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Research: Investigate Banned Adaptogens under China's NHC

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Research: Investigate Banned Adaptogens under China’s NHC

Banned and Regulated Adaptogens under China’s NHC

Overview

The regulation of adaptogens and functional botanical ingredients in China is primarily overseen by the national-health-commission-nhc (NHC) and the state-administration-for-market-regulation-samr (SAMR) [1, 10]. Unlike jurisdictions that rely on negative lists (banning specific substances), China operates on a strict positive list system. Therefore, any adaptogen or botanical extract that does not appear on the NHC’s approved lists—such as the “Three New Foods” directory or the list of Traditional Chinese Medicines (TCM) approved for dual-use—is effectively unauthorized (banned) for commercial food and beverage applications [1, 3, 15].

Regulatory Frameworks Governing Adaptogens

Navigating the Chinese regulatory landscape for functional ingredients requires understanding the intersection of food, supplements, and traditional medicine, which often leads to beverage-vs-supplement-ambiguity.

The “Three New Foods” System

The NHC governs novel food ingredients through the “Three New Foods” framework (encompassing new food raw materials, new food additives, and new food-related products) [3]. If an adaptogen is approved as a novel food, it can be used in both specialized health foods and general conventional foods, significantly broadening its market access [1].

  • Recent Approvals: In recent years, the NHC has accelerated approvals for functional ingredients. For example, Sakura polyphenol, Stevia polyphenol, Yerba mate, and olive fruit polyphenols have received authorization [1, 2, 3].
  • International Reliance: The NHC is increasingly utilizing international safety assessments. Ingredients with Generally Recognized As Safe (GRAS) status from the US fda or approvals from the european-food-safety-authority-efsa or Canada are frequently referenced during domestic reviews [3].

Health Food Registration vs. Filing Track

For adaptogens not approved for general food use, brands must apply through SAMR under the Health Food regulations [1].

  • Registration: A stringent process requiring human or animal clinical trials to prove efficacy (e.g., claims around joint health support or immunity) [11]. The SAMR recently lifted a virtual freeze on imported health food registrations that had been in place since 2018 [14].
  • Filing: A faster track restricted to “low risk” ingredients, such as vitamins and minerals, that already appear on the Health Foods Raw Materials Directory [12].

The Food and Medicine Continuum (Dual-Use Substances)

Because of the cultural importance of Traditional Chinese Medicine, the NHC maintains a specific positive list of substances classified as both food and drugs. Adaptogens on this list are legally permitted for use in health foods [1].

In late 2023, the NHC expanded this list by authorizing 9 new botanical substances for dual food and TCM use, including:

  • Ganoderma lucidum (Reishi mushroom)
  • American Ginseng
  • Astragalus
  • Codonopsis pilosula
  • Cistanche deserticola
  • Eucommia ulmoides [13]

Usage Restrictions: Even when authorized, the NHC mandates strict consumption guidelines. These dual-use adaptogens are recommended for moderate consumption following traditional methods and are explicitly restricted from use by pregnant women, lactating women, infants, and young children [13]. Furthermore, the NHC limits the use of certain botanical extracts to specialized health foods; a 2002 notice established 114 substances explicitly allowed in health foods but banned from conventional food categories [15].

While the search data does not isolate a specific “banned list” published by the NHC, international trends heavily influence the Chinese supply chain and regulatory reviews [3]. Several popular adaptogens are currently facing severe regulatory crackdowns globally, which dictates functional-beverage-regulations and international export viability:

  • Ashwagandha (Withania somnifera): Under intense scrutiny in the EU and UK due to safety concerns. Countries like France and the Netherlands have proposed or enacted national bans on Ashwagandha in food supplements [6, 8, 9].
  • Kratom and Melatonin: Currently under regulatory review in the EU for classification and safety restrictions [8].
  • Mushroom Extracts: Water-based extraction of fruiting bodies (like Lion’s Mane and Chaga) are generally recognized, but dehydrated mycelium powders and ethanol extracts are frequently flagged under novel-food-regulations requiring pre-market safety authorizations [9].

Identified Gaps and Contradictions

  • Lack of a Centralized Negative List: The available sources heavily detail the positive lists managed by the NHC and SAMR (ingredients approved for use). There is a distinct data gap regarding explicitly published “banned” lists by the NHC, as the regulatory framework intrinsically bans anything not explicitly approved [1, 15].
  • Cannabis Ambiguity: One source notes Cannabis sativa L. as being included on a historical NHC dual-use list for health foods [1]. However, broader global and Chinese regulatory contexts often tightly restrict or ban CBD and THC. Clarification is needed on whether this refers exclusively to hemp seeds or includes active cannabinoid extracts.

Suggested Additional Sources

To build out a more robust understanding of banned adaptogens in China, researchers should query:

  1. The NHC’s “List of Substances Prohibited in Health Foods”: Seeking specific administrative rulings that explicitly ban previously used botanicals.
  2. SAMR Enforcement Actions: Investigating recent penalties for the unauthorized use of Western adaptogens (like Ashwagandha, Rhodiola, or Maca) in domestic Chinese beverage manufacturing.
  3. Updates on Hemp/CBD Regulations in China: To resolve the contradiction regarding the status of Cannabis sativa L. in functional beverages.

References

  1. China: Master the Ingredient Regulations for Health Foods — khlaw.com
  2. Monthly Update: China & Global Food Regulatory Highlights | March 2026 - ZMUni Compliance Centre — zmuni.com
  3. China’s National Health Commission Approved 14 New “Three New Foods” — cisema.com
  4. [PDF] Report Name:NHC Approves New Food Materials and Additives — apps.fas.usda.gov
  5. China NHC Newly Approved 5 New Food Raw Materials, 11 New Food Additives, and 6 Food-related Products - Regulatory News - Food & Food Contact Materials - CIRS Group — cirs-group.com
  6. Ministry of Health and Welfare proposes standards for the determination of types of medicinal herbs permitted as food ingredients — Food Compliance International — foodcomplianceinternational.com
  7. Ashwagandha | Food Standards Agency — food.gov.uk
  8. Restrictions on Herbal Supplements including Ashwagandha | RegASK — regask.com
  9. [PDF] Understanding Food Supplements Regulations — hfma.co.uk
  10. Regulations Impacting Natural Products in China — supplysidesj.com
  11. China adds joint health support to list of approved claims — nutraingredients.com
  12. China SAMR to release new health foods regulations — nutraingredients.com
  13. 9 new substances authorized for use as food and as ingredients in traditional Chinese medicine — Food Compliance International — foodcomplianceinternational.com
  14. China Revitalizes Approval for Imported Health Foods — khlaw.com
  15. China-List of Substances Allowed in Functional Health Food — chinafooddb.com

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