Tobacco Product

Tobacco Products Regulatory Consulting Services

Developing vape and tobacco products is governed by a complex landscape of laws and regulations aimed at protecting public health and reducing youth access and use. While increased regulatory scrutiny has made market entry more challenging, we believe it should not stand in the way of ethical, innovative entrepreneurs who are committed to delivering responsible products.

At JJCC Group, we specialize in guiding clients through every step of the regulatory process. From configuring and submitting PMTA applications to preparing product and ingredient listings, and navigating HPHC requirements, we help you achieve full compliance efficiently and thoroughly.

Our mission is to provide unmatched support in meeting federal food and drug compliance standards. We’re committed to ensuring that your product is not only effective and market-ready but also compliant and ethically developed.

We offer expert support in the development, manufacturing, and regulatory approval of your:

Navigating the PMTA Process with Confidence

Submitting a Premarket Tobacco Product Application (PMTA) is a critical first step for any company seeking FDA authorization to market a new tobacco product in the United States. As outlined by the FDA, a PMTA must include comprehensive scientific data demonstrating that the product is “appropriate for the protection of public health.” This is a rigorous and complex process—but it’s one you don’t have to face alone.

At JJCC Group, our consulting services are designed to support you every step of the way. We help you understand and meet the FDA’s requirements, streamline the preparation of your application, and position your product for the best chance of approval.

Here’s how we support your PMTA journey:

  • Regulatory Strategy & Planning
    We begin by helping you map out a clear regulatory strategy tailored to your product, market goals, and timeline. Our team evaluates your current development stage and advises on next steps to align with FDA expectations.

  • Data Gap Analysis
    Our experts conduct a detailed review of your existing data to identify any gaps in scientific, toxicological, or behavioral research. We then outline a roadmap to gather the necessary evidence required for a complete PMTA submission.

  • Scientific & Technical Support
    We assist with compiling and presenting scientific evidence on product composition, health risks, user behavior, and manufacturing processes. This includes toxicological testing, HPHC (Harmful and Potentially Harmful Constituents) assessments, and any clinical or nonclinical data needed.

  • Document Preparation & Submission
    Our team ensures that every section of your PMTA is professionally prepared, technically sound, and fully compliant with FDA formatting and content standards. We manage the submission process from start to finish, including electronic submission setup via the FDA’s ESG system.

  • Ongoing Regulatory Liaison
    Even after submission, we act as your liaison with the FDA, handling any information requests, amendments, or post-submission updates that may be required.

  • Post-Authorization Support
    If your product is authorized, we continue to support you with guidance on marketing requirements, compliance monitoring, and future updates or renewals.

With JJCC Group by your side, you gain a trusted regulatory partner committed to helping you bring responsible, compliant tobacco products to market. Our goal is to remove the guesswork, reduce delays, and give your PMTA the best possible chance of success.

Harmful and Potentially Harmful Constituents (HPHCS) Guidance

The FDA requires that all vape and tobacco manufacturers report the exact levels of harmful and potentially harmful ingredients
found in their products. These ingredients may include chemicals in your product or your product’s byproduct (such as smoke) that could cause significant harm to people that use your product.

In the world of vaping and tobacco use, HPHCs are almost unavoidable. Therefore, the best practices for all vape and tobacco products is to be transparent and honest in all stages of planning, development, and market dispersion while not underestimating the value your product could bring to the United States market.

Partner with JJCC Group – we will help you seamlessly plan, develop, and implement your vape or tobacco product while abiding by all necessary regulatory compliance requirements.

Consumer perception study and clinical study.

Understanding Consumer Perception is Essential to Your Success

Consumer perception isn’t just a marketing metric—it’s a driving force behind product success, sales performance, and long-term brand strategy. How your audience views and uses your vape or tobacco product can influence critical business decisions and shape your position in the marketplace.

Conducting a consumer perception study provides valuable insights into your target market. It allows you to see your product through the eyes of potential customers, uncover unfiltered feedback, and make informed, ethical decisions about product development, marketing, and positioning.

But designing an effective consumer perception study isn’t easy—especially without the guidance of experts who have done it successfully time and again. That’s where JJCC Group comes in.

As experienced regulatory compliance consultants, we help you plan and execute tailored consumer perception studies that meet both regulatory expectations and business goals. Our team will guide you in capturing how U.S. consumers perceive, understand, and interact with your product—and how it compares to others on the market.

Our services include:

  • Study design and objective setting

  • Target audience identification and recruitment

  • Survey development and testing methodology

  • Data collection, analysis, and interpretation

  • Compliance with FDA expectations for PMTA submissions

We’re proud to offer complimentary assistance with the planning and implementation of consumer perception studies for companies preparing to bring vape or tobacco products to market. With JJCC Group, you gain not only regulatory insight but also a deeper understanding of your consumers—helping you build a better, more compliant product.

Ready to connect with your audience in a meaningful way?
Contact us to learn how a consumer perception study can drive smarter decisions and support your path to market success.

FAQ

To obtain a marketing order for a tobacco product, the FDA requires a consumer perception study as a part of the statutory requirement of the Premarket Tobacco Product Application (PMTA). Besides being a prerequisite for the marketing of your tobacco or vape product and a requirement of the Premarket of Tobacco Product (PMTA), a consumer perception study will help you and your organization get a crystal-clear vision of the way the public consumes products like yours and perceives your product.

A consumer perception study is a methodical evaluation designed to collect knowledge of your consumer’s perception of the risks associated with tobacco and vape products. This evaluation addresses peoples’ interest in and intentions to use a tobacco or vape product. It even includes populations of non-users of tobacco products (including vulnerable populations such as youth and young adults).

The consumer perception study consists of qualitative and quantitative research conducted with various groups of consumers, including current and former adult tobacco users, young adult tobacco users and adolescents who either use tobacco or are susceptible to tobacco use initiation. Your consumer perception study should include significant scientific evidence supporting the fact that the marketing of your tobacco or vape product doesn’t disrupt the overall protection of public health (AHHP).

The clinical study of a tobacco product should include an evaluation of the pharmacokinetics of nicotine in an in-vitro study. Your study should consider the addictiveness and abuse potential of your new product and the users’ exposure to nicotine while using your product.

In this study of tobacco products, J&J CC Group evaluates tobacco use behavior among multiple individuals, placing emphasis on recording and understanding the likelihood of initiation and cessation of your product among smokers and non-smokers.

In your consumer perception study, JJCC Group will gather tobacco product use patterns into a topography study, thus allowing us to demonstrate how individual users consume your product (such as the number of puffs one takes, one’s puff duration, one’s puff intensity, and overall duration of one’s use). The consumer perception study also serves to record the frequency with which consumers use the product and the trends by which users consume the product over time.

At JJCC Group, our scientists and researchers work with CRO and IRB licensing facilities to design and execute all the protocols for the clinical and non-clinical studies that meet the FDA requirement as described in the PMTA guidance.

Allow JJCC Group’s vape and tobacco regulatory compliance consultants to assist you in the creation and implementation of your consumer perception study. Our strategic methods will expedite your FDA pre-marketing approval process and increase your likelihood of attaining PMTA approval from the FDA. We are ready and willing to answer any and all questions you have today. Be sure to call us at (800) 988-1712 to speak to one of our friendly consultants.