Dietary supplement products

The Third National Health and Nutrition Examination Survey (NHANES III), a national study conducted by the National Center for Health Statistics (NCHS) and the U.S. Centers for Disease Control (CDC) reported that 40% of Americans had used a dietary supplement in the month before they were interviewed for the study. Although NHANES did not break down supplement use into specific subtypes, the data gives some interesting insights into the growing acceptance of dietary supplement products in America. 

The molecular structure of ephedra resembles that of amphetamine, a stimulant. Dietary supplement product manufacturers often mixed caffeine with ephedra. Some experts believe that caffeine probably enhances or heightens ephedra s stimulant effects. Ephedra may also be combined with other herbs in supplements, depending on the desired effects. 

Thompson, R.D. Carlson, M. Liquid chromatographic determination of dehydroepiandrosterone (DHEA) in dietary supplement products. J. AOAC Int. 2000, 83 (4), 847-857. 

A drug product that contains the same active constituent as a botanical product would be regulated according to different paths, as long as they are marketed with different intent. The combination of caffeine with any other stimulant, such as ephedrine alkaloids2, may not be sold as an OTC drag product (20). However, dietary supplement products that contain ma huang (a source of ephedrine) and natural product stimulants such as kola nut (50% caffeine) are permitted on the market under DSHEA. 

Yohimbe (Pausinystalia yohimbe) is a purported aphrodisiac that contains a number of alkaloids, including yohimbine. This compound has been used in prescription formulations as a treatment for certain types of impotence (Sonda et al., 1990) but has been reported to cause serious adverse reactions (Grossman et al., 1993). Despite the potency of yohimbine itself, there have been no reports of an adverse reaction to yohimbe in the peer-reviewed hterature. This lack of adverse reactions to yohimbe products in the United States is probably due to the very low levels (or absence) of alkaloids in dietary supplement products on the market, and adverse reactions would be expected if alkaloid levels in products were increased by manufacturers (Betz et al., 1995). 

In 2001, USP created the Dietary Supplement Verification Program (DSVP) to help inform and safeguard the growing number of consumers who use dietary supplements. The program responds to the need to assure the public that dietary supplement products contain the ingredients stated on the product label. If a product submitted to DSVP meets USP s rigorous standards, it will be awarded the DSVP verification mark. The mark helps assure consumers, healthcare professionals and supplement retailers that a product ... 

The American Herbal Products Association has established a trade requirement (AHPA 2011) that dietary supplement products that contain caffeine, whether as a direct ingredient or as a constituent of herbal ingredients, be labeled to disclose the presence of caffeine in the product and the quantity of added caffeine if greater than 25 mg be formulated and labeled in a manner to recommend a maximum of 200 mg of caffeine per serving, not more often than every 3 to 4 hours and bear the following or similar statement on the label of any dietary supplement that contains caffeine in sufficient quantity to warrant such labeling ... 

The American Herbal Products Association has established a trade requirement (AHPA 2011) that dietary supplement products that contain caffeine, whether as a direct ingredient or as a constituent of herbal ingredients, be labeled... 

Whitmore, A. 1997. FDA warns consumers against dietary supplement products that may contain digitalis mislabeled as "plantain." U.S. Food and Drug Administration. 

Eussen SRBM, Verhagen H, Klungel OH, Garssen J, Van Loveren H, Van Kranen HJ, Rompelberg CJM (2011) Functional foods and dietary supplements products at the interface between pharma and nutrition. Eur J Pharmacol 668 S2-S9... 

By law (DSHEA), the manufacturer is responsible for ensuring that its dietary supplement products are safe before they are marketed. Unlike drug products that must be proven safe and effective for their intended use before marketing, there are no provisions in the law for the US Food and Drug Administration (FDA) to approve dietary supplements for safety or effectiveness before they reach the consumer. Also unlike drug products, manufacturers and distributors of dietary supplements are not required by law to record, investigate, or forward to the FDA any reports they receive of injuries or illnesses that may be related to the use of their products. Under DSHEA, once the product is marketed, the FDA has the responsibility to show that a dietary supplement is unsafe before it can take action to restrict the product s use or remove it from the marketplace. 

The use of dietary supplements continues to increase worldwide. In the US, sales of dietary supplement is reaching 30 billion per year, but their use transcend cultural barriers, and dietary supplement products now can be found virtually anywhere in the world. 

---