Exporting food and supplements from Taiwan to the US: what changes on the label?

A Taiwanese label cannot simply be translated into English and used in the United States. A packaged food exported to the US must be relabeled under 21 CFR Part 101. That means the mandatory label statements in English, a Nutrition Facts panel with the serving size set from the RACC (Reference Amount Customarily Consumed), the nine major food allergens including sesame under FD&C Act § 403(w), and a net quantity of contents in both US customary and metric units. A health supplement sold in the US as a dietary supplement must also switch to a Supplement Facts panel (21 CFR 101.36). Its statement of identity must include "dietary supplement", and the only benefit statements it may carry are structure/function claims with the 21 CFR 101.93 disclaimer. Health benefits approved for Taiwan's "health food" (健康食品) green logo cannot be carried over as they stand.

Start here: which US category does the product fall into?

The format of a US label depends on the product category. So the first step is classification; translation comes after. US food labeling has two main formats: conventional foods use Nutrition Facts, and dietary supplements use Supplement Facts.

Under FD&C Act § 201(ff) (21 U.S.C. 321(ff)), a dietary supplement must meet all of these conditions:

• it contains a dietary ingredient, such as a vitamin, mineral, herb or other botanical, or amino acid, and is intended to supplement the diet;
• it is intended for ingestion in tablet, capsule, powder, softgel, liquid or similar form;
• it is not represented as a conventional food or as a sole item of a meal or the diet;
• it is labeled as a dietary supplement.

Taiwan classifies products differently, so the categories do not map one to one:

"Health food" is a statutory category under Taiwan's Health Food Governing Act (健康食品管理法). A product may claim a health benefit only after approval by the Ministry of Health and Welfare (MOHW, 衛生福利部). The US has no equivalent premarket approval system. Being a health food in Taiwan therefore does not make a product a dietary supplement in the US.

Side by side: Taiwan label → US label

The table starts from the label items in Article 22 of Taiwan's Act Governing Food Safety and Sanitation (食品安全衛生管理法) and lists the matching US rule for each. The Taiwan rules are for comparison only. Whether a US label complies depends on the US provisions in the right-hand column.

Nutrition labeling: from "per serving + per 100 g" to Nutrition Facts

Taiwan's Regulations on Nutrition Labeling for Prepackaged Food Products (包裝食品營養標示應遵行事項) let a business choose one of two formats: "per serving + per 100 g (or mL)" or "per serving + percentage of daily reference value". The business sets the serving size itself, based on the amount usually eaten. The US works differently:

• Everything is per serving. All nutrients are declared per serving (21 CFR 101.9(b)). A per-100 g column may only be added as an extra column (101.9(b)(10)(i)). It cannot replace the per-serving column.
• The business does not choose the serving size. The serving size is derived from the RACC for the product category in the table in 101.12(b). It is expressed in a common household measure (cup, piece, slice and so on) followed by the metric amount in parentheses, for example "2 cookies (30g)" (101.9(b)(7)). For example, the RACC for cookies is 30 g, and for sweetened tea drinks and other beverages it is 360 mL.
• Single-serving containers. A package sold individually that contains less than 200% of the RACC is one serving (101.9(b)(6)). So a 500 mL bottle of Taiwanese tea (about 139% of the RACC) must be labeled in the US with the whole 500 mL bottle as one serving. A package that contains 200% to 300% of the RACC needs dual columns, per serving and per package (101.9(b)(12)(i)).
• The required nutrients differ. Taiwan requires calories, protein, fat, saturated fat, trans fat, carbohydrate, sugars and sodium. The US also requires cholesterol, dietary fiber, added sugars under total sugars, and vitamin D, calcium, iron and potassium (101.9(c)). If these values were never tested, test or calculate them first.
• The format is fixed. The title, heavy bars, type sizes and the layout of the %DV column are all prescribed (101.9(d)). The Taiwanese table layout cannot be reused.
• Bilingual nutrition labeling. If the nutrition label must also show Chinese, use two separate panels, or one panel with the English first and the Chinese after it. All required information must appear in both languages (101.9(d)(14)).

