National Center for Health Research, May 16, 2019
National Center for Health Research’s Public Comments on Responsible Innovation in Dietary Supplements Request for Comments
[FDA-2019-N-1388]
I’m Jack Mitchell, Director of Health Policy for the National Center for Health Research, a non-profit think tank which analyzes research with implications for public health, and patient and consumer safety. We accept no money from the pharmaceutical or medical device companies and have no conflicts of interest to report.
We support FDA’s recent efforts to crack down on manufacturers who make false or misleading claims about their dietary supplements. A good example was given this morning with supplements masquerading as legitimate opioids treatments. A study published last fall in the JAMA “Network Open” journal, and done by the California Department of Public Health, concluded that there were unapproved and sometimes dangerous drugs in almost 750 dietary supplements, most of them marketed for sexual enhancement, weight loss, or muscle growth.
Industry representatives might call these “fringe” products to legitimate vitamins and other, more conventional dietary supplements; but they are in fact very widely used dietary supplements.
For its own protection, the dietary supplement industry has made substantial progress in weeding out bad actors since the “wild, wild West”, largely unregulated days of the mid- 1990’s. At that time, I worked in the FDA Commissioner’s Office and my office conducted an investigation of the industry, finding substantial harm to consumers, and the gross under-reporting of adverse events. A senior FDA pathologist told me at the time that the substantial number of adverse reports to FDA regarding to dietary supplements probably represented about only five to ten percent of the true total.
Nonetheless, there is much to be done. Discussing the scope of permissible ingredients is laudable, but should have been done many years ago. Indeed, speaking of dietary supplements, recently-departed FDA Commissioner Dr. Scott Gottlieb told the New York Times in February that: “People haven’t wanted to touch this framework or address this space in, really, decades.” He promised an online “watch list” of specific dietary supplement ingredients that the agency was concerned about.
There is a long and discouraging history involving dietary supplements. In 1997, at the instruction of the then-FDA Commissioner, I helped organize a CFSAN advisory committee on the safety of the stimulant ephedrine in supplements. The Committee unanimously voted that there was no safe level of ephedrine in dietary supplements.
But due in part to intense lobbying by the well-connected supplement industry, it took the agency seven more years to ban ephedrine, from these products. It wasn’t until 2007 that supplement makers have been required to report to FDA serious adverse events involving their products.
Problems remained. In 2010, sixteen years after the passage of the DSHEA law which governs this industry, I helped convene a Senate Committee oversight hearing at which the GAO identified numerous examples of misleading or false advertising by dietary supplement vendors. GAO also discovered potentially hazardous contaminants in 37 of the 40 dietary products tested, although in fairness, none at acute hazard levels of toxicity.
The chief executive of a respected consumer testing lab, a former FDA official, also testified that one-quarter of 2,000 supplement products tested had a quality problem. The hearing concluded that senior citizens need to be especially cautious about the potentially hazardous interaction of dietary supplement ingredients with their medications.
Despite improvements during the past decade, problems remain, including questionable or unsafe ingredients, deceptive marketing, phony claims, and quality control problems. These issues are much the same as they were ten and even twenty years ago.
The burden is still on FDA to prove harm before regulatory action is taken. Especially in this on-line age with limited control over Internet marketing and deception, FDA needs to move more quickly to keep up with the explosion of products, ingredients, and claims made by some players in this industry.
The DSHEA law which governs dietary supplements as foods was introduced 25 years ago, and the agency is will struggle to keep up with a generation of new complex new ingredients and an expanding global marketplace.
We need to work together to better protect consumers and tighten up oversight of this industry, whose customers include fifty percent of American consumers.
Thank you for the opportunity to speak.
The National Center for Health Research can be reached at info@center4research.org.