Making Compliant Claims in Animal and Pet Nutrition

By: Casey L. Bradley, Ph.D. – President and Founder of Animistic?

As a consultant in the animal and pet nutrition industry, one of the most common questions I get is, "Can I make this claim about my [fill in the blank] nutritional product?" If you've ever asked this question yourself, you've probably been met with a flat “No” from regulatory teams, right??

But here’s the thing — I don’t believe in starting with a hard stop. Instead, I like to begin with, "It depends." I understand how frustrating it can be for sales and marketing teams to feel like they're running into brick walls when dealing with regulatory departments. Instead of looking for ways to say “no,” I prefer to start the conversation with how we can make it work.?

In my career, I’ve had the privilege of working closely with state and federal regulators, navigating the complex landscape of both research and nutrition. This understanding of the regulatory landscape is crucial in making valid, compliant claims that benefit the product and uphold consumer trust. So, let’s talk about what a claim really is and how to approach it with strategy and confidence.?

What is a claim?

Regarding product labeling, the FDA defines a claim as any statement about the relationship between a substance—typically a nutrient or food component—and a health-related condition, disease, or physiological effect. These claims are closely regulated and fall into three main categories: nutrient content, health claims, and structure/function claims.?

In the animal and pet nutrition world, we have our own set of regulatory guidelines to navigate. While we don’t have to notify the FDA within 30 days of marketing a structure/function claim like 'supports digestive health,' as required for human dietary supplements, our claims must still comply with the Federal Food, Drug, and Cosmetic Act and various animal feed regulations. But it doesn't stop there. Organizations like AAFCO (Association of American Feed Control Officials) and individual state regulatory agencies also play a key role in monitoring our labels and claims. With ongoing regulatory changes, such as the FDA’s recent decision to end its Memorandum of Understanding (MOU) with AAFCO, the industry constantly presents challenges and opportunities.?

Another common question I encounter is, what exactly constitutes a label when making a claim? The FDA defines a label as any written, printed, or graphic matter that is directly affixed to a product’s container or packaging. This includes everything physically attached to the packaging, such as stickers, tags, or printed labels. Beyond the label itself, the FDA also considers labeling to include any written, printed, or graphic materials accompanying the product—this could be brochures, flyers, websites, or other promotional content used at the point of sale.?

Whether for human or animal products, the FDA requires that all labels are accurate and not misleading. This means that every label must include essential information such as the product’s name, ingredients, intended use, manufacturer’s details, and any claims made about the product’s benefits. The goal is simple: to ensure consumers and regulators can easily understand the product’s purpose and nutritional value.?

Claims in the Real World

Example 1: "Enzyme A increases ADG by 4.0% when fed to weaned pigs through slaughter."?

What’s Wrong with This Claim??

The use of the word "increases" suggests a drug-like effect, which can only be legally claimed for products registered as drugs with the FDA. For example, Paylean? can legally state "increases weight gain" because it is registered as a drug with the FDA and has undergone the necessary approval process. However, enzymes, such as Enzyme A, are generally not classified or registered as drugs, meaning they cannot legally make such specific claims about increasing growth.?

How to Fix It:?

To stay compliant and avoid suggesting a drug-like effect, you can use more general language. A compliant and scientifically accurate way to phrase this would be:?

- "Enzyme A optimizes overall animal performance."?

This statement is broad enough to avoid any regulatory issues while still conveying the benefit of the product.?

Presenting Data Effectively:?

If you want to highlight the specific results, you can refer to published research rather than making an outright claim. For instance:?

- "According to research by Doe et al. (2024), feeding Enzyme A to weaned pigs for 42 days significantly improved ADG by 4.0% (P = 0.002)."?

This approach allows you to present scientific evidence without directly making a non-compliant claim on the product label or in marketing materials.?

Example 2: Doggie Biz’s Movement Supplement “reduces osteoarthritis in dogs.”?

