FDA can take action if it has information that an ingredient or cosmetic product is unsafe to consumers. Consumers can report adverse events associated with cosmetic products via the FDA’s MedWatch reporting system, either online or by phone at 1-800-FDA-1088, or by contacting your nearest FDA district office consumer complaint coordinator. For more information, please see the FDA’s webpage on how to report a cosmetic-related complaint.
19. Can patients gain access to cannabis or cannabis-derived products for medical use through Right to Try?
A. FDA is aware that unapproved cannabis or cannabis-derived products are being used for the treatment of a number of medical conditions including, for example, AIDS wasting, epilepsy, neuropathic pain, spasticity associated with multiple sclerosis, and cancer and chemotherapy-induced nausea.
Questions and Answers
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.
When a product is in violation of the FD&C Act, FDA considers many factors in deciding whether or not to initiate an enforcement action. Those factors include, among other things, agency resources and the threat to the public health. FDA also may consult with its federal and state partners in making decisions about whether to initiate a federal enforcement action.
Ingredients that are derived from parts of the cannabis plant that do not contain THC or CBD might fall outside the scope of this exclusion, and therefore might be able to be marketed as dietary supplements. However, all products marketed as dietary supplements must comply with all applicable laws and regulations governing dietary supplement products. For example, manufacturers and distributors who wish to market dietary supplements that contain “new dietary ingredients” (i.e., dietary ingredients that were not marketed in the United States in a dietary supplement before October 15, 1994) generally must notify FDA about these ingredients (see section 413(d) of the FD&C Act [21 U.S.C. § 350b(d)]). Generally, the notification must include information demonstrating that a dietary supplement containing the new dietary ingredient will reasonably be expected to be safe under the conditions of use recommended or suggested in the labeling. A dietary supplement is adulterated if it contains a new dietary ingredient for which there is inadequate information to provide reasonable assurance that the ingredient does not present a significant or unreasonable risk of illness or injury (see section 402(f)(1)(B) of the FD&C Act [21 U.S.C. 342(f)(1)(B)]).
Regarding imports, if it appears that an article is adulterated, misbranded, in violation of section 505 of the FD&C Act, or prohibited from introduction or delivery for introduction into interstate commerce under section 301(ll) of the FD&C Act, such article will be refused admission (see section 801(a)(3) of the FD&C Act [21 U.S.C. § 381(a)(3)]).
The FDA is evaluating the regulatory frameworks that apply to certain cannabis-derived products that are intended for non-drug uses, including whether and/or how the FDA might consider updating its regulations, as well as whether potential legislation might be appropriate. The information we have underscores the need for further study and high quality, scientific information about the safety and potential uses of CBD.
The FDA is actively working to learn more about the safety of CBD and CBD products, including the risks identified above and other topics, such as:
In addition, CBD can be the cause of side effects that you might notice. These side effects should improve when CBD is stopped or when the amount used is reduced. This could include changes in alertness, most commonly experienced as somnolence (sleepiness), but this could also include insomnia; gastrointestinal distress, most commonly experienced as diarrhea and/or decreased appetite but could also include abdominal pain or upset stomach; and changes in mood, most commonly experienced as irritability and agitation.
Evaluation of the regulatory frameworks
You may have noticed that cannabidiol (CBD) seems to be available almost everywhere, and marketed as a variety of products including drugs, food, dietary supplements, cosmetics, and animal health products. Other than one prescription drug product to treat seizures associated with Lennox Gastaut syndrome (LGS), Dravet syndrome (DS), or tuberous sclerosis complex (TSC) in people one year of age and older, the U.S. Food and Drug Administration (FDA) has not approved any other CBD products, and there is very limited available information about CBD, including about its effects on the body.
The FDA continues to believe the drug approval process represents the best way to ensure that safe and effective new medicines, including any drugs derived from cannabis, are available to patients in need of appropriate medical therapy. The agency is committed to supporting the development of new drugs, including cannabis and cannabis-derived drugs, through the investigational new drug and drug approval process.
Unlike the FDA-approved CBD drug product, unapproved CBD products, which could include cosmetics, foods, products marketed as dietary supplements, and any other product (other than Epidiolex) making therapeutic claims, have not been subject to FDA evaluation regarding whether they are effective to treat a particular disease or have other effects that may be claimed. In addition, they have not been evaluated by the FDA to determine what the proper dosage is, how they could interact with other drugs or foods, or whether they have dangerous side effects or other safety concerns.
The FDA’s top priority is to protect the public health. This priority includes making sure consumers know about products that put their health and safety at greatest risk, such as those claiming to prevent, diagnose, treat, mitigate, or cure serious diseases. For example, the agency has warned companies to stop selling CBD products they claim are intended to prevent, diagnose, treat, mitigate, or cure serious diseases such as cancer, Alzheimer’s disease, psychiatric disorders and diabetes. While we have focused on these types of products, we will continue to monitor the marketplace for any product that poses a risk to public health, including those with dangerous contaminants, those marketed to vulnerable populations, and products that otherwise put the public health at risk.
A February 2019 Brazilian Journal of Psychiatry found that 300 milligrams of may be the optimal dose for treating social anxiety associated with public speaking. Photo by: Gina Coleman/Weedmaps
CBD oil usually comes with a dropper to allow consumers and patients to measure out their dose. Photo by: Gina Coleman/Weedmaps
CBD is psychoactive in the sense that it directly affects mental processes of cognition and mood. CBD’s most well-known psychoactive effect is the calming feeling frequently associated with the cannabinoid. CBD is, however, non-intoxicating, which means it doesn’t produce the “high” of THC. THC is also psychoactive, but because its effects can leave consumers temporarily impaired, it is intoxicating. The non-intoxicating qualities of CBD are what cause some to consider it a “non-psychoactive” cannabinoid.
9. CBD is generally safe and therapeutic for dogs
According to a 2019 survey from Gallup, 1 in 7 Americans, or 14%, use some form of CBD, mostly for medicinal purposes. As CBD’s presence continues to grow, consumers and patients are becoming more curious about the ins and outs of this therapeutic cannabis derivative.
When it comes to finding the most effective CBD dosage for a specific condition, there is no exact measurement or universal guideline that works for everyone. Part of the reason may have to do with the fact that genetic mutations of our cannabinoid receptors cause variances in the way a body reacts to CBD. If you, for example, are walking around with a different CB1 receptor variation than your friend, the two of you may react differently to the same dose of CBD. In other words, an effective CBD dose for one patient may not work for another. There are several other factors that determine the effectiveness of a CBD dose, including the product itself, the method of consumption, as well as the patient or consumer’s physiology.
One of the major CBD selling points to come out of the compound’s recent product boom is that the cannabinoid is both therapeutic and “non-psychoactive,” as opposed to the extraordinarily psychoactive THC. While you might commonly read this “fact” about CBD, it isn’t accurate to say that CBD is devoid of any psychoactive effects.
In addition, it’s also important to note that not all CBD oils and CBD-infused products are created equal. Although some reputable CBD companies adhere to strict labeling standards, subpar or falsely advertised CBD products with vague labels with buzzwords like “pure,” “all-natural,” and “organic” can be deceiving. Also beware of products labeled as hemp oil or hemp seed oil, which usually do not contain any CBD at all. As the FDA begins to crack down on CBD oil labels with unproven claims, consumers should still be on the lookout for the following on all CBD oil labels: