The Pew Charitable Trusts submitted comments this month supporting draft guidance that the Food and Drug Administration issued in August on the new dietary ingredients (NDI) notification process for supplement manufacturers and distributors. NDIs are vitamins, minerals, or herbs that were not on the market before Oct. 15, 1994. Manufacturers are required in most cases to notify FDA before marketing a product that contains an NDI to show that the substance is “reasonably expected to be safe.”
Unlike drugs, which must go through testing for safety and effectiveness before being made available to patients, dietary supplements typically do not require premarket review or approval by FDA, making the NDI process an important protection for consumers. FDA’s draft guidance includes when the supplement industry should submit an NDI notification, what to include, and how to conduct appropriate safety assessments.
The guidance also attempts to provide clearer direction on manufacturing processes and chemical alterations that significantly change the source material, essentially creating an NDI that may or may not be safe. For example, manufacturing changes that alter the chemical or molecular composition or structure of a dietary ingredient could affect how it behaves when ingested, potentially rendering it toxic. This guidance will help ensure that if an ingredient is extensively altered, manufacturers and FDA have the evidence to conclude that the new ingredient is reasonably expected to be safe.