Last week, FDA’s Center for Tobacco Products (CTP) announced the release of its Searchable Tobacco Products Database. This tool provides easy access to a list of legally marketable tobacco products within the United States, integrating a user-friendly design with sophisticated search functionalities, making navigation and information retrieval very easy. The FDA has committed to monthly updates, ensuring the availability of current and accurate product information.

FDA categorizes listed tobacco products into three groups:

  1. New Tobacco Products: products that have successfully navigated through one of the FDA’s pathways for new tobacco product market authorization.
  2. Pre-existing Tobacco Products: Identified through a voluntary determination program, these products were commercially available as of February 15, 2007.
  3. Provisional Tobacco Products: that have been withdrawn from the FDA review process.

The database fosters enhanced transparency that aligns with the needs particularly of retailers, to empower stakeholders to better meet regulatory requirements. It encompasses nearly 17,000 tobacco products, including more than 12,000 Pre-existing Tobacco Products category. The database provides detailed information for each listed product, including the product name, manufacturer, categorization, the statutory or regulatory basis for its marketability in the U.S., and the specific date of the FDA’s decision. It also provides access to an array of regulatory and scientific documents associated with the tobacco product application, including Order Letters, Decision Summaries, Environmental Assessments (EAs), and their related documentation.

FDA has also introduced a supplementary resource, the Searchable Tobacco Products Database – Additional Information, designed to demystify the terminology and contextual background of the database content. It includes clarifications on frequently asked questions, (including addressing the issue of unauthorized products with pending applications).

FDA regards this database as a key component of its broader initiative to enhance transparency and provide clear, actionable information to both regulated industry and the public. The launch of the Searchable Tobacco Products Database demonstrates FDA’s ongoing commitment to ensuring informed compliance within the tobacco industry, fostering a transparent and informed regulatory environment.

Diaz Trade law has significant experience in FDA pre-compliance as well as assistance in successfully navigating FDA enforcement actions. We provide FDA compliance assistance for tobacco, food, dietary supplements, alcoholic beverages, over-the-counter drugs, cosmetics, and medical devices. Get in touch with us at info@diaztradelaw.com.

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