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No More Wild West: The Need for Wellness Professional Standards

Published online by Cambridge University Press:  30 December 2024

Barbara J. Zabawa*
Affiliation:
Associate Professor of Law, University of Missouri Kansas City Law School

Abstract

The burgeoning wellness industry attracts a lot of practitioners who are largely unregulated. This “wild west” of wellness creates uncertainty for insurers, employers, consumers, and practitioners as to: (1) what services and items wellness practitioners can offer; (2) whether those practitioners are qualified; and (3) whether they behave in an ethical manner. Some guideposts for these wellness stakeholders would be welcome and may reduce consumer harm. Guideposts for wellness is especially crucial in a time when the Braidwood Management, Inc. v. Becerra case threatens the delivery of preventive care services in the health care sector. As we have learned from the health care sector, the state licensure scheme is confining and not conducive to national practice, particularly in the wake of virtual platform technologies. Thus, instead of state licensure, this article proposes a private Standard Development Organization (SDO) scheme that can create and enforce standards within the wellness industry.

Type
Articles
Copyright
© 2024 The author(s). Published by Cambridge University Press on behalf of American Society of Law, Medicine & Ethics and Trustees of Boston University

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References

1 29 C.F.R. § 2590.702(c)(3) (2014).

2 42 U.S.C. § 12112(d)(4) (2008).

3 29 C.F.R. § 2590.702(a)(1) (2014); 45 C.F.R. § 156.125 (2022); see also Mary Crossley, Discrimination Against the Unhealthy in Health Insurance, 54 Kan. L. Rev. 73, 75 (2005).

4 26 U.S.C. § 213(d); see also Barbra J. Zabawa & JoAnn Eickhoff-Shemek, The Rules of Workplace Wellness Programs 147-49 (Am. Bar Assoc. Book Publ’g 2d. ed. 2021) (noting that § 213 is an exception carved out of the general rule of § 262, which prohibits deductions for personal, living, or family expenses).

5 Id. (citing Publication 502 (2023), Medical and Dental Expenses, Internal Revenue Serv., https://www.irs.gov/publications/p502 [https://perma.cc/8NK2-ZNNM]) (noting that expenses for cosmetics, toiletries, weight-loss programs that are not to treat a specific disease diagnosed by a physician, vitamins, health club dues, and other general wellbeing activities or items are not deductible).

6 Stephen McInerney, Can You Diagnose Me Now? A Proposal to Modify the FDA’s Regulation of Smartphone Mobile Health Applications with a Pre-Market Notification and Application Database Program, 48 U. Mich. J.L. Reform. 1073, 1086-87 (2015); U.S. Food & Drug Admin., Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration (2007) (citing 21 U.S.C. § 321(g)(1) to define “drug”).

7 U.S. Food & Drug Admin., General Wellness: Policy for Low Risk Devices (2019); see also Yvonne Abraham, Dietary Supplements, Largely Unregulated, Deserve the State’s Skepticism, Bos. Globe (Jan. 29, 2020, 5:53 AM), https://www.bostonglobe.com/2020/01/29/metro/dietary-supplements-largely-unregulated-deserve-states-skepticism/ [https://perma.cc/94J5-KLHP].

8 See Robert I. Field, Why Is Health Care Regulation So Complex?, 33 Pharm. & Therapeutics 607, 607 (2008) (“Health care regulations are developed and enforced by all levels of government — federal, state, and local — and also by a large assortment of private organizations. At times, they operate without coordination.”); Katie Suleta, Health Care Coaches Are the Next Big Thing. They’re Also Completely Unregulated, STAT (May 9, 2023), https://www.statnews.com/2023/05/09/health-care-coaches-regulation/ [https://perma.cc/W8XD-HG7N]; see also Lisa Held, Psychic Mediums Are the New Wellness Coaches, N.Y. Times (Mar. 3, 2019), https://www.nytimes.com/2019/03/19/style/wellness-mediums.html [https://perma.cc/T2HQ-5VZ2] (noting that psychic mediums are self-regulated).

9 Sharon Elayne Fair, Wellness and Physical Therapy 23 (Jones & Bartlett 2009).

10 Colleen Derkatch, Why Wellness Sells 6-7 (2022).

11 Jessica Wapner, Medicine’s Wellness Conundrum, New Yorker (Nov. 6, 2021), https://www.newyorker.com/science/annals-of-medicine/medicines-wellness-conundrum [https://perma.cc/PU9B-6EQX]

12 Id. (noting that wellness has expanded to include the elimination of disease and disability, particularly those illnesses viewed as lifestyle driven).

13 Id. at 24. Later in this article and in a separate article I highlight the faultiness in this assumption. See Barbara Zabawa, Countering Workplace Wellness Bias through Wellness-Legal Partnerships, J. L. & Health (forthcoming 2024).

14 Shaun Callaghan et al., Still Feeling Good: The US Wellness Market Continues to Boom, McKinsey & Co. (2022), https://www.mckinsey.com/industries/consumer-packaged-goods/our-insights/still-feeling-good-the-us-wellness-market-continues-to-boom [https://perma.cc/96ZE-8NRS].

15 Id.

16 32 Health and Wellness Business Ideas for 2022, Wellpreneur, https://wellpreneur.com/health-and-wellness-business-ideas/ [https://perma.cc/3HA2-2NCH] (listing the following wellness practitioner titles: health and wellness coach, holistic health counselor, corporate wellness coach or consultant, yoga teacher, personal trainer, nutritionists and nutritional therapists, herbalists, acupuncturist, weight loss coach, personal chef, massage therapist, services related to aging and senior health, wellness retreats); Held, supra note 8; see also Jenny Cowley et al., Almost Anyone Can Become a Life Coach. A Hidden Camera Investigation Reveals Why That’s a Problem, CBC News (Feb. 26, 2022, 4:00 AM) https://www.cbc.ca/news/canada/marketplace-life-coach-1.6364745 [https://perma.cc/5YKE-T6YH] (finding some life coaches in Canada trying to treat clients’ anxiety and depression without proper credentials and training).

