By Sasha G. Aguilar
Increasingly health care providers, including physical therapists, encounter patients using cannabis or medical marijuana to treat a number of conditions, ranging from Alzheimer’s disease to eating disorders. Cannabidiol or CBD is the second most prevalent active ingredient in marijuana. While CBD is an essential component of medical marijuana, it is derived directly from the hemp plant, which is a cousin to the marijuana plant.
CBD has gained popularity and researchers continue to study its many uses and benefits. So, what does a physical therapist do when CBD will benefit his or her patient? Like many other issues in physical therapy, this decision requires a thoughtful, documented decision. This article outlines some of the risks physical therapists who wish to integrate CBD into their practice face and examines the legalization and regulation of CBD, as well as the use and sale of CBD at a physical therapy practice.
Proposition 64 passed in 2016 and made recreational marijuana use legal in California. The Medicinal and Adult Use Cannabis Regulation and Safety Act (“MAUCRSA”) became effective in 2018. However, Proposition 64 did not make clear whether CBD use is still considered legal if it is sold outside of a state-sanctioned recreational or medical dispensary. The uncertainty can be a cause for concern for businesses looking to enter the CBD industry.
The good news is CBD usage is generally legal in California because marijuana is legal. Hemp-sourced CBD, and marijuana-sourced CBD for medical and recreation use are all legal; thus, CBD products are legal in California. The only exception is that the California Department of Health prohibits CBD from being added to food until it has been approved by the Food and Drug Administration (“FDA”). For this reason, physical therapists need to be wary of any CBD-food-type supplement.
California is one of the states that has laws in place authorizing the production of industrial hemp, the source of CBD. However, California has not yet fully set up its industrial hemp registration and licensing system – once it does so, there will likely be more legal guidance and clarity on the sales of hemp and CBD-based products. According to the California state Department of Food and Agriculture (“CDFA”): “All growers of industrial hemp for commercial purposes must register with the county agricultural commissioner prior to cultivation. Registration is not yet available. The fees and process for registration will be developed by CDFA, which will consider recommendations from the Industrial Hemp Advisory Board.” CDFA recommend you contact your local public health official for more information on general rules and restrictions that may apply to any products you intend to manufacture or sell.
Additionally, the California Department of Public Health (CDPH) has published answers to frequently asked questions related to manufactured food products containing cannabinoids, and the United States Food and Drug Administration has published guidance related to cannabis and cannabis-derived productions, including foods and CBD. For more information regarding California and federal guidelines on industrial hemp-derived products, contact CDPH’s Food and Drug Branch.
Physical Therapy Practice Act
Currently, neither the Physical Therapy Board regulations nor the Physical Therapy Practice Act address or directly regulate CBD products. They neither prohibit the sale of such products nor do they authorize integration of CBD products into a physical therapy practice. And a search of the Board’s website reveals little in the area of policy issued on the subject.
The biggest risk to a physical therapist discussing cannabis or CBD with a patient stems from Business and Professions Code section 651, which applies to all health care providers and prohibits dissemination of false or misleading information regarding services or products, which would include CBD or any other supplement. A physical therapist cannot make any false or misleading statements about their services or products. Broken down, here is what a physical therapist cannot do (that is grounds for license discipline and could be a misdemeanor):
- To disseminate misleading information to directly or indirectly induce (or sell) services of products.
- This includes Internet and electronic communication.
- To create unjustified “expectations of favorable results.”
Thus, the risk to a physical therapist, or any health care provider to which Section 651 applies, is in the communication about CBD to patients.
Communication about CBD Use
Even though the Physical Therapy Board has not yet regulated this area, physical therapists must educate themselves about CBD. The staff of a physical therapy practice must also be educated about CBD as there lacks substantial research about its efficacy. Although there has been evidence that CBD can help reduce pain and inflammation and promote wound healing, there is continuing research in this area.
