U.S. Representatives Tom Cole (R-Oklahoma) and Cole Bishop (D-Georgia) reintroduced legislation in Congress in an effort to change the FDA predicate date under the FDA tobacco regulations. Known as the FDA Deeming Clarification Act of 2017 (HR 1136), this legislation would also adopt new regulations relating to e-cigarette and vapor products. HR 1136 is an updated version of HR 2058 and the Cole/Bishop amendment.
The re-introduced bill would change the predicate date from Feb. 15, 2007 to Aug. 8, 2016, the date when the FDA deeming regulations took effect. This move would allow newly deemed tobacco products that were on the market as of Aug. 8, 2016–including e-cigarettes, vapor, cigars, pipe tobacco, hookah tobacco, nicotine gels and dissolvable nicotine products–would not need a special Substantial Equivalency Application or Pre-Market Tobacco Application to be filed with the FDA in order to remain on store shelves and in the market. These products would still be required to comply with the other FDA tobacco regulations, however.
Specifically for vapor products, the bill would also establish a product standard for vapor product batteries. The product standard would include technical characteristics that batteries for vapor products would need to meet in order to be used in an e-cigarette or vapor product. Vapor product manufacturers, wholesalers, and retailers would not be allowed to advertise a vapor product in a newspaper, magazine, periodical or other publication except an adult publication whose readers younger than 18 years old constitute no more than 15 percent of the total readership and fewer than 2 million people younger than 18 years older.
This bill would have a major impact on various part of the tobacco industry. First, it would relieve some of the burden placed on manufacturers of varying ages and sizes. Companies founded after Feb. 15, 2007 would be able to continue operating with their products readily available in the market. As is, compliance costs could drive many newer manufacturers out of business. Second, changing the predicate date would give many manufacturers more product on the market. This also could drastically change the course of the vapor industry, much of which was established long after 2007. The vapor industry is also greatly founded in technology and the ongoing improvement and development of said technology. Anything that was on the market prior to the 2007 predicate date, which is very little, would likely not be promoted or used by vapor consumers today. There are also a great deal of questions and concerns regarding the FDA approval process for tobacco products like cigars, pipe tobacco and vapor products, which is likely to be a very long, costly and confusing process.
Many in the vapor industry view HR 1136 as the first necessary step in developing appropriate regulation for the vapor industry. On its website, the Consumer Advocates for Smoke Free Alternative Association (CASAA) commented, “Different efforts and strategies are required to keep moving the ball forward. Looking to the future, fair regulatory treatment of vapor products is part of the larger campaign to change the tobacco control culture int he United States. Ultimately, policy makers, regulators, and public health advocates must change their abstinence-only approach to one of the comprehensive harm reduction in order to humanely reduce the morbidity and mortality associated with smoking cigarettes.”
The passing of HR 1136 would be a major breakthrough for those hit by the FDA deeming ruling. You are encouraged to reach out to your state representatives and voice your support for the bill, either through email, phone or attending a town hall meeting.
For updates on this and other tobacco-related bills, visit natocentral.org.