Just cleaning out the day job e-mail account early this morning and came across something, I should’ve posted this a month ago when FDA sent me this release.
There are obvious problems with US federal regulation of dietary supplements related to lack of proven efficacy, bioavailability of purported active constitutents, and thinly-veiled medical marketing.
However, few people are aware of the fact that adulteration of dietary supplements is a real problem and, in the case below, potentially life-threatening:
From the FDA MedWatch adverse drug reaction (ADR) reporting program:
MedWatch – The FDA Safety Information and Adverse Event Reporting Program
The FDA notified healthcare professionals and consumers of a warning not to purchase or consume Zimaxx, Libidus, Neophase, Nasutra, Vigor-25, Actra-Rx, or 4EVERON, illegal drugs with undeclared ingredients that are
promoted and sold on web sites as “dietary supplements” for treating erectile dysfunction and enhancing sexual performance. These products have not been approved by FDA, and there is no guarantee of their safety
and effectiveness, or of the purity of their ingredients. [emphasis added] They pose a threat to consumers because the undeclared ingredients may interact with nitrates found in some prescription drugs (such as nitroglycerin) and lower blood pressure to dangerous levels.
Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. FDA advises consumers who have used any of these products to discontinue use and to consult their healthcare provider.
Read the complete MedWatch 2006 Safety summary, including a link to the
FDA News Release, at: