It’s High Noon for Dietary Supplements
— The user fee legislation in Congress proposes useful regulations, but doesn’t go far enough
by Peter Lurie, MD, MPH June 10, 2022
By now, calling the dietary supplement marketplace “The Wild West” has taken on the mantle of hoary cliché. But that doesn’t mean it’s wrong.
That moniker seems entirely appropriate for an industry that has grown from about $4 billion in 1994, when Congress clarified the FDA’s authority over the products, to over $40 billion today. At present, the industry sells some 50,000 products (the FDA estimates their number to the nearest 10,000), many without any evidence of effectiveness. Some have clear proof of danger in the form of unintended contaminants, pharmaceutical ingredients that presumably were added intentionally, and ingredient quantities that often stray from labeled amounts. Yet, the 1994 legislation sharply curtailed FDA’s authorities over these products.
According to a recent industry survey, 80% of consumers use dietary supplements, with many recently turning to supplements in response to COVID-19. And patients often keep their providers in the dark about their supplement use — or providers fail to ask about it.
But a reckoning might loom over the horizon.
Every 5 years, Congress must pass so-called “user fee legislation” — fees levied upon the various industries regulated by FDA that supplement the often-meager funds appropriated by legislators. Typically, congresspeople use this as an opportunity to pursue their other FDA priorities. This year, one long-overdue target is the dietary supplements industry.
Based on legislation developed by Senators Dick Durbin (D-Ill.) and Mike Braun (R-Ind.), the user fee bill includes what industry cognoscenti call “listing” — a public database of all the dietary supplements currently being marketed. Yes, you heard that right: FDA doesn’t currently have such a list despite being expected to police the marketplace. The bill also improves oversight of high-risk supplements and products with pharmacological activity fraudulently marketed as dietary supplements, such as tianeptine and phenibut.
Those are good ideas, but they don’t go nearly far enough. What else can be done?
The database is critical — even the more responsible members of the industry support it, which ought to tell you something — but it should offer more extensive information. The listings should provide consumers with access to recent FDA enforcement actions where food safety and labeling laws have been violated. It should also be linked to product labels so that consumers can look up those they are considering buying and doctors can thoroughly research those they are considering recommending to patients. There is also a need to address an existing provision whereby companies can simply self-certify new ingredients as safe, without even telling FDA, much less providing any evidence. The FDA also needs to be alerted to any new ingredients, and they should be added to the database before the products can be altered and sold.
The bill should also allocate more funding. FDA’s beleaguered Office of Dietary Supplement Programs should be provided with at least $5 million more per year than appropriated in the bill, as this would bring a level of funding I believe to be sufficient to improving the agency’s oversight of this sprawling industry.
Another hoary cliché has it that the COVID-19 pandemic has shone an unforgiving light upon existing deficiencies in our healthcare system. Right again. One of those issues is the rampant disinformation. Already we’ve seen the defrocked minister Jim Bakker peddling colloidal silver and leading anti-vaxxer Joseph Mercola, DO, pushing, well, just about anything he can. Accurate and transparent information across the healthcare system, including the supplements industry, is critical.
It’s time to bring some law and order to this unruly marketplace. For there’s no telling what these folks will do For a Few Dollars More.
Peter Lurie, MD, MPH, is the president and executive director of the Center for Science in the Public Interest. He is a former associate commissioner of the FDA.