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March 2012

Potential Costs and Benefits of New Regulations on Dietary Supplements

Significant discussion about how strictly the U.S. Food and Drug Administration (FDA) should monitor dietary supplements has become a popular topic in field of integrative medicine. According to a recently published article by Umhau and colleagues, all of whom work for either the National Institutes of Health (NIH) or the Substance Abuse and Mental Health Services Administration, one of the most debated topics regarding a new proposal is how costly the new guidelines will be, both for dietary supplement manufacturers and consumers.

According to the Dietary Supplement Health and Education Act of 1994 (DSHEA), manufacturers of new dietary supplements are required to notify the U.S. Food and Drug Administration (FDA) prior to marketing a new product. However, the specific guidelines regarding which supplements require this notification and how much new data needs to be provided were not clearly defined.

In an effort to resolve this situation, the FDA proposed new guidelines in July 2011 to help the administration assess new dietary supplements. Based on this new guidance, the safety of any new ingredients added to supplements must be proven before the product can be marketed.

Forcing manufacturers to conduct these clinical trials to confirm the safety of dietary supplements is a huge financial cost. While pharmaceutical companies invest billions of dollars into evaluating the safety and effectiveness of new drugs, patent laws allow these companies to be the only manufacturer of the new products for a number of years after the drug is approved by the FDA. This allows these companies to make more money from the sale of these new drugs than was spent on the initial evaluation. However, claiming exclusive rights to sell dietary supplements is difficult. Therefore many companies can begin producing a product, even if only one manufacturer paid to evaluate the safety and effectiveness of the supplement.

Since these new guidelines were proposed, many dietary supplement manufacturers have argued that the new regulations will increase the cost of developing new dietary supplements and may even force companies to stop producing certain products already on the market if the cost of conducting safety studies is not possible.

According to Umhau and colleagues, the increased cost could actually discourage reliable dietary supplement manufacturers from investing in new product development, rather than just preventing dishonest manufacturers from selling unsafe and potentially dangerous "natural" supplements that actually contain drug ingredients.

Umhau and colleagues explain that it is important that both the FDA and dietary supplement manufacturers reach an acceptable agreement regarding product safety, because more than half of all people living in the United States currently use supplements, spending approximately $28 billion in 2010 alone. Furthermore, some supplements, such as folic acid and probiotics, have shown significant medical benefits in clinical trials.

In addition, the authors believe that some supplements may eventually be proven to have a specific established role in treating or preventing diseases. They use digoxin, a purified part of the foxglove plant that is sold as Digitek, Lanoxicaps, Lanoxin or Cardoxin to treat certain heart conditions, as an example of how this has already occurred. Therefore despite the additional cost, it may be necessary to evaluate the safety and effectiveness of dietary supplements more rigorously, because these products may contain chemicals that are more similar drugs than just foods or vitamins.

However, without the stricter guidelines, the authors explain that the medicinal effects of dietary supplements are much less clear than the effects of prescription drugs. Unlike positive results confirmed by clinical trials, historical benefits of some supplements may be due to only placebo effects. Unfortunately, these placebo effects could result in patients delaying medical treatment that is actually necessary.

According to Umhau and colleagues, the increased cost of evaluating dietary supplements to confirm their safety and effectiveness may actually decrease the overall cost of healthcare. The authors explain that if the FDA guidelines result in the production of only beneficial supplements, then the half of Americans who use these supplements may experience health benefits and may eventually require fewer visits to the doctor and less prescription drugs. Because supplements are not paid for by insurance companies, their use does not increase healthcare costs, unlike the use of prescription medications.

Overall, the authors believe that regulating dietary supplements may improve the overall health of many Americans by reducing the number of sham supplements on the market. However, they also stress that it may be equally important to consider the financial impact on both dietary supplement manufacturers and consumers if these guidelines are enforced, since the health of the American population and the economic success of the healthcare industry are, to some extent, related.

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


  1. Natural Standard: The Authority on Integrative Medicine.
  2. Umhau JC, Garg K, Woodward AM. Dietary supplements and their future in health care: commentary on draft guidelines proposed by the Food and Drug Administration. Antioxid Redox Signal. 2012 Mar 1;16(5):461-2. Epub 2011 Dec 19. View Abstract
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