Why Do I Need a Consumer Perception Study for a Tobacco Product?

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.

What is a Consumer Perception Study?

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).

Description of a Clinical Study for a Tobacco or Vape Product

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.

What Happens During the Tobacco Study?

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.

FDA PMTA Consulting Service

Premarket of Tobacco Products

JJCC Group guides tobacco and vape companies through FDA PMTA applications, product listings, and HPHC compliance efficiently and reliably.

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1 (800) 999-7781

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Tobacco Compliance

Every new tobacco product needs FDA marketing authorization

A tobacco product not on the U.S. market as of Feb 15, 2007 needs an FDA marketing order before it can be sold. That includes e-cigarettes, e-liquids, nicotine pouches, cigars, hookah and heated tobacco. Since April 2022 it also includes synthetic and other non-tobacco nicotine. Our founder has spent the last six years preparing PMTAs for ENDS companies, working with scientists, engineers, toxicologists and medical advisors.

PMTA Guidance

Navigating the PMTA Process with Confidence

Submitting a PMTA is a crucial step for FDA authorization. JJCC Group guides you through every requirement, ensuring scientific compliance and maximizing approval chances efficiently.

Premarket Tobacco Product Application (PMTA)

New products with no suitable predicate, including most ENDS

01/

Section 910(b)

Substantial Equivalence (SE) report

New product equivalent to a predicate on market Feb 15, 2007 or found SE

02/

Section 905(j)

SE exemption

Minor additive change to a legally marketed product

03/

Section 905(j)(3)

Modified Risk Tobacco Product (MRTP)

You want to claim reduced risk or exposure

04/

Section 911

Ongoing Regulatory Liaison

We act as your FDA liaison after submission, handling information requests, amendments and all post-submission requirements efficiently.

05/

Post-Authorization Support

If authorized, we continue supporting marketing compliance, and future updates, ensuring regulatory adherence and smooth operations.

06/

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

Consumer Insights

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.

Core Services

Your Partner in PMTA Success

At J&J Compliance Consulting Group, we specialize in guiding clients through every stage of the PMTA (Premarket Tobacco Product Application) process with precision, regulatory insight, and a personalized approach. Our goal is to ensure your submission is not only complete, but strategically positioned for FDA approval.

Establishment registration and product listing

(section 905).

Ingredient listing and HPHC reporting

(section 904).

Required warnings

under 21 CFR Part 1143, including the nicotine addiction warning.

Sales and marketing restrictions

under 21 CFR Part 1140, including the federal minimum age of 21.

Postmarket reports

required by your marketing order.

Pathway strategy

and data gap analysis.

PMTA and SE preparation

module by module. See our FDA PMTA Application page.

Consumer perception and intention studies

See Tobacco Consumer Perception Research.

Toxicology, HPHC testing plans

Complete Guide to Vape and Tobacco Compliance Standards

Regulatory Guidance

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.

Best Compliance with 5 Star

99% Happy Clients

Testimonial

What our clients say about JJCC Group

Our clients trust JJCC Group for expert MoCRA compliance guidance, efficient FDA registration, and accurate cosmetic regulatory support worldwide.

Professional guidance and clear communication from JJCC Group made our PMTA process completely stress-free.

Sarah Bennett OWNER

Thanks to JJCC Group, our vape product fully complied with HPHC reporting and labeling requirements.

Bts Ashik OWNER

JJCC provided detailed analysis and guidance, making our PMTA submission complete, accurate, and FDA-ready.

Shadin De Manager

Faqs

Frequently Asked Questions

JJCC Group answers your most common queries about PMTA submissions, HPHC reporting, and tobacco product compliance. Learn how our experts guide you through regulatory processes, consumer perception studies, and FDA requirements. We help ensure your products meet all federal standards efficiently, reduce risks, and achieve successful market authorization.

Which products does FDA regulate as tobacco products?

Cigarettes, cigars, smokeless, pipe and hookah tobacco, e-cigarettes and e-liquids, nicotine pouches, heated tobacco and their components and parts.

Does FDA regulate synthetic nicotine?

Yes. Since April 14, 2022, products with nicotine from any source, including synthetic nicotine, are tobacco products under FDA’s authority.

Does every new tobacco product need a PMTA?

No. A PMTA is one of three premarket pathways. Some products qualify for an SE report or an SE exemption instead.

What is the Feb 15, 2007 date?

Products on the U.S. market on that date are “grandfathered” and need no premarket review. They can also serve as predicates for SE reports.

What is substantial equivalence?

An SE report shows a new product has the same characteristics as a predicate, or different ones that raise no different public health questions.

