Page 21 - February 2019 Veterinary 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 https://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. 21