I recently came across a mention on Instagram that Elixicure was the “first and only FDA approved over-the-counter CBD product,” and I was stopped dead in my tracks wondering how I could have missed such a monumental moment in cannabis history. I immediately began researching. First, the FDA website. No announcements of a new CBD approval or about Elixicure or its labeler, Honest Globe. Then my most trusted cannabis news sources. Nothing. I moved to a google search and found: an online retail site selling “The ONLY FDA-approved CBD-infused topical analgesic for Over-The-Counter Sale,” and an article “First US over-the-counter CBD drug given FDA certification.” What?!?!?
Next I found Honest Globe’s press release: “Elixicure CBD-Infused Pain Relief Product Listing Receives FDA certification,” which boasts: “This marks the very first, and currently only, Over-The-Counter (OTC) Topical drug with Cannabidiol (CBD) to be registered and certified to date,” and provides a quote from the company’s CEO, “We are ecstatic to announce that Elixicure’s Registration has been Certified by the FDA.” Wow!
But what does that mean? As an intellectual property law firm, we monitor the federal framework on cannabis and cannabis-derived goods VERY closely. While the current federal legal position does not pose an issue for patentability of cannabis innovation, it must be carefully navigated to obtain trademark protection around cannabis. To help us dig into this issue, we called on our good friends at The GMP Collective, who are focused on helping cannabis businesses navigate GMP compliance.
The quick answer for those short on time: Elixicure does appear in the FDA’s directory of drug listings and includes cannabidiol as a third ingredient, after menthol and camphor, under nonproprietary name but not as a substance name. Registration of this type is voluntary and is certified by the drug labeler, not the FDA. Registration of this type is NOT the same as FDA approval that GW Pharma’s prescription drug, Epidiolex, received. Elixicure is considered an over-the-counter drug because it’s two primary ingredients, menthol and camphor, are approved for use as topical painkillers/analgesics.
While we are excited to see a cannabis company attempt to make headway with the Food and Drug Administration (“FDA”) and take pride in its commitment to compliance, we believe in providing safe and informed access to consumers, especially those who may not have familiarity with the FDA to understand what this means and what it does not mean. With that, let’s start with what “FDA certification” does NOT mean.
So if it is not “FDA approved,” then what does it mean for a drug to “receive FDA certification”?
To be honest, we weren’t sure initially because this is not wording used by the FDA. Conducting a search on the FDA website for “FDA certification,” pulls up as a first hit information about “FDA Export Certificates.” But this is not what the press release is about. So we went back to basics, that is, the current biggest federal hurdle for CBD products, The Food Drug & Cosmetics Act (“FD&CA”).
The FD&CA requires all domestic and foreign establishments that manufacture, repack, or re-label drug products for the United States to register with the FDA and list all drugs manufactured, prepared, propagated, compounded, or processed for commercial distribution in the U.S.
Drug products must be identified and reported using a unique, three-segment number, called the National Drug Code (NDC), which serves as a universal product identifier for drugs. In addition, establishments must also provide, among other things, the proprietary name of the product, the dosage form and route, the nonproprietary name and strength of each active ingredient(s) and the substance name for each active ingredient(s). The FDA publishes the listed NDC numbers along with the information submitted in the NDC Directory and uses this information for implementation and enforcement of the FD&CA, for example, for post-marketing surveillance, potential user fee assessments, counterterrorism, monitoring of drug shortages and availability, and determining products that are being marketed without an approved application.
The NDC Directory containsONLY information on final marketed drugs submitted to FDA in SPL electronic listing files by labelers. (A labeler may be either a manufacturer, including a repackager or relabeler, or, for drugs subject to private labeling arrangements, the entity under whose own label or trade name the product will be distributed.)
Inclusion of information in the NDC Directory does not indicate that FDA has verified the information provided.
The content of each NDC Directory entry is the responsibility of the labeler submitting the SPL file.
Assignment of an NDC number does not in any way denote FDA approval of the product.
Any representation that creates an impression of official approval because of possession of an NDC number is misleading and constitutes misbranding. (21 CFR 207.37 (a)(2))
Neither inclusion in the NDC Directory nor assignment of an NDC number is a determination that a product is a drug as defined by the FD&C Act, nor does either denote that a product is covered or eligible for reimbursement by Medicare, Medicaid or other payers.
It is important to note that it is the labeler, not the FDA, that provides the information.
Once a product is listed in the NDC Directory, there is an annual requirement to update NDC product code or “certify” that no changes have occurred for products. Since the ultimate responsibility for submitting product listings lies with the labeler, certification of product listings is also the responsibility of the labeler, not the FDA. Certification of an NDC product code is a statement by the labeler that all product data has been reviewed and deemed accurate and up-to-date by the labeler. That’s it.
So while it may be correct to say that the product listing has been certified, it is the labeler, NOT the FDA, who certifies the information. And, while it is impressive to see a labeler successfully register a CBD product in the NDC directory, the information provided by the labeler has not been verified, much less certified or in any way approved, by the FDA as the title of Honest Globe’s press release seems to imply.
