WASHINGTON – Yesterday, the House Appropriations Committee passed an amendment to its Fiscal Year 2017 Agriculture Appropriations Bill that would change the predicate date of the Food & Drug Administration’s (FDA) proposed tobacco regulations. Representative Tom Cole (R-OK) introduced the amendment, which passed by a vote of 31-19.
In April 2014, the FDA issued proposed tobacco regulations bringing newly “deemed” products under its regulatory authority, including electronic cigarettes, cigars and pipe tobacco. Under the 2009 Tobacco Control Act, any newly “deemed” products must either be “substantially equivalent” to a tobacco product on the market as of February 15, 2007—the predicate date—or otherwise must undergo a costly and lengthy Premarket Tobacco Application (PMTA).
E-cigarettes were not on the market as of February 15, 2007, and therefore, a manufacturer would not be able to use the substantially equivalent pathway since there was no predicate product on the market at that time. While e-cigarettes could remain on the market while undergoing the PMTA process, the process is extremely expensive and the outcome is uncertain. The FDA has indicated that it does not have the authority to change the predicate date, and that it could only be done by congressional action.
Last year, Representative Cole introduced a similar amendment that would change the predicate date for newly deemed products to the date of the FDA’s final deeming rule. This year the Cole amendment included additional consumer protections such as requiring safety product standards for e-cigarette batteries, requiring face-to-face sales, requiring “keep out of reach of children” and “underage sale prohibited” displays on vapor products, restricting advertising of the products to children, and labeling of nicotine content. The amendment also requires retailers to register with the FDA if they engage in the retail sale of vapor products, unless a retailer is already subject to an active registration under any state law relating to tobacco products.
Speaking in favor of his amendment, Representative Cole noted that without changes contained in his amendment, FDA is making it “substantially more difficult to bring a vapor product to the market”—even though vapor products are less harmful than cigarettes.
Representative Henry Cuellar (D-TX) shared that he supported the Cole amendment this year, because of the additional protections. He opposed the amendment last year.
Last week, The Hill reported that the FDA is expected to release its final deeming regulations by the end of the month. The House Agriculture Appropriations bill now awaits consideration by the House of Representatives.
Editor's Update:
In February 2017, Congressmen Tom Cole (OK) and Sanford Bishop (GA) introduced legislation to ensure sensible regulations for newly deemed tobacco products by the FDA. Named the “FDA Deeming Authority Clarification Act of 2017,” this legislation would amend the Federal Food, Drug and Cosmetic Act to change the predicate date for newly deemed tobacco products, impose common-sense licensing and advertising guidelines for vapor products and direct the FDA to establish product standards for vapor product batteries.
Lyle Beckwith, SVP of government relations at NACS, said: “With the change in leadership at FDA and the renewed push legislatively, we are hopeful that the predicate date will be moved to the 2016 date.”