CCAGW: Include Cole-Bishop Provisions in Omnibus Bill

February 22, 2018

The Honorable Mitch McConnell
S-230
The Capitol
Washington, D.C. 20510

Dear Majority Leader McConnell,

The Family Smoking and Prevention Tobacco Control Act became law in June 2009 and gave the Food and Drug Administration (FDA) authority to regulate the manufacture, distribution, and marketing of all tobacco products. In May 2016, the FDA finalized a rule that brought all tobacco products under its authority, including Electronic Nicotine Delivery Systems (ENDS) like e-cigarettes and other vaping products. The rule became effective on August 8, 2016 with a compliance deadline of August 8, 2018.

Positive provisions of the rule banned sales of vaping products to anyone under age 18 and required warning labels. But, it also mandated that vaping manufacturers, unless their products were on the market prior to February 2007, submit a burdensome and expensive pre-market tobacco application (PMTA) to get marketing approval for all vaping items. These costs could range anywhere from $2 million to $10 million per item, according to the regulatory consulting firm SciLucent LCC.

If the predicate date of February 2007 is not changed, small manufacturers of e-cigarettes will be unable to jump the costly FDA’s hurdles and simply go out of business. The American Vaping Association estimates that 99 percent of vaping products currently sold today will eventually be prohibited under the FDA regulations.

Fortunately, the FDA is beginning to recognize that ENDS products cause far less harm than smoking. On July 28, 2017,the agency announced a new regulatory framework to strike “an appropriate balance between regulation and encouraging development of innovative tobacco products that may be less dangerous than cigarettes.” As a result, the agency delayed the submission of PMTAs for non-combustible products such as ENDS until August 8, 2022. But, delaying compliance is not a permanent solution.

In the House-passed Fiscal Year 2018 House Agriculture, Rural Development, FDA, and Related Agencies Appropriations bill, Section 753, also called the Cole-Bishop provision, would change the predicate date for newly-deemed tobacco products, such as e-cigarettes, to August 8, 2016, the date the final rule took effect. By changing the “grandfathered” date, an e-cigarette manufacturer would have to provide to the FDA the far less onerous application demonstrating its product is substantially equivalent to a product that was on the market prior to August 8, 2016.

The legislation also contains other important provisions, such as mandating that ENDS labels contain the phrase, “Keep Out of Reach of Children” and “Underage Sale Prohibited,” requiring an accurate statement of nicotine content, and telling the FDA to develop product standards for flavors and batteries.

Other countries are seeing the benefit of harm-reducing tobacco products such as ENDS. In July 2017, England’s Department of Health announced its long-awaited tobacco control plan to cut smoking rates. The government recognized the evidence is increasingly clear that ENDS products are “significantly less harmful than smoking tobacco.” Part of the government’s plan to reduce smoking is to emphasize the important role e-cigarettes and similar devices can play in smoking cessation and reducing harm.

We urge you to make sure that the Cole-Bishop provision is included in the final omnibus appropriations bill. Doing so will help keep e-cigarettes on the market, save lives, and reduce costs for government-funded health programs such as Medicare, Medicaid, and the Veterans Health Administration.

Sincerely,

Tom Schatz
President, CCAGW

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