17 Barbara J. Zabawa, Health Coach Legal Guidelines, Wellness Council of Am., https://www.welcoa.org/blog/health-coach-legal-guidelines/ [https://perma.cc/SKN9-PBHH].

18 Crystal L. Park et al., Who Practices Yoga? A Systematic Review of Demographic, Health-Related, and Psychosocial Factors Associated with Yoga Practice, 38 J. Behav. Med. 460, 463 (2015).

19 Wellness Specialist Demographics and Statistics in the US, Zippia, https://www.zippia.com/wellness-specialist-jobs/demographics/ [https://perma.cc/KP7K-EUTA]; What Does a Wellness Specialist Do?, Zippia, https://www.zippia.com/wellness-specialist-jobs/what-does-a-wellness-specialist-do/ [https://perma.cc/R6MF-67L9] (last updated Feb. 16, 2024) (defined “wellness specialist” as a person “responsible for guiding clients in achieving their wellness and healthy lifestyle goals by creating fitness training and programs according to clients’ needs and concerns,” conduct regular counseling for their clients regarding daily activities, exercise, routines, stress levels, and eating habits, suggests various supplementary medication and meal recommendations to help stabilize clients’ immune systems and energize them on daily tasks).

20 Best Colleges and Majors for Wellness Specialists, Zippia, https://www.zippia.com/wellness-specialist-jobs/education [https://perma.cc/XD2A-ZLBX]. It is unclear from the data whether the certificate statistic overlaps with the degree statistic.

21 Jennifer Miller, Why are Nurses Quitting? Ask the Nurse No Hospital Will Hire., Wash. Post (Feb. 21, 2023, 8:00 AM), https://www.washingtonpost.com/lifestyle/2023/02/21/katie-duke-instagram-nursing-pandemic/ [https://perma.cc/DU3J-VWYB]. Anecdotally, in my almost ten-year practice as a wellness lawyer, I have seen a growing interest in wellness from registered nurses, physician assistants, nurse practitioners, psychologists, respiratory therapists, and even physicians. Most of these individuals have expressed exhaustion with traditional health care, particularly in the aftermath of COVID-19.

22 Off. of the Assistant Secy for Planning & Eval., Dept of Health & Hum. Servs., No. HP-2022-13, Impact of the COVID-19 Pandemic on the Hospital and Outpatient Clinician Workforce 13 (May 2022), https://aspe.hhs.gov/sites/default/files/documents/9cc72124abd9ea25d58a22c7692dccb6/aspe-covid-workforce-report.pdf [https://perma.cc/DTG2-G9Y5].

23 Id.

24 See, e.g., Rina Raphael, The Gospel of Wellness 266 (2022) (discussing how egg freezing start-ups’ use of trendy terms like “self-care” transforms a medical procedure into something more empowering and destigmatizes fertility treatment).

25 Marisa Meltzer & Dani Blum, A Ketamine Clinic Treads the Line Between Health Care and a “Spa Day for Your Brain, N.Y. Times (Mar. 14, 2022), https://www.nytimes.com/2022/03/11/well/mind/wellness-ketamine-mental-health.html [https://perma.cc/SL77-25EB].

26 Dana Goodyear, California Makes Marijuana a Wellness Industry, New Yorker (Jan. 31, 2018), https://www.newyorker.com/culture/photo-booth/california-makes-marijuana-a-wellness-industry [https://perma.cc/47N6-NPYT] (noting that “thousands of people—disproportionately people of color—have been arrested or jailed on marijuana-related charges,” but marijuana is now being marketed to affluent Californians as a way to optimize personal experience, regulate moods, appetites, pain and creative flow).

27 Held, supra note 8.

28 Tonia Callender, Adding Color to Wellness, in The Future of Wellness 2021 63, 64 (2021) (discussing how the wellness industry is largely catered to white individuals).

29 Tainya C. Clark et al., Use of Yoga, Meditation, and Chiropractors Among U.S. Adults Aged 18 and Over, at 4 (Natl Ctr. for Health Stats., Data Brief No. 325, 2018), https://www.cdc.gov/nchs/products/databriefs/db325.htm [https://perma.cc/XW8D-F46Q] (noting that past research has identified yoga, meditation, and seeing a chiropractor as some of the most commonly used complementary health approaches).

30 Suruchi Mishra et al., Dietary Supplement Use Among Adults: United States, 2017-2018, at 2 (Natl Ctr. for Health Stats., Data Brief No. 399, 2021), https://www.cdc.gov/nchs/products/databriefs/db399.htm [https://perma.cc/7UBH-J8SD].

31 Cary Funk et al., Pew Rsch. Ctr., Vast Majority of Americans Say Benefits of Childhood Vaccines Outweigh Risks 32 (2017), https://www.pewresearch.org/science/2017/02/02/vast-majority-of-americans-say-benefits-of-childhood-vaccines-outweigh-risks/ [https://perma.cc/SE52-95ZT].

32 Id.

33 Colleen Derkatch, Why Wellness Sells: Natural Healing in a Pharmaceutical Culture 11-12, 25 (2022) (ebook) (“Underneath all the pills, products, gurus, clinics, and mantras that wellness culture comprises is a drive to access some approximation of what we perceive as the good life” and maintaining that wellness is ultimately an object of ‘cruel optimism’—something we ardently desire that, in our seeking it, becomes an obstacle to our flourishing.”).

34 Id. at 25. The author also quotes Nicole Cliffe, who “mused” on Twitter, “The person who came up with ‘wellness’ as a product adjective is probably living in a castle carved out of gold right now.” Id. (quoting Nicole Cliffe (@Nicole_Cliffe), Twitter (Mar. 26, 2015, 2:31 PM), https://twitter.com/Nicole_Cliffe/status/581206965885399040 (archived by author at https://www.colleenderkatch.com/2018/04/20/archivedcliffetweet/)).

