Regulation of dietary supplements should focus less on whether vitamins, minerals, and herbal extracts actually do what advocates claim and more on whether they are safe to take, a public health expert and former regulator says.
The market for dietary supplements is riddled with unsafe products that may be spiked with pharmaceuticals, poorly manufactured, or even missing ingredients listed on the bottle, says Joshua M. Sharfstein, former Food and Drug Administration principal deputy commissioner.
Yet despite hundreds of recalls and incidents involving death and disability, federal law on supplements has not shifted, says Sharfstein, now associate dean at the Johns Hopkins University Bloomberg School of Public Health.
“Stories in the media about bad outcomes associated with some supplements are gaining traction and the behavior of some manufacturers could tarnish the image and reputation of the entire industry,” Sharfstein says. “It’s time we actually made progress, and we’re going to have to find a path to do it. We need to think about safety first.”
Benefit Versus Risk
What’s keeping progress from being made, Sharfstein and a colleague say, is dispute over whether many supplements work. Manufacturers and many consumers say they do. Many public health officials and doctors disagree.
A truce on questions of efficacy—letting people buy and take the dietary supplements they want as long as the products aren’t dangerous—can bring the two sides together to improve safety, Sharfstein and recent Bloomberg School graduate Akshay Kapoor argue.
“The key equation in drug regulation is benefit versus risk. That is, do the potential benefits from using the drug outweigh the potential risks?” Sharfstein says. “This framework, however, has led to gridlock for dietary supplements. An alternative framework is access with safety. That is, can we find a way ensure that dietary supplements are safe for consumers to take?”
Surveys show that Americans want assurance that supplements are safe, but want to make their own decisions about whether they work. Sharfstein says that many manufacturers would likely support stronger safety controls if they were not tied to more scrutiny of product claims.
A recent study in the New England Journal of Medicine estimated that 23,000 emergency department visits in the United States every year can be attributed to dietary supplements.
Roughly 100 million Americans purchase supplements each year, including calcium for osteoporosis and multivitamins for general health as well as supplements for sexual dysfunction, joint health, and weight loss. US sales of dietary supplements reached an estimated $36.7 billion last year, according to the National Institutes of Health.
Federal law allows supplement manufacturers to make many types of claims, though not about treating or preventing specific diseases. FDA authority over supplements is limited by law and has left the agency unable to protect consumers effectively, Sharfstein says.
The FDA also has limited capability to oversee manufacturing standards for supplements. There are by most estimates at least 15,000 domestic and foreign manufacturers of supplements sold in the United States; most of the raw materials originate overseas.
FDA conducts just 400 inspections of facilities a year, the researchers say. It finds significant deficiencies in about two-thirds of those inspections, with most facilities cited for multiple serious violations.
Hundreds of times a year, FDA recalls dietary supplements that contain pharmaceuticals. Non-prescription sexual enhancement products may contain prescription erectile dysfunction drugs; weight-loss products may include banned pharmaceuticals; and sports supplements may have antihistamines and anabolic steroids.
The first thing needed, Sharfstein and Kapoor say, is a requirement for manufacturers to register each dietary supplement product with the FDA. Registration would allow FDA to deny manufacturers with poor track records the ability to sell new supplements.
Second, FDA should establish standard manufacturing procedures and a standard lab technique to characterize products, making adulteration more difficult.
Third, FDA needs more authority to look for adverse effects, suspend sales when there is sufficient concern and remove ingredients that pose a significant risk. Such a standard would be far more effective than the current unreasonably high standard for action, Sharfstein says.
Kapoor, A., and Sharfstein, J. M. (2015)
Breaking the gridlock: Regulation of dietary supplements in the United States
Drug Test. Analysis, doi: 10.1002/dta.1892.
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