Structure/function claims are one of the common claims found on U.S. food labels. They describe how a nutrient or dietary ingredient supports or maintains normal structure or function in the human body. These claims must not mention or imply any disease. A disease claim involves stating that a product can diagnose, cure, mitigate, treat, or prevent a disease. According to 21 CFR 101.93(g), a “disease” is damage to an organ, part, structure, or system of the body such that it does not function properly (e.g., cardiovascular disease), or a state of health leading to such dysfunctioning (e.g., hypertension); except that diseases resulting from essential nutrient deficiencies (e.g., scurvy, pellagra) are not included in this definition.

Recently, China’s National Center for Food Safety Risk Assessment (CFSA) issued a set of FAQs on “three new foods” and substances traditionally used as both food and traditional Chinese medicine (TCM), covering a total of 25 questions. In this article, CIRS Group compiles common strain-related issues concerning “three new foods.”

On August 28, 2024, the China National Center for Food Safety Risk Assessment (CFSA) issued a call for public comment on three new food raw materials: lemon myrtle leaf, Maqui Berry anthocyanins, and wheat polar lipids. Comments are welcome until September 27, 2024. The details are as follows

Recently, China’s National Center for Food Safety Risk Assessment (CFSA) issued a set of FAQs on “three new foods” and substances traditionally used as both food and traditional Chinese medicine (TCM), covering a total of 25 questions. In this article, CIRS Group compiles common regulatory issues concerning “three new foods” and substances traditionally used as both food and TCM.

On August 26, 2024, China’s National Center for Food Safety Risk Assessment (CFSA) issued a set of FAQs on “three new foods” and substances traditionally used as both food and traditional Chinese medicine (TCM), covering a total of 25 questions. In this article, CIRS Group summarizes the key issues regarding the use of various food ingredients, including food extracts, red ginseng, Ganoderma spore powder, and protein hydrolysates, that are of concern to businesses.

On August 26, 2024, China’s National Health Commission (NHC) and the State Administration for Market Regulation (SAMR) jointly issued Announcement No. 4 of 2024, adding four substances—Rehmannia glutinosa Libosch., Ophiopogon japonicus (L.f) Ker-Gawl., Asparagus cochinchinensis (Lour.) Merr., and Citri grandis exocarpium—to the list of substances traditionally used as both food and traditional Chinese medicine (TCM).

As of now, China has officially approved 15 lactose-free/low-lactose infant formulas for special medical purposes. These are designed for infants aged 0 to 12 months with lactose intolerance. The 15 products consist of 12 domestic formulas and three imported ones from 14 companies. Among these, Wissun International has had two formulas approved, while the other 13 companies each have had one. All 15 products are in powdered form. Notably, only one low-lactose formula for special medical purposes has been approved, which is Neng Dun by Wissun International.

Hydroxytyrosol is a naturally occurring polyphenol primarily found in olives and their products, such as olive oil and olive leaves. It is widely studied for its outstanding antioxidant properties and has numerous applications in the food and cosmetic industries. As a powerful antioxidant, hydroxytyrosol helps reduce oxidation in foods, extending shelf life and preserving flavor. Due to its health benefits, hydroxytyrosol is often added to health foods to support cardiovascular health, boost immunity, and reduce inflammation.

On August 5, 2024, China’s National Health Commission (NHC) issued Announcement No. 3 of 2024, officially approving eight “three new foods.” Among them is hydroxytyrosol, a new food additive for which CIRS Group assisted a client in the synthetic biology field in securing approval.

On August 14, 2024, the China National Center for Food Safety Risk Assessment (CFSA) issued a call for public comment on four new food additives: one new food additive, one new food nutrition enhancer, and two food additives with expanded scope. Comments are welcome until September 14, 2024.