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NASC Able to Manage Risk of Animal Supplements Through Custom Adverse Event Reporting System

by By Gina DePinto | Jan 6, 2005, 11:27 AM

Over the past three years, the National Animal Supplement Council (NASC) successfully initiated its CompliancePlusSM program that provides a framework of best manufacturing practices for quality assurance, risk assessment/management and a commitment to ongoing research. These developments stand alone in the industry.

As part of this groundbreaking program, NASC initiated its Adverse Event Reporting System (NAERS), of which the Food and Drug Administration (FDA) has complete access, something not even done on the human side of the supplement industry. NASC members represent about 65 percent of the multibillion dollar animal supplement industry, and the current database consists of more than 300 million total administrations of various supplement products for horses, dogs and cats.

“Due to the business limiting factors for our industry, it is cost prohibitive for suppliers to conduct safety studies such as those required for drug companies,” stated Bill Bookout, NASC president. “However, we do understand the need to maintain vigilance for both products and ingredients, so by initiating our adverse event reporting system our members are provided a comprehensive system to help them properly evaluate adverse events and take corrective action if necessary.”

As Bookout explained, NASC is capable of producing a risk report for any ingredient the members market that in essence goes far above and beyond any safety study.

“This revolutionary system allows our industry members and the regulatory agencies access to quantative and qualitative data never before available,” said Bookout. “Although the NAERS system is proprietary and the data confidential, we are posting ingredient risk reports for glucosamine HCl and MSM on NASC’s website to illustrate the comprehensive nature of the data we make available to the FDA’s Center for Veterinary Medicine. It is a revolutionary system and one in which our members can justifiably take pride.”

For the NAERS system, NASC considers an adverse event a low threshold, and refers to a complaint linked to any negative physical effect or health problem that may or may not be connected to or associated with use of an animal supplement. By our definition, an adverse event includes transient occurrences such as diarrhea or vomiting. Each member company is required to report, investigate and resolve any adverse event monthly.

NAERS has been in place since 2003, but to get a more complete view, NASC members are entering historical data as far back as 1995. NASC members are required to enter their adverse events on a monthly basis, or attest there were no events reported, while administration data is entered quarterly. The system tracks adverse events by product/ingredient, as well as the aggregate administrations for 643 ingredients in the marketplace. In the 12 months following the system going live, NASC members accounted for nearly 220 million supplement administrations and only reported 133 adverse events, none of which were serious nor resulted in any long-term injury to an animal.

NASC is committed to ensuring the continued availability of high-quality supplements for non-human food chain animals and holding member companies accountable for supplying only those supplements that are in compliance with NASC guidelines and properly labeled products. For more information or to review the extensive member list, go to www.nasc.cc or call (760) 751-3360.