FDA WARNING_LETTER - Nova Distributors, LLC

The FDA's Center for Tobacco Products reviewed tarbarfilter.com and determined that disposable cigarette filters sold there are "tobacco products" under the FD&C Act, specifically components of products made from tobacco and intended for human consumption. These products are subject to FDA jurisdiction.

The FDA found that several disposable cigarette filter products are adulterated under section 902(8) of the FD&C Act because they are "modified risk tobacco products" sold without a required FDA order. The website makes claims such as "removes, tar, nicotine," "removes a significant amount of damaging impurities," "average tar removal of 33 percent and nicotine removal of 19 percent," "smoker will normally breathe better in 7-14 days," and "reduces the yellow staining of teeth." These claims implicitly or explicitly represent a lower risk of tobacco-related disease, less harm, or reduced exposure to substances, classifying them as modified risk tobacco products under section 911(b)(2)(A)(i) of the FD&C Act.

Introducing or delivering modified risk tobacco products into interstate commerce without an FDA order is prohibited under section 911(a) and renders the product adulterated under section 902(8). The letter demands immediate correction of these violations and similar issues across all advertising platforms. Failure to comply may result in civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure,