Food labels in the US must comply with the requirement of American federal regulations (21 CFR 101.9 for general food; 21 CFR 101.36 for dietary supplement). In order to convey the correct nutrition facts to consumers, label makers should fully understand the requirements of food labels and ensure that every details is standardized. In this article, we will provide a detailed interpretation on the requirements of US nutrition labels.

The State Administration for Market Regulation (SAMR) officially issued the Key Points for the Review of the Change of Registration Certificate for Health Foods with No Validity Period and No Technical Requirements in Production and Sale (hereinafter referred to as the Key Points) on November 1st, 2024 in order to standardize the health food registration certificates of products with no validity period.

Currently, China has officially approved 22 special medical use carbohydrate component formulas designed for people over one year who suffered from specific diseases or needs carbohydrate supplementation. 22 carbohydrate component formulas are domestically made by 20 companies, among which, DAISY FSMP and Tibet DUOXIN HEALTH were approved for 2 products each, and the other 18 companies were approved for 1 product. The largest number of approved companies is in Jiangsu Province, with a total of 7 products. The first carbohydrate component formula 泉克 was registered and approved by Tibet DUOXIN HEALTH in 2020, other carbohydrate component formulas were approved mostly in 2021, 2023 and 2024.

NDI, or New Dietary Ingredient is defined in 21 CFR as dietary ingredients, ingredients used a supplements, introduced to the US market after October 15, 1994. As required by FDA, manufactures must notify FDA as least 75 days prior to the marketing of a product containing NDI. Almost all NDI notifications (NDIN) and their corresponding FDA response letters are publically available on the FDA website. The acceptance of the information provided in each NDIN is a procedural matter that does not preclude FDA from taking action against the NDI if is to be found to be unsafe in the future.

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