The FDA is seeking more data and evidence about the safety of cannabis derivatives while touting its progress to aid agencies at state level in exposing a company that sells Delta-8 THC chewables that have “damaging” after effects. The FDA has also been criticized recently due to lack of rules allowing hemp-derived products to be marketed as diet supplements. The agency insists on the need for more data and seeks support from the legislative arm of Congress.
In a data collection bid, the FDA published a fact-finding notice seeking information on the availability and capabilities of able small-business sources to research about product challenges (quality issues), fatal effects on users and misinformation sites based on real-world data to aid in filling up knowledge pockets on these products.
Hemp and the derivatives became legal through the 2018 Farm Bill, making accessibility and demand for their products skyrocket.
The agency seeks businesses that can create reports on cannabinoid discoveries in write-ups as well as webinars of collected data, giving permission to the FDA to share this with stakeholders.
With this information, the FDA can develop regulations for the cannabis market even though it’s currently “taking action” against some hemp enterprises-selling products with suspicious packaging or ingredients by serving warning letters. For example, regulators from Minnesota were tipped off by the FDA recently on consumer complaints about a product, leading to a lawsuit against the entity Northland Vapor, accusing it of breaching the state’s THC Edibles Act enacted in 2022.
The FDA and pharmaceutical board initiated a task force in November leading to 140,000 parcels of Delta-8 THC gummies and 2,300 syrups being confiscated. The products contained doses of THC above the permitted amounts. Regulators also noted that the products’ packaging could entice kids and the company failed to furnish the state with the necessary testing results.
To protect the public, the pharmacy board banned these products from circulation and asked the court to order the destruction of $7 million worth of illicit products and stop further production and sale of Northland Vapor brand products. Republican House members M. Griffith and B. Guthrie wrote to the FDA, calling out the agency’s continued slacking on the regulations for CBD. Griffith and others also penned yet another letter expressing annoyance over the FDA’s insufficient answer to their bill asking for permission for hemp-derived cannabis to be allowed as an additive to food.
Lawmakers insist that the FDA enforce its mandate in providing clarity and a pathway for CBD industry as opposed to just issuing warning letters to companies under suspicion.
The regulatory issues surrounding cannabis compounds are so complex that some companies seeking to develop medicinal formulations, such as India Globalization Capital Inc. (NYSE American: IGC), are much better off since their path to FDA approval is clearly known.
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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