A new study released, “CBD Does Not Cause Liver Toxicity.”
For six months from August 2020 to February 2021, 839 participants completed the study led by 12 companies, commissioned and designed to respond to the FDA’s requests.
The study of 839 participants — ages 18–75 across the country who take hemp-derived CBD products took CBD for a minimum of 60 days orally — showed that CBD at the doses taken in the study is not associated with clinical liver toxicity.
After seven months of clinical investigation, investigators met with the U.S. Food and Drug Administration’s Cannabis Product Council members to share initial findings from the industry-sponsored, decentralized human safety study of hemp-derived CBD products.
“We are encouraged by these findings and hopeful this study provides FDA with sufficient science-based data to determine and take action on a safe regulatory path forward,” said Dr. Aqua. “We will continue to analyze these real-world data and are adding a second cohort to this study to increase statistical certainty for liver safety and secondary measures across diverse populations and consumers with various medical conditions.”
In March 2020, the FDA published a Congressional report and issued a public statement on potential regulatory pathways for selling hemp-derived CBD products, listing liver toxicity as the top concern for consumer safety. The report concluded with the Agency’s commitment to working efficiently to further clarify a regulatory approach to these products, stating – “as always, using science as our guide and upholding our rigorous public health standards. And protect and promote the health and well-being of the American public, and base our decisions in support of our public health mission on sound science.“
While the FDA continues to cite a lack of safety data for delaying the development of a regulatory framework for other cannabinoids and CBD, this new evidence questions the Agency’s claims and arguments against moving forward with regulation.
The FDA has yet to fulfill its commitment nearly three years after legalizing hemp-derived CBD. Regulatory uncertainty continues and is dismantling the market, stifling manufacturing with limited demand. At the same time, bankruptcies happen due partly to the overproduction of raw materials, which leads manufacturers down an economic hardship for farmers left with crops they cannot sell. Meanwhile, bad actors threaten the industry’s integrity as the FDA blames current law for its “stalemate position,” suggesting Congressional action may be required. Last year at a Consumer Healthcare Products Association event, Acting Commissioner Janet Woodcock argued that current law is “fairly clear,” barring the Agency from action on CBD, putting FDA in “a stalemate position.” She followed up: “I don’t know that it’s a matter of FDA policy. I think it may well be a matter of law.”
With the findings from this study and prolonged inaction to regulate CBD, Congress must prioritize passing H.R 841 — The Hemp and Hemp-Derived CBD Consumer Protection Act before year’s end.
“CBD products are exploding in popularity, but the lack of federal regulation surrounding them has put consumers at risk and left businesses looking for clarity,” Reps. Kathleen Rice (D-NY) said in a press release. “The bipartisan CBD Product Safety and Standardization Act will establish the clear regulatory framework needed to provide stability for business and ensure unsafe products stay off the shelves.”
While hemp and its derivatives were federally legal under the 2018 Farm Bill, there are no rules in place to allow for the lawful marketing of CBD-infused products. That’s even though such products are widely available in markets across the U.S.—just without regulations.
For years, hemp farmers and CBD consumers have been struggling due to the inaction of regulations by the FDA. Regulatory uncertainty has led to a sharp decline in hemp prices and economic hardship for hemp farmers. In the meantime, many of the CBD products are being sold, some of which raise significant quality, safety, and other consumer protection concerns.
The Agency was mandated under appropriations legislation enacted in 2019 to update its regulatory approach to CBD, and it did in March of last year. The update stated that “FDA is currently evaluating issuance of a risk-based enforcement policy that would provide greater transparency and clarity regarding factors FDA intends to take into account in prioritizing enforcement decisions.”
In closing, company’s like medibles.io have taken it upon themself and are adhering to the highest-quality standard known as current Good Manufacturing Practices (cGMP). To ensure consumers are getting the best CBD product on the market. Please visit medibles.io, take our online health assessment using our proprietary algorithm, and get your doctor-recommended personalized CBD regimen delivered right to your door. For more great content, please follow us on social media.
References:
Bipartisan Bill To Regulate Hemp-Derived CBD In Food And …. https://cannabiscultivatornews.com/home/index.php/2021/12/03/bipartisan-bill-to-regulate-hemp-derived-cbd-in-food-and-beverages-filed-in-congress/.
H.R. 841 | RegulateCBDnow. https://www.regulatecbdnow.com/about-1
NEW! Study Reports No Evidence of Liver Toxicity …. https://hempsupporter.com/news/new-study-reports-no-evidence-of-liver-toxicity-associated-with-cbd.