A newsletter article published in the Burdock Advisor a year ago1 described an existential threat to the AAFCO system of approval of Feed Ingredient Definitions (FID). The threat arose as a result of the FDA’s Center for Veterinary Medicine (CVM) determination that an FID does not confer federal compliance. According to CVM, as many as 500 ingredients in AAFCO’s Official Publication (OP) may be affected. Today’s article also describes a pathway for AAFCO to survive another threat to its existence by utilizing its most powerful tool, the OP.
Recently, AAFCO has taken under consideration publication in the OP of Generally Recognized as Safe (GRAS) conclusions that have been granted “No Questions” status by CVM. However, AAFCO has balked at publishing so-called “self-GRAS” conclusions2 i.e., GRAS conclusions whose authors have decided to not notify CVM of the GRAS status of the use of a substance. Because notification of a GRAS to CVM for review is voluntary, a conclusion of GRAS status not notified to CVM is no less federally compliant than one that has been notified and to which CVM has “not objected.”3 However, AAFCO sees self-GRASes as producing another existential dilemma: (1) with the growth of the self-GRAS movement, if AAFCO chooses not to list self-GRASes, the OP will lose its designation as the unofficial compendium of US feed ingredients; but (2) if self-GRASes are listed in the OP, what happens if an ingredient produces adverse effects in animals and, is AAFCO responsible? The most common response to the dilemma is for AAFCO (or the states) to review the self-GRAS conclusions to determine if the substances are indeed, safe. Such a review could be expensive and who would perform the review? Only AAFCO or the large states would potentially have the resources to perform a safety review of the self-GRASes. But what if AAFCO’s experts decide the substance was not proven safe, would this decision precipitate a lawsuit from the manufacturer defending the decision of its expert panel? Would the states or even AAFCO reviewers have to show cause for their rejection? All things considered, scrutinizing a substance for safety or efficacy may not be the best method to address a listing of self-GRAS status in the OP.
As stated by an opinion leader of AAFCO at the recent winter meeting of AAFCO, a fear AAFCO has about listing self-GRASes in the OP, is that self-GRAS (as opposed to a CVM notified GRAS) might have (unintended) adverse effects because of the lack of a thorough vetting for safety. However, in this regard (i.e., is the GRAS substance really safe?), what in the past protected AAFCO from finalizing a FID that may have been a bad actor? In the more recent past, AAFCO relied on CVM to determine if a substance is safe for its intended use, but this could not have been a very thorough vetting, as CVM has always claimed it’s plate was full and; a review by CVM could not have been much of a firewall given that everything was done by CVM on an informal basis.4 That is, as noted elsewhere, “enforcement discretion” does not mean “approval” much less “indemnification”. Therefore, if and when an ingredient proved to be a problem, AAFCO would be on its own. Even more to the point, what did AAFCO rely upon for ingredient safety review before relying on CVM? If anyone has any information on what AAFCO did for scientific input in the pre-CVM era, it would be interesting to hear about it, but the best guess is that there was no safety review.
Regardless of past practices, AAFCO has as much protection against a potentially harmful, self-GRAS substance without CVM notification as it would for any substance approved via a feed additive petition or a “No Questions” GRAS notification. That is, although CVM scrutinizes FAPs and notified GRAS conclusions, it relies on the integrity of the petitioner that the data submitted is valid – trust has to begin somewhere and penalties for submitting falsified data can be severe. When AAFCO incorporates a new feed additive regulation into the OP, it does so with the knowledge that the substance is compliant with federal law and that it has been reviewed by competent people at CVM. Likewise, if AAFCO incorporates a self-GRAS into the OP, it does so knowing the substance has been thoroughly researched and reviewed by competent scientists (i.e., the GRAS Expert Panel, whose professional expertise is on a par with that available at CVM) and, the penalties for falsifying data are the same as that for an FAP. In this sense, the risk of falsified data is the same for an FAP, notified GRAS or self-GRAS.
This is not to say that unintended consequences never happen. They do and have occurred with approved human drugs and some have been withdrawn from the market. A bright spot in the food category is that no ingredient found to be GRAS has been recalled when the ingredient was used as intended.
Despite the fact GRAS ingredients have a 60-plus year history of safe use, AAFCO could set itself up for exposure to liability if it did make claims of having reviewed the safety or efficacy of a self-GRAS; or for that matter, a feed additive or “no objection” GRAS. If AAFCO plainly states in the OP that it only included a self-GRAS into the OP that, according to the manufacturer, the ingredient conforms to federal law.
Therefore, the only possible threats to the OP’s existence would be self-inflicted by either (1) not listing self-GRASes and losing readership or (2) by implying the self-GRASes were vetted by AAFCO. Listing self-GRASes would, in fact, bolster the sales of the OP and the OP could retain the title as the unofficial compendium of substances used in the United States. Byfar and away, the greatest threat to the OP would be if AAFCO or any of the states would make or imply that the self-GRAS had been vetted for safety or efficacy.
The positive aspect of AAFCO listing ingredients in the OP is that AAFCO could demand a fee for doing so. Because AAFCO is not in the business of offering safety reviews, it does not have to spend the money to pay for them.
The listing of self-GRAS substances in the OP can be a win-win for industry, CVM and AAFCO. Industry saves time and money producing a self-GRAS as opposed to an FAP, CVM saves precious resources for tasks other than scrutinizing FAPs and GRAS notifications and, AAFCO not only preserves the OP, it stands to make some revenue from the fees for the listing of self-GRAS substances in the OP.
References:
At the behest of FDA, GRAS determinations, should henceforth be referred to as GRAS “conclusions”.
CVM does not approve a notified GRAS, an affirmative response is a response from CVM of “No Objection”.
Currently, a review of a GRAS notification requires 270 days by CVM and a food additive petition, a year or more. Also, CVM has made it clear that a “no questions letter” is not an approval of the ingredient by CVM. Even in the case of a food additive petition, as is the case for drugs, a regulation approving an ingredient does not indemnify the manufacturer against potential lawsuits.