Source: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm459779.htm
Timestamp: 2019-04-25 02:17:36+00:00

Document:
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) reviewed your cigarette product labeling and determined that your cigarette products are manufactured and distributed or offered for sale to customers in the United States. We note that ITG Brands, LLC recently acquired ownership of Winston brand cigarettes, among others, from R.J. Reynolds Tobacco Company. 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), these products are tobacco products because they are made or derived from tobacco and intended for human consumption. Certain tobacco products, including cigarettes, are subject to FDA jurisdiction under section 901(b) of the FD&C Act (21 U.S.C. § 387a(b)).
A tobacco product is considered a “modified risk tobacco product” under section 911(b)(2)(A)(i) of the FD&C Act (21 U.S.C. § 387k(b)(2)(A)(i)) if its label, labeling, or advertising explicitly or implicitly represents that: (1) the product presents a lower risk of tobacco-related disease or is less harmful than one or more other commercially marketed tobacco products; (2) the product or its smoke contains a reduced level of a substance or presents a reduced exposure to a substance; or (3) the product or its smoke does not contain or is free of a substance. 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)). Your product labeling for Winston cigarettes, which uses the descriptor “Additive Free,” represents explicitly and/or implicitly that the products or their smoke do not contain or are free of a substance and/or that the products present a lower risk of tobacco-related disease or are less harmful than one or more other commercially marketed tobacco products. As such, these products are modified risk tobacco products. Because these products are sold or distributed 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)).
FDA recognizes that R.J. Reynolds Tobacco Company entered into a consent order with the Federal Trade Commission (FTC) regarding the company’s use of additive free claims in the advertising of tobacco products, including Winston cigarettes (Federal Trade Commission, In the Matter of R.J. Reynolds Tobacco Company, a corporation, Docket No. C-3892, Decision and Order, Issued August 16, 1999). This order requires, in part, that the company display certain disclosures (e.g., “No additives in our tobacco does NOT mean safer”) in any advertisements using claims that represent tobacco products as having no additives, unless the company possesses and relies upon competent and reliable scientific evidence demonstrating that such products pose materially lower health risks than other tobacco products of the same type. This consent order predates the Tobacco Control Act, which was enacted on June 22, 2009 and gave FDA authority to regulate the manufacture, sale, distribution, and promotion of tobacco products, including authority over modified risk tobacco products under Section 911 of the FD&C Act (21 U.S.C. § 387k). As noted above, 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)). Because you sell or distribute modified risk tobacco products without an appropriate FDA order in effect under section 911(g) of the FD&C Act (21 U.S.C. § 387k(g)), you are in violation of the FD&C Act, notwithstanding the consent order with FTC.

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