Agricultural hemp products are now federally legal in the United States, having been removed from the Controlled Substances Act with the signing of the 2018 Farm Bill on December 20, 2018. This means that hemp-derived ingredients, including cannabidiol (CBD), are no longer classified as controlled substances or illegal. However, what remains in limbo is the FDA’s stance on CBD, currently (as of the writing of this article) not allowing CBD to be listed as a food or supplement ingredient.

In a statement issued by FDA commissioner Scott Gottlieb, MD following the signing of the 2018 Farm Bill, it’s stated that: Congress explicitly preserved the agency’s current authority to regulate products containing cannabis or cannabis-derived compounds under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and section 351 of the Public Health Service Act. In doing so, Congress recognized the agency’s important public health role with respect to all the products it regulates. This allows the FDA to continue enforcing the law to protect patients and the public while also providing potential regulatory pathways for products containing cannabis and cannabis-derived compounds.

At the same time that this statement was issued, the FDA released another statement confirming that hulled hemp seed, hemp seed oil, and hemp seed protein powder are generally recognized as safe (GRAS) based on their intended conditions of use. In other words, hemp-seed derived ingredients, in general, are considered safe for human consumption.

The FDA still maintains that CBD and Tetrahydrocannabinol (THC), the two most active phytocannabinoids found in Cannabis sativa, are to be classified as FDA-approved drugs since they were subjected to clinical trials prior to being marketed in the food and supplement market. To date, only one CBD-containing drug, Epidiolex, has been approved for consumption by the FDA.

Furthermore, what is yet to be confirmed are standardized clinical dosing recommendations with ingredients like CBD and THC. There are no current industry-accepted guidelines for dosing based on conditions, and these ingredients are, therefore, not included in medical standards of care.

As a result, the current legality of hemp-derived CBD remains somewhat in limbo, but all signs point to the FDA approving hemp-derived CBD for use in foods and supplements within the coming months. Federally, CBD is now legal for general consumption, but due to its previous classification as a drug ingredient, the FDA still needs to issue a formal change in regulation to allow CBD to be used in foods and supplements.

It is suggested that all clinicians prescribing hemp-derived CBD products to their patients do so with caution. Dosing should be conservative until further research establishes dosing standards.

For more information about dosing recommendations and a review of the current literature, click here. 2018 Year in Review

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