The Food and Drug Administration (FDA) wants to expand its tobacco product regulation to e-cigarettes, shisha, pipe tobacco, cigars, nicotine gel, non-regulated dissolvables — and has invited the public to comment.

“This proposed rule is the latest step in our efforts to make the next generation tobacco-free”, Health and Human Services Secretary Kathleen Sebelius said. FDA and its Centre for Tobacco Products are part of HHS. The Tobacco Control Act of 2009 gives FDA the power to regulate cigarettes, cigarette tobacco, roll-your-own tobacco and smokeless tobacco. The Act allows the agency to expand its authority, which is what is now being proposed.
Makers of products that fall under the proposed expansion would be required to register with FDA and provide the agency product and ingredient listings. Products defined as new will require FDA approval. However there are “different compliance dates for various provisions so that all regulated entities, including small businesses, will have adequate time to comply”, FDA said.
Distribution of free samples would be prohibited, as would sales to minors. Health warnings are proposed along with a ban on vending machine sales of those products, where youth might gain access to the machines. Products claiming reduced risks must have those claims confirmed by FDA. The public is asked to comment on whether premium cigars should be treated differently than other cigar products.
Information on characterising flavours also will be solicited during the 75-day public comment period to begin after publication of the proposed rule in the Federal Register on 25 April.
The full proposal is available at: https://www.federalregister.gov/articles/2014/04/25/2014-09491
“FDA is aware that some tobacco products, such as e-cigarettes and certain cigars, are being marketed with characterising flavours, and that these flavours can be especially attractive to youth”, the agency states in a document posted with the proposed rule.
“The prohibition against characterising flavours established in the Tobacco Control Act applies to cigarettes only. FDA requests comments on the characteristics or other factors it should consider in determining whether a particular tobacco product is a “cigarette” as defined in sector 900(3) of the FD&C (Federal Drug & Cosmetic) Act and, consequently, subject to the prohibition against characterising flavours, despite being labeled as a little cigar or other non-cigarette tobacco product. FDA is also seeking research regarding the long-term effects of flavoured tobacco product usage including data as to the likelihood of whether users of flavoured tobacco products initiate cigarette usage and/or become dual users with cigarettes.”