The Food and Drug Administration (FDA) regulates cannabis and cannabis-derived compounds under the Federal Food, Drug and Cosmetic Act (FD&C) (21 U, S, C. With a growing market and a hands-off approach by the Federal Food and Drug Administration, states have intervened to protect consumer safety through laws and regulations governing the manufacture and sale of CBD products). However, change is on the horizon, as two California legislature bills would allow and regulate CBD products, including foods, beverages, cosmetics and dietary supplements. With respect to products labeled to contain hemp that may also contain THC or CBD, as mentioned above, it is prohibited under section 301 (ll) of Act FD&C to introduce or deliver for introduction into interstate commerce any food of animal origin to which THC or CBD has been added.
This police raid was aimed at companies that submitted unsubstantiated statements about CBD products about drugs without competent and reliable scientific evidence, and sanctions were imposed that included civil fines and negotiations to reach an agreement that required notification and reporting to customers. Ingredients derived from parts of the cannabis plant that do not contain THC or CBD could be outside the scope of standard 301 (ll) and could therefore be added to foods. The FDA has approved Epidiolex, which contains a purified form of the drug CBD, for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients aged 1 year and older. Most states regulate the production of hemp and CBD under federally legal hemp programs, while marijuana remains illegal under state and federal laws on controlled substances (although many states allow marijuana to be sold under state regulated cannabis regimes).
The FDA has several resources available that address cannabis and cannabis-derived products, such as CBD, and the agency wants to ensure that consumers and other interested parties have access to these resources in a centralized location. There is significant interest in the development of therapies and other consumer products derived from cannabis and its components, including cannabidiol (CBD). Companies that sell CBD products must not only comply with this mosaic of state laws, but also with the applicable provisions of the FDCA, which in some cases may conflict with state laws. Therefore, the FDA has concluded that it is prohibited to introduce or deliver for introduction into interstate commerce any food (including any food or animal feed) to which THC or CBD has been added.
While there is speculation that the FDA's final regulation on CBD products will include a serving size limit for foods and dietary supplements, the FDA is still evaluating safety data to inform any such regulation. The following questions and answers explain some of the ways in which certain parts of the FD&C Act may affect the legality of CBD products. States like Colorado went from banning the commercial activity of CBD to modifying their food and drug laws to affirmatively allow CBD as an ingredient, regularly improving their regulations to include strict packaging, labeling and testing requirements that serve as a national model.
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