The nation’s top food safety regulator has for decades left it up to manufacturers to decide whether their food ingredients are safe, sometimes with tragic results, a Bloomberg Law investigation reveals. Last year, nearly 400 people across the US fell ill after eating a lentil and leek meal shipped by the plant-based food company Daily Harvest. Some 133 people were hospitalized, and several had to have their gallbladders removed, government records show. More than a decade earlier, scores of young adults suffered serious harm and some died after drinking Four Loko, a low-cost but potent alcohol and caffeine drink packaged in a 23.5 ounce can.
Both products were put on the market under a Food and Drug Administration process known as Generally Recognized as Safe (GRAS) that lets private companies bypass a two-year FDA approval process and determine the safety and combinations of substances in their own products.
For a food ingredient to be GRAS, a company is supposed to show there is scientific evidence and consensus that a product is safe for its intended use. But companies can self-designate substances as GRAS with no legal requirement to inform the FDA. By merely putting the new or reconfigured item for sale after its own review, the company is attesting to its safety.
The result is the agency knows little about how companies decide what substances are going into foods. The FDA has said it has no idea how many GRAS determinations companies are making. A voluntary notification program gives the agency a chance to review companies’ GRAS determinations, but it’s completely up to companies to decide whether to seek FDA review. Few do.
There are more than 10,000 substances allowed in food, yet the FDA had just 1,147 requests for review since 1998 (many of them duplicates). And in the few requests the FDA gets, it rarely acts: the FDA last rejected a company’s voluntary GRAS submission 12 years ago. For years watchdogs and Congress have questioned the way the FDA regulates food.
GRAS is an honor system some say is long overdue for reform. “That’s really dangerous for consumers,” said Melanie Benesh, a vice president for the nonprofit Environmental Working Group. “It means the FDA is flying blind.” An FDA spokesperson said existing food safety laws limit what they can require of manufacturers. “The way the law is written, it’s on the companies and manufacturers to ensure the safety of the products they put on the market,” the spokesperson said.
The agency also said in written responses to questions from Bloomberg Law that it has questioned GRAS determinations and “taken action as appropriate.” The FDA noted it has proposed a new food safety program “to develop a faster and more nimble process for evaluating chemicals in the food supply.”