By Tom Nelter
The FDA is charged with regulating the safety of chemical food additives, but the “generally recognized as safe” exemption to the FDA’s approval process has been stretched beyond recognition to cover virtually all new substances, writes the Environmental Defense Fund’s Tom Neltner.
Every day, another news story breaks about the contamination of communities due to PFAS—per- and polyfluorinated alkyl substances. As we watch the Environmental Protection Agency deal with the harm caused by these chemicals, many forget that addressing PFAS, which has been and continues to be used in food packaging and cosmetics, is also the responsibility of the Food and Drug Administration.
The FDA’s vacillating approach to PFAS over the years is a symptom of its broader failure to protect the public from chemicals in these products. Rarely are chemical risk issues framed around the FDA and its responsibilities to protect people from chemicals in food and cosmetics.
Those who focus on protecting people from harmful chemicals—whether they represent industry, advocacy groups, government, or academia—typically frame regulatory issues around the EPA, the Toxic Substances Control Act (TSCA), and the various pollution control and cleanup laws.
All too often, FDA approval of a chemical’s use is referenced as a signal that the substance poses little risk of harm. Perhaps it is because practitioners prefer to think of chemicals added to food and cosmetics as wholesome ingredients. Or they may assume that if there was any field where our regulatory programs would be strongest it would be for those products.
Consumer Concern About Chemicals in Food
Consumers see it differently. According to an annual food and health survey, the presence of chemicals in food has been consumer’s top food safety concern since 2017—29% in 2021.
It consistently scores higher than foodborne illness from bacteria and much higher than pesticides, antibiotics, allergens, and bioengineered food, and everyone rated chemicals in food as one of their top three concerns. They also don’t see the FDA as responsible for reviewing additives’ safety.
The FDA has begun to recognize the concern by seeking almost $20 million in annual appropriations to hire 40 staff to address “emerging chemical and toxicology issues” and “modernize and streamline its regulatory frameworks for products that in certain cases pose potential chronic risks to human health.”
The agency specifically mentions PFAS as a priority in its budget justification. Congressional approval looks promising based on key House and Senate committee reports.
FDA’s Statutory Authority Over Chemical Additives
On the surface, consumers’ concern for chemicals in food seems misplaced. The FDA has strong statutory authority to ensure substances added to food are safe based on the Food Additives Amendment of 1958 to the Federal Food Drug and Cosmetic Act of 1938.
With few exceptions, food manufacturers must file a food additive petition when planning to use new chemicals such as preservatives, stabilizers, sweeteners, etc., or expand their previously approved use. And they must secure pre-market approval from the FDA through a formal rulemaking process. The requirement extends to chemicals used in packaging and processing equipment that may get into food, although in 1997 Congress provided a streamlined notification system for food contact substances.
Food additives must meet a safety standard that is among the most protective in the world—there must be “a reasonable certainty in the minds of competent scientists that the substance is not harmful under the conditions of intended use” after considering three factors including the “cumulative effect of the substance in the diet, taking into account any chemically or pharmacologically related substance or substances in such diet.” Additionally, food additives must not be “found to induce cancer in man or animal.”
Bypassing FDA Chemical Safety Reviews
Unfortunately, faced with a rising backlog of decisions at the FDA in the 1990s, food manufacturers began to bypass the petition process to determine that new chemicals used in foods were safe without the FDA’s knowledge, review, or approval.
They did this by pushing the limits of the “generally recognized as safe” (GRAS) exemption to the statutory definition of food additives. This exemption was intended by Congress for ingredients like oils, spices, and salt, not for new chemicals.
The FDA accepted this flawed interpretation of the GRAS exemption in a 1997 proposed rule that became the basis for the current voluntary GRAS notification program.
Today, voluntary GRAS notices to the FDA outnumber food additive petitions for new chemicals by more than 50 to 1. A 2011 publication estimated 1,000 chemicals had been determined by their manufacturers to be safe without notice to the FDA or the public’s knowledge.
The FDA finalized the rule in 2016, effectively embracing secret safety determinations. The Environmental Defense Fund and others, represented by Earthjustice and Center for Food Safety, challenged the rule in 2017 and await a court decision.
FDA Must Close the Loophole
The FDA has allowed the GRAS exemption to be stretched beyond recognition to cover virtually all new substances. As a result, the FDA is unable to fulfill its statutory responsibility of ensuring food is safe since it has no means of knowing what chemicals are actually being used in food. In addition, the FDA has not been vigilant about reassessing its past approvals regarding the safety of phthalates, PFAS, and other substances when new scientific evidence emerges of their health risk.
The FDA has diminished its role as a regulator by allowing the GRAS loophole to effectively swallow the law and lacking vigilance of emerging risks ultimately undermining food safety. It also leaves companies vulnerable to push back from state regulators and consumers that keep up to date with scientific evidence and are more prone to hold companies accountable for exposing people to harmful chemicals.
The FDA needs to close the GRAS loophole it created, modernize its science, reassess the safety of chemicals that it approved as food additives long ago, and restore confidence in food safety.
This column does not necessarily reflect the opinion of The Bureau of National Affairs, Inc. or its owners.
Write for Us: Author Guidelines
Tom Neltner is an attorney and chemical engineer at the Environmental Defense Fund. As chemicals policy director, he leads efforts to remove or minimize hazardous chemicals from products and the marketplace through cross-cutting policy initiatives.