Modified Fast: Overweight Problem : Part 3

by Food and Drug Administration (FDA)

(Page 3 of 3)

Of the first 58 reports, 17 deaths were of relatively young people (average age 35 years) who had no underlying disease to which the deaths could have been attributed. Six of the dieters died suddenly, six died in the hospital (having been admitted after fainting), and five nonhospitalized dieters suffered cardiac arrest.

In 13 of the cases, the dieters total caloric intake came solely from a liquid collagen or gelatin protein solution. Two patients supplemented their liquid protein once a day with a high-quality protein food. The remaining two used powdered products of a high-quality protein, one containing mineral supplements.

No single brand product was used by more than two individuals. The daily caloric intake for all dieters was from 300 to 400 calories, and all took a vitamin or vitamin-mineral supplement. Twelve of the dieters were under some form of medical supervision, ranging from thorough to infrequent follow-ups without laboratory tests.

In December 1977, FDA first proposed to require warnings on the labels and labeling of protein products for weight reduction, and the following December a tentative final rule was published in the Federal Register. The final rule, requiring three different warnings for protein products deriving more than 50 percent of their total caloric value from protein, was published in April 1980.

A month after publication, the Council for Responsible Nutrition a trade association whose membership includes manufacturers of dry, whole-protein products filed suit to invalidate the labeling regulations. Although the court upheld FDA's overall labeling plan, it decided against the agency, finding insufficient evidence to support FDA's finding that diets between 400 and 800 calories per day may cause serious illness or death. So, the court ordered the regulation back to FDA for further study and reformulation.

In the Federal Register of June 11, 1982, FDA proposed a revised rule for protein product labels. After reviewing comments received in response to the new proposal, a final rule was developed. It became effective Aug. 6, 1984. The rule concerned label requirements for any food product in liquid, powdered, tablet, capsule, or similar form that derives 50 percent of its total caloric value from either whole protein, protein hydrolysates, amino acid mixtures, or a combination of these, and that is . . . promoted for use to reduce weight.

Protein products are exempt from the labeling requirements if the product is represented as part of a nutritionally balanced diet plan providing 400 or more calories per day and the label specifies the diet plan in detail or briefly describes the plan and provides information on where it can be obtained. In this case, the label must bear the following statement: NOTICE: For weight reduction, use only as directed in the accompanying diet plan (the name and specific location in labeling of the diet plan may be included in this statement in place of accompanying diet plan). Do not use in diets supplying less than 400 calories per day without medical supervision.

FDA, as a regulatory agency, does not formally approve diet plans. Unlike drugs, foods do not require pre-market approval. An agency talk paper released Dec. 30, 1982, in response to inquiries about the safety of extremely low calorie diets, stated that There is a general consensus among nutrition and obesity control experts that extremely low calorie diets diets providing less than 400 calories per day are physiologically unsound regardless of their overall nutrient composition.

The paper further stated that there is also a consensus among these experts that diets providing less than 800 calories per day should be used only under proper medical supervision, and that FDA concurs with the consensus.

Going It Alone

FDA's division of nutrition deputy director Victor Frattali, Ph.D., is wary of fasting diets in general. He is especially concerned, however, about dieters who use very low calorie diet products without medical supervision. He says there are two critical factors to consider in very low calorie diets: the quality of the product and the directions for use. The powder or liquid in the newer products that are sold directly to consumers may or may not provide all the nutrients you need, says Frattali, but even if they do, I have serious concerns about diets of less than 800 calories per day.

FDA's position is that diets of less than 800 calories a day should be undertaken only with proper medical supervision, and Frattali maintains that, in fact, almost anyone can lose weight on 1,200 calories a day.

Nutritionist Marilyn Stephenson of FDA?s Office for Nutrition and Food Sciences says a reasonable goal for weight reduction is to lose a pound or so a week. To lose one pound of fat a week, food consumption must be reduced by 500 calories a day.

A 1,000- to 1,200-calorie-per-day diet should be combined with increased physical activity, which raises your metabolism, [burns more] calories, and improves physical fitness, Stephenson advises. For many people, simply eating smaller portions of the foods usually eaten, keeping fried and other fatty foods and rich desserts to a minimum, and exercising more is an appropriate approach to weight loss and weight maintenance.

Stephenson also advises consulting a physician and then, if possible, a nutritionist or dietitian before beginning a diet. This is especially prudent for people who have a medical condition or have many pounds to lose. Certain diets pose serious health hazards for people with some diseases such as diabetes or intestinal disorders.

About the Author

www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.