Black Buffalo Inc. Partners with Sanova, LLC to Advance Regulatory Strategy and Scientific Innovation Programs

CHICAGO, Dec. 16, 2025 /PRNewswire/ -- Black Buffalo Inc., the leading modern alternative to traditional smokeless tobacco, has partnered with Sanova, LLC, a premier scientific and regulatory consulting agency, to support its robust regulatory, compliance, and scientific research programs.

Sanova brings extensive experience helping nicotine manufacturers navigate complex regulatory frameworks, including the U.S. Food and Drug Administration's (FDA) Premarket Tobacco Product Application (PMTA) and Modified Risk Tobacco Product (MRTP) pathways. Sanova's partnership with Black Buffalo includes helping guide the company through the final and most critical phases of FDA review, including substantive scientific review, a rigorous process that evaluates the health impact and overall safety profile of nicotine products intended for adult use.

"The Sanova team combines decades of FDA and industry insight with a forward-looking approach," said Kellsi Booth, Chief Legal Officer of Black Buffalo. "Enlisting Sanova as a key partner represents our commitment to full regulatory transparency, scientific excellence, and responsible innovation within the nicotine space."

Sanova supports the design and execution of both non-clinical and clinical studies, working with third-party research partners to deliver robust data packages. Sanova has a proven track record of successfully demonstrating that novel products meet FDA's stringent standards of "appropriate for the protection of public health," enabling their partners to navigate the evolving regulatory framework with confidence.

"We are excited to support Black Buffalo in their regulatory and scientific endeavors, helping them to prepare for and navigate the most stringent phase of PMTA review," said Sarah Marking, Sanova's Chief Strategy Officer. "Black Buffalo's novel product format provides potential benefits for adult consumers and unique regulatory considerations, which our team is prepared to address through rigorously designed scientific studies and ongoing FDA engagement."

Black Buffalo remains focused on delivering a satisfying, ritual-driven dip experience without tobacco leaf or stem — crafted for age 21+ adult consumers who currently use nicotine or tobacco products. As Black Buffalo continues to lead the smokeless alternatives market with compliance, responsibility, and innovation, Sanova will serve as a key partner in ensuring every step aligns with the highest scientific and regulatory standards.

About Black Buffalo

Founded in 2015, Black Buffalo has created America's leading smokeless tobacco alternative products, backed by over 25,000 hours of research and development. The Company is a 4-time recipient of the Inc. 5000 Fastest-Growing Private Companies in America award (most recently in 2025), and Black Buffalo has won major Best New Product awards from the convenience trade.

Black Buffalo smokeless tobacco alternative products are sold in-store and online. To learn more about Black Buffalo, visit the Company's website or use the Company's store locator to find Black Buffalo products at a local retailer near you. Interested retailers may contact [email protected] to learn more about Black Buffalo.

Certain Black Buffalo smokeless tobacco alternative products contain pharmaceutical-grade, tobacco-derived nicotine, which is an addictive chemical, and all of Black Buffalo's products are intended for adults aged 21 and older who are consumers of nicotine or tobacco.

About Sanova

Sanova is a scientific and regulatory consulting firm that partners with companies across the nicotine and pharmaceutical industries to design, manage, and interpret studies that support FDA submissions and public communications. Sanova has contributed to successful PMTAs and MRTPs, and supported other critical regulatory, scientific and innovation activities for some of the industry's most recognized names.

Black Buffalo's Forward-Looking Statements

Any projections or other estimates herein are forward-looking statements and are based upon certain assumptions that Black Buffalo Inc. ("Black Buffalo," the "Company," "we," "us," "our," "ours," et. al as noted in context herein) has deemed reasonable. Financial, market, economic or legal conditions, the performance of the Company, regulatory developments, and other factors could cause actual results to differ materially from those set forth in the forward-looking statements herein. The business and prospects of the Company may have changed materially since the date hereof. Some of the factors that could cause actual results to differ materially from the forward-looking statements contained herein include, without limitation: (i) the contraction or lack of growth of markets in which we compete and in which our products are sold, (ii) unexpected increases in our expenses, including manufacturing expenses, (iii) delays or cancellations in spending by our suppliers or customers, (iv) delayed action on or issuance of marketing denied orders in response to our Premarket Tobacco Product Applications, or other negative actions taken by, the U.S. Food and Drug Administration, and (v) the impact of pandemics or natural disasters on our sourcing operations and supply chain. Forward-looking statements in this release are made pursuant to the safe harbor provisions contained in the Private Securities Litigation Reform Act of 1995.

Black Buffalo Media Contacts 
Jeffery David (JD), Co-Founder + Chief Brand Officer
[email protected]
Matthew Hanson, Chief Growth Officer
[email protected]

SOURCE Black Buffalo Inc.