Overweight and out of shape? Want to lose pounds without dieting and eliminate inches without exerting any effort?
So do millions of Americans who believe that somehow, as if by waving a magic wand, they will be thin and firm. Unwilling or unable to lose weight through diet and exercise, they turn to weight-loss gimmicks ranging from pills that supposedly let them eat unlimited pasta to rubber suits that make them sweat while they sleep.
Most current diet gimmicks seem to fall into two categories:
(1) custom garments or body wraps that claim to “melt” fat away in a short time, and
(2) pills that supposedly curb appetites without side effects, or allow dieters to eat as much as—or more than—normal and still lose weight. The pills are usually touted as the product of some previously undiscovered process.
Who can blame the fretfully flabby for being lured by the promise of losing inches without doing anything more strenuous than popping a pill or wrapping up the offending flesh? Who can resist ads for body wraps that promise “to burn away fat even while you sleep,” to “lose 4-6 inches the first day?”
Some of the plastic or rubber garments are worn around the waist, some cover the waist, hips and thighs, and others cover nearly the entire body.
Some are to be worn while carrying out routine activities, others while exercising, and some while sleeping. One is inflated with air from a vacuum cleaner. Another uses an electric hair dryer to blow in warm air. Some are used after a cream, gel or lotion is applied or after the wrap is soaked in a solution.
The Food and Drug Administration has investigated a number of these products and has taken action against several promoters of wrapping devices and latex exercise or sweat suits for making unsubstantiated medical or therapeutic claims.
The garments and wraps, with or without lotions and creams, reduce body dimensions by removing fluids. Most medical experts agree that such treatment will cause a loss of inches and perhaps pounds due to profuse perspiration. But the reductions are temporary. The fluid is soon replaced by drinking or eating. But rapid and excessive fluid loss is potentially dangerous because it can bring on severe dehydration and can upset the balance of important electrolytes in the body.
Wraps have no effect on fat deposits and will not dissolve fat, even temporarily. Fat is not broken down by perspiration. It is gotten rid of only when fewer calories are consumed than are needed to meet the body’s energy requirements.
The latest twist in the body wrap bonanza is a product called La Creme, a balm to be applied to parts of the body where loss of inches is desired. La Creme differs from other wrap products in that the wrap is not sold along with it. Rather, consumers may choose their own wraps from among the plastic products normally used to wrap food. La Creme is applied and then six or seven layers of the plastic wrap are wound around the creamed area.
A leaflet for the product claims: “Lose up to two inches from those problem areas in just one hour.” An advertisement adds, “Its gentle warmth penetrates into your skin and helps melt fatty deposits.” But, as with other wraps, any weight or inches that disappear are lost from perspiration. (See “Fat Won’t Melt,” an Update in the November 1981 FDA Consumer.)
Promotional literature distributed to retail outlets, such as department stores and specialty salons, claimed that FDA had approved or classified La Creme as a skin toner, tightener and smoother. In truth, FDA had never been given an opportunity to evaluate the product and had no idea what it contained.
FDA advised a distributor of La Creme that, based on the product’s labeling, it should be regulated as a drug because it claimed to alter the size, shape or conformity of the body–a drug function as defined by the federal Food, Drug, and Cosmetic Act. When the distributor contended that La Creme was a cosmetic and therefore not subject to safety and efficacy requirements, FDA replied that claims of even temporary reduction of body measurements were not appropriate to a cosmetic.
The company has not replied to FDA’s comments. In the meantime, many of the department stores that carried La Creme have stopped selling it.
In resorting to magical slimming items, the weight conscious are often either taking risks with untested products that may alter the body’s functioning or being duped by products that have no more effect than a placebo. (Only two drugs–phenylpropanolamine and benzocaine, along with caffeine–should be used in non-prescription diet aids, according to an FDA advisory panel. Those recommendations have not been acted on by the agency.)
Yet, the marketing of untested diet aids persists. They appear on the market without FDA approval because manufacturers often contend that their product is a food and thus not subject to premarket approval from FDA as a drug would be.
Often a product does not come to FDA’s attention until it has been used by a substantial number of persons, some of whom may be harmed by it.
Starch blockers are an example of a product sold as a food but considered by FDA to be a drug. Advertised and sold nationwide, starch blockers allegedly block or impede starch digestion and thus help in weight control and weight reduction. One manufacturer touted the product as “a revolutionary new concept in natural weight control.” Print and TV ads claimed people taking starch blocker pills could eat up to 600 calories a day of foods such as bread, potatoes, and pasta without absorbing the calories.
Manufacturers did not seek FDA approval before putting starch blockers on the market. They claimed the product, prepared from raw beans, was a “special dietary food” instead of a drug.
FDA disagreed. The agency asked the manufacturers to discontinue marketing starch blockers until scientific testing could confirm their safety and efficacy as drugs.
