The U.S. Food and Drug Administration has been busy this year issuing 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. And through all this, patients and doctors are not talking to each other about the use of dietary supplements.
So, where are we now?
The FDA’s latest statement largely concerned a major issue in the dietary supplement market — that safety and efficacy standards are in the hands of manufacturers. As a result, pills, powders, 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,” Dr. Margaret A. Hamburg, commissioner of the FDA, said in the statement.
The statement noted 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.
But the poor communication is not entirely an industry-side faux pas, Jennifer Strohecker of the Intermountain Medical Center in Murray, Utah, told MedPage Today.
“What we find is that patients use a lot of supplements due to the fact that they don’t have labeling requirements. It’s difficult from a pharmacist’s or physician’s standpoint to identify individual ingredients of what one particular supplement may be,” she said.
Strohecker noted that labels may not be entirely clear, even without the inclusion of illegal ingredients. “The front [of a package] may say ‘antioxidant’ and, when you turn it over, there may be 15 ingredients, some of which say, ‘Proprietary blend,’ and the individual ingredients may not be listed — [patients] may not know what the supplement contains.”
She added that more than half of the most common dietary supplements are not single-entity products, such as products that boost immune health and similar products, and contain multiple ingredients — which may complicate matters when one of those ten ingredients may interact poorly with a patient’s medication.
Strohecker has also recently completed research that looked into inconsistency issues between ingredient amounts between brands of supplements.
She explained that the lack of uniformity in dosing requirements may put patients at an unsafe risk for overdosing on a particular ingredient — a potentially harmful outcome, when some supplements may have no negative interaction in a patient’s body or with drugs a patient is taking up to one amount, while producing adverse events when taken in higher doses.
Strohecker and the FDA spokesperson concluded their discussions with MedPage Today with the same message: It is imperative to discuss with a healthcare provider — and for providers to ask their patients — about any dietary supplements a patient may wish to take before taking them.
It’s a discussion that could help save a life.