The agency is deciding what to do about “old” supplements—tell them what you think! Action Alert!
Last year, we told you about the FDA’s massive attack on supplements that came in the form of a guidance document. That guidance is meant to provide clarity to supplement companies regarding “new supplements”—referred to as new dietary ingredients, or NDIs.
Federal law requires companies to submit a notification to the FDA before an NDI is sold in the US. Federal law also defines a NDI as an ingredient that was not marketed in the US before 1994—meaning that supplements marketed before 1994 are “old dietary ingredients,” or ODIs, for which no notification is required.
This leaves the question: how will companies know which supplements are considered NDIs and which are considered ODIs?
The FDA is asking for feedback from the public on whether or not to develop an official list of ODI ingredients.
While the creation of an official list may sound like a good thing, we think it’s possible that the FDA would use such a list to target supplements. FDA inspectors could simply go to a vitamin store with their ODI list, and anything that is either not on the list or doesn’t have an approved NDI notification would be wiped off the shelves.
ANH-USA has prepared comments to submit to the FDA that make the following points:
- As FDA staff have themselves pointed out, no law requires the creation of an ODI list; therefore, no ODI list should be created;
- If the FDA does decide to create a list, the omission of a supplement from the list should be “neutral”—meaning the exclusion of an ingredient from the list does not automatically make it an NDI;
- The list should never be closed, accepting new ODIs on a rolling basis;
- The FDA should broadly interpret the term “marketed” when creating an ODI list. The FDA has maintained that, for a supplement to be an ODI, it needed to be marketed in or as a dietary supplement before 1994. This excludes many nutrients that were in the food supply but not listed on the bottle of a supplement. Instead, the FDA should consider ODIs to be dietary ingredients that were sold, in any form, before 1994.
The FDA’s proposed NDI notification process remains one of the largest threats to the supplement industry ever. A win here would be a significant step toward fixing the mess that the FDA created.
Action Alert! Write your own message to the FDA, urging them to follow the course outlined above. Please send your message immediately.
