PAWSYears FDA Disclaimer and Claims Policy

At PAWSYears, we are dedicated to providing innovative supplements to support canine longevity and health. As a Mumbai-based company offering products that may be accessed or shipped internationally, including to the United States, we adhere to relevant regulations from the U.S. Food and Drug Administration (FDA). This policy outlines our approach to FDA disclaimers, permissible claims, and compliance practices for our pet supplement products. Our goal is to ensure transparency, accuracy, and consumer trust while complying with FDA guidelines on animal food, supplements, and labeling.

Please note that PAWSYears products are formulated as dietary supplements for dogs and are not intended as drugs. We encourage consulting a veterinarian before introducing any new supplement to your pet's routine.

1. Understanding FDA Regulation of Pet Supplements

The FDA regulates pet supplements differently from human dietary supplements. Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), pet products are categorized as either animal food or drugs based on their intended use and claims.

• Animal Food Classification: Supplements intended to supplement a pet's diet, without claims to diagnose, treat, cure, or prevent disease, are treated as animal food. These must be safe, produced under sanitary conditions, contain no harmful substances, and be truthfully labeled.

• Drug Classification: If a product makes claims implying it can diagnose, treat, mitigate, or prevent a disease (e.g., "cures arthritis" or "prevents cancer"), it is considered an unapproved new animal drug, subject to stricter FDA approval processes.

• Gray Area for Supplements: Pet supplements often fall into a regulatory gray area. The FDA does not pre-approve them for safety or efficacy before marketing, unlike drugs. Instead, it focuses on post-market enforcement, such as investigating adulterated products or misleading claims.

• No Specific "Dietary Supplement" Category for Pets: Unlike human products under the Dietary Supplement Health and Education Act (DSHEA), there is no equivalent federal category for pet supplements. Claims must avoid implying drug-like effects to prevent misclassification.

We comply with FDA guidelines by ensuring our products are manufactured safely and labeled accurately, without unauthorized disease claims.

2. Required FDA Disclaimer for Supplements

To promote transparency and comply with FDA requirements for structure/function claims (claims about effects on the body's structure or function without referencing disease), we include a standard disclaimer on all product labels, packaging, and website pages where claims are made. This disclaimer informs users that our products have not undergone FDA evaluation for therapeutic purposes.

Standard FDA Disclaimer Text

The following disclaimer must appear prominently on labels and marketing materials, often in a boxed format for visibility:

These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.

• Placement and Formatting: On websites, the disclaimer should be in a boxed format with a 1-pixel border, placed near any health-related claims (e.g., at the bottom of product pages). It must be in a readable font size, not obscured, and repeated on all relevant pages such as product descriptions, blogs, or ads.

• Why It's Required: This prevents misleading consumers into believing the product is FDA-approved for medical uses. For pet products, it helps avoid drug classification while allowing general wellness claims.

• Adaptation for Pet Products: Although primarily for human supplements, many pet supplement companies adopt this disclaimer voluntarily to align with best practices and reduce regulatory risks.

For PAWYears products, this disclaimer appears on all labels and digital content discussing benefits like "supports cellular health" or "promotes vitality."

3. Permissible Claims Under FDA Guidelines

Claims on pet supplements must be truthful, not misleading, and supported by scientific evidence. The FDA prohibits disease claims but allows certain structure/function or general wellness statements.

Types of Allowed Claims

• Structure/Function Claims: These describe how a product may affect normal body structures or functions without referencing disease. Examples include:

  • "Supports healthy aging processes".

  • "Promotes mitochondrial function".

  • "Helps maintain joint mobility".
    These must be substantiated by evidence and include the FDA disclaimer.

• General Wellness Claims: Broad statements like "supports overall health" or "promotes vitality" are permissible if not tied to specific diseases.

• Nutritional Claims: Claims about ingredients, such as "contains antioxidants" or "provides omega-3 fatty acids," must be accurate and based on the product's composition.

• Examples from PAWSYears Products: Based on our formulations (e.g., Trigonelline + C15 for epigenetic support), we use claims like "supports NAD+ levels for cellular energy" or "enhances mitophagy for muscle endurance," always with substantiation and the required disclaimer.

Prohibited Claims

• Disease Claims: Any implication of treating, preventing, or curing conditions like "reduces risk of cognitive decline" or "treats metabolic dysfunction" could classify the product as a drug, requiring FDA approval.

• Unsubstantiated Claims: All claims must have scientific backing; unsubstantiated ones can lead to FDA enforcement actions.

• Other Restrictions: Avoid implying superiority over veterinary care or using terms like "cure" or "therapy".

We substantiate all claims through peer-reviewed studies and internal research, ensuring compliance.

4. Compliance and Substantiation Practices

PAWSYears follows FDA best practices to maintain product integrity:

• Evidence Requirements: For structure/function claims, we maintain records of substantiating evidence, such as clinical studies on ingredients like Urolithin A or Spermidine.

• Labeling Standards: Labels include product name, net quantity, ingredient list (in descending order of predominance), manufacturer details, and the FDA disclaimer.

• Adverse Event Reporting: We monitor and report serious adverse events to the FDA as required for dietary supplements.

• Manufacturing Compliance: Products are produced in facilities adhering to Good Manufacturing Practices (GMP), with ingredients verified for safety.

• State and International Considerations: While focused on FDA, we also align with guidelines from bodies like the Association of American Feed Control Officials (AAFCO) and India's regulations where applicable.

5. Consumer Guidance and Limitations

• Consult a Veterinarian: Always discuss supplements with a licensed veterinarian, especially for pets with health conditions. PAWSYears products are not a substitute for professional veterinary advice.

• Limitations: The FDA does not approve pet supplements for efficacy before marketing. Efficacy is based on available research, but results may vary by individual dog.

• Updates to This Policy: We may update this policy to reflect regulatory changes. Check back for the latest version.

6. Contact Us

For questions about our FDA compliance, claims, or products:

• Email: compliance@pawsyears.com

• Address: PAWSYears Headquarters, Mumbai, Maharashtra, India

Thank you for trusting PAWSYears to support your dog's longevity. We are committed to science-backed innovation while upholding the highest standards of regulatory compliance.