WASHINGTON -- The U.S. Food & Drug Administration (FDA) yesterday posted a proposed rule amending the Agency's regulations to allow the manufacturer of a cigarette or smokeless tobacco product with a trade or brand name that is also the trade or brand name of a nontobacco product to continue to use the name if the tobacco product was sold in the U.S. on or before June 22, 2009.
The Family Smoking Prevention & Tobacco Control Act's restriction on product names reads: "A manufacturer shall not use a trade or brand name of a nontobacco product as the trade or brand name for a cigarette or smokeless tobacco product, except for a tobacco product whose trade or brand name was on both a tobacco product and a nontobacco product that were sold in the United States on January 1, 1995."
This provision, like other provisions in the 1996 final rule, was intended to ensure that the restrictions on sale and distribution to children and adolescents were not undermined by how the product was presented to the public. If a manufacturer was permitted to use a popular nontobacco product trade name and put it on a tobacco product, the manufacturer could attempt to exploit the imagery or consumer identification attached to the nontobacco product to make the tobacco product appeal to young people, the FDA said in proposing the change.
The FDA is proposing to amend the grandfather date from January 1, 1995, to June 22, 2009, "in recognition of the fact that 14 years elapsed since the publication of the 1996 final rule." Using the January 1995 date significantly changes the rule "from a provision that was intended to apply prospectively to one that applies retroactively."
The proposed rule would amend the section to allow cigarettes and smokeless tobacco products sold in the United States on or before June 22, 2009, to continue to be sold under their trade or brand name, even if the trade or brand name was also used for a nontobacco product sold during that time. "Thus, the proposed amendment would restore the FDA's original intention that the restriction apply prospectively only," it said.
The FDA is also proposing to amend the rule to ensure that a manufacturer may continue to use the trade or brand name of its cigarette or smokeless tobacco product if the trade or brand name is later registered with the U.S. Patent & Trademark Office (USPTO) or used on a nontobacco product. Thus, a tobacco manufacturer would not be required to monitor whether a trade or brand name is registered for a nontobacco product after it initiates the sale of its tobacco product under a particular trade or brand name.
In order to ensure that tobacco companies can comply with and FDA can enforce the proposed restriction, the proposed amendment would make explicit that the prohibition on the use of a nontobacco trade or brand name turns on whether such name is "registered," that is, whether it is listed in the USPTO's registration listing. FDA believes that this proposed change is consistent with the intent of the provision as originally issued in 1996 to prevent tobacco product manufacturers from exploiting the imagery and consumer identification associated with the trade or brand name of a nontobacco product, it said. Thus, the provision should apply to situations where the use of the trade or brand name on the nontobacco product precedes the sale of a tobacco product with the same trade or brand name and should not restrict trade or brand names of tobacco products in other situations.
In addition, FDA is proposing to amend the rule to permit manufacturers to request an exemption from the restriction based on information that adequately demonstrates that their proposed trade or brand name does not substantially appeal to children or adolescents. The goal of the restriction is to ensure that manufacturers cannot exploit the imagery or consumer identification attached to the nontobacco product to make the tobacco product appeal to young people. If the manufacturer demonstrates in a written submission to the director of FDA's Center for Tobacco Products that the proposed name--through the associated imagery or consumer identification attached to the nontobacco product--does not have substantial appeal to young people, then the potential for such exploitation is unlikely and the request for an exception would be granted.
The FDA is encouraging people to view this document and submit comments, and to visit www.fda.gov/tobaccoguidance for more information.
Click here to read the Proposed Rule Amending Brand Name Provision (1140.16(a)) of Regulations Restricting the Sale & Distribution of Cigarettes & Smokeless Tobacco.
Submit Comments for Docket No. FDA-2011-N-0493 and RIN 0910-AG40 via the Internet at www.regulations.gov.
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