The FDA this year has issued several statements and recalls regarding dietary supplements discovered to contain undeclared drug ingredients. Studies have shown that some supplements may increase potentially lethal risks to patients and contain varying amounts of active compounds between brands.
The FDA’s latest statement highlighted a major issue –that in the dietary supplements market, safety and efficacy standards have been left up to the manufacturers and largely unregulated. As a result, pills, powders, supplements, and other products that contain drug or drug-like ingredients may be released and marketed as dietary supplements despite being drug products, the FDA statement said. “These tainted products can cause serious adverse effects, including strokes, organ failure, and death,” Margaret A. Hamburg, MD, commissioner of the FDA, said in the statement.
The statement indicated that the FDA and supplement industry are working together to stem the flow of illegally marketed drug products sold under the veil of “dietary supplements,” including weight-loss, body-building, and sexual enhancement products.”Part of the difficulty in regulating dietary supplements is that [some companies] operate outside of the law and don’t include manufacturer information on the label, so it can be impossible to contact someone and request a recall,” an FDA spokesperson told MedPage Today.”If you’re thinking about taking a supplement, always talk to a healthcare provider first — they know you best and what drugs you’re taking,” the spokesperson said.