The citizen's petition requests FDA to stop excluding hemp-derived CBD from the definition of a dietary supplement, and includes an NDIN from cbdMD, which the petition asks FDA to substantively review, unlike previous NDINs.
The Natural Products Association (NPA; Washington, D.C.) filed a citizen’s petition to the U.S. Food and Drug Administration (FDA) requesting the following actions by the Commissioner regarding the regulation of cannabidiol (CBD):
In its petition, NPA argues that CBD qualifies as an “old dietary ingredient” marketed as a dietary supplement prior to the passage of The Dietary Supplement Health and Education Act (DHSEA). As proof, NPA cites the United States Pharmacopeia (USP), an independent, non-profit organization that was recognized by Congress in 1848 through the Drug Importation Act as setting standards for identity, purity, and strength for specified material. According to NPA’s citizen’s petition, USP first documented the use of hemp-derived products with its entry, “Extractum Cannabis. Extract of Hemp,” that was listed as being an alcohol-based “extract of the dried tops of Cannabis sativa – variety Indica” in 1850. The documentation by USP should meet the bar of proof that hemp-derived extracts, including CBD, were marketed prior to the passage of DSHEA, and therefore are “grandfathered,” exempting them from premarket review via New Dietary Ingredient notifications (NDINs) or the Drug Preclusion Clause used by FDA as the reason it is not recognized as a dietary ingredient.
In addition to citing USP, NPA also includes the example of two other ingredients, namely L-carnitine and caffeine, which were not only marketed as dietary supplements prior to the passage of DSHEA, but also used as active ingredients in drug products. Specifically, the petition quotes Senator Orrin Hatch from a Senate Report published by the Committee on Labor and Human Resources as stating:
“On occasion, a substance that is properly included as a dietary ingredient in a dietary supplement (food) product may also function as an active ingredient in a drug product. There is nothing particularly surprising about this fact.
As an example, the dietary substance, L-carnitine may properly be used as an ingredient in a dietary supplement (as FDA itself has acknowledged), although it is also the active ingredient in a drug product that has been approved by FDA for a particular prescription-only usage. Similarly, the substance caffeine is a natural component of food products such as coffee and tea; it is used as an added ingredient in foods, including carbonated beverages, and it has only been approved by FDA as a drug.”
From NPA’s point of view, it is clear from the Report’s language that Congress intended these ingredients to continue to be marketed as both drugs and dietary supplements after the effective date of DSHEA, October 15, 1994. Additionally, because previous NDINs did not receive substantive review by FDA of submitted identity and safety data, due to the agency’s policy of not recognizing CBD as a dietary ingredient, NPA included in its citizen’s petition a full NDIN from cbdMD documenting its product’s identity and safety. This is essentially forces FDA’s hand to properly review the notification. The petition states:
“cbdMD spent approximately $1,000,000 (USD) to prepare identity and safety data to answer all safety questions posed by the Agency, and the Agency has no proper justification to refuse review of cbdMD’s data or NDI submission under the faulty pretense that CBD is excluded from the definition of a dietary supplement under DSHEA…After all, submitting cbdMD’s confidential data to the Agency without the guarantee that it will be reviewed and appropriately replied to does nothing other than expose cbdMD to the risk of disclosure of the data along with potential misrepresentations of the data without any benefit to cbdMD…For this reason, this Petition requests that the Agency confirm that it will actually review and reply to cbdMD’s safety data in earnest before it is included with cbdMD’s NDIN.”
“For more than four years, the dietary supplement industry has done all but beg the FDA to make safety determinations for CBD. In that time, 36 U.S. states have established regulatory standards and the European Union has decided on an interim level for CBD consumption. While we wait for a broader regulatory path for CBD, today’s action by NPA paves the way for the agency to review individual products and render an opinion on a case-by-case basis,” said Daniel Fabricant, PhD, president and CEO of NPA, in a press release.