After years of contentious debate about the safety of ephedra, the weight-loss herb was effectively banned by the US federal government on Dec 30. The ruling, announced by US Department of Health and Human Services Secretary Tommy G Thompson and Food and Drug Administration Commissioner Mark B McClellan, MD, PhD, bans the manufacture or sale of ephedra. The ruling states, ?Dietary supplements containing ephedra present an unreasonable risk of illness or injury.? It takes effect in March. The FDA also issued a consumer alert and sent letters to 62 manufacturers telling them they must stop selling ephedra products. California, Illinois and New York have already banned ephedra sales in their respective states.
The US Food and Drug Administration is considering amendment alternatives to its recently revamped health claims system. It has invited public comment on the following.
- Option 1—Incorporate interim procedures and an evidence-based ranking system into a regulation.
- Option 2—Reinterpret the Significant Scientific Agreement (SSA) standard to apply to the accuracy of the characterisation of the evidence supporting the claim, instead of the underlying substance-disease relationship, and subject qualified health claims to notice-and-comment rulemaking.
- Option 3—Regulate qualified health claims solely on a post-market basis, if they are false or misleading.
Comment is sought on each of these options from the perspective of public health, policy, law and practicality.
Go to: www.fda.gov/dockets/ecomments.