Don’t Ignore an FDA Warning Letter: The Legal Risks Your Business Can’t Afford

The U.S. Food and Drug Administration (FDA), in collaboration with the U.S. Department of Justice (DOJ), has made it clear that the agency will not hesitate to enforce the law when it comes to the sale of unauthorized tobacco products. In the case of Boosted LLC, the company had been previously warned that its actions were in violation of the Federal Food, Drug, and Cosmetic (FD&C) Act’s premarket review requirements. These requirements mandate that any new tobacco products must first obtain marketing authorization from FDA before being sold or distributed.

Despite these warnings, Boosted LLC continued to operate in defiance of the law. This led to DOJ, on behalf of FDA, filing a complaint that ultimately resulted in the consent decree, a legal agreement between FDA, DOJ, and the Boosted LLC. Under this decree, Boosted LLC and its owner are prohibited from resuming their business activities until they meet requirements, including obtaining FDA marketing authorization and passing an FDA inspection.

This case highlights the importance of taking FDA warning letters seriously. They are a clear signal that a company’s products or practices are on FDA's radar. Ignoring these warnings can lead to severe consequences, including permanent injunctions, substantial financial penalties, and damage to your company’s reputation.

FDA and DOJ have been increasingly aggressive in their enforcement actions against companies that fail to comply with the FD&C Act. Since October 2022, this is the eighth time FDA and DOJ have initiated injunction proceedings to enforce premarket review requirements for new tobacco products. 

What This Means for Your Business

If your business receives a warning letter from FDA, it is crucial to take immediate action. The consequences of ignoring such warnings can be dire, as evidenced by the Boosted LLC case.

If you have received a warning letter or are concerned about your company’s compliance status, we can provide the guidance and representation you need to protect your business.  Don’t wait until it’s too late. Contact us today to protect your business from the costly consequences of non-compliance.

Have questions? Give our office a call today at (917) 546-6997, we would be happy to speak with you.

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