The Food and Drug Administration has made permanent a rule that allows food companies to add new ingredients to the food supply with almost no federal oversight. Thousands of substances have already been added under the rule, which was first proposed in 1997 and has effectively been in place ever since.
The rule is meant to provide guidance for companies seeking to classify new food ingredients as safe, or GRAS for "generally recognized as safe." But it has been widely criticized by watchdog groups, including Consumer Reports, who say that it puts consumers at risk by allowing the food industry to bypass crucial safety checks for new ingredients. Those critics had hoped that the finalized version would include some major changes to the '97 draft. It did not.
"FDA missed a major opportunity to clean up the food system," says Laura MacCleery, vice president of Policy and Mobilization for Consumer Reports. "Companies will still be able to introduce novel substances into food in secret, without having to show they are safe. The agency also failed to fix the rampant conflicts of interest that affect the review process for ingredients."
A 2016 survey by the Consumer Reports National Research Center found that the term GRAS can be misleading for consumers: 77 percent of respondents believed that 'GRAS' means the FDA has evaluated the ingredient and deemed it to be safe; and 66 percent believed that the agency monitors GRAS ingredients' safety and use. Neither statement is true.
The GRAS designation is rooted in a 1958 law that was meant to require companies to demonstrate the safety of prospective ingredients, but created an exemption for common ingredients like vinegar and baking soda that were already widely used and known to be safe.
The loophole was supposed to spare only the most time-tested substances from the rigors of pre-market approval. But in 1997, the FDA introduced a new rule that allowed companies to decide for themselves what ingredients qualify as GRAS, and to report those designations to the FDA—or not—on a voluntary basis. Critics say the result has been a string of questionable practices on the part of food companies, and a lack of response from the FDA.
For example, the Flavor and Extract Manufacturers Association (FEMA) has classified several possible carcinogens as GRAS, and when pressed has failed to produce peer-reviewed safety data on those chemicals. Some GRAS-designated substances, like trans-fats and mycoprotein or Quorn (a meat substitute made primarily of fungus), have been the subject of high-profile criticism.
But it's the unknown ingredients—that have never been reported at all, let alone publicly evaluated—that most worry scientists and advocates. Food additives have multiplied exponentially in the past half-century, from a few hundred chemicals to several thousand. They can be found in virtually any processed food—from breakfast cereals and energy drinks to frozen dinners and all manner of snacks.
Data suggest that the food industry is seeking FDA approval for fewer and fewer of these chemicals, and is instead designating more and more of them as GRAS. In all, there are an estimated 1,000 GRAS substances for which safety decisions were made by the food industry without any notice at all to FDA, and thousands more chemicals for which both proof of safety and continued federal oversight are minimal.
In 2010, the Government Accountability Office (GAO) agreed with food industry critics, determining that the FDA was not doing an adequate job at ensuring the safety of GRAS substances. The GAO advised the agency to at least require food companies to report all new GRAS designations.
In 2014, the Center for Food Safety sued the FDA in an effort to force a final decision on the '97 proposed rule. Other watchdog groups, including the policy and mobilization arm of Consumer Reports, have long argued that the GRAS process is unlawful because it violates the very 1958 law from which the designation first originated.
GRAS designation should not be granted to novel chemicals, or to substances deemed risky by authoritative scientific bodies.
GRAS designations should not be based on unpublished studies and should be made only by experts without a conflict of interest.
The FDA should make GRAS notifications mandatory and public, not voluntary and secret.
None of these suggestions were included in the final rule.
In a press release, the FDA said that while GRAS substances are not subject to premarket approval, they are still held to the same safety standards as other ingredients. "The FDA can question the basis for an independent GRAS conclusion, whether notified or not, and take action as appropriate," the agency said. While the newly finalized rule for reporting GRAS substances is only voluntary, the agency said it "strongly encourages" companies to follow it.
But Consumer Reports' MacCleery says that the agency has fallen short of its responsibility. "This final rule on the safety of food ingredients fails consumers," she says. "That is unacceptable and deeply disappointing."