Editorial

The ‘Structure-Function’ Dysfunction

I recently presented a webinar that discussed current research on the use of nutritional supplements for the prevention and treatment of common illnesses. A company that sells dietary supplements to health-care practitioners contacted me and asked if I would be willing to repeat the webinar for their clients. Well, not exactly repeat it; in order to comply with Food and Drug Administration (FDA) regulations, I would have to change all references to diseases and health conditions into “structure-function” language. I told the company that using structure-function language makes it difficult to teach anything useful, and that converting my presentation to such language would ruin it. The company was not surprised by my reply, because it had been forced to deal with the structure-function demon for many years.

FDA regulations prohibit the dietary supplement industry from claiming on product labels or on any accompanying literature that a supplement may be useful for preventing or curing a disease. There are some exceptions to this rule; for example, claims that calcium can prevent osteoporosis and that folic acid can prevent neural tube defects are allowed. However, there are hundreds of other health benefits of dietary supplements for which the FDA restricts the dissemination of truthful scientific information. As a rather pathetic consolation prize, the FDA does allow various structure-function claims. Thus, while you are not allowed to say that St. John’s wort relieves depression, you can say that it helps improve mood. It is acceptable to claim that magnesium helps maintain a healthy circulatory system, but not that it can prevent cardiovascular disease. It is permitted to say that a supplement supports the immune system, but not that it can help prevent or treat colds or influenza.

The problem with structure-function language is that its lack of precision often renders it nearly useless. For example, research suggests that saw palmetto is beneficial for benign prostatic hyperplasia, that flower pollen can be used to treat prostatitis, and that high-selenium yeast may help prevent prostate cancer. However, because FDA regulations limit the claims for each of these products to something vague like “supports prostate health,” there is no way of knowing which products may be helpful for a particular person. Similarly, a product that “helps maintain a healthy circulatory system” may or may not be effective for specific conditions such as intermittent claudication, hypertension, high cholesterol, congestive heart failure, or cardiac arrhythmias. The FDA’s restrictions on the dissemination of truthful scientific information prevents people from learning about treatments that could help them, impedes medical progress, and causes some individuals to waste money on products that are not appropriate for them.

Some supplement manufacturers have taken the FDA to court, claiming that the restrictive language required by the FDA interferes with freedom of speech. So far, these legal challenges have mostly been unsuccessful. However, it may now be the time for the supplement industry to mount another challenge against the FDA. In 2012, the United States Second Circuit Court of Appeals ruled on a case regarding the FDA’s right to prohibit drug companies from disseminating scientific evidence about off-label uses of approved drugs. According to the ruling, the truthful promotion of off-label drug use is constitutionally protected free speech that is not subject to FDA regulation. The court noted that prohibiting this type of speech “interferes with the ability of physicians and patients to receive potentially relevant treatment information; such barriers to information about off-label use could inhibit, to the public’s detriment, informed and intelligent treatment decisions.” The FDA tried to do an end-run around this ruling by requiring that drug companies allow the FDA to edit off-label marketing materials prior to their release. However, a drug company challenged that regulation in court, and a judge recently ruled that the FDA has no authority to restrict the drug company’s First Amendment rights.¹

I am not a lawyer or constitutional scholar, but it seems that these recent court rulings have set a precedent that could also apply to the supplement industry. A new court challenge might finally put an end to the FDA’s arbitrary and harmful restrictions against truthful speech about dietary supplements. If the industry could successfully reign in the FDA, then I would be able to repeat my webinar without making any changes. I would not have to change “reverses actinic keratoses” to “promotes skin health,” or change “decreases the mortality rate in patients with congestive heart failure” to “helps maintain a healthy circulatory system,” or change “decreases the symptoms of multiple sclerosis” to “contributes to normal functioning of the nervous system.”

Alan R. Gaby, MD

Notes

1. A free-speech clinic for the FDA. Wall Street Journal. August 15–16, 2015:A10.