How Can We Know if Dietary Supplements Are Safe?

I opened this week’s JAMA Internal Medicine table of contents to find a short editorial note that I would like to share. It’s written by Dr Michael Katz, in response to this study by Zarel and colleagues, which reviewed dietary supplement recall data in the US over the last decade (sexual enhancement, body building, and weight loss products were amongst the high hitters on the recall list).

Dr Katz writes:

Americans spend over $20 billion annually on

dietary supplements. Although supplements

are regulated by the US Food and Drug

Administration (FDA) under the Dietary Supplement

Health and Education Act, there is no requirement for

supplement manufacturers to demonstrate efficacy or

safety of their products prior to marketing them. However,

companies may not include unapproved ingredients.

It turns out that even this minimal requirement

is not fulfilled. Harel et al identified 237 dietary

supplements that were recalled by the FDA owing to

inclusion of unapproved drug ingredients. Given the

limited regulation of these products, it is likely that

the number of recalls grossly underestimates the number

of products on sale with unapproved ingredients.

Dietary supplements should be treated with the same

rigor as pharmaceutical drugs and with the same goal:

to protect consumer health.

The mechanism by which the FDA identifies and recalls potentially dangerous dietary supplements is haphazard: either through spot inspection of manufacturing plants; tips from retailers; or reporting of adverse events by patients or physicians. The stringent regulatory process required for prescription medications to be approved is not in place for dietary supplements.

As the Zarel article writes:

To protect the health and

safety of the public, increased efforts are needed to regulate

this industry through more stringent enforcement

and a standard of regulation similar to that for pharmaceuticals.

Keeping the status quo may taint the dietary

supplement industry as a whole.

The bottom line: As it stands now, we cannot know if dietary supplements are safe.