By Barbara J. Zabawa, JD, MPH
What is “functional medicine?”
According to the Institute for Functional Medicine:
Functional Medicine is a systems biology–based approach that focuses on identifying and addressing the root cause of disease. Each symptom or differential diagnosis may be one of many contributing to an individual’s illness.
Thus, wellness professionals who want to incorporate functional medicine principles into their wellness practice will inevitably be diagnosing conditions and looking to address the root cause of those conditions.
Diagnosing is an activity of licensed professions, particularly medicine. Hence, the name functional “medicine.” Of all licensed professions, medicine has the broadest scope. Physicians licensed as Medical Doctors (MDs) or Doctors of Osteopathy (DOs) can perform a wide variety of activities related to health and illness. All other licensed health practitioners have a narrower scope that MDs or DOs. They are usually limited to a certain body part, or to certain modalities. Or, they must practice under the supervision of a physician to perform their licensed duties, such as nurses or physician assistants, depending on each state’s licensure laws.
As a result, wellness professionals who wish to practice functional medicine must first decide if diagnosing and finding the root cause of disease or illness falls within their scope of practice. To do this, one must look to the professionals state licensure laws, and in particular the definition of the professional’s practice. If the definition of the licensed wellness professional’s practice includes the ability to diagnose (or to “examine,” for example), then functional medicine may be something the wellness professional can incorporate. Wellness professionals who are interested in starting a functional medicine practice who are not licensed MDs or DOs should work with their legal counsel to confirm that functional medicine falls within the professional’s scope of practice.
Just to reviews, the Federation of State Medical Boards defines “scope of practice” as:
The activities that an individual health care practitioner is permitted to perform within a specific profession. Those activities should be based on appropriate education, training, and experience. Scope of practice is established by the practice act of the specific practitioner’s board, and the rules adopted pursuant that act.”
If a wellness professional, in consultation with their legal counsel, determines that functional medicine is within their scope of practice, the professional should also consider whether using the term “functional medicine” also presents compliance risk. If the wellness professional is not a licensed MD or DO, using the term “medicine” to describe the scope of your services could be interpreted as misleading at best, or as the unlicensed practice of medicine at worst. Wellness professionals such as chiropractors, nurses, physical therapists and others should work with legal counsel to ensure that any messaging is not in violation of Federal Trade Commission (FTC) standards or state licensure laws. Such practitioners could consider practicing “functional health” instead of “functional medicine” to reduce compliance risk.
But what about unlicensed wellness professionals, such as health coaches or exercise professionals? Currently, there is no definition under any state licensure law as to the coach or fitness professional’s scope of practice. Some certifying organizations provide a “scope of practice” description of sorts for their various levels of certification.
However, it is highly unlikely that courts will consider scope of practice descriptions provided by professional organizations when analyzing scope of practice violations. Courts will determine scope of practice violations two ways: (a) criminal charges due to crossing over the line into a licensed practice, and (b) civil claims such as negligent conduct (resulting in harm to someone) due to practicing outside one’s credentials (e.g., education, training, and experience).
In their practice, fitness and wellness professionals could cross over into licensed professions such as medicine (e.g., diagnosing and treating a medical condition), physical therapy, athletic training, etc. However, one of the biggest concern is in the areas of nutrition/dietetics. Proper nutrition is a big part of Functional Medicine practices. Fitness and wellness professionals often have (a) received some nutrition education in their academic programs, (b) one or more of the many nutrition certifications, or (c) even a degree in nutrition. But none of these qualifications allow for the practice of dietetics/nutrition in any of the states that require a license to practice nutrition or dietetics.
Penalties for violating state licensing statutes are specified in the statute. See the table below for the types of penalties that someone can face who has crossed over the line into a license practice. To prevent these types of penalties, fitness and wellness professionals need to be aware of how scope of practice is defined in applicable state statutes. For example, if fitness and wellness professionals provide “individualized” nutrition advice and services (e.g., nutrition assessments, nutrition counseling), it would likely be considered practicing dietetics without a license. However, if they stick to providing “general” nutrition education, it likely will not constitute the practice of dietetics. Ohio statutes provide guidance to help understand the distinction between what licensed dietitians do in their practice and what non-licensed individuals can do to prevent being exposed to any criminal penalties.
Penalties for Violating State Licensing Statutes*
A Cease and Desist Notice: Issued to any person violating this statute. The violation can result in a fine between $500 and $5000. Each day the unlicensed practice continues after the notice, a separate violation can be charged.
3rd Degree Felony: Minimum penalty — Fine of $1000 and mandatory period of incarceration of 1 year.
2nd Degree Felony: Practice results in serious bodily injury; Minimum penalty same as 3rd degree felony.
