Tablets and Capsules: Stricter Standards for Excipients?

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.

Currently, a dietary supplement excipient must either be FDA-approved as a food additive according to the Code of Federal Regulations (21 CFR), or be deemed Generally Recognized as Safe by a qualified panel of independent experts for use specifically in dietary supplements. The dietary supplement Good Manufacturing Practices (GMP) guidelines require excipients to adhere to GMP regulations for food.

However, says Schoneker, food-additive companies strongly believe that GMPs for food may not be appropriate for excipients. “There are big differences between food additives and standard food materials,” said Schoneker.

He explained that while foods are typically sourced from a natural environment such as the farm or the ocean, food additives are often created in large-scale manufacturing plants producing synthetic chemicals.

Those involved in food additives, including IPEC and the International Food Additives Council (IFAC), have banded together to create stricter GMP standards for food additives, including excipients for dietary supplements.  IPEC already published GMPs for pharmaceutical excipients several years ago, which have become the world standard for excipient GMPs, says Schoneker. These proposed food-additive GMPs fall somewhere between the level of GMPs for food and those for dietary supplements, he said.

“Food-additive suppliers are taking proactive actions to address a higher level of GMPs, and dietary supplement companies need to begin requiring this level of GMP compliance when determining who their suppliers will be for excipient products,” said Schoneker.

And, FDA is listening. “I can tell you that FDA is extremely interested in working with IFAC to develop appropriate GMPs for food additives because they also believe that the standard food GMPs are not enough for this kind of chemical-manufacturing type of operation,” he said. IFAC has already met with FDA’s Center for Food Safety and Applied Nutrition, including the Office of Dietary Supplements, and FDA was very interested to see the draft Food Additive GMP document being prepared, he said.