New bipartisan CBD legislation introduced in the Senate

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Senators Ron Wyden (D-Oregon), Rand Paul (R-Kentucky), and Jeff Merkley (D-Oregon) have introduced a new bill to regulate hemp and CBD products called the “Hemp Access and Consumer Safety Act.” To ensure that hemp-derived CBD is regulated by FDA like other legal products used in foods, dietary supplements, and beverages, the proposed legislation amends the so-called “exclusion clauses” of Section 201(ff)(3)(B) of the Federal Food, Drug, and Cosmetic Act. More specifically, the bill inserts “(other than hemp, hemp-derived cannabidiol, or a substance con- taining any other ingredient derived from hemp)’’ after ‘‘an article.”

The new language would therefore read as follows:

“The term ‘dietary supplement’ –

(B) not include—

(i) an article (other than hemp, hemp-derived cannabidiol, or a substance containing any other ingredient derived from hemp) that is approved as a new drug under section 505, certified as an antibiotic under section 5077, or licensed as a biologic under section 351 of the Public Health Service Act (42 U.S.C. 262), or

(ii) an article (other than hemp, hemp-derived cannabidiol, or a substance con- taining any other ingredient derived from hemp) authorized for investigation as a new drug, antibiotic, or biological for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public.”

The bill also adds a provision for the regulation of CBD in food, by adding “(other than hemp, hemp-derived cannabidiol, or a substance containing any other ingredient derived from hemp)” to Section 301(ll) of the Federal Food, Drug, and Cosmetic Act.

The revised language would therefore read:

“The following acts and the causing thereof are hereby prohibited:

(ll) The introduction or delivery for introduction into interstate commerce of any food to which has been added a drug approved under section 505, a biological product licensed under section 351 of the Public Health Service Act, or a drug or a biological product for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public (other than hemp, hemp-derived cannabidiol, or a substance containing any other ingredient derived from hemp)”

The legislation also authorizes FDA to establish labeling and packaging requirements for CBD-containing supplements and foods.

Industry has responded positively to the proposed legislation. “The Hemp Access and Consumer Safety Act is a huge win for American consumers, farmers, and the hemp industry as a whole,” said Jonathan Miller, general counsel, U.S. Hemp Roundtable (Washington, D.C), in a press release. “Consumers will benefit from knowing that CBD products must be manufactured according to FDA-approved CBD processes. Struggling American farmers will benefit from a stabilized marketplace. It also will stimulate innovation and job creation in the hemp industry.”

“Americans deserve to have assurances that the hemp and CBD products they include in their food and dietary supplement choices are properly regulated,” stated Michael McGuffin, president of the American Herbal Products Association (AHPA; Silver Springs, MD), in a press release. “AHPA supports this legislation since it would clarify the lawful pathways for bringing such products to market.”

The Natural Products Association (NPA; Washington, D.C.) supports the provision for regulation CBD in food but says that it falls short by not calling on FDA to set a safe level of daily consumption for CBD. “Setting a safe level of daily exposure remains the number one issue when it comes to regulating CBD products,” said Daniel Fabricant, PhD, president and CEO of NPA, in a press release. “It’s Congress’ job to keep the FDA accountable, but this is like slapping a band-aid on a bullet wound. Setting a safe level of daily consumption will not only keep the FDA accountable, but also set an important precedent that will pave the way for future cannabinoids and hemp constituents in foods and dietary supplements.”

Other CBD legislation was introduced by the House in February.