420 with CNW — FDA Passes the Buck, Gives Congre
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The current tense situation regarding CBD-containing products will be maintained for the time being as a result of the U.S. Food and Drug Administration’s recent announcement that it will not regulate those products, instead delegating that responsibility to Congress. This adds to the workload for a Congress that is already becoming more acrimonious and creates more uncertainty for businesses considering entering the $4 billion-plus CBD market.
Congress must make decisions regarding intoxicating cannabinoids derived from hemp, such as delta-10 THC and delta-8, in addition to tackling broader cannabis policy reform, which includes banking access, tax relief and the issue of federal legalization.
For the time being, the FDA has largely stayed out of the CBD product market, sending enforcement letters only to businesses that advertise goods using false medical claims in violation of the federal Food, Drug and Cosmetic Act.
While Congress is negotiating a new iteration of the 2018 Farm Bill, which is set to expire this year, one of the issues that could be resolved is whether cannabinoids should be allowed in drinks, gummies or other products. The bill, an extensive piece of legislation ratified as a law by former President Donald Trump, legalized hemp production throughout the country. It also paved the way for the CBD boom and the emergence of new, hemp-derived intoxicating cannabinoids.
Since then, the FDA has been tasked with determining how to regulate a flood of hemp-derived CBD and other cannabinoid-containing products. Last week, however, the FDA decided against regulation, claiming that its current regulatory frameworks were insufficient and that Congress should instruct the FDA on what to do.
Trade organizations that represent producers of hemp products and hemp growers expressed their disappointment with the FDA’s announcement; the groups had hoped that the agency would have provided clear guidelines rather than putting the issue on hold. For now, existing product manufacturers will continue to be in a state of uncertainty.
The FDA may be selected by Congress as the appropriate agency to oversee cannabis products or Congress may decide that a completely new agency should be in charge of overseeing hemp-derived cannabinoids, which is another unintended but unavoidable consequence of the farm bill revision that has now been added to Congress’s growing list of things to do.
Several jurisdictions, such as Colorado and Utah, have adopted marijuana-like regulations for hemp products.
For enterprises such as India Globalization Capital Inc. (NYSE American: IGC) that lean toward the medicalization of cannabis, there is a clear process to follow in order to obtain FDA approval for any formulations that are developed. For that reason, companies of this nature don’t need to be concerned about the FDA’s efforts to throw back the regulatory guidance task to Congress on matters of CBD supplements.
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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