'Deeming' Update

More comments emerge on possible FDA tobacco regulations

Published in CSP Daily News

WASHINGTON -- More organizations have revealed the comments that they submitted to the U.S. Food & Drug Administration (FDA) on whether certain tobacco products should fall under the agency's authority.

Aug. 8 was the deadline for interested parties to submit public comments to the FDA on the proposed tobacco "deeming" regulations--"Deeming Tobacco Products to Be Subject to the Food, Drug & Cosmetic Act, as Amended by the Family Smoking Prevention & Tobacco Control Act; Regulations on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products" ( FDA-2014-N-0189).

Among its detailed comments, the National Association of Tobacco Outlets (NATO) said it "disagrees with setting a minimum retail price of $10 per premium cigar as this price is unrealistic, arbitrary and capricious since not all manufacturers have a minimum suggested retail price, the retail price of a cigar will vary from state to state due to differences in state tobacco excise taxes and a significant majority of premium cigars have a retail price below $10."

It also has "a serious concern that if the FDA requires manufacturers of tobacco products that were not on the market as of Feb. 15, 2007, to file a pre-market tobacco application, then many smaller manufacturers may cease selling their products due to the time and cost involved in submitting this application. … In turn, this means that retail stores will be negatively affected because of the inability to sell such tobacco products."

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The National Association of Convenience Stores (NACS) said, among other comments, that it "opposes the proposed requirement that sellers of individual cigars place a warning statement adjacent to each cash register in a store. This is very valuable space for retailers. In addition, the final rule should clarify that manufacturers (and not retailers) are responsible for developing and submitting rotation plans for product warning statements, and simply stating that tobacco products are available in a store does not constitute an 'advertisement' for tobacco products."

It also said, "The final rule should be extended to cover online sales of newly deemed tobacco products, and should be enforced against tribal retailers to the same extent that it is enforced against non-tribal retailers.

And "the distinction between 'components' of tobacco products that would be subject to FDA authority and “accessories” of tobacco products that would not be subject to such authority should be clarified in the text of the final rule and not relegated to the preamble."

Click here to view the full NACS comments.

Greensboro, N.C.-based Lorillard Inc.'s comments address only the regulation of electronic cigarettes. The company, which has been acquired by Reynolds American Inc., Winston-Salem, N.C., makes the blu e-cigarette brand.

"Lorillard welcomes FDA regulation of electronic cigarettes and other tobacco products,but believes that the promise and opportunity presented by electronic cigarettes demands a unique and thoughtful regulatory approach. Electronic cigarettes hold the potential to advance the public health dramatically by moving existing users of conventional tobacco products to lower risk options. … Given the compelling public health benefit offered by electronic cigarettes, FDA must ensure that the application of its tobacco authorities to electronic cigarettes permits the continued development of this product category and does not unnecessarily inhibit innovation."

Click here to view Lorillard's complete comments.

Altria Group Inc., Richmond, Va., posted comments including "warnings should, as a matter of principle and policy, be uniform for all products in the same tobacco product category. ... The presence of non-uniform, inconsistent or conflicting warings for tobacco products in the same category will confuse consumers and could erroneously signal a difference in health risk among the products. ... FDA should act to prevent consumer confusion by requiring all tobacco products in the same category to include uniform warnings for risks that are common to all in the category and should work to harmonize applicable warning requirements."

Altria also posted the comments of its NuMark e-cigarette subsidiary and John Middleton cigar and pipe tobacco subsidiary. "FDA's regulatory framework should recognize the harm reduction continuum and the role that tobacco-derived nicotine products (TDNPs) may play in reducing the population harm associated with the use of tobacco products," NuMark said.

Click here to view the complete comments of Altria and its companies.