Doggie Biz’s Movement Supplement lists its active ingredients as Glucosamine (500 mg/serving) and Chondroitin (400 mg/serving), with feeding directions advising one serving per day for a 40-lb dog. While clinical trials show that this dosage is effective in supporting joint health for dogs of this weight, the problem lies in how the claim is framed.?

The label specifically claims that the supplement "reduces osteoarthritis in dogs." This is problematic because such a statement crosses the line into a drug claim, which suggests treating or curing a disease. Since glucosamine and chondroitin are not FDA-approved drugs, this type of claim is not allowed for dietary supplements.?

Why This Claim is Incorrect:?

- "Reduces osteoarthritis" implies a therapeutic or drug-like effect, which is only permitted for FDA-approved drugs.?

- Even though there may be scientific support for glucosamine and chondroitin benefiting dogs with joint issues, the claim should not suggest it can cure or treat a specific disease without regulatory approval.?

How to Fix It:?

Instead, the label could legally claim:?

- "Supports joint health" or?

- "Helps maintain healthy joints and cartilage in dogs."?

These claims focus on supporting overall joint health rather than implying a treatment or cure, making them compliant for dietary supplements and consistent with regulatory guidelines.?

Example 3: Poultry Layer 17% with Super Phytase.?

The product Poultry Layer 17% with Super Phytase lists a total phosphorus (P) content of 0.60% on the label. However, the formulator used a phytase enzyme matrix intended to release 0.10% of phosphorus, reducing the need for inorganic phosphorus supplementation. When the feed was tested by an Indiana inspector, the phosphorus level came back at 0.49%, which was below the labeled 0.60%.?

As a result, the inspector issued a stop-sale order for two main reasons:?

1. The phosphorus content was off-label, as the tested value of 0.49% did not match the declared 0.60%.?

2. The product label did not include the required phytase enzyme inclusion level, despite the use of Super Phytase to release additional phosphorus.?

How to Fix the Issue?

To prevent future labeling issues and ensure compliance, the following steps should be taken:?

1. Accurately Reflect Phosphorus Values:??

Adjust the label to accurately reflect the total phosphorus content, taking into account the phytase matrix value. In this case, the label should state 0.50% total phosphorus (or a value closer to what is actually achieved after phytase supplementation), instead of the original 0.60%. This ensures the product is not misleading and avoids discrepancies during inspections.?

2. Include Phytase Enzyme Information:?

Add the phytase inclusion level to the label. This is critical when using enzymes to enhance nutrient availability. For example, the label could state:???

?"Contains 500 FTU/kg of Super Phytase, releasing 0.10% available phosphorus."???

This provides transparency about how the enzyme is contributing to the phosphorus level.?

3. Ensure Consistent Testing:??

Regularly test the final product to ensure the phosphorus levels and other nutrient contents match what is stated on the label, particularly when using enzyme matrices that affect nutrient release.?

By taking these corrective actions, the product will comply with regulatory requirements, avoiding further issues and building trust with both regulators and customers.?

Concluding Remarks?

Navigating the complexities of product labeling and regulatory compliance in the animal and pet nutrition industry can be challenging. As we've seen in these examples, even small missteps—whether in phosphorus content, enzyme usage, or product claims—can lead to costly setbacks like stop-sale orders or loss of consumer trust. Ensuring that your products meet both nutritional and regulatory standards requires careful attention to detail and a strong understanding of the legal landscape.?

At Animistic, we bring years of experience working with both state and federal regulators, as well as a deep knowledge of animal nutrition. Whether you need help formulating compliant products, creating accurate labels, or ensuring your marketing claims are scientifically sound, our team is here to guide you every step of the way.?

Is your business ready to take the next step in regulatory compliance and optimized animal nutrition? Book a call with Animistic today to discover how we can help you avoid costly mistakes and ensure your products meet the highest standards of quality and compliance. Let’s work together to build a future where your business thrives through science and heart.?

Book a Call Now or visit animistic.co to learn more about our services.?

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