Tobacco Products Regulatory Consulting Services
Various laws and regulations surround vape and tobacco product development to protect public health and combat smoking in young people and other vulnerable populations. However, we believe that the increased scrutiny placed on the tobacco and vape industry should not prevent trailblazing entrepreneurs from bringing an ethical and valuable vape or tobacco product to the market.
At JJCC Group, we’ll help you configure and ace all PMTA applications, show you how to submit product listings and ingredients listings, and offer HPHC guidance so that you can rapidly and thoroughly achieve full compliance for your vape or tobacco product.
We are focused on providing our clients with unparalleled guidance when it comes to meeting federal food and drug regulatory compliance standards. We’re here to make sure that the product you develop is functional, compliant, and ethical.
We’ll help you develop, manufacture, and achieve market approval for your:
- Vaping devices (such as vape pens).
- Vaping products (such as e-juice).
- Tobacco products (such as cigarettes or nicotine products).
- Tobacco devices (such as hookah pens).
Premarket Tobacco Product Applications (PMTA Applications)
Submitting a PMTA is the first step for someone seeking FDA approval for the development and marketing of a new tobacco product. According to the FDA, a PMTA “must provide scientific data that demonstrates a product is appropriate for the protection of public health.”
But what does this mean for you?
As you know, cigarette smoking, the use of vape products, and tobacco smoking can be dangerous to the public. At JJCC Group, we help you prepare, gather, and accurately present information such as the risks and benefits of your tobacco or vape product through your PMTA.
By assessing the information provided in your PMTA, the FDA will also address other important factors regarding your product that will potentially lead to the approval or rejection of your initial new product application, such as whether this product could help those who are currently vaping or using tobacco lessen their use, or whether or not this product could tempt non-tobacco users to begin using your vape or tobacco product. To approve your product, the FDA will also consider your methods of production and the way you will pack your new product.
Compliance officers view these applications under increasing scrutiny, which is where JJCC Group’s industry experts can help you avoid oversights and strategically communicate your product’s benefits, features, and vital information. Through our tried-and-true premarket tobacco application practices, we help you quickly attain FDA approval for your tobacco or vape product.
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.
Consumer Perception Studies: Tobacco & Vape Regulatory Compliance Consulting
Consumer perception matters. The way your consumers perceive your product and use your product will have an immense impact on your sales and influence the weightiest business decisions you make. Consumer perception studies connect you with your audience, allow you to have an unadulterated view into your targeted market, and help you become the most ethical seller of vape and/or tobacco products possible.
However, it can be difficult to understand how to design your consumer perception study without the help of seasoned professionals who have done so hundreds of times. That’s where JJCC Group regulatory compliance consultants are here to help you.
Track and record the way your potential customers perceive and interact with other vape and tobacco products on the United States market through a detailed and targeted consumer perception study. JJCC Group offers complimentary assistance with the planning and implementation of consumer perception studies to those looking to market their vape or tobacco product in the future. Read on to learn more about our services and how they can impact your business.
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.