New Dietary Ingredient Notifications: Top 3 NDI Notification Mistakes

During the life of the New Dietary Ingredient Notification (NDIN) program at the Food and Drug Administration (FDA), the rejection rate has averaged approximately 70 percent of submitted NDINs. During more recent years, the rate has approached a 90 percent rejection. The reasons vary, but below are the top three most common mistakes that contribute to a failed NDIN.

It is important to note that, the majority of cases, NDINs fail because the ingredient does not meet the definition of a dietary supplement. More specifically, (1) the proposed label directions actually indicate the substance is to be used as a drug or device; (2) the substance is to be used as a food ingredient or; (3) the substance was never a part of food and therefore cannot be used as a supplement to the diet.

1. The substance is actually a drug or device.

Within the category of substances actually making its use a drug are those for which substantive clinical studies have been initiated (i.e., for drug use) such as cotinine or niacin. Also, the substance cannot not be a drug mimetic such as Cholestin®, a cholesterol synthesis inhibitor; a barley extract that produces significant modulation of glucose metabolism or; N-acetyl-L-hydroxyproline for treatment of arthritis. Products that meet the definition of a device rather than a supplement have also been rejected, including an eye patch.

2. The substance is to be used as a food ingredient.

Substances may not be touted as dietary supplements that are actually foods, including lo han kuo and stevia, both of which whose primary use is as sweeteners.

3. The substance was never a part of food.

Substances never present in food which have been rejected include killed bacteria (Streptococcus pneumonia, Neisseria catarrhalis, Streptococcus pyrogens, Haemophilius influenzae and Stapylococcus aureus), humic and fulvic acids from peat, milk vetch, King Solomon’s root and porcine relaxin (a hormone). However, substances have been approved, that while originally from food, are harvested from a non-food source; these include inositol from pinebark; the carotenoid, astaxanthin, from the algae Haematococcus pluvialis.

Other causes of rejection include a defective submission wherein not all supporting data was submitted, the failure to identify the product accurately (ex: plant product or part of plant used, type of extract or chemical name of the substance) or that some of the supporting documentation was not in English.