Harkin, Hatch Take Swing At FDA Pitch To Evaluate NDIs As Food Additives
This article was originally published in The Tan Sheet
The staunch industry allies explain their concerns about the potential for regulating new dietary ingredients as food additives in a letter to FDA Commissioner Hamburg. They point out DSHEA includes “an essential exclusion of dietary ingredients from the statutory definition of food additives.”
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More than four years after beginning to revise its widely criticized initial draft guidance on NDI notifications, FDA on Aug. 11 released a second draft. "I think it is reflective of a new effort by the agency to have a dialogue with the industry," says Steve Mister, president and CEO of the Council for Responsible Nutrition.
The draft guidance for a key component of expanding the number and variety of dietary ingredients allowed for use will generate immediate response from across the sector and garner interest from the industry's Capitol Hill allies instrumental in FDA's 2012 decision to revise the draft published a year earlier.
Consumer Reports criticizes FDA current regulation of the dietary supplement industry, saying it found 15 supplement ingredients that are “potentially harmful” and can cause organ damage, cancer and "possibly death."