Dr. Clif CleavelandEach year Americans spend tens of billions of dollars on dietary supplements, which are widely available over-the-counter or online. This is a largely unregulated market whose products may have had limited testing. These compounds are often referred to as "botanicals," as if the reference to natural sources somehow guarantees their safety and effectiveness.
Supplements are touted for a wide range of uses, including memory enhancement, prevention of dementia, weight loss, restoration of libido and improvement of athletic performance. Labels are often flashy, highlighting claims for dramatic health improvement. Advertisements are widely disseminated on television, in print media and online.
Prior to 1994, there were an estimated 4,000 products, largely combinations of vitamins and minerals, which were marketed as dietary supplements. But that year, Congress enacted, with bipartisan support, the Dietary Supplement Health and Education Act (DSHEA), which broadened the category of these compounds to include a wide variety of herbal and other nutritional and medicinal products. The act excluded these products from effective regulation by the U.S. Food and Drug Administration and, six years after enactment of the law, more than 70,000 supplements were marketed in the U.S. A current figure for how many supplements are out there is not available.
Manufacturers of supplements are not required to submit pre-marketing evidence that their product is safe or effective. They must submit a statement of the ingredients and function of the compound to the FDA, which requires this addendum for each product: "This statement has not been evaluated by the FDA. The product is not intended to diagnose, treat, cure, or prevent any disease." Labels also must to include the words "dietary supplement."
Under terms of the Dietary Supplement act, a supplement can contain one or a variety of vitamins, minerals, amino acids, fatty acids, herbs or other botanical products. Derivatives of these materials can be included with no regard to the concentration of any ingredient.
Adverse reactions are difficult to track for products approved under the act. For instance, several drugs promoted in recent years for weight loss and improved strength contained 1,3-dimethylamylamine, which was sometimes called "geranium extract" to suggest a safe, botanical origin. But it had an amphetamine-like effect, and some users developed rapid pulse, high blood pressure, chest pain and shortness of breath. Rarely, heart attacks occurred.
After much prodding by the FDA, makers of drugs containing the dimethylamylamine agreed to a voluntary withdrawal in 2013. A recent Internet survey, however, shows products with the substance are still readily available from major online retailers.
In February of this year, the New York attorney general's office reported adulteration of several of dietary supplements. Instead of the herbal ingredients listed on labels, products contained wheat, rice, starch or pulverized plants. The fraudulent products could cause allergic reactions in unsuspecting users. New York authorities based their report on tests of store brands from Walgreens, Target, GNC and Wal-Mart. Retailers were ordered to remove the products from their shelves.
In the end, the FDA needs the authority, budget and manpower to tackle a shadow industry that is out of control.
I investigated one product recently that was widely advertised as a means to improve memory. The ad cited personal testimonials of effectiveness from unidentified users. These are generally unreliable. Independent clinical studies were cited which I could not find by visiting the manufacturer's website. Double-blind studies, where neither the person administering or receiving a drug knows if it is real or placebo, represent the gold-standard for determining safety and effectiveness.
When considering use of a dietary supplement, research it on the Internet to determine its ingredients, who makes it and where it's made. If a scientist is featured in promotions, track down his/her credentials to determine if they are relevant to the product.
Remember that there is no guarantee of purity, safety or effectiveness. If you take prescription medications, remember also that chemicals in the dietary supplement may block or alter the desired effects of the drugs that you actually need. Finally, ask yourself why you need to take the compound.
Contact Clif Cleaveland at cleaveland1000@comcast.net.