BRS to assist with compliance

Charlie’s Chalk Dust has engaged Blackbriar Regulatory Services (BRS) to assist in the preparation and submission of Premarket Tobacco Product Applications (PMTA) to the Federal Food and Drug Administration (FDA) for certain of its e-liquid products.

Per section 910 of the Federal Food, Drug, and Cosmetic Act (FDCA), all manufacturers of any newly deemed tobacco products, including e-liquid derived from tobacco, must seek authorization approval to sell such products in the United States.

In July, a U.S. District Court judge issued an order requiring that manufacturers of newly deemed tobacco products submit PMTAs by May 12, 2020. Once submitted, FDA has 180 days to review and respond to timely filed PMTA applications.

“The PMTA process is challenging and complex,” said Ryan Stump, COO of Charlie’s Holdings. “We are fortunate to have a strong relationship with the leadership team at Blackbriar, a result of prior manufacturing agreements with Avail Vapor, their sister company. We are confident that guidance from BRS will further ensure Charlie’s continued compliance with the regulations put forth by FDA, further supporting Charlie’s leadership in the nicotine e-liquid vape space.”