Pet Food: We continue to follow the American Association of Feed Control Officials (AAFCO)’s deliberations and decisions, as they work with the Food and Drug Administration (“FDA”) regarding the regulation of pet food. Of special note is AAFCO’s approval this summer of its Pet Food Labeling Modernization Initiative (PFLM), to be implemented beginning January 1, 2024. We are also monitoring the Pet Food Institute’s (“PFI”) recent proposed framework for a new system of federal regulation of pet food, and AAFCO’s opposition to that proposal.
CBD: As in the past, we are monitoring proposed state and federal legislation,as well as both FDA and AAFCO discussions and research which may lead to pet food labeling changes and regulatory requirements for the sale of products containing CBD.
AAFCO Approval of the Pet Food Labeling Modernization Initiative (PFLM)
As referenced in prior Regulatory Updates, AAFCO has been working since 2015 to support label consistency with human food by updating the information on pet food labels under the AAFCO Pet Food Label Modernization project. In 2018, 2019, and 2022, AAFCO conducted consumer research to maintain its high regulatory standards for the industry, while ensuring that pet food labels can be easily interpreted by consumers. In both 2020 and 2022, AAFCO shared drafts of the proposed Pet Food Model Regulations for public comment and subsequently made revisions based on the feedback. In 2021, a survey went out to state feed program administrators to gather information on each state's knowledge of the proposed draft Pet Food Model Regulations and how they would impact each state. Using this information, AAFCO developed a plan to support uniform state implementation of the new regulations, which aim to enhance transparency and expand safety.
At its Annual Meeting (July 30 - August 2, 2023), the Pet Food Labeling Modernization Initiative was approved by the AAFCO Membership and will start to be implemented beginning January 1, 2024. Although the implementation period given will be 6 years, states are encouraged to use regulatory discretion and accept both current labels stating Guaranteed Analysis while companies transition to the new requirements of “Nutrition Facts.”
Some key points of this initiative are:
- The foundation for the initiative is to more closely align Pet Food and Specialty Pet Food Labels with labeling requirements for human food.
- This initiative results in significant changes to the Model PF (Pet Food) labeling requirements in the AAFCO Official Publication.
- An initial training session for regulatory personnel was conducted just prior to the start of the meeting summarizing the new labeling requirements and emphasizing the 6-year implementation period recommended by AAFCO.
- Additional training programs will be conducted at AAFCO meetings along with other meetings focusing on Pet Food.
- Again, this is a significant change to the current labeling format and content and we strongly encourage our members to be familiar with the changes and timeframes for implementation.
AAFCO’s Official Announcement regarding the passage of its New Model Pet Food and Speciality Pet Food Regulations is below:
Official AAFCO Announcement:
AAFCO Membership Approves New Model Pet Food and Specialty Pet Food Regulations
Changes to pet food and specialty pet food packaging will provide consistency and transparency
CHAMPAIGN, Ill., July 31, 2023 - Pet owners will soon find updated packaging and labels when shopping for pet food and specialty pet food products, including treats and supplements -- the first major update in more than 40 years. The Association of American Feed Control Officials (AAFCO) approved the new suggested labeling guidelines that include standardized nutrition information, clear ingredient statements, and storage and handling instructions. The modern design and updated information will ensure consistency and transparency, so consumers can easily make more informed buying decisions for their pets.
The passage of the revised Model Regulations for Pet Food and Specialty Pet Food sets a new standard for pet food manufacturers and distributors to follow. Feed regulatory professionals across the United States and Canada worked cooperatively with consumers and professionals within the pet food industry on a strategic course to ensure pet food labels provide a more comprehensive view of the product.
"The feedback we received from both consumers and industry advisors throughout this process was an important part of our collaboration to make improvements. We sought public comment to learn more about how pet food label changes would enhance transparency and provide clearer information in a consumer-friendly format. New packaging and labels will be well-defined and easy to understand. And that's good news for all of us, from pet owners and manufacturers to pets themselves," said Austin Therrell, executive director of AAFCO.
