Last fall, before being named the senior U.S. health official, Robert F. Kennedy Jr. said the Trump administration would liberate Americans from the FDA’s “aggressive suppression” of vitamins, dietary supplements, and other substances — ending the federal agency’s “war on public health,” as he put it.

In fact, the FDA can’t even require that supplements be effective before they are sold. When Congress, at the agency’s urging, last considered legislation to require makers of vitamins, herbal remedies, and other pills and potions to show proof of their safety and worth before marketing the products, it got more negative mail, phone calls, and telegrams than at any time since the Vietnam War, by some accounts. The backlash resulted in a 1994 law that enabled the dietary supplement industry to put its products on the market without testing and to tout unproven benefits, as long as the touting doesn’t include claims to treat or cure a disease. Annual industry revenues have grown from $4 billion to $70 billion since.

With Kennedy now in the driver’s seat, the industry will likely expect more: It aims to make bolder health claims for its products and even get the government, private insurers, and flexible spending accounts to pay for supplements, essentially putting them on an equal footing with FDA-approved pharmaceuticals.

On Feb. 13, the day Kennedy was sworn in as secretary of Health and Human Services, President Donald Trump issued a “Make America Healthy Again” agenda targeting alleged corruption in health regulatory agencies and instructing them to “ensure the availability of expanded treatment options and the flexibility for health insurance coverage to provide benefits that support beneficial lifestyle changes and disease prevention.”

Kennedy has said exercise, dietary supplements, and nutrition, rather than pharmaceutical products, are key to good health. Supplement makers want consumers to be able to use programs like health savings accounts, Medicare, and even benefits from the Supplemental Nutrition Assistance Program, or SNAP, to pay for such items as vitamins, fish oil, protein powders, and probiotics.

“Essentially they’re seeking a government subsidy,” said Pieter Cohen, a Harvard University physician who studies supplements.

As the Senate Finance Committee questioned Kennedy during his Jan. 29 confirmation hearing, supporters in the Alliance for Natural Health lunched on quinoa salad in the U.S. Capitol Visitor Center and crowed that the moment had finally arrived for their health freedom movement, which has combined libertarian capitalism and mistrust of the medical establishment to champion unregulated compounds since the 19th century.

“The greatest opportunity of our lifetimes is before us,” said Jonathan Emord, the group’s general counsel, who has brought many successful lawsuits against the FDA’s restrictions on unproven health claims. “RFK has dedicated his whole life to opposing the undue influence” of the pharmaceutical industry and “assuring that our interests triumph,” Emord said.

In speeches and in a pamphlet called “The MAHA Mandate,” Emord and alliance founder Robert Verkerk said Kennedy would free companies to make greater claims for their products’ alleged benefits. Emord said his group was preparing to sue the FDA to prevent it from restricting non-pharmaceutical production of substances like biopeptides — complex molecules related to drugs like Ozempic.

HHS spokesperson Andrew Nixon did not respond to a request for comment on the agency’s plans vis-à-vis dietary supplements.

While the basic law governing the FDA establishes that a substance alleged to have treatment or curative effects is by definition a “drug,” and therefore comes under the agency’s requirements for high standards of scientific evidence, the new administration could reallocate money away from enforcement, said Mitch Zeller, former head of the FDA’s Center for Tobacco Products.

As a Senate aide early in his career, Zeller investigated a tainted L-tryptophan supplement that killed at least 30 people and sickened thousands in the U.S. in 1989. The scandal led the FDA to seek heavier regulation of supplements, but a powerful backlash resulted in the relatively weak supplements law of 1994.

Even that law’s enforcement could be undercut with a stroke of the pen that would keep FDA inspectors out of the field, Zeller said.

Sweeping changes couldn’t come too soon for Nathan Jones, founder and CEO of Xlear, a company that makes products containing xylitol, an artificial sweetener. The Federal Trade Commission sued Xlear in 2021 for making what it called false claims that its nasal spray could prevent and treat covid.

Jones points to a handful of studies evaluating whether xylitol prevents cavities and infections, saying the FDA would require overly expensive studies to get xylitol approved as a drug. Meanwhile, he said, dentists have been bought out by “Big Toothpaste.”

One can hardly find any products “without fluoride for oral health,” he said. “Crest and Colgate don’t want it to happen,” he said.

Kennedy’s desire to rid water supplies of fluoride because of its alleged impact on children’s IQ is welcome news, he said, and not only because it could highlight the value of his products. Jones stresses, as do many health freedom advocates, that clean air and water and unadulterated food do more to prevent and cure disease than vaccines and drugs. For example, he and other advocates claim, wrongly, that the United States eliminated the crippling disease polio through better sanitation, not vaccination.

