• Supplement ingredients are a real problem

    In last week’s Healthcare Triage News, I covered the fact that many supplements have switched from 1,3-dimethylamylamine (banned) to 1,3-dimethylbutylamine (not banned yet).

    Yesterday, in JAMA, a new study told an even worse story:

    The US Food and Drug Administration (FDA) initiates class I drug recalls when products have the reasonable possibility of causing serious adverse health consequences or death. Recently, the FDA has used class I drug recalls in an effort to remove dietary supplements adulterated with pharmaceutical ingredients from US markets. Approximately half of all FDA class I drug recalls since 2004 have involved dietary supplements adulterated with banned pharmaceutical ingredients.

    Prior research has found that even after FDA recalls, dietary supplements remain available on store shelves. However, it is not known if the supplements on sale after FDA recalls are free of the adulterants. In the present study, dietary supplements purchased at least 6 months after FDA recalls were analyzed to determine if banned drugs were still present.

    This study looked at supplements being sold 6 months after bans went into place. Between 2009 and 2012, 274 supplements were recalled by the FDA. About 10% of those were recalled because of an adulteration of an ingredient, were still available for purchase in mid 2013.

    At least one of the adulterants (banned) were still identified in two-thirds of the products. About 85% of sports enhancement supplements were still adulterated. So were 67% of weight loss supplements, and 20% of sexual enhancement supplements. And lest you think this is a foreign problem, 65% of the products made by US manufacturers were still adulterated.

    And get this: while 63% of the supplements contained the same banned supplement before the ban was enacted, more than 20% contained at least one additional banned ingredient.

    Supplement ingredients are not a problem to be ignored. We don’t regulate them nearly as carefully as drugs and other substances.

    @aaronecarroll

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