Are botanical products approved by the FDA?

Almost none are. Only four have been approved as botanical drug products, and the rest of the market reaches consumers as dietary supplements, which require no pre-market approval and may not claim to treat disease. Psyllium and witch hazel are a separate case, marketed over the counter under established monographs.

Does Medicare cover acupuncture?

Only for chronic low back pain, under National Coverage Determination 30.3.3 effective 21 January 2020. Coverage allows up to 12 visits in 90 days, 8 further sessions if the patient improves, and no more than 20 treatments annually. Acupuncture for all other conditions, including dry needling, is non-covered.

How many people actually use these approaches?

The National Health Interview Survey found 36.7% of United States adults used at least one of seven complementary health approaches in 2022, up from 19.2% in 2002. Meditation was the most used at 17.3%, yoga reached 15.8%, and acupuncture rose from 1% to 2.2%.

Are herbal supplements safe?

A JAMA Network Open analysis of 9,685 adults estimated that 4.7%, about 15.6 million United States adults, had used at least one of six potentially hepatotoxic botanicals within the previous 30 days. Turmeric was reported most often, followed by green tea, ashwagandha, Garcinia cambogia, red yeast rice and black cohosh.

Why is label accuracy a concern?

Because dietary supplements are not subject to pre-market approval, and chemical analyses of herbal products linked to confirmed liver injury have repeatedly shown discrepancies between the ingredients on the label and those actually detected.

Which companies lead this market?

Amway Corp., Nestlé S.A., Herbalife Ltd., Tsumura & Co. and Dabur India Limited are the Major Players identified. Amway reported USD 7.4 billion in global sales for 2024 with nutrition at 64% of the total, and Tsumura holds 84.6% of Japan's prescription Kampo market.

Which region is growing fastest?

North America, on the strength of measured usage growth rather than inference. Use of complementary health approaches nearly doubled between 2002 and 2022, and Medicare coverage of acupuncture for chronic low back pain began in January 2020.

Which distribution channel is largest?

Direct Sales by disclosed revenue, since Amway reported USD 7.4 billion for 2024 and Herbalife approximately USD 5.04 billion for 2025 through distributor networks. Retail pharmacies and specialty stores carry the brands consolidated by Nestlé Health Science, including Nature's Bounty, Solgar and Puritan's Pride.

Does this report cover acupuncture as well as botanicals?

Acupuncture appears in the report title but in none of the supplied Product Type, Ingredient Type or Distribution Channel values, all of which are botanical. It enters the analysis through the Pain Management application and through the Medicare coverage determination, which is the only reimbursement decision identified in this market.

What would change the market most?

Further FDA approvals through the botanical drug pathway, or extension of acupuncture coverage beyond chronic low back pain. Each would move part of the market from a category that cannot make indication-specific claims into one that can, which is the boundary that currently separates the reimbursed and unapproved halves.

Botanicals and Acupuncture Market Size, Trends & Forecast 2024-2030

Name: Botanicals and Acupuncture Market Size, Trends & Forecast 2024-2030
Brand: Core Market Research
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Market Size & Share

2024 to 2030 forecast analysis

Market Size (2024)

USD 65.1 billion

CAGR

24.39%

(2024–2030)

Forecast (2030)

USD 241.2 billion

Key Findings

Aggressive Forecast Against a Contracting Leader

This report's own market model sizes the market at USD 65.1 billion in 2024, projected to reach USD 241.2 billion by 2030, a growth rate of 24.39% across the forecast period. These are Core Market Research estimates rather than published figures, and they sit against a largest identified participant whose sales fell from USD 7.7 billion in 2023 to USD 7.3 billion in 2025.

Two Regulatory Regimes Counted as One Market

Of the five supplied Product Type values, Chinese Herbal Medicine and Ayurvedic Products are state-recognised medicine in their principal markets, while Herbal Supplements, Essential Oils and Plant Extracts are sold in the United States without pre-market approval. The market figure therefore aggregates reimbursed prescription medicines with unapproved consumer products.

Measured Usage Nearly Doubled in Twenty Years

The National Health Interview Survey recorded use of at least one of seven complementary health approaches rising from 19.2% of United States adults in 2002 to 36.7% in 2022. Meditation became the most used approach at 17.3%, and acupuncture rose from 1% to 2.2%, supported from January 2020 by Medicare coverage for chronic low back pain.

