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The U.S. Food and Drug Administration has issued warning letters to three pet product companies for marketing unapproved animal drug products containing CBD and mushroom-based supplements, according to an announcement from the National Animal Supplement Council (NASC).
The warning letters, posted by the FDA on April 7, 2025, targeted:
According to NASC, the FDA's review of these companies' websites and social media channels revealed claims indicating their products were intended to diagnose, cure, mitigate, treat, or prevent disease in animals. Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), such claims classify these products as new animal drugs.
To be legally marketed, products classified as new animal drugs require an approved new animal drug application, conditional approval, or index listing—which the cited products do not possess. The regulatory framework for animal drugs differs from human dietary supplements, with more stringent requirements for products making therapeutic claims.
Additionally, certain products marketed as edible CBD treats for dogs were deemed adulterated under the FD&C Act due to the presence of CBD, which is not approved for use in animal food. This classification creates legal barriers even for products not making explicit disease claims, as CBD itself represents an unapproved food ingredient for animals.
The distinction between dietary supplements (which may make structure-function claims) and drugs (which claim to treat, prevent, or cure diseases) becomes critical in animal products. The FDA appears to have determined that the companies' marketing language crossed from permissible supplement claims into drug territory.
The FDA expressed particular concern about food safety related to products marketed for food-producing animals, citing a lack of research on residue formation and human safety. This issue extends beyond companion animals to livestock and poultry that enter the human food supply.
If CBD or mushroom-based supplements are administered to food-producing animals, residues could potentially remain in meat, milk, or eggs consumed by humans. Without research establishing safe withdrawal periods or demonstrating that no harmful residues transfer to human food, the FDA views such products as presenting unacceptable food safety risks.
The food-producing animal concern represents a distinct regulatory consideration from companion animal products, even when the same ingredients are involved. Products intended for livestock face additional scrutiny regarding their potential impact on the human food supply.
NASC noted the warning letters indicate an increase in FDA regulatory inspection and surveillance activities, as previously highlighted by legal counsel at the NASC Annual Conference. The timing suggests the FDA is dedicating more resources to monitoring the pet supplement market, particularly products containing CBD and novel ingredients like functional mushrooms.
The increased enforcement activity may reflect growing market size for pet CBD products, consumer complaints, or agency priorities regarding unapproved animal drugs. Whether this represents a temporary enforcement surge or sustained regulatory focus on the pet supplement category remains to be determined.
NASC, a nonprofit organization operating since 2001 with the mission of protecting and enhancing companion animal and horse health throughout the United States, stated it remains committed to ensuring compliance with and responsible marketing of animal supplements within the allowable regulatory framework.
The organization encouraged all member companies to review these warning letters carefully and ensure their product claims align with FDA regulations. NASC noted that non-compliant claims and labeling "cast a disparaging shadow on our industry," emphasizing reputational concerns beyond individual company consequences.
The industry organization's response indicates recognition that enforcement actions against some companies affect broader market perception and regulatory scrutiny of all pet supplement manufacturers. Collective compliance becomes important for maintaining the category's viability and avoiding more restrictive regulations.
CBD remains in regulatory limbo for animal products despite widespread market availability. The FDA has not approved CBD for use in animal food or as a veterinary drug, creating a situation where numerous products are marketed despite unclear legal status.
The 2018 Farm Bill legalized hemp and hemp-derived products federally, but specifically preserved the FDA's authority to regulate CBD as a drug ingredient. This regulatory framework applies to both human and animal products, meaning that hemp legalization did not automatically authorize CBD use in pet foods or supplements.
The FDA's Center for Veterinary Medicine has stated it is evaluating potential pathways for legal CBD animal products but has not established clear regulatory routes. This creates uncertainty for manufacturers attempting to bring compliant products to market and for retailers deciding which products to carry.
The warning letters also addressed mushroom-based supplements, which represent an emerging category in pet products paralleling trends in human supplements. Functional mushrooms like reishi, lion's mane, and turkey tail are marketed for various health benefits in both human and animal products.
Mushroom supplements face similar regulatory considerations as CBD regarding disease claims. While mushrooms themselves may be generally recognized as safe food ingredients in some contexts, products making therapeutic claims cross into drug territory requiring approval pathways.
The combination of CBD and mushrooms in some cited products compounds regulatory concerns, as both ingredients present unapproved drug issues when marketed with disease claims.
The FDA's review of companies' social media channels alongside websites highlights that all marketing communications—not just formal labeling—factor into regulatory compliance determinations. Social media posts, customer testimonials, and influencer content may contribute to establishing a product's intended use.
Companies cannot maintain compliant product labels while simultaneously making disease claims through social media or other marketing channels. The FDA evaluates the totality of marketing communications when determining whether products are being marketed as unapproved drugs.
This enforcement approach requires companies to implement compliance protocols across all customer-facing communications, including social media management, influencer partnerships, and customer service responses.
Companies receiving FDA warning letters must respond within 15 business days outlining how they will correct violations. Responses typically must address specific corrective actions, implementation timelines, and steps to prevent future violations.
Failure to adequately respond or correct violations can result in escalated enforcement actions including product seizures, injunctions, or criminal prosecution in severe cases. The warning letter represents an opportunity to achieve compliance before facing more serious consequences.
Whether the cited companies will reformulate products, revise marketing claims, or cease operations remains to be seen as they respond to FDA citations and determine viable paths forward.
The warning letters may affect retail distribution as some retailers reassess which pet CBD and mushroom products they carry. Major retailers often remove products after FDA warning letters to avoid association with non-compliant manufacturers.
Pet owners using CBD or mushroom supplements for their animals should be aware that efficacy and safety data for many claims remain limited. Consulting veterinarians before starting supplement regimens provides professional guidance on appropriate animal health management.
The enforcement actions underscore that widespread product availability does not indicate FDA approval or regulatory compliance. Pet owners should evaluate marketing claims critically and recognize that therapeutic disease claims for unapproved products violate federal regulations.
As FDA increases enforcement activity in the pet supplement market, manufacturers need comprehensive compliance systems to ensure product claims, labeling, and marketing communications align with federal regulations.
Qredible's Q-Trust quality management platform provides claim substantiation documentation, marketing compliance review, label verification, and regulatory monitoring for pet supplement manufacturers.
Contact our team to learn how our compliance solutions can help your business maintain appropriate product claims, document safety and quality standards, implement compliant marketing practices, and reduce enforcement risk in the increasingly scrutinized pet supplement market.
