The FDA’s NDI Draft Guidance Controversy
Recently the FDA’s regulations and increasingly restrictive legislation concerning health and nutritional products has been a substantial burden on vitamin and supplement companies. A current hot topic in this department is the new NDI (new dietary ingredients) draft guidance which would require that a NDI notification be filed whenever a NDI is included in a product or in a reformulation of a product. Many of those in the industry point to this as further evidence of over-regulation since the guidelines now instruct supplement companies to file NDI notifications on every product that includes a NDI and not just on the ingredients themselves.
There has been opposition to these new guidelines from leading industry representatives, some calling for immediate withdrawal of these guidelines. As is the case with other FDA regulations, the NDI draft guidance requires a substantial time commitment and additional effort even in situations where it does not seem necessary. For example, if a product formulation changes slightly, a new NDI notification would need to be filed for that product in addition to the original NDI notification that would have already been submitted. Preparing a NDI notification can cost a manufacturer approximately 100-350 hours of work.
The FDA’s previous regulation regarding NDIs required a NDI notification to be filed for each ingredient, but not each finished product. The new, and more demanding, guidelines will require manufacturers to report on each finished product that contains a NDI. With increasing regulations, it is becoming more difficult for supplement companies to thrive. The additional red tape overburdens these companies with the requirement for what many believe is superfluous documentation. Many feel that this hinders business, at times with unnecessary warnings to consumers and the increasing demand for more time and effort to be devoted to documentation.
Reasons for the push for the FDA to withdraw the NDI Draft Guidelines:
- They require NDI notifications to be filed for every new formulation change
- They are product specific, not ingredient specific
- They significantly deviate from the FDA’s original NDI regulations
Visit the Nutritional Outlook website for more information on these regulations and the reactions the NDI Draft Guidance has incurred.