Is FDA Man’s Best Friend’s Best Friend?

On January 7, 2025, FDA announced that back on November 12, 2024, the Center for Veterinary Medicine (“CVM”) issued Warning Letters to six online retailers marketing unapproved new animal drug products that purported to treat and control seizures and epilepsy in dogs and cats.  At minimum, this autumnal burst of Warning Letters from CVM is notable because CVM only issued a total of 22 Warning Letters in 2024—at least that have been made public by the Agency.

In each November 2024 Warning Letter, FDA explains that it reviewed the target company’s online promotion from October through November 2024—including Facebook, Amazon, and other third-party webpages—and determined that the six companies were marketing and selling unapproved new animal drug products in violation of the federal Food, Drug, and Cosmetic Act (“FDCA”).  Half of the products were available for purchase on Amazon, indicating that FDA is keeping an eye on Amazon sales.

The six target companies, including their FDA-cited violative products, are:

• Energetic Essences, LLC d/b/a Pet Essences (Seizures formula(s))
• Evolution Pets (SeizureGuard Plus and Life Span Arthritis & Mobility Advanced Enzyme Therapy)
• HD Frenchies, LLC/Bully Baum (HDBully Baum No Seize, Can-B-Gone – Cancer Oil Extract, and Brain & Neurological)
• Intermarket Industries Inc. d/b/a Doc Ackerman’s Pet Products (Doc Ackerman’s – Epilepsy & Seizure Formula)
• Nutrition Strength Ltd. EOOD (Dog Seizure and Epilepsy Supplement and Blood Support for Dogs)
• Vet Select Formula, Inc. (Vet Select Nuroplex Capsules, Vet Select Nuroplex – 2oz Homeopathic Spray, and Vet Select Nuroplex – Full Treatment Pack)

New animal drug products must be approved by FDA via a New Animal Drug Application (link), Abbreviated New Animal Drug Application (link), Conditional Approval (link), or have an index listing (link).  21 U.S.C. §§ 360b, 360ccc, 360ccc-1.  The marketing of a new animal drug product which has not been approved by FDA through one of these three regulatory pathways or included in an index listing renders the product adulterated.  21 U.S.C. § 351(a)(5) (“A drug … shall be deemed to be adulterated … if it is a new animal drug which is unsafe within the meaning of section 360b of” the FDCA.); see also id. § 360b(a) (requiring that, for a new animal drug to be legally marketed, it must have been approved by FDA via one of the aforementioned pathways).  The marketing of an unapproved and therefore unsafe, adulterated new animal drug is a violation of the FDCA.  Id. § 331(a) (listing as a prohibited act “[t]he introduction or delivery for introduction into interstate commerce of any … drug … that is adulterated or misbranded.”).

Here, the companies marketed their products as intended to treat idiopathic seizures or epilepsy in dogs and cats.  FDA found that each of the companies were marketing products that were unapproved new animal drug products because the products at issue were “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” and/or “intended to affect the structure or any function of the body of … [an] animal.”  Id. § 321(g)(1), (v).  Notably, FDA has only conditionally approved two animal drugs to treat idiopathic epilepsy in dogs—KBroVet-CA1 and Fidoquel-CA1.  Because FDA established the products at issue were unapproved new animal drugs, the Agency found the products to be unsafe and adulterated and the companies to have committed a prohibited act per the FDCA.

It will be interesting to see whether CVM carries this flurry of activity into 2025, especially as it relates to online retailers, which have quickly become hubs for pet-related products.  We will continue to monitor and report on further developments.