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CRN Database Compiles FDA Warning Letters

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By: Sean Moloughney

Editor, Nutraceuticals World

The Council for Responsible Nutrition (CRN) has developed a free online tool that compiles FDA Warning Letters sent to dietary supplement companies into a searchable database to help industry achieve better regulatory compliance. The database can be used to evaluate FDA’s warning letter allegations of good manufacturing practice (GMP) violations, products making impermissible claims, and products tainted with illegal ingredients.

According to CRN President & CEO Steve Mister, “Our goal is to help companies in the supplement industry better understand the types of transgressions that will trigger a warning letter from FDA, so that all companies can learn from others’ mistakes and identify priorities in FDA enforcement, thereby raising the level of compliance with the law.”

The database is searchable by key criteria including: product name; company; ingredient; issue date; potential violations; regulations cited; FDA district office issuing the warning; or a combination of criteria. It includes almost 300 warning letters publicly released by FDA from January 2008 through August 2014, to companies that the agency claims: 1) have violated dietary supplement GMPs; 2) are illegally marketing a dietary supplement that contains undisclosed pharmaceutical ingredients; or 3) are making impermissible claims to prevent, treat, cure or mitigate a disease.

“Monitoring violations cited in FDA warning letters is one of the best ways to understand the agency’s current enforcement priorities and expectations,” Mr. Mister noted. “When companies have compliance questions, they can search previous warning letters for similar circumstances and review the contents of those letters to consider the positions taken by the agency in those situations, and avoid these mistakes.”

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