New Adverse Event Reporting Section Proposed for NSF/ANSI Standard 173

Deadline Approaching for Public Comment on American National Standard

Ann Arbor, MI – To reflect changes in federal policy, NSF International announced that it has proposed a new section on Adverse Event Reporting (AER) to be added to NSF/ANSI Standard 173: Dietary Supplements. An open comment period regarding new AER requirements is set to end on February 22nd following a vote by the independent NSF Joint Committee on Dietary Supplements, which includes a balanced representation of regulatory officials, industry groups and consumers/end users of a product.

The proposed update to the standard will incorporate new federal legislation requiring dietary supplement manufacturers to have a system in place to notify the U.S. Food and Drug Administration (FDA) of any adverse events associated with dietary supplement products. The Dietary Supplement and Nonprescription Drug Consumer Protection Act was signed into law December 2006 and will become effective December 2007.

In accordance with the new law, adverse events that must be reported include:

  • Life-threatening experience
  • Disability or incapacity
  • Inpatient hospitalization
  • Birth defects
  • Requirement of medical or surgical intervention
  • Death

According to federal mandates, the AER reports must be submitted to the FDA no later than fifteen business days from the date that a consumer reports a problem with a product. This policy applies to all dietary supplement products manufactured and marketed beginning in December 2007. If products labeled at that time do not have the proper information for reporting an adverse effect on its label, the product will be considered misbranded under section 403(y) of the Federal Food, Drug and Cosmetic Act.

“As part of our full accreditation from ANSI as a U.S. national standards developer, NSF provides an open forum for all stakeholders to ensure that the standards development process is truly a consensus process,” said Dr. Lori Bestervelt, Chief Technical Officer and Senior Vice President for NSF.

NSF is accredited by the American National Standards Institute (ANSI) to develop American National Standards in conjunction with professionals who are directly and materially affected by the scope of the standard. This process is based on NSF’s sixty years of experience in developing seventy-two American National Standards. NSF/ANSI Standards are constantly being reviewed and updated to ensure that they are consistent with new legislation and the latest technical developments.

NSF/ANSI Standard 173 is the only American National Standard covering dietary supplements. Certification of products to this standard provides consumers confidence that what is on the label matches what is in the product, according to Dr. Bestervelt. Certification also ensures that dietary supplements are produced in accordance with Good Manufacturing Practices (GMPs) and certified free of harmful contaminants such as pesticides and heavy metals.

Any modifications to the NSF/ANSI 173 will be reflected in NSF’s Dietary Supplement Certification Programs. “These changes verify that manufacturers are in compliance, enable regulators to rely on independent certification, and help consumers make an informed decision when choosing a supplement with the NSF Mark,” said Dr. Bestervelt.

If you would like to participate in the open comment period or submit comments related to the proposed AER addition to NSF/ANSI 173, please email Jaclyn Bowen, Standards Specialist, NSF International, at [email protected] by February 22nd.

For more information on the new AER legislation, please contact Stan Hazan, Senior Director of Regulatory Affairs at [email protected].

Link to bill:

About NSF International: NSF International, an independent, not-for-profit organization, helps protect you by certifying products and writing standards for food, water, air and consumer goods ( Founded in 1944, NSF is committed to protecting public health and safety worldwide. NSF is a World Health Organization Collaborating Centre for Food and Water Safety and Indoor Environment. Additional services include safety audits for the food and water industries, management systems registrations delivered through NSF International Strategic Registrations, Ltd., organic certification provided by Quality Assurance International and education through the NSF Center for Public Health Education.

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