America’s Changing Views of Dietary Supplements

medications-342462_640A June 2, 2015 article from the New York Post reports the tragic death of a young, Ivy League track star. The city medical examiner ruled that Timothy Hamlett, a twenty-year-old runner at the University of Pennsylvania, died from suicide by drowning. He disappeared last year—he was last seen near the George Washington Bridge on December 26, 2014. His body was recovered from the Hudson River last week.

We cannot fathom the grief and pain that Timothy’s parents are experiencing. The loss of a loved one will always be difficult, but the loss of a child entering the prime of his life is perhaps as bad as it gets. Timothy’s parents are now searching for an explanation, and they have come to believe that dietary supplements are to blame for their son’s death.

The New York Post article reports that Timothy had been taking male enhancement and energy supplements. Timothy’s parents say that he exhibited “increasingly bizarre” behavior after starting to take the supplements, believing that he suffered from a “supplement-induced psychosis.” They withdrew Timothy from school to try to help him deal with his psychological issues.

While we will never know for sure what led to Timothy’s suicide, his parents’ belief that dietary supplements played a role reflects our society’s shift in attitude toward supplements. Twenty-one years ago, Congress passed the Dietary Supplement Health and Education Act of 1994 (“DSHEA”) by unanimous consent. It was a law overwhelmingly supported by the American people. Supplements were seen as beneficial to public health, and industry was trusted.

As time has passed, Americans—fueled by the relentlessly negative coverage of the American mainstream media—have soured on dietary supplements. Articles decrying the supplement industry pop up on a weekly basis, frequently (and incorrectly) calling the dietary supplement industry “unregulated.” Articles often refer vaguely to the “dangers” of supplements. And sometimes, like with Timothy Hamlett, supplements are blamed for death or injury. We’ve reached the point where “supplement-induced psychosis” seems quite reasonable to grieving parents.

A recurring cast of characters star in many supplement-critical articles. For example, Dr. Pieter Cohen, an assistant professor at Harvard Medical School, and Dr. Paul Offit, the chief of the division of infectious diseases at the Children’s Hospital of Philadelphia, are outspoken critics of the current status of dietary supplements and their regulation. Both doctors are cited in the New York Post article about Timothy Hamlett. Dr. Offit is quoted as saying: “The dietary supplement industry is unregulated, and we often don’t know what’s in the bottle, and the label doesn’t reflect what’s in the bottle.” After Dr. Offit’s misstating the law, the article continues under the assumption that the supplements that Timothy took were “drugs.”

It is evident that dietary supplement marketers have targets on their backs. So how can they best avoid trouble—FDA and FTC regulatory action, class action lawsuits, or other issues that may affect their business? If you are in the supplement industry and your product or brand gets negative publicity (and the associated increase in scrutiny), the best thing you can do is to have all of your regulatory ducks in a row: you should be GMP-compliant, your products’ labels should conform to FDA regulations, and your advertising and claims should be fully substantiated, among other things. That way, when your brand is dissected, you can show that you are complying with all lawful requirements and doing your part to market products that are both fully safe and fully legal. If you have any questions about your obligations under the law, call the dietary supplement lawyers at Collins, McDonald & Gann, 24/7, at 516-294-0300.