The New England Journal of Medicine
e-mail icon  FREE NEJM E-TOC    HOME   |   SUBSCRIBE   |   CURRENT ISSUE   |   PAST ISSUES   |   COLLECTIONS   |    Advanced Search
Sign in | Get NEJM's E-Mail Table of Contents — Free | Subscribe
 
Correspondence
PreviousPrevious
Volume 348:2255-2256 May 29, 2003 Number 22
NextNext

Inappropriate Advertising of Dietary Supplements

 

This Article
- PDF
-PDA Full Text

Tools and Services
-Add to Personal Archive
-Add to Citation Manager
-Notify a Friend
-E-mail When Cited
-E-mail When Letters Appear

More Information
-Related Article
by Drazen, J. M.
-PubMed Citation
To the Editor: With regard to Dr. Drazen's Perspective article on the inappropriate advertising of dietary supplements (Feb. 27 issue),1 a recent survey, conducted by Harris Interactive for Robert Butler and the International Longevity Center, showed widespread and potentially dangerous public ignorance of the regulation and labeling of vitamins, minerals, and food supplements. Most people believe wrongly that dietary supplements must be approved by a government agency such as the Food and Drug Administration (FDA) (59 percent of the respondents), that manufacturers are not allowed to make claims about their safety and their effectiveness unless there is solid, scientific evidence to support such claims (55 percent), and that the government requires that labels include warnings about potential side effects or dangers (68 percent). It is alarming that so many people believe that dietary supplements are regulated as if they were pharmaceuticals, when of course they are not.


Humphrey Taylor
Harris Interactive
New York, NY 10003

References

  1. Drazen JM. Inappropriate advertising of dietary supplements. N Engl J Med 2003;348:777-778. [Free Full Text]
 
To the Editor: According to the Dietary Supplement Health and Education Act of 1994, the manufacturer of a dietary supplement is responsible for determining that the product is safe and that any claims made are substantiated by adequate evidence. This requirement has several practical implications.

First, the manufacturer does not have to disclose to the FDA or to consumers what evidence it has to back up its claims about the product or its safety. Second, the manufacturer is not required to record, investigate, or forward to the FDA any reports of adverse events. Finally, the manufacturer establishes its own manufacturing practice guidelines to ensure that the dietary supplements are safe and contain the ingredients listed on the label. The FDA does not routinely analyze the content of dietary supplements. The only notification that the FDA may receive is that a dietary supplement contains a "new dietary ingredient." However, it is up to the manufacturer to determine whether an ingredient is "new," since there is no authoritative list of "old" dietary ingredients.

I hope most consumers are aware of these caveats.


Mario L. de Lemos, Pharm.D.
British Columbia Cancer Agency
Vancouver, BC V5Z 4E6, Canada
mdelemos{at}bccancer.bc.ca

 
To the Editor: In his Perspective article, Drazen states, "New legislation has made it legal for companies to market dietary supplements without approval of the Food and Drug Administration." This statement is incorrect; throughout American history, vitamins and herbs have been sold without prior federal permission. The Dietary Supplement Health and Education Act of 1994, to which Drazen apparently refers, formalized the status of supplements in response to fears that those products could be banned.

Under this act, manufacturers must submit safety documentation for new ingredients, which the FDA may disallow at will. Existing products that prove to be hazardous can also be prohibited. These requirements strike a fair balance between laboratory science and human experience. The safety of common herbs is as well established by traditional knowledge as is the safety of many vegetables, spices, and beverages with presumed fitness for consumption that is unsupported by rigorous American studies in animal models or clinical studies. Indeed, arguments against the act carry the bizarre implication that dual-use botanicals, such as ginger, may be safe when eaten as vegetables but hazardous when taken as supplements.


Wendy L. Applequist, Ph.D.
Missouri Botanical Garden
St. Louis, MO 63166-0299
wendy.applequist{at}mobot.org

 
Dr. Drazen replies: The letters from Drs. Applequist and de Lemos and Mr. Taylor all indicate that consumers in the United States are confused about the exact status of dietary supplements. Since, for all practical purposes, these materials are advertised as if they were medicines, they should, in my opinion, be regulated as such.


Jeffrey M. Drazen, M.D.


 

This Article
- PDF
-PDA Full Text

Tools and Services
-Add to Personal Archive
-Add to Citation Manager
-Notify a Friend
-E-mail When Cited
-E-mail When Letters Appear

More Information
-Related Article
by Drazen, J. M.
-PubMed Citation

HOME  |  SUBSCRIBE  |  SEARCH  |  CURRENT ISSUE  |  PAST ISSUES  |  COLLECTIONS  |  PRIVACY  |  HELP  |  beta.nejm.org

Comments and questions? Please contact us.

The New England Journal of Medicine is owned, published, and copyrighted © 2008 Massachusetts Medical Society. All rights reserved.