35 Funk et al., supra note 31, at 33.

36 Park et al., supra note 18, at 460.

37 Derkatch, supra note 33, at 13-14 (noting that these impacts are compounded for queer, disabled, Black, Indigenous and other people of color who live under the additional weight of individual and institutionalized discrimination, marginalization, economic disadvantage, and personal and intergenerational trauma).

38 Raphael, supra note 24, at 125; see also Richard S. Isaacs, 5 Steps to Restore Trust in U.S. Health Care, Harv. Bus. Rev. (Sept. 8, 2022), https://hbr.org/2022/09/5-steps-to-restore-trust-in-u-s-health-care [https://perma.cc/7EEX-NCYL]; Paul Hudson & Michelle A. Williams, People Are Much Less Likely to Trust the Medical System if They Are from an Ethnic Minority, Have Disabilities, or Identify as LGBTQ+, According to a First-of-Its-Kind Study by Sanofi, Fortune (Jan. 31, 2023, 7:30 AM), https://fortune.com/2023/01/31/people-trust-health-medical-system-ethnic-minority-disabilities-identify-lgbtq-study-sanofi-hudson-williams/ [https://perma.cc/4UL9-W7Q9].

39 See supra note 38; see also Francesca Butler, Is the Wellness Industry Dangerous for Our Health?, Health Poly P’ship: Blog (July 3, 2023), https://www.healthpolicypartnership.com/is-the-wellness-industry-dangerous-for-our-health/ [https://perma.cc/D8EV-TBXT] (citing Rina Raphael’s The Gospel of Wellness, which argues, according to Butler, that, “many people (especially marginalized groups) are failed by health systems… [because] they are under-represented in clinical trials and many of the challenges they face… are frequently dismissed. Furthermore, the significant gaps in the provision of mental health services mean that people have to find other ways of helping themselves,” such as the wellness industry).

40 Allana Akhtar, 3 Shady Ways Wellness Brands Lure Women into Buying Expensive, Useless Products, According to New Book “The Gospel of Wellness, Bus. Insider (Oct. 27, 2022, 5:32 PM), https://www.insider.com/rina-raphael-gospel-of-wellness-alternative-medicine-supplements-natural-organic-2022-10 [https://perma.cc/57YT-R2GK] (defining “medical gaslighting” as dismissing a patient’s symptoms and quoting Rina Raphael as saying, “For many women, traditional Western medicine seems built to make a buck, not to significantly care for their needs.”).

41 See Wapner, supra note 11.

42 See id. To be fair, as studied by the American Medical Association, physicians, like nurses, are also facing burnout and are under a lot of stress from administrative burdens, inadequate support in practices and health systems to mitigate obstacles, deliberate disinformation campaigns, political attacks on medical science, and third-party interference in the patient-physician relationship. See Jack Resneck Jr., Burnout Is a Health Crisis for Doctors—and Patients, AMA (Mar. 9, 2023), https://www.ama-assn.org/about/leadership/burnout-health-crisis-doctors-and-patients [https://perma.cc/5XLX-BLAK].

43 Dan Clarin, Kauffman Hall, 2022 State of the Healthcare Consumer Report: Who Will Help Consumers Put the Pieces Together? 9 (Sept. 27, 2022) https://www.kaufmanhall.com/insights/research-report/2022-state-healthcare-consumer-report [https://perma.cc/T4K2-3BSP] (stating that seventy percent of surveyed respondents report wanting health systems to be more actively involved in supporting their health management activities).

44 John Gerzema, Harris Poll, The Patient Experience: Perspectives on Todays Healthcare 7 (2023) https://www.aapa.org/download/113513/?tmstv=1684243672 [https://perma.cc/VGD4-558S] This poll was conducted in English and Spanish online in the United States and surveyed 2,519 adults age 18+ between February 23 and March 9, 2023.

45 Id. at 7.

46 Wapner, supra note 11 (even with the wellness industry standing ready to fill in gaps left by conventional medicine, it too is not meeting all consumers’ needs); see Callaghan et al., McKinsey & Co., supra note 14 (according to McKinsey & Company, the wellness industry fails to sufficiently meet consumer needs around sleep and mindfulness, as well as the particular needs for Black consumers; specifically, 47 to 55 percent of Black consumers said they needed more wellness products and services to meet their needs, compared to 35 to 39 percent of Asian consumers and 30 to 35 percent of White consumers); see also Ash-Har Quaraishi et al., Teens Turning to TikTok for Mental Health Advice are Self-Diagnosing, CBS News (Feb. 27, 2023), https://www.cbsnews.com/news/social-media-mental-health-self-diagnosis/ [https://perma.cc/UQ5E-MJMD] (many young people are turning to TikTok for mental health needs, leading to untrained social medial influencers to deliver misinformation about mental illness; notes that what is online is a “free-for-all” and that there is no accountability and no responsibility taken).

47 See, e.g., The Gold-Standard Wellness Certification, Natl Wellness Inst., https://nationalwellness.org/certification/ [https://perma.cc/XT3S-2QRR]; Chap. Inst., Certified Wellness Program Coordinator (2018) https://chapmaninstitute.com/wp-content/uploads/Level_I_Course_Workbook_Live_2018.pdf [https://perma.cc/V6VP-FPNY].

48 See, e.g., Nutrition Certifications & Courses, Precision Nutrition, https://web.archive.org/web/20230324005825/https://www.precisionnutrition.com/nutrition-certification; The Health Coach Training Program, Inst. for Integrative Nutrition, https://course.integrativenutrition.com/the-health-coach-training-program [https://perma.cc/24KF-D82D].

49 Steve Aldana, 22 Best Wellness Certifications, Personal Training and Health Coaching in 2023, WellSteps, https://www.wellsteps.com/blog/2020/01/02/wellness-certifications-health-coach-certifications-personal-training-certifications/ [https://perma.cc/UE8M-AW3J] (listing six fitness training organizations).

