| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||Center for Tobacco Products|
9200 Corporate Boulevard
Rockville, MD 20850-3229
OCT 29, 2013
VIA Electronic Mail
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website, http://www.snusdirect.com, and determined that your smokeless tobacco products listed there are offered for sale to customers in the United States. Under section 201(rr) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. § 321(rr)), as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), the products advertised on the website are tobacco products because they are made or derived from tobacco and intended for human consumption. Certain tobacco products, including smokeless tobacco,are subject to FDA jurisdiction under section 901(b) of the FD&C Act (21 U.S.C. § 387a(b)).
FDA has determined that several of your smokeless tobacco products are adulterated under section 902(8) of the FD&C Act (21 U.S.C. § 387b(8)) because you promote them as modified risk tobacco products without an FDA order in effect that permits such promotion. You can find the FD&C Act through links on FDA’s homepage at http://www.fda.gov.
Modified Risk Tobacco Product Violations
You describe smokeless tobacco products that you offer for sale on the website http://www.snusdirect.com, as being mild by referring to them as such in product labeling or advertising and adding the qualifier “mild” to the product descriptions. Specifically, our review of the website, http://www.snusdirect.com, revealed that you offer for sale the following smokeless tobacco products described as “mild”: “Catch Licorice Mini Portion”, “Catch Licorice White Portion”, “Röda Lacket Loose”, and “Röda Lacket White Portion.”
A tobacco product with a label, labeling, or advertising that uses the descriptor “light,” “mild,” or “low,” or a similar descriptor, is a “modified risk tobacco product” under section 911(b)(2)(A)(ii) of the FD&C Act (21 U.S.C. § 387k(b)(2)(A)(ii)). Under section 911(a) of the FD&C Act (21 U.S.C. § 387k(a)), no person may introduce or deliver for introduction into interstate commerce any modified risk tobacco product without an FDA order in effect under section 911(g) of the FD&C Act (21 U.S.C. § 387k(g)). A product that is in violation of section 911(a) of the FD&C Act (21 U.S.C. § 387k(a)) is adulterated under section 902(8) of the FD&C Act (21 U.S.C. § 387b(8)). Because the website uses the descriptor “mild” or similar descriptors for the above listed products, these products are modified risk tobacco products. Because these products are offered for sale to customers in the United States without an appropriate FDA order in effect under section 911(g) of the FD&C Act (21 U.S.C. § 387k(g)), these products are adulterated under section 902(8) of the FD&C Act (21 U.S.C. § 387b(8)).
We note for your information that you are also required to follow all other applicable federal laws and regulations. For example, section 3 of the Comprehensive Smokeless Tobacco Health Education Act (Smokeless Tobacco Act), as amended by section 204 of the Tobacco Control Act, mandates that advertisements for smokeless tobacco products comply with certain requirements, including those regarding warning label statements and format.
In addition, section 3(b)(3) of the Smokeless Tobacco Act requires the quarterly rotation of the warning label statements on advertising for each brand of smokeless tobacco. Quarterly rotation must be done “in accordance with a plan submitted by the tobacco manufacturer, importer, distributor, or retailer” and approved by FDA.
Conclusion and Requested Actions
The violations discussed in this letter do not necessarily constitute an exhaustive list. You should immediately correct the violations that are referenced above, as well as violations that are the same as or similar to those stated above, and take any necessary actions to bring your tobacco products into compliance with the FD&C Act.
It is your responsibility to ensure that your tobacco products and all related promotional materials on this website, on any other websites, and in any other media or retail establishment(s) in which you advertise, comply with each applicable provision of the FD&C Act and FDA’s implementing regulations. Failure to ensure full compliance with the FD&C Act may result in FDA initiating further action without notice, including, but not limited to, civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction. Please note that adulterated and misbranded tobacco products offered for import into the United States are subject to detention and refusal of admission.
Please submit a written response to this letter within 15 working days from the date of receipt describing your corrective actions, including the dates on which you discontinued the violative promotion, advertising, sale, and/or distribution of these tobacco products and your plan for maintaining compliance with the FD&C Act.
Please note your reference number, RW1300134, in your response and direct your response to the following address:
PAL-WL Response, Office of Compliance and Enforcement
FDA Center for Tobacco Products
9200 Corporate Boulevard
c/o Document Control Center
Rockville, Maryland 20850
If you have any questions about the content of this letter, please contact Ele Ibarra-Pratt at (301) 796-9235 or via email at CTPCompliance@fda.hhs.gov.
Ann Simoneau, J.D.
Office of Compliance and Enforcement
Center for Tobacco Products