On June 25, six past commissioners of the U.S. Food and Drug Administration met in Aspen, Colorado, for a gathering in which they discussed the shortcomings of the agency in meeting its safety objectives.
Ex-commissioners Margaret Hamburg, Jane Henney, David Kessler, Mark McClellan, Andrew von Eschenbach and Frank Young were present at the meeting, The Atlantic reports. They discussed the inconsistency of the FDA's role as possibly the most consequential health agency in the nation, yet it is nested under the Department of Health and Human Services and funded by the Department of Agriculture.
During the discussion, a clinical psychologist present in the audience asked about the FDA's stance on dietary supplements:
"I'm not so concerned that those supplements don't really hurt anybody medically—and they probably do. I'm more concerned with the lack of regulation, where a legitimate medical patient is taking supplements when they could be taking real medicine. What's that cost? And will the FDA ever regulate this industry?"
Growth in the global market for dietary supplements has been consistent and strong for the past decade or so. In 2013, the worldwide market for supplements topped $82 billion, with the U.S. accounting for more than 25 percent.
Supplements, unlike pharmaceutical products, can be sold on the market without safety, purity or quality testing by the FDA. The common feature among supplements which allows these products (which are often new) to be sold on store shelves is that they are "not intended to treat, diagnose, prevent, or cure diseases."
While the FDA has some authority over the manufacture of supplements, limited resources make it difficult for the agency to enforce this authority.
The real impetus for change in the way supplements are regulated would need to come from Congress rather than the FDA.
In 2015, half of all dietary companies inspected by the FDA were flagged for not complying with current good manufacturing practices, according to Natural Products Insider.
FDA senior advisor Cara Welch said of these violations:
"On our end, [it is] of course concerning that these firms are not bringing the basic aspects of the GMP system into compliance. We’ve cited them. We go back, and they still have the same violations."