An animal health supplement is a product intended to support or maintain normal structure or function in animals not intended for human consumption, such as dogs, cats, horses, and specialty pets.

In 1994, Congress passed the Dietary Supplement Health and Education Act (DSHEA), which provided strict guidelines for the labeling and marketing of human dietary supplements. 

DSHEA established supplements intended for human consumption as a new class of food for purposes of federal regulation. However, DSHEA does not apply to animal health supplements, which technically makes these products illegal.

Most of the legislation is effective immediately upon becoming law.

Facility/Brand Owner Registration

Must be completed within 180 days after enactment.

Product Listing

Must be submitted within 30 days after each animal health supplement is first marketed. Any material change to a listed product must also be submitted within 30 days.

New Labeling Requirements

Companies will have one year after the Secretary issues final regulations establishing the format and content of the Product Facts box to comply. Until that deadline, a supplement cannot be deemed misbranded solely for failing to comply with the new labeling requirements.

There are several possibilities to move the Animal Health Supplement  Act (AHS Act) forward. We will evaluate all options, but ultimately our goal is to make this an issue that would move quickly and efficiently in Congress. 

This provision would establish a baseline for both products and ingredients that were on the market prior to the passage of the AHS Act. Both products and ingredients have a long history of safe and beneficial use for dogs, cats, and horses. 

Existing ingredients will generally be grandfathered if they were marketed before enactment. An ingredient is not considered a “new animal health ingredient” if, before enactment, it was marketed in the United States in an animal supplement or similar product that would satisfy the bill’s new definition of an animal health supplement. 

The grandfathering does not apply where the product containing the ingredient was subject to a final agency action finding it adulterated, misbranded, or an unapproved new animal drug, or where FDA demonstrates that the ingredient was not marketed consistently with the bill’s definition of an animal health supplement.

There is a formal process for FDA to affirm grandfathered ingredients. Within 180 days after enactment, FDA must begin a public proceeding to identify and affirm ingredients marketed in animal health supplements before enactment, and it must complete that proceeding within 365 days after initiation.

The evidence can include the NASC Adverse Event Reporting System (NAERS®) database, product labels and marketing materials, sales/distribution/manufacturing records, trade-association or other third-party records, publicly available information, and other reliable evidence. In particular, an ingredient's inclusion in the NAERS database as of enactment constitutes prima facie evidence that it was marketed before enactment, unless reliable evidence contradicts that conclusion.

The new-ingredient provision requires a manufacturer or distributor to submit a safety notification at least 75 days before introducing a supplement containing a new animal health ingredient into interstate commerce. Grandfathered ingredients don't have to go through the new 75-day notification process merely because they predate the AHS Act. Because qualifying pre-enactment ingredients are expressly defined as not new, they avoid that new-ingredient requirement on that basis.

The protection also follows an existing ingredient through certain changes. A previously qualifying ingredient generally does not become “new” merely because of a change in serving amount, dosage form, combination with other ingredients, or manufacturing process, unless the change materially affects the ingredient's identity or safety under its intended conditions of use.

The AHS Act establishes a baseline for all ingredients currently in the marketplace based on the long history of safe use, while also defining a responsible path for new and innovative ingredients to be reviewed, approved, and successfully marketed. The bill creates a premarket notification pathway for new animal health ingredients, generally requiring manufacturers or distributors to notify FDA at least 75 days before marketing and provide information supporting a reasonable expectation of safety.

The AHS Act would not affect any product regulated as animal food/feed. The bill is very narrowly focused and primarily addresses products containing ingredients not recognized as providing nutrients as components of daily nutritional requirements.

The bill does not specifically address hemp products; however, it would support and recognize all ingredients that are marketed in animal health supplements at the time the bill passes, including herbs or botanicals, their concentrates, metabolites, constituents, and extracts, as well as other substances intended to support or maintain normal structure or function. 

Accordingly, a hemp-derived ingredient could potentially fall within the new framework if it otherwise satisfies the bill’s requirements. In short, the AHS Act would help define a responsible path forward for hemp and hemp-derived compounds in non-human food chain animals, based on the long history of safe use, with very restrictive limits on contaminants and THC. 

The short answer is no. Treats are regulated as animal food, and the pathway is already defined for all food/feed products. In fact, the AHS Act supports the Association of American Feed Control Officials (AAFCO) and State Feed programs, typically overseen by the Department of Agriculture in each state, by preserving their traditional authority over feed and narrowly defined feed supplements while creating a separate federal framework for animal health supplements. 

No. Nothing in the bill affects topical products or cosmetics. 

No, this only applies to animal health supplements, which are intended for use in non-human-food-chain animals.

Yes. This is a particularly important component of the AHS Act. By requiring a product identification or registration number to appear on the product label, veterinarians, retailers, and consumers would be able to quickly identify products listed with the Secretary under the AHS Act. This requirement would virtually eliminate bad actors and irresponsible companies. 

The pathway is ingredient-based for determining whether an ingredient may be used, but product-based for ongoing compliance. New animal health ingredients are subject to the 75-day FDA notification requirement and safety pathway, while previously marketed or otherwise recognized ingredients generally are not considered “new.” 

At the product level, each animal health supplement must comply with requirements related to its intended use as identified by the labeling statement or claims, as well as adverse event reporting, and federal product listing.

A remedy state is a state that has the authority, as established in state statutes, to provide oversight of animal remedies. Remedy laws are intended for approved animal drugs and medicated feed/food for animals. 

• California (equine only)
• Florida
• North Dakota
• Oregon
• South Dakota
• Texas
• Vermont
• Virginia
• Wyoming

Animal health supplements may be eligible for registration in states with animal remedy laws, even though they are not approved animal drugs. The issue is inconsistency across states. A national industry cannot operate in an environment of inconsistent and oftentimes subjective state regulation. The inconsistency issue is growing rapidly and requires immediate attention. The bill intends to make treatment of animal health supplements nationally uniform. 

Under the bill, once the AHS Act applies, a state generally may not establish or continue a requirement that differs from, adds to, or is otherwise non-identical to federal requirements concerning labeling, claims, ingredient safety/new ingredients, cGMPs, adverse event reporting/recordkeeping, or product registration/listing. States may, however, enforce requirements that are identical to federal law. 

How does this affect state revenue?

This is a two-part answer. First, companies marketing animal health supplements would no longer be required to register those products in these states. However, because state remedy laws were not intended to apply to animal health supplements, we anticipate the resulting economic impact on states would be minimal.

Second, we are highly confident that the legislation could generate additional state revenue. The FDA would likely enter into agreements with states to provide regulatory services, including inspections, consistent with existing federal/state partnership models. This could provide states with additional federal funding while allowing them to continue playing an important role in regulatory oversight. 

How does this affect state authority?

The AHS Act would not preempt any state’s ability to act against irresponsible, opportunistic companies. States may enforce requirements identical to federal law. However, the AHS Act does preempt private rights of action, including consumer protection, unfair competition, and similar claims, which are based on an alleged violation of the AHS Act or its implementing regulations.

Currently, certificates of free sale are unavailable for animal health supplements because they are classified as unapproved new animal drugs. The AHS Act would make these certificates available, enabling companies to export animal health products more easily. This change would significantly benefit U.S. suppliers by expanding access to international markets and creating new global business opportunities.

As mentioned above, the AHS Act would benefit all companies supplying animal health supplements to international markets by enabling them to obtain certificates of free sale. This would benefit U.S. suppliers tremendously by expanding business opportunities in the global market. International companies could also export products or ingredients to the U.S. without the risk of shipments being detained or denied entry by U.S. Customs. 

Supplement companies could still pursue approval of products as new animal drugs. The AHS Act does not change a company's ability or requirements to seek approval for an animal drug. 

The AHS Act would have no impact, as the bill is based on the NASC requirements developed through the organization’s approach to co-regulation and its long history of working with the FDA. Simply stated, the AHS Act would formally recognize the processes and programs most of the industry already follows and NASC has developed, refined, and implemented over the last 25 years working with regulators. 

