US FDA publishes draft guideline on NDI in food (dietary) supplements.

The FDA has just published a draft guidance for US companies, concerning New Dietary Ingredient (NDI) used in food supplement. NDI can be somewhat likened to EU’s novel foods.

The 1994 ‘Dietary Supplements Health & Education Act’ (DSHEA) places an obligation on US companies to notify the FDA, when they want to market an NDI, providing also evidence of safety. Exceptions are ingredients used before 10/15/1994: they are ‘grandfathered in’ and considered safe.

The present guidance tends to maintain this stance, defining  some aspects that were not well clarified before. Ingredients used before 1994 in common foods have to be considered as NDI, if they are now used in food supplements. Ingredients used in food supplement, before than 1994 but outside the USA, have to be considered NDI as well.

Another specification of the present draft guidance is related to the manufacturing process; if it alters the chemical structure or composition of the ingredient, it makes it an NDI.

The draft guidance is open for comment.

Armando Antonelli – Sport Nutrition Team

One Response to US FDA publishes draft guideline on NDI in food (dietary) supplements.

  1. sgeysbeek says:

    Something related to the FDA and supplements that people should know about. please visit over 100,000 people die every year by taking properly prescribed medicine. Hmmm. The number of people who use vitamin supplements is on the rise. It is a $60 BILLION a year industry. How many people have died because of taking them? There is not a lot of data but suffice it to say that it’s certainly NOT 100,000. Now the FDA is trying to regulate supplements out of our lives.

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