03.24.15
In response to an inquiry about DNA testing by Senators Orrin Hatch (R-UT) and Martin Heinrich (D-NM) submitted in late February, the FDA responded, noting that "if the FDA were to use DNA methods on botanical extracts, we would use them in combination with established chemical or other acceptable methods historically used to verify the identity."
FDA's response issued March 18, also noted it has not stated that DNA barcode testing is inappropriate, but any evaluation would be based on a specific firm's methodology for the specific product and whether the testing was appropriate and scientifically valid. FDA stressed that it has not received the testing methodology or results from the New York Attorney General and can't address the validity of those testing results.
FDA also highlighted current good manufacturing practice (cGMP) requirements that companies must conduct at least one appropriate test to confirm the identity of each incoming dietary ingredient before being used in a finished supplement and test finished product batches to verify that they meet established specifications for identity, purity, strength, composition and limits on contamination.
Regarding labeling requirements, FDA stated that labeling of unintentional, trace amounts of agricultural materials is not part of the ingredient labeling requirements, but the cGMP rule does address intentional and unintentional adulteration of finished products by establishing a production and process control system.
Mike Greene, vice president, government relations for the Council for Responsible Nutrition stated: “We are appreciative that Senators Hatch and Heinrich asked FDA to clarify the agency’s role in regulating the industry. FDA’s response is helpful as other State Attorneys General and the media evaluate what’s going on in New York. In our ongoing discussions with State AGs and the press, we continue to emphasize that the NY AG used the wrong test, leading to inaccurate conclusions, and that FDA has ample and appropriate good manufacturing regulations in place to help ensure that consumers are getting products that contain what’s on the label. We will share this letter widely as it confirms many of the things we have been saying. The fact is there are regulations in place, and responsible companies are following those regulations.”
For more information:
FDA responses to Sens. Hatch and Heinrich
Sens. Hatch and Heinrich's letter to FDA
FDA's response issued March 18, also noted it has not stated that DNA barcode testing is inappropriate, but any evaluation would be based on a specific firm's methodology for the specific product and whether the testing was appropriate and scientifically valid. FDA stressed that it has not received the testing methodology or results from the New York Attorney General and can't address the validity of those testing results.
FDA also highlighted current good manufacturing practice (cGMP) requirements that companies must conduct at least one appropriate test to confirm the identity of each incoming dietary ingredient before being used in a finished supplement and test finished product batches to verify that they meet established specifications for identity, purity, strength, composition and limits on contamination.
Regarding labeling requirements, FDA stated that labeling of unintentional, trace amounts of agricultural materials is not part of the ingredient labeling requirements, but the cGMP rule does address intentional and unintentional adulteration of finished products by establishing a production and process control system.
Mike Greene, vice president, government relations for the Council for Responsible Nutrition stated: “We are appreciative that Senators Hatch and Heinrich asked FDA to clarify the agency’s role in regulating the industry. FDA’s response is helpful as other State Attorneys General and the media evaluate what’s going on in New York. In our ongoing discussions with State AGs and the press, we continue to emphasize that the NY AG used the wrong test, leading to inaccurate conclusions, and that FDA has ample and appropriate good manufacturing regulations in place to help ensure that consumers are getting products that contain what’s on the label. We will share this letter widely as it confirms many of the things we have been saying. The fact is there are regulations in place, and responsible companies are following those regulations.”
For more information:
FDA responses to Sens. Hatch and Heinrich
Sens. Hatch and Heinrich's letter to FDA
