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Incense Specialities Inc., the brand that markets the melatonin-containing brownie popularly known as “Lazy Cakes” (and since renamed “Lazy Larry”), received an FDA warning letter on July 28.

Excipients might not always be the star of a dietary supplement product-that role most likely goes to the active ingredient-but make no mistake that excipients are more than just “filler.” And, excipients will need to answer to stricter FDA regulation in the near future, according to David Schoneker, director of global regulatory affairs for Colorcon (Harleysville, PA) and past chairman of the International Pharamceutical Excipients Council (IPEC). Schoneker spoke at a recent webcast sponsored by the Council for Responsible Nutrition and Virgo Publishing.