FDA Disclosures
How We Use Words, Studies, and Labels
(Regulatory transparency for Old West Holistic)
Who regulates what (and why our wording looks the way it does)
FDA (CVM) — animal drugs.
For any product regulated as an over-the-counter (non-prescription) animal drug, labels must include “adequate directions for use” so a layperson can use the product safely for its intended purpose (21 CFR 201.5). Claims in public-facing materials must be truthful and must not go beyond the lawful labeling to avoid “misbranding” (FD&C Act § 502 / 21 U.S.C. § 352). (21 CFR 201.5; 21 U.S.C. § 352). eCFRLegal Information Institute
Also, “labeling” includes anything that accompanies the product—like inserts or web pages referenced by the label/QR—so we hold those pages to label-level standards (FD&C Act § 201(k),(m) / 21 U.S.C. § 321). (21 U.S.C. § 321(k),(m)). Legal Information Institute
Note: Unapproved new animal drugs cannot be legally marketed; lawful status requires approval, conditional approval, or indexing. (FDA/CVM). U.S. Food and Drug Administration+1
USDA (APHIS-CVB) — biologics.
Veterinary biologics—vaccines, bacterins, antisera, certain diagnostic kits—are regulated by USDA’s Center for Veterinary Biologics to ensure products are pure, safe, potent, and effective (Virus-Serum-Toxin Act; 9 CFR 101–118). (USDA APHIS-CVB overview). APHIS+1
Our current products are marketed as drugs (not biologics), so FDA drug rules—not USDA biologics rules—apply to them. (FDA “Animal Biologicals” explainer). U.S. Food and Drug Administration
Texas DSHS — state enforcement.
In Texas, the Texas Food, Drug & Cosmetic Act prohibits distributing a misbranded drug and defines misbranding to include misleading labeling or advertising; Texas often adopts federal regulations as state rules and can impose penalties. (Tex. Health & Safety Code ch. 431; §§ 431.003, 431.021, 431.244). Texas Statutes
What appears on our labels & inserts
You’ll see the required building blocks, for example:
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Name & place of business (manufacturer/packer/
distributor). (21 CFR 201.1). eCFR -
Statement of identity and net quantity (OTC drug subpart). (21 CFR 201 Subpart C). Legal Information Institute
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Active/inactive ingredients, warnings, lot/expiration, and adequate directions for use so non-veterinarians can follow them safely. (21 CFR 201.5; Part 201 overview). eCFR+1
Heads-up: FDA has proposed standardized content & format for labeling of approved/conditionally approved animal drugs (including OTC). If finalized, we’ll update formatting accordingly. (Proposed rule, Mar 12 & May 22 2024). Federal Register+1
How we use words, studies, and links (our “evidence” policy)
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Label-true language only. We stick to the product’s intended use, directions, and risk info as written in labeling; otherwise, it could be “misbranding.” (FD&C Act § 502 / 21 U.S.C. § 352). Legal Information Institute
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Education ≠ endorsement. When we discuss background biology or ingredients, we link to independent sources (journals, government, textbooks). Unless stated, those studies do not test our specific product, and no regulator’s endorsement is implied. (FDA/CVM labeling principles). U.S. Food and Drug Administration
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Advertising substantiation. Outside the label (e.g., web, emails, social), health-related claims must be truthful, not misleading, and supported by competent and reliable scientific evidence; we also follow the FTC’s rules for clear, conspicuous disclosures and testimonials. (FTC Health Products Compliance Guidance, Dec 2022). Federal Trade Commission
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About “clicks” to studies. FDA does not require a specific number of clicks to reach a study. On character-limited platforms, material risk info should appear in the same communication as benefits (no “one-click/three-click” safe harbor). We therefore keep consumer pages simple and put full-text studies in a separate Evidence Librarythat you can navigate to in a couple steps. (FDA draft guidance on character-space limits). U.S. Food and Drug Administration+1
Why you won’t see the DSHEA disclaimer here
The familiar “These statements have not been evaluated by the FDA…” text applies to human dietary supplements. FDA has stated DSHEA does not apply to animal products; animal items are regulated as food or drugs based on intended use. (FDA pet-food explainer; Federal Register 61 FR 17706, Apr 22 1996). U.S. Food and Drug AdministrationGovInfo
Plain-English takeaways (with sources)
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FDA/CVM governs animal drugs, including OTC; labels need adequate directions for use, and public claims must match lawful labeling. (21 CFR 201.5; 21 U.S.C. § 352). eCFRLegal Information Institute
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USDA/APHIS-CVB governs biologi
cs (vaccines, bacterins, antisera, certain diagnostics). (USDA APHIS-CVB). APHIS -
Texas DSHS enforces Texas law aligned with federal rules, including misbranding and adoption of federal regulations as state rules. (Tex. H&S Code ch. 431; §§ 431.003, 431.021, 431.244). Texas Statutes
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FTC requires that ad claims are truthful, not misleading, and scientifically substantiated. (FTC Health Products Compliance Guidance, 2022). Federal Trade Commission
Questions or an adverse event to report?
Contact us so we can help and document it. You may also report directly to FDA/CVM using Form FDA 1932a(Veterinary Adverse Experience, Lack of Effectiveness or Product Defect Report). (Form 1932a; FDA “How to Report” page). U.S. Food and Drug Administration+1
Old West Holistic Company • support@