Data published in the Journal of the International Society of Sports Nutrition indicated that 100 mg per day of CBD (cannabidiol) for three months was well tolerated and not associated with any adverse events in healthy young men and women, compared with placebo.
Speaking with NutraIngredients-USA, Dr Sibyl Swift, cbdMD’s Chief Science Officer & VP Regulatory Affairs, said the safety data obtained in the new study aligns with previous results from animal studies.
“We actually didn't administer as high of a dose as we know is safe based upon the rodent studies,” she said. “Over the 90-day study it was completely well tolerated with no adverse effects, no issues with liver or what have you.
“It aligns with what we've already seen. It aligns with data that we've submitted in the UK and other jurisdictions.”
The study, led by Dr. Shawn Arent at the University of South Carolina, also found sex-specific differences between the groups, with women in the CBD group experiencing lower pain scores, lower levels of “tension-anxiety”, and had higher levels of “vigor-activity”.
On the other hand, men in the placebo group were found to have lower levels of inflammatory markers and “anger-hostility” scores.
“To our knowledge, this is the first study to rigorously evaluate a wide range of health effects of a hemp-derived CBD product in healthy adults over 12 weeks,” wrote the researchers.
Building the science, running into regulatory brick walls
cbdMD has been at the forefront of investing in scientific studies to support the safety and efficacy of its products, but the US Food and Drug Administration has maintained a stance that it does not consider CBD to be a legal dietary ingredient, that it does not think the ingredient is safe, and that a new regulatory pathway is needed for the category.
“It’s difficult to justify continued research in the space,” said Dr. Swift. “Let's just be honest, from a domestic perspective, I don't see there being a chance anywhere in the near term for federal clarity. But that also doesn't mean that we can't talk about what we studied, and we can't talk about the benefits that we found.
“Is there a risk? Absolutely. But we have the data to support it. And we have the data to support safe doses. So, I think it's all about the business decision around if you are willing to take on the risk.
“I'm not going to run out and say that CBD will benefit anxiety because that's a disease claim, but just overall mood? Absolutely. Does it help with daily aches and pains? Yes. I think pain is a four-letter word for so many people, they're afraid of touching it. But I think if you qualified it appropriately, and you have data to support it, I really feel strongly that that's a place for us to start pushing.”
Despite running into federal brick walls at home, Dr. Swift pointed to the company’s success in other markets. “There are plenty of opportunities in other countries to look for a way in which we can monetize this [science],” she said. "We're actively selling in a number of Latin American countries, and we're working on the final steps towards approval in UK FSA. So, there are places where we can actually utilize this, and there are plenty of regulatory agencies that are willing to review the safety that are willing to consider the statements that we've supported. So, I think that there's relief internationally for now.”
Watch the video above for the full interview and click the link below to read the full study (open access).
Source: Journal of the International Society of Sports Nutrition
Published online ahead of print, doi: 10.1080/15502783.2024.2370430
“The effects of a brand-specific, hemp-derived cannabidiol product on physiological, biochemical, and psychometric outcomes in healthy adults: a double-blind, randomized clinical trial”
Authors: G.F. Mastrofini et al.