50 Id. (listing nine health coaching certification organizations); see also Sarah Haye Coomer & Aleana Hall, Best Health Coach Certification Programs 2023, Forbes (Sept. 25, 2023), https://www.forbes.com/health/wellness/best-health-coach-certification/ [https://perma.cc/8JXA-8VXN] (listing six health coaching programs); Approved Training Programs, Natl Bd of Health & Wellness Coaching, https://nbhwc.org/find-an-approved-training-program/#!directory/ord=rnd [https://perma.cc/M36T-RNKQ] (listing 126 health coach training programs at both universities and private organizations that have been “approved” by the National Board of Health and Wellness Coaching).

51 See, e.g., You Are a Healer: Professional Training for Holistic Practitioners, Sacred Wellness Sch. of Healing Art, https://www.sacredwellness.co/ [https://perma.cc/P9YE-Q2YV] (offering an “Energy Medicine Practitioner Diploma,” Reiki certifications, and crystal energy healing certifications).

52 The Best Mental Health Coach Certifications in 2023, Life Coach Mag., (Jul. 15, 2023) https://www.lifecoachmagazine.com/best-mental-health-coach-certification/ [https://perma.cc/6TSX-MRDH] (listing five programs in mental health and wellness coaching).

53 Yoga All., Yoga Alliance Annual Report: 2020-2021 16-17 (2021) https://issuu.com/yogaalliance/docs/annual_report_2020-2021_final [https://perma.cc/P2AY-J4GS].

54 For example, a Google search for “list of wellness certifications” reveals programs such as Cornell University Online’s “Wellness Coaching Certificate” and Functional Medicine Coaching Academy, Inc.’s “Functional Medicine Training program.” See, e.g., Wellness Counseling: Cornell Certificate Program, eCornell, https://ecornell.cornell.edu/certificates/healthcare/wellness-counseling/ [https://perma.cc/KN5D-CETM]; Transform Lives As a Functional Medicine Health Coach, Functional Med. Coaching Acad., Inc. https://functionalmedicinecoaching.org/program/health-coach-certification [https://perma.cc/53P6-VL53].

55 See Wellness and Physical Therapy, supra note 9.

56 Health and Wellness: Designing a Sustainable Nutrition Plan Certificate Program, Harv. Med. Sch. Exec. Ed., https://execonline.hms.harvard.edu/health-and-wellness [https://perma.cc/MJT7-4F3C].

57 Wellness Counseling: Cornell Certificate Program, eCornell, https://ecornell.cornell.edu/certificates/healthcare/wellness-counseling/ [https://perma.cc/KN5D-CETM].

58 About Us, Inst. for Credentialing Excellence https://www.credentialingexcellence.org/About [https://perma.cc/6DVH-RRG8].

59 Id.

61 Inst. for Credentialing Excellence, Accreditation Through I.C.E.: A Benchmark of Quality 2 https://www.credentialingexcellence.org/Portals/0/Docs/Accreditation/I_C_E_-Accreditation-Brochure.pdf [https://perma.cc/79FR-6K73].

63 Id.

64 For example, the American Council on Exercise (ACE) has wellness certificate programs accredited by ICE, but does not list anywhere on its website a code of ethics for individuals who complete that certificate. See Standards & Professionalism, Am. Council on Exercise, https://www.acefitness.org/about-ace/our-efforts/professionalism/ [https://perma.cc/VJ38-X2F5] (requesting exercise professionals to obtain a certification from an accredited program and stating that ACE participates in efforts to adopt standards in the wellness industry but not listing any ethical standards for ACE certificate holders specifically). Another ICE-accredited education organization, the National Exercise Trainers Association (NETA), fails to list any Code of Ethics for wellness certificate holders and does not list any grievance procedure for those adversely impacted by a NETA-trained individual. See A Clear Path to Achieve All Your Personal & Professional Fitness Goals, Natl Exercise Trainers Assn, https://www.netafit.org/ [https://perma.cc/K984-KLJS]. Cf. ACSM Member Code of Ethics, Am. Coll. of Sports Med., https://www.acsm.org/membership/member-code-of-ethics [https://perma.cc/8TFE-CRBQ] (American College of Sports Medicine (ACSM), which also has certificate programs accredited by ICE, but does have a Code of Ethics for members to follow. The website shows not only a Code of Ethics for ACSM members but also a complaint form that consumers can complete if they believe an ACSM member has violated the code of ethics); see also Accountability, Yoga All., https://www.yogaalliance.org/Our_Standards/Accountability [https://perma.cc/DB7P-FMMG] (last updated Apr. 9, 2021) (referencing and linking to a Code of Conduct for Yoga Alliance members and offering a complaint procedure and enforcement mechanism for those members who fail to adhere to the Yoga Alliance Code of Conduct, Ethical Practice and Standards). The Wellness Compliance Institute (WCI) offers a Code of Conduct for workplace wellness professionals, but there is no enforcement mechanism for failure to abide by the code. See Codes of Conduct, Wellness Compliance Inst., https://wellnessci.org/codes-of-conduct/ [https://perma.cc/D57E-Z5FD].

65 ACSM Member Code of Ethics, supra note 64.

66 Approved Training Program, Natl Bd. for Health & Wellness Coaching, https://nbhwc.org/find-an-approved-training-program/#!directory/ord=rnd [https://perma.cc/HE8U-DY25] (listing 126 health coach training programs at both universities and private organizations that have been “approved” by the National Board of Health and Wellness Coaching).

67 Program Approval Published Standards, Natl Bd. for Health & Wellness Coaching, https://nbhwc.org/program-approval-standards/ [https://perma.cc/NEQ4-JET3].

68 Approved Training Program, supra note 66.

69 Sarah Hays Coomer, What Is a Health Coach and What Do They Do?, Forbes, https://www.forbes.com/health/nutrition/what-is-a-health-coach/ [https://perma.cc/T2DJ-2TR4] (last updated Jan. 9, 2024).

70 Code of Ethics, Natl Bd. of Health & Wellness Coaching, https://nbhwc.org/code-of-ethics/ [https://perma.cc/Q89Q-R3F5] (last updated Feb. 1, 2017). In addition to approving health coaching education programs, NBHWC also offers a “Board Exam” for health coaches that complete an NBHWC-approved education program, complete 50 health and wellness coaching sessions, and document that they have completed at least an associate’s degree or 4,000 hours of work experience. Become a National Board Certified Health and Wellness Coach (NBC-HWC): Eligibility Requirements, Natl Bd. of Health & Wellness Coaching, https://nbhwc.org/exam-eligibility-requirements/ [https://perma.cc/E3EN-XB6L].