Is it nonetheless noteworthy that Elixicure is listed in the NDC Directory?
A search of the NDC directory for the nonproprietary name “cannabidiol” pulls up the following four listings: 3 for Elixicure and 1 for Epidiolex.
Technically speaking, Honest Globe is the only over-the-counter drug containing cannabidiol to appear in the NDC Directory. While cannabidiol has not been recognized by the FDA as an over-the-counter drug, Elixicure’s two primary ingredients, menthol and camphor, are approved over-the-counter drugs for use as topical painkillers/analgesics.
Interestingly, while cannabidiol is identified as the nonproprietary name of the third active ingredient in the three products, the strength and substance name for only the first two actives, menthol and camphor, are included, 30 mg/mL and 70 mg/mL, respectively, but there is not a third strength corresponding to the strength of the third active, cannabidiol. In addition, the substance name for cannabidiol is not provided, only the substance name for camphor and menthol. Also note, the DEA designation is “N/A,” again, because menthol and camphor are not controlled substances. The 2018 Farm Bill, “hemp” defined as “any part or derivative of the Cannabis sativa L. plant containing less than 0.3 percent tetrahydrocannabinol (“THC”) by weight” was removed from the definition of “marijuana” in the Controlled Substances Act, thereby declassifying hemp as a Schedule I controlled substance. However, it is surprising to note that the start manufacturing date provided is January 2, 2017, almost a full two years before the 2018 Farm Bill was signed on December 20, 2018. Further, the FDA has made clear that although hemp is no longer an illegal substance under federal law, it continues to regulate cannabis products under the FD&C Act and Section 351 of the Public Health Service Act. Therefore, any cannabis product marketed with a claim of therapeutic benefit, regardless of whether it is hemp-derived, must be approved by the FDA before it can be sold. Elixicure is marketed as a “CBD-infused pain relief product” in the Honest Globe’s own press release.
When you compare the listing for Epidiolex, the only FDA approved prescription drug containing cannabidiol, you will note that unlike in the listing for Elixicure, in the listing for Epidiolex “cannabidiol” appears both for the “nonproprietary name” and the “substance name.” In addition, in the listing for Epidiolex the strength for cannabidiol is provided, i.e., 100 mg/mL. Finally, unlike the listing for Elixicure, which provides the the DEA designation of “N/A,” the DEA designation in the listing for Epidiolex is “CV” referring to DEA Schedule V. Schedule V drugs, substances, or chemicals are drugs with the lowest potential for abuse of the five classes and consist of preparations containing limited quantities of certain narcotics.
The significance of these differences and the strategy, if any, behind them is not clear at this time but they are important differences nonetheless.
So what next?
This is also unclear to us. As mentioned above, the FDA uses the information in the NDC Directory for implementation and enforcement of the FD&CA. Presumably, Honest Globe has just put themselves on the FDA’s radar for enforcement, but why?
The press release mentions a commitment to quality and compliance with the most rigid standards set by the FDA’s Current Good Manufacturing Processes (“CGMPs”) for the food, beverage, drug, cosmetic, medical device, and supplement industries as well as certification by the Banned Substances Control Group (“BSCG”), which it says offers certification, testing and GMP compliance services.
CGMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities. Their purpose is to protect consumers by requiring that manufacturers of medications adequately control manufacturing operations in order to assure the identity, strength, quality, and purity of drug products. The controls include establishing strong quality management systems, obtaining appropriate quality raw materials, establishing robust operating procedures, detecting and investigating product quality deviations, and maintaining reliable testing laboratories. This helps to prevent instances of contamination, mix-ups, deviations, failures, and errors and assures that drug products meet their quality standards. The FDA inspects manufacturing facilities for compliance with CGMPs.
Perhaps this is the move of a trailblazer in the industry seeking to demonstrate for the FDA a path forward for CBD that involves compliance with CCMPs.
However, the FDA is still evaluating the science, safety, and quality of products containing CBD as well as the regulatory frameworks that will apply to cannabis-derived products. Until the regulatory framework is put in place, we are left only with this clear message from the FDA provided in an update on November 25, 2019, the same day it issued warning letters to fifteen (15) companies for illegally selling products containing CBD in ways that violate the FD&CA:
The FDA has approved only one CBD product, a prescription drug product to treat two rare, severe forms of epilepsy.
It is currently illegal to market CBD by adding it to a food or labeling it as a dietary supplement.
The FDA has seen only limited data about CBD safety and these data point to real risks that need to be considered before taking CBD for any reason.
Some CBD products are being marketed with unproven medical claims and are of unknown quality.
The FDA will continue to update the public as it learns more about CBD.
The cannabis industry is one for which few things are clear, especially when it comes to the legal landscape. While it is important that the industry strive for state, and eventually federal, compliance, it is equally important that companies do not seek or gain a competitive edge and that consumers are not misled on the basis of the very murky legal landscape of this new and emerging market.