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How Does the PMTA Regulation Affect the Vaping Industry?
Jul 20,2022

Current situation of tobacco product supervision

Tobacco products are one of the most heavily regulated in the United States and the FDA has imposed several rules and requirements that tobacco and vaping companies must follow to operate. For e-cig companies, the Premarket Tobacco Product Application (PMTA) has impacted various aspects of the industry; this article will explore three of these effects.

1. The PMTA acts as a barrier to industry entry

The PMTA demands stringent quality standards for every component and e-juice of each device, especially for e-juices. For instance, the FDA will assess toxicological and addictive effects, chemical and physical identity, and quantities of aerosol emissions of e-liquids. As a result, any company which has the confidence to apply for e-liquid under the PMTA can be seen as one of the industry's highest for quality. If a PMTA for e-liquid is successfully obtained, this may be viewed as getting a "monopoly certificate" for producing e-liquid. In the past two years, fewer companies have applied for e-liquid PMTA, with successful applicants including enterprises such as Beard Management Inc. This is the company behind multiple globally recognized e-liquid brands such as Beard Vape Co. and The One E-liquids. There will inevitably be fewer and fewer leading comprehensive e-cig companies in the industry going forwards since the PMTA acts as a barrier to getting into the industry.

2. Survival issues for medium-size companies

Another major issue is the cost of the whole application process. Apart from those large e-cig companies which can afford the time and high budget during the process, it is pretty extravagant for medium-sized companies possessing adequate resources to cope with such a complex, expensive, and time-consuming procedure. Notably, there is no guarantee for companies to pass the application if they submit all documents correctly. In other words, all budgets spent on preparing PMTA applications could be wasted. Hence, medium-sized and start-up vaping companies face a severe survival dilemma in the industry in upcoming years.

3. Variation in products

Product portfolios which, until now, had been popular, will look different in the future. More specifically, every item sold requires its application, from flavors to nicotine concentration to vaporizer hardware. Companies will likely begin discontinuing certain products due to budget plans or regulation threats. Therefore, e-cig companies are likely to change their product features to cater to PMTA requirements. For example, the FDA stipulates the removal of certain flavors, colors, and other specific characteristics, and also requires more stringent labeling regarding product ingredients, and for warnings forbidding children and adolescents from trying e-cigs. Consequently, the packaging style of e-cigs now tends to avoid colorful, fashionable, and eye-catching designs in favor of a more formal and business-like type. This tendency reflects the marketing requirements from the new regulations to inspire health-conscious labeling with warnings and to prevent and fight youth addiction.

These strict PMTA regulations put everything a company produces under detailed scrutiny to ensure it's safe for public consumption. That is to say, the products obtaining PMTA are crafted with the highest quality ingredients and most advanced vaporizing components. From the product producers' point of view, it is a pain for companies to go through such a time-consuming, expensive process with no guarantee of success, which may well stifle competition in the market. Nowadays, there is a tendency that only comprehensive e-cig companies with enough capital and high-end technology support have a higher possibility of obtaining PMTA successfully.

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E-cigarette product contains nicotine. Nicotine is an addictive chemical.