If you’re a careful shopper like me, you read food labels, including ingredients lists. If so, you may assume that all ingredients have been approved by the FDA (or some other federal agency) after being assessed for safety. Not so. Most food ingredients have not undergone FDA review, thanks to a law that allows ingredients to be considered “generally recognized as safe,” or GRAS, without testing or evaluation. It’s a confusing and much-criticized system that makes many people, including me, worry about the untested ingredients in processed foods.
GRAS regulations were part of the Federal Food, Drug, and Cosmetic Act as amended by Congress in 1958. This law set up a two-tiered system. For new “food additives,” companies have to get pre-marketing approval from the FDA, based on safety data they submit. But there was an exemption for GRAS ingredients. The idea was that hundreds of common substances—such as vinegar, baking soda, and caffeine—that had long been in use and were assumed to be safe, would be exempted from the approval process and put on the GRAS list.
In 1997 the FDA added a provisional rule that made the GRAS regulations even laxer. It allowed food companies on their own to decide if additional ingredients are GRAS, based on a safety review by “qualified experts” they themselves choose (this is called “self-affirmed” GRAS status). Companies don’t even have to notify the FDA about their new GRAS ingredients, let alone submit safety data—FDA notification is voluntary. Under this GRAS loophole, more than a thousand substances have been added to the food supply, with little or no federal oversight. Many of them don’t show up on ingredients lists, hidden under the phrase “natural and artificial flavoring,” for example. Meanwhile, because of the strict regulatory process, the industry has sought FDA approval for fewer and fewer “food additives.”
For years, nonprofit watchdog groups such as Consumers Union, the Center for Science in the Public Interest (CSPI), and the Environmental Working Group have lobbied the FDA to toughen the 1997 interim rule in ways to ensure food safety. It took almost 20 years, but last August the FDA, undoubtedly under pressure from the food industry, finalized the rule with little improvement. Yes, the fox has been left guarding the henhouse.
Three-quarters of people incorrectly think that GRAS means the FDA has evaluated an ingredient and deemed it safe, according to a survey by Consumer Reports in 2016.
Lax rules, vague definitions
The laxity and vagueness of the GRAS regulations are troubling. For instance, what exactly do “reasonable certainty,” “adequately shown,” and even “safe” mean? Who are these “qualified experts” selected by food companies to assess the safety of GRAS ingredients? To no one’s great surprise, many of these experts have industry ties. A study in JAMA Internal Medicine in 2013 looked at the expert panels behind 451 GRAS notifications voluntarily submitted to the FDA. It found that “financial conflicts of interest were ubiquitous” and that “the lack of independent review in GRAS determinations raises concerns about the integrity of the process and whether it ensures the safety of the food supply.” In a commentary to that study, Marion Nestle (a well-known professor of nutrition, food studies and public health at NYU) called these findings “alarming,” indicative of “undue food industry influence on food safety policy.”
In rare cases, when the health risks of a GRAS ingredient become clear, the FDA can remove its GRAS status. That happened with partially hydrogenated vegetable oils (because they supply trans fat) and cyclamate (an artificial sweetener that caused cancer in lab animals). Similarly, CSPI has called on the FDA to revoke the GRAS status of sodium so that it can be more strictly regulated and reduced.
It would make much more sense to evaluate the safety of food ingredients—especially new ones—openly, independently, and systematically, rather than making us a nation of guinea pigs. Unfortunately, the FDA has passed up the opportunity to strengthen the GRAS regulations. All the more reason to limit your intake of processed foods and, when you do eat them, to choose ones with shorter lists of ingredients.
Also see Sugar Daddies of Nutrition Research.