In a letter to Patricia Kuntze in the US Food and Drug Administration (FDA) Office of External Affairs, the members of the working group note that since “dietary supplements are addressed in other regulations and legislation”, they should be exempt from the new paradigm.
The SIDI working group is a coalition of the dietary supplement trade associations. The letter is signed by Marcia Howard, PhD, director, regulatory & scientific affairs for the Consumer Healthcare Products Association (CHPA), Douglas Mackay, ND, VP, scientific & regulatory affairs for the Council for Responsible Nutrition (CRN), and Harry Rice, PhD, VP regulatory & scientific affairs for the United Natural Products Alliance (UNPA).
Supply chain integrity
“The Working Group concurs with Commissioner Dr. Margaret Hamburg’s December 15, 2010 letter to the dietary supplement industry which identified establishing a strong program of qualifying raw material suppliers, testing incoming ingredients, and verifying the contents of finished products as important steps to reduce the risks of contamination, adulteration, or other supply chain failures,” states the letter.
“As the global supply chain becomes more complex, proper supply chain management is critical. A robust testing program must be balanced with knowledge of the ingredient suppliers’ quality practices.
“Several FDA regulated industries, including the dietary supplement industry, have been developing voluntary guidelines for supplier qualification for their respective industries. FDA is requested to consider the documents developed by the Working Group as a basis for the important work that will be done throughout the implementation of the [Food Safety Modernization Act],” it added.
The group continues that its initiatives are “directly in line” with the principles intended by the FSMA, and that its voluntary guidelines should serve as a basis for guidelines and regulations.
“We support the Agency’s effort to establish accredited third party auditors, which will further the Working Group’s efforts to ensure supply chain integrity,” added the working group.