Illegal “Fast-Track” Puts Americans at Risk for More than Fifteen Years

Center for Food Safety (CFS) today filed a lawsuit against the Food and Drug Administration (FDA) over the agency’s failure to protect the public from dangerous food additives by failing to follow legal rulemaking requirements.  For more than 15 years, FDA has allowed food manufacturers to decide whether a food additive requires FDA review.  Under the proposed rule, which has never been finalized, FDA created a fast-track for manufacturers who believe a substance should be “generally recognized as safe” (GRAS).  In its lawsuit, CFS identifies several substances allowed under the fast-track process that may pose health risks and asks the court to order FDA to fulfill its responsibility to protect public health.

“It has been 15 years since FDA handed authority to determine GRAS status over to the corporations it is meant to regulate.  FDA has an obligation to provide the regulatory scrutiny the public deserves,” said Andrew Kimbrell, executive director for Center for Food Safety.   “FDA’s failure to appropriately regulate food additives has had serious consequences, exposing the public to risky products without adequate due process.”

In 1958, Congress passed a law requiring FDA to conduct rigorous premarket reviews of food additives, and approve or reject them based on scientific evidence.  Common food ingredients like sugar and gelatin were deemed “generally recognized as safe” (GRAS), and thereby exempted from FDA review on the basis of a history of safe use.  Manufacturers could also formally petition FDA to approve a food additive as GRAS based on published studies.  FDA would then assess the evidence, decide whether or not the additive was safe, and approve or reject it.  But over the past 15 years, FDA has operated under a proposed rule that allows food additive makers to determine whether their products are safe.

"Over 250 food additives have entered the food supply based on manufacturer safety claims, without FDA approval, some likely harmful to human health.  Our nation's food safety agency has become little more than a rubber stamp for the food industry," said Bill Freese, science policy analyst for Center for Food Safety.

FDA proposed the new rule in 1997, and it has completely supplanted the petition process. Under this never-finalized rule, a manufacturer simply notifies FDA that a substance is GRAS by submitting a “GRAS exemption claim.” Because FDA review is cursory, the Agency refuses to confirm whether or not the additive is generally recognized as safe.  Instead, it relies on manufacturers’ assertions about the safety of their products. 

Despite the fact that the agency never fulfilled its legal obligation to finalize the 1997 rule, FDA still operates under this faulty rule today.  The majority of new ingredients now enter the food supply through this inadequate, illegal process.

“FDA has deprived the public of the right of participation, jeopardizing its ability to fulfill its mission to protect public health,” added Kimbrell. “FDA’s action violates the law and ignores the agency’s mandate to protect consumers.”

In 2010, the Government Accountability Office (GAO) issued a report sharply criticizing FDA’s GRAS program.  In 2013, the Journal of the American Medical Association (JAMA) called into question substances granted GRAS status under what it determined was a potentially biased, deficient policy (PDF). 

CFS’s lawsuit cites several substances that achieved GRAS status under 1997 rule that may pose serious risks to human health, including mycoprotien (the fungus-based meat substitute known by its brand name Quorn) and Olestra. The lawsuit asks the Court to vacate FDA’s 1997 “proposed” rule and order the agency to revert to the traditional GRAS petitioning process.