Recommended Enforcement Discretion Period
As states begin the rulemaking process of adopting and enforcing the Model Regulations for Pet Food and Specialty Pet Food, AAFCO strongly encourages uniform and timely adoption to ensure alignment and consistency. Each state should make a determination on adoption and enforcement with the recommendation to begin the formal rulemaking process. AAFCO is committed to working with our members and partners to ensure as much of a uniform adoption process as possible.
AAFCO recommends that state feed regulatory programs utilize enforcement discretion in the review of pet food labels for a period of six years, based on the date of the availability of the printed version of the 2024 Official Publication.
AAFCO's Pet Food Committee will evaluate this enforcement discretion recommendation annually, taking into consideration potential issues or challenges that may arise such as: methodology alignment, instrumentation procurement and time to build data sets pertaining to total dietary fiber; label and formulation development, website/e-commerce platforms and other software development related to market activities; and access to packaging design, printing and laboratory analysis support.
Major Label Changes
Below is a snapshot of what to expect from label updates in four key areas:
- Nutrition Facts Box - Updated to resemble human-food labeling more closely.
- Intended Use Statement - Updated to new location on the lower-third of the front display panel to help consumers easily identify the purpose of the pet food.
- Ingredient Statement - Updated to clarify the use of consistent terminology and allow parentheticals and common or usual names for vitamins.
- Handling and Storage Instructions (optional) - Updated and standardized with optional icons for greater consistency.
About Pet Food Label Modernization (PFLM)
AAFCO and its key stakeholders have worked together since 2015, to develop the revised Pet Food Model Regulations. Multiple rounds of consumer research were conducted to understand how pet food labels can better communicate important information. AAFCO used the feedback from consumers and industry officials to develop this new update and to support uniform state implementation of the new regulations. This initiative has been a key example of the benefit of industry and consumer collaboration to solve challenges and make improvements to pet food labels. For more information about PFLM, visit aafco.org/pflm.
The Association of American Feed Control Officials (AAFCO) has been guiding state, federal and international feed regulators with ingredient definitions, label standards and laboratory standards for more than 110 years, while supporting the health and safety of people and animals. Its members are charged by their state or federal laws to regulate the manufacture, sale and distribution of animal feeds and feed ingredients. Learn more at aafco.org.
PFI’s Proposal for a New System of Federal Regulation of Pet Food
In early May of this year at the Petfood Forum 2023, PFI members proposed recommendations for creating a comprehensive and uniform federal system of pet food regulation. According to PFI, the present system amounts to a patchwork of varying state regulations that creates costly challenges and delays to selling pet food products across state lines. Under the existing system, although partnered with the Food and Drug Association (“FDA”), state agencies work independently under state regulations to assure the safety of pet food. According to PFI’s president, “[t]he biggest issue is the inconsistency in state interpretation of AAFCO label definitions. Although many states adopt or reference AAFCO’s Model Bill for Pet and Specialty Pet Food, often the nuanced application or understanding of these model regulations by an individual state or individual regulator creates a barrier for compliance in one state, while the same product with the same packaging passes scrutiny in others.”
PFI’s proposal would create the Center for Companion Animal Nutrition within the FDA to federally regulate pet food and treats for dogs and cats. Under this new framework, state governments would be preempted and prohibited from assessing registrations fees, mandating label reviews and premarket approval and any other actions to regulate pet food sales.
