Pet Supplement Regulations: Does the FDA Regulate Them?

Are pet supplements regulated? The short answer is yes. Albeit not nearly as heavily regulated as human nutritional supplements.

Unlike many industries with transparent and centralized oversight, the regulation of pet supplements is multifaceted. Understanding its history is key to navigating this landscape.

Navigating the Maze of Pet Supplement Regulations

Prior to 2001, the pet supplement category as we know it today did not exist. The FDA has regulated animal feed additives under the Federal Food, Drug, and Cosmetic Act of 1938, a consequence of a tragic incident involving a mislabeled human drug. For animal-specific concerns, the Veterinary Medical Branch (VMB), established in 1953 and later becoming the Center for Veterinary Medicine (CVM) in 1984, primarily focused on ensuring the safety of animal drugs, both for the animals themselves and for animals entering the food chain. A top priority for CVM is safeguarding the food supply and the safety of medications used for pets. [insert link to CVM milestone doc]

For decades, the regulatory focus remained on the safety of animal medicine and the safety of humans through the regulation of livestock feed additives. Supplements for companion animals were largely absent from this framework. Essentially, the FDA and CVM regulate the ingredients allowed in pet foods.

The American Association of Feed Control Officials (AAFCO), a non-regulatory organization formed in 1909, initially aimed to standardize laws and regulations for the interstate movement of commercial feed. The AAFCO Official Publication (OP) is now the nationally recognized standard for ingredients in commercial pet food and livestock feed. State authorities have adopted AAFCO standards, and USDA officials regulate accordingly. Since the USDA and AAFCO concentrated on feed additives, a sub-category of pet supplements known as "Food Supplements" has existed since the early 1900s. These products are added to a pet's diet to provide extra nutrients or support specific health needs, commonly including multivitamins, skin and coat products, digestive aids, and some immune support. Consumers can often identify these by their label, which resembles a pet food label. We'll discuss "non-Food Supplements" shortly.

The human dietary supplement industry emerged in the early 1990s, experiencing rapid, largely unregulated growth in the preceding decades as healthier lifestyles gained popularity. This led to the Dietary Supplement Health and Education Act (DSHEA) of 1994. DSHEA aimed to ensure continued consumer access to dietary supplements and provide information about their intended uses.

Crucially, DSHEA did not include dietary supplements for pets. As the FDA began enforcing DSHEA, a challenge arose for the nascent pet supplement industry: unless a pet supplement fell under the USDA and AAFCO's definition of a Food Supplement, it risked being classified as an illegal drug.

In practical terms, common pet supplements like those for hip and joint health, calming, liver support, cardiovascular health, and kidney function were now potentially illegal. An entire industry faced significant risk.

Related Content: Why NASC Certification is Critical

In 2001, a small group of companies united to understand this evolving regulatory landscape and dedicated resources to finding a viable path forward. This led to the formation of the National Animal Supplement Council (NASC) [nasc.cc], built on three core principles:

1. Quality: The NASC collaborated with the FDA and AAFCO to establish current Good Manufacturing Practices (cGMPs) for pet supplement manufacturing, ensuring that all NASC-seal bearing products meet high-quality standards.

2. Accurate and Consistent Labeling: NASC worked directly with the FDA to develop pet supplement label formats that are clear and transparent for pet owners.

3. Safety: The NASC's NAERS (National Animal Event Reporting System) is the largest post-market surveillance platform managed by a voluntary industry organization. This system collects adverse event reports, creating an ingredient-based risk assessment platform.

The collaborative efforts of the NASC with the FDA and CVM have established a regulatory space for "Health Supplements." This category includes hip and joint support products, calming, liver health, cardiovascular function, kidney support, and other non-Food Supplement products. Health Supplements are permitted to make structure-function claims but cannot claim to diagnose, treat, cure, or mitigate any disease. The purpose of Health Supplements is to support normal, healthy functions in dogs, cats, and horses.

Returning to our initial question: Who regulates pet supplements?

Here are the key takeaways:

• The FDA and CVM are the primary regulatory bodies for pet supplements under Title 21 of the Code of Federal Regulations. https://www.ecfr.gov/current/title-21
  
  
• • Food Supplements: Labeled similarly to pet food. They must contain only ingredients listed in the AAFCO OP and can only have an intended use of providing additional nutrients to support specific conditions.
    Pet supplements fall into two main sub-categories:

• • Health Supplements: Labeled as Health Supplements according to NASC guidelines. They may be intended to support normal structures and functions within the body.
    
    

• The AAFCO OP provides the list of approved ingredients for Food Supplements and offers labeling guidance for these products.
  
  
• State USDA offices can issue "stop ship" orders for Food Supplements that do not comply with AAFCO guidelines.
  
  
• FDA can issue warning letters for Health or Food Supplements making drug claims