Post Two of a Series: The Relationship Between the Level of Regulation under the FDCA and the Health Status of a Product’s Targeted Population

The first post of this series began by asking whether functional foods should be regulated as drugs if they claim to treat abnormal health conditions. For example, was it appropriate for the FDA to characterize Cheerios as a drug as a result of its advertising claim that “you can Lower Your Cholesterol 4% in 6 weeks?” An abnormally high cholesterol level is a serious risk factor for disease and those with high cholesterol levels are in an abnormal state of health. By virtue of its claims to help this group of unhealthy consumers with their struggle to return to a normal state of health, should the manufacturer of Cheerios be required to undergo the FDA's premarket approval process to show that eating Cheerios is effective in lowering cholesterol as claimed?

The answer to this question may become more apparent by looking at another category of products that claim to help unhealthy people return to a normal health status – weight loss products.

The Obesity Crisis and Weight Loss Products

The United States’ obesity crisis is gaining momentum. In only fifteen years, eighty percent of Americans will be either overweight or obese. Being overweight or obese places an individual at a significant risk for developing hypertension, Type II diabetes, heart disease, stroke and cancer.

Conservative estimates predict that the health care costs associated with this epidemic will reach $956.9 billion in the 2020s. One of every six dollars spent on health care will be associated with the conditions of being overweight and obese. Significantly, for the first time in over a century, children and young adults will have a shorter life expectancy than their parents.

"This obesity epidemic has been matched by a rapid growth in the weight loss supplement industry. Overweight consumers desperate to lose weight are being lured by ‘magic bullet’ claims into purchasing ‘quick-fix’ weight loss supplements in order to lose weight and decrease their risk for disease. As the result of prodigious marketing campaigns, many adults and adolescents ... are turning to weight loss supplements as an alternative to diet modification and exercise.

Advertisements for the ‘quick-fix’ product that works to melt off pounds without diet or exercise, some even while you sleep, are everywhere. Enforma Natural Products, Inc. ran an infomercial marketing its product Exercise in A Bottle claiming it “helps your body burn more calories while you’re just standing or sitting around doing nothing – even while you are sleeping” and “[y]ou can enjoy all those delicious foods like fried chicken, pizza, cheeseburgers, even butter and sour cream, and stop worrying about the weight.” The manufacturer of a similar product called Maxiline advertised heavily by taking out full-page newspaper advertisements stating “[s]leep … and lose weight in just a few nights … you eat whatever you want.” The advertisement stated that the product worked because “the body’s fat cannot defend itself from attack while asleep.”

Commercials on television and radio, lengthy infomercials, magazine advertisements, mass mailings of brochures and Amway and “Avon-Calling” type visits from friends and neighbors hawking miracle potions for magical weight loss flood the American consciousness. In 2000, the sale of weight loss supplements in the United States reached $4.7 billion, with a projected increase of ten to twenty percent annually.

In the book Through the Looking Glass, Alice said, “[o]ne can’t believe impossible things.” The White Queen answered: “I daresay you haven’t had much practice . . . . When I was your age . . . I’ve believed as many as six impossible things before breakfast.”

Like Alice, for many, the impossible weight loss claims made by the current breed of snake oil salesmen defy credibility. However, viewed in context, these beliefs are more understandable. Many of these consumers, and, shockingly, their physicians, incorrectly believe that the FDA requires premarket testing to establish that these weight loss supplements are both safe and effective. In fact, the FDA does not require that these products undergo clinical testing for safety or efficacy prior to being placed on the market. This vast market exists in spite of the fact that there is little to no evidence that most of these products actually work. To the contrary, there is growing evidence that many are ineffective and unsafe.

In 2002, the FTC issued a report that fifty-five percent of the claims made within advertisements of over-the-counter weight loss products were either false or misleading. According to the FTC, more consumers are defrauded by weight loss products than any other product it has examined." Slaying the Hydra: The History of Quack Medicines

Why isn’t the FDA using its premarket approval authority to keep these sham products from entering the market in the first place? Not surprisingly, the weight loss supplement industry is marketing its products as dietary supplements and is claiming the safe haven protections from FDA regulation offered under the Dietary Supplement Health Education Act (“DSHEA”) and the National Labeling Education Act of 1990 (“NLEA”). What is surprising is that the FDA appears to agree. Are the weight loss supplement industry and the FDA correct?

The next several posts in this series will examine the history of the relationship between the FDCA, the FDA and predatory commercial interests and will ask whether there are lessons from the past that can assist in the analysis of current regulatory issues involving food, functional food and dietary supplements. If so, do these lessons also offer insights into the regulation of nanotechnology used in consumer products for direct and indirect human consumption — including food (directly and through the food production process), food supplements, cosmetics and sunscreens?