TFDA Functional Food Regulation Update: Taiwan FDA Plans New Category Between Health Food and General Food

Hsinchu, Taiwan — June 2026 — Sinew Consulting Group(SCG) is closely tracking Taiwan FDA’s latest policy discussions on the proposed establishment of a new Functional Food regulatory category.

According to TFDA advisory meeting records, Taiwan is considering a new system comparable to Japan’s “Foods with Function Claims,” positioned between Taiwan’s existing Health Food framework and ordinary General Food products. The discussion indicates that the future system may focus on products carrying functional or physiological claim wording, while avoiding the misunderstanding that such products have received the same level of government endorsement as approved Health Food products.

What Is Taiwan’s Proposed Functional Food Category?

The proposed Functional Food category is expected to address a long-standing regulatory gap in Taiwan’s food market. Many products are currently sold as supplements, functional beverages, probiotics, lutein products, collagen products, fish oil capsules, botanical extracts, and other wellness-oriented foods. However, under the current system, most of these products are still legally managed as General Food with limited functional claims unless they have obtained Health Food approval.

SCG observes that the proposed category may create a more structured pathway for companies that wish to communicate ingredient-based or function-based benefits, but it should not be interpreted as a free opening for aggressive claims. The key issue will be whether the product, ingredient, evidence, label wording, and advertising claims can withstand regulatory review.

How Functional Food Differs from Health Food in Taiwan

Taiwan’s Health Food system is already a formal legal framework. Products must complete scientific efficacy evaluation and obtain official approval before using the Health Food mark, approval number, and approved health-care efficacy claims. TFDA has also emphasized that Health Food remains food, not medicine, and does not have disease treatment effects.

By contrast, the proposed Functional Food category appears to be under policy discussion and has not yet become a fully implemented regulation. In our view, the most important distinction is this: Health Food is an officially approved category; Functional Food, if implemented, may become a managed claim category rather than a government-endorsed efficacy approval.

What Companies Should Know About TFDA Functional Claim Management

The main compliance risk will not be the product format itself, but the claim language. TFDA’s existing approach already treats disease-related claims, disease risk reduction claims, and claims overlapping with Health Food efficacy as high-risk. Official materials also show that scientific substantiation remains central to whether physiological function wording may be accepted.

For companies, this means that imported claim wording from Japan, China, the United States, or the European Union should not be copied directly into Taiwan labels or advertisements. Even if a claim is acceptable in another market, Taiwan may classify the same wording as exaggerated, misleading, medical, or reserved for Health Food.

Sinew’s View: Early Compliance Review Is Now Necessary

SCG believes the proposed Functional Food system is not merely a new marketing opportunity. It is a clear signal that Taiwan may move toward more systematic control of functional food claims, ingredient evidence, registration data, and consumer-facing communication. Companies should begin reviewing product classification, ingredient legality, functional ingredient content, claim wording, label presentation, scientific substantiation, and advertising materials before the new system is finalized. Products currently relying on vague wellness language, borderline physiological claims, or overseas claim translations may face the highest adjustment pressure.

Sinew will continue monitoring TFDA’s official announcements and assisting food, dietary supplement, health food, functional beverage, probiotic, and functional ingredient companies in preparing for Taiwan’s evolving regulatory framework.

FAQ: Taiwan Functional Food Regulation

Q1. Is Taiwan’s Functional Food regulation already effective?

No. Based on currently available official information, the Functional Food category is still under policy discussion. Companies should not treat it as an effective regulation until TFDA formally announces the applicable rules later.

Q2. Will Functional Food replace Taiwan’s Health Food system?

No. The proposed Functional Food category appears to be an additional management tier. Taiwan’s Health Food system, including official approval, Health Food mark, approval number, and approved efficacy claims, remains separate.

Q3. Can general food or supplement products now make functional claims?

Not automatically. Until the new rules are officially implemented, food products must still comply with Taiwan’s current food labeling and advertising requirements. Medical claims, exaggerated efficacy claims, and claims reserved for Health Food remain high risk for being illegal and fining.

Q4. What should companies do now?

Companies should conduct an early compliance review covering product classification, ingredient legality, functional ingredient content, scientific evidence, label wording, website claims, social media advertising, and distributor sales scripts. In Sinew’s view, companies that prepare before the regulation is finalized will have a stronger position once TFDA announces the formal new pathway.