Confusion about supplement disclaimers

With the news seeming to bring regular reports of dietary supplements being recalled for problems, contaminants or not containing what the label says, or for making unsubstantiated disease claims, many consumers appear to be attributing it to a failure of the FDA to protect them. It’s not exactly the FDA’s fault, in the way you might think.

A recent study in the Journal of Community Health by Johns Hopkins University may help to explain the source of some of the confusion. The researchers, led by Dr. Bimal H. Ashar, M.D., FACP, Assistant Professor of Medicine at Johns Hopkins University School of Medicine, randomly surveyed 300 patients in three primary care practices in the Baltimore area. The adults all had internet access and some exposure to online advertising. The researchers asked questions to assess the public’s understanding of the regulation of supplements.

More than half of the adults didn’t realize that supplements aren’t approved by the government and nearly two-thirds didn’t realize that dietary supplement advertisement claims weren’t validated by the FTC or any government agency. In fact, a full 10% were certain that the FDA approved dietary supplements, meaning they were safe, with another 42% unsure. These beliefs could make them more vulnerable to being taken advantage of or harmed.

A helpful point to understand is that supplements are not regulated like other foods or medical products. The Dietary Supplement Health and Education Act (DSHEA) of 1994 was passed, on the grounds it would empower consumers to make their own choices and in response to consumers who believed supplements provided health benefits. As the FDA explains, with the passage of DSHEA, ingredients in supplements no longer have to be approved by the government, and supplements don’t have to be registered with the FDA or undergo safety evaluations before they can be sold, “as is required of other new food ingredients or for new uses of old food ingredients.” With this legislation, the government also doesn’t validate a manufacturer’s claims or test supplements to verify their purity, strength or that they contain what the label says.

With the passage of DSHEA, supplement manufacturers are allowed to say their products provide nutritional support, effect the body’s function or structure, or support general well-being. DSHEA also expanded the meaning of dietary supplement beyond essential nutrients (such as vitamins and minerals for deficiencies) to include other substances and nutraceuticals (including ginseng, garlic, fish oils, psyllium, enzymes, glandulars, etc.). The Nutrition Labeling and Education Act of 1990 added herbs or similar nutritional substances to the term “dietary supplement.”

With dietary supplements no longer considered “drugs” under DSHEA, the FDA’s role in regulating them dramatically changed. The FDA legally cannot act to take a fraudulent product off the market until it proves a supplement is unsafe. The FDA has been given the burden of proof and must prove a product is unsafe and poses “a significant and unreasonable risk” before it can act... and then, only after a product is already being sold. Even ingredients that are useless but harmless are protected.

As Dr. Stephen Barrett, M.D., explains:

Because manufacturers are not required to submit safety information before marketing "dietary supplements," the FDA must rely on adverse event reports, product sampling, information in the scientific literature, and other sources of evidence of danger. Since the FDA is unable to monitor and regulate thousands of individual products, the public is virtually unprotected against supplements and herbs that are unsafe.

According to FDA Commissioner Jane E. Henney, M.D., they’ve found even ingredients like prescription drugs or illicit drugs being sold as dietary supplements. As we’ve seen repeatedly, the moment a company receives a FDA warning letter, though, they can just set up shop somewhere else or give their products a new name; or just ignore the letters altogether, as the fines are typically only a fraction of the money they’re making. So, trying to chase after fraudulent products is intrinsically ineffective.

It’s up to consumers to educate and protect themselves with all medicines. Supplement companies, however, haven’t had to report adverse reactions to the FDA and few doctors file reports, which makes getting information even more difficult. With the recent passage of the Supplement and Nonprescription Drug Consumer Protection Act (Public Law 109-462), manufacturers of supplements sold in the United States are now supposed to report to the FDA all serious adverse events (deaths, life-threatening condition, hospitalization, disability, congenital anomaly or birth defect, or requires surgical or medical intervention) due to their supplements.

The Office of Dietary Supplements at the FDA keeps a listing of FDA warnings and advisories for consumers, as well as a link for consumers to report adverse reactions here. And if you think you’ve suffered a harmful effect from a supplement, you and your doctor are encouraged by the FDA to report it to them at 1-800-FDA-1088. The FTC has Operation Red Flag [click on image to enlarge], which provides information for people on how to avoid false claims that might hurt them or defraud them of their money here and keeps a list of companies that have been cited for fraudulent weight loss claims here.

The FDA and FTC work together — with the FDA overseeing the product, label and product literature, and the FTC overseeing the marketing and advertising. Both say they determine if claims are truthful and not misleading to the public, based on whether the company can substantiate their claims with “competent and reliable scientific evidence.” According to Vickey Lutwak at the FDA Office of Nutritional Products, Labeling, and Dietary Supplements, they look at the manufacturers’ evidence to ensure that each study is actually related to the claim (a surprising number of studies on reference lists aren’t); each study is a valid test (looking at bias and if it’s a “fair test”) and uses reliable design and analysis; the study methodologies are reliable to support the claim (i.e. tests on humans versus test tubes; clinical trials versus observational correlations or testimonials); if the claim is meaningful and biologically plausible; and the overall strength of the body of evidence.

These are the same valuable techniques important for us to use to protect ourselves with any health product. No government agency will ever be infallible.

What’s the story with a “disease” claim?

You've seen the disclaimer on supplement claims that says: "This statement has not been evaluated by the FDA. This product is ot intended ot diagnose, treat, cure or prevent any diease." But, as the Johns Hopkins' researchers found, this doesn't make the regulations clear to significant numbers of consumers.

It might seem logical that it would be illegal for any company to make any claims for products affecting our body or health that aren’t true, and many medical professionals wish for that, too. But that’s not how DSHEA works, either. Dietary supplements can claim pretty much anything and stay under the radar unless they specifically make a “drug” claim. (The Food, Drug and Cosmetic Act defines a “drug” as anything intended for the “diagnosis, cure, mitigation, treatment or prevention of a disease...”)

Only then, can the FDA take action to protect the public and stop products from making unsubstantiated claims. That’s why those FDA warning letters so thoroughly review disease claims.

The DSHEA has been a topic of increasing controversy, with two huge financial interests wrangling. The huge supplement industry objects to any changes in this legislation that might make supplements, like other drug, have to conduct clinical trials and demonstrate their supplements are safe and effective before they can be approved for marketings. The drug industry wants supplements that claim health effects to be regulated like other drugs. With U.S. consumers spending more than $322 million just on supplements for weight loss in 2005, according to the Obesity Society, it has been most active in working to change DSHEA for weight loss supplements that compete directly with GlaxoSmithKline’s over-the-counter Alli (low-dose Xenical, a fat blocker, and the first FDA-approved over-the-counter prescription diet pill, with anticipated annual sales of $1.5 to $3.9 billion).

Regardless of the source, taking a critical eye to any advertising claims for pills and potions, and giving careful consideration of the evidence of demonstrated benefits and harms, using the fair test method, can help keep us all safer.