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Earlier this week, the FDA published its final guidance on cannabis drug development in the federal register. This comes after it released a draft version in 2020. The guidance outlines the basic clinical study standards, considerations for researchers and the drug development process.
The legalization of hemp in the 2018 Farm Bill is one major reason for the guidance’s release because it made the drug development process for hemp different from marijuana, which is still classified as a Schedule I substance under the Controlled Substances Act. In its statement, the agency said that the guidance outlined its views on topics related with the development of cannabis and cannabis-derived drugs for humans.
The FDA also made a number of nonbinding recommendations for scientists interested in the development of cannabis drugs that could be commercialized. The advice, the agency noted, was centered on addressing the regulatory controls and legal definitions related to cannabis as well as specific questions raised about drugs that contained cannabis.
One section of the guidance centers on how hemp can be distinguished from marijuana by calculating THC content. Legally, hemp is defined as cannabis that contains not more than 0.3% THC by dry weight.
In its final guidance, the FDA advises that researchers determine THC content in their proposed cannabis investigational drug products in the early stages of the development process. The agency notes that this may be useful because any drug products that contain more than 0.3% THC may be considered Schedule I substances.
Meanwhile, legislators and advocates await the FDA’s actions on permitting the marketing of hemp-based products such as CBD oil. Earlier in November, the agency sent warning letters to five companies that sold beverages and food containing CBD. While it did not specify why those particular companies were targeted, the agency did state that the companies sold products that individuals could confuse for traditional beverages or foods, resulting in overconsumption or unintentional consumption of CBD.
CBD (cannabidiol) is an active ingredient derived from the hemp plant. This compound is said to be beneficial for various health issues and, unlike THC, it does not induce any highs when ingested. A continued lack of clear regulations for CBD leaves stakeholders in the grey area and many more frustrated over the FDA’s slow rulemaking process.
In other news, the FDA has been tasked with carrying out a scientific review on marijuana to aid in the evaluation of its federal scheduling, as directed by President Joseph Biden.
For entities that are already conducting cannabis drug development, such as India Globalization Capital Inc. (NYSE American: IGC), the new guidance may simply clarify what they are already doing because any clinical development program can only take place once the needed approvals are granted by regulators, such as the DEA and the FDA.
NOTE TO INVESTORS: The latest news and updates relating to India Globalization Capital Inc. (NYSE American: IGC) are available in the company’s newsroom at https://cnw.fm/IGC
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