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Thursday, November 29, 2018

FDA: FOIA Response #3

I recently wrote "Scott Gottlieb: JUUL is Now Your Bitch" and "Scott Gottlieb: JUUL's Industrial Revolution Runs Away" (where I talk about this FOIA request).



As part of the latter I filed another FOIA request related to "The changes that FDA is allowing to these labels reflect the fact that although any nicotine-containing product is potentially addictive, decades of research and use have shown that NRT products sold OTC do not appear to have significant potential for abuse or dependence.

The changes being recommended by FDA include a removal of the warning that consumers should not use an NRT product if they are still smoking, chewing tobacco, using snuff or any other product that contains nicotine—including another NRT."

This statement used to be present on the FDA web site but was recently removed: see this.

I began interacting with the FDA FOIA people (interestingly this request went directly to a fellow with "JD" after his title who was relatively aggressive in responding).

In the end here's where it ended up: "Good Morning Todd,

Thanks for having a look at what’s been located thus far and clarifying the request for me.

I think I’ve located exactly what you’re asking for.

The consumer updates announcements are the consequence of the Federal Register announcements, like a news headline. They are usually based upon permanent agency notices. In this case the notice was this: “Modifications to labeling of Nicotine Replacement Therapy Products for Over-the-Counter Use,” 78 FR 19718, published on April 2, 2013. Please navigate to this link: https://www.regulations.gov/document?D=FDA-2013-N-0341-0001 , and scroll down to section IV, “published Literature Supporting Proposed Labeling Revisions.” You will find the complete list of references for the labeling changes. 

I will call in a few minutes to confirm that this is what you’ve been looking for.

Many thanks,
..."

(NOTE: The FDA FOIA responder made clear NRT does not include vaping.)

Following the link (https://www.regulations.gov/document?D=FDA-2013-N-0341-0001) you see section IV.

I have underlined several items related to, for example, nicotine inhalers and flavoring, that seem quite interesting.

The next step will be to track down these actual documents.

(From FOIA the link...)

IV. Published Literature Supporting Proposed Labeling Revisions

The published literature we have relied on in making the determinations contained in this notice is listed in this section of the document. Copies of the published literature will be on display in the Division of Dockets Management (see ADDRESSES) and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday, and are available electronically at http://www.regulations.gov.

1. Batra, A., et al., “Smoking Reduction Treatment With 4-Mg Nicotine Gum: A Double-Blind, Randomized, Placebo-Controlled Study,” Clinical 78(6):689-96, 2005.

2. Benowitz, N.L., et al., “Suppression of Nicotine Intake During Ad Libitum Cigarette Smoking by High-Dose Transdermal Nicotine,” Journal of Pharmacology and Experimental Therapeutics, 287(3):958-62, 1998.

3. Blondal, T., et al., “Nicotine Nasal Spray With Nicotine Patch for Smoking Cessation: Randomised Trial With Six Year Follow Up,” BMJ, 318(7179):285-8, 1999.

4. Bohadana, A., et al., “Nicotine Inhaler and Nicotine Patch as a Combination Therapy for Smoking Cessation,” Archives of Internal Medicine, 160(20):3128-34, 2000.

5. Bolliger, C.T., et al, “Smoking Reduction With Oral Nicotine Inhalers: Double Blind, Randomised Clinical Trial of Efficacy And Safety,” BMJ, 321(7257):329-33, 2000.

6. Bullen, C., et al., “Precessation Nicotine Replacement Therapy: Pragmatic Randomized Trial,” Addiction, 105(8):1474-83, 2010.

7. Dale, L.C., et al., “High-Dose Nicotine Patch Therapy. Percentage of Replacement and Smoking Cessation,” JAMA, 274(17):1353-58, 1995.

8. Etter, J.F., et al., “Nicotine Replacement to Reduce Cigarette Consumption in Smokers Who Are Unwilling to Quit: A Randomized Trial,” Journal of Clinical Psychopharmacology, 22(5):487-95, 2002.

9. Etter, J.F., et al., “Post intervention Effect of Nicotine Replacement Therapy on Smoking Reduction in Smokers Who Are Unwilling to Quit: A Randomized Trial,” Journal of Clinical Psychopharmacology, 24(2):174-79, 2004.

10. Etter, J.F., et al., “Nicotine Gum Treatment Before Smoking Cessation—A Randomized Trial,” Archives of Internal Medicine, 169(11):1028-34, 2009.

11. Hajek, P., et al., “Dependence Potential of Nicotine Replacement Treatments: Effects of Product Type, Patient Characteristics, and Cost to User,” Preventive Medicine, 44(3):230-34, 2007.

12. Hall, S.M., et al., “Extended Treatment of Older Cigarette Smokers,” Addiction, 104(6):1043-52, 2009.

13. Hatsukami, D., et al., “Effects of High Dose Transdermal Nicotine Replacement in Cigarette Smokers,” Pharmacology, Biochemistry, and Behavior, 86(1):132-39, 2007.

