The AAFP recently signed on to a letter(84 page PDF) sent by two dozen health care organizations to the FDA urging the agency to extend its jurisdiction over all nicotine-delivery devices. The Academy sent its own comments(2 page PDF) on the proposed deeming rule to the agency on June 2.
The Aug. 8 letter crafted by the Campaign for Tobacco-Free Kids addresses the FDA's proposed tobacco deeming rule(www.federalregister.gov) and states that "the deeming of all tobacco products as subject to FDA's regulatory authority is critical to protecting the public health against the risks posed by an increasingly dynamic and diverse marketplace in tobacco products."
The letter goes on to declare that the deeming rule must be comprehensive and include currently unregulated cigars and e-cigarettes to prevent manufacturers of tobacco products from designing and marketing products not regulated by the Family Smoking Prevention and Tobacco Control Act.
Scope of Deeming Rule
The letter's signatories reaffirmed their opposition to the possibility of exempting "premium cigars" from regulation. "All cigars are harmful and potentially addictive to users," says the letter, noting that the cigar industry's arguments for exemption are based on the premise that premium cigars are not hazardous because their users (older individuals, ostensibly) don't inhale, a position that is not consistent with scientific evidence. The letter also points out that all cigars threaten nonusers' health through secondhand smoke.
- The AAFP joined 23 other organizations in signing on to a letter to the FDA supporting the agency in extending its jurisdiction over all nicotine-delivery devices.
- In light of the recent dramatic increase in childhood nicotine poisonings from the liquid nicotine in e-cigarettes, the letter calls for mandated child-resistant containers for liquid nicotine.
- The groups request that the deeming rule and any additional related regulations be issued within one year of the proposed rule.
Flavored tobacco products also are targeted in the letter and are described as a major tactic to attract young people. The groups say that manufacturers of tobacco products should provide evidence showing that any flavoring added to their products enhances the product's efficacy in helping users quit smoking, does not contribute to starting tobacco product use and does not lead to continued use of tobacco products by those who would have otherwise quit.
Regarding e-cigarettes, the letter notes that with the recent dramatic increase in childhood poisonings from the liquid nicotine contained in e-cigarettes, mandatory child-resistant containers for liquid nicotine should be issued by September.
In addition, the groups propose that the FDA mandate health warnings on all tobacco products -- including cigars and e-cigarettes -- to avoid misconceptions about the hazards they pose, especially among young people, explaining that nicotine is addictive regardless of the form or product in which it is sold.
Further Regulatory Issues
In addition to extending its premarket review provisions to deemed products including cigars and e-cigarettes, say the groups, the FDA also should shorten the period of non-enforcement from 24 months to 12 months from the date of the final deeming rule, and impose significant conditions when manufacturers of deemed products seek to market their products to children.
The letter also points out that the FDA's Regulatory Impact Assessment (RIA) that accompanied the proposed rule underestimated the net welfare gain from promulgation of the rule because it inadequately described the benefits and because its application of the concept of lost consumer surplus is flawed. "The RIA appropriately recognizes the increased health and longevity from smoking cessation or non-initiation, but then erroneously excludes 70 percent of that welfare gain to take account of 'lost consumer surplus,' i.e., the 'pleasure' that individuals give up by not smoking."
The groups contend the concept of lost consumer surplus is intended for contexts in which consumer buying decisions are fully informed and rational. But the vast majority of smokers begin smoking and become addicted when they are underage and have an imperfect understanding of the harms of smoking. The letter goes on to say that a large majority of smokers regret starting smoking and try to quit each year. This addiction is not a "pleasure" but, instead, a severe burden, says the letter.
The groups' letter concludes with a request that the deeming rule and any additional related regulations be issued within one year of the proposed rule (i.e., April 25, 2015).
From the time the FDA first indicated its intention to deem all tobacco products under its regulatory authority through the Tobacco Control Act, it took three years for the proposed deeming rule to be published. During that time, the flavored cigar and e-cigarette markets exploded, both targeting young people.
Related AAFP News Coverage
AAFP, Others Move to Pre-empt Cigar Exemption in FDA Proposed Rule
Academy Calls on Agency to Closely Scrutinize E-cigarettes
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Advocacy: Tobacco Use