This review, published in Regulatory Toxicology and Pharmacology, applied publicly available safety data to make recommendations for oral ingestion of hemp-derived CBD. According to the study, the 100 to 160 mg range was determined for healthy adults and does not apply to those who are trying to conceive, are currently pregnant or breastfeeding, and at that point the UL ) drops to 70 mg per day.
“Healthy adults” in this study excluded those who were being treated for or diagnosed with any medical condition, or who were currently taking any medications.
For this review, scientists determined intake levels by examining available evidence from 28 human clinical trials and laboratory animal studies. CBD can increase levels of liver enzymes, which can be a sign of liver damage, but this usually occurs when CBD is taken in high doses or when used in conjunction with certain medications. It happens in case. Approximately 18 of the human clinical trials that scientists investigated included sensitive populations to determine the significant effects of elevated liver enzymes.
The researchers also considered additional studies that addressed potential health concerns beyond liver dysfunction. Scientists evaluated the substances' mutagenicity, or their ability to cause permanent changes in the structure of DNA. Scientists found that pure CBD isolate was “non-mutagenic, non-cyopathogenic, and non-genotoxic” under evaluated animal experimental conditions. Another peer-reviewed journal reported no increase in tumor incidence in mammals over a 2-year period. Conversely, the researchers observed a decrease in hormone-mediated tumors in older animals.
Approximately 15% of Americans use CBD on a regular basis, reporting intake levels ranging from 20mg to 1,000mg per day. The study cites a survey of 45,300 adults aged 16 and older living in the United States and Canada, with approximately 16% to 26% of respondents using CBD-containing products in the past 12 months of the observation period. I conclude that it did.
“Consumer use of CBD and other hemp-derived products continues to increase,” the researchers wrote. “[This]creates an urgent need to establish evidence-based intake recommendations to enable the continued safe use of CBD-containing products.”
Holly Johnson, chief scientific officer of the American Herbal Products Association (AHPA), independently commented on the study and said the review presents substantial evidence from both human and animal studies. – told USA.
“The various clinical trials investigated evaluated a wide range of dosing regimens and trial durations in both healthy adults and patients with specific diagnoses,” Johnson said. “The currently available data provides sufficient evidence for regulators in the UK, Canada and Australia to set recommended CBD intake limits similar to the recommendations in this paper.”
FDA response to research
An FDA spokesperson told NutraIngredients-USA that they appreciate the reviews, including those sponsored by Charlotte's Web and Canopy Growth Corporation, that are giving CBD the attention it needs.
“In general, however, FDA does not comment on specific studies, but evaluates them as part of the body of evidence that improves our understanding of specific issues and supports our mission to protect the public health.” ” they said.
Jane Wilson, director of program development and staff liaison for AHPA's Cannabis Committee, said, “Other reviews of the safety of CBD are occurring, and FDA will likely review all of the same information from previously published studies. It is likely that most, if not all, of them can be accessed.” , it seems unlikely that this review will allay FDA's concerns about CBD in particular. ”
Earlier this year, the FDA convened a high-level internal working group to consider potential regulatory pathways for CBD products. The new regulatory pathway “balances the regulatory oversight needed to manage risk with the desire of individuals seeking access to CBD products,” according to a written statement from Janet Woodcock, principal deputy commissioner in the FDA Office of the Commissioner. It was determined that it was necessary.
Such a pathway would benefit consumers by providing safeguards and oversight to manage and minimize risks associated with CBD products, she said.
Eric Postow, managing partner at Hollon Law Partners, a law firm specializing in cannabis law, said the review is important to understanding the safe margins of CBD.
“Providing information to consumers is a good thing,” Postow added. “I think the FDA has some role in that process, driving standards and recommendations. But I think CBD should be treated like any other herbal supplement.”
This means that any supplement or food can be considered toxic if taken at higher than “normal” levels. However, this does not mean that everything should be regulated.
“We know that chamomile can be harmful in certain proportions and can affect the fetus. Certain concentrations can cause labor, so you should avoid using this herb during pregnancy. “They say it's better not to take other herbs,” Postow said. “Why are we so obsessed with CBD?”
Legal challenges for dietary supplements and food additives
The researchers provided no insight into the U.S. debate over CBD. However, they looked at journal articles that evaluated other countries' recommended intake limits for adults using novel foods and/or dietary supplements containing CBD. The UK, Canada and Australia have all adopted CBD levels for their uses.
However, the FDA and the European Food Safety Authority concluded that this was not the case, citing data uncertainties and stating that the available data were insufficient for this purpose. They argue that additional data on long-term exposure and potential effects on liver and reproductive toxicity are needed. Additionally, the FDA has stated that it does not intend to pursue rulemaking to allow the use of CBD in dietary supplements or conventional foods. For example, they said they haven't found enough evidence to determine how much CBD can be taken and for how long before it causes harm. In order for any substance containing CBD to be legally sold as a dietary supplement or food additive, it must meet certain safety standards.
In January, the FDA announced regulations from the Consumer Healthcare Products Association (CHPA), Council for Responsible Nutrition (CRN), and Natural Products Association (NPA) to issue regulations allowing cannabidiol products to be sold as food. refused the request. supplement.
Source: Regulatory Toxicology and Pharmacology
Published online ahead of print, doi: 10.1016/j.yrtph.2023.105482
“Safety Considerations for Cannabidiol: Development of Potentially Tolerable Daily Intakes and Recommended Upper Intake Values for Dietary Supplement Use.”
Author: RG Henderson, et al.
