Posted: June 5, 2009 3:00 a.m. EDT
Following a March 17 meeting with officials from the U.S. Food and Drug Administration’s Center for Veterinary Medicine, the National Animal Supplement Council set a June 30, 2010, deadline for several long-planned requirements, group president Bill Bookout told attendees, including a senior FDA official, at its annual meeting in San Diego in May.
Those requirements include adhering to the organization’s newly finalized current good manufacturing practices, passing an NASC on-site audit of its facilities bi-annually, and registering facilities and products as drugs with the FDA.
The good manufacturing practices and audit process are designed in part to ensure member companies would fare well during FDA inspections.
During the meeting with the FDA, the NASC also committed to continuing its adverse event reporting system. The NASC plans to conduct an outreach program to veterinarians to ensure participation.
The NASC also committed to continuing good labeling practices and random testing of finished products, with two tests planned for 2009 and then quarterly in 2010.
In turn, the NASC requested the FDA publish a written, but possibly informal, statement regarding its plans to continue to exercise enforcement discretion with regard to animal supplements and advise its inspectors of the NASC’s good manufacturing practices so that inspectors would have realistic expectations during inspections.
In addition, the NASC requested that the FDA commit to continued action against animal supplement marketers that violated labeling claims. Supplement makers cannot make specific health claims in marketing their products if the products are not approved as drugs.