In 1994, federal legislation, passed after intensive lobbying by the supplements industry, essentially removed dietary supplements from most regulation by the FDA. Dietary supplements, according to the Dietary Supplement Health and Education Act (DSHEA), are to be regulated as a class of foods, not drugs. All else follows from this—that supplements need not be screened for safety and effectiveness before they are marketed, for example, and that it is the responsibility of the Food and Drug Administration (FDA) to prove that supplements are harmful.
However, the law does limit the claims made on supplements’ labels and on the Internet (even in testimonials and website links). With only a few exceptions, they cannot assert that the supplements treat or cure disease. They may make only “structure/function” or “health maintenance” claims. Here are some examples:
- A label can say “helps improve your mood” but can’t say “reduces depression.”
- It can say “maintains a healthy circulatory system” but not “prevents cardiovascular disease.”
- It can say “maintains cholesterol in a healthy range” but not “lowers cholesterol.”
- It can say “supports the immune system” but not “helps prevent colds and flu.”
For years, the FDA has attempted to make a distinction between “disease claims” (also called “medical claims”), which it strictly limits, and “structure/ function claims” or “health maintenance claims,” which are largely unregulated. It is nearly impossible for consumers to tell the difference between reasonable, permitted claims and the overblown ones—or to spot deceptive advertising. The fine line between a disease claim and a structure/function claim is hard for even the experts to define.
Disease claims. These focus on preventing, treating, curing or diagnosing a disease or its signs or symptoms. Some examples: “prevents osteoporosis,” “protective against cancer,” “lowers cholesterol,” “reduces the pain and stiffness of arthritis,” “alleviates constipation” and “improves urine flow in men.” Such claims require prior FDA review for efficacy, including “significant scientific agreement.” Among the few explicit health claims that have met the FDA’s high standards of proof are the claims that calcium helps prevent osteoporosis and that folic acid (a B vitamin) helps prevent birth defects.
Even “implied” disease claims require FDA approval, though this is where things get really murky. Such claims would include “prevents bone frailty,” “promotes urinary tract health,” “improves joint mobility and reduces joint inflammation” and “helps maintain intestinal microflora.” Supplement manufacturers, denying that these are medical/disease claims, often push to see how far they can go with such implied claims.
“Health maintenance” or “structure/function” claims. These include claims such as “maintains a healthy circulatory system” as well as claims about common conditions associated with “life stages,” such as aging, menopause or pregnancy. Other nondisease claims include “arouses sexual desire,” “boosts stamina,” and “enhances muscle tone.” None of these vague claims need FDA approval, but there must be a printed disclaimer on the label saying that the statement has not been evaluated by the FDA and that the product is not intended to diagnose, treat, cure or prevent disease. Of course, this disclaimer is usually in tiny type, and many people only see the words “Food and Drug Administration” and think this indicates approval.
Qualified health claims. In 2004, bowing to pressure from industry via freedom-of- speech court cases, the FDA started allowing more questionable “qualified” health claims, which are hedged with qualifiers and based on “very limited,” “preliminary” and possibly even poor-quality evidence. Because of all the qualifiers, supplement makers rarely put such claims on labels. Though the industry pushed for the right to use qualified health claims, some supplement makers have challenged the restrictive wording demanded by the FDA by taking the agency to court and arguing that their freedom of speech is being limited.
In 2012 and 2013, the FDA issued a record number of warning letters to marketers about illegal disease claims made on supplement labels, in ads and on the Internet. And in late 2012, an investigation by the Inspector General of the Department of Health and Human Services concluded that many supplement companies make unsubstantiated health claims on their labels and do not comply with federal law in other ways. The report recommended that the FDA be given greater authority in order to crack down on such illegal claims.
What about supplement risks?
Though they are almost never listed on labels or mentioned on websites, the risks include the following:
- Some supplements have been associated with serious and even fatal side effects: kava with liver failure, for instance, and aristolochic acid with kidney failure and cancers of the urinary tract.
- Some supplements have the same beneficial effects and adverse effects as prescription drugs. For example, supplements like red yeast rice that claim to lower cholesterol actually contain a statin drug. Supplements that claim to “cure” impotence may contain the drug sildenafil (Viagra), along with other potentially dangerous adulterants. But while the drugs require a doctor’s supervision (and precautionary labeling), people generally take supplements on their own, so there’s no one to check for side effects.
- People who self-medicate with supplements may be missing out on treatments or dietary measures that could really help them.
- Dietary supplements can interact with both prescription and nonprescription medications, making the drugs less or more potent.
Published January 30, 2014