Despite legislative requests from stakeholders, legislators and advocates, the FDA has stated that it will not develop regulations allowing the promotion of CBD as nutritional supplements, leaving the vast industry unregulated. After conducting a “careful study” of the nonintoxicating cannabinoid, the FDA concluded that CBD won’t be regulated along the same lines as food supplements. The agency stated that it would instead like to collaborate with Congress to gain a fresh perspective.
Meanwhile, the FDA is also rejecting three citizen petitions that asked for rulemaking regarding CBD marketing. Days prior to this announcement, the agency issued finalized guidelines outlining the procedure and particular factors for scientists to take into account when working with marijuana-based drugs, particularly marijuana and hemp.
The agency didn’t say that CBD shouldn’t be regulated; rather, it said that certain safety issues and information gaps make it impossible to regulate administratively under the laws in place at the moment. When necessary, the agency will collaborate with various governmental partners to take action regarding CBD and other cannabinoid products in order to protect the public.
In related news, the FDA rejected public petitions from the Consumer Healthcare Products Association, Council for Responsible Nutrition, and Natural Products Association for cannabidiol rulemaking. This comes as a drawback for those who have been pressing the FDA to take some kind of regulatory action on CBD and other hemp-based products because the market is still expanding quickly and there aren’t many safeguards in place.
Since industrial hemp and its products were made federally legal in the Farm Bill of 2018, the agency has come under pressure from trade associations and legislators on both sides to take action. Leaders from the agency have in the past expressed their belief that Congress may need to work to effectively regulate CBD. Michael Bronstein, president of the American Trade Association for Cannabis and Hemp (ATACH), affirmed that the FDA’s findings regarding the regulatory framework for CBD products used in food, beverages and dietary supplements do indeed call for more Congressional action during a press release.
FDA chief Robert Califf agreed in the House oversight committee in May that the authority had moved sluggishly with the proposed rule for CBD regarding food production. To guide future rules, he said that the agency was taking measures to check into the tolerability of cannabidiol. However, he disagreed with the backlash from Congress over the agency’s failure to act, stating that he does not believe the existing policies on the food or narcotics sides are providing what is required to achieve the right trajectories forward.
This regulatory lacuna doesn’t affect entities such as India Globalization Capital Inc. (NYSE American: IGC) because they are focused on developing therapeutic formulations that meet the FDA’s requirements for any drug that is intended to be availed through the healthcare system.
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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