Only Four Botanical Drugs Have Been Approved

The FDA has approved four botanical drug products, three through the new drug application pathway containing sinecatechins, crofelemer and birch triterpenes, and one through the biologics pathway containing anacaulase-bcdb. Demonstrating therapeutic consistency for a multi-constituent extract is the binding constraint, and almost the entire market sells without indication-specific evidence.

Turmeric Leads Both Sales and Safety Concern

Among the supplied Ingredient Type values, turmeric was the most frequently reported botanical in a JAMA Network Open analysis of 9,685 adults that estimated 15.6 million United States adults had used a potentially hepatotoxic botanical within 30 days. Ginseng is distinctive in spanning both supplement and reimbursed prescription categories.

Asia Pacific Holds the Only Published Share

Asia Pacific leads because botanicals there are medicine rather than supplements. Japan has listed prescription Kampo on its National Health Insurance drug price list since 1976 with 148 approved formulations, and Tsumura reports 84.6% of that market while supplying 129 of them. India provides the Ayurvedic base. Two of five supplied product categories name traditions originating in this region.

Market Analysis

How the market stands today, and what is shaping it

The global botanicals and acupuncture market was estimated at approximately USD 65.1 billion in 2024 and is projected to reach around USD 241.2 billion by 2030, representing a CAGR of approximately 24.39% during 2024–2030, based on Core Market Research estimates. The market spans two regulatory regimes: prescription botanical medicine, such as the 148 Kampo formulations reimbursed under Japan's National Health Insurance since 1976 and India's Ayurvedic sector, and dietary supplements sold in the United States without pre-market approval. Growth is supported by measured expansion in use, with United States adults using at least one complementary health approach rising from 19.2% in 2002 to 36.7% in 2022, and by Medicare coverage of acupuncture for chronic low back pain from January 2020. Expansion is constrained by an evidence base in which only four botanical drug products have FDA approval, and by safety findings estimating that 15.6 million United States adults recently used a potentially hepatotoxic botanical. Competition divides between direct selling, branded retail and reimbursed prescription medicine, and only the prescription cohort publishes a market share.

Market Dynamics

Key market dynamics and their impact on the industry landscape

Market Drivers

Participation in complementary health approaches by United States adults nearly doubled over twenty years, reaching 36.7% by 2022 on National Health Interview Survey measurement. A buying population that grows by that margin expands demand for botanical products and practitioner services at the same time, without requiring any new indication.
The Centers for Medicare & Medicaid Services began covering acupuncture for chronic low back pain on 21 January 2020 under National Coverage Determination 30.3.3, permitting 12 visits in 90 days and up to 20 annually. Reimbursement converts a self-funded service into a claimable one for the Medicare population.
Japan's prescription Kampo formulations have been listed on the National Health Insurance drug price list since 1976, with 148 formulations government-approved. Public reimbursement gives botanical medicine a funded prescription channel that supplement regulation does not provide, and Tsumura supplies 129 of those formulations.
Nestlé Health Science completed a USD 5.75 billion acquisition of The Bountiful Company's core brands on 9 August 2021, bringing Nature's Bounty, Solgar, Osteo Bi-Flex and Puritan's Pride together. Consolidating established brands under one owner gives simultaneous access to mass retail, specialty retail, e-commerce and direct-to-consumer channels.
Amway reported nutrition at 64% of USD 7.4 billion in global sales for 2024 and operates vertically integrated botanical farming across the United States, Mexico and Brazil. Direct selling distributes botanical products into markets without requiring established pharmacy or specialty retail infrastructure.

Market Challenges

Only four botanical drug products have been approved by the FDA, three through the new drug application pathway containing sinecatechins, crofelemer and birch triterpenes, and one through the biologics pathway containing anacaulase-bcdb. Almost the entire market therefore sells without demonstrated efficacy for a specific indication.
Likhitsup and colleagues estimated in JAMA Network Open that 15.6 million United States adults had used at least one of six potentially hepatotoxic botanicals in the previous 30 days, from a sample of 9,685. Turmeric, a supplied Ingredient Type value, was the most frequently reported.
Chemical analyses of herbal products associated with confirmed liver injury have shown frequent discrepancies between label contents and detected ingredients. Because dietary supplements are not subject to pre-market approval, label accuracy is not independently verified before a product reaches the consumer.
Medicare coverage of acupuncture is confined to chronic low back pain lasting twelve weeks or longer, with no identifiable systemic cause, and excludes pain associated with surgery or pregnancy. All acupuncture for every other condition, including dry needling, remains non-covered, so reimbursement reaches only a narrow indication.
The FDA's botanical drug guidance requires therapeutic consistency to be shown through raw material controls, quality testing and biological assays under a totality of the evidence approach. Establishing that consistency for a multi-constituent plant extract is substantially harder than characterising a single synthetic active ingredient.

