US Supplement Market Growth: Is The Industry In Its Own Way?
This article was originally published in The Rose Sheet
Longtime supplement industry attorney Scott Bass says supplement manufacturers should work with FDA as an ally, including registering products with the agency pre-market, while FDA's second-in-command for supplement industry oversight, Robert Durkin, says the agency is not interested in preventing more safe products from reaching the market.
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Highlighting dietary supplement sector's self-regulation at a recent supplement industry regulatory conference, the sports nutrition product marketer's chief counsel Bill Carter described his experience in federal court in 2012. He suggested some supplement firms, like Bodybuilding.com previously, don't consider themselves likely to incur litigation or criminal charges linked to regulatory problems when they learn about other businesses that have. "Just because you don't hear about a lot of FDA's office of Criminal Investigations doesn't mean they're not active," he said.
FDA doesn't expect o continue increasing GMP inspections at the rate established from fiscal 2013 through 2017, says Cara Welch, assistant director of the office in the agency's Office of Dietary Supplement Programs."We're not going to keep growing at that rate because we have a lot of regulations we have to inspect and we're always resource strapped," she said at a recent industry conference.
CHPA and CRN look forward to working with FDA to develop a path for the identification of pre-DSHEA ingredients, but say the FDA’s revised draft guidance for new dietary ingredient notifications still hampers innovation.