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Introducing ‘The FDA Deeming Authority Clarification Act of 2017’

Congressmen Cole and Bishop introduce a legislation with the aim of ensuring sensible regulations for tobacco products which are subjected to the FDA’s deeming rule.

Diane Caruana

February 17, 2017

Yesterday on the 16th of February, Congressman Tom Cole (OK-04), together with Congressman Sanford Bishop (GA-02), put forward the “FDA Deeming Authority Clarification Act of 2017.” This long awaited legislation would amend the Federal Food, Drug and Cosmetic Act to change the nominated date for newly “deemed” tobacco products, ensure that licensing and advertising guidelines set for vaping products are practical, and push the FDA to set in place product standards for e-cig batteries.

The Tobacco Control Act

Back in 2009, the Tobacco Control Act (TCA), gave the FDA authority to regulate tobacco products under a “deeming process.” Instead of grandfathering existing products, in 2016, the FDA implemented a deeming rule that extended the agency’s authority to cigars, pipe tobacco and vaping products, using the February 15, 2007 predicate date set in statute.

In reality the FDA’s deeming rule has so far only been serving to push small vaping entrepreneurs out of business.

This latter date is considered unfair to the manufacturers of the newly deemed tobacco products because they were not on notice of pending regulation. However the FDA argues, some newly deemed products will qualify as “grandfathered” products under the statute and any that are not will be able to apply for a premarket authorization.

The negative effect set in motion by the ‘deeming rule’

In reality the FDA’s deeming rule has so far only been serving to push small vaping entrepreneurs out of business, whilst contributing to the thriving of big tobacco companies which are now also branching out to vaping products, and are the only ones able to afford the unreasonable licensing fees imposed by the agency.

The worst part yet is the fact that over regulating these products, is making it harder for the millions of smokers who either use the products or would like to use them for smoking cessation, to have access to them. In fact it is driving many to purchase the devices on the black market where they are unregulated and possibly unsafe.

“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.”Congressman Sanford Bishop

The FDA Deeming Authority Clarification Act of 2017 builds on the Cole-Bishop Amendment which was included in the House version of the Fiscal Year 2017 Agriculture Appropriations Bill.

Striving to move forward

“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.” said Congressman Cole, adding, “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.”