FDA faces lawsuit over GRAS program
by Jeff Gelski
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WASHINGTON — A lawsuit filed Feb. 20 seeks changes in the Food and Drug Administration’s Generally Recognized As Safe (GRAS) program, possibly reverting to rules in place before 1997 that required the FDA to approve food additives as safe.
The Center for Food Safety, a non-profit organization incorporated in the District of Columbia, filed the lawsuit in the US District Court for the District of Columbia. According to the lawsuit’s allegations, for the past 15 years the FDA has exempted substances from food additive regulations that may pose risks to human health and welfare.
“It has been 15 years since FDA handed authority to determine GRAS status over to the corporations it meant to regulate,” said Andrew Kimbrell, executive director for the Center for Food Safety. “FDA has an obligation to provide the regulatory scrutiny the public deserves. FDA’s failure to appropriately regulate food additives has had serious consequences, exposing the public to risky products without adequate due process.”
An FDA representative said the agency does not comment on pending litigation.
The GRAS program dates to 1958 when Congress enacted a Food Additives Amendment to the Federal Food, Drug and Cosmetic Act. The amendment required manufacturers to show through scientific studies why a proposed food additive was safe. The FDA had to approve the additive’s use in food before it could be added to food. A petition process required the FDA to notify the public and provide opportunity for comment.
The process changed after the FDA published a proposed rule in the April 17, 1997, Federal Register
. The rule eliminated the petition process and replaced it with a notification process, but a final rule was never issued. Manufacturers now voluntarily may submit a GRAS claim. The FDA no longer approves or disapproves of a food additive’s safety but instead reports whether or not it has questions about the submitted claim.
According to the lawsuit, the failure to issue a final rule without considering and responding to public comments violates the rule-making requirements of the Administrative Procedure Act. According to the lawsuit, the FDA never responded to public comments, not in 1997 and not when it asked for updated comments in 2010.
According to the lawsuit, the court should vacate the 1997 proposed rule. The court should require the FDA to apply the GRAS rule in place before 1997 until the FDA issues a new final GRAS rule in accordance with the Administrative Procedure Act.
The lawsuit named Kathleen Sebelius, secretary of the US Department of Health and Human Services, and Margaret Hamburg, commissioner of the FDA, as defendants.
The lawsuit singles out three ingredients that it claims may not be GRAS.
Allyl isothiocyanate (AITC), the chief component of volatile oil of mustard, is used as a preservative either directly in food or incorporated into food packaging. Scientific studies, including a two-year study conducted on rats by scientists at the National Institutes of Health, showed AITC is a potential human carcinogen, according to the lawsuit.
Olestra, an indigestible, man-made compound of sugar and fat, may be used in low-fat foods. People have submitted to the FDA reports of adverse reaction to olestra in the form of gastrointestinal problems, according to the lawsuit. Mycoprotein, known by the brand name Quorn, is a fungus-based meat substitute that has been shown to cause allergic reactions, according to the lawsuit.
The lawsuit referenced two other instances of weaknesses found in the current GRAS program.
The US Government Accountability Office in 2010 pointed out three issues: companies are not required to inform FDA of GRAS determinations, the FDA has not issued any guidance to companies on how to document GRAS determinations, and the FDA has yet to issue a final regulation for its 1997 proposed rule.
The second instance involved a study published on-line Aug. 7, 2013, in JAMA Internal Medicine
. It dealt with how companies determine whether food additives are safe. The study found conflicts of interest were ubiquitous in determinations of whether a food additive was GRAS. The study’s results did not prove the conflicts of interest it identified compromised the GRAS decision process, but it raised concerns.