Cannabidiol (CBD) Enforcement Policy; Draft Guidance for Industry; Availability
2020-502 ORA CVM CDER CFSAN Guidance for Industry Cannabidiol (CBD) Enforcement Policy OPEN
2020-10-13 2020-11-20 2020-11-23
FDA-2020-D-1640-0003 FDA-2020-D-1640-0004 FDA-2020-D-1640-0005
04:00:00 05:00:00 05:00:00
https://api.regulations.gov/v4/comments/FDA-2020-D-1640-0003 https://api.regulations.gov/v4/comments/FDA-2020-D-1640-0004 https://api.regulations.gov/v4/comments/FDA-2020-D-1640-0005
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Overview:Cannabidiol is widely used over the counter and is espoused to be a virtual miracle cure for many diverse ailments. Critical to the process of determining what is real and what is false in such regard is determining standardization of the substance. In addition, many preparations of OTC cannabidiol have been found to contain a variety of contaminants including significant percentages of delta-9-THC thus making such a preparation essentially a marijuana preparation. Specifically, The Draft Guidance on Cannabidiol addresses the recommended oral CBD solution to be 100mg/ml, and in addition recommends that such preparations contain no more than 0.10% THC. The guidance also outlines processes to assure the appropriate Botanical Raw Material as the source for the cannabidiol. This guidance will significantly move forward the availability and study of CBD in a controlled and scientific manner, rather than current widely variable environment that we exist in. I support the guidance as proposed as an expert in Pain Management and Addiction with approximately forty years experience with and expertise in marijuana and the use of related cannabinoids.  I am a Master of Public Health student with the Milken Institute School of Public Health at the George Washington University, and I am currently taking a course titled Prescription Drugs, Policy, and Public Health.  As such, this notice piqued my interest as I have begun to learn more about pharmaceuticals, the Food and Drug Administration (FDA) approval process, and more over the past several months. Given that the FDA approved cannabidiol use with Epidiolex a couple of years ago, the Draft Guidance on Cannabidiol seems to set clear expectations for the pharmaceutical and cannabidiol/marijuana industries and I believe that the FDA should proceed with taking the next steps to finalize the guidance.Cannabidiol can not only be found as an ingredient in a wide variety of cosmetics, especially lotions, creams, and balms, but also in teas, drink mixes, and more these days. Not only that, but a quick search of the internet can yield more recipes featuring cannabidiol than one could fathom, including recipes for salad dressing. That said, the FDAs own consumer-facing website clearly states that it is currently illegal to market CBD by adding it to a food or labeling it as a dietary supplement.1 It goes on to indicate that 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, and some CBD products are being marketed with unproven medical claims and are of unknown quality.1 This conflict between messaging from the FDA and available products and recipes online creates a potential safety hazard for the everyday consumer.With having a clear framework laid out in the draft guidance, the pharmaceutical and cannabidiol/marijuana industries should be able to apply for an in vivo bioequivalence study waiver more quickly, and therefore hopefully provide a safer, more regulated product to the public sooner. If cannabidiol were to become a more standardized product, it could be expected that the FDA and the public would be better able to track and report on adverse reactions or outcomes following its use, and therefore increase the safety for the public. Since Epidiolex is the only cannabidiol drug that has been approved for the treatment of seizures associated with multiple syndromes in minors,2 assuming other companies would be able to meet the bioequivalence requirements, this would allow for the development of other brand name drugs and generic drugs that would help ensure more patients in need can have better options. Given that minors and those with chronic conditions are populations that are being addressed with Epidiolex, this could also help pave the way for more equitable research on cannabidiol use in vulnerable populations, as they are often overlooked in pharmaceutical and research studies.Additionally, this seems, to me at least, like an excellent next step in greater collection of data for users of cannabidiol for research implications. A recognized strength, route, and dosage form of a 100 mg/mL oral solution (which limits tetrahydrocannabidiol concentrations), as laid out in the guidance, will enable uniformity in product delivery that will help researchers be able to have a uniform base level that may not be as easy to attain in unregulated cannabidiol products. The additional data that can be collected will only help strengthen the FDAs ability to help the pharmaceutical and cannabidiol/marijuana industries conduct research into the aforementioned unproven medical claims and address the unknown quality concerns. By finalizing the guidance, the FDA will not only play a key role in advancing science and research, but will also help let consumers know that they are using a regulated, consistent, and reliable product that has been approved by the FDA.References1. What You Need to Know (And What Were Working to Find Out) About Products Containing Cannabis or Cannabis-derived Compounds, Including CBD. https://www.fda.gov/consumers/consumer-updates/what-you-need-know-and-what-were-working-find-out-about-products-containing-cannabis-or-cannabis 2. FDA Approves First Drug Comprised of an Active Ingredient Derived from Marijuana to Treat Rare, Severe Forms of Epilepsy. https://www.fda.gov/news-events/press-announcements/fda-approves-first-drug-comprised-active-ingredient-derived-marijuana-treat-rare-severe-forms I have no background in public health or in food  drug efficacy and safety. But I do have an opinion. Specifically I think that President Trump is a liar, a crybaby and a sore loser.Georgia Secretary of State, a so-called Republican (RINO), wont let the people checking the ballots see the signatures for fraud. Why? Without this the whole process is very unfair and close to meaningless. Everyone knows that we won the state. - President TrumpFirst off as opposed to running campaigns, overseeing elections is a nonpartisan process. But President Trump only cares about loyalty, which means supporting him regardless of the facts. This is why he whines about Obama judges, angry Democrats and now RINOs.Second if the Trump campaign had a problem with ballot counting procedures, they should have brought this up months before the election. But now that theyve lost they want to change the rules.And last, only delusional MAGA morons think that Trump won the state. Everyone with a functioning brain knows that he lost not only Georgia but other must-win states including Pennsylvania, Michigan, Wisconsin, Nevada and Arizona.So listen up, Donnie. Youre a loser. You got crushed by 72 electoral votes and over 6 million popular votes. Youre fired, simp.