VALIDATING OLD DIETARY INGREDIENTS (ODI)

Ingredients used in dietary supplements, prior to the Dietary Supplement Health and Education Act (DSHEA) of 1994, are considered Old Dietary Ingredients (ODIs). These require documentation to verify their status as ODIs. This helps to exempt them from the submission of a New Dietary Ingredient (NDI) notification to the Food and Drug Administration (FDA). 

A letter of support verifying ODI status is a proficient way to validate that the ingredient used is safe for consumption. The status of historical use, supported by product and manufacturing records, gives the ingredient impunity. This makes a letter of support verifying ODI status a cost-effective, time-saving tool. In spite of this, TulipLab still conducts its own investigations through scientific literature to support the identity of the ingredient. 

• TulipLab provides expert advice to minimize regulatory risk.
• Research is TulipLab’s cornerstone. For ODIs, we use our robust library of ancient pre-DSHEA dietary ingredients to substantiate the ODI claim.
• In-depth labelling and claim management systems provide verifiable evidence.
• Finally, TulipLab creates its own official letter of support, summarizing findings required to substantiate ODI status.