Consumers and retailers may be surprised to learn that manufacturers of some of their favorite low-carb foods are breaking the law.

The U.S. Food and Drug Administration has sent warning letters to food manufacturers whose packaging states that their food product is ?low carb? or contains ?only? a certain number of carbohydrates per serving.

That?s because no approved nutrition content claim currently exists for low-carbohydrate food—and it could take years to develop one. The FDA has never defined ?low carb? or any of its cousins—net carbs, effective carbs, impact carbs and the like. Industry members are arguing about the veracity of claims that certain carbs ?don?t count? because the body does not absorb them. The safety of sugar alcohols like maltitol and xylitol for diabetics is also at issue.

In the interim, it?s illegal to use the term low carb on package labels, said attorney Susan Brienza, who practices in the area of food and supplement law at the Denver office of Washington, D.C.-based Patton Boggs LLP.

?It is an unauthorized nutrition content level claim,? and such a claim may mislead consumers into believing that the FDA has established standards when it has not, Brienza said. Some manufacturers have turned to package statements like ?only 3 carb grams,? but ?that is not permitted either,? Brienza added. ?That word?only?implies low carb, and, in fact, the FDA has sent some warning letters to companies on that very point.?

Atkins Nutritionals, Pure Delite Products Inc., Universal Nutrition Inc. and Flowers Foods Inc. have changed their package statements in response to warning letters from the FDA. But an actual rule-making procedure is needed before the term is legally defined.

The typical rule-making process includes publication of a proposed rule in the Federal Register, several months for public comment and FDA analysis of those comments. After publication of a final rule, the FDA will set an effective date six to 18 months later, to allow manufacturers to comply, Brienza said.

At an October obesity symposium, presented by the FDA and the U.S. Department of Health and Human Services, Alison Kretser, director of scientific and nutrition policy for the Grocery Manufacturers of America, said GMA intended to file a citizens? petition to the FDA in early 2004, outlining its recommendation for the definition of a low-carbohydrate claim. With food companies clamoring to obtain any competitive advantage in the low-carb wars, Kretser said, ?We hope this FDA will address this planned request as soon as possible.?

One manufacturer, Keto Foods Inc., will underwrite a scientific conference in June at which medical researchers, physicians and biochemists will explore the scientific underpinnings of low-carb eating and its effects on metabolism and weight.

Meanwhile, the Physicians Committee for Responsible Medicine has criticized low-carb diet plans, saying people have reported health problems, ranging from constipation and bad breath to kidney stones, diabetes, cardiovascular disease and gout, and the sudden death of a teen-age girl whose mineral imbalances were blamed on a high-protein diet.

The report was particularly critical of the Atkins diet?s emphasis on animal protein, saying nutrient analysis of Atkins menus found daily intake of 120 to 143 grams of protein, 97 to 125 grams of fat (of which 38 to 45 grams were saturated fat), 834 to 886 milligrams of cholesterol, and 2 to 18 grams of fiber. The FDA?s recommended daily values for adult nutrition include less than 20 grams of saturated fat, less than 200 milligrams of cholesterol and more than 25 grams of fiber per day.

Low-carb proponents point out the lack of scientific rigor. ?PCRM uses what is, at best, anecdotal information and presents it in the guise of a scientific investigation,? said Mary Dan Eades, M.D., and Michael Eades, M.D., authors of Protein Power. ?Compared to the standard American diet, most people following a low-carb diet end up consuming significantly fewer carbohydrates, about the same or marginally higher amounts of protein and fat, and a smaller number of total calories.?

Both food labeling and the science behind low-carb claims will be on the agenda at the first-ever Low Carb Summit, to be held Jan. 22-23 in Denver. For information, go to www.lowcarbiz.com or call 303.296.1200, ext. 109.

Natural Foods Merchandiser volume XXV/number 1/p. 9