Recently, a startup company called Pico IV in California, USA, received a severe warning letter from the FDA (Food and Drug Administration) for selling intravenous CBD products as "dietary supplements," instantly sparking discussions in the health product industry. It is reported that Pico IV claims to provide the world's first injectable CBD product. This product is a high-purity CBD (cannabidiol) designed specifically for intravenous infusion into the bloodstream.

This Sacramento based company promotes the treatment of chronic pain, Crohn's disease, and arthritis on its official website, and provides multiple "recommendation letters" as evidence. However, in the warning letter issued by the FDA last Monday, the FDA explicitly stated that Pico IV's marketing of this injectable product as a "dietary supplement" is illegal. The FDA explicitly states: Classification error: According to the Federal Food, Drug, and Cosmetic Act (FD&C Act), injectable products do not meet the definition of "dietary supplements" (limited to oral form only) and must be declared as drugs or biologics. Safety risk: If intravenous injection products fail the sterility and stability review, they may lead to fatal risks such as sepsis and thrombosis. Violation of efficacy claims: The official website mentions that "treating chronic diseases" is a drug efficacy claim that requires clinical data support.

Toxicologists point out that CBD injections may pose contamination risks: cannabis plants are prone to adsorbing heavy metals and pesticides, and even if third-party testing is qualified, the purity standards for injections are much higher than those for oral products (which must comply with USP<797>sterile formulation specifications). However, supporters believe that if injectable CBD is marketed in compliance, it can fill the gap in the pain management market. According to data from Brightfield Group, the size of the CBD market in the United States alone is expected to reach $6 billion in 2023, with the medical sector accounting for over 40%. The demand for alternative therapies among patients continues to grow.

In response to the FDA's warning, Pico IV CEO Joe Young quickly responded. In an email statement sent to SFGATE, he stated, "Public safety is our top priority," and emphasized that the company's products have undergone strict processes aimed at ensuring sterility and safety: "We are confident in the safety of our products and are working to provide necessary information to the FDA to address their concerns. However, the FDA believes that its marketing model still carries the risk of misleading consumers and medical institutions.

Pico IV, headquartered in Sacramento, California, was founded in 2020 by biotechnology expert Joe Young. The company's mission is to revolutionize the delivery of cannabinoids, focusing on developing high-purity and highly bioavailable cannabinol (CBD) products. Its core team consists of pharmaceutical engineers, toxicologists, and clinical doctors, dedicated to expanding the application of medical marijuana from traditional oral and topical use to intravenous injection. According to the official website, Pico IV's patented technology uses supercritical CO ₂ extraction process combined with nano purification technology to produce CBD crystals with a purity of 99.9%. The product claims to have direct access to the circulatory system through intravenous injection, with a bioavailability of 95% (far exceeding the 6% -15% for oral administration), targeting patients with chronic pain, Crohn's disease, and arthritis. At present, the product is only sold through authorized medical clinics and practicing doctors, priced at $150-300 per injection.