Turning Point Brands, Inc. issued the following announcement on September 8.
Turning Point Brands, Inc. (“TPB”) (NYSE: TPB), a leading provider of Other Tobacco Products (“OTP”) and adult consumer alternatives, today announced it has submitted to the U.S. Food and Drug Administration (“FDA”) Premarket Tobacco Applications (“PMTAs”) covering 250 products. This is an important and necessary step for TPB to offer adult consumers an extensive portfolio of products that serve as alternatives to combustible cigarettes and satisfy a wide variety of consumer preferences.
The PMTAs cover a broad assortment of products in the vapor category including multiple proprietary e-liquid offerings in varying nicotine strengths, technologies and sizes; proprietary replacement parts and components of open system tank devices through partnerships with two leading manufacturers for exclusive distribution of products in the United States; and a closed system e-cigarette. The PMTAs provide clarity to customers and retail partners of TPB’s continued support behind products across multiple leading brands including Solace™, VaporFi®, South Beach Smoke™, HorizonTech®, FreeMaX® and other developing brands and partnerships.
The filings provide detailed scientific data to demonstrate that the products are “appropriate for the protection of public health,” as required by law. Each of the applications will further drive the growth of TPB proprietary products in the NewGen segment. Studies to support the applications were performed over the course of the past year and include five pharmacokinetics studies, a likelihood of use study, and a patterns of use study, in addition to a toxicological review. Data throughout the applications underline that TPB products do not appeal to never users, youth, or former users; that an extremely small percentage of users are never users, youth, or former users; that a significant majority of users have completely ceased use of combustible cigarettes; that a low percentage of users engage in dual or poly use; and that the products are substantially less harmful than combustible cigarettes and comparable to other products in the vapor category. TPB also provided a detailed marketing plan to illustrate how it will continue to prevent youth exposure to the products.
“We look forward to engaging with the FDA as it reviews our submissions,” said Larry Wexler, President and CEO. “We committed significant resources to put forward comprehensive applications and view this as a critical process to offer products that consumers can trust. We have long posited that our strong and unique regulatory experience would create an opportunity as the vapor market moves into this next phase of FDA regulation. It has been our company’s belief that a diverse market is beneficial both to consumers and to industry alike, and our strategy to put forward a broad array of products positions our vapor business as a premier player for years to come. The data compiled as part of these PMTAs will be applicable to future applications as products in the market continue to develop.”
About Turning Point Brands, Inc.
Louisville, Kentucky-based Turning Point Brands, Inc. (NYSE: TPB) is a leading U.S. provider of Other Tobacco Products and adult consumer alternatives. TPB, through its focus brands generates solid cash flow which it uses to finance acquisitions, increase brand support and strengthen its capital structure. TPB does not sell cigarettes. More information about the company is available at its corporate website, www.turningpointbrands.com.
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