On May 11, the American Feed Industry Association (AFIA) issued its initial response to PFI’s proposal, raising the potential impact of the new framework on ingredient suppliers providing products for all animals, including dogs, cats and livestock. According to the AFIA, these ingredient suppliers could be subject to dual and duplicative registration requirements at the state and federal levels.
https://www.thefdalawblog.com/2023/06/pet-food-institute-proposes-modernization-of-pet-food-and-treats-regulation/ (Hyman, Phelps & McNamara FDA Law Blog)
AAFCO Perspective on a Proposed New Federalized Regulatory System for Pet Food
On May 30, AAFCO issued a response to PFI’s proposal, stating that, as “an independent organization guiding state and federal feed regulators,”
A federally regulated approach is not in the best interest of pets or pet owners. AAFCO predicts that a federal-led system will significantly decrease the number of qualified inspectors in the marketplace and reduce the regulatory oversight of pet food and pet food ingredients. In addition, prohibiting state-led inspections at manufacturing facilities across the country would eliminate the routine collection of tens of thousands of samples for potential contaminants or adulterants, which may dangerously impact animal health and reduce consumer confidence in the marketplace.
According to AAFCO, state feed programs are more accessible and equipped than a federal regulatory system to locally inspect and regulate pet food products and to quickly and effectively respond and take action in the event of illnesses, recalls and other issues. AAFCO reaffirmed its commitment to “working closely with its members and agricultural agencies across the country to ensure the regulatory oversight of pet food and treats continues to be an integrated food safety system with the scientific resources from the FDA, the compliance and enforcement resources of state agencies, and the collaborative process from AAFCO and its stakeholders,”
To access the entire AAFCO statement, click here:
As the PFI proposal would be a drastic change from the current landscape, discussions are taking place at multiple levels regarding the positives and negatives of this new approach. We will continue to provide updates as these discussions progress.
Other AAFCO Activities
Common Food Index
AFFCO Announces Common Food Index
On May 2 and in an effort to open up dialogue and facilitate best practices, AAFCO announced it is instituting a new Common Food Index (CFI) and implementing a process by which items may be added for consideration by stakeholders and the public. As a repository of common foods that may be appropriate for use in animal food, the CFI is a tool to aid with review of ingredients on an animal food label, thereby providing harmonization and transparency.
“Our intention in creating the Common Food Index is to aggregate historically safe items, with a broad consensus, that can serve as a trusted resource to animal food manufacturers and consumers,” said Austin Therrell, executive director of AAFCO. “To be clear, the CFI is not a substitute for the AAFCO process for new feed ingredient definitions, which remains clearly delineated in the Official Publication.”
According to AAFCO,
Common foods are defined as food items commercially available and suitable for use in animal food but are not defined by AAFCO, including but not limited to certain whole seeds, vegetables, or fruits. Common food for animals may include common human foods that are known to be safe for the intended use in animal food. Manufacturers are responsible for determining whether a common food is safe and has utility for its intended use prior to commercial distribution as animal food.
AAFCO’s subcommittee of experienced ingredient definition and label reviewers assessed and identified the first list of most common and well-known ingredients. To view the proposed list of the initial 72 items, click here:
Since its proposal, the CFI process has progressed. The initial list has been evaluated by working groups under the Ingredient Definitions Committee (IDC) and will be published in the very near future along with processes for additional ingredients to be added to the list of acceptable ingredients. On the initial list are ingredients such as 3 specific species of mushrooms (Champignon Mushroom (AKS White Button), Shiitake Mushroom, Portobello Mushroom), New Zealand Green Mussel, Plantain, Cranberry, etc., just under 70 in total. Claims/benefit statements associated with ingredients in the CFI when published should be consistent with those allowable for food, supporting taste, aroma, nutritional benefit or technical effect. Additional information will be posted as soon as it becomes available.
What this means for the Pet Food Industry:
There is now a process in place by which a company might include an ingredient in pet food and claim it should be allowed as a common food as long as the intended use or benefit of the ingredient is consistent with the requirements for food. Claims guidance can be found in the Pet Food and Specialty Pet Food Labeling Guide on the AAFCO web site.
For more information on the Common food Index, click here:
AFFCO updated the following definitions in its Official Publication:
AAFCO’s new standard for human grade pet and specialty pet food products, along with AAFCO’s Guidelines for “Human Grade” Claims, outline how all human grade pet food products should be manufactured in accordance with the acceptable regulations for ready-to-eat human food.
