Well Done


US Senators Ron Wyden (D-Ore.), Rand Paul (R-Ky.), and Jeff Merkley (D-Ore.) introduced legislation on May 21 to ensure hemp-derived cannabidiol (CBD) is regulated by the US Food and Drug Administration (FDA) like other ingredients used in dietary supplements, foods, and beverages.

Under the Federal Food, Drug and Cosmetic Act (FFDCA), it is unlawful to introduce into interstate commerce a food (including any animal food or feed) to which has been added a substance that is an active ingredient in an approved drug product, or a substance for which substantial clinical investigations have been instituted and the existence of such investigations has been made public. FDA has approved one drug, Epidiolex®, which contains CBD. Consequently, because CBD has been approved as a drug ingredient, FDA’s current legal position is that CBD cannot be legally contained in a dietary supplement or food product. Notably, this restriction only applies to dietary supplements and foods. Cosmetics containing CBD are not subject to this particular provision.

If passed, the Hemp Access and Consumer Safety Act would amend the definition of a dietary supplement in the FFDCA, creating an exception for “hemp, hemp-derived cannabidiol, or a substance containing any other ingredient derived from hemp” from the prohibition on the use of ingredients that have been approved in drugs, or substances for which substantial clinical investigations have been instituted. Consistent with the definition of “hemp” under the Agricultural Marketing Act, this exception would only apply to extracts from the plant Cannabis sativa L. with a tetrahydrocannabinol (THC) concentration of not more than 0.3 % on a dry weight basis. The proposed legislation would create a legal avenue for the use of hemp-derived CBD and other cannabinoids in dietary supplements, foods, and beverages in compliance with all existing federal regulations for these types of product.

The bill would also create an avenue for submissions to FDA seeking approval for CBD or other hemp-derived cannabinoids as dietary ingredients or food additives through regulatory pathways such as New Dietary Ingredient (NDI) notifications, Generally Recognized as Safe (GRAS) notices, or Food Additive Petitions. How FDA would treat hemp-derived ingredients for use in dietary supplements and foods, i.e., requiring an NDI or GRAS submission and imposing limits on use levels or servings, would potentially require all products that currently include CBD as an ingredient to submit regulatory filings and relabel products.

The bill follows the passage of several state laws and the creation of state regulations permitting the sale and distribution of dietary supplements and foods that contain CBD. For example, the New York State Department of Health announced proposed regulations for hemp products in October 2020, which will implement the NY Controlled Substances Therapeutic Research Act’s provisions on hemp and hemp extracts.