The U.S. Food and Drug Administration last week sent a warning letter to a California manufacturer that has been marketing an injectable hemp CBD product to medical patients.
The letter, dated March 6, was sent to Sacramento-based Pico IV and asserts that its “intravenous form of cannabidiol” is an “unapproved new drug” that violates federal law and could “pose risks of serious harm to users.”
“Injectable products are delivered directly into the body and therefore bypass some of the body’s key defenses against toxins and microorganisms that can lead to serious and life-threatening conditions,” the FDA wrote to Pico IV.
The agency also cited Pico IV’s marketing on its website and said it appears to be selling its injectable hemp products as “dietary supplements,” in violation of federal law. The Pico IV website specifically features ads aimed at patients suffering from anxiety, chronic pain and Crohn’s disease, while also claiming to support general bone health and other immune system functions.
The FDA warned Pico IV that its product was not federally approved for interstate commerce and that it could face sanctions if it doesn’t course-correct. The FDA gave Pico IV 15 days to respond to the letter.
“Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction,” the letter warned.
Pico IV CEO Joe Young told SFGate that his company was cooperating with the FDA to obtain necessary approval in order to continue operations.
“We are confident in the safety profile of our product and are working diligently to provide the FDA with the necessary information to resolve their concerns,” Young said in a statement to SFGate.
Pico IV’s injectable hemp CBD is not available over the counter, contrary to most hemp goods in the U.S. market. Rather, it can only be obtained through “physicians, providers and IV therapy clinics,” according to the company website.
[[{“value”:”The FDA advised Pico IV that its injectable product is an “unapproved new drug.”
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