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U.S. FDA Tobacco Product Regulations

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)" according to the Food, Drug, and Cosmetic Act (FDCA). This term does not include an article that is a drug, a device, or a combination product as defined in the FDCA. Therefore, the "tobacco products" is not limited to products containing tobacco, but also includes components, parts, and accessories of tobacco products, whether they are 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.

The U.S. FDA regulates tobacco products intended for consumption in the United States. Registrar Corp provides Registration, U.S. Agent, and Regulatory Compliance Assistance for U.S. and Non-U.S. Companies in the Tobacco Product Industry.

U.S. FDA Establishment Registration and Listing Requirements
U.S. FDA Registration and U.S. Agent Requirement
U.S. FDA registration is required for all facilities that manufacture, process, pack, or store tobacco products intended for use in the United States. Companies located outside the United States must designate a U.S. Agent for U.S. FDA communications. For assistance with U.S. FDA Tobacco Establishment Registration and Tobacco Product Listing regulations, simply click the Tobacco Certificate of Registration shown on the left.
   
Tobacco Product Labeling Review
Tobacco Label and Ingredient Reviews
Labeling mistakes result in more than 22% of all detentions in the United States. Registrar Corp helps companies modify their tobacco labeling to comply with U.S. FDA regulations. Registrar Corp provides revised graphic files ready to be printed or edited, and a report that details the regulations, compliance guides, warning letters, import alerts, and other guidance documents. To learn how U.S. FDA tobacco labeling regulations apply to your products, simply click the Notice of FDA Action shown on the left.
   
Certificate of Registration issued by Registrar Corp
Tobacco Certificate of Registration
Companies registered with U.S. FDA often are asked by their customers and suppliers to verify their U.S. FDA registrations. A Certificate of Registration issued by Registrar Corp serves as a third-party confirmation of your U.S. FDA registration. For more information, click the Tobacco Certificate of Registration shown on the left.




 
U.S. FDA Regulations:

U.S. FDA Tobacco Regulations: 21 C.F.R.












Registrar Corp assists businesses with U.S. FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. U.S. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the U.S. Food and Drug Administration.

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