Strategies for Implementing the New GMPs for Dietary Supplements

| 01 February 2011

Dietary supplements have been in the news a lot of late, mostly for the wrong reasons. Last October, the US Food and Drug Administration (FDA) reported that in 2010 there were three times as many dietary supplement recalls as over-the-counter (OTC) and prescription drug recalls combined. Products marketed as dietary supplements, but containing pharmaceutical ingredients, were the subject of 80 Class I recalls in the first three quarters of 2010, compared to 50 in 2009 and 10 in 2008. In December 2010, FDA announced1 that it has issued consumer alerts about hundreds of products marketed as dietary supplements but containing the same active ingredients as FDA-approved drugs, analogs of the active ingredients in FDA-approved drugs or other compounds such as novel synthetic steroids that do not qualify as dietary ingredients. These consumer alerts involve more than 80 products marketed for sexual enhancement, more than 70 marketed for weight loss and more than 80 marketed for bodybuilding. On 15 December 2010, the FDA commissioner wrote2 to dietary supplement industry trade associations that the agency intends to increase its efforts to alert consumers about tainted dietary supplements and take enforcement actions against manufacturers, ingredient suppliers and distributors under the Dietary Supplement Health and Education Act of 1994 (DSHEA) and 21 CFR 111 containing the current Good Manufacturing Practice (CGMP)3 requirements for dietary supplements. The enforcement actions include FDA inspections, consumer warnings, product recalls, product seizures and criminal investigations, and might not involve a Warning Letter before such actions are initiated.


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