The Alliance for Natural Health hopes that in lieu of strict FDA standards, Kennedy will enable companies to make expanded marketing claims based on evidence from non-FDA sources, Verkerk said, such as the National Institutes of Health’s nutritional information site, which describes the pros and cons of different supplements.

Kennedy has also called for relaxing the strictures on psychedelic drugs, which interest some veterans as potential remedies for such conditions as post-traumatic stress disorder. VETS, a San Diego-based organization, has paid for 1,000 veterans to get treatment with the powerful hallucinogen ibogaine at clinics in Mexico and other countries, said the group’s co-founder Amber Capone.

She got involved after her husband, a retired Navy SEAL, pulled out of a suicidal spiral after spending a week at an ibogaine clinic near Tijuana, Mexico, in 2017. She wants NIH, the Defense Department, and the Department of Veterans Affairs to fund research on the illegal substance — which can cause cardiac complications and is listed as a Schedule I drug, on par with heroin and LSD — so it can be made legally available when appropriate.

Coincidentally, the push for less onerous standards on supplements and psychedelics would come while Kennedy is demanding “gold-standard science” to review preservatives and other food additives that he has said could play a role in the country’s high rate of chronic diseases.

“Put aside the fact that there’s precious little evidence to support” that idea, said Stuart Pape, a former FDA food center attorney. “There’s been no indication they want the same rigor for supplements and nutraceuticals.”

Although most of these products don’t have major safety concerns, “we have no idea which products work, so in the best case people are throwing away a ton of money,” Zeller said. “The worst-case scenario is they are relying on unproven products to treat underlying conditions, and time is going by when they could have been using more effective FDA-authorized products for diseases.”

Supplement makers aren’t entirely unified. Groups such as the Consumer Healthcare Products Association and the Council for Responsible Nutrition have advocated for the FDA to crack down on products that are unsafe or falsely represented. The Alliance for Natural Health and the Natural Products Association, meanwhile, largely want the government to get out of the way.

“The time has come to embrace a radical shift — from reactive disease management to proactive health cultivation, from top-down public health diktats to personalized, individual-centric care,” Emord and Verkerk state in their “MAHA Mandate.”

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People-centred care represents an essential evolution from patient-centred care, which “restores a functional life”, to person-centred care, which “promotes a meaningful life.”[1] As the authors explain, “People-centred care expands the scale and scope of person-centred care to the level of health systems and populations. People-centred care requires a whole-of-government approach that engages patients, carers, families, and communities in shared decision-making to ensure health services are provided ‘at the right time, in the right place, in the right way’.”[2]

The Commission seeks to fill crucial gaps by defining how people-centred care can be “operationally defined, rigorously measured, and effectively implemented across various settings and income levels.”[2] Achieving this will require determining the current state of people-centeredness in different contexts, developing optimal measurement approaches, and identifying best practices for the co-production of health systems and services through “shared partnership and leadership alongside people with lived experience.”[2]

Notably, the Commission is grounded in participatory principles, using “community-engaged methods and shared governance models”[2], starting with an open call for commissioner nominations. The authors emphasise, “Such a shift toward transparency and shared decision-making is crucially needed in publications with such global influence as the Lancet, which can intentionally contribute to dismantling unequal power structures in global health.”[2]

The open call aims to recruit a “diverse, independent group of multidisciplinary experts on people-centred care including people with lived experience, academic researchers, policymakers, health-care providers, private sector actors, and civil society.”[3] Commissioners will be selected rigorously based on their experience, impact, commitment to equity, networks, and availability.[3] Selection will ensure an appropriate mix of skills and diversity across gender, geography, income-level and inclusion of marginalised groups.[3]

Over 2.5 years, the Commissioners will formulate research questions, synthesise evidence, and conduct new research to inform policy and practice recommendations for operationalising people-centred care in diverse settings.[3] Working groups will use participatory, community-engaged methods aligned with people-centred principles.[3]

Through this innovative and inclusive approach, the Commission aims to “forge a new way of knowing and practicing health care in the post-Sustainable Development Goal era, using people-centred care as our guide to achieving Universal Health Coverage”[2]. If successful, this could help reorient health systems worldwide to be for and with the people they serve truly.

References:

1. Håkansson Eklund J, Holmström IK, Kumlin T, et al. “Same same or different?” A review of reviews of person-centered and patient-centred care. Patient Educ Couns 2019; 102: 3–11.

2. Duong DB, Holt B, Munoz C, Pollack TM. For and with people: announcing the Lancet Global Health Commission on people-centred care for universal health coverage and a call for commissioner nominations. Lancet Glob Health 2024; published online May 29.

