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 Provisional Tobacco Products: that have been withdrawn from the FDA review process.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

More information on importing tobacco:

• CBP Seized My Tobacco Products as Drug Paraphernalia, Now What?
• E-Sigs Deemed Tobacco Under FDA New Proposed Rule
• The End of Vape Shops, Hookah Shops, And E-Cigs? FDA’s New “Deeming” Laws

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 U.S.C. 1595a(c), but those individuals bringing in the items are subject to a monetary penalty pursuant to 19 U.S.C. 1595a(b).   

Latest CIT Decisions Regarding Marijuana-Related Accessories 

There are two decisions by the Court of International Trade that have significant implications for importers of marijuana-related paraphernalia. The first case, Eteros Technologies v. United States, No. 21-00287, concerns the interplay between federal and state laws governing marijuana-related drug paraphernalia. Pursuant to 21 U.S.C. § 863, it is illegal under federal law to import, export, or sell drug paraphernalia, which includes items used to manufacture, plant, propagate, cultivate, grow, harvest, manufacture, compound, convert, produce, process, prepare, test, analyze, pack, repack, store, contain, or conceal controlled substances.  

In Eteros, the court granted the plaintiff’s motion for judgment on the pleadings and denied the government’s cross-motion, finding that the plaintiff’s products (which included vaporizers, grinders, and rolling papers) were not drug paraphernalia under federal law. The court noted that while the plaintiff’s products could potentially be used to consume marijuana, they were also commonly used for other legal substances, such as tobacco. Moreover, the court found that the plaintiff’s products were marketed and sold in compliance with state laws governing marijuana-related products, which suggested that the products were intended for lawful use. 

In Keirton U.S.A., Inc. v. United States, No. 21-00452, the court discussed exclusion from entry into the United States of “parts and components” used to manufacture a product called the “Twister Trimmer,” which is primarily used to process marijuana plants. The plaintiff, Keirton, challenged the denial of its protest of the exclusion by CBP. The court’s jurisdiction was pursuant to 28 U.S.C. § 1581(a), which grants the exclusive court jurisdiction over actions arising under federal customs law. The standard of review was de novo based on the record developed before the court. 

In Keirton, the court granted the plaintiff’s motion for judgment on the pleadings and denied the government’s cross-motion, finding that the exclusion of the plaintiff’s parts and components was not supported by substantial evidence. The court noted that CBP had relied on a letter from the Drug Enforcement Administration (DEA) that stated that the plaintiff’s products were “designed and marketed for use with marijuana.” However, the court found that the DEA’s letter did not provide any specific evidence that the plaintiff’s products were intended to be used with illegal drugs, and that the plaintiff had presented evidence that its products were used in the legal cultivation of hemp, which is a non-psychoactive strain of the cannabis plant. 

Conclusion 

The Esteros and Keirton cases highlight the complex legal landscape surrounding marijuana-related products, and the importance of careful compliance with federal and state laws governing these products.  

Importers of marijuana-related paraphernalia should: 

• consult with competent customs counsel prior to importation and at the pre-compliance stage to carefully review and comply with both federal and state laws governing their products, including any licensing or regulatory requirements, ensure that their products comply with applicable laws and regulations and consider taking proactive measures to mitigate the risk of customs seizures like requesting a CBP Binding Ruling prior to importation. 
• be aware of the potential risks of customs seizures at the time of importation. 

• be aware of the potential for CBP to rely on guidance, policy or letters from other federal agencies, such as the DEA, in making their determinations. 

If you have any questions about the importation of merchandise into the U.S., contact info@diaztradelaw.com. 

In response to the increase in enforcement discussed below, Diaz Trade Law is hosting a NEI accredited webinar, FDA – Is it a Cosmetic, a Drug, or Both? Mitigating FDA Enforcement Actions to train industry on top compliance tips to avoid enforcement, and best practices in responding to various FDA enforcement.

Why Should Industry Register for the Webinar?

Warning Letters in 2021:

• Just yesterday, FDA teamed up with the Federal Trade Commission (FTC) to publicly admonish 5 companies with warning letters for illegally selling dietary supplements claiming to treat infertility because FDA advised the products are unapproved drugs.
• Since the beginning of 2021, alone, the FDA has already issued 260 warning letters. 55 of those warning letters were issued against firms, including cosmetic firms, for selling unapproved drugs that are misbranded or adulterated or selling unapproved and misbranded products related to COVID-19.

Import Alerts in 2021:

• FDA has 208 active import alerts. Since the beginning of 2021, the FDA has already updated 74 import alerts to add new violators. 4 of the 74 import alerts are specifically for unapproved drug violations:

• FDA has updated Import Alert 66-41 a total of 274 times since the beginning of 2021, with the most recent update on May 6, 2021. This import alert lists 379 violative cosmetic products which are (because of their claims) unapproved drugs. This import alert will be discussed in detail at the webinar. The speedy increase in the number of firms subject to the this import alert indicates that manufacturers, importers, and distributors of cosmetic and over-the-counter drugs must review their labeling and pre-compliance protocols to avoid being targeted by the FDA.
• Important to note that on February 25, 2021, FDA published Import Alert 62-08, which allows for the “Detention Without Physical Examination of Alcohol-Based Hand Sanitizers Manufactured in Mexico.”