71 Code of Ethics, supra note 70.

72 Id. Although NBHWC mentions that the Code of Ethics are intended to be “enforceable standards” and asks NBHWC-credentialed coaches to pledge compliance with the Code of Ethics, there is no enforcement mechanism for consumers provided on its website.

73 See e.g., Coomer, supra note 69 (stating that health coaches, a type of wellness professional, can work for insurance companies, for corporate wellness programs or private practice); see also Suleta, supra note 8 (stating that health coaches can be hired independently from $50 to $150/session or through a workplace wellness program).

74 Heather D. Bennett et al., Health Coaching for Patients with Chronic Illness, 17 Fam. Prac. Mgmt. 24, 24-29 (2010) (stating that health coaches can help family physicians as part of the care team).

75 Occupational Outlook Handbook: Fitness Trainers and Instructors, U.S. Bureau of Lab. Stats., https://www.bls.gov/ooh/personal-care-and-service/fitness-trainers-and-instructors.htm (last visited Feb. 28, 2024).

76 Serena Oppenheim, How the Corporate Wellness Market has Exploded: Meet the Latest Innovators in the Space, Forbes (June 11, 2019), https://www.forbes.com/sites/serenaoppenheim/2019/06/11/how-the-corporate-wellness-market-has-exploded-meet-the-latest-innovators-in-the-space/?sh=3a2c6e495d91 [https://perma.cc/V8BX-H3U8] (highlighting several innovative wellness startups in the corporate wellness space); see also Abdo Riani, Four Innovative Startup Opportunities in Wellness and Mental Health, Forbes (Aug. 31, 2023), https://www.forbes.com/sites/abdoriani/2023/08/31/4-innovative-startup-opportunities-in-wellness-and-mental-health/?sh=32a96e6d3747 (featuring four wellness startups that could employ wellness professionals).

77 Victoria Franca, The Rise of Corporate Wellness to Support Employee Retention, Forbes (Nov. 4, 2022), https://www.forbes.com/sites/forbesbusinesscouncil/2022/11/04/the-rise-of-corporate-wellness-to-support-employee-retention/?sh=57ea7f124649 [https://perma.cc/J5AS-XL7T] (citing Wellable Labs, 2022 Employee Wellness Industry Trends Report 8 (2022)).

78 Id.

79 See Individual Malpractice Insurance: Fitness, Wellness & Coaching, CPH Ins., https://cphins.com/individual-wellness/ [https://perma.cc/46UG-JGKW] (offering professional liability insurance to those working in fitness, wellness and coaching).

80 See Health Coach Insurance, Alt. Balance, https://alternativebalance.com/health-coach-liability-insurance/ [https://perma.cc/PH3G-NU96] (offering professional liability insurance to health coaches, ayurveda and aromatherapy professionals, yoga professionals, and energy work professionals, among others).

81 See Healthcare Professions Covered Through HPSO, Healthcare Providers Serv. Org., https://www.hpso.com/Insurance-for-you/Individual-Practitioners/Other-healthcare-providers/Professions-covered [https://perma.cc/2Y2K-T2ZH] (offering malpractice insurance to fitness professionals, health coaches and wellness counselors, to name a few).

82 See Professional Liability Insurance Specialists for Over 100 Years, CM&F Group, https://www.cmfgroup.com/ [https://perma.cc/R7NP-QDXS] (offering malpractice insurance to various health and wellness professionals, including coaches, nutritionists and reiki practitioners).

83 Barbara Zabawa et al., Creating Standards for Wellness Professionals: The Why, Who, and How, Webinar for the National Wellness Institute (Oct. 26, 2023) (Charles Hodson stating that CPH & Associates, the professional liability insurance company he owns, does not have any standards by which to measure a policyholder’s competency and insurability risk).

84 Id.

85 Our Mission, Alt. Balance, https://alternativebalance.com/mission-ethics/ [https://perma.cc/784G-QWNW]; see also E-mail from Miriam Ball, Chief Ins. Officer of Alt. Balance, to Barbara J. Zabawa, Assoc. Professor of L., U. of Mo. Kan. City Sch. of L. (Dec. 14, 2023) (on file with author) (stating that those insureds who do not share the company’s standards are declined membership).

86 Alt. Balance, supra note 85.

87 See supra note 64 and accompanying text.

88 Press Release, U.S. Fed. Trade Comm’n, FTC Warns Almost 700 Marketing Companies that They Could Face Civil Penalties if They Can’t Back up Their Product Claims (April 13, 2023), https://www.ftc.gov/news-events/news/press-releases/2023/04/ftc-warns-almost-700-marketing-companies-they-could-face-civil-penalties-if-they-cant-back-their [https://perma.cc/TQ3J-L4FL] (stating that the FTC sent notices of penalty offenses that could total up to $50,120 per violation to “approximately 670 companies involved in the marketing of OTC drugs, homeopathic products, dietary supplements, or functional foods” and putting them on notice that they “could incur significant civil penalties if they fail to adequately substantiate their product claims”).

89 See, e.g., Press Release, U.S. Food & Drug Admin., KC Medical Spa Owner Pleads Guilty to Illegal Treatments, (July 27, 2022), https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/press-releases/kc-medical-spa-owner-pleads-guilty-illegal-treatments (finding owner of Kansas City, Missouri medical spa guilty of obtaining “Botox and Juvederm Ultra 3 over the internet and without a prescription from a website in China” and then used those illegally obtained drugs to treat patients without physician supervision; ten patients suffered adverse effects from the non-FDA approved products, which is what triggered the FDA investigation).

