Supplements: The Regulatory Picture

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Under current law, such potentially hazardous products can easily wind up on the market. Dietary supplements have never had to stand up to the scrutiny that drugs do, meaning they do not have to be approved—or even evaluated—by the government before they are sold. Recently, with the passage of the Dietary Supplement Health and Education Act (DSHEA) in October 1994, supplement manufacturers received even wider latitude in the claims they can make. The act also expands the definition of dietary supplement to include a greater range of substances within this loosely regulated realm.


Traditionally, dietary supplements were considered to be only vital nutrients such as vitamins and minerals. In 1990 the Nutrition Labeling and Education Act (NLEA), which established rules for ingredient lists and health claims on foods, added “herbs, or similar nutritional substances” to the definition of dietary supplement. DSHEA expanded that definition further to include chemicals such as amino acids, fish oils, enzymes, mixtures of these, and even drugs that were marketed as supplements or food before they were approved as drugs.


How does the FDA ensure that all these products are safe? It does not, for the most part. At times, the FDA has tried to exert tighter control. Twenty years before the tryptophan tragedy, there was a move to ban amino acids from the marketplace. However, that and other efforts of the 1960s and 1970s—including one to regulate high-dose vitamins and minerals as drugs—failed due to red tape, court challenges, and ultimately, the Proxmire Amendment.


Still, for many years, supplements were regulated much like foods. As it can with foods, the FDA could challenge whether there were adequate data to support the safety of a new ingredient in a supplement before it hit the market. Now though, under DSHEA, manufacturers no longer have to provide evidence that a new supplement is safe before it is sold. Just about any sort of supplement can be sold. To take a product off the market, the FDA must prove that the product is unsafe.


The FDA will soon, however, exert some control over the purity and quality of supplements. The agency is now drafting a document that outlines “good manufacturing practices” (GMPs) for the preparation, packing, and storage of supplements. DSHEA granted the FDA the authority to set up GMPs, but the approved rules probably will not be finalized for at least two years.


Labels
Under DSHEA, the FDA still retains some control over what a supplement can say on its label, especially in the area of health claims, which specify a relationship between a substance and a disease. To make a health claim for a supplement, a manufacturer must get approval from the FDA, which will grant it only when there is “significant scientific agreement” that the claim is true. So far, the FDA has authorized only two health claims for supplements: calcium's ability to prevent osteoporosis and folic acid's ability to reduce the risk of neural tube defects.


But “nutritional support statements” are another story. Under this second category of claims, allowed only on dietary supplements, a claim can describe the supplement's effect on the structure and function of the body, the biological mechanism by which the supplement acts, and effects on well-being. It can also describe a benefit relating to a nutrient deficiency disease.


Before DSHEA, structure and function claims would have implied that a product was a drug and would have allowed the FDA to regulate it as such. Now, however, a label can tout, for instance, that a supplement “makes joints feel better” or “helps you sleep”—as long as it does not mention a benefit for a specific ailment such as arthritis or insomnia. Manufacturers must notify the FDA that they are making a nutritional support statement. They are supposed to have data to substantiate it, but do not have to supply this to the FDA. Instead, the FDA must prove that a statement is false or misleading.


Enforcement

Although the FDA still has the authority to crack down on unsafe products or misleading labels, it only has the resources to do so in the most egregious circumstances. That is because taking action requires preparing a legal case and taking it before a judge. Nevertheless, the agency is now marshaling its troops to fight ephedrine.


By the end of 1996 FDA officials plan to institute restrictions on ephedrine formulations. These could range from setting a maximum allowable dose—which would undoubtedly be far below that in supplements such as Herbal Ecstasy—and mandating specific warning labels, to establishing standards for the active ingredient, whose form now varies between products. The FDA could ultimately ban ephedrine, but that would take more regulatory firepower than the FDA has plans to assemble just now.


The Upshot: Buyer Beware

For the many untested pills, capsules, powders, and liquids that remain on the shelves, it pays to be cautious. Here are a few tips for dealing with the supplement conundrum.
*Bone Up: Before taking a supplement, find out what evidence supports its advertised benefits—and dangers. It is a good idea to glean information from a variety of sources, not just one book or magazine article.

*Do Not Overdo It: Learn what scientists know about safe dosages and do not exceed them. In particular, do not use a large variety of herbs on a regular basis. There are no data on the safety of any botanical when combined with another herb or drug.

*Do Not Trust the Label: It can make any number of claims that are not backed by good science or, in some cases, any science at all. Do pay attention to the print that reads: “This statement has not been evaluated by the Food and Drug Administration.”

*Discuss Supplement Use With a Doctor: Inform a doctor about supplement use, including vitamins. Pregnant women and people with genetic defects that impair their ability to metabolize a nutrient should not use any supplements without approval or recommendation from their physicians.

*Consider Food: When possible, it is generally better to get nutrients from food than from supplements. Consumers should learn what foods supply those they need most and include them in their diet.

*Report Adverse Reactions to FDA: Anyone who believes he or she has symptoms related to dietary supplement use should call 1-800-332-1088 or 1-800-332-4010.