June 8, 2014
My colleague Suzaynn Schick and some others just submitted this public comment to FDA.
The FDA should not exempt “premium” cigars from regulation (i.e., reject "Option 2) and should include the fifth FTC warning (Tobacco Use Increases the Risk of Infertility, Stillbirth and Low Birth Weight) on the packaging of all cigars.
Although large, expensive cigars may be used differently by different sectors of society, there are still plenty of people in the U.S. who can afford to smoke them regularly. Premium cigar smokers should neither be excluded from the education that health warnings provide, nor spared the emotional distress the warnings may provoke. All tobacco and nicotine deliver products need to be labeled clearly and consistently. Failure to do so creates the false impression that products without health warnings are less risky to use than labeled products. In the case of premium cigars, this is certainly not true.
June 6, 2014
Lauren Dutra and I just submitted this public comment to the FDA on the deeming rule (PDF version):
The Proposed Two Year Phase in for Requiring Premarket Approval of Newly Deemed Tobacco Products is Too Long; 6 Months Would be More Appropriate
Docket No. FDA-2014-N-0189
Lauren M Dutra, ScD
Stanton A Glantz, PhD
Center for Tobacco Control Research and Education
University of California San Francisco
June 6, 2014
The FDA has proposed a 2-year delay in implementing the premarket approval provisions of the Family Smoking Prevention and Tobacco Control Act for newly deemed products. Products would be allowed to remain on the market, and the FDA would not “initiate enforcement action against the product for failing to have an FDA marketing authorization unless and until FDA issues an order denying the PMTA [premarket tobacco applications] under 910(c)” (p. 23176). The FDA also asked for public comment on the possibility of “extending the compliance period” for small manufacturers (p. 23177).
June 4, 2014
A group of scientists from UCSF and Stanford (Ganna Kostygina, PhD, Elizabeth Couch, RDH, MS, Margaret Walsh, Ed.D., Rachel Grana, MPH, PhD, Bonnie Halpern-Felsher, PhD, FSAHM,*Lauren K. Lempert, JD, MPH, Pamela M. Ling, MPH, MD) have submitted an extensive public comment to FDA on the issue of flavored tobacco products.
The full comment is 13 pages long and available as a PDF here.
Here is the first two paragrpahs oft he comment:
June 3, 2014
June 3, 2014
Docket No. FDA-2014-N-0189
I am resubmitting the following public comment, submitted to an earlier docket:
Grana, R., Ling, P.M., Barnes, R.L., Lempert, L., Glantz, S.A. (2013). Comment submitted regarding Feed and Drug Administration actions related to Nicotine Replacement Therapies and smoking-cessation products; report to Congress on innovative products and treatments for tobacco dependence; public hearing; extension of comment period. tracking # 1jx-835b-n9ph.
This comment is referenced in the following comment, which was just submitted to the current docket: FDA Should Prohibit E-cigarette Marketing that Promotes False Health Claims, tracking number 1jy-8cgs-l1sq
Stanton A. Glantz, PhD
Professor of Medicine
This is comment number 1jy-8cgt-ek20. (This file has all the advertising examples in it.)
June 3, 2014
A group of scientists from UCSF and Stanford, led by Lauren Dutra, has submitted a comment to the FDA calling on the agency to block current false advertising by e-cigarette companies and also include such prohibitions in the current deeming rule.
Here is the comment (without the illustrations, which you can get by dowloading the PDF of the comment).
FDA Should Prohibit E-cigarette Marketing that Promotes False Health Claims
Docket No. FDA-2014-N-0189
LM Dutra, ScD1; RA Grana, PhD1; L Lempert, JD1; JK Cataldo, RN, PhD1; SA Glantz, PhD1; BL Halpern-Felsher, PhD2; PM Ling, MD1; L Popova, PhD1; M Walsh, EdD1
1 Center for Tobacco Control Research and Education
University of California San Francisco
2 Department of Pediatrics, Stanford University
June 3, 2014