90 See Taylor J. Newman & Angela E. Surrett, A “License to Kale” - Free Speech Challenges to Occupational Licensing of Nutrition and Dietetics, 52 St. Marys L.J. 1181, 1191 (2021) (noting that by 1905 almost all states in the U.S. had enacted a medical licensing scheme regulating who could practice medicine) (citing Paul Starr, The Social Transformation of American Medicine (1982)); Rosemond v. Markham, 135 F. Supp.3d 574, 579 (E.D. Ky. 2015) (noting that many states have “a statutory framework for regulating the practice of psychology”); see also Nutrition Practice Laws, Council of Holistic Health Educators, https://holisticcouncil.org/nutrition-laws/ [https://perma.cc/R2AL-N4MM] (identifying 14 states that require a license to practice dietetics).

91 See, e.g., U.S. Fed. Trade Comm’n, supra note 88 (warning wellness companies to not claim their products can cure, mitigate or treat a serious disease such as cancer or heart disease unless they can back up that claim through accepted standards of scientific testing); Petition for a Writ of Certiorari at 2, Del Castillo v. Fla. Dep’t of Health, 26 F.4th 1214 (11th Cir. Apr. 27, 2022) (No. 19-13070), 2022 WL 7684540, cert denied, 143 S. Ct. 486 (stating the petitioner was communicating individualized diet advice without a license in Florida); see also Cooksey v. Futrell, 721 F.3d 226, 230 (4th Cir. 2013) (unlicensed wellness practitioner calling himself a “Diabetes Warrior” investigated by North Carolina Dietetics Board for providing individualized advice to clients with diabetes); Meg Jordan & John B. Livingstone, Coaching vs. Psychotherapy in Health and Wellness: Overlap, Dissimilarities, and the Potential for Collaboration, 2 Global Advances in Health & Med. 20, 20 (2013); see also Cowley et al., supra note 16 (finding some life coaches in Canada trying to treat clients’ anxiety and depression without proper credentials and training).

92 See, e.g., Nathan Cortez, The Law of Licensure and Quality Regulation, 387 New Eng. J. Med. 1053, 1054 (2022).

93 Barbara Zabawa & Mark Mollenhauer, Raw Data from Telephone Survey Conducted between January and May 2022 (2022) (unpublished) (on file with author).

94 Louise G. Trubek, New Governance and Soft Law in Health Care Reform, 3 Ind. Health L. Rev. 139, 149 (2006) (stating a failure of malpractice litigation as a major tool to prevent errors and improve quality of care is the random selection of cases, the high cost of litigation, and the resistance of health care institutions to use the information gained in lawsuits).

95 Bernie Garrett et al., A Taxonomy of Risk-Associated Alternative Health Practices: A Delphi Study, 30 Health Soc. Care Cmty. 1163, 1166 (2022).

96 Id. at 1169-74. Each of these harms were supported by at least three citations of evidence. Id. at 1167.

97 See, e.g., Plaintiff’s Original Petition at 3, Texas v. Davis, No. DC-22-01388 (D. Tex. Feb. 1, 2022), 2022 WL 348709, at *3 (alleging wellness influencer’s online nutrition and fitness plans were not delivered to consumers as advertised).

98 Id. at 7 (alleging that one consumer of defendant wellness influencer almost passed out from inadequate nutrition and defendant did not respond to consumer’s emails asking for assistance).

99 U.S. Food & Drug Admin., supra note 89 (noting that during the three-year operation of the medical spa, “there was never a medical doctor associated with the spa, nor was there a doctor overseeing procedures”).

100 State v. McFadden, No. CAAP–14–0000802, 2015 WL 5567996, at *1 (Haw. Ct. App. Sept. 21, 2015) (energy healer accused of sexually assaulting client); Dep’t of Licensing and Regul. Affs. v. Duncan, No. 345778, 2020 WL 359648, at *1-2 (Mich. Ct. App. Jan. 21, 2020) (disciplining licensed professional counselor who also worked as a life coach and while allegedly serving a client as a life coach, sexually assaulted her; life coach claimed he did not violate any counseling standard because he was acting as a life coach when alleged sexual encounter occurred).

101 Monier-Kilgore v. Flores, Nos. C054502, C056348, 2009 WL 1865126 at *2-3 (Cal. Ct. App. June 30, 2009) (massage therapist, reiki master and clairvoyant who befriended a client, engaged in sexual relations with her, encouraged client to avoid her family, accepted large financial gifts, including when client died, her entire estate and life insurance proceeds).

102 Cowley et al., supra note 16 (video shows a Canadian life coach that provides sexual conversion therapy and asks a client to reenact a sexual assault, causing the client overdose on drugs).

103 Garrett et al., supra note 95, at 1169-74, tbl.5.

104 Id.

105 Id.; see also Plaintiff’s Original Petition, supra note 97, at 3 (alleging wellness influencer’s online nutrition and fitness plans advertised as providing one-on-one coaching and personalized plans but in fact provided cookie cutter plan to all consumers).

106 Garrett et al., supra note 95 at 1169, tbl.5.

107 Id.

108 Id. at 1171, tbl 5.

109 Id.

110 Id.

111 Id.

112 Id. at 1173, tbl.5.

113 Id. at 1174, tbl.5.

114 Dep’t of Licensing & Regul. Affs. v. Duncan, No. 345778, 2020 WL 359648, at 1-2 (Ct. App. Mich. Jan. 21, 2020) (disciplining licensed professional counselor who also worked as a life coach and while allegedly serving a client as a life coach, sexually assaulted her; life coach claimed he did not violate any counseling standard because he was acting as a life coach when alleged sexual encounter occurred).

115 See, e.g., Plaintiff’s Original Petition, supra note 97, at 3.

116 Monier-Kilgore v. Flores, Nos. C054502, C056348, 2009 WL 1865126 at *12-13 (Cal. Ct. App. June 30, 2009).

117 Cowley et al., supra note 16 (video shows a Canadian life coach that provides sexual conversion therapy and asks a client to reenact a sexual assault, causing the client overdose on drugs).

