April 2006 / Issue 10
Legal Briefs
The Changing Regulatory Scene: Member Input Wanted
By Debora Eisen
Assistant Director of Legislative Affairs & Associate Counsel, APPMA
Many pet product manufacturers will be affected by regulatory schemes that are in the works. APPMA’s Government Affairs Group is watching these issues and will continue to inform members when there are new developments. However, we also want to hear from you as to what regulatory issues are important to you. What regulatory challenges are you facing? What information will be most helpful to your business? The APPMA Government Affairs Group is planning to hold a Regulatory Conference this September in Washington DC and seeks your input as to regulatory topics that you may be interested in learning more about. Please contact Ed@appma.org with any thoughts you may have on particular regulatory issues.
During this past year we have heard numerous news reports relating to the safety of feed products. These reports will likely strengthen the Food and Drug Administration’s (FDA) and the American Association of Feed Control Officials’ (AAFCO) call for increased process control and safety regulations for feed manufacturing facilities. Both the FDA and AAFCO are simultaneously working on these new regulatory programs and once established it will likely increase the government’s ability to oversee your plant. For more information on these proposed regulatory schemes, access the Feed Manufacturing Process Control Web page under the Products & Law section of the APPMA web site.
Another area that is “heating” up, although no new regulations appear to be imminent, is the area of novel ingredients in pet foods. Some call these ingredients “nutraceuticals”, “novel’ or “functional.” Whatever they are called, there appears to be a market for these ingredients both in pet food and as supplements, but quite a bit of regulatory uncertainty remains as to how they can be marketed legally. The regulatory uncertainty has resulted in inconsistent enforcement efforts, including registration refusals/stop sales of pet products containing these ingredients occurring in some states. APPMA has a nutraceuticals committee which recently held a meeting at Global Pet Expo in San Diego. At that meeting, members heard a presentation from the President of the National Animal Supplement Council (NASC), on its efforts to reduce regulatory uncertainty in the area of supplements for pets. Shortly thereafter, the Pet Food Institute (PFI) and the National Grain and Feed Association (NGFA) held a meeting in Washington DC on the issue of Novel Ingredients in Pet Foods. Dr. Daniel McChesney, Director of FDA’s Center for Veterinary Medicine, Office of Surveillance and Compliance spoke on the FDA’s position regarding these novel ingredients. These ingredients do not fall into the category of traditional food, approved drugs, Generally Recognized as Safe (GRAS) ingredients, or AAFCO defined ingredients. So although the ingredients are being used, there is no clear regulatory program that they fall under. On the human side, the Dietary Supplement Health and Education Act (DSHEA), is the legal authority for these products to be sold. However, with regard to the use of these products for animals, the FDA has held that 1) the Act does not apply to animals and 2) the Act does not apply to dietary supplements that are included in food. Dr McChesney stated that the agency is developing a Compliance Policy Guide for the use of Glucosamine, but it is unknown when that will be released. Of the approximately 100 attendees at the meeting, 8 were FDA representatives who monitored the four breakout sessions, where approaches to regulating these ingredients were discussed. One consensus that was reached among the participants is that these ingredients should be regulated as food, and not as drugs.
Another regulatory scheme that is upcoming and anticipated by manufacturers of aquatic and small animal remedies is the publication of the proposed Minor Use Minor Species Animal Health Act (MUMS) Indexing regulations. Although these regulations were slated for release in February, we are now told they are expected to be released during April. APPMA’s Minor Animal Species Remedies Committee (MASRC) met at the Global Pet Expo and will be sending a comment to the FDA on these regulations. When the regulations are published, APPMA will be posting a “blog” site for members to provide comments and will host a teleconference for Committee members to discuss the proposal.
For additional information on any of the regulatory issues mentioned in this article, check out the Products & Law pages of the APPMA web site. If you would like to discuss regulatory issues for APPMA’s upcoming regulatory seminar or future teleconference seminars please contact Ed Rod at ed@appma.org or at (203) 532-3600.