A spokesman for the Agency told this website that the information presented by the primetime show’s segment on safety and lab testing would be taken seriously and that FDA “will determine an appropriate course of action”.
The Dateline NBC exposé aired on March 18, 2012 and focused on excessive selenium levels in a liquid vitamin product called Total Body Formula, which was withdrawn from the market in early 2008.
The segment also highlighted the practice of dry labbing whereby analysis is claimed to be done, but in reality the conclusions are guessed at or copied from other sources without actually doing any analysis.
Responsibility
The spokesman added that FDA's main focus for GMP compliance is on manufacturers and suppliers.
“However, ultimately the firms are responsible for following good manufacturing practices and under FDA regulations are responsible for ensuring the safety of their products.”
“FDA inspectors review documents and SOPs on how the responsible party ensures that the information from the contract lab is used to ensure that the requirements in subpart J of the cGMP rule are met,” said the spokesman.
“For example if a firm doesn't have data, chromatography, or other records to support Certificates of Analysis from a lab that may be an indicator of a larger problem as it pertains to cGMP compliance.”
To read our initial coverage of the Dateline show, please click here.
To read the response from the American Herbal Products Association (AHPA), please click here.