Can vapes use the SE pathway?

In practice, rarely. No e-cigarette was on the market in 2007 in a form that works as a predicate, so ENDS products use PMTAs.

What does FDA issue when it authorizes a product?

A marketing granted order for a PMTA or an SE order for an SE report. FDA does not “approve” tobacco products.

What is a marketing denial order?

An MDO means FDA found the application did not show the product is appropriate for the protection of public health. The product cannot be sold.

Do tobacco establishments register with FDA?

Yes. Manufacturers register their establishments and list their products with FDA, and update listings as products change.

What are HPHCs?

Harmful and potentially harmful constituents. Manufacturers report quantities of listed HPHCs in their products to FDA.

What warnings do vapes need?

The nicotine addiction warning on packages and ads, covering at least 30% of the two principal display panels, under 21 CFR Part 1143.

Is there a tobacco GMP rule?

FDA proposed tobacco product manufacturing practice requirements in 2023 but has not finalized them. We build systems that will meet them.

Can retailers sell unauthorized products?

No. Retailers, distributors and importers face enforcement for selling products without a marketing order.

Can I claim my product is less harmful?

Only with an MRTP order under section 911. Implied claims such as “safer” or “cleaner” also require one.

Do you help with markets outside the U.S.?

Yes. We prepare EU TPD and UK notifications and review labels for those markets.

How do we get started?

Book a free pathway assessment. We will tell you which pathway fits and what data you already have.

Why Choose a Dedicated PMTA Consulting Service

The Regulatory Landscape for Tobacco Product Manufacturers

Since the passage of the Family Smoking Prevention and Tobacco Control Act, the FDA has held broad authority to regulate the manufacturing, marketing, and sale of tobacco products in the United States. This landmark legislation extended the agency’s oversight beyond traditional cigarettes to include electronic nicotine delivery systems, cigars, and other emerging product categories. For tobacco product manufacturers, this means that no new product, whether a disposable vape, an e-liquid, or a next-generation heated tobacco device, can legally enter the U.S. market without first securing authorization through a Premarket Tobacco Product Application (PMTA).

Given the scientific, technical, and administrative complexity involved, most companies find that working with an experienced PMTA Consultant is not simply helpful, but essential. The application requirements span toxicology, environmental science, behavioral research, manufacturing documentation, and ongoing post-market obligations. A single missing data set or improperly formatted submission can result in a Refuse to Accept letter, months of delay, or an outright denial. This is where a specialized PMTA Consulting Service like JJCC Group becomes a critical partner rather than an optional resource.

What Sets an FDA PMTA Consultant Apart

Not all regulatory advisors are created equal. An effective FDA PMTA Consultant brings together deep familiarity with FDA guidance documents, hands-on experience assembling successful submissions, and the scientific literacy needed to interpret and respond to agency feedback. At JJCC Group, our team combines Tobacco Regulatory Consulting expertise with direct experience in Premarket Tobacco Product Application development, giving clients a single point of contact for every stage of the process, from early feasibility assessments through post-authorization compliance.

Our approach to PMTA Regulatory Strategy Consulting begins long before a single document is drafted. We evaluate your product’s formulation, intended use, and target population, then map out the specific data packages the FDA will expect to see. This proactive strategy reduces wasted research spend, shortens submission timelines, and significantly improves the odds of a favorable outcome. For companies entering the vape category specifically, our Vape PMTA Consulting services address the unique behavioral and toxicological questions that arise with electronic nicotine delivery systems, including device performance, e-liquid formulation, and aerosol chemistry.

Supporting the Full Spectrum of the Tobacco Industry

The tobacco industry today looks vastly different than it did even a decade ago. Traditional combustible product manufacturers now share the regulatory stage with e-liquid formulators, hardware innovators, and companies developing novel nicotine delivery formats. Regardless of where your business fits within this evolving landscape, the core expectation remains the same: any Tobacco Product Application PMTA filing must demonstrate that authorizing the product would be appropriate for the protection of public health.

JJCC Group works with manufacturers across this full spectrum, tailoring our Tobacco Regulatory Consulting services to the specific risk profile and market position of each client. We understand that a small, independent e-liquid brand faces different resource constraints than a multinational tobacco product manufacturer, and we structure our engagement models accordingly—offering scalable support whether you need comprehensive, end-to-end PMTA development or targeted assistance with a single compliance gap.

Ultimately, our goal as your PMTA Consulting Service is to remove the guesswork from an inherently complex regulatory process. By pairing scientific rigor with practical, business-minded strategy, JJCC Group helps tobacco and vape companies move through FDA review with clarity, confidence, and a stronger likelihood of success.