FDA Issues Draft Guidance on Ban Against Marketing Tobacco Products with Non-Tobacco Products
The Food and Drug Administration has posted a draft guidance document for manufacturers, retailers, importers, and FDA staff on the scope of the recent prohibition against marketing a tobacco product in combination with another article or product regulated under the Food, Drug, and Cosmetic Act (FDCA) such as drugs, biologics, food, cosmetics, medical devices, and dietary supplements.
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Comments are due by December 31, 2009.
(The Family Smoking Prevention and Tobacco Control Act (Public Law 111-31) signed into law in June 2009, provides FDA with new authority over tobacco, amends section 201(rr)(4) of the FDCA to introduce the above prohibition, and makes other changes. See ITT's Online Archives or 06/24/09 news, 09062415, for BP summary.)
FDA Lists Prohibited/Non-Prohibited Activities, Alternative Approaches Possible
The guidance discusses certain activities that FDA believes do and do not fall within the scope of the prohibition. It is not intended to be an exhaustive analysis, and it is not binding. Alternative approaches may be used if they satisfy the requirements of the applicable statutes and regulations.
Prohibited Activities
The FDA believes that the following activities are included within the scope of the prohibition and would therefore be prohibited:
Physically combining & marketing tobacco & non-tobacco products. FDA believes that physically, chemically, or otherwise combining or mixing a tobacco product and a non-tobacco product regulated under the FDCA to produce a single entity that is marketed as containing both would be prohibited. For example:
Mouthwash (which may be a drug or a cosmetic under the FDCA) should not be added to a cigarette's ingredients and the cigarette identified as containing mouthwash.
Compressed or powdered tobacco should not be added to candy or gum (which are foods under the FDCA), and the candy or gum identified as containing a tobacco product.
Nicotine that is derived from tobacco should not be added to water, juice, or soda (which are foods under the FDCA), and the water, juice, or soda identified as containing a tobacco product.
Packaging tobacco & non-tobacco products as single unit. FDA believes that packaging a tobacco product and a non-tobacco product regulated under the FDCA together in a single package or unit would be prohibited. Therefore, a pack of cigarettes should not be shrink-wrapped or sold in a box, bag, or other container with a bottle of mouthwash.
Offering coupon for non-tobacco products with tobacco products. FDA states that offering a coupon for a discount on a specifically identified non-tobacco product regulated under the FDCA that is contingent upon the purchase of a tobacco product would be prohibited. For example, a coupon for a discount on a specifically identified mouthwash should not be offered contingent upon the purchase of a pack of cigarettes.
Non-Prohibited Activities
FDA believes that the following activities are excluded from the scope of the ban and therefore would not be prohibited:
Tobacco products packaged together. FDA believes that two or more tobacco products may be packaged together in a single package or as a unit. For example, a pack of cigarettes may be sold in a box, bag, or other container with a package of pipe tobacco.
Jointly advertising tobacco & non-tobacco products in same store. FDA believes that advertising tobacco products and non-tobacco products regulated under the FDCA on the same store sign or in the same store circular would be allowed. For example, cigarettes and mouthwash could be advertised on the same sign in a store window or in the same store advertising circular.
Selling tobacco & non-tobacco products in same store/magazine. FDA states that selling tobacco products and non-tobacco products regulated under the FDCA in the same retail establishment or advertised in the same place would also be allowed, such that cigarettes and mouthwash could be sold in the same store or advertised in the same magazine.
FDA contact - Michele Mital (301)796-4800
FDA notice (D/N FDA2009D0470, FR Pub 10/02/09) available at http://www.federalregister.gov/OFRUpload/OFRData/2009-23866_PI.pdf
FDA draft guidance, (dated 09/30/09) available at http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/ucm184283.htm