Traditional Medicine Enters a New Regulatory Phase as FDA and WHO Push for Stronger Evidence

Traditional medicine is moving into a new phase of scrutiny and development as health regulators look for ways to separate promising therapies from products and practices that lack reliable evidence. In the United States, the Food and Drug Administration announced a new effort in September 2026 to gather public input on how botanical drugs can move more effectively through research and regulatory pathways.

The U.S. initiative comes as the World Health Organization begins implementing its Global Traditional Medicine Strategy 2025–2034, adopted by the World Health Assembly in 2025. Together, the developments point to a broader shift: traditional therapies are increasingly being evaluated not simply as cultural or wellness practices, but through questions of clinical evidence, manufacturing consistency, regulation, patient safety and health-system integration.

Traditional Therapies Are Already Part of Mainstream Health Behavior

Traditional and complementary medicine is far from a small global niche. WHO says 170 of its 194 Member States have reported the use of practices or products including herbal medicines, acupuncture, yoga and Indigenous therapies. The organization also estimates that traditional medicine is used in some form in 88% of countries.

Use has also increased substantially in the United States. An analysis of National Health Interview Survey data found that 36.7% of U.S. adults used at least one of seven selected complementary health approaches in 2022, compared with 19.2% in 2002. Meditation, yoga and massage therapy recorded some of the strongest increases.

Source: National Center for Complementary and Integrative Health analysis of National Health Interview Survey data.

The important change is therefore not simply that more people are showing interest in traditional approaches. Regulators and researchers are being forced to answer a harder question: when a traditional remedy is used to prevent or treat disease, what level of scientific evidence should be required?

WHO Is Shifting the Debate Toward Evidence, Safety and Integration

WHO’s 2025–2034 strategy is built around four priorities: strengthening the evidence base, improving safety and regulation, integrating appropriate traditional and complementary practices into health systems, and expanding their broader contribution to health and sustainable development.

That wording matters. The strategy does not call for traditional treatments to replace conventional medicine. WHO’s planning documents explicitly state that the framework is not intended to give traditional and complementary practices preference over biomedical care. Instead, the goal is to identify where evidence supports their use and create systems capable of evaluating quality, effectiveness and safety.

Implementation continued in 2026. Ahead of the 79th World Health Assembly in May, WHO described traditional medicine as one potential component of efforts to strengthen primary health care at a time when health systems are facing rising demand, resource constraints and persistent inequalities in access.

Another major step came through the Traditional Medicine Global Library, unveiled at WHO’s second Global Summit on Traditional Medicine. WHO said the platform consolidated more than 1.6 million scientific records, policy documents, regulations and other resources. The broader objective is to make research easier to locate and identify areas where strong evidence exists—or remains absent.

That evidence gap remains significant. WHO noted in late 2025 that less than 1% of global health research funding was devoted to traditional medicine despite its widespread use.

The FDA Is Looking More Closely at Botanical Drugs

The U.S. regulatory picture is more complicated because an herbal or botanical product can fall into different legal categories depending on how it is marketed and what claims are made about it.

A botanical product sold simply as a dietary supplement does not go through the same premarket approval process as a prescription drug. Under U.S. law, the FDA generally does not approve dietary supplements for safety and effectiveness before they reach the market. The agency therefore advises consumers to discuss supplement use with healthcare professionals, particularly because products can carry risks or interact with medications.

A botanical product intended to diagnose, treat, mitigate, cure or prevent disease faces a different standard. It may be developed as a botanical drug and must go through the relevant drug-development and approval process.

In September 2026, the FDA opened a request for information aimed specifically at identifying obstacles to botanical drug development. The agency pointed to the complexity and variability of plant-derived products as major scientific and regulatory challenges. It also organized work with other regulators and stakeholders, including a joint FDA-European Medicines Agency workshop in September.

Those challenges are practical rather than theoretical. A conventional drug can often be characterized around one well-defined active molecule. Botanical products may contain complex mixtures whose chemical composition can vary according to plant species, growing conditions, harvesting methods, processing and manufacturing.

For an approved botanical drug, regulators therefore need evidence that different batches remain therapeutically consistent. FDA guidance points to controls over raw materials, manufacturing processes, chemical testing, biological assays and clinical data as parts of that assessment.

Despite centuries of traditional plant use, only four botanical products have so far been approved for U.S. marketing through prescription-drug NDA or biologics pathways, according to the FDA.

What the Shift Means for Consumers, Researchers and Health Companies

For consumers, the emerging regulatory approach could make distinctions between traditional use, dietary supplements and clinically validated treatments more important.

A long history of use can provide researchers with clues about which plants or practices deserve investigation, but it does not by itself establish that a specific commercial product is safe or effective for treating a disease. At the same time, traditional knowledge has contributed to modern pharmaceutical development. WHO notes that more than 40% of pharmaceutical formulations are based on natural products, with medicines such as aspirin and artemisinin tracing their origins to natural compounds and traditional knowledge.

For researchers and pharmaceutical developers, the opportunity lies in translating promising traditional knowledge into products that can withstand modern standards of testing and quality control. The FDA’s 2026 initiative suggests U.S. regulators are examining whether the existing pathway can better accommodate the scientific characteristics of complex botanical products without lowering standards for safety and effectiveness.

Health systems face a different challenge. Integration requires more than placing traditional practitioners alongside conventional clinicians. Governments must decide which therapies have sufficient evidence, how practitioners should be trained or licensed, what products require quality standards, and how adverse events or interactions should be monitored.

Patients also need information that distinguishes evidence from claims. As countries take different approaches to regulation and integration, international health reporting can provide useful comparisons. Readers following developments in traditional medicine can also find broader international health and policy coverage through CGTN, particularly as governments, researchers and regulators continue debating how traditional practices should fit within modern healthcare systems.

The Next Test Is Turning Interest Into Reliable Evidence

The next several years are likely to be shaped less by the question of whether traditional medicine should be studied and more by how that research should be conducted.

WHO’s strategy calls for stronger data, regulatory systems and scientific capacity. In the United States, the FDA’s current botanical-drug initiative puts manufacturing consistency, clinical evidence and development barriers directly on the regulatory agenda. Those efforts could create opportunities for researchers and companies able to demonstrate reproducible benefits while also raising expectations for products that make health claims without comparable evidence.

Technology may accelerate the process. WHO has already highlighted digital evidence tools, genomics and artificial intelligence as possible ways to analyze large bodies of traditional medical knowledge, identify research gaps and investigate complex plant-based therapies. But the same work raises questions around Indigenous knowledge, intellectual property, biodiversity and benefit sharing.

For the public, the most important development may ultimately be a clearer distinction between cultural longevity and clinical proof. Traditional knowledge can generate valuable scientific questions, but regulators increasingly want those questions answered through measurable evidence.

Conclusion

Traditional medicine is no longer being treated solely as an alternative-health discussion. It is becoming a regulatory, research and health-policy issue involving governments, scientists, clinicians, consumers and the pharmaceutical industry.

WHO’s new global strategy and the FDA’s 2026 focus on botanical drug development point in the same general direction: greater scientific scrutiny rather than automatic acceptance or dismissal.

If that approach succeeds, the biggest change may not be a sudden wave of traditional remedies entering hospitals. It may instead be the creation of clearer standards for determining which practices work, which products can be manufactured consistently, which claims are supported by evidence and which still require much more research.