The Food and Drug Administration (FDA) is releasing its latest draft guidelines that would speed up the approval process for generic oral CBD medications. In this article I will explain the guidelines and its ramifications for producers of CBD medicines. I will also discuss an upcoming FDA meeting for women and CBD safety, the search by the FDA to find a contractor to study CBD products and FDA help for growers to protect their intellectual property.
The FDA New Guidelines for CBD-Based Medications
An in vivo bioequivalence study is typically used by the FDA to ascertain whether a prospective pharmaceutical medication has an equivalent product already in the marketplace. The FDA is allowing CBD companies to request a waiver for this study as long as they meet specific requirements.
- The generic version of 100mg/ml oral CBD solutions must contain the same active ingredient, the same concentration and the same dosage as the product already on the market known as the Reference Listed Drug (RLD).
- It may not contain any inactive ingredient nor formula change from the RLD that significantly affects its bioavailability.
- Any new CBD-based medication must be derived from Cannabis sativa L with a limit of 0.1% THC.
- To ensure the identity of the botanical raw material (BRM), the following two criteria must be met:
- The BRM must be collected from the Cannabis sativa L species
- The Cannabis sativa species must be correctly identified and authenticated using macroscopic, microscopic and/or DNA bar-coded methods
- Because of the variety of cultivars that exist within this species, researchers are required to identify and authenticate the plant species at the cultivar level if the potential cultivar will be used as the basis of the BRM.
- The collection process of the raw cannabis must follow the guidelines of the established Good Agricultural and Collection Practices (GACP) procedures to make sure that there are as few variations as possible in BRM. The goal is to guarantee consistency from one batch of the drug to another.
The FDA published a notice in the Federal Register on Wednesday, September 23, 2020 asking the public for its feedback on guiding researchers who plan to submit Abbreviated New Drug Applications (ANDAs) for CBD-based oral solutions. ANDAs covers generic drugs which are comparable in every way to brand drugs. It is abbreviated because it does not require the presentation of animal and human data to establish its safety and effectiveness.
Public Comment Period
The public will be able to comment on the FDA draft guidance until November 23, 2020. Here is the link to the comment line.
Public Meeting on How Sex/Gender Differences Impact CBD Effects
On Thursday, November 19, 2020 the FDA Office of Women’s Health hosted a virtual public meeting to discuss the role that sex and gender play on the use and response of CBD and other cannabinoids. The conditions for which CBD is often recommended, such as chronic pain, anxiety, depression and sleep problems, affect women more than men. For that reason, the FDA felt the need to provide a forum to address the safety of CBD products specifically for women.
FDA To Award Contract To Help Study CBD
In July, 2020 the FDA submitted its report to Congress on the state of the CBD marketplace. It showed significant discrepancies between the actual cannabinoid concentrations contained in the products and what is listed on the label. There was very little evidence to conclude that these products contain any dangerous metals and minerals.
In response to these findings, the FDA solicited applications for a company to study CBD and related cannabinoid products. The contractor would be tasked with collecting and analyzing 1000-3000 samples for the purpose of establishing quality assurance and control which is sorely lacking in the current marketplace. The categories of samples would include the following CBD-based packaged and processed foods, health and cosmetics from across the country:
- Baked Goods
- Oils and Tinctures Added To Human and Animal Foods
- Gel Caps
- The company would also test for the following contaminants:
- Industrial Chemicals
Microbial Contaminants such as salmonella
The samples will be tested for CBD, CBDA, THC, THCA and other cannabinoid content using techniques which include liquid and gas chromatography.
The cosmetic samples must be shipped to a third party for analysis. The results of this study will be presented to Congress. The goal is to develop guidelines for future policy decisions and provide the FDA more insight into understanding the nature of CBD and associated cannabinoid products and how they are distributed.
The application period for a contractor for this study ended on August 31, 2020.
FDA Helps Cannabis Cultivators Protect Their Intellectual Property
The FDA hosted a webinar in September, 2020 which focused on helping cannabis-based drug growers and developers protect their exclusive information as well as to advance research into the cannabis plant.
The FDA encouraged the use of Drug Master Files (DMFs) which are submitted to the FDA by pharmaceutical manufacturers. They are the source of confidential, detailed information about the facilities, the processes or articles that are used in the manufacture, processing, packing and storing of drugs. DMFs allows the safe transmission of documents for proposed Investigational New Drug Applications (INDs) that protects trade secrets from falling into the hands of the competition.
Progress towards the regulation of the CBD market is definitely being made!
marijuanamoment.net, New FDA Guidance Will Make It Easier To Approve CBD-Based Medicines, Kyle Jaeger, Sept. 23, 2020
marijuanamoment.net, FDA Explains Effects of CBD and Marijuana Compounds Based on Sex and Gender Differences, Kyle Jaeger, Sept. 22, 2020
marijuanamoment.net, The FDA Is Hiring A Contractor To Study Thousands of CBD Products, Kyle Jaeger, Aug. 14, 2020
marijuanamoment. net, FDA Teaches Marijuana Growers and Researchers How To Protect Trade Secrets From Competitors, Kyle Jaeger, Sept. 10, 2020