FDA Regulations Support for Tobacco and Related Products
Successfully navigate the complex regulations around tobacco and related products — so you can take your business to the top
Navigate the Complex FDA Regulations and Compliances with Us
Navigating the complex landscape of FDA regulations for tobacco, e-cigarettes, nicotine pouches, hookah, and related products can be challenging. Our firm specializes in providing tailored legal solutions to help you comply with these regulations effectively.
The Tobacco Control Act regulates disclosure, labeling, manufacturing, distribution, advertising, modified risk, and safety data requirements. Ensure you have detailed knowledge of FDA regulations to successfully market and sell your products.
We can support you in obtaining an STN. A Submission Tracking Number or STN is becoming a critical part of successfully importing tobacco products, such as vape devices. An STN can serve as proof that a tobacco product is currently pending review by the Food and Drug Administration's Center for Tobacco Products. Tobacco products imported or offered for import into the United States must comply with all the applicable requirements of the FDA’s laws and regulations.
A submission tracking number for a tobacco product typically refers to a unique identifier assigned to a specific submission made to the U.S. Food and Drug Administration (FDA) as part of the premarket review process for tobacco products. When a manufacturer or distributor submits an application or notification to the FDA regarding a tobacco product, it is assigned a tracking number to facilitate the tracking and processing of the submission.
Need help filing a PMTA or determining if your PMTA Exempt? A Premarket Tobacco Application (PMTA) is required for all new tobacco products. The only exception is if a tobacco product is PMTA Exempt, which applies to a small subset of tobacco products.
At FDA Atty, our goal is to empower our clients with our expertise. We help tobacco companies gain compliance in several FDA tobacco regulations:
- PMTAs
- Identifying PMTA Exemptions
- Obtaining an STN
- Ingredient, additive, and harmful and potentially harmful constituent disclosure requirements
- Health document submissions
- Good Manufacturing Practice guidance
- Substantial Equivalency determinations and exemptions
- Modified Risk Tobacco Product Applications
- Labeling requirements
- Retailer compliance issues
- Tobacco product testing requirements
Get rid of the anxiety around ensuring compliance. We focus on the FDA regulations for you, ensuring your business meets the requirements.
How We Help
Services
Are you in trouble with the FDA?
Don’t panic — you’ve got backup. Download 5 Tips to Help You Navigate FDA Enforcement and learn how to resolve the situation now.
Expert knowledge of FDA regulations that helps you strategically grow your business
Legal Services for Compliance with FDA Regulations
Our firm provides comprehensive legal services to address all aspects of FDA compliance:
- Tobacco Regulations
- E-cigarette Regulations
- Nicotine Pouch Compliance
- Heated Tobacco Regulations
- Smokeless Tobacco Compliance
- Vape Product Regulations
Legal Representation for FDA Compliance
We offer expert legal representation to guide you through regulatory compliance processes and address any legal challenges.
Guidance on Regulatory Submissions
Our team provides detailed guidance on preparing and submitting regulatory documents to the FDA.
Defense in Compliance Enforcement Actions
In the event of an enforcement action, we offer defense strategies to protect your interests and resolve compliance issues effectively.
Why Choose Us for Your Legal Needs?
- Expertise in FDA Regulations: With a deep understanding of FDA regulations, we provide specialized legal advice to navigate the complex regulatory environment.
- Comprehensive Legal Services: We offer a full range of services, from regulatory guidance to defense in compliance actions, ensuring all legal needs are covered.
- Commitment to Client Success: Our client-centered approach focuses on achieving successful outcomes and ensuring your business complies with all regulatory requirements.
“