FDA Unveils Searchable Tobacco Products Database to Bolster Compliance and Transparency

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 Provisional Tobacco Products: that have been withdrawn from the FDA review process.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 […]

New Court Rulings on Marijuana-Related Paraphernalia: Understanding the Impact on Importers

The marijuana industry is rapidly growing, with more and more states legalizing its use for medical and/or recreational purposes. With this growth, there is an increase in the importation of products such as grinders, storage containers, rolling paper, pipes, and vape pens, both for business and personal use. More businesses are asking why there is an issue importing such items when they only intend to sell and distribute within the many states where marijuana is legal for medical or recreational use and have established their regulations for marijuana-related products. It is still essential to remember, while many states have legalized marijuana for medical or recreational use, marijuana remains illegal under federal law. 

This blog will address recent Court of International Trade (CIT) cases on this very topic and will be a part 2 to our previous blog covering U.S. Customs and Border Protection (CBP) seizures of drug paraphernalia 

CBP Authority 

CBP has the power to seize “drug paraphernalia” products.  This does not only cover importations of products for commercial use, but also items for personal use with individuals traveling internationally seeking entry into the United States.  CBP’s website section: Know Before You Go – Prohibited and Restricted Items encourages individuals to contact CBP prior to traveling and make sure that prohibited or restricted items, such as drug paraphernalia, are not brought into the country, as they are not only subject to seizure pursuant to […]

Don’t be a Target, Learn Best Practices to Mitigate FDA Enforcement

The U.S. Food and Drug Administration (FDA) is in full enforcement mode issuing 260 warning letters in 2021 alone! Now is the time to ensure your products are in compliance with the Federal Food, Drug, and Cosmetic Act (the Act) prior to importation. Manufacturers, importers, distributors, and others engaged in the production or sale of over the counter (OTC) drugs or cosmetic products must be aware of FDA’s various enforcement mechanisms, and more importantly,  how to avoid and/or mitigate such actions.  FDA’s most common enforcement activities include notices of FDA action, warning letters, seizures, voluntary recalls, injunctions, and criminal prosecution.

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HELP! CBP Seized My Tobacco Products as Drug Paraphernalia, What Now?

Our office has increasingly received requests for guidance on importation of marijuana paraphernalia products to the U.S. where twenty-six (26) states have legalized the use of marijuana for medical purposes and/or personal consumption such as California, Massachusetts, Maine and Nevada. The purpose of this article is to dispel the confusion as to why paraphernalia products (grinders, storage containers, rolling paper, pipes, vape pens, etc.) are continuously being seized by U.S. Customs and Border Protection (CBP), even when such products may be used by tobacco smokers. It is important to address the realities between federal and state laws regulating drug paraphernalia products so importers can avoid CBP’s enforcement of U.S. Laws.

Why Does CBP Stop Drug Paraphernalia?

  • CBP secures America’s borders at and between ports of entry by stopping inadmissible people and illicit goods. The Tariff Act of 1789 provides one of CBP’s core functions: to act as the leading federal agency in determining the admissibility of goods that may enter the Commerce of the United States. Even though each State has internally legalized marijuana either for medical or recreational purposes, CBP still has the express power to authorize or not any merchandise that comes into the U.S. Thus, CBP can detain and seize “drug paraphernalia” even if you did not intend to use the product that purpose pursuant to 19 U.S.C. § 1595a(c) stating a violation of 21 U.S.C. § 863.

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The End of Vape Shops, Hookah Shops, And E-Cigs? FDA’s New “Deeming” Laws

On April 24, 2014, the U.S. Food and Drug Administration(FDA) announced that it was officially “deeming” e-cigs, e-hookah, vape pens, and other tobacco products subject to the Federal Food, Drug, and Cosmetic Act (FD&C Act). This article covered the proposed regulation at the time. On May 10, 2016 the FDA published the final rule on the new deeming law.

What Are Tobacco Products and What’s Being Regulated?

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