Allergens: Taiwan's 11 vs. the US nine

Taiwan's Regulations on Food Allergen Labeling (食品過敏原標示規定) were announced on 21 August 2018 and took effect on 1 July 2020. They make 11 items mandatory. The US defines nine major food allergens in FD&C Act § 201(qq). Sesame is the ninth, added by the FASTER Act, and applies to foods entering interstate commerce from 1 January 2023.

The US "Contains" statement has a set form. It begins with the word "Contains", followed by the name of the food source of each major food allergen. It is printed immediately after or adjacent to the ingredient list, in a type size no smaller than the ingredient list (403(w)(1)(A)). A direct English translation of the common Taiwanese wording 「本產品含有○○，不適合對其過敏體質者食用」 ("This product contains ○○ and is not suitable for people allergic to it") does not meet this form if it sits elsewhere or in smaller type. Allergens in incidental additives such as flavorings, colorings and processing aids must also be declared (403(w)(4)).

Supplements: health food, capsule and tablet foods and dietary supplements do not map one to one

Supplement Facts and related labeling

If the product is a dietary supplement in the US, redo the label as follows:

Taiwan's capsule and tablet foods use the "per serving + percentage of daily reference value" format, with the serving size set to the recommended intake. Vitamin and mineral tablet and capsule foods follow the separate Regulations on Nutrition Labeling for Prepackaged Vitamin and Mineral Tablet and Capsule Foods (包裝維生素礦物質類之錠狀膠囊狀食品營養標示應遵行事項), in the same per serving + percentage of daily reference value format. This is close to the US approach. But the title, nutrient order, %DV basis and format all differ, so the whole panel still has to be redone.

Why green-logo health benefits cannot carry over

The US divides health-related statements on a product into two types, which work in completely different ways:

1. Health claim: describes a relationship between a food substance and a reduced risk of disease. Only three kinds may be used: claims FDA has authorized by regulation (21 CFR 101.14 and 101.72–101.83 in Subpart E); for conventional foods, claims notified on the basis of an authoritative statement under FD&C Act § 403(r)(3)(C); and qualified health claims FDA allows under enforcement discretion. The product must meet the conditions and the wording must follow the rules. For example, the calcium, vitamin D and osteoporosis claim in 101.72 has its own ingredient and wording conditions. Translating "bone health" (骨質保健) into English does not make it usable.
2. Structure/function claim: describes the effect of an ingredient on the structure or function of the body. For dietary supplements the basis is FD&C Act § 403(r)(6). The claim needs the disclaimer in 101.93(c), and FDA must be notified within 30 days after first marketing (101.93(a)). For conventional foods the basis is § 201(g)(1)(C), and the effect must derive from nutritive value. Neither type may be a disease claim.

The green logo stands for health benefits approved by Taiwan's Ministry of Health and Welfare. As of the announcement of 3 July 2025 there are 14, including regulating blood lipids, regulating blood glucose, helping to regulate blood pressure, liver protection, helping to adjust an allergic constitution, and knee joint health. These approvals have no legal effect in the US. Translated directly into English, many of them become disease claims under 21 CFR 101.93(g):

• 101.93(g)(1) names hypertension as an example of a disease state. Translating 「輔助調節血壓」 ("helps regulate blood pressure") as "helps lower high blood pressure" claims an effect on a disease.
• FDA's small entity guide on structure/function claims says "reduces cholesterol" is an implied disease claim. Only wording limited to the normal range, such as "maintain cholesterol levels that are already in the normal range", may be acceptable.
• Under 101.93(g)(2)(iv), the product name, a statement about the formulation, cited publications, pictures or symbols can all make a disease claim. So check the wording and images next to the logo as well as the claim text.

