Bea Lydecker’s Naturals, Inc. – FDA Warning Letter, Jun 24, 2021

The FDA inspected Bea Lydecker’s Naturals, Inc. (15443 South LaTourette Road, Oregon City, Oregon) on June 6, 11, and 24, 2021, and reviewed product labels, catalogs, brochures, and the website (www.bealydecker.com) in February 2022.

The FDA determined that numerous products, including Enzymes Plus, Artho Flex, Herbal Extract, and CBD Oil Procana Spectrum, are unapproved new drugs under section 201(g)(1) of the Act [21 U.S.C. § 321(g)(1)] due to claims of intended use in the cure, mitigation, treatment, or prevention of disease. These products are not generally recognized as safe and effective and lack FDA approval, violating sections 301(d) and 505(a) of the Act. Some human-use products are also misbranded under section 502(f)(1) for lacking adequate directions for use, violating section 301(a).

Additionally, several products, including Equine Calmer and CBD Oil Procana Spectrum, are deemed unapproved new animal drugs under section 201(v) of the Act [21 U.S.C. § 321(v)] for similar disease claims in animals, lacking required approvals