On October 18th, the FDA held a listening session to discuss the regulation of animal foods with certain types of claims, including environmental impact claims, production claims and claims referring to the microbiome. This session was intended to present ideas on how the FDA might modernize or improve their process in regulating these ingredients.
In addition to comments made by the FDA, there were 20 additional speakers that participated in the discussion. The comments period ends on November 17th. Use this link to submit comments: https://www.regulations.gov/document/FDA-2022-N-2015-0001
Claims about diagnosing, curing, mitigating, treating or preventing a disease are considered drug claims and not allowed on any food. On top of these restrictions , ingredients that make claims regarding environmental impact, enhanced production or claim to alter the microbiome are considered drug claims in the United States and are not allowed on any food item. Claims about aroma, taste and nutritive value are allowed on food items in addition to structure and function claims about supporting the normal, healthy state.
Currently, any ingredient or food claiming to have any of the above effects must obtain New Animal Drug Approval, which is a much more costly and lengthy process than that of obtaining ingredient approval as a food (which is still a lengthy and expensive process). These same claims are allowed in many other parts of the world, including the EU, Australia, Canada, Brazil and Chile, putting the US at a competitive disadvantage. This is why your feedback is so important on these new regulations.
Interestingly, there are animal foods currently on the market that make microbiome claims, which according to the FDA should be regulated as drugs. It will be interesting to see if any FDA warning letters are issued in compliance with how the FDA has chosen to regulate these claims (maybe this is part of the inconsistent regulation that was brought up numerous times).
The majority of the presenters discussed the environmental impact of livestock production in the United States. There are many companies developing innovative ingredients to help reduce emissions from livestock production. Many of these products are algal products, which are both environmentally friendly and sustainable.. Algae is currently acceptable as a food ingredient only for its nutritive effects (source of protein, fat, etc.). Any claims about its ability to reduce methane released into the environment are considered drug claims and not allowed. There were some interesting comments made from several presenters about whether or not it is appropriate for the FDA to be the regulatory body on this issue. One representative from the state of California raised the concern that there are MANY animal food ingredients being sold in the state with the intent of lowering methane emissions. Some of these ingredients are approved for other purposes but others are not allowed in animal food. CFRP is evaluating the safety of many of these ingredients in conjunction with the CA Air Resources Board. A call to action to develop a National Advisory Workgroup in order to pool the resources of states and federal agencies was proposed.
Several presenters expressed their opinion that the microbiome resides within the lumen of the GI tract and in the digesta, so technically is not a part of the body and therefore claims about impacts on the microbiome should not be regulated as drug claims, but as food claims. The microbiome is defined as the population of microorganisms that reside in various locations in the body. I agree that it is separate from the body itself. There is a vast body of research supporting the function of certain ingredients in altering the microbiome. With advancing research on the microbiome and the critical role it plays in so many aspects of health and well-being, it seems that a modernized consideration of the microbiome as a separate entity from the animal itself makes good sense.
While the majority of the presenters spoke in favor of allowing these claims on food or ingredients, there was one speaker from the Environmental Defense Fund who expressed an opposite opinion, stating that prioritizing speed to market is inadequate to protect animals and humans and that speeding the process is a risky pathway that will lead to consumer skepticism. The process for obtaining ingredient approval for a particular function is quite rigorous already. An ingredient that is not already approved for use in animal food would still have to go through this same process and although it doesn’t take as long as a drug approval process, it does still take multiple years and a significant investment. Allowing approved animal food ingredients to have certain claims about functions that they are already providing does not seem to me a risky path.
Only one presenter had anything to say about pet food specifically and her comments were in relation to veterinary prescription pet foods. She is an attorney and while I am not certain about her involvement with the class-action suit that is moving forward against Hill’s, her comments were pretty interesting. Pet foods with certain claims that suggest treatment or mitigation of a disease have been allowed when sold only through the veterinary channels by prescription. However, her argument was that requiring a prescription implies that these foods are actually drugs and consumers are being misled to paying inflated prices because they believe that these are actually something that either contains a prescription medication or something significantly different from OTC diets that have very similar claims. Yet another interesting class-action to keep an eye on.
As is the case with any potential regulatory change, the timeline is not going to be short on this. Impacts will be significant to the livestock food industry if there is movement to allow claims that previously have not been allowed. It makes sense for the US to align with other markets that have similar or even more stringent scientific standards when it comes to safety and efficacy, but standing alone and resisting change to current policies has been a long-standing tradition. I think the fact that this listening session happened at all is a potential light at the end of a long, dark tunnel. If things do change regarding these specific types of claims, it will be interesting to see how much this might then trickle over to the pet food world. We may see new claims about enhancing performance from an athletic or reproductive view or altering the microbiome. To stay up to date on these changes, and all important changes in the industry, follow us on Twitter and LinkedIn to be notified whenever we publish new information!