This one-hour webinar will provide an overview of FDA regulatory enforcement actions. Our international trade attorneys will discuss top labeling dos and don’ts to lower your risk of FDA enforcement, while offering best practices. You will learn about FDA regulations and laws pertaining to over-the-counter (OTC) drugs and cosmetics marketed in the United States. The presentation will discuss real case scenarios. The objective of the webinar is to teach manufacturers, importers, and the like, how to navigate FDA’s regulatory framework, provide TOP compliance tips to avoid FDA enforcement actions, and top strategies to implement when you are faced with an enforcement action.

Manufacturers, importers, distributors, and others engaged in the production or sale of Over the Counter (OTC) drugs or cosmetic products are encouraged to attend our one-hour webinar, “Is it a Cosmetic, a Drug, or Both? FDA Enforcement Actions” either live on June 9, 2021 at 12:00 PM, or on demand thereafter.

Diaz Trade Law’s president, Jennifer Diaz, accompanied by DTL’s Associate Attorney Denise Calle, will be our featured speakers. Importers, exporters, brokers, and others interested in trade policy are encouraged to attend. REGISTER HERE!

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.

What Constitutes Drug Paraphernalia?

In 2014, a smoke shop owner imported different merchandise from China described as “glass hookahs and parts”. The Central District of California considered these products, which were valued at $82,933.64 as drug paraphernalia and thus detained and seized the merchandise pursuant to 19 U.S.C. § 1595a(c) for violations of 21 U.S.C. § 863. The U.S. sued the shop owner and the Court concluded that “despite…[the] erroneous characterization of the merchandise as ‘hookah pipes’…they are bongs, and are therefore barred from entry into the United States.”

To determine whether the product is drug paraphernalia, the Court will not only consider the Code, but also other relevant factors such as the existence and scope of legitimate uses of the product in the community and expert testimony concerning its use. Under 21 U.S.C. Section 863(e), the following items are used to determine if a product is drug paraphernalia:

(1) instructions, oral or written, provided with the item concerning its use;

(2) descriptive materials accompanying the item which explain or depict its use;

(3) national and local advertising concerning its use;

(4) the manner in which the item is displayed for sale;

(5) whether the owner, or anyone in control of the item, is a legitimate supplier of like or related items to the community, such as a licensed distributor or dealer of tobacco products;

(6) direct or circumstantial evidence of the ratio of sales of the item(s) to the total sales of the business enterprise;

(7) the existence and scope of legitimate uses of the item in the community; and

(8) expert testimony concerning its use.

There is no requirement that the violator had specific knowledge that the merchandise constituted drug paraphernalia. United States v. 160 Cartons of Glass Water Pipes, Case No. CV 12-8965- BRO (VBKx) (C.D. Cal. Mar.  10, 2014).

What Must You Refrain From Doing?

• Sell or offer to sell drug paraphernalia
• Mail drug paraphernalia or transport it through interstate commerce
• Import or Export drug paraphernalia

REMEMBER: CBP is the federal agency that has control over everything that is imported and exported to/from the U.S. and therefore, they have the power to detain and seize your products when it constitutes drug paraphernalia. This will continue to happen until Congress decides to enact a Federal Law that allows marijuana consumption on a federal level or drug paraphernalia within the U.S.

What Do You Do if CBP Detains and/or Seizes Your Merchandise?

CBP has the power to detain persons or merchandise and make admissibility decisions. If CBP believes merchandise should be detained, it is required to send a Notice of Detention no later than five (5) business days from the day of examination. Often, the Notice of Detention does not specify the circumstances of the detention or is not even issued. It is important during this detention phase to communicate with CBP to discuss why your merchandise should not constitute drug paraphernalia and should be released.

CBP also has the ability to seize your merchandise if it is contrary to law and CBP will send a Seizure Notice, which you will have 30 days to respond, and typically we respond in the form of a Petition. Seizure cases are complicated, it is best to hire an expert who knows the policies, internal procedures and practices of U.S. Customs. Most importantly, getting involved early in the detention process is the best way to tackle this issue.

Want to Know if Your Product Will be Considered Drug Paraphernalia Prior to Importing?

Prior to importing your product, we recommend you review your product with an expert and determine whether to request a Binding Ruling from CBP. In CBP Ruling HQ H150766, an importer inquired on whether its hookah and hookah components constituted drug paraphernalia. The major issue CBP decided was whether the hookahs are “primarily intended” for use with drugs since it is considered a multiple-use item. CBP ruled that hookahs are admissible merchandise into the United States and held that they are not considered drug paraphernalia based on the weight of the evidence addressing the 8 criteria as set forth in 21 U.S.C. § 863, specifically its intended use for tobacco and not drugs.

