Intended for healthcare professionals


FDA moves to regulate e-cigarettes and pipe and hookah tobacco

BMJ 2014; 348 doi: (Published 25 April 2014) Cite this as: BMJ 2014;348:g2952
  1. Michael McCarthy
  1. 1Seattle

The US Food and Drug Administration announced on Thursday 24 April that it would propose rules to extend its authority to cover a variety of currently unregulated tobacco products, including electronic cigarettes, cigars, pipe tobacco, nicotine gels, water pipe (hookah) tobacco, and dissolvable tobacco products.1 Any future products that meet the statutory definition of a “tobacco product” would also come under its authority, the FDA said.

Writing in FDA Voice, the agency’s official blog, the FDA commissioner, Margaret Hamburg, noted that the rapid introduction of new tobacco products into the marketplace had raised “many unanswered questions” about their effects on health.2

She wrote, “Especially in the shadow of alarming increases in the number of youths using unregulated products like electronic cigarettes and cigars, it’s more crucial than ever to help prevent early tobacco use that could lead to a lifetime of nicotine addiction.”

Currently the FDA regulates cigarettes, cigarette tobacco, rolling tobacco, and smokeless tobacco under the authority of the Tobacco Control Act.

Under the new rules, which are open for public comment for 75 days, sale of the newly regulated products would be forbidden to anyone under 18. In addition, manufacturers would be required to disclose to the FDA their products’ ingredients and to report harmful and potentially harmful constituents.

The regulated products would also be made to carry health warnings; and any claims that the products had lower health risks or other health benefits could be made only after FDA review and approval. After adoption of the rules, the FDA will give the industry two years to comply.

The proposed rules, however, will not ban radio or television advertising or internet sales of the products, nor the use of flavorings, which critics say the industry uses to attract young non-smokers.

Although the FDA’s action has been generally welcomed by antitobacco groups, some have criticized the agency for taking so long to act. In a statement the Campaign for Tobacco-Free Kids chastised the agency for its “inexcusably long delay.”

The group also criticized the FDA’s decision not to ban flavorings in cigars and e-cigarettes or to take strong steps to curtail “the egregious marketing for e-cigarettes.”

Its statement said, “The FDA must now move quickly to develop additional regulations addressing these important issues. These additional regulations should restrict marketing that appeals to kids, prohibit flavors that are attractive to kids and also require packaging for e-cigarettes that addresses the recent surge in nicotine poisoning cases related to e-cigarettes.”3


Cite this as: BMJ 2014;348:g2952


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