Guidance Draft FAQs

Isn’t it true that all dietary supplements will be regulated as drugs if this guidance is finalized? For instance, the guidance says that claiming cranberry tablets “maintain the health of the urinary tract” is OK, but if you say that the same tablets “prevent urinary tract infections,” then they become regulated as drugs. Doesn’t this mean that all dietary supplements must now be treated like drugs?

No. Dietary supplements, as already defined in the Dietary Supplement Health and Education Act (DSHEA), cannot claim to “diagnose, treat, cure, or prevent any disease.” This is because they are foods, not drugs. Again, this guidance does not change any regulations with regard to CAM products.