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New Study Confirms Safety of CBD

A new study validates the safety of CBD, reinforcing the hemp industry’s demand that the FDA regulate cannabidiol products.

A new comprehensive study involving over 1,000 participants has proven the safety of orally ingested cannabidiol products and provided data that satisfies the FDA’s concerns regarding CBD’s safety. The two-part study found no link between daily CBD usage and increased liver tests, low testosterone levels, or daytime drowsiness across a variety of common retail goods and serving sizes.

Validcare, a research firm, partnered with 17 CBD companies to investigate safety concerns raised by the FDA earlier. Validcare served as the contract research organisation, which includes getting FDA approval of the research protocol, performing the study, and disseminating the findings.

Dr Robert Kaufmann, director of research for Validcare and a former professor at Southern Illinois University School of Medicine, said in a statement from the US Hemp Roundtable, “The data in this study looks good; it’s highly significant, and the chances of it being wrong are very, very small.” “I am quite optimistic that this information will enable the FDA to regulate these widely used CBD products.”

The study’s first cohort, which was peer-reviewed and published in Cannabis and Cannabinoid Medicine last year, looked at how CBD products from 12 different manufacturers affected the liver function of 839 people. The second cohort included 222 more people who were using CBD products from five different companies. According to the researchers, the inclusion of the additional study individuals improved the statistical reliability of both the liver safety and sleep and testosterone outcomes, as well as achieving statistical relevance for both.

Adults aged 18 to 75 who had been consuming oral CBD products for at least 30 days were included in the study. The 17 CBD enterprises involved in the study recruited participants for the decentralised observational study. During the trial, the companies gave participants their regular CBD regimen. All product manufacturers provided a third-party certificate of analysis (COA), which was verified by a neutral third party to ensure that the delivered product’s composition matched both the label and the COA.

CBD is still unregulated by The FDA

After the 2018 Farm Bill legalised hemp, the FDA recognised Congress’ “clear interest in supporting the development of acceptable hemp products” and stated that the agency “could adopt a regulation,” allowing for the lawful marketing of CBD as a dietary supplement. “Using science as our guide and keeping our strict public health standards,” the FDA said it would strive to better explain a regulatory strategy for CBD products. The EPA, on the other hand, has taken no significant moves to regulate CBD, stating that it needs more real-world data to proceed.

The FDA issued a congressional report and public statement in March 2020 on potential regulatory pathways for the sale of hemp-derived CBD products, citing liver injury as the top consumer safety concern, along with “male reproductive toxicity, or damage to fertility in males or male offspring of women.”

“We are pleased to announce that the FDA’s request for ‘real-world data’ resolves the agency’s safety concerns,” said Jonathan Miller, general counsel for the US Hemp Roundtable, the hemp industry’s national lobbying group. “The FDA should regulate CBD and other hemp derivatives now.”

The study’s findings have prompted CBD manufacturers and the hemp industry to call on the FDA to speed up the regulation of CBD products.

“Being a part of this study has allowed us to contribute to the evidence needed to prove the safety profile of CBD to regulators, scientists, product formulators, and other stakeholders,” said Blake Schroeder, CEO of Medical Marijuana Inc. and its subsidiary, Kannaway, one of the companies that participated in the research. “We hope that this, along with our other research initiatives in Brazil and Mexico, will not only help break the stigma surrounding CBD but also assist legislators to appreciate the necessity of free, legal access to the entire cannabis plant,” says the team.

The US Hemp Roundtable is urging Congress to pass relevant legislation if the FDA does not move to regulate CBD products. H.R. 841, H.R. 6134, and S. 1698 are three measures now pending in Congress that would compel the FDA to develop regulatory procedures for the sale of hemp extracts such as CBD in ingestible form.

“We are honoured to have been a part of this groundbreaking study on CBD products, and we are confident in our products’ good testing results.” “These findings bode well for assisting the hemp business against FDA anxieties, which had previously been a roadblock in their regulatory process,” said Vince Sanders, owner of CBD American Shaman. “We’re excited that they can now rely on this study to confirm that CBD products are safe for the human liver, have no effect on daytime drowsiness, and have no negative effect on low testosterone levels or reproductive harm in male participants or male offspring of women in the study,” says the author.

Buying CBD

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You can get CBD products from ThoughtCloud. Some you can check out include:

Isolate CBD in Cold Pressed Hemp Seed Oil

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People have been on the fence about CBD because they are worried about the side effects. But we are here to tell you that it is completely safe for humans as well as pets! Try it out and see the differences for yourself.

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