Orally ingested CBD deemed safe in industry-backed study, amid calls for FDA regulation

20 May 2022 --- Daily consumption of oral cannabidiol (CBD) has a strong safety profile, an industry-backed study has revealed. The findings set to be presented to the US Food and Drug Administration (FDA) aim to minimize the agency’s safety concerns surrounding CBD and pave the way for regulation.

“Right now there are thousands of unregulated products on the marketplace, some of which pose health and safety concerns to the public. It is critical for the FDA to regulate CBD to ensure that consumers are protected,” Jonathan Miller, US Hemp Roundtable General Counsel, tells NutritionInsight.

“It is important to study because the FDA has not legally recognized or regulated CBD, claiming that they want more information to demonstrate its safety,” Miller adds.

The study was sponsored by 17 companies, including Impact Naturals.

“It's way past time to stop thinking of CBD as some kind of fad. Formulated correctly and in appropriate dosages, research confirms CBD to be a valuable wellness supplement,” says Impact Naturals’ Chief Medical Officer Dr. James Lowder.

“CBD won't be taken seriously until we all hold the industry to a serious standard, just as any other health-oriented product. Studies like this are an important step on that journey."

Significant results from the study contradicts previously mentioned health concerns.Analyzing impact
Over 1,000 participants were involved in the study, with the findings revealing that CBD does not impact liver function.

“Concerns about liver health are always important to examine. We can be quite confident in the overall safety profile of orally ingested CBD. We look forward to taking this research even further as we advocate for FDA regulation,” adds Lowder.

Prevalence of Type 2 diabetes was lower than expected, while no increase in daytime drowsiness was reported, according to Impact Naturals.

CBD use was associated with improved daytime alertness and the product’s use by male study participants did not increase prevalence of low testosterone.

The distribution of daily consumption was spread among the participants from a minimum of 30 days up to 12 months. The majority participated in the study for one year.

“The study results indicate that daily consumption across a range of typical retail products and serving sizes is not associated with elevated liver tests, low testosterone levels, or daytime drowsiness,” explains Dr. Keith Aqua, principal investigator who conducted the study with the third-party contract research organization Validcare.

FDA approval to combat chaosThe FDA has previously flagged concerns of negative health impacts of CBD consumption.
Companies across the CBD space are eager for FDA regulation, notes Vassili Kotlov, CEO of Impact Naturals.

“Regulation establishes a baseline of how to create, evaluate and set standards for safe, quality CBD products – and hold all makers accountable to that standard. Without regulation, the CBD market can become chaotic with profit valued over quality and hype over substance, which isn't good for consumer safety and doesn't respect the health benefits that quality products, when correctly used, can provide."

“FDA has the authority to begin the regulation process immediately, and we are encouraging them to do so. If not, we are asking Congress to pass legislation that requires the FDA to regulate CBD as a dietary supplement and food additive,” says Miller.

The FDA has previously flagged the usage of CBD compounds, as it is claimed to have negative impacts on males such as a decrease in testosterone production, the development and function of sperm and impairment of their sexual behavior.

Studies of CBD have many gaps to fill and the FDA has emphasized the importance of data collection in several different health aspects before legislation is possible.

By Beatrice Wihlander

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