The Claims Game: The Consumer
Loses
For: Double Standards,
December 2003
Here are examples of what a label on a dietary supplement can and cannot claim:
• It 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 healthy cholesterol," but not "lowers cholesterol."
• "Supports the immune system," yes, but not "helps the body resist infection."
Now can you keep that straight? Unlikely.
Old rules, new rules, no rules for labels
Since Congress deregulated dietary supplements in 1994, some of the most confusing things on the labels of supplements have been the health and medical claims. Some people may assume that such claims are approved by the Food and Drug Administration (FDA) or at least closely monitored by it. But, in fact, regulation of claims on labels has been minimal and confused, as a visit to any health-food store will show you. New FDA rules that are going into effect this year are unlikely to improve matters.
For years the FDA has attempted to make a distinction between "disease claims" (also called "medical claims"), which it strictly limits, and "structure or function claims" or "health maintenance claims," which are essentially unregulated. The new rules are intended to clarify this distinction. Unfortunately, it will still often be impossible for consumers to tell the reasonable and permitted claims from the overblown ones.
Disease claims say something about preventing, treating, curing, or diagnosing a disease or one of its signs or symptoms. Some examples: "prevents osteoporosis," "protective against cancer," "reduces the pain and stiffness of arthritis," "alleviates constipation," "lowers cholesterol," "improves urine flow in men over 50." 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 helps prevent birth defects.
Even "implied" disease claims now 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 flora." Supplements manufacturers, denying that these are medical/disease claims, often push to see how far they can go with such implied claims.
Claims relating to the "structure or function" of the body 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 claims need FDA approval, but there must be a printed disclaimer on the label saying that the product is not intended to diagnose, treat, cure, or prevent disease and has not been reviewed by the FDA. 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.
The new regulations are supposed to protect consumers by limiting pseudo-health claims. But thanks to pressure from the supplements industry, politicians, and some consumer groups, the FDA did not accomplish this. In many ways, manu-facturers can now make broader and bolder claims on labels than before.
Words to the wise
Don’t believe claims you read on supplements labels. Many, if not most, of them are wishful thinking, overstatement, or outright deception. The same is true for the implied health claims made on the labels of many "functional foods" that are spiked with herbal compounds.
Manufacturers do not have to offer any proof to the FDA that supplements are safe and effective. If the FDA has questions about the safety of products or about claims made on labels, it has to take the manufacturer to court. The agency has limited resources, and thus it takes action against few of the many questionable supplements and their claims.
The situation is even worse concerning ads or brochures for supplements, since the Federal Trade Commission (FTC), which is in charge of them, has lower standards regarding health claims.
To file a report
If you think that a supplement is falsely labeled, you can report it to your regional FDA office—look in the U.S. Government listings in the White Pages under Health and Human Services. Report misleading ads to the FTC (click on "File a Complaint") or the FDA.
UC Berkeley Wellness Letter, April 2001
