AAFP, Others Move to Pre-empt Cigar Exemption in FDA Proposed Rule

Academy Calls on Agency to Closely Scrutinize E-cigarettes

June 17, 2014 04:15 pm Chris Crawford

The AAFP recently signed on to a letter(www.apha.org) sent to leaders of the House Committee on Appropriations in which the signatories opposed any potential amendment to the FDA funding bill that would exempt cigars from the agency's proposed tobacco deeming rule(www.federalregister.gov) or "impede the current rulemaking process the FDA has initiated to determine the appropriate level of oversight for tobacco products not currently regulated by the agency."

[Single cigar on white background]

"We oppose any amendment that would interfere with the current rulemaking process, prevent a science-based decision-making process, and place a broad category of cigars beyond the reach of FDA," said the May 27 letter, which was crafted by the Campaign for Tobacco-Free Kids and signed by more than 30 medical organizations. "An amendment to exclude certain types of cigars would prevent FDA from implementing even basic common-sense rules such as requiring manufacturers to report what ingredients are contained in their products."

The good news, according to Teresa Baker, senior government relations representative for the AAFP, is that after members of the House Appropriations Committee met on May 29 to debate the Agriculture, Rural Development, FDA and Related Agencies Appropriations Act, 2015,(beta.congress.gov) (H.R. 4800), they reported the measure out to the full House with no tobacco-related amendments.

However, after beginning debate on the bill on June 11, House Majority Leader Eric Cantor, R-Va., put consideration of the measure on hold; debate may resume later this summer.

Story highlights
  • The AAFP recently signed on to a letter to the House Committee on Appropriations opposing any FDA funding bill amendment that would exempt cigars from the FDA's proposed tobacco deeming rule.
  • The letter cited various statistics showing the hazards of cigar smoking, especially among youth.
  • On June 2, the AAFP sent comments to the FDA on the agency's proposed tobacco deeming rule in which the Academy called for, among other things, rigorous research on e-cigarettes.

The Senate Committee on Appropriations already approved a companion bill(beta.congress.gov) on May 22, also without any amendments, said Baker. That measure has since been introduced in the full Senate.

Letter Cites Research Evidence

Although the health risks of cigar smoking do not precisely mirror those of cigarette smoking, according to the letter, cigar smoke is composed of the same toxic and carcinogenic components found in cigarette smoke.

"According to the National Cancer Institute, cigar smoking causes cancer of the oral cavity, larynx, esophagus and lung, and cigar smokers are at increased risk for an aortic aneurysm," said the letter. "Daily cigar smokers, particularly those who inhale, have an increased risk of heart disease and chronic obstructive pulmonary disease."

The letter also noted that cigar smoking is not limited to adults; it is the second most common form of tobacco use among youth. The group supported this claim with findings from national surveys, including a Morbidity and Mortality Weekly Report article(www.cdc.gov) that found 17.8 percent of high-school boys currently smoke cigars (i.e., large cigars, cigarillos and small cigars).

Also referenced were national survey results(www.samhsa.gov) from the Substance Abuse and Mental Health Services Administration that found more than 2,700 children and adolescents younger than 18 try cigar smoking for the first time every day.

Furthermore, said the letter, a 2012 article(smokingcessationleadership.ucsf.edu) published in the American Journal of Public Health found that younger adults were also much more likely than older adults to be cigar smokers: 15.9 percent of those ages 18-24 smoked cigars compared with 4.9 percent of those ages 45-64.

AAFP Comments on Proposed Rule

On June 2, the AAFP sent its comments(2 page PDF) to the FDA on the agency's proposed tobacco deeming rule in accordance with the allotted public comment period, specifically addressing e-cigarettes in its response.

The AAFP expressed its support for the FDA's assertion of authority over all "nicotine delivery devices" and agreed that tobacco products should not be sold to anyone younger than 18. "Given that nicotine is an addictive drug, AAFP policy specifies that the FDA must have full jurisdiction over all tobacco products and nicotine delivery devices and be permitted to use the same procedures to regulate tobacco," the letter stated.

Although use of e-cigarettes may be less toxic than smoking combustible tobacco cigarettes, said the Academy, the empirical evidence is inadequate to support the efficacy of e-cigarettes as a smoking-cessation device. Therefore, the AAFP called for rigorous research that would include randomized controlled trials involving e-cigarettes to assess their safety, quality and efficacy as a potential cessation device.

The AAFP also recommended that marketing and advertising of e-cigarettes to children and youth cease immediately. Finally, the Academy urged the FDA to "promulgate promptly a final rule and begin in earnest to regulate the manufacture, distribution and safety of e-cigarettes and other nicotine delivery devices."

Related AAFP News Coverage
FDA Proposes to Extend Tobacco Authority to Include E-cigarettes, Other Unregulated Products
AAFP to Closely Scrutinize, Comment on Proposal


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