NRDC Criticizes FDA GRAS Process for New Food Ingredients

The environmental group characterized the oversight process as "shockingly weak and hidden from public scrutiny."

April 7, 2014

7 Min Read
NRDC Criticizes FDA GRAS Process for New Food Ingredients

WASHINGTON—An environmental action group today characterized as "woefully inadequate" federal protections that are aimed to shield consumers from unsafe ingredients in foods, claiming flaws in the system may be exposing Americans to health risks.

In a report, "Generally Recognized as Secret: Chemicals Added to Food in the United States", Natural Resources Defense Council (NRDC) cited a lack of appropriate oversight by FDA, calling for legislative changes to the process by which new ingredients are added to the U.S. food supply.  

Under federal law, any substance that is added to food is deemed a food additive that is subject to premarket approval by FDA unless it is considered "generally recognized as safe" (GRAS) by qualified experts or otherwise excluded from the definition of a food additive.  

Although food companies can notify FDA that a panel of experts has made a GRAS determination, they are not required to do so. NRDC identified 275 chemicals from 56 companies that appear to be marketed as GRAS and used in food based on safety determinations that did not have to be reported to FDA or the public.

When companies submit to FDA a GRAS determination, the agency rejects the determination or prompts a withdrawal in one of five cases, according to NRDC. Based on GRAS notices submitted to FDA, but subsequently withdrawn, NRDC cited cases in which companies certified their chemicals as safe for use in food in spite of potentially serious allergic reactions or adverse reactions in combination with common drugs. The report also said companies also have proposed using chemicals in food at significantly higher levels than the quantities the company determined are safe.

NRDC cited four chemicals that are marketed to the public in spite of FDA's safety concerns and withdrawn GRAS notices, including the following: epigallocatechin-3-gallate (EGCG); gamma-amino butyric acid (GABA); sweet lupin protein, fiber and flour; and theobromine. According to a 2010 report from the U.S. Government Accountability Office (GAO), once a company determines a food ingredient is safe, it "may market the substance, even if FDA finds that the notice does not provide a sufficient basis for a GRAS determination."

"Americans should expect that their food is safe to eat, but sadly today there's no guarantee because safety oversight from federal agencies and food manufacturers is shockingly weak and hidden from public scrutiny," said Tom Neltner, NRDC health scientist and co-author of the report, in a press release. "Congress should close the loophole responsible for this failing now. Until it does, FDA should strictly limit companies' conflicts of interest and require them to disclose to the agency when they self-approve the safety of a chemical."

The Grocery Manufacturers Association (GMA), which represents companies in the consumer packaged goods industry, denied that the current GRAS process is ineffective.

"It is a very thorough and comprehensive process that has, under the current law provided FDA with authority to challenge the improper marketing of an ingredient as GRAS, and if necessary, act to remove products containing that ingredient from the food supply," GMA said in response to NRDC's report.

"We are committed to working with the FDA and other stakeholders to identify ways of continuing to strengthen the GRAS review process so that it can continue to help ensure the safety of our food supply, just as it has done for decades," GMA added.

In an email, Neltner said NRDC hasn't begun reaching out to lawmakers on GRAS reform but has received calls from staff members of Sens. Dick Durbin (D-Ill.) and Kirsten Gillibrand (D-N.Y.)

Robert McQuate, Ph.D., co-founder and CEO of the consulting firm, GRAS Associates LLC, asked about administrative changes that FDA could implement to meaningfully improve current GRAS practices.

In an emailed statement, he said there would be associated costs if Congress stepped in, requiring FDA to review and validate all GRAS determinations.

"Would such costs result in a commensurate enhancement of the safety of [the] U.S. food supply? Would other aspects associated with the regulation of foods, for example, broader inspections for GMP compliance, suffer if resources were re-allocated to the expanded review of the safety of food ingredients?," McQuate asked. "These aspects warrant careful consideration as the dialogue expands."

Dietary supplement firms that want to introduce a new ingredient into the market follow a different regulatory process than GRAS. However, there is a connection to GRAS. In draft guidance, FDA stated that if a substance is GRAS or an approved food additive and used in food, the substance can be added into a dietary supplement without submitting a so-called new dietary ingredient (NDI) notification, McQuate explained last year in a phone interview.

Theresa Eisenman, an FDA spokesperson, confirmed that a company can make an independent GRAS determination under current law without notifying the agency. 

"While notification is not required, the GRAS notification program and other forms of consultation with FDA offer companies valuable assistance in meeting their obligation to market safe foods," she said. "They also build greater consumer confidence that foods are safe."

NRDC argued the voluntary notification program is inadequate to protect the food supply and unlike food-safety oversight systems in other developed countries.

"There have been a few reports of acute health problems related to chemicals added to foods, such as energy drinks containing a mixture of caffeine and alcohol, or rice with excessive amounts of the vitamin niacin. But chemicals added to food are more likely to be associated with health problems that may appear after years of frequent food and beverage consumption," NRDC stated in the report. "These problems are often chronic in nature. The FDA is unlikely to detect an adverse health effect (short of immediate serious injury) unless companies notify it about the chemical and its use in food."

NRDC published its report several months after the Pew Charitable Trusts questioned whether GRAS determinations are biased based on the experts' relationships with food manufacturers.

Pew researchers found that 22.4 percent of safety assessments were made by an employee of an additive manufacturer, 13.3 percent by an employee of a consulting firm chosen by the manufacturer, and 64.3 percent by an expert panel tapped by either a consulting firm or a manufacturer.

That an employee would make a GRAS determination is troubling because it can present a major conflict of interest, NRDC said.

The Pew researchers last year acknowledged they did not examine whether the conflicts actually influenced the decisions of experts, according to the Council for Responsible Nutrition (CRN), a trade organization that represents dietary supplement manufacturers and ingredient suppliers.

"We're very careful to make sure we don't tell a potential customer, 'if you want GRAS, we will give it to you,'" McQuate of GRAS Associates said last year in a phone interview. "There are times when the data simply don't support a GRAS conclusion, and we are not willing to comply with the client's wishes if the safety documentation isn't there."

The GRAS regulatory regime dates back to a 1958 law (Food Additives Amendment) signed by President Dwight Eisenhower. Although the law exempted from the formal approval process such common ingredients as vinegar and vegetable oil, the "exemption has been stretched into a loophole that has swallowed the law," NRDC argued.

FDA regulations state that a food substance may be GRAS either through scientific procedures, or for a substance that was used in food before 1958, through experience based on common use in food.

"When making a safety determination for a GRAS ingredient based on scientific procedures, the same quantity and quality of scientific evidence is required as is required to obtain approval for a food additive," Eisenman said. "GRAS determinations are based on publically available information."

In 2004 draft guidance, FDA explained that its response to a voluntary GRAS notification does not constitute its approval.

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