3. Supplementary Appendix to Duong et al. Lancet Glob Health 2024.

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Amidst this evolving demographic, the proliferation of smartphones, wearable health monitoring devices, telemedicine, and other health-tech applications driven by today’s digital age has transformed the way consumers engage with healthcare. This has given rise to an increasingly informed patient population who are constantly looking for ways to take their health into their own hands and on the alert for innovative self-management solutions.

Against this backdrop, we are seeing a steadily rising sector in the healthcare industry that has been gaining momentum – Consumer Healthcare (CHC).  Offering affordable and accessible options for preventive care and symptom management, the CHC sector is designed to provide easily accessible services for consumers such as over-the-counter medications, personal care items, and supplements. Having reached a value of USD 284.16 billion in 2022, the global CHC market is projected to soar to USD 608.39 billion by 2032, growing at a promising trajectory of 7.91% CAGR[3]. From a SEA context, CHC represents a captivating prospect for mitigating its demographic hurdles while unlocking growth opportunities for healthcare enterprises. Here’s how healthcare businesses can tap into this potential and leverage CHC to improve patient outcomes.  

The Perfect Storm: Challenges Driving CHC Demand in APAC

There are two key challenges creating a surge in CHC demand, with the first being growing non-communicable diseases (NCDs) in the region.

NCDs are a leading cause of mortality in SEA, responsible for approximately 62% of all deaths annually, and totalling around 9 million lives lost[4]. Alarmingly, half of these deaths occur among individuals aged 30 to 69 years, highlighting the significant impact on the productive age group[5]. Among NCDs, cardiovascular diseases (CVDs) claim the highest number of lives (3.9 million deaths), followed by cancers, chronic respiratory diseases, and diabetes.  Moreover, rapid urbanization has led to lifestyle changes characterized by sedentary behaviour, unhealthy diets, as well as increased tobacco and alcohol consumption. Traditional diets are being replaced by high-calorie, low-nutrient foods, contributing to obesity, hypertension, and diabetes. Additionally, despite efforts to curb tobacco consumption, smoking rates remain the highest (26.5%) in SEA[6]. Alcohol consumption is also increasing, particularly among young adults. Along with diagnosed cases, there is a substantial portion of the population living in rural areas of SEA with undiagnosed NCDs and who are unable to afford treatment. These factors point to a considerable unmet need for NCD-specific treatments and diagnostics to address the growing burden of these diseases in the region.

The burgeoning NCD burden in Southeast Asia highlights a critical need for accessible and affordable treatments and diagnostics. CHC products have the potential to fill this market gap, offering viable solutions to address the escalating prevalence of NCDs in the region.

Secondly, the heavy NCD burden is coupled with a critical shortage of trained healthcare professionals in the region, with insufficient doctors, nurses, and other medical personnel available to meet the healthcare needs of its population. For example, Indonesia faced a staggering deficit of 31,481 specialist doctors in 2023[7]. In the same year, the Philippines health department said that the country needed 125,890 nurses and 116,032 doctors to meet WHO standards, and it would take 25 years to close the doctor-patient demand gap[8]. As a result, patients may face long wait times for appointments, limited access to specialized care, and challenges in receiving timely medical attention. Furthermore, the shortage can lead to overburdened healthcare facilities, increased workloads for existing staff, and compromised quality of care as professionals feel burnout[9]. This exacerbates healthcare disparities and hampers efforts to ensure equitable access to healthcare.

Given SEA’s shortage of healthcare professionals, there is an urgent call for accessible and self-directed healthcare options. With the increasing demand for CHC products amidst these hurdles, the CHC sector offers a hopeful means to narrow the healthcare access divide and enable individuals to manage their health proactively.

Bridging the Gap: CHC’s Transformative Power

CHC also provides a wealth of benefits that cater to the region’s dynamic needs. One significant advantage of CHC is its appeal to the rising middle-class population in the Asia-Pacific region. By 2030, Asia Pacific’s (APAC) middle-class population is projected to grow from 1.38 billion in 2015 to 3.49 billion[10], indicating a surge in consumers with increased disposable income who prioritize personal well-being. In addition, 51% of APAC consumers are willing to pay more out of pocket for healthcare, while 50% of high-income groups are spending more on nutritional supplements[11]. This demographic shift underscores the growing demand for health-related products and services, positioning CHC as a key player in meeting evolving consumer needs.

Additionally, CHC products have the potential to overcome geographical barriers and reach underserved areas where traditional healthcare services are lacking. More than one-third – 1.6 billion – of the APAC population lack effective access to social health protection, and less than half of its workforce enjoys legal entitlement to income security in the face of illness[12]. Due to inadequate infrastructure, CHC can provide essential over-the-counter medications and healthcare essentials in remote and rural communities with limited access to clinics and hospitals. Within these communities, chain pharmacies, personal care stores, hospitals, and clinics can function as essential healthcare nodes, acting as the first point of contact for medical care and self-care. CHC products and OTC medicines, therefore, ensure that healthcare remains accessible to all.

