Claudia Lewis spoke with Bloomberg about the FDA’s new food additive oversight rule and concerns about its potential impact on the agency’s resources and review capacity. Her comments appeared in the article “New Food Additive Oversight Rule Stokes Fears of FDA Backlog." The following is an excerpt:
Regulators, in their impact analysis of the draft rule, said making GRAS submissions mandatory will task the agency with roughly 98 additional notices to review annually. Claudia Lewis, a partner at Venable and co-chair of the firm’s FDA group who advises clients on GRAS notices, said that’s an undercount.
“There’s hundreds and hundreds of ingredients,” Lewis said. “I think the volume is going to be significantly larger than the agency anticipates.”
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