FDA says CBD federally illegal despite advertisers’ claims
The push for state legalization of recreational marijuana appears to be well under way, with 11 states and the District of Columbia having sanctioned it since 2012. Washington and Colorado led the way that year, with Illinois and Vermont recently becoming the first to legalize recreational marijuana through legislative action rather than by ballot.
These efforts have sparked an interest in the potential benefits from products derived from hemp, the Cannabis plant fiber traditionally used to make paper, rope and some fabrics. In 2018, President Trump signed the Farm Bill, which legalizes production of the fiber — historically, it’s been unlawful to grow or sell it in the U.S., although it can be bought legally from overseas markets.
Hemp contains the ingredient cannabidiol (CBD), the non-psychoactive agent in marijuana (it does not produce the “high” associated with the drug). Those who want CBD legal say it can help relieve anxiety, stress, pain and insomnia and has an effect on seizure disorders and cancer; its popularity finds it in everything from skin creams, tea, tinctures, salves, gummies, lip balm and pet products to beer. Federal law renders CBD illegal when infused in food.
In fact, the “CBD legal” status as a whole is unclear. While advertisements proclaim CBD legal in all 50 states, the federal Food and Drug Administration (FDA) has not approved any Cannabis marketing application for any treatment. The agency has OK’d one Cannabis-derived and three Cannabis-related drug products, and they are available only with a prescription from a licensed healthcare provider. It has deemed every other form of CBD illegal.
As testing continues en route to determining what exactly makes CBD illegal, marketers who advocate CBD legal sales place the oil form of the substance into two effectiveness camps — full-spectrum (or broad-spectrum) and isolate. As the name implies, full-spectrum CBD oil refers to a solution that includes all the naturally occurring plant compounds, including cannabinoids such as tetrahydrocannabinol, marijuana’s psychoactive ingredient. It allegedly requires less chemical processing, and its components combine to produce a greater effect than they would individually.
The isolate form produces the opposite type — it is refined to remove any additional cannabinoids and components found in the hemp plant. The result is a fine white powder contains around 99 percent cannabidiol.
In either case, the extract is obtained through soaking the hemp plant in a solvent — grain alcohol or the environmentally friendly carbon dioxide. The extracted mixture is then combined with 200-proof alcohol, stirred vigorously and placed in a deep freezer to ready it for filtration. The oil then goes through a second distillation, wherein the extract is heated and each compound is separated and isolated so it can be used by itself.
Even as it calls CBD illegal, the FDA held a May 31 public hearing to obtain scientific data and information about the safety of products containing cannabis or cannabis-derived compounds, saying the meeting was not designed to modify findings that render CBD illegal.
“FDA,” the agency said in announcing the parley, “does not intend for this hearing to produce any decisions or new positions on specific regulatory questions, but this hearing is expected to be an important step in our continued evaluation of cannabis and cannabis-derived compounds in FDA-regulated products” and whether it finds evidence to proclaim CBD legal.