Snake Oil or Health Tonic?

What the FDA doesn't want you to know about dietary supplements

Snake oil is a worthless preparation fraudulently sold as a cure for many ills. Nineteenth century medicine shows notoriously peddled all manner of tonics and physicks to cure everything from bunions to cancer. The U.S. Food and Drug Administration (FDA) was established ostensibly to protect the public against such hucksters. But nowadays the FDA is also treating companies and people who want to communicate scientific findings about nutritional supplements to the public as though they, too, are snake oil hawkers.

For example, I recently got a form letter from William Faloon, who heads up the Florida-based Life Extension Foundation (LEF), from which I receive discount vitamins and supplements, warning me to stock up on a three-month supply because the FDA had "initiated an intrusive multi-day inspection" of the group's facilities. (Full disclosure: I've been a member of the LEF for a couple of years.) Faloon is worried because the FDA has actually arrested him and LEF founder Saul Kent in the past for allegedly violating FDA regulations. This is not to say that there are not real snake oil sellers out there, but the LEF hardly seems a likely candidate.

What's at issue? "The fundamental question is whether or not consumers can receive information based on peer-reviewed scientific studies and authoritative government statements about how foods and supplements affect their health," says Jonathan Emord, one of LEF's attorneys. In 1997, Congress enacted the Food and Drug Administration Modernization Act, which explicitly allows supplement makers and distributors to make health claims for their products if a government agency "has published an authoritative statement, which is currently in effect, about the relationship between a nutrient and a disease or health-related condition to which the claim refers." That is, vitamin and supplement makers can communicate to their consumers the findings of conclusive government research. Only, the FDA now says that they cannot.

Emord notes that the FDA has set up guidelines that clearly undermine the intent of the law. The rules allow the FDA alone to decide whether or not a government agency's statement is sufficiently "authoritative." Furthermore, according to Emord, the FDA has now worked out tacit agreements with most federal scientific agencies to issue disclaimers with their research findings saying that they're not "authoritative." This bit of underhandedness is "a way to restrict scientific information to government elites and disallow access to it by the public," says Emord.

Let's look at a few telling cases. Supplement makers Durk Pearson and Sandy Shaw (again full disclosure: Pearson and Shaw have been supporters of the Reason Foundation) wanted to add the following claims to their supplements based on peer-reviewed scientific studies:

• "Consumption of antioxidant vitamins may reduce the risk of certain kinds of cancers."

• "Consumption of fiber may reduce the risk of colorectal cancer."

• "Consumption of omega-3 fatty acids may reduce the risk of coronary heart disease."

• ".8 mg of folic acid in a dietary supplement is more effective in reducing the risk of neural tube defects than a lower amount in foods in common form."

The FDA opposed all of them. Yet the American Association for Cancer Research cited many peer-reviewed articles in 1999 supporting the claim that antioxidant vitamins helped prevent cancer. As it turns out, there is now some doubt that high fiber diets protect against colon cancer, yet that had been the advice of nutritionists and oncologists for nearly three decades. The case for the cardio-protective effects of omega-3 fatty acids has only been strengthened over the years. And most bafflingly, whereas the FDA wouldn't allow supplement makers to point out the benefits of folic acid, in 1996 the agency required that bread and pasta makers include the nutrient in their products.

In 1999, the Federal District Court for the District of Columbia ruled against the FDA in Pearson v. Shalala, ordering the FDA to set up a procedure whereby such claims could be properly evaluated. Nevertheless, since then the FDA has resisted nearly every proposed benefit claim for a nutritional supplement that has been brought before it.

For example, the FDA nixed the claim that B vitamins can lower homocysteine levels. (High homocysteine levels are increasingly associated with heart disease.) The FDA also disallowed the claim that saw palmetto extract may relieve the symptoms of enlarged prostates. Fortunately, the agency has lost nearly every one of these cases in court.

Companies should, of course, be held legally accountable for disseminating false and/or misleading information. Furthermore, if a supplement has a defined level of toxicity, e.g., vitamin A, then warning labels are appropriate. But surely the Federal District Court was right when it noted in Pearson v. Shalala that: "Truthful advertising related to lawful activities is entitled to the protections of the First Amendment." It's high time that the FDA recognized that that includes scientific information about health supplements and vitamins.