NTU Urges Congress to Overturn Overzealous FDA Regulations

The Honorable Tom Cole
United States House of Representatives
2467 Rayburn House Office Building
Washington, D.C. 20515 
The Honorable Sanford Bishop
United States House of Representatives
2407 Rayburn House Office Building
Washington, D.C. 20515

Dear Congressmen Cole and Bishop,

On behalf of National Taxpayers Union’s (NTU) members all across the country, I write in support of your legislation, H.R. 1136, the “FDA Deeming Authority Clarification Act of 2017.” Your bill is an important step toward curbing regulatory excess at the Food and Drug Administration (FDA).

On June 22, 2009, President Obama signed the “Family Smoking Prevention and Tobacco Control Act” (Tobacco Control Act) into law. The Tobacco Control Act gave the FDA the authority to regulate manufacturing, distribution and marketing of tobacco products. The Act also gave the FDA authority to regulate pipe tobacco, cigars, electronic cigarettes and vapor products.

The Tobacco Control Act set an arbitrary date of February 15, 2007 (the predicate date), beyond which all new tobacco products would need to prove they are the “substantial equivalence” to products sold before such date in order to avoid a costly and drawn out pre-approval process with the FDA. If a product cannot prove it is substantially equivalent to a product on the market on the predicate date, the manufacturer must file a lengthy and costly pre-market tobacco application. This arbitrary date in the Tobacco Control Act has placed electronic cigarettes and vapor products in regulatory limbo because they were not widely available in the United States until well after 2007. As a result, there are currently thousands of small businesses that are jeopardized by the FDA’s overzealous regulation.

Unless Congress acts to push the predicate date back, the FDA’s pre-approval process will stifle a burgeoning marketplace that is providing products that help Americans kick their smoking habits. Left unchanged, the predicate date will effectively serve as barrier to entry for small electronic cigarette and vapor manufacturers who, by the FDA’s own conservative estimates, will need to file up to 20 applications, each costing approximately $330,000. The small businesses at the heart of the nascent electronic cigarette market simply cannot afford these types of regulatory costs.

As countless studies have confirmed, electronic cigarettes are an integral part of the efforts of millions of Americans to beat smoking addiction. Simply put, these products are much healthier alternatives to cigarettes. Unless Congress stops the FDA’s efforts to curb a growing market, many of these products will be regulated out of existence. For these reasons, NTU is pleased to endorse H.R. 1136 and encourages all Representatives to cosponsor your bill and work towards its swift passage. 


Clark Packard
Counsel and Government Affairs Manager