If you have questions on whether or not your product constitutes drug paraphernalia and are interested in requesting a binding ruling, or if CBP has detained or seized your product, contact our office at info@diaztradelaw.com or (305) 456-3830 for assistance.

What Are Tobacco Products and What’s Being Regulated?

New Tobacco Products Regulated include: All cigars (premium and domestic), pipe tobacco, e-cigarettes, e-hookah, e-cigars, vape pens, advanced refillable personal vaporizers, electronic pipes, hookah tobacco, dissolvable tobacco products, and nicotine gels. As well as any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product. All of the above have been deemed tobacco products and are now subject to FDA regulation.

How Does FDA Regulations Affect Manufacturer, Distributor, Importer, and Retailer?

Under §1140.10; Each manufacturer, distributor, importer, and retailer is responsible for ensuring that the cigarettes, smokeless tobacco, or covered tobacco products it manufactures, labels, advertises, packages, distributes, imports, sells, or otherwise holds for sale comply with all applicable requirements under this part.

Hookah/Vape Shops Become Manufacturers.

An additional effect of the new deemed tobacco products by the FDA will consider, and regulate some retailers as manufacturer. Under §1140.3 manufacturer means any person, including any rapacker and/or relabeler, who manufactures, fabricates, assembles, processes, or labels a finished tobacco product. This means that retailers that mix e-liquids for e-cigarettes or vapor devices, that prepare, compounds or process tobacco products will meet the definition of tobacco product manufacturer.

Rules, Regulations, and Requirements for Tobacco Products   

Methods of Sale

In Person Sales

Under the FDA regulation retailers may only sell cigarettes or smokeless tobacco to:

• persons over the age of 18,
• whose age is verified by means of photographic identification containing the bearer’s date of birth,
• in a direct, face-to-face exchange without the assistance of any electronic or mechanical device.

Tobacco products regulation is slightly different. Retailers may only sell tobacco products to:

• persons over the age of 18,
• whose age is verified by means of photographic identification containing the bearer’s date of birth.

Internet Sales

Retailers may, however, sell tobacco products (not including cigarettes or smokeless tobacco) with the assistance of electronic or mechanical devises, if the retailer can ensure that no person younger than 18 years of age has access to it. This leaves the internet as a possible method of sale, as long as the retailer can ensure that no person under the age of 18 is allowed access. The FDA added a comment to this specific issue saying that it did not intended to prevent the sale of tobacco products over the internet, as long as it was to persons over the age of 18 only.

Vending Machine Sales

This also means, that a retailer may sell tobacco products with the use of a vending machine, if the retailer can ensure that no person under 18 is allowed in the area where the vending machine is located.

Warnings, Advertisement, And Packaging.

All tobacco product’s, other than cigars, packages must bear a required warning statement on the package label. “WARNING: This product contains nicotine. Nicotine is an addictive chemical.” Advertisements must display this warning in the ad as well, in order to be lawful. Both warnings (package and advertisements) are subject to FDA regulation and standards.

Cigars are subject to additional warnings, besides the nicotine warning. These warnings include warnings about cancers of the mouth and throat, warnings about lung cancer and heart disease, and warnings about smoking while pregnant. Advertisements of cigars must display this warning as well. Both Warnings are subject to FDA regulation and standards.

Warning Plan Required – Rotating: Cigars manufacturers, retailers, importers, and distributors must have a warning plan on how warnings will be randomly displayed, distributed on packages, and rotated on advertisements, this plan must be submitted to and approved by the FDA.

Additional Regulation for manufacturers

Pre-Market Review and Pathways

Just like manufacturers and importers of cigarettes, smokeless tobacco and roll your own tobacco, manufacturers and importers of the newly deemed tobacco products will need to comply with premarket review requirements.

There are three pathways to enter into the US newly deemed “tobacco” products, and its extremely important to keep in mind that pre-market review requirements will consistently include the predicate date (grandfather date) of February 15, 2007, which means, because your product was commercially marketed in the United States, without any modifications, as of February 15, 2007 you are therefore “grandfathered in” and are not a “new” product and therefore, don’t have to comply with one of the 3 pathways below:

1. Premarket tobacco product applications (PMTA – 24 months to submit your application),
2. Substantial Equivalence (SE – 18 months to submit your application) – Provide data to demonstrate that the characteristics of your new product are the same as the predicate that’s been on the market by or before February 15, 2007 (or differences don’t raise new questions of public health), or
3. Exemption from Substantial Equivalence (SE Exemption – 12 months to submit your application) – The importers and manufacturers of tobacco products that were on the market between the grandfathered date and August 8, 2016, will have to submit a substantial equivalence (SE exemption) request to keep their products on the market.

Compliance with the FDA can be complicated and exacting, especially if you have products already on the market and aren’t sure which pathway will apply to you and you want to make sure you meet your deadline to continue marketing your product. You’ll need to ensure you have an expert by your side to assist you through the process.  Diaz Trade Law specializes in compliance with the FDA and other regulatory government agencies – Call 305-456-3830 or email info@diaztradelaw.com today for a consultation!  Visit www.diaztradelaw.com for more information.