Saturday, May 26, 2012

DSHEA: The Regulation of Supplements


For some odd reason, many people still believe that the FDA regulates everything consumable in their daily lives.  In actuality, the FDA does not regulate much and they are not a very powerful entity either.  For almost all of the 20th century, there was almost no regulation on consumable products, including supplements and alternative medicine.  But it wasn't until the early 1990's when consumers pushed for regulation of alternative therapies, thus the creation of the Office of Alternative Medicine and subsequent passage of DSHEA were born.
Although the creation of DSHEA is relatively new, it still struggles to maintain order in such a fast-paced, over stimulated, market.  The result being that it sometimes fails to protect consumers from harmful products. Under DSHEA, the dietary supplement or dietary ingredient manufacturer is responsible for ensuring that the supplement or ingredient is safe before it is marketed.  There remains to be one large loophole and it is that the FDA is responsible for taking action against any unsafe dietary supplement product after it reaches the market.  This current supplement approval method explains why some supplements are allowed to contain ineffective ingredients, toxic ingredients, and powerful ingredients.  One such ingredient was ephedra, which was found to be unsafe in large dosages but remained on the market for years consequently being sold to millions.  It took twenty-three reports of serious health problems and one teenage death before the FDA could force the manufacturers to voluntarily recall it.  An amended DSHEA could place greater responsibility on the manufacturers to prove pre-market product safety and give the FDA more authority in the regulation of products being marketed.
 Sales of dietary supplements have approximately doubled since 1998. This means more consumers are using dietary supplements and/or those using supplements are consuming more. Many supplements are purchased over the internet from foreign countries, like China and South America, and are not made with the same quality checks required in the U.S.  Consumers need to be accurately informed of what products’ uses are and how safe they are. Only 19% of people are receiving their information from CAM providers, 28% from doctors, the remainder from friends/family, advertising, and heath food store sales people. Therefore, the majority of people using dietary supplements are receiving their information from unqualified sources. In 2009, US Government Accountability Office (GAO) reports determined that consumers have difficulty understanding labels on dietary supplements and are not well informed when it comes to safety and efficacy of products.
The supplemental hormone melatonin is now available in the US, but the FDA would have to prove melatonin unsafe before removing its over-the-counter status. We see a wider selection of supplements presently available through health food stores and mail order companies because the FDA bears the burden of proof for supplement safety, not the producers or retailers.  According to Jane E. Henney, M.D., Commissioner Food and Drug Administration, Department of Health and Human Services, “The dietary supplement industry has grown exponentially since the passage of DSHEA. Surveys show that more than half of the U.S. adult population uses dietary supplement products. Annually, consumers spend $12 billion on dietary supplements, according to Nutrition Business Journal in their 1998 Annual Industry Overview.”
As a preventive measure, DSHEA grants FDA explicit authority to establish good manufacturing practice regulations for dietary supplements. Such regulations are intended to assure purity and consistency in dietary supplement products. Regarding labeling, DSHEA seeks to provide consumers with information to help guide personal choice. This includes specially tailored requirements for ingredient and nutrition labeling.
DSHEA also provides for use of claims to affect the structure or function of the body, claims of general well-being from consumption of a nutrient or dietary ingredient, and claims of benefits related to classical nutrient deficiency diseases. These claims require notification to FDA within 30 days after marketing, must be substantiated, and must be accompanied by the disclaimer: "This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease." Finally, DSHEA contains ground rules for publications used in connection with the sale of dietary supplements.
Currently dietary products have to be proven unsafe, contain a controlled substance or have incorrect ingredient labeling to be removed from shelves. If the DSHEA continues to exist, it should impose more regulations to ensure the consumers’ safety. Supporting and strengthening DSHEA means dietary supplements will continue to be widely available and competitively priced for all who make or use them.  The European Union’s Food Supplements Directive is more restrictive than DSHEA. The Food Supplements Directive establishes a “positive list” that enumerates which vitamins, minerals, and other ingredients are permitted in dietary supplements. Amending DSHEA and incorporating several provisions of the Food Supplements Directive would be beneficial and better protect American consumers from unsafe dietary supplements.

Sources:

Bimal, H, Ashar, M, et al. Physician’s Understanding of Regulation of Dietary Supplements. Arch Intern Med. 2007;167(9):966-969.

Denham BE. Dietary Supplements-Regulatory Issues and Implications for Public Health. JAMA July 5, 2011.

Dietary Supplements. U.S. Food and Drug Administration. (2011) accessed on October 22, 2011, from http://www.fda.gov/food/dietarysupplements/default.htm

Gurley BJ, Gardner SF, Hubbard MA: Content versus label claims in ephedra-containing dietary supplements. Am J Health Syst Pharm 2000, 57:963–969.

Nowak RE. DSHEA’s Failure: Why a Proactive Approach to Dietary Supplement Regulation is Needed to Effectively Protect Consumers. U Ill L Rev. 1045. 2010.

http://illinoislawreview.org/article/dsheaas-failure-why-a-proactive-approach-to-dietary-supplement-regulation-is-needed-to-effectively-protect-consumers/ Accessed October 22, 2011. Full PDF: http://illinoislawreview.org/wp-content/ilr-content/articles/2010/3/Nowak.pdf

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