118 Jessica L. Roberts & Leah R. Fowler, How Assuming Autonomy May Undermine Wellness Programs, Health Matrix, 27 Health Matrix 101, 105 (2017) (noting that the social determinants of health constrain certain people’s ability to make healthier choices and as a result, behavioral interventions may not impact those individuals resulting in unsuccessful wellness programs); see also Laura D. Hermer, The Means and Ends of Wellness Programs, 23 J. Health Care L. & Poly, 227, 228 (2021) (noting that medical care only plays a small role in most people’s overall health and often social, environmental and personal factors are far more important); Carrie Griffin Basas, What’s Bad About Wellness? What the Disability Rights Perspective Offers About the Limitations of Wellness, 39, J. Health Polit. Poly & L., 1035, 1052 (2014) (stating that the wellness imperative shifts the attention from societal barriers to health, discrimination based on perceived unhealthy states, and inequitable resource allocation to personal improvement and paternalistic intervention).

119 Hermer, supra note 118, at 251.

120 Of course, the health care industry must earn this respect by doing a better job of listening to patients, meeting their needs (particularly with preventive care and chronic conditions). See generally Raphael, supra note 24, at 131 (“There is a level of connection, compassion, and tailor-fit care [missing from institutionalized medical care]. Someone has to take time to ask you questions, discuss your background and body composition … It’s so personal and so detailed. And I think that’s what is attracting women to wellness.”). See also Germeza, supra note 44, at 15.

121 Raphael, supra note 24, at 145. Steve Jobs is by far not the only cancer patient to die from choosing alternative treatments. According to a Yale study, cancer patients using alternative health care in favor of medicine contributed to higher death rates. Garrett et al., supra note 95, at 1164.

122 Vera Lúcia Raposo, Complementary and Alternative Medicine, Medical Liability and the Proper Standard of Care, 35 Complementary Therapies Clinical Prac. 183, 183 (2019) (“The definition of the proper standard of care is crucial for patients, so they can conform their expectations in what regards the type of health care to be provided by complementary and alternative medicine (CAM) practitioners. It is relevant for CAM practitioners because they must know what is expected from them – by patients, health authorities, and courts – in what regards their services. It is also important for the ones that will assess the activity of the CAM providers, especially for courts in case of legal proceedings.”); see also Cary Coglianese & Angel Reed, Opinion, Law’s Interaction with Voluntary Codes and Standards, Regul. Rev. (Aug. 22, 2022), https://www.theregreview.org/2022/08/22/coglianese-reed-laws-interaction-with-voluntary-codes-and-standards/ [https://perma.cc/F8B9-WZWT].

123 Coglianese & Reed, supra note 122.

124 Id.

125 Charles Hodson, Chief Exec. Officer, CPH & Assocs., Address at the National Wellness Institute Webinar on Creating Wellness Standards (Oct. 26, 2023).

126 E-mail from Charles Hodson, Chief Exec. Officer, CPH & Assocs., to Barbara Zabawa, Assoc. Professor of L., U. of Mo. Kan. City Sch. of L. (Nov. 30, 2023) (on file with author).

127 Id.

128 Zabawa & Eickhoff-Shemek, supra note 4, at 176-79.

129 Id. It should be noted that workplace wellness programs are also not required to be accredited or based on particular evidence-based standards. See Jennifer L. Pomeranz, Workplace Wellness Programs: How Regulatory Flexibility Might Undermine Success, 104 Am. J. Pub. Health 2052, 2053-54 (2014) (noting that the federal wellness plan incentive rules promulgated at 78 FR 33158 (June 3, 2013) do not require health contingent wellness programs to be accredited or based on particular evidence based standards and that there is no evaluation component built into the wellness plan regulations to determine whether the wellness program is effective); see also Camila Strassle & Benjamin E. Berkman, Workplace Wellness Programs: Empirical Doubt, Legal Ambiguity, and Conceptual Confusion, 61 Wm. & Mary L. Rev. 1663, 1683 (2020) (stating that HIPAA regulations for wellness programs do not need to have a scientific record that the method promotes wellness).

130 Braidwood Mgmt. Inc. v. Becerra, 627 F. Supp. 3d 624 (N.D. Tex. 2022) (finding the U.S. Preventive Services Task Force (PSTF), which recommends the preventive services that health plans ultimately must cover at no cost, violates the Appointments Clause under the U.S. Constitution and therefore insurers are not required to cover any recommendations made by the PSTF since the enactment of the Affordable Care Act in 2010).

131 Id. at 644. The PSTF is a group of volunteer experts who make evidence-based scientific recommendations about the contemporary standard of care in preventive medicine. Id.

132 Id. at 646.

133 Id. at 647.

134 Brief for Am. Cancer Soc’y & Am. Cancer Soc’y Cancer Action Network et al. as Amici Curiae Supporting Appellants, Braidwood Mgmt. Inc. v. Becerra, 2023 WL 3244310, at *11 (5th Cir. 2023) [hereinafter Brief for Am. Cancer Soc’y].

135 MaryBeth Musumeci & Sara Rosenbaum, The ACA’s Promise of Free Preventive Health Care Faces Ongoing Legal Challenges, Commonwealth Fund (Oct. 20, 2023), https://www.commonwealthfund.org/blog/2023/acas-promise-free-preventive-health-care-faces-ongoing-legal-challenges [https://perma.cc/2SVA-6NP2].

136 Brief for Am. Cancer Soc’y, at *11, supra note 134. See also Sabrina Geisler, Braidwood Mgmt. v. Becerra & a Texas District Court’s Decision to Stop Enforcement of Preventive Care Coverage Requirements Under the ACA, 49 Am. J.L. & Med. 112, 119 (2023) (noting a likely reduction in access to health care services should private insurers implement cost sharing for preventive services).

137 See Germeza, supra note 44, at 6-7.

138 Carl F. Ameringer, State Medical Boards and the Politics of Public Protection 15 (1999)

(writing about the history of the medical profession and stating that changing public perception of medicine and of professions in general created the need for enhanced oversight and accountability and that medicine’s leaders were well aware that if the profession did not act, government would).

