FDA Faulted for Giving Additives a Free Pass

(March 8) -- A new report from federal investigators says the Food and Drug Administration has failed to ensure the safety of thousands of additives manufacturers put in what we eat.

The Government Accountability Office, the congressional watchdog agency, singled out a longstanding and controversial exception to FDA rules that for decades has concerned consumer and public health advocates. Substances "generally regarded as safe" by food companies' own scientific panels are immune from rigorous FDA analysis, meaning that manufacturers that want to include an additive in a product are often spared having to spend hundreds of thousands of dollars in safety tests and can save years in getting the product to market.

The GAO determined that:

• The FDA generally doesn't know about most of these determinations of "generally regarded as safe," or GRAS, because companies are not required to inform the agency.

• The FDA has not taken steps that could help ensure the safety of additives listed as GRAS.

• Food products may contain numerous ingredients, including GRAS substances, making it difficult, if not impossible, for public health authorities to attribute a food safety problem to a specific GRAS additive.

• The FDA does not systematically reconsider the safety of GRAS substances as new information or new methods for evaluating safety become available.

The investigators also noted that while the FDA has issued guidance to minimize the potential for conflicts of interest among its own staff members who look at the safety of GRAS substances, it has not issued any restrictions for companies to use with their hired scientific experts.

"There is a relatively small community of experts qualified to sit on the GRAS designation panels, and, inevitably, these experts may have corporate or financial affiliations that could bias their decisions," the report said.

The investigators said it was almost impossible to link adverse effects to GRAS additives because their presence in food is rarely known to anyone beyond those responsible for it.

The GAO report was issued Friday, a day after the FDA recalled HVP, a GRAS-designated flavor enhancer used in thousands of foods, because of possible salmonella contamination.

In the new report, the GAO said the FDA told it that complaints and public concerns could prompt it to reconsider the safety of a GRAS substance. But since banning the artificial sweetener cyclamate 40 years ago, the FDA has turned down at least 11 petitions from safety and consumer groups to remove specific substances from GRAS designation.

A serious debate over another GRAS additive is going on today and is generating repeated demands from unions, public health experts and others for another ban. The substance is diacetyl, a chemical butter flavoring linked to a handful of deaths and hundreds of illnesses among workers in microwave popcorn factories, bakeries and other processing plants.

Worker and food safety advocates are angry that many manufacturers say they have switched to a substitute additive that government researchers have determined contains just as much or more diacetyl than the old formula. But it too is listed as "generally regarded as safe" under FDA rules.

The GRAS designations started in 1958, when Congress amended the Federal Food, Drug and Cosmetic Act to say that the safety of an additive "does not need to be established with absolute certainty." Instead, the law said, a scientific panel selected by the manufacturer can rule that no harm will result from the intended use of an additive.

In reality, the only ones who know whether the additives are actually safe are the company and its own analysts, or the outside labs it hires.

Thousands of exemptions are granted by panels designated by food industry trade groups. The largest such organization, the Flavor and Extract Manufacturers Association, has bestowed GRAS on more than 2,600 additives since 1960.

The GAO expressed added concern over two specific areas -- imported additives, where the level of safety consideration is often completely unknown, and the growing use of GRAS designation in engineered nano-material in food.

In responding to the report, the FDA said it agreed with many of the faults the GAO documented but said the agency would have to seek authority from Congress to require all companies to inform it of their designation of additives as GRAS.

If that were to happen, the FDA said, it could place an added burden on food producers and tax the FDA's resources.

The GAO investigation was requested by two Democrats, Iowa Sen. Tom Harkin and Connecticut Rep. Rosa DeLauro.