DSHEA Tutorial: Herbs as Substitutes to Drugs


Non-Compliant Workaround #9: implying a disease claim by suggesting that the product is a substitute for a product that is a therapy for a disease.

Summary: A formula claiming to mimik the action of a drug or being a replacement for a drug is making a disease claim because drugs treat disease, and supplements aren’t allowed to do that.

Xue Fu Zhu Yu Tang (Blood Mansion Eliminate Stasis Decoction)
Herbal Platelet Inhibitor

Again, according to the FDA source on the topic:

Inhibiting or decreasing platelet aggregation is the mechanism of action of a number of drug products approved for the treatment or prevention of stroke and heart attack. Thus, the agency would consider a claim to inhibit normal platelet function to be an implied claim to treat or prevent these disease conditions.

A formula promoted as an herbal version of an existing drug too is against the rules. Drugs treat diseases, and so an herbal version of a drug would be considered a drug or at least thought to be making a drug claim.

Xiao Yao San (Rambling Powder)

Herbal Prozac

In the words of the FDA:

Claiming that a product is a substitute for a specific drug or therapy, e.g., “Herbal Prozac,” is a different means of communicating that a dietary supplement is intended to treat a disease than claiming that the product belongs to a class of drugs associated with treatment or prevention of that disease, e.g., “antidepressant.” [although equally non-compliant]

Next: disease claims by suggesting that your formula can assist drugs to do their job.

Last modified: August 7, 2009  Tags: ,  В·  Posted in: Claims