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Immunity Food Products Registration and Notification in the USA

Immunity food products containing curcumin (turmeric), moringa and elderberry supplements play a vital role in keeping the body’s immune system intact. Being one of the most effective species of the East India and Middle East, Curcumin (turmeric) offers multiple health benefits to the human body. Similarly, moringa provides super immune-boosting powers to the human body and elderberry provides the necessary antioxidants and vitamins to human immune system. In this on-going situation of Covid-19, the intake of Curcumin/Moringa/Elderberry supplements are essential for public to boost their immune systems. However, amid the disruptions of supply chain, ensuring that the demands of public are met is becoming a challenge.

To ensure the world sustain the international health crisis, as a prominent immunity food product (IFP) manufacturer you might be willing to market your curcumin-based supplements across the globe or to be specific in the USA. In the USA, Curcumin/Moringa/Elderberry supplements are classified as dietary supplements and are regulated by the United States Food and Drug Administration (US FDA) under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Additionally, the Dietary Supplement Health and Education Act (DSHEA) is responsible for monitoring the safety and efficacy of the immunity food products and their claims.

Immunity Food Products – Freyr’s Regional Focus

With a vast knowledge on the US FDA and IFP (Curcumin/Moringa/Elderberry) Regulatory requirements, Freyr team of subject matter experts (SMEs) can assist you with compliance check of the Immunity Food Product registration, label and claims to identify if the product is able to comply to the requirements listed by FDA or will need to submit NDIN/GRAS. If the client has to submit an application for NDIN or GRAS, Freyr team can assist in preparing, compiling and submitting the complete application to FDA as per the regulations on approval for non – specified ingredients. Freyr is specialized in:

  • Immunity Food Product (Curcumin/Moringa/Elderberry) registration in the USA
  • Immunity Food Product (Curcumin/Moringa/Elderberry) market entry
  • Evaluation of your label or labeling information for compliance
  • Review of immunity boosting claims
  • Design or develop artwork for Immunity boosters
  • Review or assess the product formula to identify the product category and to check the acceptability of all the ingredients in the product in line with the US FDA
  • Suggesting mandatory, missing information and nutritional/supplemental facts or the corrections to be made on the label of the product as per the country specific regulations
  • Monitor compliance with US FDA including advising on general labelling and advertising issues, nutrition labelling, and evaluation of permissible claims (e.g., health claims, nutrient content claims, and structure-function claims)
  • Prepare and submit dossier for Immunity Food Product (Curcumin/Moringa/Elderberry) registration
  • Assist with devising a robust Regulatory pathway for your product

As a responsible Regulatory partner, Freyr has already started assisting clients to accelerate and fast track registrations of Immunity Food Product (Curcumin/Moringa/Elderberry) in the USA.

  • Immunity Food Products (Moringa, Turmeric, Curcumin, Elderberry) For a different country?

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