FDA WARNING_LETTER - www.snusdirect.com

The FDA's Center for Tobacco Products reviewed the website http://www.snusdirect.com and determined that smokeless tobacco products offered for sale to U.S. customers are adulterated. The products are considered tobacco products under section 201(rr) of the FD&C Act.

The primary violation is promoting products as "modified risk tobacco products" without an FDA order, which constitutes adulteration under section 902(8) of the FD&C Act. Specifically, products like "Catch Licorice Mini Portion," "Catch Licorice White Portion," "Röda Lacket Loose," and "Röda Lacket White Portion" are described as "mild" in their labeling or advertising. Using descriptors like "light," "mild," or "low" makes a product a "modified risk tobacco product" under section 911(b)(2)(A)(ii). Introducing such products into interstate commerce without an FDA order under section 911(g) is prohibited by section 911(a).

The letter also reminds the recipient of other applicable federal laws, such as the Comprehensive Smokeless Tobacco Health Education Act, which mandates specific warning label statements and quarterly rotation on advertisements.

The FDA requires immediate correction of these violations and similar ones, ensuring all tobacco products and promotional materials comply with the FD&C Act. Failure to comply may result in civil money penalties, no-tobacco-sale orders, criminal