NATO Submits Comments to FDA on Nicotine, Flavors

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LAKEVILLE, Minn. – The National Association of Tobacco Outlets (NATO) has submitted comments to the U.S. Food and Drug Administration (FDA) in response to the agency’s Advance Notice of Proposed Rulemaking (ANPRM) regarding a potential regulation that would set a maximum level of nicotine in cigarettes and possibly other combustible tobacco products, as well as restrict the use of flavors in tobacco products.

The third and final ANPRM that the FDA had opened up in the tobacco category, this one for premium cigars, was scheduled to end July 25.

In the nicotine ANPRM, the FDA requested comments from the public and the industry about setting nicotine levels in an attempt to make cigarettes and other tobacco products “minimally addictive or nonaddictive.” The ANPRM indicates that the agency is looking at reducing nicotine levels in cigarettes by up to 90% from current nicotine levels.

In its comments on the nicotine ANPRM, NATO focuses on many different issues and concerns raised by potentially limiting the amount of nicotine, which include:

1. The need to allow a market for alternative noncombustible and heat-not-burn products to be regulated and approved before maximum nicotine levels in combustible tobacco products would be required.
2. The need for the FDA to conduct an educational campaign so that adults do not serve as a source of tobacco products for underage youth. In the ANPRM, the FDA specifically says that most underage individuals obtain tobacco products from non-retail sources; NATO has recommended to the FDA for several years to conduct a media campaign to dissuade adults from providing tobacco to minors.
3. The level of nicotine being considered by the FDA is close to zero, which could potentially violate the restriction imposed on the FDA by Congress that the agency cannot require the level of nicotine in any tobacco product to be zero.
4. The likelihood of a significant illicit market for cigarettes and tobacco products with current levels of nicotine if the FDA mandates a lower nicotine level in these products.
5. The decline in the legal sale of cigarettes and tobacco products and the need for a fiscal impact analysis so that state and federal lawmakers are aware of the potential for reduced cigarette and tobacco product excise tax revenue and sales tax collections.
6. The public misperception that very low nicotine content cigarettes are less harmful than current cigarettes.
7. The impact of a lower nicotine level on the public health.

In the ANPRM regarding the role of flavors in tobacco products, the FDA requested comments from the public and the industry about the use of flavors in cigarettes (menthol) and other tobacco products. This ANPRM indicates that the agency is considering restrictions or prohibitions on the use of flavors in tobacco products.

In NATO’s comments, the association focuses on many different issues and concerns raised by this ANPRM, which include:

1. The importance of consumer choice for flavored products, whether that be soft drinks, coffee, alcohol beverages or tobacco products.
2. The Congressional limitation imposed on the FDA that prohibits the agency from banning an entire class of tobacco products. However, an across-the-board ban on flavors would, for all intents and purposes, prohibit the sale of pipe tobacco and many other categories of products, including certain cigars, electronic cigarettes, vapor products and hookah tobacco.
3. The FDA’s potential consideration of restricting or prohibiting the advertisement of flavored tobacco products is unconstitutional because the First Amendment of the U.S. Constitution protects free speech, which includes commercial speech in the form of advertising.
4. The likelihood of a significant illicit market for menthol cigarettes and flavored tobacco if the FDA mandates the elimination of flavors.
5. The need to conduct an educational campaign so that adults do not serve as a source of tobacco for underage youth.
6. The decline in the legal sale of cigarettes and tobacco products and the need for a fiscal impact analysis so that state and federal lawmakers are aware of the potential for reduced cigarette and tobacco product excise tax revenue and sales tax collections.
7. The impact of banning flavors in tobacco products on the public health.

The FDA will review all the comments submitted in response to the ANPRMs and then decide whether to propose a maximum level of nicotine in cigarettes and possibly other tobacco products, as well as what action to take, if any, regarding flavors in tobacco products.

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