1st Degree Misdemeanor: Minimum penalty is a fine of $500 and imprisonment for 30 days
*Florida’s Law: Unlicensed practice of a health care profession. Fla Stat. § 456.065
Practice of Dietetics and General Non-Medical Nutrition Information
Practice of Dietetics* — restricted to those with a license
- Nutritional assessment to determine nutritional needs and to recommend appropriate nutritional intake, including enteral and parenteral nutrition.
- Nutritional counseling or education as components of preventive, curative, and restorative health care.
- Development, administration, evaluation, and consultation regarding nutritional care standards.
* Dietetics. Ohio Rev, Code Ann § 4759-01, 2013. http://codes.ohio.gov/orc/4759
General Non-Medical Nutrition Information** — not restricted Providing information on the following:
- principles of good nutrition and food preparation;
- food to be included in the normal daily diet;
- the essential nutrients needed by the body;
- recommended amounts of the essential nutrients;
- the actions of nutrients on the body;
- the effects of deficiencies or excesses of nutrients; or
- food and supplements that are good sources of essential nutrients
** Dietetics. Ohio Rev, Code Ann § 4759-2-01(M), 2009. http://www.dietetics.ohio.gov/bulletins/bulletin8.pdf
Civil Claims – Negligence
In criminal cases, the issues often deal with conduct that violates state licensing statutes, not any conduct that causes harm. If individuals are harmed (physically or emotionally) due to the instruction/advice given to them by a fitness/wellness professional, it can lead to a various civil claims including negligence and gross negligence against the professional and his/her employer.
Additional issues that need to be addressed are (a) what action(s) an employee can take if he/she is injured while participating in the company’s fitness/wellness programs, i.e., a negligence claim or workers’ compensation claim, and (b) should employees sign a waiver prior to participation. Both types of claims can be costly for the employer, so focusing on the prevention of injuries is essential. Generally, if an injury is compensable under workers’ compensation, the employee cannot sue his/her employer for negligence.
An example of a negligence case involving a wellness professional is Capati v. Crunch Fitness, Mrs. Capati a young mother of two children, was taking medication for hypertension. While on this medication, her personal fitness trainer at Crunch Fitness advised her to take a variety of nutritional and dietary supplements including some that contained ephedra. One day, while performing squats at the Club, Mrs. Capati became very ill and later died of a stroke at the hospital. Her husband filed a $320 million wrongful death claim against the defendants (the trainer, the Club, and a variety of other defendants including Vitamin Shoppe Industries) seeking both compensatory and punitive damages. The trainer testified that he did give her advice as to certain foods and supplements but he did not inform her that there may be negative health consequences to consume those foods or supplements while on hypertension medication and while working out. The trainer probably did not realize that the combination of hypertension medication and ephedra can be lethal, i.e., he did not understand the precautions he needed to take for someone on hypertension medication. The case was settled out of court for over $4 million with the trainer and Club being liable for $1,750,000 and the other defendants being liable for the remaining amount.
In addition to risks associated with recommending supplements, fitness/wellness professionals need to realize that any nutritional/dietary advice they provide to someone who is later harmed by that advice can lead to a negligence claim/lawsuit against them. Fitness/wellness professionals cannot claim, as a legally-effective defense, that they were unaware of any harmful consequences that occurred due to the nutritional advice they provided. Wellness professionals can be found negligent for any harm they caused from their improper instruction or advice. It is best to only provide “general, non-medical nutritional information” and refer participants/clients to a qualified dietitian/nutritionist or their primary care doctor for “individualized” advice. It also is important to realize that RDNs often conduct different health screenings than wellness professionals such as health coaches. For example, they screen for all types of medical conditions and they also know the specific nutritional needs for individuals with medical conditions.
Functional medicine offers an important alternative to traditional medical care, and it is understandable why so many clients of the Center for Health and Wellness Law, LLC embrace it. However, it is important that wellness professionals establish practices that are compliant with the law, both for the protection of the professional’s practice and the people they serve. Having a strong legal partner such as the Center for Health and Wellness Law, LLC is essential to any thriving wellness practice. We can help with setting the proper expectations between you and your patients or clients, as well as ensuring your business is established in the best way possible for you and the community you serve. Contact the Center for Health and Wellness Law, LLC.
 Assessing Scope of Practice in Health Care Delivery: Critical Questions in Assuring Public Access and Safety, Federation of State Medical Boards (2005). Available at: https://www.fsmb.org/Media/Default/PDF/FSMB/Advocacy/2005_grpol_scope_of_practice.pdf (last visited September 23,, 2016).
 David L. Herbert, 1999. $320 Million Lawsuit Filed Against Health Club, The Exercise Standards and Malpractice Reporter 13(3):33,36 (June 1999).
 Wrongful Death Case of Anne Marie Capati Settled for Excess of $4 million, The Exercise Standards and Malpractice Reporter 20(3): 36 (May 2006).