Q: What does FDA’s Regulation of Tobacco Products Have in Common with its Regulation of Dietary Supplements? A: FDA’s Interpretation of “Marketing.”

October 8, 2009

By Ricardo Carvajal

FDA has issued a draft guidance document that addresses FDCA section 201(rr)(4), which prohibits a tobacco product from being “marketed” in combination with any other FDA-regulated product.  The guidance provides the following as an example of prohibited conduct: "Nicotine that is derived from tobacco is added to water, juice, or soda (which are foods under the FDCA) and the water, juice, or soda is identified as containing a tobacco product."

This example suggests that, if a food is not “identified” as containing a tobacco product, then the prohibition in section 201(rr)(4) does not apply because the tobacco product has not been “marketed.”  This result is consistent with FDA’s interpretation of the term “marketed” as used in FDCA section 201(ff)(3)(B), otherwise known as the dietary supplement exclusionary clause.  In part, the exclusionary clause excludes from the definition of a dietary supplement an article that is approved as a new drug unless it is first “marketed” as a dietary supplement (or as another type of food).  In applying the exclusionary clause, FDA has taken the position that an article is not “marketed” as a supplement when it is merely present in a supplement that is offered for sale; rather, the article must have been sold or offered for sale as a supplement, or as a component of a supplement where the labeling or advertising for the supplement identified the presence of the article.

What FDA’s draft guidance leaves unsaid is that one can circumvent the prohibition in section 201(rr)(4) by not “identifying” a food as containing a tobacco product, but still run afoul of several adulteration and misbranding provisions of the FDCA.

Categories: Tobacco