Silva, et al. Prenatal tetrahydrocannabinol (THC) alters cognitive function and amphetamine response from weaning to adulthood in the rat. Neurotoxicol and Teratol 2012; 34(1): 63-71.
The study of cannabis and cannabis-derived compounds in clinical trial settings is needed to assess the safety and effectiveness of these substances for the treatment of any disease or condition. FDA’s December 2016 Guidance for Industry: Botanical Drug Development provides specific recommendations on submitting INDs for botanical drug products, such as those derived from cannabis, in support of future marketing applications for these products. The agency’s July 2020 draft guidance, Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research Guidance for Industry, highlights quality considerations for anyone wishing to conduct clinical research in this area, particularly those who are less familiar with the FDA.
A. To date, the agency has not approved a marketing application for cannabis for the treatment of any disease or condition. FDA has, however, approved one cannabis-derived and three cannabis-related drug products. These approved products are only available with a prescription from a licensed healthcare provider.
The FDA will continue to facilitate the work of companies interested in appropriately bringing safe, effective, and quality products to market, including scientifically-based research concerning the medicinal uses of cannabis. Additional information concerning research on the medical use of cannabis is available from the National Institutes of Health, particularly the National Cancer Institute (NCI) and National Institute on Drug Abuse (NIDA).
Children and Pregnant/Lactating Women
A. Expanded access is a potential pathway for a patient with a serious or life-threatening disease or condition to try an investigational medical product (drug, biologic, or medical device) for treatment outside of clinical trials when there are no comparable or satisfactory therapies available. Manufacturers may be able to make investigational drugs available to individual patients in certain circumstances through expanded access, as described in the FD&C Act and implementing regulations.
Hemp seeds are the seeds of the Cannabis sativa plant. The seeds of the plant do not naturally contain THC or CBD. The hemp seed-derived ingredients that are the subject of these GRAS notices contain only trace amounts of THC and CBD, which the seeds may pick up during harvesting and processing when they are in contact with other parts of the plant. Consumption of these hemp seed-derived ingredients is not capable of making consumers “high.”
As discussed above (see Question #2), the 2018 Farm Bill removed hemp from the CSA. This change may streamline the process for researchers to study cannabis and its derivatives, including CBD, that fall under the definition of hemp, which could speed the development of new drugs.
A. All ingredients in animal food must be the subject of an approved food additive petition or generally recognized as safe (GRAS) for their intended use in the intended species. If an animal food contains an ingredient that is not the subject of an approved food additive petition or GRAS for its intended use in the intended species, that animal food would be adulterated under section 402(a)(2)(C)(i) of the FD&C Act [21 U.S.C. § 342(a)(2)(C)(i)]. In coordination with state feed control officials, CVM also recognizes ingredients listed in the Official Publication (OP) of the Association of American Feed Control Officials (AAFCO) as being acceptable for use in animal food. At this time, there are no approved food additive petitions or ingredient definitions listed in the AAFCO OP for any substances derived from hemp, and we are unaware of any GRAS conclusions regarding the use of any substances derived from hemp in animal food. Learn more about animal food ingredient submissions here.
A. A cosmetic is defined in 201(i) as “(1) articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and (2) articles intended for use as a component of any such articles; except that such term shall not include soap.”
CBD doesn’t cause that high. Instead, it’s thought to work with other elements in the body linked to feelings of well-being, especially useful for travelers. Studies have shown that CBD can be used to help alleviate symptoms associated with insomnia, anxiety, and some muscle pains.
While it is legal to travel with CBD products containing less than 0.3 percent THC domestically in the United States, other countries have different laws regarding CBD use.
IRA Contribution Limits for 2019 and 2020
CBD and THC are the most common cannabinoids found in cannabis products. THC and CBD are in both marijuana and hemp. Marijuana contains much more THC than hemp, while hemp has a lot of CBD.
When transporting hemp, the product has to be produced lawfully under the 2018 Farm Bill, and the United States Department of Agriculture (USDA) has to have issued approved regulations and procedures within that specific state. Each production plan was submitted individually by states.
International travel guidelines
Before bringing CBD products along for international travel, check on the regulations of the country you are traveling to in order to abide by that country’s laws. If you are unsure, professionals suggest leaving CBD products at home since many countries have stricter CBD-related drug laws than the United States.
The 2018 Farm Bill legalized, on the federal level, the regulated production of hemp, or any part of the cannabis plant with a THC concentration below 0.3%. States, however, have the final say in whether or not cannabis-derived products are legal within their state lines.
The following states have legalized CBD, some only for specific medical purposes:
Is CBD Legal in the U.S.?
CBD must be legal on both the federal level and the state level in order for it to be legal in your state.
There are 17 states called that legalized both medicinal and recreational use of marijuana as long as you meet the minimum age requirement.
Is CBD Legal in my State?
In addition to these states, sever other states have legalized medical marijuana: