This summer, the FDA rolled out a final rule on GRAS substances. The comment period for the rule is open until it takes effect on October 17.

GRAS status depends on evidence and recognition within the community of food and drug experts. To gain GRAS status, substances must meet a few interconnected criteria:

  • Scientific evidence that can be used to demonstrate safety of the substance
  • Publications qualified to evaluate the evidence
  • Wide recognition by “appropriate qualified experts”

Many ingredients added to food must be approved by the FDA before manufacturers can use them. Then there’s a category called GRAS, which comprises ingredients that are “Generally Recognized as Safe.” Ingredients in this category don’t require FDA approval.

Where’s the confusion?

FDA provides a list of GRAS substances, but that list isn’t comprehensive. Instead, they’ve rolled out—but never finalized—rules for submitting a substance for GRAS approval. And in 1998 they began an inventory of GRAS notices submitted.

This year’s final rule was developed partly in response to a 2014 lawsuit brought by the Center for Food Safety. The FDA proposed a rule in 1997 that sought to clarify GRAS criteria. CFS sued because the rule was never finalized, and because they believed it illegally “created a fast-track for manufacturers who believe a substance should be ‘generally recognized as safe’ (GRAS).”

Essentially, if an ingredient doesn’t qualify as an additive requiring FDA approval, manufacturers can decide if it meets GRAS criteria, and they don’t have to report its use.

The CFS lawsuit asked, among other things, for mandatory FDA notice of a company’s adding a substance it asserted was GRAS to a food.

History of GRAS

The history of GRAS might reveal how today’s rules have become so convoluted. Lawmakers recognize that “generally recognized” is a nebulous term that creates an awkward situation for manufacturers.

The 1958 Food Additives Amendment established GRAS substances and is largely responsible for the language still used today. It bases safety of substances on a long history of use and the abovementioned scientific evidence and expert approval.

In a recent Food Safety News article, Jessica Almy, deputy director of nutrition policy at the Center for Science in the Public Interest, said, “decisions about the safety of substances in our food supply should be transparent and unbiased.” Almy believes the current rule “gives companies a green light to make decisions about which substances are GRAS and. . . fails to ensure that the experts [who] make those decisions do not have conflicts of interest.”

What’s next?

Since FSMA was signed into law, many feel that food safety reform is long overdue and that its principles of prevention and transparency should make a clean sweep into all corners of manufacturing practice. GRAS approval and notification is one area that seems to be lagging behind or proving more difficult to fully regulate.

According to a recent Food Processing article, things may not change much under the finalized  rule. The level of FDA-required support remains essentially the same. Manufacturers are required neither to update notices submitted since 1998 nor to provide any supplemental information.

The new rule does update and mandate a 7-part formatting requirement for GRAS notices. It also requires that information supplied by manufacturers must be published, readily accessible, and peer-reviewed by scientific experts in order for added ingredients submitted to achieve GRAS status.