Marc Ullman, a partner in the firm Ullman, Shapiro & Ullman, has investigated the issue on behalf of three clients: Fuji Health Sciences, which has filed NDIs on its astaxanthin ingredients, Mitsubishi Gas Chemical, which has an NDI for its PQQ ingredient, and XSTO Solutions, the exclusive distributor for Hamari, which has filed a notification on its zinc carnosine.
“All three of these companies are starting to see issues in the marketplace where they are losing sales to competition that is significantly undercutting their price. When we do some research we find that these new entries into the marketplace have never submitted NDI notifications. They have just skipped the process and gone straight to market,” Ullman said.
Any reasonable reading of the NDI portion of DSHEA leads one to conclude that every ingredient that qualifies as an NDI (i.e. one that wasn’t on the market in an article of food on or before Oct. 15, 1994) needs to have a notifcation on file with FDA 75 days before going to market, Ullman said. But many companies are not playing by those rules, he said.
And in some cases these newer entries are not made in remotely the same way as those for which the NDI notifications are on file, leading to the question: if they not made the same way, how can the same safety data apply? In some cases these are synthetic versions of botanical ingredients.
“It’s a separate issue with the synthetic. FDA has taken the position that the only thing you can have that is a synthetic is a vitamin or a mineral. So when we look at it from that angle, the synthetic knockoffs don’t even qualify as dietary ingredienst. But even if we remove that issue, they would still be required to submit a NDI notification to FDA,” Ullman said.