An American Physical Therapy Association magazine article provides:
CBD, 1 of many cannabinoids found in marijuana that exhibits medicinal properties, is non-psychoactive and legal to use… It can be difficult to get an unbiased view of MMJ [medical marijuana] and cannabis. On one hand, although the FDA website contains updated information about states that have legalized marijuana, it’s a federal website that, along with other federal websites (such as for the Centers for Disease Control and Prevention), presents a certain perspective. Websites that are strongly pro-cannabis (such as the National Organization for Reform of Marijuana Laws [NORML] and the Marijuana Policy Project), meanwhile, present a different perspective.
Given the developing science on CBD and its uses for treating different types of chronic pain, it is important that a physical therapist base any recommendations upon proper studies. For example, a study from the European Journal of Pain showed, using an animal model, CBD applied on the skin could help lower pain and inflammation due to arthritis. Another study demonstrated the mechanism by which CBD inhibits inflammatory and neuropathic pain, two of the most difficult types of chronic pain to treat. More study in humans is needed in this area to substantiate the claims of CBD proponents about pain control.
Integration into Practice –Compliance
To achieve the physical therapist’s goal to reduce pain and manage symptoms of certain conditions, such as sports injury or physical rehabilitation following surgery, integrating CBD into the practice poses some risks as described above. But both the Medical Board and the Veterinary Board offer some guidance by analogy.
The Medical Practice Act provides a safe harbor provision regarding providing nutrition advice at Business and Professions Code section 2068. The section states that “This chapter shall not be construed to prohibit any person from providing nutritional advice or giving advice concerning proper nutrition.” It also requires someone providing nutritional advice to post a notice that such advice is not “diagnosis, prevention, treatment, or cure of any disease, pain, deformity, injury, or physical or mental condition.” The Notice is set forth below.
Such a notice clarifies any expectation a patient may have about the curative properties of supplements, and a similar type notice would be useful for CBD products to avoid the pitfalls of Business and Professions Code section 651 discussed above.
As referenced above, the Veterinary Medical Board has actually tackled the issue of what to communicate with pet owners regarding CBD. That Board suggests that veterinarians document discussions with clients and may include:
- The variability of quality, source, safety, and testing of cannabis products (pesticide contamination, potentially harmful co-ingredients).
- No federal or state agency oversees standardization of cannabis product concentrations.
- Research to date is lacking conclusions regarding dose, toxicity, and efficacy.
- The side effects and signs of overdose or toxicity (e.g., ataxia, depression, vomiting, urinary incontinence, bradycardia, hyperthermia, tremors, anorexia, adipsia, hypothermia, seizure, stupor, tachycardia, weakness).
- Safeguarding of cannabis products from pets and human exposures.
- Possible interactions with other treatments and prescribed medications.
- Reminder to the client that cannabis is not being recommended or prescribed by the veterinarian.
- The importance of periodic re-evaluation of the patient in accordance with good veterinary practice.
The physical therapist should engage in similar discussions or admonitions as appropriate, being mindful that unlike a veterinarian, the physical therapist is not a diagnostician, and patients should consult their physicians.
The issue with integration of CBD products into a physical therapy practice is the current uncertainty regarding regulation and the risk of miscommunication or misunderstood patient expectations.
As the law develops on the regulation of CBD, further permissible uses will become clear. As of now, physical therapists must be prepared to provide very clear guidance on the use and purpose of the CBD products, how they are in no way prescribing medication, and avoid indicating that the products will have a certain effect on their patients’ health. It is always recommended that physical therapists seek the advice of experiences health care lawyers regarding this everchanging landscape of CBD.
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Sasha G. Aguilar is an Associate Attorney with the Government and Administrative Law firm of Simas & Associates, Ltd., in Sacramento, San Luis Obispo, San Jose, and San Diego, California. Ms. Aguilar practices in the areas of Healthcare Regulation, Professional Licensing and Regulation and Workplace and Employment Regulation. The firm has proudly served as legal counsel to the California Physical Therapy Association since 2004 and can be reached at email@example.com.