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NTU Urges House Appropriations Committee to Curb Overzealous FDA Regulations

by Clark Packard / /

House Committee on Appropriations
The Capitol, H-305
Washington, D.C. 20515

Dear Chairman Rogers and Members of the Committee on Appropriations,

On behalf of National Taxpayers Union’s (NTU) members all across the country, I urge you to support Rep. Tom Cole’s amendment to the House’s Fiscal Year 2017 Agriculture Appropriations bill to change the so-called “predicate date” for newly deemed tobacco products.  

As you may know, 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 Food and Drug Administration (FDA) the authority to regulate manufacturing, distribution and marketing of tobacco products. The Act also gave the FDA authority to regulate 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. 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. 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 cannot afford the estimated $2-$3 million in regulatory costs necessary needed to bring a product to market.

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 urges you to support efforts to push back the date and allow a nascent marketplace to continue to meet demand.

Sincerely, Clark

Packard
Policy and Government Affairs Manager