“While there is disagreement about whether certain tobacco products should be regulated or not, there should be agreement that new regulations should apply to products moving forward, and not retroactively. Inconsistent authority like this will be detrimental and unfair to many manufacturers and businesses. This legislation preserves the FDA’s ability to regulate these products on part with cigarettes, grandfathers currently available products and then requires the FDA’s approval before any new product is introduced.” - Representative Tom Cole (OK-04)
In 2009, the Tobacco Control Act gave the FDA authority to regulate tobacco products under a “deeming process.” Instead of using its flexibility to grandfather existing products, in 2016, the FDA finalized a deeming rule to assert jurisdiction over cigars, pipe tobacco and vapor products, using the February 15, 2007 predicate date set in statute.
The FDA Deeming Authority Clarification Act of 2017, introduced on February 16, 2017 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.
Congress needs to act quickly to ensure that the FDA regulates (not eliminates) e-vapor products in a manner that both (1) accelerates protections for consumers and minors, and (2) makes sense in light of the public health opportunities that e-vapor products offer. The FDA Deeming Authority Clarification Act of 2017 serves both objectives.
The legislation will move the grandfather date, will save companies and jobs and allow adult consumers to continue to purchase responsibly manufactured products. It will accelerate FDA's action with respect to consumer and youth protection measures without undermining its ability to comprehensively regulate the e-vapor category, while ensuring its regulations make sense. It will require the FDA to address those areas that are of greatest concern to the public as reflected in media and news reports: a product manufacturing standard for batteries; restrictions on flavors; limits on marketing and advertising; and, retail registration.
The FDA Deeming Authority Clarification Act of 2017 will:
- Require "Keep out of Reach of Children" and "Underage Sale Prohibited" language on labeling of vapor products;
- Restrict advertising of vapor products only to publications that meet FDA's existing regulatory criteria for an adult-only publication;
- Prohibit self-service displays of vapor products;
- Require nicotine content to be labeled on all vapor product packaging;
- Require vapor retailers to register with FDA, unless they are otherwise required to do so as a retailer under state law or as a manufacturer under FDA requirements; and
- Require the FDA to issue a final product standard for vapor product batteries by August 8, 2018 (24 months after the effective date of FDA's final deeming rule).
Download a copy of the FDA Deeming Authority Clarification Act of 2017 here.