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Listing Of Ingredients In Tobacco Products FDA 3742 - Official Federal Forms
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration LISTING OF INGREDIENTS IN TOBACCO PRODUCTS Form Approved: OMB No. 0910-0650 Expiration Date: 12/31/2012 (See page 8 for Burden 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 act) by adding a new chapter granting FDA important new authority to regulate the manufacture, marketing, and 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" by December 22, 2009. This section applies only to those tobacco products manufactured and distributed before June 22, 2009, and which are still manufactured as of the date of ingredient listing submission. 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 on the date of enactment" of the Tobacco Control Act. 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 8. DEFINITIONS FDA intends to use the following definitions in implementing the ingredient listing requirements of section 904 of the act. 1. Additive: The term "additive" means "any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristic of any tobacco product (including any substances intended for use as a flavoring or coloring or in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding), except that such term does not include tobacco or a pesticide chemical residue in or on raw tobacco or a pesticide chemical" (section 900(1) of the act (21 U.S.C. 387(1)). 2. Importer: The term "importer" means the importer of record at the time of entry of a tobacco product into the United States. 3. Pouch: The term "pouch" means a permeable pouch, intended to be filled with pre-portioned tobacco product and placed in the oral cavity with the tobacco product. (Continued on next page) FORM FDA 3742 (12/10) Page 1 PSC Graphics (301) 443-6740 EF American LegalNet, Inc. www.FormsWorkFlow.com DEFINITIONS (Continued) 4. Tobacco Product: The term "tobacco product" means "any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product)" (section 201(rr) of the act (21 U.S.C. 321(rr))). This term does not include an article that is a drug, a device, or a combination product as defined in the act (section 201(rr) of the act (21 U.S.C. 321(rr))). Thus, the term is not limited to products containing tobacco, but also includes components, parts, and accessories of tobacco products, whether they are sold for further manufacturing or for consumer use. For example, tobacco, papers and filters are tobacco products, whether they are sold to consumers for use with roll-your-own tobacco or are sold for further manufacturing into a product sold to a consumer, such as a cigarette. 5. Tobacco Product Manufacturer: The term "tobacco product manufacturer" means "any person, including any repacker or relabeler, who (A) manufactures, fabricates, assembles, processes, or labels a tobacco product; or (B) imports a finished tobacco product for sale or distribution in the United States" (section 900(20) of the act (21 U.S.C. 387(20)). Thus, the term is not limited to persons who manufacture products containing tobacco, but includes anyone who manufactures any tobacco product as defined above. FORM FDA 3742 (12/10) Page 2 American LegalNet, Inc. www.FormsWorkFlow.com DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration LISTING OF INGREDIENTS IN TOBACCO PRODUCTS See pages 10-13 for Instructions Form Approved: OMB No. 0910-0650 Expiration Date: 12/31/2012 (See page 8 for Burden Statement) Please type. An item followed by an asterisk (*) denotes a required field. SECTION I - SUBMISSION TYPE 1. Submission Type (Check only one)* New Submission 1a. 1b. Ingredient listing for tobacco product(s) on the market as of June 22, 2009 Ingredient listing for tobacco product(s) not on the market as of June 22, 2009 Update to Previous Submission (See instructions on pages 10-13 for required fields.) 1c. 1d. Add, delete, or change the quantity of additive(s) Other update (e.g., address changes) (Specify below) SECTION II - SUBMITTER IDENTIFICATION Submitter Type (Check one)* Manufacturer Company Name* Importer Company Headquarters DUNS Number Company Headquarters FEI Number Address* City* State, Province or Territory* Country* ZIP or Postal Code* Submitter Point of Contact Title (e.g., Mr., Ms., Dr.): First/Given Name Middle Name Last Name Position Title Email Address Telephone (Include Country Code if applicabl
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