Listing Of Ingredients In Tobacco Products {FDA 3742}

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration LISTING OF INGREDIENTS IN TOBACCO PRODUCTS Form Approved: OMB No. 0910-0650 Expiration Date: 6/30/2019 (See page 12 for PRA Statement) FAMILY SMOKING PREVENTION AND TOBACCO CONTROL ACT On June 22, 2009, the President signed the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) (Public Law 111-31) into law. The Tobacco Control Act amended the Federal Food, Drug, and Cosmetic Act (the distribution of tobacco products to protect the public health generally and to reduce tobacco use by minors. STATUTORY REQUIREMENTS Section 904(a)(1) of the act requires that each tobacco product manufacturer or importer submit "a listing of all ingredients, including tobacco, substances, compounds, and additives that are, as of such date, added by the manufacturer to the tobacco, paper, filter, or other part of each tobacco product by brand and by quantity in each brand and subbrand.". Section 904(c)(1) of the act requires that a tobacco product manufacturer provide all information required under section 904(a) at least 90 days prior to the delivery for introduction into interstate commerce" of a tobacco product not on the market as of June 22, 2009 (for cigarettes, cigarette tobacco, roll-your-own (RYO), and smokeless tobacco) or [publication date] (for other tobacco products). Section 904(c)(2) of the act requires that a tobacco product manufacturer advise the FDA in writing at least 90 days prior to adding any new tobacco additive or increasing in quantity an existing tobacco additive, except for those additives that have been designated by the FDA through regulation as not a human or animal carcinogen, or otherwise harmful to health under intended conditions of use. Section 904(c)(3) of the act requires that a tobacco product manufacturer advise the FDA in writing within 60 days of eliminating or decreasing an existing additive, or adding or increasing an additive that has been designated by the FDA through regulation as not a human or animal carcinogen, or otherwise harmful to health under intended conditions of use. To assist persons making these ingredient submissions, FDA has issued its Guidance for Industry: Listing of Ingredients in Tobacco Products (Guidance). This Guidance and the Tobacco Control Act are available through the web links listed on page 12. You may also refer to the Definitions and Instructions sections starting on pages 14 and 15. FORM FDA 3742 (11/16) General Information ­ Page i PSC Publishing Services (301) 443-6740 EF American LegalNet, Inc. www.FormsWorkFlow.com This page is deliberately blank. American LegalNet, Inc. www.FormsWorkFlow.com DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration LISTING OF INGREDIENTS IN TOBACCO PRODUCTS See pages 15-17 for Instructions Form Approved: OMB No. 0910-0650 Expiration Date: 6/30/2019 (See page 12 for PRA Statement) Please type. An item followed by an asterisk (*) denotes a required field. SECTION I - SUBMISSION TYPE 1. Submission Type (Check only one box. Please ensure that all products under this submission meet the definition of the checked submission type.)* Type a: Initial submission per 904(a)(1) for other tobacco product(s) on the market as of June 22, 2009 (for cigarettes, cigarette tobacco, RYO, and smokeless tobacco) or as of August 8, 2016 (for other tobacco products) Type b: Initial submission per 904(c)(1) for new product(s) Type c: Initial submission per 904(c)(1) for modification to existing product(s) Type d: Initial submission per 904(c)(2) for modification to existing product(s) Type e: Initial submission per 904(c)(3) for modification to existing product(s) Type f: Amendment to correct previous product ingredient submission(s) If Type f submission, enter the previous product ingredient submission tracking number (STN): TI If modification to a product involves more than one ingredient and is subject to both 904(c)(2) and 904(c)(3) reporting requirements, treat the modification to the product as falling under 904(c)(2). If you are only reporting an update or correction to contact information, do not use this form. Instead, please submit a letter to FDA indicating the update or correction. SECTION II - SUBMITTER IDENTIFICATION Submitter Type (Check one)* Company Name* Company Headquarters D&B D-U-N-S ® Number Company Headquarters FDA-assigned Facility Establishment Identifier (FEI) Number City* Manufacturer Importer (Complete Section III) Address* State, Province or Territory* Country* ZIP or Postal Code* Authorized Representative (Responsible official authorized to represent the submitter) Prefix (e.g., Mr., Ms., Dr.): First/Given Name M.I. Last Name Generational Suffix (e.g., Jr., III) Email Address Ph.D.) Professional Suffix(e.g., MD, Position Title Telephone (Include Country Code if applicable) FAX FORM FDA 3742 (11/16) Page 1 American LegalNet, Inc. www.FormsWorkFlow.com Authorized Representative (Continued) Company Name* Check here if same as company previously identified as submitter, and skip to Address. Address* Check here if same as previous, and skip to Section III. City* State, Province or Territory* Country* ZIP or Postal Code* SECTION III - MANUFACTURER OF IMPORTED PRODUCTS (Complete if Submitter Type is checked as Importer in Section II) Note: If you are reporting ingredient information for products from multiple manufacturers, please submit a separate submission for each manufacturer. Company Name* Company Headquarters D&B D-U-N-S ® Number Company Headquarters FDA-assigned Facility Establishment Identifier (FEI) Number City* Address* State, Province or Territory* Country* ZIP or Postal Code* U.S. Agent (For foreign firm where Authorized Representative does not reside in the U.S.) Prefix (e.g., Mr., Ms., Dr.): First/Given Name M.I. Last Name Generational Suffix (e.g., Jr., III) Email Address Ph.D.) Professional Suffix (e.g., MD, Position Title Telephone (Include Country Code if applicable) Company Name* Address* FAX Check here if same as company previously identified as manufacturer, and skip to Address. City* Check here if same as previous, and skip to Section IV. State, Province or Territory* Country* ZIP or Postal Code* FORM FDA 3742 (11/16) Page 2 American LegalNet, Inc. www.FormsWorkFlow.com SECTION IV - TOBACCO PRODUCT IDENTIFICATION 1. Tobacco Product Brand/Sub-brand Name or Other Commercial Name* (e.g., Acme Lights 100's or Acme Reconstituted Tobacco #202) 2. FDA-Assigned Trackin