Recently, a friend of mine ended up in the emergency department a few days after starting a dietary supplement that she assumed was safe since it could be purchased without a prescription. What she didn’t realize is that many supplements, just like prescription medications, have side effects and can interact with other medications. Fortunately, she recovered completely, but is now much more careful about taking these products. Exactly what is a dietary supplement and how does it differ from a FDA-approved medication?
In response to popular demand, the Food and Drug Administration (FDA) may have “opened a can of worms”, allowing a profusion of questionable health-related products to hit the market. The 1994 Dietary Supplement Health and Education Act (DSHEA) passed in part because “millions of consumers believe dietary supplements may help to augment daily diets and provide health benefits.” This resulted in a different set of regulations governing dietary supplements than those covering conventional foods and drug products (prescription and over-the-counter).
The DSHEA established a formal definition of “dietary supplement” using several criteria. Chiefly, a supplement is considered to be “a product (other than tobacco) that is intended to supplement the diet that bears or contains one or more of the following dietary ingredients: a vitamin, a mineral, an herb or other botanical, an amino acid, a dietary substance for use by man to supplement the diet…”
Nowhere in the defining criteria, however, is there anything that relates to the effectiveness of the supplement. In fact, the FDA specifically states that “claims may not be made about the use of a dietary supplement to prevent, mitigate, treat, or cure a specific disease.” Manufacturers may describe the supplement’s effects on “structure or function” of the body or the “well-being” achieved by consuming the dietary ingredient, but very little proof is required to back up these claims. The manufacturers are simply required to attest that their statements are truthful, which seems uncomfortably similar to allowing the fox to guard the hen house.
Even the provisions in the act that try to assure the safety of dietary supplements are dubious. Under DSHEA, a dietary supplement is considered to be “adulterated” if it or one of its ingredients presents “a significant or unreasonable risk of illness or injury.” Although the Secretary of Health and Human Services “may declare that a dietary supplement poses an imminent hazard to public health or safety” and have it removed from the market, the mechanism by which adverse effects or abuse potential is monitored is unclear. And guess who is responsible for ensuring that its products are safe and properly labeled—the manufacturer, of course.
This is not to say that all dietary supplements are ineffective or unsafe. Many supplements (herbal products, multivitamins and mineral supplements, etc.) have excellent safety records and are used successfully by millions of consumers. Unlike drug products that must be proven safe and effective for their intended use before marketing, however, there are no provisions in the law for FDA to “approve” dietary supplements for safety or effectiveness before they reach the consumer. Also unlike drug products, manufacturers and distributors of dietary supplements are not currently required by law to record, investigate or forward to the FDA any reports they receive of injuries or illnesses that may be related to the use of their products.
So the next time that you’re tempted to purchase a dietary supplement that claims to restore hair growth, dissolve fat from your hips, give you a six-pack abdomen or a myriad of other fantastic results, just remember that very little proof of their effectiveness or safety is required before they hit the market. Caveat Emptor (Buyer Beware)!
