Sometime in early 2010, we can expect a game-changing set of circumstances with the FDA's Center for Veterinary Medicine (CVM), as it will initiate the process for acceptance of generally recognized as safe (GRAS) notifications for animal-feed ingredients.

The change should spell new opportunities for ingredients manufacturers of traditional ingredients, but producers of ingredients that 'optimise' some facet of an animal's physiology — such as a nutritional benefit or improved metabolism — would benefit as well, as such claims would be allowed within the current rubric.

Some people within CVM are also of the belief that certain 'health claims' might be made, too. However, CVM has made a few things clear. One is that 'dietary supplements' per se cannot be added to animal feed because CVM is already on record not believing that the Dietary Supplement Health and Education Act (DSHEA) pertains to animals (this is debatable).

Two, CVM says no claims may be made for substances as 'nutrients' that are not recognised by the National Research Council or have achieved a consensus as a nutrient among academics.

Third, no claims could be made for feed ingredients regarding production characteristics, such as growth rate, feed efficiency or milk or egg production, which would still be regarded as drug claims by CVM.

Also, for any substance to be administered in the feed of animals that are part of the food chain (such as those producing meat, milk or eggs), the safety of the substance-residue level in the animal products must be established. Pets, including dogs, cats and horses, which are not part of the food chain or products such as wool, would not require that safe levels of human exposure be established.

Despite the restrictions in place, a wide variety of opportunities present themselves for the manufacturer that wants to market an 'added value' to a product through the addition of a new ingredient.

Staking your claim
One of the major problems in the past with petitions for new ingredients was that CVM was intent on limiting the functionality (or 'utility') of an ingredient to those conventional technical functional effects listed in the Code of Federal Regulations (CFR) at chapter 21, section 170.3(o). In contrast, the human food side has recognised that ingredient innovation has expanded beyond what was state of the science in the late 1970s and has exhibited some flexibility of what a technical effect must be. Both the human food side of FDA and CVM recognise that food consists primarily of ingredients conferring taste, aroma and nutritive value forcing the agency to recognise that other functionalities might have to be considered beyond these limiting three attributes.

This broader interpretation of what a food ingredient might be leaves the door open to these so-called 'optimising' ingredient claims, such as lycopene, lutein esters, phytosterols and fibre, that do not fit neatly into the functionality categories of the CFR or even the potentially pre-appellate decision that food consisted of ingredients that conferred only taste, aroma and nutritive value.

The next step beyond 'optimising' claims is health claims. At this point, CVM appears to be split into two camps regarding inclusion of a potential health claim in a GRAS notification. In one camp are those within the CVM that are not in favour of any health claims in the animal-feed world. The other camp seems to be saying that health claims are okay — in fact, you don't even need the much higher threshold of 'significant scientific agreement' required for human food ingredients. With the latter camp, if a supplier or manufacturer convenes a GRAS-style panel of experts to vouchsafe that the ingredient has a health benefit, you could make a health claim. The bottom line: CVM may be more stringent on functionality claims, but more liberal on health claims, where the human food side is just the opposite.

The advantages of the GRAS notification process are several. The first and immediate advantage to manufacturers is that the standard of ingredient approval would become more uniform, the system would become more transparent and the manufacturer could have more of a voice in the approval process.

With the new GRAS notification process, a manufacturer has the option of a pre-submission meeting with CVM to get the agency's take on the definition of the ingredient, specifications, utility and safety package. Of note, the safety package must be specific for the specific life stage of the target animal. The agency may offer suggestions regarding potential weak spots in the notification, which the manufacturer has the opportunity to address before submission and possible rejection. Also, during the period of notification review by the agency, the manufacturer may be contacted by the agency with questions regarding the ingredient.

None of these advantages — the pre-notification meeting, direct questioning by the agency or even potential questions on claims — is possible under the current regime.

Hear ye, hear ye
How is the notification process expected to work? While the format and content of a notification for CVM may be a little different than one for the human food side of FDA, the responses would not. A favourable response would be CVM has "no questions at this time" — meaning that it has no objection to the findings of safety or possible claim articulated in GRAS. Although the exact wording has not yet been worked out, an unfavourable response would be something on the order of "this notification does not provide a basis for GRAS determination."

Interestingly, this latter statement is no more of a 'refusal' than the former is an 'approval.' The first is simply "no questions at this time" and should be taken literally — CVM has no questions now, but may have later. The latter is a finding that CVM does not feel the basis for a GRAS has been achieved, but does not mean that the substance is not GRAS. In other words, while CVM does not agree it is GRAS, your experts have determined it is GRAS and essentially, you are on your own should you decide to market the product. If FDA feels the substance is unsafe, it can declare it to be an unapproved food additive and an administrative method for taking it off the market is available to CVM.

More probably, if CVM does not feel the substance meets the threshold for 'safety-in-use,' it will contact the petitioner and notify him that the notification has deficiencies and may suggest that it be withdrawn. A withdrawal from the notification process is 'without prejudice' and may be submitted again, once the deficiencies have been addressed.

Finally, any GRAS petition requires a fair evaluation of the data — you cannot ignore the contradictory data or 'cherry-pick' the data; to do so is against the law. Any product containing the material approved under false circumstances could undergo a recall. The need for an experienced hand at review of safety data and the regulations cannot be overemphasised.

George A Burdock, PhD, is President of Burdock Group Consultants, a full-service food safety and regulatory compliance consulting firm offering customised solutions for FDA compliance needs. www.burdockgroup.com