The Ingredient Definitions Committee recommended publishing a new tentative definition for T36l11(a) to Lentillactobacillus hilgardii on page 407 of the 2023 Official Publication.
Black Soldier Fly Larvae Oil:
Definition 33.29 Black Soldier Fly Larvae Oil is now official and published in the Oficial Publication.
A new definition of “Labeling” has been proposed and accepted for inclusion in the Official Publication for clarity:
“The term ‘labeling’ means all labels and other written of graphic materials in print or electronic form that are published or disseminated by a guarantor or distributor (1) upon a commercial feed or any of its containers or wrappers, or 92) accompanying or promoting such commercial feed.” Comments were made that “labeling” currently included items other than the actual product label and regulators have this authority currently, however some states do not include extension of labeling, such as web sites, so it was felt additional clarification would be helpful.
At the AAFCO Annual Meeting, a new tentative definition for Dried Cricket Meal (T60.119) was discussed, allowing this ingredient for use in Adult Dog Food.
Also at the Annual Meeting, the Feed and Feed Ingredient Manufacturing Committee discussed:
Establishing a new term and classification for “zootechnical animal food substances" which in part states -
(i) is added to the food or drinking water of animals;
(ii) is intended to affect emissions from an animal or its waste;
And would allow substantiated structure function claims (iii) achieves its intended effect by acting solely within the gastrointestinal tract of the animal.
Copper Level Guidelines
Expert Panel Upholds AAFCO Guidelines for Copper Concentrations in Foods for Normal Dogs
In March AAFCO reported that it had recently announced the findings of an expert panel convened in response to a February 2021 article in the Journal of the American Veterinary Medical Association (JAVMA) concerning the current AAFCO guidelines for maximum concentrations of copper (Cu) in foods for normal dogs.
While the JAVMA article, “Is It Time to Reconsider Current Guidelines for Copper Content in Commercial Dog Foods?” noted that Cu content in dogs’ livers has been increasing over the past 25 years, AAFCO questioned whether the increase resulted from a change in the methods used to quantify liver Cu concentrations or from other factors unrelated to dog food.
To avoid making regulatory recommendations based on implications or associations without definitive proof of cause and effect, “the AAFCO Pet Food Committee felt it was prudent to convene an expert panel and ask noted experts in animal nutrition and health to assess whether it is necessary to revise the copper guidelines in the current AAFCO Dog Food Nutrient Profiles,” according to Austin Therrell, AAFCO executive director of AAFCO.
After an extensive review of relevant veterinary literature, the 13-member expert panel concluded that data for establishing a safe upper limit or maximum tolerance for Cu in dog foods was insufficient when the 2006 Nutrient Requirements of Dogs and Cats was published, and no scientific data on a safe upper limit for dietary Cu for dogs has been published since then.
The Association will be paying close attention to veterinary literature around this topic, but until science definitively shows additional controls or restrictions are needed, AAFCO believes its recommendations for Cu concentration in foods for normal dogs are appropriately and sufficiently regulated at present.
As usual, states also have passed or are actively considering legislation affecting pet food producers or retailers.
New York Senate Bill 4314 would permit commercial feed manufacturers to use the term "human food grade" for certain pet food if it conforms to certain state and federal standards. Having been substituted for companion Assembly Bill 7658, SB 4314 passed the Assembly in June and has been returned to the Senate.
Illinois House Bill 1290 would provide that pet food and specialty pet food are misbranded if the label fails to disclose whether the pet food contains a major food allergen. "Major food allergen" is defined as milk, eggs, fish, crustaceans, tree nuts, wheat, peanuts, soybeans, and food ingredients that contain protein derived from those foods. The bill has been held over to the 2024 legislative session.
