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GAO: FDA Oversight on Additives Lacking

The U.S. Food and Drug Administration (FDA) does not exercise adequate oversight over certain widely used food additives, according to a Government Accountability Office (GAO) report released last week.

The GAO, the investigative research arm of Congress, found that FDA’s oversight process simply “does not help ensure the safety” of new additives deemed “generally regarded as safe” (GRAS) by food companies.

“Currently, companies may determine a substance is GRAS without FDA’s approval or knowledge,” said the report. As GAO notes, there are have been instances where additives initially deemed GRAS were later banned for safety reasons.

In 1986, FDA banned the use of sulfites on fruits and vegetables intended to be served raw and added labeling requirements for food containing the additive because of potentially severe allergic reactions.  Sulfites had been considered GRAS since 1959.

Despite a slew of concerns from consumer groups over the safety over certain GRAS additives, the GAO found that FDA has not reconsidered the safety of any substances in the category since the 1980s.

“FDA is not systematically ensuring the continued safety of current GRAS substances,” according to the summary of findings. This lack of oversight goes against FDA regulations, which require the agency to reconsider the GRAS status of a substance as new scientific information emerges.

Not only is the agency not reviewing the safety of GRAS additives, but it has not responded to a series of petitions from consumer groups over certain substances. 

Individuals and consumer groups submitted 11 petitions between 2004 and 2008, expressing concerns on salt, partially hydrogendated oils, and other substances, and FDA has only definitively responded to one.

(Click to see an overview of pending food safety petitions and their current status).

GRAS Report Table 4.jpgThe report also expressed concerns about the FDA’s lack of information and oversight on nanomaterials in GRAS substances. While the report acknowledged certain nanomaterials could enhance food safety, there are also potential public health risks and “uncertainties remain about how to determine their safety in food.”

“FDA encourages, but does not require, companies considering using engineered nanomaterials in food to consult with the agency regarding whether such substances might be GRAS.”

Under the current voluntary notification scheme, companies are not required to identify nanomaterials in GRAS substances.

According to GAO, “FDA has no way of knowing the full extent to which engineered nanomaterials have entered the U.S. food supply.”

The report also points out that in Canada and the European Union, any food ingredient that incoporporates engineered nanomaterials must clear regulatory hurdles before being approved for the marketplace.

The full report is available here.

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