A. The Animal Medicinal Drug Use Clarification Act of 1994 (AMDUCA), permits veterinarians to prescribe extralabel uses of approved human and animal drugs for animals under certain conditions. Extralabel use must comply with all the provisions of AMDUCA and its implementing regulation at 21 CFR § 530. Among other limitations, these provisions allow extralabel use of a drug only on the lawful order of a licensed veterinarian in the context of a valid veterinarian-client-patient relationship and only in circumstances when the health of an animal is threatened or suffering, or death may result from failure to treat.
Signs that your pet may be suffering adverse effects from ingesting cannabis may include lethargy, depression, heavy drooling, vomiting, agitation, tremors, and convulsions.
The existence of substantial clinical investigations regarding THC and CBD have been made public. For example, two such substantial clinical investigations include GW Pharmaceuticals’ investigations regarding Sativex. (See Sativex Commences US Phase II/III Clinical Trial in Cancer Pain )
Children and Pregnant/Lactating Women
 Hayatbakhsh, et al. Birth Outcomes associated with cannabis use before and during pregnancy. Pediatric Research. 2012; 71 (2): 215-219.
15. Can I import or export cannabis-containing or cannabis-derived products?
6. What is FDA’s reaction to states that are allowing cannabis to be sold for medical uses without the FDA’s approval?
1. What are cannabis and marijuana?
The proliferation in the last few years of cannabidiol (CBD)-containing products in the U.S. markets has been greatly accelerated by changes in the regulatory environment, and by perceptions of their health benefits and presumed safety. The result has been aggressive marketing of many types of products, some of dubious quality, making or implying drug-type claims. The recent approval by the U.S. Food and Drug Administration (FDA) of CBD in the form of Epidiolex®, further complicates the regulatory picture. In addition, a number of studies suggest that, at least at high doses, there may be serious adverse effects or drug interactions associated with CBD. At present, CBD-containing products do not meet the strict definition of dietary supplements, but the FDA is continuing to consider some framework under which they might be allowed. Meanwhile, FDA has adopted a “risk-based” enforcement policy. Possible approaches to a new framework for regulation of CBD products as dietary supplements are discussed here, including expanded research emphasis, a robust corporate stewardship program, and a rigorous adverse event reporting program.
Keywords: Cannabidiol; dietary supplements; regulations.
The Farm Bill removed hemp-derived CBD from Schedule I of the CSA, which means it will not be regulated as a controlled substance by the Drug Enforcement Agency (DEA). However, the Farm Bill did not affect other agencies with jurisdiction over the substance. FDA explicitly retains jurisdiction to regulate the use of CBD in food, beverages, dietary supplements and other FDA-regulated products. FDA takes the position that CBD may not be sold in the U.S. due to provisions in the Food, Drug and Cosmetic Act (FDCA) related to the use of dietary supplement and food ingredients that have been previously studied as drug ingredients. If a substance has been authorized for investigation as a new drug, “substantial clinical investigations” have started, and the existence of these investigations has been made public before the substance was used in a food or supplement, then the ingredient in question falls outside the definition of a dietary supplement or a food 3 . According to FDA, there is evidence that a CBD ingredient used in a drug product met these criteria prior to CBD ingredients’ use in food or supplements. These exclusionary provisions of the FDCA were designed to help protect drug companies’ investments in research and development, not because of any concerns that ingredients that are studied as drugs are inherently unsafe in dietary supplements. There are currently a number of ingredients that are marketed both as dietary supplements and drugs, with no concerns about their safety profile, such as fish oil products.
Cannabidiol (CBD) is a compound extracted from hemp or marijuana. The Agriculture Improvement Act of 2018 (Farm Bill) excluded hemp and its constituents from the definition of marijuana and removed it from the Controlled Substances Act (CSA). Hemp is a valuable agricultural commodity and contains only trace levels of tetrahydrocannabinol (THC), the intoxicating compound in marijuana. Hemp has been cultivated throughout human history for many purposes, including food, fiber and oil. Modern science has demonstrated that, in addition to its value as a food and fiber, hemp extracts naturally contain CBD and that CBD may have its own health-promoting benefits. Now, by excluding hemp from the definition of marijuana, hemp with no more than 0.3 percent THC (and its constituents such as CBD) is no longer a controlled substance under the CSA.
Research suggests that CBD can safely be used in dietary supplements. It has been established that CBD contains negligible amounts of THC, the psychoactive component of cannabis, and that it is non-psychoactive and does not cause a “high” in users. Further, CBD does not have the potential for abuse or addiction. The World Health Organization (WHO) Expert Committee on Drug Dependence recommended not scheduling CBD within the International Drug Control Conventions. WHO cited the fact that there are no case reports of CBD abuse or dependence; no public health problems have been associated with CBD use; CBD has been found to be generally well tolerated with a good safety profile; and that there is no evidence that CBD is liable to be abused.1 Furthermore, the U.S. Health and Human Services Department (HHS) conducted a scientific review on CBD and concluded that it does not present a significant risk to the public health. HHS found that there is no evidence for classic drug withdrawal, no evidence that CBD causes physical or psychic dependence and no potential for abuse under the CSA 2 .
Is CBD safe?
Yes. The FDCA allows the HHS Secretary to create a regulation permitting the use of an ingredient in food and dietary supplements, despite a determination that it was first subject to clinical drug investigations as described above. This alternative would allow FDA to clearly establish a legal pathway to market for CBD as a food and dietary supplement. FDA Commissioner Dr. Scott Gottlieb raised the possible use of this authority in a December 20, 2018 statement on CBD following the passage of the Farm Bill. Clearly, FDA is open to and exploring this pathway 4 .
CBD’s prior status as a Schedule I controlled substance presented significant barriers to clinical research. However, in the past few years, changes to state and federal laws have removed some of the obstacles to conducting research. Scientists and physicians have demonstrated that CBD may have multiple benefits throughout the body. Emerging research shows that CBD interacts with cellular receptors in physiological processes that influence sleep, mood, and appetite without intoxicating effects.
Exploring a legal path to market for food, beverages and dietary supplements containing CBD is consistent with FDA’s strong public health goals. Recognizing CBD products as lawful foods, beverages or dietary supplements would allow the agency to impose a reasonable regulatory framework around the processing, manufacturing and marketing of CBD products not intended for use as drugs. It would also permit the agency to enforce existing regulations regarding registration of manufacturing facilities; observance of good manufacturing practice regulations; supply chain security; compliance with food additive and new dietary ingredient provisions for food and dietary supplements; and post-market surveillance of serious adverse events. If FDA fails to act, consumer interest in CBD will continue to grow along with a thriving but plainly unlawful array of CBD products. No one benefits from a “wild west” scenario in which companies willing to risk FDA enforcement distribute these products without appropriate FDA oversight and guidance.
1 WHO Expert Committee on Drug Dependence, fortieth report. Geneva: World Health Organization; 2018 (WHO Technical Report Series, No. 1013). License: CC BY-NC-SA 3.0 IGO.