On May 12th, the US Food and Drug Administration (FDA) issued marketing denial orders (MDOs) to 10 companies, all of which produced and sold approximately 6,500 flavors of e-cigarette oil and vape products. The MDOs prohibit these companies from marketing or distributing these products in the US, and retailers selling these illegal products will face enforcement actions from the FDA.
The tobacco products they submitted for pre-market tobacco product applications (PMTA) included a variety of flavored e-cigarette products, but they failed to provide sufficient evidence that allowing the sale of these products would meet public health protection requirements. The flavors of the products that were denied included citrus, strawberry cheesecake, cool mint, and mint.
Today's actions furthered the FDA's continued progress in reviewing and making decisions on over 26 million new tobacco product applications received since spring 2020, with a majority being for electronic cigarette products. Thus far, the FDA has completed reviews for 99% of these products.
Dr. Matthew Farrelly, director of the Office of Science at the FDA's Center for Tobacco Products (CTP), stated that...
Science is the cornerstone of the FDA's tobacco product review process. Today's decision to reject nearly 6,500 products was based on a lack of scientific evidence in the applications. We will continue to ensure that all new tobacco products undergo rigorous, scientific pre-market evaluations to determine whether they meet appropriate public health standards for legal marketing.
The FDA evaluates PMTAs based on public health standards, taking into account the risks and benefits to the entire population. When reviewing PMTAs for these companies, the premise is whether the products have additional advantages for adult smokers compared to tobacco flavors.
However, the evidence submitted by these applicants was insufficient to prove the existence of such advantages, hence they have received a marketing rejection order.
Brian King, the director of CTP, stated:
The applicant is responsible for providing sufficient scientific evidence to demonstrate that the introduction of a new tobacco product to the market meets the requirements for public health protection. To date, including the product in question, no flavored electronic cigarette products have met the standard for scientific adequacy. However, if the applicant meets this standard, the FDA will approve the product.
The companies that have obtained a marketing rejection order include:
Imperial Vapors LLC, Savage Enterprises, Big Time Vapes, SWT Global Supply Inc., Great Lakes Vapor, DNA Enterprise LLC doing business as Mech Sauce, and Absolute Vapor Inc., and ECBlend LLC are among the companies in the vaping industry. However, two other companies' names are not being disclosed by the FDA in order to protect potential commercial confidential information (CCI).
The FDA is committed to ensuring that all members of the industry, including manufacturers, importers, distributors and retailers, comply with the law.
Tobacco products that have been denied approval are prohibited from being sold, distributed, or marketed in the United States. They cannot be introduced or placed in interstate commerce, and if the product is already on the market, it must be removed or face enforcement action.
Reference:
The Food and Drug Administration (FDA) has issued orders denying marketing requests for around 6,500 flavored e-cigarette products.
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