Supplement Safety

How much do you know about supplement safety?  If you don’t know a lot, you are not alone.  A 2002 study of primary care physicians found that 42% were not aware of any drug-herb interactions that had appeared in the medical literature, nor had they treated a patient that had one.  A more recent study (2007) of internal medicine residents revealed that one-third did not know that supplements do not need to be approved by the FDA, or that safety and efficacy data are not required before supplements are put on the market.

This ignorance is not limited to physicians in training.  A survey of consumers has shown that 68% of consumers believed that supplements were regulated by the government, 59% believed dietary supplements were FDA-approved like medications, and 55% believed that manufacturers could not make claims of product efficacy without scientific evidence.

Regulation of Supplements

Here are the facts:  dietary supplements are currently regulated according to the Dietary Supplement Health and Education Act of 1994.  This permits the initial marketing of an herbal or other dietary supplement product without proof of safety, efficacy, bioavailability, or standardization.  The manufacturer is held responsible for ensuring a product’s safety.  The FDA is responsible for taking action against any product that is found to be unsafe after it is on the market, and for monitoring information on labeling and package inserts.  The Federal Trade Commission is responsible for any false advertising claims.  You can find more detailed information about supplements and how they are regulated from the government.

Use of Herbal Supplements is Common

Studies of surgical patients have shown that nearly one third take at least one herbal product on a regular basis.  The problem is that many patients don’t discuss this to the surgeon or to the anesthesiologist prior to surgery.  Without the bottle in hand, one in five patients were unable to identify what they were taking when asked.  A study of pregnant women in Australia revealed that 36% took an herbal product while pregnant.  A 2007 survey showed that 38% of American adults and 12% of children used dietary supplements.

What is the Best Way to Be Safe with Dietary Supplements?

You can be a responsible consumer of dietary and herbal supplements by reading labels carefully.

Look for certifications such as “USP Dietary Supplement Verified”, or certification by ConsumerLab, NSF International, or Good Housekeeping.  The certifications vary, but it’s a start, and they at least indicate evidence of laboratory testing.  USP stands for U.S. Pharmacopeia, and the standard include testing for uniformity, cleanliness, and freedom from environmental contaminants such as lead, mercury, or drugs.  It is safer to buy single-herb products that clearly show how much of the herb each dose contains than to buy a mixture of several herbals with unknown amounts of each herb.  And be very wary of buying any herbs that have not been manufactured in the U.S., EU, or Canada, as supplements from other countries have been found to contain contaminants.

Resource for learning more:

http://www.nlm.nih.gov/medlineplus/druginformation.html

http://www.naturalstandard.com/

References:

1. Ashar BH, Rice TN, Sisson SD. Physicians’ understanding of the regulation of dietary supplements. Arch. Intern. Med. 2007;167(9):966-969.
2. Ashar BH, Rice TN, Sisson SD. Medical residents’ knowledge of dietary supplements. South. Med. J. 2008;101(10):996-1000.
3. Kennedy J. Herb and supplement use in the US adult population. Clin Ther. 2005;27(11):1847-1858.
4. Timbo B, Ross M, Mccarthy P, Lin C. Dietary Supplements in a National Survey: Prevalence of Use and Reports of Adverse Events. Journal of the American Dietetic Association. 2006;106(12):1966-1974.
5. Barnes PM, Bloom B, Nahin R. CDC National Health Statistics Report #12. Complementary and Alternative Medicine Use Among Adults and Children: United States, 2007. December 10, 2008.

by Christina Peterson, M.D.

updated July 10 , 2021