Latest FDA Refusal to Approve CBD as a Food Ingredient or Supplement Causes Stakeholder Frustration

The federal Food & Drug Administration (“FDA”) has refused to consider an application by Charlotte’s Web Holdings, Inc. (“Charlotte’s Web”) for a CBD product to be sold as a dietary ingredient. This decision was outlined in an FDA letter to the company found here.

“Under 21 U.S.C. § 350b(a), the manufacturer or distributor of a dietary supplement containing a new dietary ingredient that has not been present in the food supply as an article used for food in a form in which the food has not been chemically altered must submit to FDA, at least 75 days before the dietary ingredient is introduced or delivered for introduction into interstate commerce, information that is the basis on which the manufacturer or distributor has concluded that a dietary supplement containing such new dietary ingredient will reasonably be expected to be safe. FDA reviews this information to determine whether it provides an adequate basis for such a conclusion. Under 21 U.S.C. § 350b(a)(2), there must be a history of use or other evidence of safety establishing that the new dietary ingredient, when used under the condition recommended or suggested in the labeling of the dietary supplement, will reasonably be expected to be safe. If this requirement is not met, the dietary supplement is considered to be adulterated under 21 U.S.C. § 342(f)(1)(B) because there is inadequate information to provide reasonable assurance that the new dietary ingredient does not present a significant or unreasonable risk of illness or injury.

FDA has carefully considered the information in your notification and other available information and determined that your NDI 1202 cannot be used in dietary supplements pursuant to the dietary supplement exclusion provision in 21 U.S.C. § 321(ff)(3)(B) (section 201(ff)(3)(B) of the Act). The definition of a dietary supplement is set forth in 21 U.S.C. § 321(ff) (section 201(ff) of the Act), which states in relevant part:

(ff) The term ‘dietary supplement’ . . . (3) does . . . (B) not include – (i) an article that is approved as a new drug under section 355 of this title . . . or (ii) an article authorized for investigation as a new drug . . . for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public,

which was not before such approval . . . or authorization marketed as a dietary supplement or as a food unless the Secretary, in the Secretary's discretion, has issued a regulation, after notice and comment, finding that the article would be lawful under this chapter.

FDA has concluded that CBD products are excluded from the dietary supplement definition under 21 U.S.C. § 321(ff)(3)(B) (section 201(ff)(3)(B) of the Act).

We also conclude that, even if your NDI 1202 was not excluded from the definition of dietary supplement, the agency has concerns about the adequacy of safety evidence included in your submission as a basis for concluding that a dietary supplement containing NDI 1202 will reasonably be expected to be safe under the conditions of use described in your notification.”

Many in the industry were hoping to get some additional clarity on how FDA would oversee CBD and whether FDA’s views have evolved. Unfortunately that is not the case yet. CBD continues to be an item that has an uneven regulatory scheme. 

Lanton Law is a national boutique law and lobbying firm that focuses on healthcare/life sciences and technology. Specifically we have expertise in cannabis and CBD related issues.

If you are either thinking about or are currently selling CBD and are unsure how your business model fares, contact Lanton Law so that we can go over your business model, assess potential risks and help you plan for both pending legislative and regulatory actions.