Once a statement is a disease claim, the product is regulated as a drug under 101.93(f). And if a health food is a conventional food in the US (a drink, for example), the 101.93 disclaimer and notification system does not apply to it. A conventional food's structure/function statement must derive from nutritive value, and its health claims are limited to the permitted kinds above.

Common mistakes

These mistakes are especially common when Taiwanese businesses convert their labels:

FDA facility registration, US agent, FSVP, Prior Notice: required, but not label content

Food exported to the US carries several procedural obligations. None of them appears on the label:

• A foreign food facility must register with FDA (food facility registration, 21 CFR Part 1 Subpart H) and designate a U.S. agent (21 CFR 1.232(c)(1)).
• The US importer must run a Foreign Supplier Verification Program (FSVP, 21 CFR Part 1 Subpart L).
• Prior Notice must be submitted before each shipment arrives (21 CFR Part 1 Subpart I).

These obligations matter, but they are not label content, and RegaaS does not check them. See FDA's Registration of Food Facilities, FSVP, Prior Notice guidance and Importing Human Foods.

Note that the U.S. agent and the domestic contact that 403(y) requires on the label are two different things. Do not confuse them.

How RegaaS checks this

RegaaS also reviews Taiwanese food labeling, for example the country-of-origin labeling of pork ingredients in packaged foods. This article focuses on the US label, so the list below covers only the rules applied when reviewing a US label. The Taiwan rules mentioned in this article are for comparison only.

For the topics in this article, RegaaS applies the following rules (rule set reviewed on 10 September 2026; full scope in Regulations covered):

• 21 CFR Part 101: statement of identity, ingredient list, name and place of business, net quantity of contents, serving sizes derived from the RACC, Nutrition Facts, mandatory warnings, and the conditions for nutrient content claims, health claims and structure/function claims.
• FD&C Act § 403(w): the nine major food allergens, including sesame, declared in the ingredient list or a "Contains" statement.
• Dietary supplement labeling: Supplement Facts (21 CFR 101.36), "dietary supplement" in the statement of identity (101.3(g)), the plant part for botanicals (101.4(h)(1)), the structure/function claim disclaimer (placement, box and type size under 101.93(c)–(e)), and the domestic adverse event contact (FD&C Act § 403(y); a website alone is not enough).

Each finding cites its provision, is marked on the label image and comes with replacement text you can use directly. If there is no US label design yet, RegaaS can also generate a compliant label from the product data.

Every rule applied gets one of four results: Compliant, Needs review, Potential risk or Not applicable. Where the information provided is not enough to decide, or the case is borderline, RegaaS marks the rule Needs review and refers it to regulatory staff instead of reaching a conclusion. Each Potential risk shows where the issue is on the label, the provision and the version in force, and a suggested revision. Whether a finding stands, and what to do about it, is decided by regulatory staff. When a provision is amended, RegaaS identifies the products already reviewed against it so they can be checked again.

What this guide does not cover

This article does not cover Taiwanese law itself, including the Act Governing Food Safety and Sanitation, the Health Food Governing Act and their subsidiary regulations. A Taiwanese label can be reviewed separately in RegaaS against Taiwanese rules.

The following are outside the scope of this article and of RegaaS's US label review. When RegaaS meets these topics, it reports them as out of scope instead of applying provisions that do not fit:

• FDA facility registration, the U.S. agent, FSVP and Prior Notice;
• country-of-origin marking on imported goods (for example "Product of Taiwan");
• weights and measures rules beyond FDA's net quantity requirements;
• bioengineered food disclosure and USDA organic labeling;
• US state laws, such as California's Proposition 65;
• FTC advertising substantiation requirements (RegaaS can check claim wording on e-commerce pages and website copy, but does not assess whether the substantiation FTC requires is adequate);
• meat, poultry and egg products under USDA FSIS, such as jerky and meat floss;
• most alcoholic beverages, which fall under TTB.

