Natural Health Center Raises Disciplinary and Enforcement Eyebrows
A California investigation and disciplinary action against a California naturopathic doctors suggests how physicians can incur legal jeopardy when operating a medical spa, holistic healthcare practice, or integrative medicine clinic.
In this case, the ND was director of a “Natural Health” center that advertised itself as a “space where people can begin their journeys into wellness and ‘blossom.’”
The websites offered various therapies, including, according to the Accusation from Naturopathic Medicine Committee and Department of Consumer Affairs, “detoxification, replenishment, repatterning, nourishment and/or beautification.”
The Accusation brought up several aspects of the holistic health practice.
The websites explained naturopathic medicine and that training can include:
herbal and homeopathic medicine, clinical nutrition and diet; vitamins, amino acids, minerals, enzymes and nutraceuticals; physical medicine such as massage, bodywork, exercise therapy and hydrotherapy; counseling and behavioral therapies; and health and lifestyle counseling.
The Center offered various programs such as a:
- “Health plan” program
- “Weight loss” program
- “Healthy shots” program
- “Hormones” program
- “Allergies” program
- “IV therapy” program
According to the Board, the Center also offered:
- “Skinny Shot Happy Hour”
- “Skinny Shot Party”
- “Healthy Hormones Happy Hour”
- “Healthy Shots Happy Hour”
- “Reconnection to Earth” event
Included were a “Blend Bar,” “Replenish Bar,” and “Notox Beauty Bar.”
The quote marks suggest that the regulatory and enforcement disciplinary eyebrows were raised, so to speak, even though these are not uncommon practices in the industry.
The Accusation goes on and on to quote the many advertised services such as “Girl Power” shot, “Tranquil Shot,” “Super Skinny Shot,” “Immune Boost,” “Hormone Imbalance IV,” “Detox IV,” and so on. These were supposed to stimulate this and detoxify that, get rid of body fat, bulges, cellulite … the Accusation does not comment directly on these, but at least in extensively citing them prior to discussing discipline, appears to find them problematic.
On its surface, the clinic sounds no different than many others in the field. Plans and programs for weight loss, overall health—and course, with a spiritual orientation, who wouldn’t want to “reconnect to Earth?”
In this case, enforcement appears to have begun with investigation from the California Division of Occupational Health and Safety (OSHA).
Per the Accusation, OSHA found numerous health and safety violations. OSHA provided a Notice of Proposed Penalties and a Citation and Notice of Penalty for each of the violations observed during the inspection. The violations included failure to establish and implement a written Injury and Illness Preventions Program, and various other violations such as performance of injections, IV placement, cleaning, and sharps disposal in ways that exposed employees to hazards of contact with blood and contaminated sharps.
Next knock: FDA issues a warning letter to the pharmaceutical manufacturing facility for some of the products sold by the Natural Health Center. FDA cites violations of current Good Manufacturing Practices (CGMPs).
The Board’s Accusation against the ND states that the ND, as Owner and “Medical Director” of the Natural Health center:
- Used products that had been recalled by the manufacturer (including injectables).
- Failed to establish appropriate precautions, protocols and/or procedures for the storage, disposal, and/or risk of exposure to biohazards and hazardous waste.
- Failed to use the required words and/or designations in offering and/or advertising her professional services as part of the Natural Health Center.
- Permitted non-NDs to administer IV therapy.
- Diagnosed and treated dogs, without being a license veterinarian.
Additional causes of action included improper use of a naturopathic assistant, and failure to properly identify the naturopathic corporation.
It is not easy to peer behind the veil of this kind of a long Accusation and determine exactly what motivated the investigation in the first place, or which of the charges weighed more heavily in the minds of enforcement authorities.
Significant to us is this one:
Failed to use the required words and/or designations in offering and/or advertising her professional services as part of the Natural Health Center.
Because clients often confuse professional, clinical activities from non-professional ones (such as, for example, creation of an MSO to help manage concerns about corporate practice of medicine and anti-kickback / fee-splitting), this disciplinary case suggests that MDs, NDs and other licensed healthcare providers pay special attention to delineating professional from non-professional activities.
Two other points are:
- Be sure that marketing and advertising are compliant with California law. If the marketing is overly aggressive, it could trigger enforcement scrutiny.
- Beware of ancillary violations, such as those involving OSHA or (as in this case) FDA issues tied to the manufacturer who provides products.
With detailed attention to legal compliance issues, integrative care centers, medical spas, and holistic health care centers can thrive.
Contact our healthcare law and FDA attorneys for legal advice relevant to your healthcare venture.
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