Animal health supplements are currently regulated as unapproved new animal drugs, marketed under enforcement discretion. It is impossible for industry to gain drug approval for animal health supplements. This is the very reason the AHS Act is so important, because allowing products to be marketed under enforcement discretion is not a stable foundation for an important and growing industry. 

This is a common misconception about the industry. Products are (potentially) more strictly and rigorously regulated than human dietary supplements because they may be regulated at two levels: the federal level by the FDA and the state level, depending on how the specific statutes in the state are written. Arguably, the issue is not whether there is insufficient regulation but rather that current pathways are neither appropriate nor feasible for the industry to navigate. 

How do we know they are safe? 

The NASC has a proven post-market surveillance system, the NASC Adverse Event Reporting System (NAERS®), which tracks thousands of products and ingredients and provides data on their history of safe use. 

The AHS Act would build on this by requiring serious adverse events to be reported to the Secretary no later than 15 business days after receiving such information and requiring companies to maintain records of all adverse event reports for at least six years. Reports may be submitted directly to the Secretary or through a qualifying third-party system such as NAERS®, provided the information is simultaneously or promptly transmitted to the Secretary and the Secretary has real-time or near-real-time access.

Under the bill, animal health supplements are a distinct category intended to support or maintain normal structure or function and are provided in dosage forms such as powders, capsules, tablets, liquids, chewables, soft chews, pastes, or similar forms. 

Pet food/feed is intended to provide nutrition or serve as food and remains outside this new supplement category. 

Animal drugs are products intended to diagnose, cure, mitigate, treat, or prevent disease; animal health supplements are expressly prohibited from making those disease claims.

Under current law, there are only two available regulatory pathways for animal supplements: animal food or animal drugs. Animal health supplements are currently classified as unapproved new animal drugs, which means there is no stable foundation for a $3.6 billion industry that impacts millions of dogs, cats, and horses in the U.S. every day. 

Unfortunately, this is correct. This is one of the reasons it is critical for all stakeholders to support the AHS Act. The industry, veterinarians, retailers, and consumers are at risk if a solution is not identified. In the end, it would be the animals themselves who pay the price, even though animal health supplements can help them live longer, happier, healthier lives as a beneficial component of care for our extended family members. 

None. The AHS Act does not affect human dietary supplements in any way, nor does it open the Dietary Supplement Health & Education Act (DSHEA) to potential modification. 

Animal health supplements allow ingredients that are not approved for use in animal food or treats. They have targeted health benefits, and most of the ingredients are not required to provide nutrients to satisfy daily nutritional requirements. Additionally, human dietary supplements may contain ingredients that are safe for humans but are not safe for animals. 

We are engaging with a broad range of stakeholders to gather input, including regulators, the Association of American Feed Control Officials (AAFCO), other trade associations, as well as organizations representing the human dietary supplement industry. 

We do not anticipate any increase in cost. Most of the industry, if they are reputable companies, already follow the requirements defined in the AHS Act. 

No, because the Animal Health Supplement Act will formalize the standards that most responsible industry participants already follow.

The PURR Act and the AHS Act are completely different pieces of legislation. The PURR Act applies to food for all animals. The AHS Act applies only to animal health supplements and does not change the way animal food products are regulated. 

The Fiscal Year (FY) 2026 Agriculture-FDA appropriations House and Senate report language focuses on animal food and pet food ingredients and therefore does not relate to animal health supplements. 

Your involvement is critically important and there are actions you can take now to show your support: 

Sign our Statement of Support, which will be packaged with the legislation to demonstrate broad support for establishing a clear federal framework for animal health supplements.

Sign up for updates so we can keep you informed about actions you can take as we proceed forward.  

Share this website with your colleagues, family, and friends to help us build momentum and gain traction.

The Animal Health Supplement Act is a bill that needs to be passed by the United States Congress. It could potentially affect 90 million pet-owning households in the U.S.