References for "Eight years for three bits?" by Dr John Lauterbach (TJI issue 3/2021)
1. Lauterbach JH. Can US FDA substantially equivalent predicates be developed without knowledge of and a sample of the predicate product? 69th Tobacco Science Research Conference, Naples, FL, September 20-23, 2015. Program Booklet and Abstracts, Vol. 69, No. 61, p. 54.
2. Roerty GR Jr. Review of Existing General Regulatory and Information Collection Requirements of the Food and Drug Administration – Docket FDA-2017-N-5093. December 15, 2017. Available at https://www.reginfo.gov/public/do/eoDownloadDocument?pubId=&eodoc=true&documentID=3909.
3. Chowdhury A, Skaggs KC. U.S. Smokeless Tobacco Company, a Subsidiary of Altria, Challenges FDA’s Substantial Equivalence Reporting Process in New Lawsuit. National Law Review, National Law Review, Volume VIII, Number 64, March 5, 2018.
4. Food and Drug Administration. Guidance for Industry and Food and Drug Administration Staff; Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products; Availability. Fed Regist. 2011 Jan6;76(4):789-90.
5. Family Smoking Prevention and Tobacco Control Act, Pub. Law. 111-31 (June 22, 2009); also see 21 U.S.C Subchapter IX— Tobacco Products (21 U.S.C § 387 et seq.).
6. 21 U.S.C § 387g – Tobacco product standards. Full text available at https://www.law.cornell.edu/uscode/text/21/387g.
7. FDA. FDA Commits to Evidence-Based Actions Aimed at Saving Lives and Preventing Future Generations of Smokers. April 29, 2021. Available at https://www.fda.gov/news-events/press-announcements/fda-commits-evidence-based-actions-aimed-saving-lives-and-preventing-future-generations-smokers.
8. FDA. Technical Project Lead (TPL) Review: SE0002649, SE0002651 and SE0015071. March 29, 2019. Available at https://www.fda.gov/media/132940/download.
9. Lauterbach JH, Bao M, Joza PJ, Rickert WS. Free-base nicotine in tobacco products. Part II. Determination of free-base nicotine in the aqueous extracts of smokeless tobacco products and the relevance of these findings to product design parameters. Regul Toxicol Pharmacol. 2011 Feb;59(1):8-18. doi: 10.1016/j.yrtph.2010.09.002. Epub 2010 Sep 16.
10. FDA. SMNA Appeal Decision Summary – FDA Submission Tracking Number (STN): AP0000017. APPEAL GRANTED. January 13, 2017. Available at https://www.fda.gov/media/102858/download
11. Zeller M. Perspective: FDA’s Progress on Review of Tobacco Product Applications Submitted by the Sept. 9, 2020 Deadline. Available at https://www.fda.gov/tobacco-products/ctp-newsroom/perspective-fdas-progress-review-tobacco-product-applications-submitted-sept-9-2020-deadline.