Supplement Recalls

Dietary supplements are not only perceived as safe by many consumers, but also as a necessary component to a healthy diet. While consumer ignorance is consistent across many areas of material consumption, health and nutrition knowledge is particularly concerning due to the risk of deleterious outcomes. Many fitness professionals understand that dietary supplements are not regulated and fall under the buyer beware connotation. In fact, dietary supplements accounted for more than half the Class 1 drugs recalled by the U.S. Food and Drug Administration from 2004-12. According to a new study from St. Michael’s Hospital, these products contained substances that could cause serious health problems or even death.

Of no surprise to researchers, “the majority of those recalled supplements were bodybuilding, weight loss or sexual enhancement products that contain unapproved medicinal ingredients, including steroids”, said the study’s lead author, Dr. Ziv Harel.

According to the study recently publish in JAMA Internal Medicine, almost one-quarter of the substances are manufactured outside of the United States, but unlike pharmaceutical products, dietary supplements do not require FDA approval before they can be sold. The FDA defines a dietary supplement as a product taken by mouth that contains a “dietary ingredient” such as vitamins, minerals, herbs, other botanicals, amino acids or substances such as metabolites. Researchers suggest that there are close to 65,000 dietary supplements on the market consumed by more than 150 million Americans.

The issue becomes more concerning because there tends to be a significant delay between the times the products are marketed and sold before the FDA intervention is initiated, generally due to consumer complaints or serious negative outcomes. But the problem is worsened by the fact that the process of the recall requires the FDA to contact the manufacturer and agent of sale. According to Dr. Harel, “when the FDA learns of an adulterated dietary supplement, it is required to contact the manufacturer to trace the source of the product and initiate a recall.” However, a recent investigation by the Office of the Inspector General determined that the FDA does not possess accurate contact information for 20 percent of supplement manufacturers.

According to the author, the FDA has recently introduced a number of initiatives aimed at mitigating the impact of the most common adulterated supplements. This includes creating multinational enforcement groups and engaging efforts towards widespread media campaigns to improve awareness, but experts are not confident. Dr. Harel suggests, “Despite these initiatives, products subject to Class I recalls continue to be readily available for sale, which may be due to an increasingly complex distribution network associated with these products, as well as ineffective communication by the FDA to consumers,” The other major issue is many of the companies get the products from outside of the U.S., “where manufacturing practices may not be subject to the same oversight and regulation required of domestic companies.”

Europe had experienced similar issues with cross contamination being a major concern. Surprisingly even illegal elements such as anabolic steroids have been found in dietary supplements aimed at the fitness industry. Physicians warn, that the labels and ingredient listings are not regulated either and many people are at risk for the synergistic effects between supplement products, including herbs, and prescription medications. Most people simply believe if it is sold over the counter it must be safe – this just is not the case.

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