Why does the National Association of Convenience Stores (NACS) care about this issue?
The Association for Convenience & Fuel Retailing (NACS) serves the convenience and fuel retailing industry by providing industry knowledge, connections and advocacy to ensure the competitive viability of its members' businesses. While 47 of the top 50 convenience store companies in the United States are members of NACS, the majority of its members are small, independent operators.
NACS along with its Stop The Vape Ban coalition partners (Smoke-Free Alternatives Trade Association – SFATA, American Vaping Association - AVA, Vapor Technology Association - VTA, Electronic Vaping Coalition of America - EVCA, American E-Liquid Manufacturing Standards Association - AEMSA) support the FDA Deeming Authority Clarification Act of 2017 as vapor products are important to their members - including many convenience store customers and other small businesses across the country.
Lyle Beckwith, NACS’ senior vice president of government relations, explained that the initiative provides a platform for retailers and their consumers to speak directly about their thoughts on the ill-effects of the FDA policy.
For more information about NACS, please visit our site.
What do the FDA regulations do?
Any vapor product introduced after the 2007 "predicate date" must now go through a long and expensive FDA premarket review process just to stay on the market.
The FDA premarket review process is so expensive and full of paperwork and red tape that it will stop innovation and product improvements because any and every change will have to go through this lengthy regulatory process.
The cost to get through FDA ranges from several hundred thousand dollars to several million dollars just for one product. Vapor companies and stores cannot afford these costs and many, if not most companies could go out of business.
The new FDA regulations hold vapor products to the same date as cigarette regulations – going back to 2007 – long before most vapor products were on the market.
According to Don Burke, senior vice president with Management Science Associates Inc., at NACS Show Atlanta 2016, in a session called “The Impact of FDA Deeming Regulations on the C-Store Tobacco and Vapor Business,” the new product application, which is prohibitively expensive for most companies “is going to kill the vapor category.”
The bottom line: only Congress can fix the 2007 date and stop this virtual Vape ban.
Is this really a ban?
We have identified this as a virtual ban. Unless Congress takes action, newly issued FDA regulations could make it nearly impossible for most vapor products to stay on the market. In a recent presentation at the annual NACS Show, industry expert, Don Burke of MSA, Inc. pointed out that the new regulations will affect virtually all eVapor products and “wipe out the vapor industry” because of the costly premarket application process.
What will the FDA Deeming Authority Clarification Act of 2017 Accomplish?
This legislation would ensure sensible regulations for newly “deemed” tobacco products by the Food and Drug Administration (FDA). It 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.
According to U.S. Representative Sanford Bishop (D-GA), "Vapor products offer a promising path for harm reduction for those seeking to quit or limit their smoking. This legislation would ensure the FDA’s regulatory process does not limit the availability of safer tobacco options for those seeking to make use of them.”
The FDA Deeming Authority Clarification Act of 2017 will help keep vapor and e-cigarette products on the market and improve the regulations by:
- Allowing a more sensible FDA approval process for existing and future products;
- Providing quality standard for e-cigarette & vapor product batteries; and
- Making sure that sales, advertising and marketing is done responsibly and is intended for adults.