Should the FDA Regulate Vitamins?

Cancer researcher Tim Byers says yes—it’s a matter of public safety.

Vitamins are good for you, so you should take vitamin supplements to support better health. I mean, it says so right there on the package. Bayer’s One a Day pill for women, for example, “supports bone strength, heart health, immunity” and so on, according to the package. Another Bayer product, One a Day Teen Advantage for Her, “supports healthy skin” and “immune health” as well.

Of course, there’s always a qualification, printed near the bottom of the box in tiny print: “*This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”

But that’s just not enough. Congress and the FDA need to do more to protect the public from the potentially serious consequences—including an increased risk of cancer—of taking too many vitamins, says Tim Byers, a professor and associate dean at the Colorado School of Public Health.

There is growing evidence that supplements pose a threat when taken in excess, meaning the FDA should act—and Congress should give back the agency’s authority to do so.

Byers made headlines earlier this week for remarks that were based in part on a 2012 commentary he co-authored on the subject, which suggested that taking vitamin supplements in excess of the recommended dose could raise one’s risk of certain cancers by as much as 25 percent. A number of news outlets incorrectly described his remarks as a new study, when, in fact, Byers had appeared at a forum at the 2015 annual meeting of the American Association for Cancer Research to discuss the potential risks of taking supplements in large doses, along with the need for better regulation of those supplements.

Faulty reporting aside, there seems to be some merit to what Byers is saying. Research going back several decades does indeed suggest taking large amounts of supplements such as folic acid or beta carotene may significantly increase the risk of certain cancers, though not all studies have reached that conclusion. “We’re just beginning to put this pattern together,” Byers says, noting that his comments at the Monday forum were not based on a formal, quantitative review of existing studies.

Despite that, there is growing evidence that supplements pose a threat when taken in excess, meaning the FDA should act—and Congress should give back the agency’s authority to do so, he says.

“Congress has weakened the Food and Drug Administration, saying they cannot regulate supplements,” Byers says, referring to the 1994 Dietary Supplement Health and Education Act, which classified supplements as food, substantially limiting the FDA’s power to regulate the pills.

Given that people think “vitamins are synonymous with health, and more is better” despite evidence to the contrary, Congress should empower the FDA to regulate supplements, Byers says. That means what’s actually in the supplements, how they’re marketed, and whether doses are correct and adequately displayed. “It really is a public safety issue,” he adds.

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