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Company makes drug claims in violation of FD&C Act.
May 7, 2025
By: TOM BRANNA
Chief Content Officer
The US Food and Drug Administration (FDA) issued a Warning Letter to House of Alchemy LLC dba CBD Dog Health Hamet and Love LLC dba MycoDog. FDA reviewed a company websites and social media pages. FDA determined the company’s products are unapproved new animal drugs that are unsafe under section 512(a) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. 360b(a), and are adulterated under section 501(a)(5) of the FD&C Act, 21 U.S.C. 351(a)(5).
The Agency is particularly concerned that the company markets CBD products for food-producing animals. For example, the company stated in a January 3, 2025 blog post titled “Full Spectrum Hemp Extract: The Complete Package,” on cbddoghealth.com, “When it comes to using Full Spectrum Hemp Extract for dogs and pets, FSHE [full spectrum hemp extract] has been proven to be incredibly safe, effective and well tolerated by all mammals, especially our companion animals. At Fire Flake Farm, Angela Ardolino gives all of our CBD Dog Health Full Spectrum Hemp Extract products to the variety of animals on her farm, including dogs, cats, ducks, goats, rabbits, pigs, chickens and more! Beyond our own use on the farm proving CBD’s safety, there are numerous safety studies (like this one) that show without a doubt, Full Spectrum CBD oil for pets (including THC) is safe for all mammals, even at very high doses.” (Emphasis in original).
FDA notes that in addition to raising potential concerns regarding safety for the animals themselves, CBD products for food-producing animals raise concerns regarding the safety of the human food (meat, milk, and eggs) derived from those animals. According to FDA, there is currently a lack of data about the formation of residues in edible products of food-producing animals in association with the consumption of CBD products by those animals and about safe levels of any potential residues for the human consumer. FDA requests that the company takes immediate action to cease the sale of any unapproved CBD products for food-producing animals.
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