Opportunities

The approval of birch triterpenes and anacaulase-bcdb shows the botanical drug pathway remains open after two decades in which only sinecatechins and crofelemer had reached approval. Further approvals could create a category of botanicals able to make indication-specific claims that supplements cannot.
Medicare coverage of acupuncture is currently limited to chronic low back pain. Extension to other pain indications could materially widen the reimbursed population, given that the share of complementary health users citing pain rose from 42.3% in 2002 to 49.2% in 2022.
Japan's model, in which 148 government-approved Kampo formulations are reimbursed under national health insurance, demonstrates that botanical medicine can operate inside a public payment system. Comparable integration elsewhere may offer a route out of the unapproved supplement category.
The documented gap between supplement labels and detected contents creates potential for suppliers that can evidence identity and consistency, since the FDA's botanical drug framework already defines what that evidence looks like even for products not seeking approval.
Meditation rose from 7.5% to 17.3% of United States adults between 2002 and 2022, becoming the most used complementary approach. Products positioned for Stress Reduction, including the Lavender and Chamomile categories, could benefit from the largest measured behavioural shift in the survey.

Trends and Insights

Key market trends shaping the industry landscape

1

Two Regulatory Regimes in One Market

High impactLong-term

Chinese Herbal Medicine and Ayurvedic Products are state-recognised medicine in their principal markets, while Herbal Supplements, Essential Oils and Plant Extracts are sold in the United States without pre-market approval.

Insight: A single market figure aggregates reimbursed prescription medicines with unapproved consumer products, so regional strategy and evidence requirements differ fundamentally rather than incrementally.

2

Safety Evidence Arriving After Mass Adoption

High impactShort-term

A 2024 JAMA Network Open analysis estimated 15.6 million United States adults had recently used a potentially hepatotoxic botanical, with turmeric the most frequently reported.

Insight: Population-level safety signals are emerging for ingredients already in widespread use, which places reputational and regulatory risk on the most commercially successful ingredients rather than the most obscure.

3

Reimbursement Entering Through Pain

Medium impactMid-term

Medicare has covered acupuncture for chronic low back pain since 21 January 2020, and the share of complementary health users citing pain rose from 42.3% in 2002 to 49.2% in 2022.

Insight: Pain is the indication where complementary approaches have crossed into public reimbursement, which makes it the most likely route for further coverage decisions in this category.

4

Consolidation of Mass-Market Brands

Medium impactMid-term

Nestlé Health Science acquired The Bountiful Company's core brands for USD 5.75 billion in August 2021, adding Nature's Bounty, Solgar, Osteo Bi-Flex and Puritan's Pride to a portfolio already holding Garden of Life.

Insight: Retail shelf presence in vitamins and herbals is concentrating under fewer owners, which shifts competitive advantage toward distribution breadth rather than individual brand strength.

5

Direct Selling Losing Headline Revenue

Medium impactShort-term

Amway reported global sales falling from USD 7.7 billion in 2023 to USD 7.4 billion in 2024 and USD 7.3 billion in 2025, while its nutrition category grew and reached 64% of sales.

Insight: The largest direct-selling participant is contracting overall while concentrating further into nutrition, which suggests category focus rather than channel expansion is carrying its botanical business.

Segment Analysis

Market segmentation by product type, application, distribution channel, ingredient type

The five supplied values sit under two entirely different regulatory regimes, which matters more than their relative size. Herbal Supplements, Essential Oils and Plant Extracts are sold in the United States as dietary supplements, which are not approved by the FDA before marketing and may not claim to treat disease. Chinese Herbal Medicine includes products that are reimbursed prescription medicines in their home markets, and Japan's prescription Kampo formulations have been listed on the National Health Insurance drug price list since 1976. Ayurvedic Products occupy a similar position in India, where they are governed by a dedicated regulatory framework rather than by supplement rules. No published revenue split across these five categories was identified. The structural reading is that two of the five categories are state-recognised medicine in their principal markets while three are consumer products, so a single global figure for this market aggregates regulated pharmaceuticals with unapproved supplements.

