Magazine article Science News

FDA to Evaluate Fat Substitute

Magazine article Science News

FDA to Evaluate Fat Substitute

Article excerpt

FDA to evaluate fat substitute

Two days after announcing its new fat substitute, the NutraSweet Co. agreed last week to file a petition with the Food and Drug Administration to seek "generally recognized as safe" (GRAS) status for the substance, which it calls Simplesse.

At first, company officials said at a news conference that they did not require FDA approval before giving GRAS status to Simplesse because it is made by merely changing the physical form of proteins from common foods.

But they agreed to file a petition after meeting with FDA Commissioner Frank E. Young, who said he was "perplexed" by their decision to announce the product without consulting FDA. Young, in a letter to NutraSweet Chairman Robert B. Shapiro, said the company had not provided "any information about the product to the FDA, leaving the agency unable to evaluate the company's unilateral judgment that the product is safe."

One of the key questions concerning Simplesse will be whether extracting the protein and altering it will change its toxicity and nutritional value, says Theodore Labuza, incoming president of the Institute of Food Technologists and professor of food science and technology at the University of Minnesota in St. Paul.

Labuza says NutraSweet was within legal limits when it commissioned an expert panel to determine whether simplesse was GRAS. The Flavor Extracts Manufacturers Association (FEMA), for example, also has an expert panel to determine the GRAS status of artificial flavors made from natural products.

But Gerard McCowin, director of FDA's division of food and color additives, says the FEMA situation is different because it deals with minute amounts, compared with the potentially large Simplesse market.

Although NutraSweet, a division of the St. Louis-based Monsanto Co., has done nothing illegal, some believe the company made a public relations blunder. …

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