California Assembly Bill 240 would impose a surcharge on retail sellers of dog and cat food upon each dollar of these types of pet food sold in the state and establish a spay-neuter fund. This bill has not progressed since March and remains in committee. Although it died in committee, Maryland had considered a bill (HB 365) that would: 1) establish a process through which a person may make a voluntary donation to the Spay/Neuter Fund; and (2) adjust the current fee imposed on commercial feed for inflation.
Some states are considering legislation that would exempt certain producers or retailers from sales tax. Introduced in May, New Jersey Assembly Bill 5454 and companion Senate Bill 3865 would exempt sales of pet food and medication purchased for pets from sales and use tax. Similarly, New York Assembly Bill 4244 and companion Senate Bill 5044 would exempt pet food from sales and compensating use taxes. Both bills remain in committee. While it was recommended for further study in May, Rhode Island House Bill 5476 would exempt from sales and use tax the sale of animal supplies, food and related products. A similar measure in Texas (HB 4425) that would have provided a temporary exemption from sales tax for “household goods” under $200 (to include pet supplies) died in committee.
New Jersey Assembly Bill 5392 and companion Senate Bill 3852 would establish an annual ten-day sales tax holiday for certain sales of disaster preparedness supplies and equipment. Similarly, New York Assembly Bill 1201 would establish the "emergency preparedness month act"; exempts prefabricated go-bags and individual emergency preparedness items (including pet items) from sales tax during specified time periods.
While regulation of CBD products remains relatively stagnant both at the federal and state levels, so far this year there have been developments meriting mention. For example, last month the NASC released its findings regarding its CBD tolerability study:
The National Animal Supplement Council (NASC) Announces Successful Tolerability Study of Cannabidiol Products in Healthy Dogs (Collaborative Study with Nutrasource Evaluates Tolerability of Supplementation & Determines Safe Dosage)
In a press release dated May 16, NASC has shared positive results from a recently completed study that has been submitted for peer review showing the tolerability of broad spectrum cannabidiol (CBD), broad spectrum CBD with cannabigerol (CBG) and broad-spectrum CBD with cannabidiolic acid (CBDA) in healthy male and female dogs when given a daily dose for 90 consecutive days.
To access the press release in its entirety, click here:
While the regulatory landscape for CBD pet products remains largely unchanged, the United States Food and Drug Administration (FDA) has issued communications regarding these products, as well as continued to take some enforcement action against certain companies.
Food & Drug Association (FDA) Concludes That Existing Regulatory Frameworks For Foods and Supplements Are Not Appropriate For Cannabidiol, Will Work With Congress On A New Way Forward
On January 26, 2023, the FDA announced:
that after careful review, the FDA has concluded that a new regulatory pathway for CBD is needed that balances individuals’ desire for access to CBD products with the regulatory oversight needed to manage risks. The agency is prepared to work with Congress on this matter. . .
CBD also poses risks to animals, and people could be unknowingly exposed to CBD through meat, milk and eggs from animals fed CBD. Because it is not apparent how CBD products could meet the safety standard for substances in animal food, we also do not intend to pursue rulemaking allowing the use of CBD in animal food. A new regulatory pathway could provide access and oversight for certain CBD-containing products for animals. . .
The FDA will continue to take action against CBD and other cannabis-derived products to protect the public, in coordination with state regulatory partners, when appropriate. We will remain diligent in monitoring the marketplace, identifying products that pose risks and acting within our authorities. The FDA looks forward to working with Congress to develop a cross-agency strategy for the regulation of these products to protect the public’s health and safety.
National Animal Supplement Council’s (NASC) Response To FDA Announcement
In response, the NASC issued the following statement from NASC President Bill Bookout:
Like many of you, we saw today’s announcement from the FDA, which stated that “… the agency has concluded that existing regulatory frameworks for food and supplements are not appropriate, and the agency will work with Congress on a new way forward.” Also in the announcement was a statement that, “In addition, a new pathway could provide access and oversight for certain CBD-containing products for animals,” which is very consistent with our discussions with our contacts at the FDA-CVM.