139 Paul J. Larkin, Jr. et al., Telemedicine and Occupational Licensing, 73 Admin. L. Rev. 747, 771 (2021) (noting the spread of licensing requirements over the last fifty years that now include hundreds of services including those provided by barbers, bartenders, florists, interior designers, housepainters, and tour guides); Rebecca Haw Allensworth, The (Limited) Constitutional Right to Compete in an Occupation, 60 Wm. & Mary L. Rev. 1111, 1121 (2019) (noting the Eight Circuit upholding a state’s requirement that African-style hair braiders obtain a cosmetology license and the Ninth Circuit striking down a California Structural Pest Control Board’s requirement that exterminators of rats, mice and pigeons — but not those of skunks and squirrels — obtain a state license).

140 Natl Conf. of State Legislatures, Occupational Licensing: Assessing State Policies and Practices 9 (Dec. 2020), https://documents.ncsl.org/wwwncsl/Labor/NCSL_DOL_Report_05_web_REVISED.pdf [https://perma.cc/F5NN-QA3Q].

141 Id.

142 Id. at 9, 71.

143 Raposo, supra note 122, at 184.

144 Larkin, Jr. et al, supra note 139, at 769 (“A principal hurdle to more widespread use of telemedicine — to making those temporary exceptions permanent — is the longstanding institution of state licensing of physicians.”).

145 Id. at 773-82.

146 Id. at 778. There are state licensure compacts that try to help cross-border licensed practice, but as noted by Larkin, et al., interstate compacts are insufficient.

147 Alexander C. Lemke & Alexander Macdonald, Getting a Second Wind: Reviving Natural Rights Clauses As a Means to Challenge Unjustified Occupational Licensing Regulations, 41 Pace L. Rev. 56, 56-57, 59 (2021).

148 Id. at 67.

149 Id. at 59.

150 Id.

151 Garrett et al., supra note 95, at 1167.

152 Carlos Ignacio Gutierrez et al., Lessons for Artificial Intelligence from Historical Uses of Soft Law Governance, 61 Jurimetrics J. 133, 134 (2020).

153 Id.

154 Id.

155 Id.

156 Cary Coglianese, Environmental Soft Law as a Governance Strategy, 61 Jurimetrics J. 19, 48-49 (2020).

157 Id.

158 Id.

159 Id.

160 Id.

161 Trubek, supra note 94, at 150.

162 Id. at 149.

163 Id.

164 Id.

165 Guiterrez et al., supra note 152, at 134.

166 42 U.S.C. § 18952(a) (2022).

167 Off. of Mgmt. & Budget, Exec. Off. of the President, OMB Circular No. A-119, Federal Participation in the Development and Use of Voluntary Consensus Standards and in Conformity Assessment Assignments (Jan. 27, 2016). Not every standard developing organization must qualify as an SDO. There are more flexible organizations that create standards called “Consortia” or “standards setting organizations” (SSOs) that consist of groups of like-minded participants who place a priority on developing standards quickly enough to meet market demands or harmonize or differentiate specifications within an industry. U.S. Standards System: SDOs (Private Sector), Am. Natl Standards Inst., https://www.standardsportal.org/usa_en/standards_system/sdo_private.aspx [https://perma.cc/UE5E-EU5E].

168 U.S. Standards System: SDOs (Private Sector), supra note 167.

169 Id.

170 Press Release, Dep’t of Just., Justice Department Implements the Standards Development Organization Advancement Act of 2004 (June 24, 2004).

171 Id.

172 Id.

173 Filing a Notification Under the NCRPA, Dept of Just., https://www.justice.gov/atr/filing-notification-under-ncrpa [https://perma.cc/6GKG-8K4S].

174 About the Gap Year Association, Gap Year Assn, https://www.gapyearassociation.org/about-gya/ [https://perma.cc/WT9G-ZFGS].

175 Id.

176 Id. (emphasis added).

177 Id.

178 GYA Standards and Accreditation, Gap Year Assn, https://www.gapyearassociation.org/standards-accreditation/ [https://perma.cc/HM5R-528W].

179 Id.

181 There is an organization based in the United Kingdom that aims to regulate wellness brands to ensure that they provide credible information. Raphael, supra note 24, at 273 (discussing WellSpoken). WellSpoken has a seal of approval and code of conduct for wellness information providers. See We Are WellSpoken, WellSpoken (Dec. 5, 2023), https://web.archive.org/web/20231205151722/https://wearewellspoken.com/. The code of conduct addresses endorsement of inaccurate and potentially dangerous health or wellbeing advice, ensuring information aligns with current European Union and UK legislation, ensuring information is substantiated by robust scientific evidence, not disparaging other healthcare professionals, not misrepresenting or misleading the public, being transparent and credible in the area the provider is communicating, and training in health communications. See Code of Ethics and Conduct 2017-2018, WellSpoken (Oct. 20, 2019), https://web.archive.org/web/20191020203202/https://wearewellspoken.com/wp-content/uploads/2017/10/Code-of-Ethics-and-Conduct-2017-2018-2.pdf. The website offers an email for individuals to contact the organization if the see a piece of wellness content that the individual believes “falls below a credible standard.” See WellSpoken Contact, WellSpoken (Dec. 5, 2023), https://web.archive.org/web/20231205153158/ttps://wearewellspoken.com/contact-us/.

182 See, e.g., Gutierrez et al., supra note 152, at 134-40 (noting that cybersecurity insurers give premium discounts to clients that apply National Institute of Standards and Technology cybersecurity framework and that some other indirect enforcement mechanisms include audits, certifications, internal or external reporting and oversight, insurance requirements, and litigation).

183 Trubek, supra note 94, at 163 (noting that public information about outcomes and commitment to protocols is a soft law regulatory tool).

185 Id.

186 Protect Your Services: How Can Joining the PWA Benefit Your Holistic Services?, Pro. Wellness All., https://www.pwai.us/license-benefits [https://perma.cc/62RW-BTL6].

187 Id.; ProAdvocate Grp., supra note 184.

188 ProAdvocate Grp., supra note 184.