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A series of new reports released Monday in the journal Drug Testing & Analysis is calling for greater oversight and regulation of dietary supplements, noting that the loosely regulated products pose health concerns especially for some vulnerable populations such as young athletes.
About 100 million Americans purchase dietary supplements each year and more than 50,000 are on the market. But gaps in oversight have created a host of problems, including supplements spiked with drugs, poor manufacturing standards and ingredients listed on the label that are not actually in the product, experts say.
In a paper called “Breaking the gridlock: Regulation of dietary supplements in the U.S,” Joshua Sharfstein, an associate dean for public health practice and training at Johns Hopkins Bloomberg School of Public Health, calls for a series of steps to tighten control and enhance safety. Specifically, Sharfstein and co-author Akshay Kapoor call for registration of all dietary supplements, a stronger disclaimer explaining the FDA’s limited role in evaluating product claims, clearer authority for the agency when safety concerns arise, and the establishment of standard laboratory techniques.
“Substantial sections of the market for these products remain disorganized, deceptive, and dangerous,” the paper — which was one of eight articles published by the journal Monday focusing on health issues in the dietary supplement industry — stated. “Hundreds of products marketed as supplements have been spiked with illicit pharmaceuticals, risking serious injury and death.”
Specific groups at risk
One of the journal articles on the use of dietary supplements focused on use among the military. It found that almost 70 percent of members of the armed forces consume a dietary supplement once a week, with almost one-quarter of them reporting adverse health events.
Young athletes are also particularly vulnerable to health issues related to dietary supplements, another paper reported:
Exposure to adulterated sports supplements by adolescents and young adults may be high because the dietary supplements in question are often very popular. Among high school students, the level of supplement use can be as high as 74% and is correlated with the level of sport participation. Many young athletes report using the types of products that are at a higher risk of being adulterated, namely supplements to build muscle, lose weight, and to improve athletic performance.
The regulation of dietary supplements falls under the 1994 Dietary Supplement Health Education Act (DSHEA), which does not require the FDA to approve the products before they go to market. It also does not require registration of products either before or after marketing, and critics say it sets a high bar for the FDA to demonstrate a safety problem and use its authority to pull a product off the market.
Donald Marcus, a professor emeritus of the Baylor College of Medicine in Houston, Texas, urged that DSHEA be revised or repealed in a paper also published Monday in the journal. Marcus said DSHEA is “arguably the worst health care legislative act of the twentieth century.” He argued that herbal and other medicinal products should be regulated as medicines.
Dietary supplements have come under increased scrutiny in recent months. A series of investigations and studies have found adulterated products in a variety of supplements ranging from weight-loss to body-building products. Several lawmakers are calling for more stringent oversight of the industry and some health experts have criticized the FDA for not utilizing the authority it does have over supplements more robustly.
The American Medical Association has urged Congress to modify DSHEA and require that dietary supplements and herbal remedies including the products already in the marketplace undergo FDA approval for evidence of safety and efficacy.
Lyndsay Meyer, a spokeswoman for the FDA, said dietary supplements are one of the most challenging areas that the FDA regulates.
“It encompasses a vast array of products, it has a fractured supply chain and we have a regulatory framework that limits our authority,” said Meyer.
She cautioned consumers to talk with their healthcare providers about supplements they are taking, file an Adverse Event Report if they experience a side effect that may be linked to a supplement and beware of claims that are too good to be true or claim to be fast-acting. Also, “supplements for body building, weight loss and sexual dysfunction should be taken with an abundance of caution,” she said.
TINA.org reached out to the Council for Responsible Nutrition and the American Herbal Products Association for comment on the reports but neither returned a statement as of press time.
For more of TINA.org’s coverage of the dietary supplements, click here.
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