With respect to products labeled to contain “hemp” that may also contain THC or CBD, as mentioned above it is a prohibited act under section 301(ll) of the FD&C Act to introduce or deliver for introduction into interstate commerce any animal food to which THC or CBD has been added.
Unlike drugs approved by FDA, products that have not been subject to FDA review as part of the drug approval process have not been evaluated as to whether they work, what the proper dosage may be if they do work, how they could interact with other drugs, or whether they have dangerous side effects or other safety concerns.
A. No. The FDA believes that scientifically valid research conducted under an IND application is the best way to determine what patients could benefit from the use of drugs derived from cannabis. The FDA supports the conduct of that research by:
Children and Pregnant/Lactating Women
FDA continues to be concerned at the proliferation of products asserting to contain CBD that are marketed for therapeutic or medical uses although they have not been approved by FDA. Often such products are sold online and are therefore available throughout the country. Selling unapproved products with unsubstantiated therapeutic claims is not only a violation of the law, but also can put patients at risk, as these products have not been proven to be safe or effective. This deceptive marketing of unproven treatments also raises significant public health concerns, because patients and other consumers may be influenced not to use approved therapies to treat serious and even fatal diseases.
A. To conduct clinical research that can lead to an approved new drug, including research using materials from plants such as cannabis, researchers need to work with the FDA and submit an IND application to the Center for Drug Evaluation and Research (CDER). The IND application process gives researchers a path to follow that includes regular interactions with the FDA to support efficient drug development while protecting the patients who are enrolled in the trials. For research for use as an animal drug product, researchers would establish an investigational new animal drug (INAD) file with the Center for Veterinary Medicine to conduct their research, rather than an IND with CDER.
Under the FD&C Act, cosmetic products and ingredients are not subject to premarket approval by FDA, except for most color additives. Certain cosmetic ingredients are prohibited or restricted by regulation, but currently that is not the case for any cannabis or cannabis-derived ingredients. Ingredients not specifically addressed by regulation must nonetheless comply with all applicable requirements, and no ingredient – including a cannabis or cannabis-derived ingredient – can be used in a cosmetic if it causes the product to be adulterated or misbranded in any way. A cosmetic generally is adulterated if it bears or contains any poisonous or deleterious substance which may render it injurious to users under the conditions of use prescribed in the labeling, or under such conditions of use as are customary or usual (section 601(a) of the FD&C Act [21 U.S.C. § 361(a)]).
A. With the exception of products such as the hemp seed ingredients discussed in Question #12, which have been evaluated for safety, it is important to protect children from accidental ingestion of cannabis and cannabis-containing products. FDA recommends that these products are kept out of reach of children to reduce the risk of accidental ingestion. If the parent or caregiver has a reasonable suspicion that the child accidentally ingested products containing cannabis, the child should be taken to a physician or emergency department, especially if the child acts in an unusual way or is/feels sick.
If you’re trying to find CBD locally, you should start with an online search of local medical marijuana dispensaries. These dispensaries typically sell both cannabis and hemp-derived CBD. You can also try searching for local smoke shops that sell hemp extracts.
Cannabidiol or CBD oil has become incredibly popular in the United States, known for providing a wide range of health benefits. From pain relief to seizure reduction, the benefits of CBD  products are well-supported by scientific evidence. Not only is CBD oil a popular alternative therapy, but it is becoming increasingly more available in stores and online.
Updated on August 6, 2021 – Written by Healthcanal Staff
Medically reviewed by Kimberly Langdon, MD
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While full-spectrum CBD may contain trace amounts of THC, it won’t be enough to cause any psychoactive effects. That being said, the trace amounts in full-spectrum products may be enough for you to fail a drug test. If drug tests are not a concern, there may be some benefit to choosing full-spectrum over broad-spectrum CBD. Some research suggests the benefits of CBD may be heightened when combined  with other cannabinoids and terpenes – this is called the entourage effect.