The FDA’s draft guidance on New Dietary Ingredients (NDI) was the hot button topic for 2012, but as tempers have cooled this year another issue relating to NDIs has emerged – the appearance on the market of synthetic versions of natural ingredients that have positive NDI notifications. These ‘follow-on’ ingredients are causing concern for the companies which have a legitimate NDI approval from the FDA.
Our article from earlier this week highlighted the issue with two case studies, one involving PQQ – or pyrroloquinoline quinone – and the other involving potent carotenoid astaxanthin.
Jason Sapsin, a former FDA counsel now in private practice with the firm Fox Rothschild, told us that, in his opinion, new notifications are required for every instance of an NDI brought forth by ingredient manufacturers. It’s a commitment of each company to the safety of its particular ingredient, he said.
“The reason that you do that is you are expected to explain to the agency the basis on which you—you personally, your company—have concluded that the ingredient is reasonably expected to be safe,” said Sapsin.