CIRS FAQ: Can You Directly Translate Domestic Health Food Labels for Use in the US?

On October 29, 2024, we hosted a free webinar on the key points and considerations in dietary supplement development. Many questions were raised during the webinar. We have collected the questions and made a Q&A summary as follows:

Q1: What standards govern the labeling of health food products?

A1: Health food products and similar products are generally referred to as dietary supplements in the US and could be labeled according to the requirement of dietary supplements. Regulatory reference: 21 CFR Part 101-FOOD LABELLING.

Q2: Is it possible to use the approved GRAS materials as raw materials in the product?

A2: Generally Recognized As Safe (GRAS) materials can be used according to the stipulated application scope and maximum use level.

Q3: Is it possible to use the GRAS materials as dietary ingredients in a dietary supplement?

A3: The dietary ingredient used in a dietary supplement has no relationship to whether it is GRAS material or not. You should look at whether the material is a dietary ingredient (including vitamins, minerals, and herbs), and whether it is a dietary ingredient that was on the market before October 15, 1994.

Q4: can I say “FDA approved” when I passed the Structure/Function Claim Notification?

A4: No, because the FDA does not make the Structure/Function Claim Notification.

Q5: Can you directly translate local health food labels for use in the US? What are the consequences of a direct translation for use without labeling as required for dietary supplements?

A5: No. The label requirements for domestic health food are different from those for America. When selling to the US, you need to use product labels that comply with US requirements. If you directly translate a local label and use it for the US it may lead to some adverse consequences due to labeling non-compliance, such as product recalls, market access restrictions, lawsuits, and fines.

Q6: How are the amounts in the nutrition label calculated?

A6: Ingredients listed in the Dietary Ingredient List can be obtained by testing or calculation, but regardless of their source, companies are responsible for the accuracy and compliance of the information provided on the label.

Q7: Is there any commissioned processing for food exported to the US? How do you label the commissioned and entrusted information?

A7: US food labels should indicate the name and place of business of the manufacturer, packer, or distributor. When there is a consignment relationship, if only the information of the consignee is indicated, it can be indicated as the name and place of business of the manufacturer. If only the information of the consignor is indicated, the name of the consignor's enterprise should be preceded by the following words: “Manufactured for ______” or ” Distributed by ______”, or both the commissioning party and the commissioned party can be labeled, and it is sufficient to write the identity of the enterprise.

Q8: Is there any modification rule for % daily value (DV) of dietary ingredients in the Dietary Ingredient List?

A. The %DV should be expressed as the nearest whole percentage. When the amount of a dietary ingredient is so small (but above the threshold value of 0) that the %DV is rounded to the nearest whole percentage of zero, the %DV should be declared by using “less than 1%” or “<1%” (e.g., contains 1.0% of the total amount of the dietary ingredient, or 1.1% of the total amount of the dietary ingredient). “ (e.g., a product containing 1 gram of total carbohydrates would list %DV as “less than 1%” or “<1%”).

Q9: If the FDA automatically matches the Data Universal Numbering System (D-U-N-S®) Number of the parent company, which does not match the manufacturing plant, what is the recommended follow-up?

A: Apply for a D-U-N-S® Number for the manufacturing plant for the FDA food company registration.

If you are interested in global hot topics of food compliance, you don't want to miss our webinars. We have made a list of all the free webinars scheduled for 2024 for your reference: CIRS Food – Upcoming Free Webinars in 2024.

If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.