Diosmin and Micronised Diosmin by Bordas with FDA NDI Authorisation
Obtaining NDI (New Dietary Ingredient) authorisation from the FDA for ingredients such as Bordas Diosmin and Micronised Diosmin ensures that dietary supplement formulas containing them are safe and free from undeclared ingredients. In the case of our Diosmin and Micronised Diosmin ingredients, they were subjected to a rigorous evaluation, which concluded that they are reasonably safe for supporting vascular health and improving blood circulation.
What is New Dietary Ingredient authorisation?
Supplement regulations in the United States are designed to ensure that the ingredients used in consumer products are safe and properly documented. The FDA does not approve supplements as if they were medicines, but it does require manufacturers to follow specific processes to demonstrate the safety of new or lesser-known ingredients.
The FDA (Food and Drug Administration) is a federal agency of the United States responsible for protecting public health. Its main function is to ensure the safety, efficacy and protection of medicines, as well as regulate food safety. This agency is responsible for authorising NDIs (New Dietary Ingredients), a notification process that requires companies to inform the FDA about a new ingredient before including it in dietary supplements in the US.
Within this framework are the Good Manufacturing Practices (GMP) and the obligation to notify any New Dietary Ingredient (NDI). This step is essential for brands and manufacturers to market their products in the US market with transparency and confidence.
Why is it a milestone to have this authorisation?
Having NDI authorisation offers a clear competitive advantage because it demonstrates a commitment to safety, reduces regulatory risks, and increases consumer confidence in the supplement. This process involves a formal notification that includes toxicological studies, analytical methods and data on conditions of use. This translates into a significant advantage, as incorporating the ingredient into a formula becomes much easier and safer.
The FDA reviews the evidence submitted by the manufacturer to ensure that the new ingredient is safe for consumption according to its intended use. Therefore, the first benefit derived from authorisation is consumer safety.
The FDA evaluates safety based on data. For this reason, manufacturers using ingredients with clear documentation offer a more reliable product, less exposed to regulatory objections.
Working with suppliers that already hold NDI notification greatly facilitates the work of regulatory and R&D teams, and accelerates the launch of new formulas.
Diosmin and Micronised Diosmin supported by the FDA
Diosmin is an ingredient used in formulations aimed at circulatory wellbeing. Although its use is widespread, the FDA requires manufacturers to have information that supports its safety and traceability.
Micronised Diosmin, for its part, adds an additional step, meaning suppliers must demonstrate how particle-size reduction affects the ingredient’s profile. For a manufacturer, working with this type of documentation facilitates the inclusion of the ingredient in the formula without uncertainties.
For supplement formulators and manufacturers, complying with supplement regulations and working with supported ingredients is a strategic decision. Ingredients such as diosmin or micronised diosmin, when backed by robust safety documentation, allow the launch of more competitive, safer products that are prepared to withstand any review by the US market.
