top of page
Search

FDA Updates “Import Alerts” to Reinforce CBP Detention of Unauthorized E-Cigarettes

clarkespositolaw

Effective January 3, 2025, the U.S. Food and Drug Administration (FDA) announced updates to two import alerts: 98-07 and 98-06 which U.S. Customs and Border Protection (CBP) will be enforcing. These reinforce FDA’s policies regarding unauthorized e-cigarette products and other tobacco products entering the United States.


Import Alert 98-07: Unauthorized E-Cigarette Products


FDA has strengthened its policies regarding unauthorized e-cigarette products to help prevent their importation into the United States. These changes provide additional clarity and resources for importers and federal enforcement agencies to identify and address unauthorized products. Key updates include:


  • All unauthorized e-cigarette products may be detained without physical examination and refused admission by FDA.

  • Links to FDA’s Searchable Tobacco Products Database and a downloadable list of authorized e-cigarette products are now available for guidance.

  • Pending Premarket Tobacco Production Applications (PMTAs) do not provide a legal safe harbor for unauthorized products.


Import Alert 98-06: Other Tobacco Products


In addition to e-cigarettes, FDA has updated its import policies for other tobacco products, including smokeless tobacco and nicotine pouches. These updates aim to ensure that only authorized products enter the U.S. market. Key updates include:


  • A focus on smokeless tobacco and nicotine pouches, including NOIS, LYFT, and SKRUF brands.

  • These products may also be detained without physical examination and refused admission by FDA.


Key Considerations


Compliance is critical to avoid penalties and enforcement actions. Ensure that all imported tobacco products have FDA authorization and that your operations align with federal regulations. Regularly consult FDA’s Searchable Tobacco Products Database for the most up-to-date information on authorized products and guidance for importers.


Accurate and complete declarations are essential. Work closely with your trade partners, including customs brokers, to review and confirm that all information submitted to regulatory agencies is precise and adheres to FDA requirements. Taking these steps can help prevent costly delays or enforcement actions.


We are always here to help. Our team is available to provide guidance and support in navigating these regulatory updates and ensuring compliance. If you have any questions or need assistance developing effective compliance strategies, please don’t hesitate to reach out to us. Your proactive approach to regulatory compliance helps protect your business and ensures smooth import operations.


Have questions? Give our office a call today at (917) 546-6997 or schedule an introductory call, we would be happy to speak with you.


Ready to Learn More About CBP, OFAC,

BIS, FWS, and FDA?


We have over one hundred videos in our educational library on our YouTube channel related to importing, exporting, US Customs, BIS, OFAC, FWS, FDA, NFTs, and so much more. Subscribe to our channel now to stay up to date on the latest on these topics!


Our law firm helps growing companies who import and export comply with government regulations. We love what we do and we take our oath of confidentiality over your matters very seriously. How much? Watch this video to learn about it. CLICK HERE 


 Wondering "why should you have an attorney on your side?" Click here to watch one of our attorneys, Susan Steinman, break down the critical benefits as to why you want to have one on your side - whether you hire us to help you or another law firm.


Have questions? We are determined to help you.

We listen carefully to clients to ensure our understanding of the legal issues at hand, their factual context, and any limitations that might impact a chosen strategy. Feel free to connect with us using the contact form at the bottom of the Home page or send us an email at contact@clarkespositolaw.com.  

Comments


How can we be of help?

New York Office:

211 E. 43rd Street, 7th Floor

New York, NY 10017

Connecticut Office:

9 Mott Ave., Suite 210

Norwalk,  CT 06850

917.546.6997

Stay Connected. Subscribe.

Thanks for subscribing!

  • YouTube
  • Instagram
  • LinkedIn
  • Facebook

Per The NY State Attorney Ethics Rules, See The Following Statement:

 

Attorney Advertising Disclaimer: The content of this website has been prepared by the Clark-Esposito Law Firm, P.C. for informational purposes only and should not be construed as legal advice. The material posted on this website is not intended to create, and receipt of it does not constitute, a lawyer-client relationship, and readers should not act upon it without seeking professional legal counsel. The Clark-Esposito Law Firm, P.C., did not produce and is not responsible for the content of off-site legal resources. The materials on this site may constitute advertising under various state ethics rules.

NYC, NYS, & PANYNJ M/WBE Certified Minority/Women Owned and Led Business

© 2024 by Clark-Esposito Law Firm, P.C.

bottom of page