AAFP Tells FDA to Require Warnings on Liquid Nicotine

Products Need Graphic Labels, Child-resistant Packaging

September 04, 2015 11:19 am News Staff
[E-cigarettes and liquid nicotine]

The AAFP recently weighed in on the need to regulate liquid nicotine used in e-cigarettes when Academy Board Chair Reid Blackwelder, M.D., of Kingsport, Tenn., sent a letter(2 page PDF) to Leslie Kux, FDA associate commissioner for policy, in response to the agency's request for comments(www.gpo.gov) on the topic. In the Aug. 28 letter, Blackwelder recommended requiring manufacturers of liquid nicotine to provide warning labels and child-resistant packaging for their products.

This oversight falls under the FDA's authority to regulate tobacco products(www.federalregister.gov) under the Food, Drug and Cosmetic Act as amended by the Family Smoking Prevention and Tobacco Control Act.

"The AAFP believes the FDA should require child-resistant packaging for liquid nicotine and all other novel tobacco products," said the letter. "Given that nicotine is an addictive drug, child-resistant packaging and graphical warnings are immediate and common-sense steps that manufacturers should be required to take to prevent infants and children from inadvertently consuming or being exposed to liquid nicotine."

Story highlights
  • The AAFP recently recommended that the FDA require manufacturers of liquid nicotine for e-cigarettes to provide warning labels and child-resistant packaging for their products.
  • This oversight falls under the FDA's authority to regulate tobacco products under the Food, Drug and Cosmetic Act as amended by the Family Smoking Prevention and Tobacco Control Act.
  • The letter said the Academy has long opposed the use of all forms of nicotine and the advertising of nicotine delivery products, including e-cigarettes.

The Academy has long opposed the use of all forms of nicotine and the advertising of nicotine delivery products, including e-cigarettes, the letter noted. In December 2010,(2 page PDF) the AAFP strongly advocated that the agency require full-color graphic warnings and textual warning statements on traditional cigarette packages and in advertisements to help reduce the use of tobacco products. This recommendation extends to warnings on novel tobacco products, including e-cigarettes, said Blackwelder in the latest letter.

The lack of regulatory oversight on the manufacture, distribution and safety of liquid nicotine and nicotine delivery devices is particularly concerning, he noted. "Therefore, the AAFP calls for rigorous research in the form of randomized controlled trials of e-cigarettes to assess their safety, quality and efficacy as potential cessation devices."

As another option to reduce tobacco consumption, the Academy recommended halting the marketing and advertising of nicotine delivery devices altogether, especially to children and adolescents.

Previous successes stemming from the AAFP's advocacy that manufacturers divulge explicit information about the dangers posed by nicotine and tobacco, including ensuring that strong warnings are displayed on these products, could bode well for this latest effort.

In May, for example, the FDA denied a request from R.J. Reynolds Tobacco Co. and American Snuff Co. LLC to weaken the language in one of the agency's four smokeless tobacco warning statements. This decision came after the Academy and other health care and tobacco reform advocacy groups vigorously opposed these changes.

And most recently, the FDA took action against Santa Fe Natural Tobacco Co. (a subsidiary of Reynolds American Inc.) and two other companies for misleading marketing tactics after the Academy wrote to the agency calling for a halt to such activities.

Related AAFP News Coverage
Speak Out
Tell Congress Not to Tamper With FDA's Tobacco Authority

(6/3/2015)

Don't Exempt Cigars From FDA Regulation, AAFP Tells House
(3/6/2015)


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