It was not very long ago, perhaps a decade or two, when cannabis and any of its byproducts were believed to not offer any medical benefits; also due to the negative and oppressive atmosphere surrounding cannabis use during the past century, little research had been performed to determine what, if any, medical benefits are derived from this popular plant. Ironically, it was the legalization of cannabis for medical purposes in various states (starting with California in 1996) that opened wide the door of considering cannabis products to deliver medically beneficial results in various cases.
Meanwhile, as states continue to legalize cannabis use for either medical or recreational purposes, the FDA has been doing its part in investigating the health claims of cannabidiol (CBD), perhaps the most popular derivative of cannabis. Because full results are not yet in, the FDA continues to take its usual overly cautious stance concerning various health claims of CBD and continues performing research on the safety and efficacy of CBD.
Illegally Marketed CBD Products
To date, only one medical product containing CBD has been approved by the FDA: Epidiolex. This drug treats seizures experienced by epileptic patients suffering from one of two rare forms of the disease (Lennox-Gastaut syndrome and Dravet syndrome, both known for causing severe seizures on a regular basis), as reported in a June 25, 2018 FDA news release. Any other CBD products that make medical and/or health claims have not been approved by the FDA and thus are considered illegally marketed CBD products.
The FDA takes a serious position on companies promoting products with health claims that have not yet been approved by that agency. In fact, on November 5, 2019, the FDA sent out warning letters to 15 American companies selling different products, all including CBD in them; this makes a total of 22 warning letters sent out in 2019 alone. Specifically, any company promoting products containing CBD and claiming therapeutic benefits, especially in supplements and food products (for both humans and animals), are in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
If it appears that the FDA is taking an unreasonably harsh attitude against CBD, rest assured this is their normal standard of procedure for any new product falling under their purview. As stated by FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D., “In line with our mission to protect the public, foster innovation, and promote consumer confidence, this overarching approach regarding CBD is the same as the FDA would take for any other substance that we regulate.” She further indicated that “We recognize the significant public interest in CBD and we must work together with stakeholders and industry to fill in the knowledge gaps about the science, safety and quality of many of these products.”
Continued Concerns over CBD Safety
Because the FDA has only worked with limited data concerning CBD safety so far, their careful approach should be appreciated rather than criticized. Even this limited data has pointed out concerns the FDA would like to address and resolve through further study and analysis. To date, they have identified three specific areas of concern over CBD safety that deserve further examination.
Possible Liver Injury
When reviewing the marketing application for Epidiolex, the epileptic drug containing CBD, a safety risk concerning possible liver injury was identified. It should be noted that this risk appeared to increase when taken in combination with other medicines known to cause liver injury. The FDA believes that, if monitored under medical supervision and in accordance with FDA-approved labeling, these concerns can be managed; however, due to the widespread access of CBD products being distributed outside the oversight of the FDA, these concerns remain real and serious and require additional study and testing.
Male Reproductive Toxicity
Another area where the FDA is concerned about risks involves studies of male reproductive toxicity performed on laboratory animals; this also applies to males born from a pregnant female who received CBD treatment while carrying the fetus. Changes observed among these males include change in the size of testicles, decreased circulating testosterone, and even the inhibition of both sperm growth and its development. Since no similar studies have been performed on male humans, it is not certain if CBD could reduce the fertility of males using the substance; this points to the need for more studies in this field.
Interactions with Other Drugs
Based upon the studies performed by the FDA on the epileptic drug Epidiolex, an increased risk in CBD impacting other medications being taken – or conversely, other medications affecting the dosage of CBD taken – is possible. This could result in the usefulness of other medications being diluted or, possibly worse, inadvertently increasing the effects of a prescribed medicine. The bottom line is that the FDA would prefer to see more involvement and oversight by the healthcare profession. Also of major concern to the agency is the current limited research on the interactions of CBD products with herbal and dietary supplements, which they would like to see expanded.
There are other topics which the FDA is actively studying to learn about the safety and risks of CBD products, including:
- CBD in Animals – for pets, which involves learning how certain species, breeds, or classes of animals are affected by CBD, if at all; also, studying how CBD might affect domesticated animals producing food products for humans (meats and dairy products)
- Specific Populations – to date, no specialized studies of specific demographics of humans (pregnant or lactating women, children, seniors, and adolescents) have been performed
- Cumulative Effect – perhaps of greatest concern to the FDA is learning about the cumulative effect of CBD in a person with a long history of consuming the product; of equal concern is how to differentiate its effects between different types of products (creams, tinctures, candies, etc.)
More FDA Information for Consumers
While it is common to rage against government agencies and their supposed interference in our private lives, few people doubt the value of the FDA. Thanks to its transparency, concerned citizens wishing to remain informed can find a full overview and discussion of FDA’s involvement and interest in cannabis and its derived products; visit the FDA Regulation of Cannabis and Cannabis-Derived Products, Including Cannabidiol (CBD) page and you can get full details on the following four areas of interest:
- Consumer Information
- FDA Regulations
- Regulatory Resources
- Questions and Answers
Whether or not we all agree as to the quality of work the FDA performs in the field of cannabis, the reality is that it is the agency that supervises and governs the use of cannabis products, including CBD. Equally important to remember is that the FDA is not the bad guy trying to ruin the fun of Americans; it is a professional agency dedicated to ensuring our population remains safe and healthy through proper oversight of the health and food industries. Meanwhile, do not expect a sudden or swift growth in trademarks for CBD products, particularly since the FDA is focusing on approving medical products or other “drug” cases as compared to other consumable products. It is interesting to note that there is a limited amount of hemp-based CBD products earning Federal trademarks, but none of these products involve foods, beverages, dietary supplements, or pet treats, all of which remains under the watchful eye of the FDA.
At CBD Informative, it is our goal to keep our customers and followers informed on the ever-changing landscape of cannabis and products using ingredients from this plant. Be sure to bookmark us and regularly visit to stay current with the latest news about cannabis and CBD.
