Is CBD a Regulated Substance?

The Agriculture Improvement Act, passed and signed into law by Congress, removed hemp from the federal Controlled Substances Act. This effectively legalized CBD if it is derived from hemp. However, this clarification could create a practical obstacle to the legal manufacture of most hemp-derived CBD products. Hemp extract that is not in its final form often exceeds the THC delta-9 concentration of 0.3% at some point in the extraction process before it returns to compliance with final product legislation.At first glance, the new DEA standard eliminates any doubt that hemp-derived delta-9 THC is legal, as long as the product contains less than 0.3% in dry weight.

But this standard does not help either, as it creates additional uncertainty as to whether any hemp extract, even an unfinished product, containing more than 0.3% of delta-9 THC is an illegal Schedule I controlled substance.Ian Stewart, a deputy regional managing partner of the firm's Los Angeles office and a member of the Information Governance Leadership Committee, has defended complex litigation in state and federal courts for 25 years. He focuses on product liability, complex general injuries, cannabis law, data privacy and cybersecurity, and intellectual property litigation. As co-chair of the firm's national legal practice Cannabis & Hemp, Ian leads a multidisciplinary national team of lawyers who deal with all aspects of the cannabis and hemp industries, as well as financial institutions.Under federal law, CBD derived from cannabis plants with more than 0.3% THC is not approved and would be considered illegal at the federal level. Therefore, CBD producers are not allowed to make health claims about their products.

However, CBD derived from “non-psychoactive” hemp imported to the United States is legal. This combination of cannabis compounds is also key to understanding how the Annex I classification applies to CBD products.The FDA has approved Epidiolex, which contains a purified form of the drug substance CBD, for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients aged 1 year and older. Some of these products further violated the FD&C Act because they were marketed as dietary supplements or because they involved the addition of CBD to foods.In contrast, cannabis-derived CBD products can only be purchased by qualified patients in states with medical cannabis laws (31 states and the District of Columbia at the time of writing) or by customers in states with recreational cannabis laws (9) and the District of Columbia at the time of writing). On this basis, biological products, cosmetics, drugs, foods, animal feed, medical devices and tobacco products containing CBD or any other component derived from hemp are under the jurisdiction of the FDA and are subject to applicable laws and regulations administered by the agency, regardless of individual state laws.The FDA is not aware of any evidence that could question its current findings that products containing THC and CBD are excluded from the definition of a dietary supplement under section 201 (ff) (B) of Act FD&C.

On one hand, if you're referring to a substance that can be used for medicinal applications then yes, many people would consider CBD to be a drug that generally promotes health and well-being.To further complicate matters, before the approval of Epidiolex (CBD), the FDA explicitly stated that “CBD products are excluded from the definition of a dietary supplement because CBD is a new investigational drug (IND) under the Federal Food, Drug and Cosmetic Act (Act FD&C). The FDA has sent warning letters in the past to companies that illegally sell CBD products that claim to prevent, diagnose, treat or cure serious illnesses such as cancer.Therefore retailers, manufacturers and consumers alike need to know the requirements for production, marketing, retailing and consumption of CBD-containing products even when those requirements appear to conflict across state borders. Overall hemp tends to contain significantly lower levels of THC and depending on variety substantially higher levels of CBD than marijuana.However if FDA decides to take action it will likely reduce consumers' access to CBD products.

Tonia Kilcullen
Tonia Kilcullen

Freelance social media practitioner. Lifelong writer. Typical social media specialist. Award-winning internet advocate. Devoted beer scholar.