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 Provisional Tobacco Products: that have been withdrawn from the FDA review process.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

By |2024-04-05T11:28:15-04:00April 2, 2024|Tobacco, U.S. Food and Drug Administration (FDA)|Comments Off on FDA Unveils Searchable Tobacco Products Database to Bolster Compliance and Transparency

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 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 19 […]

By |2023-03-10T12:04:07-05:00March 10, 2023|E-Cigarette, Export, Import, Seizures, Tobacco, U.S. Court of International Trade, U.S. Customs and Border Protection (CBP)|Comments Off on New Court Rulings on Marijuana-Related Paraphernalia: Understanding the Impact on Importers

Customs and Trade Law Weekly Snapshot

Here is a recap of the latest customs and international trade law news:

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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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By |2021-07-22T11:27:59-04:00May 27, 2021|Cosmetics, E-Cigarette, Food, FSMA, Gluten Free, Import, Import Alert, International Trade, Medical Devices, Pre-compliance, Reasonable Care, Tobacco, U.S. Food and Drug Administration (FDA)|Comments Off on Don’t be a Target, Learn Best Practices to Mitigate FDA Enforcement

Drug Paraphernalia, Priority Trade Initiatives, & Forced Labor

You don’t want to miss this one!

What: Drug Paraphernalia, Priority Trade Initiatives, & Forced Labor – An Update on CBP Enforcement

When: November 27th, 2018, 12:00PM-1:00PM EST

RSVP TODAY!

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By |2021-10-29T15:19:47-04:00November 13, 2018|Best Practices, Customs Broker, Events, Import, Import Alert, International Law, International Trade, Penalty, Seizures, Tobacco, U.S. Customs and Border Protection (CBP)|Comments Off on Drug Paraphernalia, Priority Trade Initiatives, & Forced Labor

HELP! CBP Seized My Tobacco Products as Drug Paraphernalia, What Now? / ¡AYUDA! CBP INCAUTO MIS PRODUCTOS DE TABACO COMO PARAFERNALIA DE DROGAS, ¿AHORA QUÉ HAGO?

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?

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By |2021-11-09T13:50:03-05:00May 30, 2017|Best Practices, Customs Broker, E-Cigarette, Import, Import Alert, International Travel, Seizures, Tobacco, U.S. Customs and Border Protection (CBP), U.S. Department of Homeland Security (DHS), U.S. Food and Drug Administration (FDA)|Comments Off on HELP! CBP Seized My Tobacco Products as Drug Paraphernalia, What Now? / ¡AYUDA! CBP INCAUTO MIS PRODUCTOS DE TABACO COMO PARAFERNALIA DE DROGAS, ¿AHORA QUÉ HAGO?

The End of Vape Shops, Hookah Shops, & 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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World Trade Month – Business Opportunities with Cuba – May 14, 2015 – #OWITonCuba

CUBA1
Are you in South Florida and thinking of doing business with Cuba? Do you want to hear from those already successfully doing business with Cuba? Do you want to fully understand what is legal now?
May 14, 2015, I have JUST the event for you! This is your LAST CHANCE to register!

[…]

By |2019-10-21T08:45:46-04:00May 11, 2015|Best Practices, Cuba, Events, Export, Import, OWIT, Speaking, Tobacco, U.S. Office of Foreign Assets Control (OFAC)|Comments Off on World Trade Month – Business Opportunities with Cuba – May 14, 2015 – #OWITonCuba

White House’s OMB Intervenes to Weaken FDA’s Proposed Regulation of E-Cigs

On April 24, 2014, the U.S. Food and Drug Administration’s (FDA) issued a proposed regulation which would subject the currently unregulated e-cigarette industry to FDA regulation under the authority of the Federal Food, Drug and Cosmetic Act (FD&C Act). The proposed rule put e-cigarettes with a list of products FDA “deemed” tobacco products, and as such, subject to the FD&C Act. OMB intervened to weaken FDA’s original proposal.

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By |2021-11-09T15:01:39-05:00July 1, 2014|E-Cigarette, Import, Tobacco, U.S. Food and Drug Administration (FDA)|Comments Off on White House’s OMB Intervenes to Weaken FDA’s Proposed Regulation of E-Cigs

E-Cigs “Deemed” Tobacco Under New FDA Proposed Rule

On April 24, 2014, the U.S. Food and Drug Administration (FDA) announced what some call a “long- awaited” proposed regulation that will impact the future of the currently booming e-cigarette industry.  Currently, e-cigarettes are not a part of FDA’s purview and have no FDA oversight – FDA’s proposed rule intends to change this in a big way.

How is Tobacco Defined Currently?

Section 201(rr) of the Federal Food, Drug and Cosmetic Act (FD&C Act), (21 U.S.C. 321(rr)),as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), currently defines the term “tobacco product,” as ” any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product… “.

The Tobacco Control Act permitted FDA to regulate cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco automatically as “tobacco product” under the FD&C Act.

Section 901 of the FD&C Act  gives the FDA leeway to include “any other tobacco products that the Secretary by regulation deems to be subject to this chapter” and therefore subject to FDA regulation under the FD&C Act.

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By |2021-11-09T15:05:13-05:00April 25, 2014|Tobacco, U.S. Food and Drug Administration (FDA)|Comments Off on E-Cigs “Deemed” Tobacco Under New FDA Proposed Rule
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