NICOTINE | N020165 | CHATTEM INC DBA SANOFI CONSUMER HEALTHCARE
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Energy Marketers of America (EMA) FDA-2023-P-2225 · 3 docket documents The Energy Marketers of America filed this citizen petition under 21 C.F.R. § 10.30 and the Family Smoking Prevention and Tobacco Control Act requesting that FDA publish a comprehensive monthly list by brand and category of electronic nicotine delivery systems and other deemed tobacco products that | Other | 2023-06-02 | Open | Energy Marketers of America (EMA) |
Citizen Petition from RAI Services Company FDA-2023-P-0430 · 4 docket documents RAI Services Company, a subsidiary coordinator for Reynolds American Inc., filed this citizen petition under 21 C.F.R. § 10.30 and the Family Smoking Prevention and Tobacco Control Act requesting that FDA adopt a new enforcement policy targeting illegally marketed disposable electronic nicotine deli | Other | 2023-02-08 | Denied | RAI Services Company |
Citizen Petition from Clark-Esposito Law Firm, P.C on behalf of Vapor Vapes, Inc FDA-2022-P-2483 · 6 docket documents Clark-Esposito Law Firm, P.C. on behalf of Vapor Vapes, Inc. filed this petition requesting that the FDA amend 21 C.F.R. §1.101(b) to establish clearer parameters for tobacco product exports including electronic nicotine delivery systems, issue a Guidance document for industry regarding tobacco prod | Other | 2022-10-07 | Denied | Vapor Vapes, Inc |
Citizen Petition from American Vapor Manufacturers FDA-2022-P-1211 · 3 docket documents American Vapor Manufacturers filed this citizen petition on June 16, 2022, requesting that the FDA exercise enforcement discretion to allow manufacturers of synthetic nicotine e-liquids used in open-system devices who submitted timely Premarket Tobacco Product Applications to continue marketing thei | Other | 2022-06-17 | Denied | American Vapor Manufacturers |
Citizen Petition from Respira Technologies, Inc. FDA-2019-P-5922 · 12 docket documents Respira Technologies, Inc. filed this citizen petition on December 16, 2019, pursuant to sections 901 through 915 of the Federal Food, Drug, and Cosmetic Act, requesting that the FDA establish comprehensive regulations for electronic nicotine delivery systems including nicotine content standards, ha | Other | 2019-12-17 | Open | Respira Technologies, Inc. |
Citizen Petition from Hyman, Phelps & Mcnamara, PC FDA-2013-P-1640 · 4 docket documents Hyman, Phelps & McNamara, PC filed this citizen petition on December 5, 2013 under Section 505 of the Federal Food, Drug, and Cosmetic Act requesting that FDA require sponsors of over-the-counter transdermal nicotine patches approved under NDAs pursuant to Section 505(b) or ANDAs pursuant to Section | 505(q) | 2013-12-12 | Partially Denied | Hyman, Phelps & Mcnamara, PC |
Citizens Petition from McKenna and Cuneo LLP on behalf of McKenna & Cuneo FDA-1995-P-0238 McKenna & Cuneo LLP, on behalf of a pharmaceutical client, filed this citizen petition pursuant to section 701 of the Federal Food, Drug, and Cosmetic Act requesting that the FDA Commissioner refrain from granting three years of market exclusivity to Nicorette and Nicorette DS (nicotine polacrilex g | Other | 2012-07-10 | Open | McKenna & Cuneo |
American Association of Public Health Physicians, Tobacco Control Task Force ... FDA-2010-P-0095 · 2 docket documents The American Association of Public Health Physicians Tobacco Control Task Force, led by Dr. Joel L. Nitzkin, filed this citizen petition on February 7, 2010 under 21 CFR 5.10 requesting that the FDA reclassify electronic cigarettes or nicotine vaporizers from drug-device combinations under sections | Other | 2010-02-23 | Open | — |
Association for the Treatment of Tobacco Use and Dependence (ATTUD) and the S... FDA-2010-P-0089 · 12 docket documents The Association for the Treatment of Tobacco Use and Dependence (ATTUD) and the Society for Research on Nicotine and Tobacco (SRNT) filed this citizen petition requesting that the FDA alter its review of drug approval applications and regulations for nicotine replacement therapy medications, specifi | Other | 2010-02-22 | Partially Denied | — |
Citizen Petition from Action on Smoking & Health (ASH) FDA-1977-P-0004 · 2 docket documents Action on Smoking and Health, along with supporting organizations and medical professionals, filed this citizen petition on May 26, 1987, requesting that the FDA recognize jurisdiction over cigarettes containing nicotine as a "drug" or alternatively as a "device" under 21 U.S.C. Section 321, and res | Other | 2008-08-05 | Open | Action on Smoking & Health (ASH) |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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