves to provide comments on the draft of the Ensuring Safe and Toxic-Free Foods Act of 2022 issued by the Senate HELP Committee on May 26, 2022.

I am an FDA regulatory consultant with a focus in the food, dietary supplement, and cosmetic sectors. I have worked in FDA-regulated industry since 1986 as a researcher, pharmacologist, and regulatory affairs specialist.  I started my consulting company, Cadman Consulting Services, LLC, doing business as FDA Compliance Simplified, in 2001.  My company has served hundreds of companies from across the globe with over 250 clients in the food and dietary supplement industries.  I have assisted in the preparation of safety evaluations for many food and dietary ingredients. I have reviewed a number of self-affirmed Generally Recognized as Safe (GRAS) notices to evaluate their scientific rigor and advise as to whether the subject ingredient has been shown to be safe.

I am concerned about several aspects of S.4316. This bill will not achieve its stated goals but will increase costs to the Food and Drug Administration and in turn, American taxpayers.  American taxpayers will be further impacted by increased costs and potential limits to their food supply by some of the implausible and unhelpful provisions in the proposed bill.

The Generally Recognized as Safe Standard, reasonable certainty of no harm, should not be altered, Section 1.

The impact this bill would have is of great concern to my company and the hundreds of food and beverage companies we serve as regulatory affairs consultants since it would greatly alter the already strong standards of safety afforded to the United States food supply.  The United States enjoys a robust, varied, and safe food supply due to the existing reasonable standards for entry of new food ingredients into the marketplace.  The current Generally Recognized as Safe (GRAS) standard of “reasonable certainty of no harm.” provides a mechanism for safety review of new food components within the capacity permitted by the technologies and methods currently available.

Per Section 1, the proposed bill seeks to set a new and implausible standard of “toxic-free” foods, a standard which cannot be met even by many unprocessed, unaltered fruits and vegetables fresh from the fields.  Caffeine, which is known to, and roundly enjoyed by the U.S. population, is both naturally occurring in coffee, tea, and many other plant products but can be toxic[1].  Similarly, many fruits and vegetables contain a wide range of naturally occurring toxins[2].  The term “toxic-free” is not only unreasonable, it is undefined. The proposal of safety legislation without definitions of this key term belies ignorance of the natural chemistry of foodstuff as well as a failure to understand the current GRAS standard and the tools available to researchers to assess safety.

While FDA has authority to prevent unsafe products from being introduced into interstate commerce, the level of safety required by the Ensuring Safe and Toxic-Free Foods Act of 2022 will not advance the safety of the US food supply but will instead limit innovation. It will also very likely lead to an even greater increase in frivolous lawsuits alleging consumer harm where there is none.  The ultimate effect will not be to increase consumer safety; rather, it will be to increase consumer costs.

The proposed conflict of interest provision is implausible, Section 2. 

The many industry sectors regulated by FDA are responsible for providing data that their products are safe for their intended use and, in the case of drugs and medical devices, efficacious. The inventing companies cannot develop a new product without considerable research and testing.  This data is incorporated into their submissions to FDA for approval along with direct studies on the safety and efficacy of the potential new health product.  None of these sectors are barred from presenting data from studies that the inventing company has funded.  In fact, research of any kind requires considerable expenditure of time and capital.  How will safety data be obtained on novel food ingredients if the sponsoring company is prohibited from conducting safety studies?  Such studies are time consuming and expensive. Is it the intention of the writers of this bill that the U.S. government would pay for all the studies that would be required to establish the safety of new food ingredients?  A more reasoned approach would be for FDA to consider all submitted data and that such data be accompanied by conflict of interest statements, a practice which is common for scientific journals across many disciplines.

Review of food additives, Section 3

My clients and I do not object to the concept of reviewing GRAS substances as scientific knowledge is expanded and technologies developed that enable reassessment.  Nevertheless, we are concerned that such reviews will prove to be burdensome and expensive for FDA, the food industry, and American consumers unless the process by which substances are chosen for re-evaluation is based on reasonable and thoughtful criteria.  The current criteria used in the GRAS process appears to be sufficient since harm has not been alleged from the several thousand ingredients that have been the subject of GRAS notices[3].  The majority of GRAS notices, including self-affirmed GRAS notices[4] are for substances that are naturally-occurring in food and are not the result of synthetic chemistry.

It is noteworthy that none of the 10 ingredients proposed for reevaluation in section 3, part (f) of the proposed bill entered the US food or food packaging supply as a result of GRAS notices submitted by industry.  Many of the listed components of interest are already under review by FDA[5],[6].[7],[8] and the use of several has been limited in recent years.

Enforcement of current regulations will do more to protect the American food supply than S.4316

FDA has considerable authority that can be used to protect the US food supply and American consumers.  Timely follow up by the agency to food safety issues identified by consumer reports and the agency’s own inspections will do more for public health without overburdening the agency or American taxpayers than the proposal in the Ensuring Safe and Toxic-Free Foods Act of 2022. On behalf of myself, my company, and hundreds of clients, I urge you not to move this bill out of committee.


Evelyn Cadman

Owner & Principal Consultant

[1] Beauchamp, G., Amaducci A, and Cook, M., Caffeine Toxicity: A Brief Review and Update, Clinical Pediatric Emergency Medicine, 2017, 18(3), p 197-202. https://www.sciencedirect.com/science/article/abs/pii/S152284011730040X

[2] Dolan, LC, Matulka, RA, and Burdock, GA, Naturally Occurring Food Toxins, Toxins 2010, 2, 2289-2232. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3153292/pdf/toxins-02-02289.pdf

[3] FDA Inventory of GRAS Notices https://www.cfsanappsexternal.fda.gov/scripts/fdcc/index.cfm?set=GRASNotices&sort=GRN_No&order=DESC&showAll=true&type=basic&search=

[4] AIBMR Life Science, Inc., Independent GRAS Self-Determination Inventory Database  https://docs.google.com/spreadsheets/d/1KdlygCppko64yts1O4ZdpzWWfsZZ3yKp97d4ooHGHdQ/edit#gid=0

[5] Perflouoroalkyl substances https://www.fda.gov/food/chemical-contaminants-food/testing-food-pfas-and-assessing-dietary-exposure, https://www.fda.gov/food/cfsan-constituent-updates/fda-makes-available-pfas-testing-results-first-survey-processed-foods, https://www.fda.gov/food/cfsan-constituent-updates/fda-issues-letter-industry-fluorinated-polyethylene-food-contact-containers

[6] Bisphenols https://www.fda.gov/media/90596/download

[7] Orthophthalates https://www.fda.gov/food/cfsan-constituent-updates/fda-limits-use-certain-phthalates-food-packaging-and-issues-request-information-about-current-food, https://www.fda.gov/food/food-ingredients-packaging/phthalates-food-packaging-and-food-contact-applications

[8] Brominated Vegetable Oil https://www.fda.gov/food/food-additives-petitions/brominated-vegetable-oil-bvo


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