The U.S. FDA’s Center for Tobacco Products (CTP) regulates tobacco and electronic nicotine delivery systems (ENDS), including e-cigarettes. Manufacturers, importers, and distributors must comply with rigorous regulatory requirements to legally market their products in the United States. Compliance ensures both legal market access and alignment with public health objectives.

At XPRO AMERICA, we provide end-to-end guidance and support for companies in the tobacco and e-cigarette sector, assisting with registration, premarket submissions, and labeling compliance.

Key Services:

• Tobacco Product Manufacturer Registration: All domestic and foreign tobacco product manufacturers must register with the FDA CTP. XPRO AMERICA manages the registration process, ensuring timely and accurate submission of facility and product information.
• Premarket Tobacco Product Applications (PMTA): New tobacco products require a PMTA demonstrating that marketing the product is appropriate for the protection of public health. Our experts assist in preparing scientific, technical, and regulatory documentation to support successful PMTA submission.
• Substantial Equivalence (SE) Applications: For products similar to those already marketed, SE applications provide a faster route to compliance. We guide clients in identifying predicate products, preparing comparisons, and compiling supporting data for FDA review.
• Warning Label & Advertising Compliance: FDA mandates specific health warnings, ingredient disclosures, and marketing restrictions for tobacco products and e-cigarettes. XPRO AMERICA reviews product labels, packaging, and promotional materials to ensure alignment with CTP regulations, reducing the risk of enforcement actions.
• Regulatory Strategy & Consultation: Our team offers strategic advice on FDA interactions, submissions, and ongoing compliance, helping manufacturers anticipate changes in regulatory expectations and maintain market access.

Why Choose XPRO AMERICA?

• Proven expertise in FDA CTP regulations and tobacco product compliance.
• Comprehensive support from facility registration to PMTA and SE submissions.
• Detailed review of labels, advertising, and marketing strategies to meet FDA standards.
• Minimizes regulatory risk and streamlines U.S. market entry.

Partnering with XPRO AMERICA allows tobacco and e-cigarette companies to navigate complex FDA requirements efficiently, ensuring regulatory compliance while focusing on innovation and market growth. Our structured approach ensures timely submissions, accurate labeling, and ongoing adherence to CTP guidelines.

XPRO AMERICA supports tobacco and e-cigarette companies with CTP registration, PMTA, SE applications, and labeling & advertising compliance.