DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration REGISTRATION AND LISTING FOR OWNERS AND OPERATORS OF DOMESTIC TOBACCO PRODUCT ESTABLISHMENTS Form Approved: OMB No. 0910-0650 Expiration Date: 6/30/2019 (See page 11 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 act) by, among other things, 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. Complete the following question and answer form to register your establishment and submit your product listing to FDA's Center for Tobacco Products. For additional information on the legislation and guidance document, access the web links provided on page 11. STATUTORY REQUIREMENTS All owners and operators must fulfill the requirements for section 905 of the act, as detailed below. In order to reduce redundant submissions, FDA strongly encourages owners to register and submit product listing information for themselves and on behalf of their operators. Section 905(b) of the act requires that "every person who owns or operates any establishment in any State engaged in the manufacture, preparation, compounding, or processing of a tobacco product or tobacco products shall register with the Secretary the name, places of business, and all such establishments of that person." Section 905(i)(1) of the act requires that all registrants "shall, at the time of registration . . . file with [FDA] a list of all tobacco products which are being manufactured, prepared, compounded, or processed by that person for commercial distribution," along with certain accompanying information, such as all labeling. Section 905(i)(3) of the act requires that certain changes in the product list be submitted biannually, once during June and once during December. DEFINITIONS FDA intends to use the following definitions in implementing the registration and product listing requirements of section 905 of the act. 1. Commercial Distribution: The term "commercial distribution" includes any distribution of a tobacco product to consumers or to another person for future manufacturing through sale or otherwise. As examples, it includes the distribution of a tobacco product as a promotional sample and the delivery of a tobacco product to another manufacturer for further processing via contract without a change in the formal ownership of the product. Commercial distribution does not include internal or interplant transfer of a tobacco product between registered establishments within the same parent, subsidiary, and/or affiliate company and it does not include providing a tobacco product for product testing in cases where such products are not made available for consumption or resale. 2. Domestic Establishment: The term "domestic establishment" means an establishment in any State or Territory or possession of the United States. 3. Establishment: The term "establishment" means a place of business under one ownership at one general physical location. A single building may house more than one distinct establishment if the establishments are under separate ownership. (Continued on next page) FORM FDA 3741 (6/16) Page 1 American LegalNet, Inc. www.FormsWorkFlow.com PSC Publishing Services (301) 443-6740 EF DEFINITIONS (Continued) 4. Labeling: The term "labeling," based on section 201(m) of the act (21 U.S.C. 321(m)), means all labels and other written, printed, or graphic matter (1) upon any tobacco product or any of its containers or wrappers, or (2) accompanying such tobacco product. 5. Manufacturing: The term "manufacturing" means the manufacture, preparation, compounding, or processing of a tobacco product, including repackaging or otherwise changing the container, wrapper, or labeling of any tobacco product package (section 905(a)(1) of the act). This term includes the activities of reconstituting and blending tobacco leaf; testing for quality control and product release; and applying any chemical, additive, or substance to the tobacco leaf other than potable water in the form of steam or mist. This term excludes the activities of de-stemming, drying, or packing tobacco leaf; mechanically removing foreign material from tobacco leaves; and humidifying tobacco leaf with nothing other than potable water in the form of steam or mist. 6. Operator: The term "operator" means a person, as defined in section 201(e) of the act (21 U.S.C. 321(e)) who has management authority over an establishment. 7. Owner: The term "owner" means a person, as defined in section 201(e) of the act (21 U.S.C. 321(e)) who has an ownership interest in an establishment. 8. 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. 9. 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 are ready 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. FORM FDA 3741 (6/16) Page 2 American LegalNet, Inc. www.FormsWorkFlow.com DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration REGISTRATION AND LISTING FOR OWNERS AND OPERATORS OF DOMESTIC TOBACCO PRODUCT ESTABLISHMENTS See page 15 for Instructions Form Approved: OMB No. 0910-0650 Expiration Date: 6/30/2019 (See page 11 for PRA Statement) Please type. An item followed by an asterisk (*) denotes a requir