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.

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

On September 20, 2024, CIRS China made a major breakthrough in the field of food contact materials regulations by successfully obtaining the formal approval of the US Food and Drug Administration (FDA) for a US Food Contact Substance Notification (FCN). This achievement not only demonstrates CIRS's professional strength in the field of food contact materials, but also paves the way for the company to explore the international market.

According to the US Federal Food, Drug, and Cosmetic Act (FD&C Act), all businesses involved in the production, processing, packaging, or storage of food (including food additives and dietary supplements) – collectively referred to as food facilities – must complete registration with the US Food and Drug Administration (FDA). These businesses are also required to update their registration every even-numbered year between October 1 and December 31 and ensure that the FDA is permitted to conduct facility inspections within the scope allowed by the FD&C Act.

Structure/function claims are one of the common claims found on US 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.

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.

In the second quarter of 2024, the US FDA's official website updated the GRAS status of 19 products. Among these, one substance was approved, while 18 are still under review.

In the US, three categories of claims can be used on food and dietary supplement labels, these include: nutrient content claims, health claims, and structure/function claims. In this article, we will introduce the requirements for these three claims in detail for your reference.

In order to help enterprises better understand the application of GM food raw materials in Europe, China, and the United States, CIRS is launching this webinar to introduce the application process and materials required, and share our experiences.