Moreover, CHC can empower individuals to take control of their health through proactive self-care practices and readily accessible OTC solutions. By promoting preventive measures and offering easy access to healthcare products, CHC fosters a culture of health-consciousness and empowerment among consumers.

The Road Ahead: Collaboration and Strategic Partnerships

In charting the road into SEA’s CHC industry, collaboration amongst key stakeholders emerges as the cornerstone for advancing healthcare access and ensuring the seamless delivery of quality products and services to patients across the region. This includes strategic partnerships amongst healthcare providers, CHC companies, and governmental organisations.

For CHC companies looking to drive accessibility of their products, the relevant stakeholders must set up efficient distribution channels to ensure the seamless delivery of CHC solutions to underserved populations, particularly in remote and rural areas. CHC companies can do this by partnering with service providers who have a strong understanding of SEA’s market complexities, strong market expansion services, and an extensive delivery infrastructure catered to the region’s specific needs. For example, DKSH Healthcare’s capillary distribution network has a 90% penetration in CHC with over 100 years of experience in Asia, with strong reach into chain and independent pharmacies, convenience stores, supermarkets, and hypermarkets.

Additionally, navigating the intricate regulatory landscapes of SEA emerges as a pivotal challenge. Here, partnering with companies that boast extensive regulatory expertise becomes essential. Such partnerships facilitate the negotiation of diverse regulatory frameworks, ensuring compliance with stringent standards while expediting the introduction of CHC products to the market. DKSH Healthcare’s team of 90 healthcare experts provided end-to-end assistance on regulatory challenges to help businesses adhere to compliance standards, while ensuring that patient safety takes priority. Thus, collaborative efforts among stakeholders herald a promising trajectory for CHC in SEA, bolstering healthcare accessibility and efficacy across the region.

Towards a Consumer-Driven Future for Healthcare

As the region continues to navigate healthcare disparities and demographic shifts, the rise of CHC emerges as a transformative force in addressing pressing challenges. By empowering individuals to take charge of their well-being and bridging gaps in healthcare access, CHC also paves the way for a brighter, healthier future in Southeast Asia. With the support of collaborative initiatives, it’s time for CHC business and healthcare organizations to tap into CHC’s potential to revolutionize healthcare accessibility and efficacy across the region, paving the way for a consumer-driven future in healthcare.

[1] https://www.worldometers.info/world-population/south-eastern-asia-population/#:~:text=South%2DEastern%20Asia%20Population%20(LIVE)&text=The%20current%20population%20of%20South,the%20latest%20United%20Nations%20estimates.

[2] https://asia.nikkei.com/Spotlight/Datawatch/Aging-Southeast-Asia-grapples-with-weak-social-safety-nets#:~:text=In%202019%2C%20the%20ratio%20of,to%20the%20%22aged%22%20category.

[3] https://www.who.int/southeastasia/health-topics/noncommunicable-diseases#:~:text=Noncommunicable%20diseases%20(NCDs)%2C%20principally,accounting%20for%209%20million%20persons.

[4]  https://www.who.int/southeastasia/health-topics/noncommunicable-diseases#:~:text=Noncommunicable%20diseases%20(NCDs)%2C%20principally,accounting%20for%209%20million%20persons.

[5]  https://www.who.int/southeastasia/health-topics/noncommunicable-diseases#:~:text=Noncommunicable%20diseases%20(NCDs)%2C%20principally,accounting%20for%209%20million%20persons.

[6] https://www.who.int/news/item/16-01-2024-tobacco-use-declines-despite-tobacco-industry-efforts-to-jeopardize-progress

[7] https://www.integrity-indonesia.com/blog/2023/10/10/overcoming-medical-workforce-shortages-opportunities-and-challenges-for-foreign-doctors-in-indonesia/#:~:text=According%20to%20a%20report%20from,serving%20a%20population%20of%20277%2C432%2C360.

[8] https://www.philstar.com/headlines/2023/11/13/2311040/ideal-patient-doctor-ratio-seen-25-years-lawmaker

[9] https://www.bmj.com/content/382/bmj.p1655

[10] https://www.statista.com/statistics/255591/forecast-on-the-worldwide-middle-class-population-by-region/

[11] https://www.bain.com/about/media-center/press-releases/2024/asia-pacific-consumers-especially-gen-z-are-taking-greater-ownership-in-health-and-well-being-bain-survey-finds/

[12] https://www.ilo.org/asia/media-centre/news/WCMS_831314/lang–en/index.htm

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