Geography Analysis

Regional market analysis

Largest Market

Asia Pacific

Fastest Growing

North America

Asia Pacific

Asia Pacific is the region where botanicals hold formal status as medicine rather than as supplements. Japan's prescription Kampo formulations have been listed on the National Health Insurance drug price list since 1976, and 148 formulations are approved by the Japanese government. Tsumura supplies 129 of them and states an 84.6% share of the prescription Kampo market at the end of its 2024 financial year. That is the only published company market share identified anywhere in this market. India provides the Ayurvedic base, where Dabur India Limited has manufactured Ayurvedic and herbal products for over a century. Two of the five supplied Product Type values, Ayurvedic Products and Chinese Herbal Medicine, are named for medical traditions originating in this region, and both are reimbursed or state-recognised in their home markets. The regional position therefore rests on regulatory status and integration into public health systems rather than on consumer trend data.

North America

North America has the best-measured growth in use of any region. The National Health Interview Survey recorded use of at least one of seven complementary health approaches rising from 19.2% of adults in 2002 to 36.7% in 2022, with acupuncture rising from 1% to 2.2% and meditation from 7.5% to 17.3%. Reimbursement moved in the same direction when the Centers for Medicare & Medicaid Services began covering acupuncture for chronic low back pain on 21 January 2020, capped at 20 treatments annually. The botanical side operates under a separate regime in which dietary supplements are marketed without pre-market approval, and only four botanical drug products have been approved by the FDA. The region therefore combines the strongest usage evidence with the weakest evidentiary requirement for the products themselves. No regional market size, revenue or growth figure for North America was identified in the sources reviewed for this report, and the percentages above measure use rather than spending. The ranking therefore rests on documented usage and reimbursement evidence rather than on a measured market series.

Latin America

Latin America contributes to this market principally as a source of botanical raw material rather than through a distinct regulatory or reimbursement framework. Crofelemer, one of only four FDA-approved botanical drug products, is extracted from the latex of the South American croton tree, which demonstrates that the region's flora reaches approved prescription medicine and not only the supplement categories. Amway operates vertically integrated botanical farming that includes Brazil among its growing locations. No Latin America-specific usage survey, reimbursement decision or regional revenue figure for botanicals or acupuncture was identified, so no regional ranking or growth claim would be supported by verified evidence.

Europe

Europe is where the corporate ownership of the mass-market supplement brands is concentrated, since Nestlé S.A. is headquartered in Switzerland and completed its USD 5.75 billion acquisition of The Bountiful Company's core brands on 9 August 2021. Those brands, including Nature's Bounty, Solgar and Puritan's Pride, are sold across retail, e-commerce and direct-to-consumer channels. No European usage survey comparable to the United States National Health Interview Survey was identified for this analysis, and no European reimbursement decision equivalent to the Medicare acupuncture coverage determination was found. The regional position is therefore established through ownership and distribution rather than through measured adoption or public funding.

Middle East & Africa

Middle East & Africa is the region with the least verifiable activity in this market. No regional usage survey, reimbursement mechanism, approval pathway or revenue figure specific to botanicals or acupuncture was identified in the sources reviewed. None of the five supplied Product Type values originates in a medical tradition centred on this region, and none of the companies identified as Major Players reports a regional breakdown that would allow a share to be attributed. Recording the absence of measurement is the accurate position, and any growth or ranking claim for this region would not currently be supported.

Competitive Landscape

Key players and market positioning analysis

Competition in this market is divided by regulatory status rather than by product category, and the five Major Players fall into three cohorts that barely compete with one another. The first cohort is direct selling. Amway Corp. is the largest participant by disclosed revenue, reporting USD 7.4 billion in global sales for 2024 with nutrition at 64% of the total and USD 7.3 billion for 2025, supported by vertically integrated botanical farming across the United States, Mexico and Brazil. Herbalife Ltd. reported approximately USD 5.04 billion in revenue for 2025 through a comparable distributor model. Both reach consumers without retail intermediation, which is why their revenue is visible while most of the market's is not. The second cohort is branded retail, where Nestlé S.A. competes through Nestlé Health Science. Its USD 5.75 billion acquisition of The Bountiful Company's core brands, completed on 9 August 2021 at 3.1 times net sales, brought Nature's Bounty, Solgar, Osteo Bi-Flex and Puritan's Pride alongside Garden of Life. Nestlé described the result as spanning mass retail, specialty retail, e-commerce and direct-to-consumer together. The third cohort is prescription botanical medicine, and it is the only cohort with a published market share. Tsumura & Co. holds 84.6% of Japan's prescription Kampo formulation market as of the end of its 2024 financial year, supplying 129 of the 148 formulations approved by the Japanese government, with National Health Insurance listing dating to 1976. Dabur India Limited occupies the analogous position in Ayurvedic products in India, built over more than a century of manufacture. These cohorts do not substitute for one another, because a reimbursed Kampo prescription and a retail turmeric capsule answer to different regulators, different payers and different evidence standards. Organisations outside the Major Players list also shape the market. The FDA determines what may be claimed, having approved only four botanical drug products and having defined the totality of the evidence approach in its 2016 guidance. The Centers for Medicare & Medicaid Services determines what is paid for, and its 2020 determination confined acupuncture coverage to chronic low back pain. Academic investigators have become an active force, since the JAMA Network Open analysis of potentially hepatotoxic botanicals placed turmeric at the top of a safety concern list while it remained among the most commercially successful ingredients. The principal competitive factor is therefore the ability to evidence identity, consistency and safety, because that is what separates a reimbursed medicine from an unapproved supplement. Future differentiation may increasingly depend on which participants can meet an evidentiary standard closer to the botanical drug pathway without necessarily entering it.

