FDA WARNING_LETTER - Biomedical Research Laboratories, LLC - July 13, 2021

The FDA issued a Warning Letter to Native Origins and BRL Sports on July 1, 2021, following a May 2021 review of their websites (nativeorigins.com, brlsports.com, brlscience.com) and social media (facebook.com/mynativeorigins). The FDA determined that products Calm Legs, Flexify, Collagen Peptides, Prohemia, Altitude RX, and Trimmunity are marketed with claims that establish them as unapproved new drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 321(g)(1)(B)].

The products are deemed "new drugs" under section 201(p) of the Act [21 U.S.C. 321(p)] because they are not generally recognized as safe and effective for their intended uses, which include treating Restless Legs Syndrome, arthritis, anemia, acute mountain sickness, and supporting immune health. Introducing these unapproved new drugs into interstate commerce violates sections 301(d) and 505(a) of the Act [21 U.S.C. 331(d), 355(a)].

Furthermore, Calm Legs, Collagen Peptides, and Flexify are considered misbranded under section 502(f)(