Thank you for contacting me about the Food and Drug Administration (FDA)'s regulation of e-cigarettes.
RESPONSE from Senator Jeff Flake: The Family Smoking Prevention and Tobacco Control Act was signed into law by the President in 2009. This law requires tobacco companies to reveal all product ingredients and seek FDA approval for any new tobacco products. Tobacco products that were commercially marketed in the United States before February 15, 2007 were not considered to be "new tobacco products," and were not subject to these requirements. As part of its implementation of the Family Smoking Prevention and Tobacco Control Act, the FDA has finalized a new regulation that extends the agency's authority over additional tobacco products like e-cigarettes. Under the final so-called "deeming rule," e-cigarette manufacturers will be required to register with the FDA, report ingredient lists, and will only be able to market new tobacco products after FDA review. Manufacturers will only be able to make direct and implied claims that the FDA has confirmed with scientific evidence. The final deeming rule goes into effect on August 8, 2016. As you probably know, Congressman Tom Cole (R-OH) introduced H.R. 2058, the FDA Deeming Authority Clarification Act, on April 28, 2015. The bill, which was referred to the House Energy and Commerce Subcommittee on Health, would amend the Tobacco Control Act by moving the deadline for grandfathering newly deemed tobacco products from February 15, 2007 to the date on which the deeming rule takes effect. All e-cigarette products on the market as of the date the deeming rule takes effect would be exempted from the rule, allowing these products to remain on the market as long as the manufacturers comply with the other requirements of the Act. In addition, H.R. 2058 would provide a 21-month period, beginning on the effective date of the deeming rule, for manufacturers of new e-cigarette products to submit a substantial equivalence application. Those products would be permitted to remain on the market until the FDA makes a final decision regarding their applications. Currently, H.R. 2058 is awaiting further consideration in the United States House of Representatives. Should this legislation come before the United States Senate for a vote, I will be sure to consider it with your comments in mind.