FDA Announces Strategy for Review of Animal Food Ingredients, With Uncertain Implications for IndustryApril 1, 2015
FDA announced a “strategy to establish ingredient definitions and standards for animal food,” pursuant to a statutory directive in the Food and Drug Administration Amendments Act of 2007 (FDAAA). As indicated in one of our prior postings, this effort has been in the works for years, but FDA’s recent announcement gives a better indication of the direction in which the agency is headed.
The stated goal of the strategy is “to align AAFCO ingredient listings with the agency’s regulatory process and requirements.” To that end, it appears that FDA intends to launch a comprehensive review through which the agency will establish as its own standards and definitions any AAFCO definitions for ingredients that are “approved by the agency as food additives” or “recognized as GRAS.” For other AAFCO definitions, FDA will review the scientific literature to determine whether that literature supports food additive approval or GRAS affirmation, and will approve or affirm those substances (apparently on the agency’s own initiative). Where data are lacking to support either of these actions, FDA will require submission of a food additive petition “to allow continued legal use” of the substance.
The planned review is reminiscent of the type of review that FDA initiated for substances used in human food in the wake of the 1958 Food Additives Amendment – a resource-intensive effort that was never completed. The planned review can therefore be expected to extend years into the future. FDA’s announcement states that “[t]he agency intends to work closely with industry during this transition to minimize disruption to animal food production.“ It’s not clear whether that close working relationship will extend to staving off a proliferation of class action litigation targeting the marketing of food ingredients under AAFCO definitions that FDA concludes are neither approved food additives nor GRAS. The marketing of such ingredients could be vulnerable to lawsuits targeting “unlawful” business practices under state law, as is feared could happen with respect to human food ingredients that FDA deems subject to a change in regulatory status (partially hydrogenated oils come to mind, as laid out in this posting by the Washington Legal Foundation).
For now, AAFCO’s new ingredient definition review process remains in operation – in fact, the Memorandum of Understanding between AAFCO and FDA that facilitates that process was recently renewed. If anything, AAFCO suggests that demand for its new ingredient definition review process is expected to increase as a result of FSMA, and that the MOU will help AAFCO accommodate that increased demand. At this time, it’s not clear how FDA will manage the strain of that increased demand on CVM’s resources, or how the continuation of AAFCO’s new ingredient definition review process will be squared with the planned review announced by FDA.