On April 19, 2016, the House Appropriations Committee approved an amendment to the FY 2017 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Bill (Agriculture Appropriations Bill) that, if adopted by the House and Senate and signed into law, would ease significantly the impact of the U.S. Food and Drug Administration's (FDA) proposed "deeming rule" on currently-marketed e-cigarettes and vapor products.
As has been widely reported, FDA is expected to issue soon its final rule to deem e-cigarettes and vapor products to be subject to the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). For more information on the FDA's deeming rule, please see our earlier alert here. Significantly, the amendment proposed by Representatives Tom Cole (R-Okla.) and Sanford Bishop, Jr. (D-Ga.) and voted out of committee earlier this week would move the February 15, 2007 "grandfather date", allowing some or all e-cigarettes and vapor products currently on the market to serve as "predicates" for products introduced after the deeming rule's effective date.
FDA proposed its deeming rule nearly two years ago. The rule's suspected snag is the grandfather date, which, if adopted as proposed, would eliminate the vast majority of the e-cigarette and vapor industry. Given that most such products came online well after February 15, 2007, the deeming rule, as currently proposed, would require virtually all of these products to go through the FDA's stringent premarket tobacco product application (PMTA) pathway.
Among other things, the amendment would: establish a new predicate date for e-cigarette and vapor products; require product safety standards for such products' batteries; require face-to-face sales of such products (with some exceptions); require certain product labeling; and require retailers to register with FDA.
More specifically, the amendment, if signed into law would:
- Effectively change the February 15, 2007 grandfather date for new tobacco product approvals to the effective date of the deeming regulation. The amendment would also change the qualifying date for predicate products for substantial equivalence determinations to the effective date of the deeming rule, and would change the date by which firms must submit section 905(j)(2) reports to FDA (i.e., report to FDA before introducing certain substantially equivalent tobacco products into interstate commerce) to 21 months after the deeming rule’s effective date.
- Require FDA to issue a proposed rule to establish a product standard for vapor product batteries no later than 12 months after the effective date of the deeming rule.
- Require FDA to issue a final batteries rule no later than 24 months after the deeming rule's effective date.
- Restrict vapor product advertising to "adult publications," which are defined in the amendment as newspapers, magazines, periodicals, or other publications: (a) whose readers under 18 years of age constitute 15 percent or less of total readership; and (b) that are read by fewer than 2 million persons under 18 years of age.
- Restrict sale of vapor products to direct face-to-face exchanges (no vending machines). However, this restriction does not apply to mail-order sales (presumably, mail-order sales include Internet sales, although this is not specified in the amendment language) or vending machine sales in adult-only facilities.
- Require FDA to issue a final regulation within 12 months after enactment of the Agriculture Appropriations Bill to require certain vapor product labeling (to include: "Keep Out of Reach of Children"; "Underage Sale Prohibited"; and an accurate statement of the nicotine content of the vapor product).
- Require all persons who own or operate an establishment engaged in retail sale of a vapor product to register with FDA within the later of: (a) 60 days after enactment of the Agriculture Appropriations Bill; or (b) 30 days after first engaging in such retail sale.
- The registration requirement would not apply to an establishment subject to an active registration under: (a) any State law relating to tobacco products; or (b) section 905 of the FD&C Act (as a manufacturer).
It remains to be seen whether or not this provision will remain in the Agriculture Appropriations Bill, but we will continue to monitor the situation and issue updates as warranted.