14. Horst, W.D., et al., “Extended Use of Nicotine Replacement Therapy to Maintain Smoking Cessation in Persons With Schizophrenia,” Neuropsychiatric Disease and Treatment, 1(4):349-55, 2005.

15. Houtsmuller, E.J., et al., “Flavor Improvement Does Not Increase Abuse Liability of Nicotine Chewing Gum,” Pharmacology, Biochemistry, and Behavior, 72(3):559-68, 2002.

16. Hughes, J.R., et al., “A Randomized, Controlled Trial of NRT-Aided Gradual Vs. Abrupt Cessation in Smokers Actively Trying to Quit,” Drug and Alcohol Dependence, 111(1-2):105-13, 2010.

17. Joseph, A.M., et al., “Chronic Disease Management for Tobacco Dependence,” Archives of Internal Medicine, 171(21):1894-1900, 2011.

18. Lerman, C., et al., “Genetic Variation in Nicotine Metabolism Predicts the Efficacy of Extended-Duration Transdermal Nicotine Therapy,” Clinical Pharmacology and Therapeutics, 87(5):553-57, 2010.

19. Lindson, N. and Aveyard, P., “An Updated Meta-Analysis of Nicotine Preloading for Smoking Cessation: Investigating Mediators of the Effect,” Psychopharmacology, 214(3):579-92, 2011.

20. Murray, R.P., et al., “Safety of Nicotine Polacrilex Gum Used by 3,094 Participants in the Lung Health Study. Lung Health Study Research Group,” CHEST, 109(2):438-45, 1996.

21. Murray, R.P., et al., “Does Nicotine Replacement Therapy Cause Cancer? Evidence From the Lung Health Study,” Nicotine & Tobacco Research, 11(9):1076-82, 2009.

22. Newhouse, P., et al., “Nicotine Treatment of Mild Cognitive Impairment: A 6-Month Double-Blind Pilot Clinical Trial,” Neurology, 78(2):91-101, 2012.

23. Piper, M.E., et al., “A Randomized Placebo-Controlled Clinical Trial of 5 Smoking Cessation Pharmacotherapies,” Archives of General Psychiatry, 66(11):1253-62, 2009.

24. Rennard, S.I., et al., “Efficacy of the Nicotine Inhaler in Smoking Reduction: A Double-Blind, Randomized Trial,” Nicotine & Tobacco Research, 8(4):555-64, 2006.

25. Rose, J.E., et al., “Mecamylamine Combined With Nicotine Skin Patch Facilitates Smoking Cessation Beyond Nicotine Patch Treatment Alone,” Clinical Pharmacology and Therapeutics, 56(1):86-99, 1994.

26. Rose, J.E., et al., “Nicotine-mecamylamine Treatment for Smoking Cessation: The Role of Precessation Therapy,” Experimental and Clinical Psychopharmacology, 6(3):331-43, 1998.

27. Rose, J.E., et al., “Precessation Treatment With Nicotine Skin Patch Facilitates Smoking Cessation,” Nicotine & Tobacco Research, 8(1):89-101, 2006.

28. Rose, J.E., et al., “Precessation Treatment With Nicotine Patch Significantly Increases Abstinence Rates Relative to Conventional Treatment,” Nicotine & Tobacco Research, 11(9):1067-75, 2009.

29. Schuurmans, M.M., et al., “Effect of Pretreatment With Nicotine Patch on Withdrawal Symptoms and Abstinence Rates in Smokers Subsequently Quitting With the Nicotine Patch: A Randomized Controlled Trial,” Addiction, 99(5):634-40, 2004.

30. T√łnnesen, P., et al., “Higher Dosage Nicotine Patches Increase One-Year Smoking Cessation Rates: Results From the European CEASE Trial,” European Respiratory Journal, 13(2):238-46, 1999.

31. Wang, D., et al., ” `Cut Down to Quit' With Nicotine Replacement Therapies in Smoking Cessation: A Systematic Review of Effectiveness and Economic Analysis,” Health Technology Assessment, 12(2):iii-iv, ix-xi, 1-135, 2008.

32. Wennike, P., et al., “Smoking Reduction Promotes Smoking Cessation: Results From a Double Blind, Randomized, Placebo-Controlled Trial of Nicotine Gum With 2-Year Follow-Up,” Addiction, 98(10):1395-402, 2003.

33. West, R., et al, “A Comparison of the Abuse Liability and Dependence Potential of Nicotine Patch, Gum, Spray and Inhaler,” Psychopharmacology, 149(3):198-202, 2000.

34. Zevin, S., et al, “Dose-Related Cardiovascular and Endocrine Effects of Transdermal Nicotine,” Clinical Pharmacology and Therapeutics, 64(1):87-95, 1998.

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