Recently, a California startup called Pico IV received a severe warning letter from the FDA (U.S. Food and Drug Administration) for selling intravenous CBD products as "dietary supplements", which instantly triggered heated discussions in the health care industry.

It is understood that Pico IV claims to provide "the world's first injectable CBD product". This product is a high-purity CBD (cannabidiol) designed for injection into the blood through intravenous infusion.

The Sacramento company has advertised its treatment of chronic pain, Crohn's disease, and arthritis on its official website, and provided multiple "recommendation letters" as evidence. However, in the warning letter issued by the FDA last Monday, the FDA clearly stated that it was illegal for Pico IV to market this injectable product as a "dietary supplement".

The FDA clearly stated:
Misclassification: 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) and must be declared as drugs or biological products.
Safety risks: If intravenous products fail to pass sterility and stability reviews, they may lead to fatal risks such as sepsis and thrombosis.
Illegal efficacy claims: The official website mentions "treating chronic diseases" as a drug efficacy claim, which requires clinical data support.
Toxicologists point out that CBD injections may have contamination risks: cannabis plants are prone to adsorb heavy metals and pesticides. Even if third-party testing is qualified, the purity standard of injections is much higher than that of oral products (must comply with USP<797> sterile preparation specifications).

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However, supporters believe that if injectable CBD is listed in compliance with regulations, it can fill the gap in the pain management market. According to Brightfield Group data, the size of the US CBD market in 2023 alone will reach US$6 billion, of which the medical field accounts for more than 40%, and patients' demand for alternative therapies continues to grow.

How to list a CBD injection product in compliance with regulations?
If a company plans to launch injectable CBD products in the United States, it must follow the following path:
Clarify product classification
Drug path: According to the new drug application (NDA) or biologics license (BLA) application, it is necessary to submit preclinical research (animal testing) and Phase III clinical trial data to prove safety and effectiveness.
Medical device path: If the product is used as a drug delivery device (such as a matching injection device), it must pass 510(k) or PMA approval.
API and DMF requirements
CBD as API standards: CBD as an active pharmaceutical ingredient must comply with the purity, impurity limits, and stability standards of USP (United States Pharmacopeia) or ICH (International Technical Requirements for Pharmaceuticals for Human Use). Companies must provide complete chemistry, manufacturing, and control (CMC) data, including synthesis process, analytical methods, and batch consistency proof.
Submit DMF: DMF (Drug Master File) is a confidential document submitted to the FDA, containing detailed production process, quality control, and safety data of the API. For CBD injections, companies must submit Type II DMF (API Master File) for FDA reference when reviewing drug applications. DMF needs to be updated regularly and reviewed by the FDA to ensure compliance with cGMP requirements.
Meet production standards
Production facilities must comply with cGMP (current Good Manufacturing Practices) to ensure sterility and pyrogen-free production. Injections must pass USP<71> sterility testing, USP<85> endotoxin testing, and submit stability study data.
Compliance claims and labels
Therapeutic efficacy claims that are not approved by the FDA (such as "relieve arthritis") are prohibited. The label must indicate the ingredients, dosage, contraindications, and potential risks, and is for prescription use only.
State-level compliance
Ensure that the CBD raw material comes from industrial hemp with a THC content of ≤0.3% (in compliance with the 2018 Farm Bill). Some states (such as Idaho) prohibit all hemp derivatives, and the legality of the sales area must be evaluated in advance.