Pico IV is a startup promising the “world’s first and only sterile CBD IV,” which it’s marketing toward licensed therapy professionals.
The company said it has developed a patent-pending process to reduce CBD and cannabinoid particles to a picometer—1,000 times smaller than traditional nanoemulsions.
Pico says this allows the particles to pass through a 0.1-micron sterile filter, making the infusion “completely safe for intravenous use with increased absorption.”
But the FDA doesn’t sound convinced. Earlier this month, it sent a warning letter to Pico IV, saying that “injectable drug products can pose risks of serious harm to users.”
The FDA said the Pico IV is apparently marketed as a dietary supplement, but noted that the FD&C Act defines dietary supplements as “intended for ingestion.”
Pico IV is not generally recognized as safe and effective and, therefore, is a “new drug,” meaning it can’t be commercially launched without approval, the FDA wrote.
The agency is giving Pico IV 15 days to respond with specific steps it intends to take to correct any potential violations.
