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FDA Seeks Penalties of Up to $11,000 Per Violation from E-Cigarette Companies


On February 25, 2023, the Food and Drug Administration (FDA) announced that it had filed civil money penalty complaints against four e-cigarette product manufacturers for violations related to the marketing and sale of their products. The companies named in the complaints include Juul Labs, Inc., Altria Group, Inc., Fontem US, LLC, and Reynolds American, Inc.


According to FDA, the companies' marketing practices were found to be in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act), which prohibits the marketing of tobacco products to minors and requires pre-market authorization for new tobacco products. FDA's complaints allege that the companies engaged in marketing practices that targeted minors, including the use of social media influencers and flavored products, and that they failed to obtain the required pre-market authorization for their products.

If the companies are found to be in violation of the FD&C Act, they could be subject to civil monetary penalties of up to $11,000 per violation, as well as other enforcement actions.


FDA's actions against these four e-cigarette manufacturers highlight the agency's commitment to enforcing regulations on the marketing and distribution of ENDS products. As the regulatory landscape continues to evolve, it is important for businesses in the vapor industry to stay up-to-date with the latest developments and seek legal guidance to ensure compliance and protect their interests.


For businesses in the vapor industry who may find themselves in a similar situation, these penalties could have significant financial and legal implications. Businesses may face regulatory action, litigation, and damage to their reputation and brand. In addition, businesses that have received warning letters from FDA may be at risk of further enforcement action.


Have you received a warning letter from FDA? Are you concerned about the threat of one or other enforcement action? We can help you understand your legal obligations and options, as well as develop compliance strategies to ensure that your products comply with FDA regulations. Have additional questions? Give our office a call today.


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