FDA Response

FDA Response Indicates Congressional Legislation Likely Required for Oversight of Full Spectrum Hemp Extracts as Dietary Supplements 

August 11, 2021

Today the U.S. Food & Drug Administration (FDA) published an “objection” to Charlotte’s Web’s New Dietary Ingredient notification (NDI) submitted for our full spectrum hemp extract (FSHE), due largely to its drug preclusion provision. This response from the FDA indicates to Charlotte’s Web that without legislation by Congress, this market will remain unregulated.

The NDI process is rigorous, scientific, and relies on intensive data with the intent to provide information that is the basis for concluding that a dietary supplement, containing a new dietary ingredient, will reasonably be expected to be safe under the conditions of use recommended in its labeling. 

Over the last 18 months, Charlotte’s Web collaborated with the FDA, providing information about the cultivation, extraction, manufacturing, use and safety behind our proprietary FSHE with naturally occurring levels of CBD. We also supplied research evidencing our FSHE to be different from purified CBD in isolate form which is an FDA-approved drug.

The FDA letter asserts that a FSHE cannot be used in dietary supplements because it is precluded and expresses safety concerns. Regarding safety, the conclusions drawn by the FDA do not appear to be based on the data provided in our NDI application (see our letter to the FDA). We requested the FDA correct the record to reflect that data.

The FDA’s position that our FSHE with naturally occurring CBD is the same as CBD isolate is inconsistent with several credible publications we provided, which evidence that the products are different pharmacologically. Since the passing of the 2018 Farm Bill, there has been significant reliance on the FDA to create a regulatory pathway for the hemp wellness category. However, after two and a half years, it is increasingly apparent that, in the FDA’s own words: “legislation might be appropriate.” 1 We agree with the FDA’s suggestion that Congress act by passing legislation to enable FDA oversight of FSHE as a dietary supplement, to properly regulate the hemp wellness category.

The FDA objection to the NDIN does not impact the existing business operations of Charlotte’s Web but does provide useful guidance about what’s required to secure a regulatory framework for FSHE as a dietary supplement.

Both the House of Representatives and the Senate introduced bills that would legislate hemp CBD as a dietary supplement. We believe this legislation is a critical step to protect consumers and to establish guidance for manufacturers, and Charlotte’s Web intends to stay at the forefront of these efforts. Our vertically integrated supply chain and category leadership uniquely position us to work effectively with Congress, and the FDA, to ensure this critical path forward for the hemp industry.

1 “…. The FDA is evaluating the regulatory frameworks that apply to certain cannabis-derived products that are intended for non-drug uses, including whether and/or how the FDA might consider updating its regulations, as well as whether potential legislation might be appropriate.”