- Apr 2, 2009
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Today, Stan Glantz criticized FDA's lack of transparency regarding Substantial Equivalence (SE) applications, and I agree (but not for same reasons as prohibitionist Glantz, who doesn't want FDA to approve any SE applications).
FDA process for approving
I sent Stan the following reply (to his e-mail) and posted it on his blog. We'll see if he allows it to be posted (although he probably won't because I point out how the deeming regulation would ban all e-cigs).
Stan,
I share your concerns about the FDA's lack of transparency for evaluating SE applications, especially since the agency has only approved 9 SE applications (including 2 for manufactured cigarettes, and 7 for RYO tobacco and papers). The FDA also has rejected 13 SE applications so far (but hasn't revealed any info on those products), and has a huge backlog of >4,000 SE applications.
Since manufactured cigarettes, RYO cigarette papers, RYO tobacco and smokeless tobacco products are all vastly different products, the FDA should have developed different criteria to evaluate SE applications for each of those four different types of products, and should make those criteria public.
Please note that unless the FDA exempts newly deemed tobacco products (i.e. e-cigs, little cigars, large cigars, smoking tobacco, shisha/hookah tobacco, dissolvables, nicotine skin creams) from Section 905(j) and Section 910 regulations for SE applications, the deeming regulation would ban ALL newly deemed tobacco products (that are currently on the market) from being introduced into the US market pending FDA approval of an SE application, which poses a conundrum for FDA (and exposes the incompetence of negotiators, sponsors and advocates of the TCA).
But assuming the FDA exempts newly deemed tobacco from Section 905(j) and Section 910 requirements (to avoid entirely justifiable lawsuits), the FDA should also develop different criteria for evaluating SE applications for each of the different types of newly deemed tobacco products.
Last week, the FDA issued a Brief Summary of “Not Substantially Equivalent” Determinations hinting at why <1% of SE tobacco product applications have been approved or rejected, and explaining (as I've done many times) why the FDA deeming regulation would ban all e-cigs currently on the market (since none are Substantially Equivalent to a product on the market before February 15, 2007) .
http://www.fda.gov/downloads/TobaccoProducts/Labeling/MarketingandAdvertising/UCM366584.pdf
According to that document, the FDA can reject any SE application simply because the agency claims to have "inadequate information" on the product.
Bill Godshall
Executive Director
Smokefree Pennsylvania
1926 Monongahela Avenue
Pittsburgh, PA 15218
412-351-5880
smokefree@compuserve.com
FDA process for approving
I sent Stan the following reply (to his e-mail) and posted it on his blog. We'll see if he allows it to be posted (although he probably won't because I point out how the deeming regulation would ban all e-cigs).
Stan,
I share your concerns about the FDA's lack of transparency for evaluating SE applications, especially since the agency has only approved 9 SE applications (including 2 for manufactured cigarettes, and 7 for RYO tobacco and papers). The FDA also has rejected 13 SE applications so far (but hasn't revealed any info on those products), and has a huge backlog of >4,000 SE applications.
Since manufactured cigarettes, RYO cigarette papers, RYO tobacco and smokeless tobacco products are all vastly different products, the FDA should have developed different criteria to evaluate SE applications for each of those four different types of products, and should make those criteria public.
Please note that unless the FDA exempts newly deemed tobacco products (i.e. e-cigs, little cigars, large cigars, smoking tobacco, shisha/hookah tobacco, dissolvables, nicotine skin creams) from Section 905(j) and Section 910 regulations for SE applications, the deeming regulation would ban ALL newly deemed tobacco products (that are currently on the market) from being introduced into the US market pending FDA approval of an SE application, which poses a conundrum for FDA (and exposes the incompetence of negotiators, sponsors and advocates of the TCA).
But assuming the FDA exempts newly deemed tobacco from Section 905(j) and Section 910 requirements (to avoid entirely justifiable lawsuits), the FDA should also develop different criteria for evaluating SE applications for each of the different types of newly deemed tobacco products.
Last week, the FDA issued a Brief Summary of “Not Substantially Equivalent” Determinations hinting at why <1% of SE tobacco product applications have been approved or rejected, and explaining (as I've done many times) why the FDA deeming regulation would ban all e-cigs currently on the market (since none are Substantially Equivalent to a product on the market before February 15, 2007) .
http://www.fda.gov/downloads/TobaccoProducts/Labeling/MarketingandAdvertising/UCM366584.pdf
According to that document, the FDA can reject any SE application simply because the agency claims to have "inadequate information" on the product.
Bill Godshall
Executive Director
Smokefree Pennsylvania
1926 Monongahela Avenue
Pittsburgh, PA 15218
412-351-5880
smokefree@compuserve.com
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