MB Solutions, LLC/BioSpectrum CBD – FDA Warning Letter, Jul 29, 2021

The FDA issued a Warning Letter to BioSpectrum CBD (www.biospectrumcbd.com, www.nasadol.com) after reviewing their websites from April to July 2021. The agency found the company markets various CBD-containing products as unapproved new drugs, misbranded drugs, adulterated human foods, unapproved new animal drugs, and adulterated animal foods, violating the FD&C Act. "Regular Strength Nasadol CBD Nasal Spray," "Extra Strength Nasadol CBD Nasal Spray," and "Pain Relief Roll-On" are unapproved new drugs (sections 505(a), 301(d)) lacking FDA approval and GRASE status. The "Pain Relief Roll-On" is also misbranded (section 502(ee)), and Nasadol sprays are misbranded (section 502(f)(1)) for inadequate directions for use. "1,000mg Canine CBD Oil" and "CBD Dog Treats" are unapproved new animal drugs, unsafe (section 512(a)), and adulterated (section 501(a)(5)). Human food products (e.g., gummies, tinctures, and "CBD Dog Treats" as human food) are adulterated (section 402(a)(2)(C)(i)) due to CBD being an unsafe food additive. Their introduction into interstate commerce is a prohibited act (section 301(ll)), as CBD is an approved drug ingredient. "CBD Dog Treats" are also cited as adulterated animal food and a prohibited act under 301(ll) for animal food. BioSpectrum CBD must respond within fifteen working days, detailing corrective actions, preventing recurrence, and providing documentation. Non-compliance may result in legal action, including seizure and injunction, emphasizing the firm's responsibility for full regulatory adherence.