Supplement Makers: The Teflon Industry - All-Natural Health Evades FDA Regulations, Invades Consumers Wallets

Demand is rising for products that promote health “naturally.” America is the industry’s honey pot, home to some 85,000 pills, powders and elixirs that purportedly increase joint mobility, support a healthy heart, augment the immune system and libido, sharpen mental acuity, and enlarge genitalia, as well as a slew of other digestive, ocular, and neuropsychiatric benefits. These “miracle” healers come with an aggregate $25 billion yearly price tag. Paradoxically, it was 1990’s FDA regulations that gave the industry its greatest boost. New rules were considered for supplements’ health claims and lobbyists framed the issue in terms of personal liberty. As a result, the law allows firms to sell vitamins, minerals, enzymes, botanicals and organic pills and metabolites without FDA approval for safety or efficacy. Moreover, although manufacturers cannot definitively claim these substances can diagnose, prevent, treat or cure a particular disease, vague claims of supporting well-being are permissible.

The FDA’s powers over the sale of these products are anemic. This year states acted in this regulatory void. New York’s attorney general charged that many supplements did not contain ingredients listed on the label. In fact, some contained none of the labeled substance and others had potentially injurious contaminants. Even such an easily manufactured item as multivitamins, when analyzed, was found to have either too much or too little of a nutrient. Moreover, recent reports of contaminated probiotics, steroid-laced vitamins, and hepatotoxic diet pills causing significant morbidity and even death have been investigated.

The question of efficacy is just as thorny. Under the 1994 law, firms must have some substantiation for their claims, but do not have to file these data with the FDA. Many “clinically-proven” effects are from anecdotal reports or trials without controls, appropriate statistical analysis, objective end-points, dose-response curves or evidence of patient compliance. Nor does it seem that future studies will provide more reliable information. There is neither incentive nor funding interest by the scientific community and the supplement makers do not want to jeopardize the cash cow.

So how does this industry survive, never mind thrive? Supplements bring a unique trifecta: lax regulation, potent marketing, and millions of credulous consumers willing to believe that the road to health and happiness is paved by innocuous “natural” substances. In addition, conventional healthcare is expensive, often complex, and fraught with innumerable warnings about serious potential side effects and less than perfect treatment benefit. And finally, if no serious pathological process is jeopardizing life and limb, there is the very potent and real placebo effect; the brain’s amen to the illusion the stuff actually works.



By Norman Silverman, MD, with Ryan McKennon, DO and Ren Carlton

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