Hemp-Derived Products Must Meet Four Criteria to Qualify for Enforcement Discretion.

Whether the FDA applies enforcement discretion to hemp-derived, consumable CBD products depends on the type of product. To qualify, such CBD products must satisfy the following criteria. Note that the fourth bullet makes the scope of this policy much narrower than Industry may have hoped.

• Product is manufactured, marketed and labeled in a manner consistent with the dietary supplement framework, such as including a supplement facts panel and structure/function claims.
• Product is not contaminated.
• Product is not packaged or labeled in a manner that would be attractive to or marketed to children.
• Product is provided to a beneficiary through a program of medical items or services payable under Title XVIII of the Social Security Act, under the direction of the patient’s treating physician, in a manner ancillary to the covered items or services furnished under such program.

Even if a CBD product is not eligible for enforcement discretion because it does not meet the fourth criterion above, it is generally advisable to meet the first three criteria, as doing so reduces the risk of enforcement and/or liability. As a practical matter, without regard to the newly announced enforcement discretion policy, the risk of FDA enforcement for CBD-containing food or dietary supplement products likely remains low, unless they are labeled or marketed with therapeutic (i.e., “disease”) claims.

Letter from FDA Cmmsnr Martin A. Makary, MD  https://www.fda.gov/media/191782/download?attachment