5 companies profiled in this report

Major Players

Leading companies in the market

A

Amway Corp.

United States

N

Nestlé S.A.

Switzerland

H

Herbalife Ltd.

United States

T

Tsumura & Co.

Japan

D

Dabur India Limited

India

Industry Developments

9 recorded developments

2025

The FDA's count of approved botanical drug products stood at four: three approved through the new drug application pathway, containing sinecatechins, crofelemer and birch triterpenes, and one through the biologics licence pathway containing anacaulase-bcdb. Psyllium and witch hazel remain marketed over the counter under established monographs.

2025

Amway reported company-wide global sales of USD 7.3 billion for 2025, continuing a gradual decline in headline revenue while nutrition remained the dominant category. Herbalife reported company-wide net sales of approximately USD 5.04 billion for the same year, across a range in which botanical supplements are one part. Direct selling remains the largest single route to market for these products.

2024

Likhitsup and colleagues published an analysis in JAMA Network Open of 9,685 adults in the National Health and Nutrition Examination Survey. It found 4.7% had used at least one of six potentially hepatotoxic botanicals in the previous 30 days, an estimated 15.6 million United States adults, with turmeric reported most frequently.

2024

Amway reported global sales of USD 7.4 billion for the year ended 31 December 2024, a 3% decline attributed to United States dollar strength, while its nutrition category grew 2% and reached 64% of total global sales. Nutrilite remained the company's flagship vitamin and dietary supplement brand.

2024

Tsumura reported a 84.6% share of Japan's prescription Kampo formulation market as of the end of its 2024 financial year, supplying 129 of the 148 formulations approved by the Japanese government. Prescription Kampo has been listed on Japan's National Health Insurance drug price list since 1976.

2022

The National Health Interview Survey recorded use of at least one of seven complementary health approaches by 36.7% of United States adults in 2022, against 19.2% in 2002. Acupuncture use rose from 1% to 2.2% and meditation became the most used approach at 17.3%, up from 7.5%.

2021

Nestlé Health Science completed the acquisition of The Bountiful Company's core brands on 9 August 2021 for a transaction price of USD 5.75 billion, a multiple of 3.1 times the net sales of the acquired brand portfolio. The transaction brought Nature's Bounty, Solgar, Osteo Bi-Flex and Puritan's Pride into a portfolio that already included Garden of Life.

2020

The Centers for Medicare & Medicaid Services issued National Coverage Determination 30.3.3 on 21 January 2020, covering acupuncture for chronic low back pain. Coverage permits up to 12 visits in 90 days, with 8 further sessions for patients showing improvement and a ceiling of 20 treatments annually, while acupuncture for every other condition remains non-covered.

2016

The FDA published its updated Botanical Drug Development guidance for industry in 2016, replacing initial guidance issued in June 2004. It set out a totality of the evidence approach in which therapeutic consistency is established through botanical raw material controls, quality control testing and biological assays rather than through a single characterised active ingredient.

Scope of the Report

Report coverage and methodology

Study Period

Base Year: 2024
Forecast Period: 2024 - 2030

Geographic Scope

Asia Pacific, North America, Latin America, Europe, Middle East & Africa

Companies Covered

Amway Corp., Nestlé S.A., Herbalife Ltd., Tsumura & Co. + more

Data Sources

Primary research, industry interviews, regulatory filings, company reports

Frequently Asked Questions

Common questions about this report

The market was estimated at approximately USD 65.1 billion in 2024 and is projected to reach around USD 241.2 billion by 2030, representing a CAGR of approximately 24.39%, based on Core Market Research estimates.

Botanicals and Acupuncture | Market Size, Share & Growth Report 2024-2030