“After discussions with the TCM, Chinese herbs and health food industries, a consensus has been reached to institutionalize and clearly define the boundaries between food and pharmaceuticals, ensuring public food safety while providing a framework for businesses to follow at the same time,” the ministry stated in the draft proposal.
Under the proposed framework, certain herbs with long-standing culinary use would remain permitted in food products, however, regulators plan to introduce requirements for dosage levels, concentration and labeling practices.
The draft regulation is open for public consultation until June 13.
Defining categories, thresholds and warnings
The proposal, first published in April, would significantly expand and formalize the list of Chinese medicinal materials permitted in food products and divides 148 approved TCM ingredients into two categories.
Category 1 includes 75 ingredients with a long history of culinary use, such as white fungus, Chinese yam and goji berries. These can be used in foods but often with restrictions on the plant part, preparation method or product format. Some may only be consumed as teas, while others are limited to use as extract or seasoning.
Category 2 includes 73 ingredients allowed only under specified daily dosage limits. This category includes herbs traditionally associated with medicinal effects, such as ginseng and Chinese angelica root. These include herbs traditionally associated with medicinal effects such as cassia seeds (4.5 g/day limit), dried Chinese angelica root (2.5 g/day limit) and dried ginseng root and rhizome (1.5 g/day limit).
Products that contain Chinese medicinal materials not permitted for use as food ingredients will also be managed as pharmaceuticals.
One of the most significant aspects of the proposal also involves dosage thresholds. Products containing more than 50% of the second category or exceeding 50% of the minimum daily intake per the Taiwan Chinese Pharmacopoeia could be legally reclassified as medicines, requiring formal approval, safety reviews and stricter manufacturing oversight.
Products would not need to be regulated as pharmaceuticals; however, if companies can provide safety evaluation reports and obtain a Health Food Permit for them.
In addition, the draft proposes restrictions on the commercial use of 38 names of classic TCM prescriptions. Manufacturers of health supplements may no longer be allowed to use names linked to well-known traditional formulas if the branding could mislead consumers into believing the products have clinically verified medicinal effects.
The proposal also stipulates warning labels for some ingredients like Szechuan lovage root, Chinese licorice and desert ginseng to protect vulnerable populations including people with impaired kidney, infants and toddlers, pregnant or breastfeeding women, and individuals taking anticoagulant medication, in some cases.
Modernizing regulation of TCM
The proposal sits within a broader effort to modernize regulation of traditional medicine in Taiwan to align oversight with contemporary public health standards and ensure sustainable growth within the national healthcare system.
In 2014, the National Health Commission and the State Administration for Market Regulation in China introduced a list of food–medicine dual-use substances for consumption under regulated conditions. The “List of Substances Traditionally Used as Both Food and TCM in China” has been expanded over time to adapt modern research to traditional practices and now includes over 100 officially approved ingredients.
Products containing these ingredients can serve as food ingredients, dietary supplements and traditional medicine and make functional claims so long as they fall within the usage scope and dosage limits listed by the authorities.
In 2019, Taiwan passed the Ministry of Health and Welfare “Traditional Chinese Medicine Development Act” to balance respect for traditional medical heritage with the promotion of scientific, evidence-based innovation. Key areas include healthcare integration of TCM and Western medicine for comprehensive care, R&D funding, public education and stronger quality and safety standards.
