FDA Regulations – Impact on Animal Feed and Pet Food Manufacturers
Friday, November 9, 2012
The FDA has regulated animal and pet food products for many years under the same authority as it does human food — the Federal Food Drug & Cosmetic Act. Many of the regulations (but not all!) are the same for all food products, whether for human or animal consumption. That said, there is some confusion within the industry as to which "human food regulations" also govern animal and pet food products, and which do not.
Under the Bioterrorism Act of 2002, all food facilities were required to register with the FDA. This registration requirement applies to all food facilities (foreign or domestic) that manufacture, process, pack or hold (which includes warehouses) food intended for consumption by humans or animals in the U.S. This means that feed and feed ingredient manufacturers, pet food manufacturers, biofuels producers who manufacture co-products for use in feed ingredients, and grain elevators are all required to register with the FDA as a "food facility". And there have been several important laws enacted since then that affect "food facilities" generally, including, in 2009, the new adverse event reporting requirement (the Reportable Food Registry), which requires "food facilities" to notify the FDA within 24 hours of determining that there is a reasonable probability that the use of or exposure to an article of food will cause serious adverse health consequence to humans or animals. Lastly, the most important revision of the U.S.'s food and feed safety laws since the 1930's, the Food Safety Modernization Act has several meaningful effects on feed and pet food manufacturers, including a requirement that such companies conduct hazard analyses and implement preventive controls to eliminate or limit the possible harm from such hazards.
These new requirements became effective in July 2012. However, because the FDA has not yet issued regulations spelling out the compliance requirements, it has indicated that it will not bring enforcement actions against violators until after the final regulations have been issued. The FDA has also indicated that it intends on issuing two distinct set of regulations – one for human food and another for animal feed and pet food. We encourage you to take steps to prepare for these new rules, and to understand which rules affect your business.
Varnum's Food Law practice includes more than a dozen attorneys experienced in the sophisticated areas of law that apply to food regulation. We help regulated businesses bring their products to market. In particular, we counsel USDA- and FDA-regulated businesses in the following areas:
Product labeling, advertising and other promotional materials.
The regulatory scheme affecting or governing such products, including mandatory and voluntary submissions (FDA-required petitions and notifications) and...