Senator Criticizes “Loophole” in Self-Affirmed GRAS System

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FDA’s Generally Recognized As Safe (GRAS) classification system for food and beverage ingredients is facing new scrutiny from Senator Edward J. Markey (D-MA), who recently sent a letter to FDA criticizing “loopholes” in the self-affirmed GRAS process. Raising concerns about possible conflicts of interest arising from self-affirmed GRAS determinations and a lack of public notification, Markey proposes a new labeling requirement to distinguish between GRAS determinations that have passed FDA review and those that have not.

In a letter dated April 26, Markey’s main challenge to the current self-affirmed GRAS system is that ingredient firms are allowed to obtain GRAS notifications in-house and through private consultants without FDA review-something the general public may not be aware of.

“The public assumes that the FDA plays a pivotal role in assessing the safety of new food ingredients by ensuring that any ingredient used in food has been thoroughly vetted and determined safe by the agency,” Markey writes. “Many would be shocked to learn that numerous ingredients are used in food and beverages without ever being evaluated by the FDA, and furthermore, in many circumstances the FDA is not even aware such chemicals are being used unless a company voluntarily discloses that information."

"Made in Secret"

While many companies choose to notify FDA of their self-determined GRAS notifications, the system is voluntary, which Markey says allows for an environment of secrecy that challenges FDA’s mission to protect the safety of the food supply.

As evidence, he points to the case of sweet lupin, an ingredient that may provoke allergy symptoms in individuals with peanut sensitivities. While FDA has expressed concern with sweet lupin in food products, the private nature of self-affirmed GRAS determinations has allowed the ingredient to appear in food products in instances when companies chose not to notify FDA of their self-affirmed GRAS review, Markey notes.

Additionally, the self-affirmed GRAS system may allow for conflicts of interest, Markey suggests, with many self-affirmed GRAS notifications conducted by individuals with vested financial interest in the ingredient’s success.

“Of the 451 GRAS notifications voluntarily made to FDA between 1997 and 2012, 22 percent were made by an employee of an additive manufacturer, 13 percent by an employee of a consulting firm to the manufacturer, and 64 percent by an expert panel selected directly or indirectly be a consulting firm and/or manufacturer,” Markey writes.

This “loose structure” can lead to GRAS reviewers placing the interest of ingredient manufacturers above public interest, he cautions.

“Existing regulations create an incentive for companies to shield the most hazardous substances from FDA’s oversight, and such a process increases the possibility that GRAS determinations made in secret are less reliable than those sent to the agency, both in terms of the quality of the scientific evaluations being made and the self-interest that afflicts their conclusions about safety,” says Markey.

New Warning Labels?

To increase public awareness of self-affirmed GRAS ingredient notifications that have not been reviewed by FDA, Markey asks FDA to explore the possibility of a new labeling requirement for foods containing these ingredients. It could be similar to the disclaimer used on some dietary supplements, but focused on the safety of the ingredients in question. For instance, “The safety of some ingredients in this product has not been evaluated by the Food and Drug Administration,” Markey proposes.

Additionally, the Massachusetts senator suggests FDA might develop stricter guidance on expert panels that make GRAS self-determinations, in hopes of minimizing conflicts of interest. He asked FDA to speak to the feasibility and potential logistics of both options, as well as its plans to strengthen oversight of GRAS substances more generally.

“Does the agency believe it needs additional authority to ensure the safety of GRAS substances? Please explain,” he concludes, requesting FDA respond to his questions by May 17, 2016.

FDA currently has plans to finalize its GRAS procedures rule by August.

Read more:

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The Future of GRAS Regulations

FDA Requesting Comments on Use of the Term "Natural"

Michael Crane
Associate Editor
Nutritional Outlook Magazine
michael.crane@ubm.com