Product Quality and Safety Issues

Product quality is an issue derived from the explosive growth of the industry in the post-DSHEA world. Quality issues revolve around products that contain wrong ingredients, incorrect claims, contamination, or incorrect amounts—either too much or not enough.

An example plant misidentification was published in 1998 by Slifman et al. Two patients were admitted to hospital emergency rooms with palpitations, vomiting, nausea, and chest pressure, among other symptoms. Both individuals, having been admitted 1 month apart, had each consumed a program of dietary supplements, one containing 14 herbs, a tablet containing 11 herbs, liquid clay, a bulking powder, and capsules containing microorganisms. Of the five supplements, the one made up of 14 herbs tested positive for cardiac glycosides.

The investigators determined that Digitalis lanata was present in the supplement. Digitalis lanata contains cardiac glycosides, which resulted in the cardiac symptoms. Further investigation revealed that raw material labeled as plantain (genus Plantago) had been contaminated with D. lanata due to mis-identification in the field.

Another quality issue that has safety manifestations was an incorrect claim on a product. PC-SPES, a combination of eight herbs, is claimed to be a nonestro-genic treatment for prostate cancer. However, several of the herbs used in this preparation do in fact have estrogenic activity. In 1998, DiPaola et al. showed a significant amount of estrogenic activity in both in vitro (yeast) and in vivo studies (mice and humans) with PC-SPES. Use of the supplement by men with prostate cancer resulted in similar side effects as would develop with estrogen therapy and theoretically could confound the results of standard therapy.

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.

In 2003, the FDA banned all products containing ephedra alkaloids. Ephedra-containing products were, until the ban, marketed in conjunction with enhancing athletic performance and/or promoting weight loss. Recent studies provided enough additional evidence that ephedra presents a significant and unreasonable risk of illness and injury that the FDA banned all ephedra-containing products from the market and advised consumers to stop taking such supplements. Strong statements were issued cautioning about the use of ephedra-containing products, especially when strenuously exercising or in combination with other stimulants, such as caffeine.

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