Side effects of CBD include nausea, fatigue and irritability. CBD can increase the level of blood thinning and other medicines in your blood by competing for the liver enzymes that break down these drugs. Grapefruit has a similar effect with certain medicines.
CBD is readily obtainable in most parts of the United States, though its exact legal status has been in flux. All 50 states have laws legalizing CBD with varying degrees of restriction. In December 2015, the FDA eased the regulatory requirements to allow researchers to conduct CBD trials. In 2018, the Farm Bill made hemp legal in the United States, making it virtually impossible to keep CBD illegal – that would be like making oranges legal, but keeping orange juice illegal.
Animal studies, and self-reports or research in humans, suggest CBD may also help with:
The evidence for cannabidiol health benefits
Some CBD manufacturers have come under government scrutiny for wild, indefensible claims, such that CBD is a cure-all for cancer or COVID-19, which it is not. We need more research but CBD may prove to be a helpful, relatively non-toxic option for managing anxiety, insomnia, and chronic pain. Without sufficient high-quality evidence in human studies, we can’t pinpoint effective doses, and because CBD currently is typically available as an unregulated supplement, it’s hard to know exactly what you are getting.
Cannabidiol (CBD) is often covered in the media, and you may see it touted as an add-in booster to your post-workout smoothie or morning coffee. You can even buy a CBD-infused sports bra. But what exactly is CBD? And why is it so popular?
How is cannabidiol different from marijuana, cannabis and hemp?
CBD has been touted for a wide variety of health issues, but the strongest scientific evidence is for its effectiveness in treating some of the cruelest childhood epilepsy syndromes, such as Dravet syndrome and Lennox-Gastaut syndrome (LGS), which typically don’t respond to antiseizure medications. In numerous studies, CBD was able to reduce the number of seizures, and, in some cases, stop them altogether. Epidiolex, which contains CBD, is the first cannabis-derived medicine approved by the FDA for these conditions.
The Farm Bill removed all hemp-derived products, including CBD, from the Controlled Substances Act, which criminalizes the possession of drugs. In essence, this means that CBD is legal if it comes from hemp, but not if it comes from cannabis (marijuana) – even though it is the exact same molecule. Currently, many people obtain CBD online without a medical marijuana license, which is legal in most states.
In early March 2020, FDA released a Congressionally requested report on the agency’s progress toward developing a regulatory framework to allow CBD in conventional foods and dietary supplements. To the frustration of many, however, it appears that little actual progress has been made. The most significant revelation from the report is that FDA is considering developing a risk-based enforcement policy that could clarify FDA’s enforcement priorities. Given the widespread availability of such products, however, an informal policy of enforcement discretion has essentially been in place for some time.
“Food additive” is defined under Section 201(s) of the FFDCA as substances that are intended, or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food. While food additives require FDA premarket clearance so as not to be found to adulterate food, there is an exemption from the definition of “food additive” for substances that are “generally recognized as safe” (GRAS) for their intended use. GRAS status can be supported by either common use in food prior to 1958 (which is not relevant to CBD) or general recognition of safety through scientific procedures—generally requiring the availability of published safety studies in peer-reviewed journals. Similarly, supplements containing new dietary ingredients are considered adulterated unless they contain only ingredients “present in the food supply as an article used for food in a form in which the food has not been chemically altered” or if, 75 days before marketing, the company submits to FDA evidence to show the dietary ingredient “will reasonably be expected to be safe” for human consumption under labeled conditions of use. In any case (i.e., to obtain premarket clearance or to support a GRAS position), there must be a robust data set supporting the safety of CBD for use in food. While FDA has had no questions concerning the use of hulled hemp seeds, hemp seed protein, and hemp seed oil as ingredients for use in human food based on existing safety data, to FDA’s knowledge, there are not adequate safety data for CBD.
Regulations concerning CBD remain in flux. It remains to be seen how Congress and FDA will address the legality of CBD in food and dietary supplements under the FFDCA. However, the CBD industry should be aware that robust safety data will most likely be required to ultimately convince FDA to permit CBD in food and dietary supplements. This endeavor will take a considerable amount of time and financial resources and will need to overcome existing data on adverse health effects. Despite these issues, we expect to continue to see CBD readily available in food and dietary supplements, provided that such products do not bear drug claims.
When Congress passed the 2018 Farm Bill (formally known as the Agriculture Improvement Act of 2018), there was widespread misunderstanding that the law legalized substances derived from the Cannabis sativa L. plant, including CBD, for use in food and dietary supplements. In fact, the relevant provisions of the Farm Bill merely removed hemp from the Controlled Substances Act definition of marijuana. The 2018 Farm Bill defined “hemp” as Cannabis sativa L. with less than 0.3% tetrahydrocannabinol (THC, a psychoactive component of cannabis) on a dry weight basis and affected the Drug Enforcement Administration’s authority over hemp farming. The change granted more authority to states to regulate the growth, production, and distribution of hemp products.
The current regulatory framework under the FFDCA does not allow FDA to affirmatively evaluate the safety of CBD for use in foods and supplements, nor does FDA have funding to sponsor the necessary studies to support the safety of CBD. Rather, FDA is waiting for the necessary safety data to be developed to evaluate CBD’s safety. While FDA held a public hearing on cannabis in May 2019 and opened a public docket to gather comments and data for FDA review (through which the Agency received approximately 4,500 comments), FDA has yet to receive the necessary safety information to allow it to agree that CBD has a suitable status for use in food and dietary supplements.