Whether an ingredient may be used in a dietary supplement at all is a product positioning question, not a labeling question. For example, 21 U.S.C. 321(ff)(3)(B) excludes articles first approved as drugs. Settle such questions with a regulatory adviser before designing the label.

A RegaaS report is a documented review against the provisions above. It is not legal advice, and it does not replace sign-off by a qualified regulatory professional.

Frequently asked questions

Can a Taiwanese nutrition label simply be translated into English? No. The US requires per-serving declaration, with the serving size derived from the RACC, and the required nutrients and format also differ (21 CFR 101.9, 101.12). The whole panel must be redone.

How many allergens must a US label declare, and how does that differ from Taiwan? The US has nine, with sesame applying from 1 January 2023 (FD&C Act § 201(qq), § 403(w)). Taiwan has 11, adding mango and sulfites. Taiwan's "cereals containing gluten" corresponds only to wheat in the US.

Can green-logo health benefits go on a US label? Not as they stand. US health claims are limited to those FDA has authorized by regulation, those notified on the basis of an authoritative statement, and those FDA allows under enforcement discretion. Structure/function statements must not concern a disease, and on a dietary supplement they need the 101.93 disclaimer. Translated directly, many of these benefits become disease claims under 101.93(g).

Is a Taiwanese capsule or tablet food always a dietary supplement in the US? Usually, but it depends on whether it meets the definition in 21 U.S.C. 321(ff): it contains a dietary ingredient, is intended to supplement the diet, is taken in tablet, capsule or similar form, is not represented as a conventional food, and is labeled as a dietary supplement. If it does, use a Supplement Facts panel (21 CFR 101.36).

Can a US label keep Chinese? Yes. But once a label uses a foreign language, all mandatory label statements must also appear in that language (21 CFR 101.15(c)(2)). For the layout of bilingual nutrition labeling, see 101.9(d)(14).

Does RegaaS check FDA facility registration or FSVP? No. These are procedural obligations, not label content. RegaaS reviews only the label itself, against US labeling rules.

Primary sources

• 21 CFR Part 101 — Food Labeling (eCFR)
• 101.3 · 101.4 · 101.5 · 101.7 · 101.9 · 101.12 · 101.15 · 101.17 · 101.36 · 101.93 · 101.100
• 21 CFR 107.20 — Infant formula labeling
• 21 U.S.C. 343 — FD&C Act § 403 (including (r)(3)(C), (r)(6), (w), (y))
• 21 U.S.C. 321 — FD&C Act § 201 (including (g)(1)(C), (ff), (qq))
• 15 U.S.C. 1453 — Fair Packaging and Labeling Act § 4
• 21 CFR Part 1 Subpart H — Registration of Food Facilities
• FDA — Questions and Answers Regarding Food Allergen Labeling (Edition 5)
• FDA — Frequently Asked Questions: Food Allergen Labeling Guidance for Industry
• FDA — Small Entity Compliance Guide on Structure/Function Claims
• FDA — Structure/Function Claims
• FDA — Dietary Supplement Labeling Guide
• Taiwan Food and Drug Administration (TFDA), MOHW — Announcement of the Regulations on Food Allergen Labeling (in Chinese)
• MOHW — Announcement of partial amendments to the Regulations on Nutrition Labeling for Prepackaged Food Products (announced 23 June 2022, effective 1 July 2024; in Chinese)
• MOHW — Regulations on Nutrition Labeling for Prepackaged Vitamin and Mineral Tablet and Capsule Foods (in Chinese)
• TFDA — Health food overview and guide (in Chinese)
• TFDA news — MOHW announces the health benefit items under the Health Food Governing Act (3 July 2025, 14 items; in Chinese)
• Laws & Regulations Database of the Republic of China (Taiwan) — Act Governing Food Safety and Sanitation, Article 22 (in Chinese)