The FDA crackdown on dietary supplements is inadequate

The Food and Drug Administration Commissioner Scott Gottlieb issued warning letters to 12 companies and announced plans to strengthen FDA oversight of supplements, as well as more effectively communicating concerns to the public. The misleading claims, touting ineffective nostra, have the attention of regulators. It is refreshing to see this agency following a mandate of protecting those less able to protect themselves.

However, while this is a welcome change, the conciliatory tone in Dr. Gottlieb’s press release is rather concerning. He reports benefits from supplements for his patients and himself. Perhaps doing so was necessary to muffle the industry response. But it is quite disconcerting that he would make these claims.

{mosads}There is no controversy that a dietary supplement confers health benefit in the presence of a true nutrient deficiency. There is no doubt that supplementing milk with vitamin D has all but eliminated rickets and iodination of salt has made goiter a thing of the past.

Since true deficiencies of most nutrients very rare in a developed world, Gottlieb and his patients must have unusual health conditions.

The credibility of the entire industry is challenged by the fact that there is no concrete proof that supplements improves health, quality of life, or longevity in healthy individuals who are without deficiency.

So the public, thirsty for a way to control their health destiny has led to an $80 billion industry being born. Worse, studies have demonstrated that supplements may harm healthy people.

In 1994, Sen. Orrin Hatch (R-Utah) and Tom Harkin (D-Iowa) seemingly deceived America with the Dietary Supplements Health and Education Act (DSHEA).

This law, which precludes the FDA from regulating most aspects of the dietary supplement industry, had huge bipartisan support and garnered more letters written to congress in its support than the entire Vietnam War has allowed the dietary supplement industry to make outrageous health claims, using strongly suggestive language while skirting the prohibition from claiming to treat or prevent disease.

Now that both Hatch and Harkin are retired, perhaps there is room for change to what the LA Times has called Hatch’s “deadliest law.”

Both Hatch and Harkin have stood against efforts to weaken the rights of the supplement industry or have increased oversight by the FDA. Both were regularly the top recipients of industry donations to their campaigns. Hatch’s son is an industry lobbyist, and his former partner  owns a supplement company in Utah, where most were headquartered when DSHEA was passed. But the list of recipients of large supplement company donations is long, and includes former presidents as well as the professional organizations that influence policy.

And deadly DSHEA has been. Green tea extract, for example, has been associated with numerous cases of acute liver failure requiring liver transplants. Green tea has a substance that blocks fat digestion, a little, and people who drink it all day tend to be thinner.  But concentrated doses, 12 cups worth in one pill in the case of green tea extract, may be deadly. Unfortunately, the harm coming from supplementation may be subtle, and may occur over long periods of time. For example, antioxidants not only fail to prevent cancer, but they may increase the risk for developing it. But finding this required years-long studies.

Currently, the only real means for regulation of the industry is through criminal prosecution or civil suit. The criminal falls to states’ attorneys general and the Federal Trade Commission for fraudulent advertising, and the civil to class action or tort when harm is caused. These are very difficult to win and the punishment often not terribly punitive.

Supplement companies cannot make claims about disease. But if a substance in the supplement causes problems when truly deficient, the company can say that it supports health.

Most consumers I’ve talked to assume that “supports heart health” means that their healthy heart will  be even healthier taking the supplement. I know of no supplement company that does not take advantage of this kind of wording. Making disease claims is how these companies can get into legal trouble. But the profits are so high, and the enforcement so difficult, many are willing to take the risk.

We as a society hold drug manufacturers to extremely high standards, requiring extensive proof of efficacy and safety. If we are taking supplements for our health, how is it we do not allow even the barest scrutiny of their claims, as long as their suggestive ads are correctly worded?

So, while it is laudable that the FDA has called attention to the bad players, it is inadequate to assume that the companies following the rules are providing benefit to anyone other than their stockholders. Greater control and oversight of the consumer health market is long overdue.

David Seres M.D. is the director of medical nutrition, associate clinical ethicist and an associate professor of medicine at Columbia University Irving Medical Center, and the chair of the Medical Nutrition Council and member of the board of directors at The American Society for Nutrition.