Users of these products have complained to FDA of nausea, vomiting, diarrhea and stomach pains. The pills are considered to be particularly hazardous to diabetics, who may rely on their purported carbohydrate-blocking effect to calculate their diets.
Although these products are made from a food substance, FDA considers them to be drugs because of the claim that they control or reduce weight by blocking or interfering with digestion. According to the starch blocker theory, the pills contain a substance that inhibits the activity of the enzyme amylase, which digests carbohydrates. This constitutes a drug action that may interfere with the body’s normal metabolism. Under the FDC Act, a substance that is offered for a non-food purpose and that affects a function of the body is a drug, not a food, even if it is derived from a vegetable.
Another natural substance promoted as a weight-loss wonder is spirulina. It is sold as a food or food supplement in the form of a dark green powder or pill in many health food stores. Spirulina is one of about 1,500 known species of blue-green algae that grow in brackish ponds and lives in mild and hot climates throughout the world. Pure spirulina is a source of protein and contains a number of vitamins and minerals. However, in the amounts normally consumed when taken according to label directions, the nutrients derived are insignificant. As a food, spirulina can be legally marketed as long as it is labeled accurately and contains no contaminated or adulterated substances.
Claims have been made that phenylalanine, an amino acid found in spirulina (and in most other protein sources), “acts on the brain’s appetite center to switch off your hunger pangs.” However, an FDA advisory panel reviewing data on phenylalanine in 1979 found no reliable scientific data to demonstrate that it is safe and effective as an appetite suppressant.
Some nutritionists fear that consuming large amounts of spirulina might have an effect similar to that of the liquid protein diets which resulted in heart problems and even death for some dieters. Helene Swenerton, a nutritionist at the University of California’s Davis Cooperative Extension, points out that because algae are single-celled organisms, they are rich in nucleic acids providing not only a lot of protein but also large amounts of uric acid, which could result in kidney stones or gout.
Another, more recently introduced “natural” pill is dubbed “Glucomannan.” Advertised as the “Weight Loss Secret That’s Been In The Orient for Over 500 Years,” Glucomannan apparently is chemically processed from the konjac root, which has been used as a food in Japan and other Oriental countries for many years.
A search of both the Japanese and English language medical literature, however, shows no studies of this food weight-loss product. The manufacturer has not supplied FDA any information to substantiate its claims. According to advertising, Glucomannan “helps transport food through your digestive system faster. . . .As a result, more of the calories you do take in (and you’re likely to take in fewer, to begin with) can pass out of your system, still undigested, to help your weight loss along even further.”
The manufacturer originally claimed that its pill was a food. When FDA wouldn’t accept that claim, the firm maintained that its product was GRAS (generally recognized as safe) because it was commonly used in food prior to 1958.
FDA responded that although konjac tubers have been used as food in the United States since at least 1899, the substance in Glucomannan is a chemically processed extract from konjac tubers. This substance is not GRAS for food use and does not have a history of food use in this country before 1958. (Under the food additive law passed by Congress in 1958, any substance intended for food use has to be either GRAS or permitted under a food additive regulation. Substances commonly used as food prior to 1958 are generally recognized as safe.) FDA said that to be marketed as a food substance, Glucomannan would have to either be affirmed as GRAS or approved as a food additive. Both of these require submission of scientific data to FDA.
In addition to miracle pills with unproven claims, another type of dieter’s delusion is still being perpetrated by some diet clinics years after both the FDA and the American Medical Association stated it was useless for weight loss.
This deceptive practice is injection with HCG (human chorionic gonadotropin). HCG is a hormone extracted from urine of pregnant women. It is approved by FDA for treatment of certain problems of the male reproductive system and in stimulating ovulation in women who have had difficulty becoming pregnant. No evidence has been presented, however, to substantiate claims for HCG as a weight-loss aid.
An article in JAMA (Journal of the American Medical Association) in 1974 stated:
No convincing scientific evidence exists that human chorionic gonadotropin has any pharmacologic effect in weight reduction. Hence, claims to the public that such effects do occur are a misrepresentation of the scientific facts.
FDA requires all labeling and advertising of HCG to state that it has not been demonstrated to be effective in the treatment of obesity. The ads must also state that HCG is not approved by FDA as safe and effective in treatment of obesity of weight control.
Yet the use of HCG for weight loss continues. For instance, advertisements for weight-loss clinics using HCG appeared in the Chicago area in the summer of 1982. The ads included the required disclaimer, but in type much smaller than that used to extol the virtues of the clinics’ program.
The pill or shot to enable a person to lose weight without danger and without eating less has not been formulated. And the garment or other device to let one firm up or lose inches without moving a muscle has yet to be invented.
It looks like those who want to be slim will have to resort to those old, unglamorous standbys–eating less and exercising more–to shake those excess pounds.
At least until the next waving of the magic wand.
This article was originally published in the November 1982 issue of FDA Consumer. At that time, Judith Willis was editor of FDA’s Drug Bulletin, a periodical for health professionals.
This article was posted on September 17, 2005