Tag: Beard Management

  • Beard Management Says PMTA has Advanced to Filing Stage

    Beard Management Says PMTA has Advanced to Filing Stage

    Beard Management announced that its premarket tobacco product application (PMTA) has advanced to the filing stage of the regulatory review process. Beard submitted 45 of its nicotine-based e-liquids to the U.S. Food and Drug Administration (FDA), including its The One and Beard Vape Co. brands. Blackbriar Regulatory Services (BRS), the company’s manufacturing partner and FDA agent of record, will be responsible for assisting Beard throughout the next steps of the FDA regulatory process.

    “We are pleased to see our application moving through the PMTA process in order to scientifically demonstrate our products are appropriate for the protection of public health,” said Casey Bates, CFO at Beard, stated in a press release. “Partnering with BRS as our manufacturer gives us much broader access to a multitude of regulatory and scientific data that is critical to our ongoing PMTA work.”

    BRS is providing Beard with cost-effective, turnkey solutions for manufacturing and regulatory needs, using a science-driven approach to testing for harmful and potentially harmful constituents, demonstrating good manufacturing practices, as well as providing additional analytical lab testing critical to the PMTA process, according to the release.

    “We are very happy to be managing Beard’s PMTAs,” said Russ Rogers, CEO at BRS. “We have strong respect for the quality and brand marketing of their products, and we are confident that we can help Beard to achieve a marketing order from the FDA.”

  • Blackbriar and Beard Management Agree to Terms

    Blackbriar and Beard Management Agree to Terms

    Photo: Tobacco Reporter archive

    Blackbriar Regulatory Services (BRS) has entered into a regulatory services, manufacturing and distribution agreement with Beard Management. BRS will become Beard’s exclusive manufacturer and a distributor for the company’s Beard Vape Co. and The One brands’ nicotine products and will take over the pre-market tobacco product application (PMTA) process for these products. As a part of the agreement, BRS will co-brand a range of PRISM e-liquid products that are complimentary to Beard’s product line, which are currently awaiting regulatory PMTA approval and being manufactured under license by BRS.  

    “We are honored that Beard, a globally recognized and respected brand, has put their trust in BRS as a key strategic partner moving forward,” said Russ Rogers, CEO of BRS. “Our combination of ISO certified cleanroom production and analytical lab facilities and industry leading FDA regulatory application team puts us in a position to provide a very compelling value proposition to customers who are making the investment to be in this industry long-term.

    “Beard’s unwavering commitment to high quality products and regulatory practices makes them a great partner and we could not be more excited to provide them with a wide array of business solutions to help them ensure that their amazing brand continues to grow and remains a long-term part of this rapidly changing and maturing industry.

    Partnering with BRS ensures the longevity of our brands

    Casey Bates, CFO, Beard

    BRS will now become Beard’s agent of record with the U.S. Food and Drug Administration and will oversee the process of providing to the FDA any additional regulatory and testing work required for Beard’s current PMTA’s to scientifically prove its products are appropriate for the protection of public health.In addition, BRS will be manufacturing all of Beard’s 45 e-liquid products, including the Beard Vape Co. and The One brands. National and international distribution and all newly required domestic shipping registrations and compliance will also be handled by BRS.

    “Partnering with BRS ensures the longevity of our brands,” said Casey Bates, CFO at Beard. “With BRS’ proven competencies as a leader in nicotine e-liquid product manufacturing and regulatory services, it puts us in the perfect position moving forward. The merging of our core competencies will allow Beard to continue delivering great products and great customer service to adults looking for tobacco alternatives. We couldn’t have done this on our own and we have a long list of people to thank, both at Beard and BRS, for making this possible.”