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February 2012

Current Regulations of Dietary Supplements Reviewed

Over the last several months, significant discussion regarding how strictly the U.S. Food and Drug Administration (FDA) should monitor the marketing of dietary supplements has erupted within the field of integrative medicine.

According to current law, which is regulated by the Dietary Supplement Health and Education Act of 1994 (DSHEA), dietary supplements may be marketed without proving that the product is safe and effective only if the ingredients contained in the supplement were sold in the United States before 1994. If dietary supplements contain ingredients that were not sold in the United States prior to 1994, the manufacturing company must provide evidence of "reasonable expectation of safety" to the FDA.

Despite the presence of this legislation, the law is not strictly enforced. Since 1994, the number of supplements marketed in the United States has increased from approximately 4,000 to 55,000. Of these 51,000 new products, the FDA has been informed of new supplement ingredients for only 170 of these agents. According to Dr. Pieter A. Cohen, an affiliate of the Cambridge Health Alliance (Somerville, MA) and Harvard Medical School (Boston, MA), this number probably represents only a small number of the actual supplements that contain new dietary ingredients.

In an effort to rectify this situation, the FDA introduced new guidance in July 2011 to help the administration assess new dietary supplements. Based on this new guidance, the FDA assesses the safety of new supplements based on: (1) its history of use (including outside the United States); (2) its ingredients and how the suggested daily dose compares to doses used historically; and (3) the length of time for which the supplement is suggested to be used.

Based on these three principles, the guidelines require that manufacturers test new dietary supplements in cells and animals if the new dose is higher than the historically used dose.

In addition, the new guidelines specify what characteristics should be used to classify an ingredient as "new". For instance, ingredients that have been used historically from natural sources but which are now created in a laboratory setting are required to be classified as new.

Since these new guidelines were initiated, many dietary supplement manufacturers have argued that the new regulations are too stringent. The manufacturers believe that the new guidelines force all dietary supplements to be evaluated as strictly as food additives, which was not the primary goal of DSHEA in 1994.

However, in Cohen's opinion, these new guidelines should go further to protect consumers from the potential dangers associated with dietary supplements. For instance, he believes that even if dietary ingredients available before 1994 have been used safely according to historical records, this should not be considered equal to clinically proven safety. Also, he believes that the guidelines should require that tolerability studies of dietary supplements be conducted in humans rather than only in cells and animals. Finally, he believes that manufacturers should be required to submit all study results, including negative data, to the FDA. By allowing the FDA to insist on scientific evidence regarding the safety of dietary supplements, Cohen believes that consumers, as well as their physicians, will be able to make better decisions regarding which dietary supplement may be the safest and most effective therapy for treating a particular condition.

For more information about the safety and effectiveness of dietary supplements, please visit Natural Standard's Foods, Herbs & Supplements Database.


  1. Cohen PA. Assessing supplement safety-the FDA's controversial proposal. N Engl J Med. 2012 Feb 2;366(5):389-391. View Abstract
  2. Natural Standard: The Authority on Integrative Medicine.
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