On April 25, 2025, we hosted a free Chinese webinar on the key points and considerations in food registration in different countries and US food label compliance. Many questions were raised during the webinar.We have collected the questions and made a Q&A summary as follows.
1. Can cold-processed pastries (shipped frozen, containing egg and dairy products) be exported to the EU? Are they considered high-risk products?
Yes, cold-processed pastries can be exported to the EU. Since pastries contain flour, eggs, and dairy ingredients, they are classified as composite foods. Exporting to the EU requires overseas registration with the EU authorities. Additionally, any dairy ingredients used must originate from countries granted for dairy imports into the EU (currently, China’s dairy products have not been granted access).
2. For egg products exported to Vietnam, does the businesses need to be registered in Vietnam?
No, registration in Vietnam is not required.
3. In dietary supplements, is it optional to include “as” in the Nutrition Facts?
Yes, it is optional. The source of dietary ingredients may be indicated in parentheses immediately after or indented under the ingredient name, prefixed with “as” or “from”, like “Calcium (as calcium carbonate)”. If not shown in the Nutrition Facts, the source must be listed in the Ingredients list.
4.What does "increment" mean in rounding rules?
An increment of 0.5g means nutritional values on the label are rounded to 0.5g, 1g, etc., with a rounding interval of 0.5g. An increment of 1g means values are rounded to 1g, 2g, etc., with a 1g interval.
5. For imported foods, is it still necessary to indicate the manufacturer information? Does the distributor have to be located in the US?
(1) According to 21 CFR 101.5, food labels must display the name and place of business of the manufacturer, packer, or distributor—one of the three is sufficient.
(2) For dietary supplements, under the Federal Food, Drug, and Cosmetic Act, a US address or phone number must be provided for reporting serious adverse events. Therefore, imported dietary supplements must have a contactable US distributor listed on the label.
6. Are data required to support structure/function claims? How should structure/function claim notifications be submitted?
(1) Structure/function claims for dietary supplements must be notified to the FDA within 30 days of the product’s first marketing. Companies are responsible for ensuring the claims are truthful and substantiated, but no data is required at the time of notification.
(2) Notifications can be submitted by mail. However, to facilitate review and speed up processing, the FDA encourages using the electronic portal.
7. If the packaging is too small for the lowercase “o” to reach 1.6 mm, is a font size smaller than 1.6 mm permissible?
If the label area on the food packaging is too small to include all required information, alternative methods for conveying the information to consumers may be used. Fonts smaller than 1/16 inch (~1.6 mm) are permissible, but a petition must be submitted according to 21 CFR Part 10.
8. Are health claims applicable to conventional foods or dietary supplements?
Yes, health claims may be used for both. For more information on permissible claims on US food labels, refer to the article What Claims are Permitted on US Food Labels?.
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