Injecting Safety into Supplements — Modernizing the Dietary Supplement Law
The Dietary Supplement Health and Education Act of 1994 created a new category of products termed “dietary supplements.” Today, this law does not protect the public from the risks associated with sophisticated and potentially potent biologic and botanical ingredients.
More than 25 years have passed since one of us helped draft the law that redefined the U.S. regulatory landscape for vitamins, minerals, botanicals, live microorganisms, and many other health products. The law, known as the Dietary Supplement Health and Education Act of 1994 (DSHEA), created a new category of products termed “dietary supplements.”
Today, this law does not adequately protect the public. Since it was written, the supplement industry has been reshaped by Internet sales and an increasingly complex global supply of new substances. What was a $4 billion market in 1994 with a few thousand products has grown into a more than $40 billion market with tens of thousands of dietary supplements.
We have become particularly concerned about the risks associated with newly discovered, sophisticated, and potentially potent biologic and botanical ingredients that are routinely introduced as new ingredients in supplements. The great majority of these ingredients are never reviewed by the Food and Drug Administration (FDA), even though review is mandated by the New Dietary Ingredients provision in DSHEA.
We believe the time has come to reform this law. For the first time, members of Congress, many manufacturers of dietary supplements, and the scientific community recognize that the law requires changes to enhance public safety.
Cohen PA, Bass S. Injecting Safety into Supplements — Modernizing the Dietary Supplement Law. New England Journal of Medicine 2019;381:2387-9. https://doi.org/10.1056/NEJMp1913004
