From Bill Godshall:
Please note that comments to OMB/OIRA on Paperwork Reduction Act of 1995 aspects of FDA proposed Tobacco Regulation are due today before midnite. Feel free to copy or paraphrase from the following comments submitted by Smokefree Pennsylvania.
To:
oira_submission@omb.eop.gov
Subject: Docket No. FDA-2014-N-0189, RIN 0910-AG38, FDA proposed Tobacco Deeming Regulation
Food and Drug Administration
[Docket No. FDA- 2014-N-0189]
RIN 0910-AG38
Title: The Food and Drug Administration Deems Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Regulations Restricting the Sale and Distribution of Tobacco Products and Required Warnings for Tobacco Product Packages and Advertisements.
These comments are submitted on behalf of Smokefree Pennsylvania regarding some of the Paperwork Reduction Act of 1995 aspects of the FDA's proposed Tobacco Deeming Regulation.
Per the FDAâs estimate (see Table 9) that 25 Applications for Premarket Review of New Tobacco Products would be submitted annually to the agency for electronic cigarette (e-cig) products, the agency agrees with our previous estimate that the proposed Deeming Regulation would ban >99% of the ten thousand plus electronic cigarette (e-cig) products currently on the market.
Even worse, since just four Applications for Premarket Review of New Tobacco Products have been submitted in the past three years, and since the FDA refused to accept any of those four applications, the agency is unlikely to approve (or even accept) most of the Applications for Premarket Review of New Tobacco Products that would be submitted for e-cig products under the proposed Deeming Regulation.
By banning >99% of e-cig products, FDAâs proposed Deeming Regulation would effectively ban 99% of the several thousand current e-cig manufacturers from marketing their e-cig products in the U.S. two years following issuance of the Final Rule (per the Tobacco Control Actâs and FDAâs proposed definition of 'manufacturer' that includes "any person, including any repacker or relabeler, who manufactures, fabricates, assembles, processes, or labels a tobacco product" and anyone who "imports a finished tobacco product for sale or distribution in the US".
Even worse for public health, the proposed Deeming Regulation would ban ALL (or virtually ALL) of the rapidly growing e-market segment consisting of ten thousand plus e-liquid products and Premium Vaporizers (AKA mods, tanks, open systems) and other 'components' or 'parts' of a tobacco product, which have been found to be far more effective for helping smokers quit smoking than the 'cigalike' segment of the e-cig market.
And yet, the FDA's proposal didn't even propose a definition for 'components' or 'parts' of tobacco products (but states that they would be regulated as âtobacco productsâ), nor did FDAâs proposal indicate if a âcomponentâ or âpartâ of an e-cig product would/could be considered to be a âfinished tobacco productâ, or if the agency has any intention of approving (or even accepting) any Application for Premarket Review of a New Tobacco Product for a âcomponentâ or âpartâ of a tobacco product (e.g. by claiming that it is not a âfinished tobacco productâ.
Further, the FDA estimate (in Table 9) that it would cost an applicant just 5,000 hours to prepare a successful Application for Premarket Review of a New Tobacco Product is far below the actual cost of doing so.
The FDAâs proposed Deeming Regulation even states (on page 179 of the printed version) âWe are clarifying here that a PMTA may require one or more types of studies including chemical analysis, nonclinical studies and clinical studies. FDA expects that chemical and design parameter analysis would include the testing of applicable HPHCs and nonclinical analysis would include literature synthesis and, as appropriate, some combination of in vitro or in vivo studies, and computational analyses. For the clinical study component, one or more types of studies may be included to address, as needed, perception, use pattern, or health impact.â
Thus, it would almost certainly cost each successful applicant >50,000 hours at >$50/hour for a cost exceeding $2.5 million for each Application for Premarket Review of a New Tobacco Product.
Since there were only several different first generation âcigalikeâ products on the market prior to February 15, 2007, and since those products were inferior to all cigalike products currently on the market, there is very little chance that any Substantial Equivalence (SE) applications/reports or Requests for Exemption for Substantial Equivalence would be submitted to FDA under the Deeming Regulation. The FDAâs proposed Deeming Regulation even acknowledges that very few, if any, SE reports would be submitted to the agency.
By banning >99% of e-cig products, FDAâs proposed Deeming Regulation also would threaten the lives of most of the several million vapers and tens of millions of smokers,
while creating a huge black market for e-cig products that would dwarf the black market FDA created for e-cigs in 2009 (when it unlawfully banned the products by claiming they were being regulated as drug devices).
The FDA Deeming Regulation would be premeditated public health malpractice (and a disaster for 99% of e-cig manufacturers) that would dwarf the US Public Health Serviceâs infamous Tuskegee syphilis study decades ago.
By banning >99% of e-cig products, FDAâs proposed Deeming Regulation would not only protect lethal cigarettes from market competition by thousands of existing e-cig companies, but also would give the entire e-cig industry to several Big Tobacco companies and perhaps several large cigalike companies (that can afford the huge costs it would take to submit a successful Application for Premarket Review of New Tobacco Products). Thus, the proposed Deeming Regulation is âcrony capitalismâ because it would benefit several large corporations at the expense all other competitors.
I presented nearly all of the this information in person at a meeting with OMB/OIRA staff on behalf of Smokefree Pennsylvania on December 19, 2013 when urging the OMB to reject FDAâs proposed Deeming Regulation. I also presented most of this information to the FDA officials and staff at various meetings during the past three years.
In sum, please reject the proposed FDA Deeming Regulation because it would ban >99% of e-cigs now on the market, would give the entire and rapidly growing e-cig industry to just several Big Tobacco companies (and perhaps several large cigalike companies), would threaten the lives of millions of vapers and tens of millions of smokers, and would create a much larger (and potentially hazardous) black market for e-cigs than FDA created in 2009.
Smokefree Pennsylvania is a nonprofit organization founded in 1990 by William Godshall, who has since served as its executive director. Smokefree Pennsylvania has advocated local, state and federal policies to ban smoking in workplaces, stop cigarette marketing to youth, hold cigarette companies accountable in civil litigation, increase cigarette tax rates, fund tobacco education and smoking cessation services, inform smokers that all smokefree tobacco/nicotine products are far less hazardous alternatives to cigarettes, and ensure that smokefree alternatives remain legal and affordable for smokers. In 2009 Smokefree Pennsylvania urged FDA to keep electronic cigarettes legal, and in 2010 we filed an amicus brief with the DC Court of Appeals in support of NJOYâs lawsuit against FDAâs unlawful e-cigarette import ban.
For disclosure, neither I nor Smokefree Pennsylvania have ever received any funding from any tobacco, drug or electronic cigarette company or trade association.
Sincerely,
William T. Godshall, MPH
