NDIs

We’re still waiting on that revised draft guidance – that will be a big development to look out for in 2014 – but the topic of New Dietary Ingredients (NDIs) has still made headlines this year, with a letter from the office of Texas congressman Steve Stockman (above) to the FDA​ urging the agency to better police the filing of NDI notifications.  The letter said that there are some ingredients in the market whose manufacturers should have filed notifications and have not.

The letter mentions three specific ingredient categories: zinc carnosine, pyrroloquinoline quinone (PQQ) and astaxanthin.  In all three categories, Stockman said NDI notifications have been submitted by individual companies who have seen other companies bring follow-on ingredients to market without filing their own NDI notifications on their ingredients. “Those companies which skirt FDA requirements for NDI notifications are putting consumers at risk by offering illegal versions of supplements whose ingredients have not been properly vetted by the FDA,”​ Stockman wrote.

Marc Ullman, a partner in the firm Ullman, Shapiro & Ullman, recently sat down with Hank Schultz to discuss the issue of follow on ingredients that rely on the safety halo provided by NDI notifications filed by competitors. Please click here to watch this interview​.