Regulatory Consulting for Tobacco Products

At J&J Compliance Consulting Group, we deliver expert regulatory solutions tailored to tobacco and nicotine product manufacturers seeking FDA approval. With a specialized focus on PMTA submissions, we provide end-to-end guidance—from strategic planning and scientific documentation to post-submission support—ensuring your product meets the highest standards of regulatory compliance.

Our unique value lies in our ability to combine scientific precision, regulatory expertise, and industry insight to deliver faster, stronger, and more successful submissions.

We understand the high stakes of FDA regulation—delays, rejections, or deficiencies can cost valuable time and resources. That’s why we act as an extension of your team, helping you navigate every detail of the PMTA process with confidence and clarity. From strategic planning and scientific data generation to submission assembly and post-filing support, we ensure your product is well-positioned for regulatory success.

Our value lies in precision, efficiency, and proven expertise:

• Comprehensive PMTA Strategy — We create tailored, data-driven regulatory strategies aligned with your product’s unique profile and current FDA requirements.
• Scientific & Technical Excellence — Our team brings deep expertise in toxicology, chemistry, behavioral science, and manufacturing compliance to build robust PMTA submissions.
• Regulatory Navigation — We simplify complex FDA processes, reducing your risk of delays, deficiencies, or denials.
• End-to-End Support — From initial gap assessments to managing FDA feedback, we remain your regulatory partner through every stage of the PMTA journey.

Whether you’re introducing a new ENDS product, modern oral nicotine pouch, or any other tobacco product, we empower your team with the clarity, structure, and confidence needed to achieve FDA authorization.

What sets us apart:

• Proven track record in successful PMTA strategies and submissions
• Deep understanding of FDA expectations and compliance frameworks
• Tailored, science-backed solutions for tobacco, e-vapor, oral nicotine, and alternative nicotine products
• Ongoing support through audits, FDA communications, and evolving compliance needs

Our mission is simple: To accelerate your path to market authorization while minimizing regulatory risk. Let’s get your product to market—compliantly and confidently.