On behalf of our members, NASC has been on the forefront of this issue since 2015. Following our testimony at the FDA’s Public Meeting in 2019, we provided the agency with our program for what we believe are components of a responsible path forward. Our program includes virtually all general requirements mentioned in the announcement, and in addition, we are in the final stages of completing our long-term safety study for CBD, CBD/CBA and CBD/CBG in dogs. The results of our study have shown very favorable results within the administration ranges we identified.
Over our 21-year history, we have always worked very successfully with the FDA to define, develop, and implement regulatory pathways that provide responsible outcomes for all stakeholders while maintaining regulatory oversight. We view this announcement and indications we have received from the FDA-CVM as positive progress, and we welcome the opportunity to continue to help shape a viable path forward.
Doing the right things right ALWAYS pays dividends in the long run.
As we have noted in prior regulatory updates, over the past several years FDA has issued several warning letters to firms that market unapproved new drugs that allegedly contain cannabidiol (CBD). In these actions, FDA has tested the chemical content of cannabinoid compounds in some of the products, and many were found to not contain the levels of CBD claimed. These products are not approved by FDA for the diagnosis, cure, mitigation, treatment, or prevention of any disease, and according to the FDA consumers should beware purchasing and using any such products.
So far in 2023 the FDA has issued warning letters to at least five companies illegally selling unapproved products containing cannabidiol (CBD) in ways that violate the Federal Food, Drug and Cosmetic Act (FD&C Act). According to the FDA, “[t]his action is a continuation of the FDA’s efforts to pursue companies that illegally market CBD products with claims that they can treat medical conditions, including opioid addiction or as an alternative to opioids.” At least two of these companies appear to market pet products.
Two pieces of legislation aimed at creating possible pathways to the regulation of CBD products were introduced in the United States House of Representatives in March.
● The “CBD Product Safety and Standardization Act of 2023” (HR 1628) would authorize the regulation of interstate commerce with respect to food containing cannabidiol derived from hemp and would direct the FDA to regulate CBD as the agency would for other food ingredients, setting requirements for quality and labeling, among other areas.
● The “Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act of 2023" (HR 1629) would make hemp, cannabidiol derived from hemp, and other hemp-derived products lawful for use as a dietary supplement unless otherwise directed by the FDA.
Both bills remain in the Health subcommittee of the House Committee on Energy and Commerce.
To access HR 1628, click here:
To access HR 1629, click here:
Virginia recently passed legislation that addresses the amount of tetrahydrocannabinol (THC) permitted for cannabidiol (CBD) and hemp products. Effective July 1, Virginia HB 2294 and SB 903 place a two-milligram limit of THC for CBD or hemp products in the Commonwealth, while also allowing for a 25:1 ratio. Other changes to Virginia’s hemp regulations include a mandatory $1,000 fee for retail permits, and the prohibition of synthetics, such as Delta-8. Enacted at the end of June, Florida Senate Bill 1676 provides that hemp extract is considered food subject to certain requirements; revises requirements hemp extract must meet before being distributed & sold; provides hemp extract may only be sold to businesses which meet permitting requirements; prohibits products intended for human ingestion which contain hemp extract from being sold to persons under specified age; provides that certain hemp extract products are subject to immediate stop-sale.
New York Assembly Bill 6435 (substituted for its companion, Senate Bill 6326) would amend definition of "commercial feed" to provide that commercial feed may include the addition of hemp seed or hemp seed products for use as feed or for mixing in feed for a pet, specialty pet, horse, or camelid. As of June 6, this bill has passed both chambers and has been returned to the Assembly.
Introduced in February, Oklahoma Senate Bill 635 would require registration of hemp-derived cannabinoid products. Massachusetts Senate Bill 40 (currently in committee) would relate to legislation “to promote the growing and use of hemp and hemp products.”