dietary supplements

Through globalization and cultural integration, many traditional medical remedies and practices have become relevant in media and consumer life. From this trend we now see practices such as acupuncture, meditation, various diets, home remedies and energy therapy becoming more prominent in United States culture.

Modern day health care has increasing expanded into various medical practices and theories. It is well documented that complementary and alternative medicine (CAM) usage has increased significantly over the last century and is now frequently being incorporated into conventional medical practices. Under the broad heading of CAM, there is a huge industry for non-drug substances with theoretical health benefits. These substances are often referred to as dietary supplements and constitute a multi-billion dollar industry. The currently accepted definition of “dietary supplement” was defined by congress in the Dietary Supplement Health and Education Act (DSHEA) of 1994.

“A dietary supplement is a product taken by mouth that contains a "dietary ingredient" intended to supplement the diet. The "dietary ingredients" in these products may include: vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandulars, and metabolites. Dietary supplements can also be extracts or concentrates, and may be found in many forms such as tablets, capsules, softgels, gelcaps, liquids, or powders. They can also be in other forms, such as a bar, but if they are, information on their label must not represent the product as a conventional food or a sole item of a meal or diet (“Overview of dietary”, 2012)”

Dietary supplements are used by many Americans; with most research suggesting nearly half of American adults use them. There is much criticism of the efficacy and safety standards dietary supplements are held to.  It is well established that the dietary supplement industry is a huge, highly profitable industry, but this has not always been true. There has been a nearly exponential expansion of the supplement industry in the last two decades. One reason why the supplement industry has expanded so rapidly is the growing interest in alternative medicine in American culture. Since the 1980’s there has been a growing trend of using holistic or natural remedies.  Holistic medicine has been a largely accepted practice in eastern civilization for centuries, but is now gaining popularity in western civilization. The growing interest in dietary supplements was a motivating factor behind significant changes in policy that lead to huge changes in the dietary supplement industry. Government regulation of dietary supplements was originally strictly enforced by the Food and Drug Administration (FDA). However, over the past 50 years changes in legislation made by congress have gradually decreased the role of the FDA in dietary supplement regulation and placed more responsibility on the manufacturers to produce safe and effective products.

Perhaps the most influential piece of legislature passed, The Dietary Supplement Health and Education Act (DSHEA) marked one of the largest changes in dietary supplement regulation. Following numerous legal challenges of the FDA’s authority to regulate aspects of dietary supplement sales, congress was forced to repeal the FDA’s dietary supplement regulations in 1983. At this point, The Nutrition Labeling and Education Act (NLEA) of 1990 authorized the FDA to require manufacturers of dietary supplements to provide evidence that there products were safe before sale and to approve the health claims made about these products before they could be used in marketing (Blendon et al, 2001). The industry continued to challenge this legislature until a new act was proposed. Media campaigns encouraged the public to demand easy access to reasonably priced dietary supplements (Nichter & Thompson, 2006).

Ultimately, DSHEA redefined dietary supplements as neither a food nor a drug, but rather a special category under the general umbrella of “foods”, which does not require the same standards of either of the other categories (“Overview of dietary”, 2012). The new act required that a manufacturer is responsible for determining that the dietary supplements it produces are safe and that any representation or claims made about them are substantiated with adequate evidence to show that they are not false or misleading. This essentially meant that dietary supplements no longer needed FDA premarket approval to be marketed.

Since the approval of DSHEA in 1994, the use of dietary supplements in the U.S. has grown exponentially.  Dietary supplement now play a large role in American health culture and represent a multi-billion dollar industry. In 1994, the U.S. sales of dietary supplements were $8.8 billion. In less than a decade after DSHEA was passed, U.S. sales increased to $18.7 billion in 2002 and continued to increase to $20.8 billion in 2004 (Nichter & Thompson, 2006).  The eruption in production and sales after the approval of DSHEA not only reflected the ease in releasing new dietary supplement products to the market, but also the growing demand from the public.

The lack of stricter regulations leaves consumer vulnerable to false or misleading claims, contaminated supplements, ineffective supplements, risks for drug-nutrients interactions, and unsafe supplements. I would argue that most Americans are not educated on the supplements they take or the regulation standards to which they are held. It is an important public health initiative to advocated for knowledge before consumptions and stricter regulatory standards.

References

Blendon, R. J., DesRoches, C. M., Benson, J. M., Brodie, M., & Altman, D. E. (2001). Americans' views on the use and reuglation of dietary supplements. Arch Intern Med, 161, 805-810.

Gardiner, P., Russell, P., & Shaughnessy, A. F. (2008). Herbal and dietary supplement-drug intrerations in patients with chronic illness. American Family Physician, 77(1), 73-78.

Mason, M. J. (1998). Drugs or dietary supplements: Fda's enforcement of dshea. Journal of Public Policy and Marketing, 17(2), 296-302. Retrieved from http://www.jstor.org/stable/30000778

U.S. Food and Drug Administration, U.S. Department of Health & Human Services. (2012). Overview of dietary supplements. Retrieved from U.S. Governement Printing website: http://www.fda.gov/food/dietarysupplements/consumerinformation/ucm110417.htm

Cohen, P. (2012). Assessing supplement safety-the fda's controversial proposal. New England Journal of Medicine, 366, 389-391

Nichter, M., & Thompson, J. J. (2006). For my wellness, not just my illness: North americans' use of dietary supplements. Culture, Medicine and Psychiatry, 30, 175-222.