NDIs
Last year’s most contentious issue is still under discussion. When we talked to the FDA’s Dr Dan Fabricant recently, he admitted that talks are on-going with the trade associations, but there is currently no timeline on a final guidance.
Topics like synthetic versions of botanical compounds remain a tempestuous issue.
The trade associations continue to fight for this issue, but the signs are that FDA is not budging easily on this.
The FDA’s view that synthetic copies of botanical constituents are not dietary ingredients - and therefore not permitted in dietary supplements - is outlined in responses to citizen’s petitions and spelled out in its 2011 draft guidance on NDIs.