Thousands of additives get into food without the FDA ensuring their safety.

by Andrew Schneider on March 8, 2010

A newly released report has criticized America’s food safety watchdog for systemically failing to ensure the safety of what food manufacturers put in what we eat.

Photo Spice Co.

Photo Spice Co.

After months of research, the Government Accountability Office told Congress it was concerned about a well-known loophole in the Food and Drug Administration regulations that for decades has concerned consumer and public health advocates.

It deals with a often controversial exception to the FDA’s practice of demanding rigorous analysis of the contents of processed food. Immunity from the FDA’s scrutiny is bestowed with the four word designation of “generally regarded as safe.”

What this means is that food manufacturers who want to include an additive in a food product are often spared having to spend hundreds of thousands of dollars in safety tests and can save years in getting something on to store shelves.

The GAO determined that:

  • FDA generally doesn’t know about most of these GRAS determinations because companies are not required to inform the agency.
  • 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 additives.
  • 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 FDA has issued guidance to minimize the potential for conflicts of interest among its own staff 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 outside those who produced it.

GAO said that the food safety agency told it that complaints and public concerns could prompt them to reconsider the safety of a GRAS substance.

Yet the FDA’s actions present a different picture.

More than 40 years ago, the GRAS-labeled artificial sweetener cyclamate was banned after allegations of serious health effects. That was pretty much it for decades.

A more 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 that has killed a handful of workers and sickened hundreds of others in microwave popcorn plants, bakeries, candy makers and other food processors.

What angers worker and food safety specialists even more is that many manufacturers say they have switched to a substitute for the old lung-destroying flavoring additive that government researchers have determined contains just as much or more diacetyl than the old concoction.

It too is listed as GRAS and the FDA knows it, but has done nothing.

Over the past 50 years, thousands of spices, artificial flavors, and binders, vitamins and minerals, and preservatives have been declared as GRAS. These substances are added to enhance a food’s taste, texture, nutritional content, or shelf life.

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

But in reality, the only ones who know whether not the additives are actually safe is the company and its own analysts or the outside labs they hire.

Thousands of exemptions are granted by food industry trade groups. For example, the largest, 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 nanomaterial in food.

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

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

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

Here is  a link to an AOLnews version of this story.

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