In a letter to Health and Human Services Secretary Tom Price, ATR president Grover Norquist today asked for an immediate two-year delay of pending pre-market review requirements imposed by the Food and Drug Administration's May 2016 "Deeming Rule." The Rule applies to vapor products, electronic cigarettes, and premium cigars. Absent immediate action by Congress or the Administration to roll back the FDA's new rules, more than ten thousand new businesses in the United States will be required to comply with an application process so expensive and onerous that over the next two years more than 95% of vapor product manufacturers and retail small businesses will be forced to shut down.
The C.D.C. estimates that more than 9 million U.S. adult consumers use vapor products, which are at least 95% less harmful than cigarettes, according to the Royal College of Physicians and other leading public health organizations.
Under the new rules, new smoke-free vapor products will be subject to the regulatory review process established in the 2009-passed Tobacco Control Act. From the letter:
"In 2009 when Congress passed the Family Smoking Prevention and Tobacco Control Act (TCA)... the FDA was granted authority to impose new regulations upon tobacco products such as cigarettes, smokeless and roll-your-own tobacco. A “predicate date” of February 15, 2007 was established whereby products on the market at or before this date were exempt from pre-market FDA review. That look-back period was just over two years when the TCA was signed in 2009. The look-back period for newly deemed products is ten years.
The FDA’s May 2016 Deeming Rule requires products which did not exist in 2007 – such as vapor products – to undergo the pre-market review process set up in the TCA. The process was designed to make it extraordinarily difficult to introduce new products to market, which is why it was supported by organizations like the Campaign for Tobacco-Free Kids."
There were a number of new requirements established in the FDA's May 2016 Rule.
"The most significant of the requirements imposed by the FDA’s new Deeming Rule is a requirement that all manufacturers of vapor products submit every product currently available to consumers for pre-market review, a process that every single manufacturer of cigarettes in the United State avoided when the TCA was signed into law. The Pre-Market Tobacco Application (PMTA) requires businesses to spend in excess of $300,000 per product and at least 500 hours of time per application. Even if businesses could afford this investment, the process is designed to end in failure. Many small businesses produce hundreds of these products and would be forced to close their doors as a result."
ATR is requesting a two-year delay in the PMTA filing deadline for newly deemed products.
I am asking you to delay the PMTA filing deadline by at least two years as Congress considers an alternative approach to regulating these very low risk products. There are multiple efforts with bipartisan support aimed at addressing the issues I’ve outlined, including the Cole-Bishop Amendment to the FY17 House Agriculture Appropriations Bill and House Resolution 1136, also sponsored by Congressman Tom Cole (R-Okla.). It is paramount that Congress acts this year to modernize the February 2007 predicate date for newly deemed products on the market.
The FDA is an agency of HHS and its commissioner reports to the Secretary of HHS.
With the emergence of smoke-free vapor products, millions of U.S. adults have successfully quit smoking traditional cigarettes with a variety of products that did not exist in 2007. Imposing this retroactive and onerous set of pre-market review rules upon reduced risk products is illogical and stands to harm decades of efforts to reduce the harm assocaited with cigarette use. The original Act was designed to make it extremely difficult to introduce new tobacco products, and not a single cigarette on the market today was forced to go through this review process. ATR strongly encourages HHS and the FDA to rein in this overreach with immediate action to delay all future filing and application deadlines imposed by the FDA's Deeming Rule.