FDA to evaluate fat substitute.

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. "It is not a legal question, but it is an issue of good regulatory sense," says Richard Merrill, chief counsel at FDA from 1975 to 1977.

"If you want to market a blockbuster product, then you better tell the regulatory agency that gets paid by the American public," says Merrill, now dean of the University of Virginia Law School in Charlottesville.

A spokeswoman for NutraSweet told SCIENCE NEWS the company went through proper legal channels, and would not comment further on the Simplesse issue. According to FDA Deputy Commissioner John A. Norris, company officials told him the whole thing was "a miscalculation on their part."

Some people believe NutraSweet officials may have wanted to avoid a long FDA review process and that they wanted to get a jump on their competition, namely Procter and Gamble's fat substitute Olestra, which is derived from sugar and edible oils and which FDA has been reviewing since June. Unlike Simplesse, Olestra has no calories, is not metabolized and can be used for cooking.

Simplesse, however, still would have broad applications. It can be used in dairy products and in oil-based products, such as salad dressings, mayonnaise and margarine, and it has 1.3 calories per gram, compared with fat's 9 calories per gram. Four ounces of traditional ice cream, for example, contains 283 calories while the same amount of Simplesse ice cream would contain 130 calories.

To simulate fat, NutraSweet scientists used a patented heating and blending process that shapes milk or egg protein into tiny round particles that roll over the tongue, creating a smooth and creamy sensation.

Once NutraSweet submits a GRAS petition, FDA's review process should take about 12 to 18 months, Norris says, which would coincide with NutraSweet's marketing goal.