Regulatory Focus™ > News Articles > Report: Regulatory Framework for Supplements Lacking Necessary Safeguards

Report: Regulatory Framework for Supplements Lacking Necessary Safeguards

Posted 07 August 2012 | By

Be careful of vitamins and supplements, warns a new report out from consumer product watchdog Consumer Reports (CR).

In its 3 August 2012 piece, 10 Surprising Dangers of Vitamins and Supplements, CR explains consumers shouldn't assume so-called "all natural" supplements, vitamins or herbal supplements are safe or effective. "They may be neither," CR remarked.

Adverse event signals-not necessarily signs of causation, but cause for further investigation-poured into the US Food and Drug Administration (FDA) by the thousands in recent years, notes the report, including 115 reports of fatalities.

Unlike prescription medications, which are typically approved for the treatment of a specific condition, the majority of supplements and vitamins have few substantial benefits to patients, Pieter Cohen, internist at Cambridge Health Alliance, told CR.

"These powerful medications with powerful side effects are actually saving lives when used appropriately," Cohen said, referencing FDA-approved prescription medications, "But when healthy consumers use supplements, there's rarely, if ever, a powerful lifesaving effect."

Safety Signals Just Scratching the Surface

Also troubling to regulators: Most safety problems related to supplements are unlikely to ever come to the attention of regulators because the products are taken outside the supervision of a healthcare professional. Even when FDA is made aware of potential problems, it is largely hamstrung to act, and must instead issue consumer warnings.

Warning labels on the products are also haphazard, lack specific information and seem geared toward minimizing the exposure of the manufacturer to potential lawsuits, wrote CR. Though manufacturers are required to list if their products contain iron or other allergens, these warnings are not FDA-approved and may not be specific enough for patients to make informed choices. Because patients may not be aware of possible side effects, they might also not associate them with the product, further reducing the chance of regulators being made aware of an adverse event.

Most dangerous of all are products actually containing prescription medications or similar active pharmaceutical ingredients, explains the report. In a statement to CR, director of FDA's Division of Dietary Supplement Programs, said such products represent the "greatest threat" to consumers because of their potential for serious side effects and lack of supervision. Over-the-counter supplements containing prescription medications have been associated with heart attack, liver failure, blood clots and death, CR noted.

The report concludes with a recommendation that regulators seek out the legal authority to compel supplement manufacturers to label their drugs with accurate warnings about side effects and contraindicated drug-drug-interactions.


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