Page 31 - August 2019 SP Product Guide

2002 | Public Health Security and Bioterrorism Preparedness and About Us
Response Act
This act consists of five separate sections. The most significant part requires facilities that
manufacture, process, pack, or hold food for human consumption in the United States to register
the facility with the FDA by December 12, 2003. This act has given the FDA a much-needed tool to
identify food facilities operating within the United States and manufacturing food for export to the
United States and to monitor food tampering or bioterrorism incidents in the future.
To learn more: visit www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/
ucm122876.htm

2006 | Adverse Event Reporting System
The Dietary Supplement and Nonprescription Drug Consumer Protection Act, passed in late 2006,
mandates the reporting of serious adverse events associated with dietary supplements. The actual
law went into effect in December 2007. Dietary supplements have a very safe track record. This
reporting system promotes earlier detection in case of an event and earlier identification of
tampered or adulterated products. This legislation should give the consumers greater confidence in
the safety of dietary supplements.

To learn more: visit www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/
dietarysupplements/ucm171383.htm

2007 | Good Manufacturing Practices for Dietary Supplements
Good manufacturing practice (GMP) regulations were designed specifically for dietary supplements
and went into effect August 24, 2007. To limit any disruption for dietary-supplement production by
small businesses, these rules had a three-year phase-in period. Companies with less than 500
employees, like Standard Process, had until June 2009 to comply. Since the DSHEA Act in 1994, the
FDA has been charged with establishing GMPs specific for this industry. These regulations establish
the GMPs needed to ensure quality throughout the manufacturing, packaging, labeling, and storing of
dietary supplements to provide consistent product free of contamination and with accurate labeling.
This final rule provides companies with a model to follow when manufacturing supplements and
guidance for new companies entering the industry, which should effectively raise the standards
throughout the industry. Standard Process is proud to be in compliance with these standards.

To learn more: visit www.fda.gov/Food/GuidanceRegulation/CGMP/default.htm

*These statements have not been evaluated by the Food and Drug Administration. These products are not intended to diagnose, treat, cure, or prevent any disease. 31