FDA seemed to clarify one of the more controversial aspects of its draft guidance on New Dietary Ingredient (NDI) notifications during the Town Hall at SupplySide West Oct. 12, suggesting that a notification would not be required for a dietary supplement that falls within ...More
The INSIDER NDI Immersion Center is a one-stop destination for all things related to the FDA's NDI Draft Guidance, and it is full of great content to help you understand the situation and what it means for your business. ...More
During the recent UNPA conference on the FDA draft guidance for New Dietary Ingredients, the agency suggested that industry take another look at the ephedra rule and its application of "unreasonable risk." Indeed industry should. ...More
We are working hard to provide the resources for you to understand what the FDA draft guidance on New Dietary Ingredients (NDIs) means and what to do. Here are some highlights. ...More
From my non-lawyer, non-bureaucrat reading, the FDA's draft guidance on New Dietary Ingredients is an aggressive attack that in some ways would take us back to pre-DSHEA days. Am I wrong? ...More
The just-released New Dietary Ingredient draft guidance from FDA will likely cause a lot of heartburn for ingredient suppliers and dietary supplement manufacturers and marketers, and it should. ...More
Melatonin-spiked brownies sold as "Lazy Cakes" and other branded products have stirred controversy in the mainstream press, motivated Sen Dick Durbin to write a letter to the FDA Commissioner questioning DSHEA, and driven one state to pursue a ban of the product. ...More
Having just returned to my office from our 13th SupplySide East show, it seems like a good time to share my observations from the show, and there are plenty to think about... ...More
For years, the dietary supplement industry complained that FDA was not enforcing the law, and rightly so. Those days are over, and aggressive FDA enforcement is upon us. ...More
The announcement that FDA and the supplement industry trade associations will work together to go after companies and individuals selling "supplements" that contain pharmaceutical, steroid and other illegal ingredients is a good thing. ...More
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