FDA issued the following Warning Letters to companies that were illegally marketing animal drugs without FDA approval:

  • May 4, 2022 – Kingdom Harvest
    Unapproved New Animal Drugs: “This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address www.kingdomharvest.com from October 2021 through April 2022 and has determined that you take orders there for various human and animal products, which you represent as containing cannabidiol (CBD) or Delta-8 tetrahydrocannabinol (THC). We have also reviewed your social media websites at https://www.facebook.com/originalkingdomharvest/ and https://www.instagram.com/kingdomharvest/?hl=en; which direct consumers to your website www.kingdomharvest.com to purchase your products. The claims on your website and social media accounts establish that your products, some of which are available in multiple varieties, “D8 sublingual oil,” “Delta 8 Disposable Vape Cartridge,” “Whole-Spectrum Hemp Extract,” “CBD Vape,” “Blood Sugar Support,” “CBD Gummies,” “Stella’s Baby Care Diaper Cream,” “Pain Relieving CBD Cream,” “Pain Relieving Cream,” “CBD & Menthol Pain Freeze Roll-On,” “Immune Boost Water Soluble Mix,” “Broad-Spectrum THC Free Organic Honey,” “CBD Fair-Trade Coffee,” “CBD Infused Organic Tea,” “Delta 8 Chewing Gum,” “Delta 8 Gummies,” “Delta 8 Peanut Brittle,” and “Delta 8 Syrup,” (hereinafter referred to as “your CBD and Delta-8 THC products for humans”), are unapproved new drugs sold in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. 355(a) and 331(d). Furthermore, your CBD and Delta-8 THC products for humans are misbranded under section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1). FDA has also determined that your “Broad-Spectrum THC Free Organic Honey,” “CBD Fair-Trade Coffee,” “CBD Infused Organic Tea,” “Delta 8 Chewing Gum,” “Delta 8 Gummies” (all varieties), “Delta 8 Peanut Brittle,” “Delta 8 Syrup,” “Ranch & Livestock Natural Whole-Spectrum Hemp Extract,” “Canine Whole-Spectrum Hemp Extract,” “Feline Chicken Flavor Zero THC Hemp Extract,” and “Pet Essentials Joint Support Tablets” products are adulterated under section 402(a)(2)(C)(i) of the FD&C Act, 21 U.S.C. 342(a)(2)(C)(i), because they bear or contain an unsafe food additive. Furthermore, it is a prohibited act to introduce your “Broad-Spectrum THC Free Organic Honey,” “CBD Fair-Trade Coffee,” “CBD Infused Organic Tea,” “Ranch & Livestock Natural Whole-Spectrum Hemp Extract,” “Canine Whole-Spectrum Hemp Extract,” “Feline Chicken Flavor Zero THC Hemp Extract,” and “Pet Essentials Joint Support Tablets” products into interstate commerce under section 301(ll) of the FD&C Act, 21 U.S.C. 331(ll). See more…
  • February 11, 2022 – Rena’s Organic
    Unapproved New Animal Drugs: “This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address www.renasorganic.com in February 2022 and has determined that you take orders there for the products “300 mg CBD Full Spectrum Oil Cannabinoid Tincture”, “600 mg CBD Full Spectrum Oil Cannabinoid Tincture,” “1500 mg CBD Full Spectrum Oil Cannabinoid Tincture,” “500 mg Pain Relief Cream,” “1000 mg Pain Relief Cream,” “1000 mg CBD Anti-Aging Beauty Cream,” “CBD Super Cider,” “CBD Super Food,” and “Rena’s Organic For Pets 300mg CBD,” all of which you promote as products containing cannabidiol (CBD). We have also reviewed your social media websites at www.facebook.com/RenasOrganic and www.instagram.com/renasorganic; these websites direct consumers to your website, www.renasorganics.com to purchase your products. The claims on your website and social media websites establish that your “300 mg CBD Full Spectrum Oil Cannabinoid Tincture,” “600 mg CBD Full Spectrum Oil Cannabinoid Tincture,” “1500 mg CBD Full Spectrum Oil Cannabinoid Tincture,” “500 mg Pain Relief Cream,” “1000 mg Pain Relief Cream,” “1000 mg CBD Anti-Aging Beauty Cream,” “CBD Super Cider,” and “CBD Super Food” products are unapproved new drugs sold in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. 355(a) and 331(d). Furthermore, these products are misbranded drugs under section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1). FDA has also determined that your “Rena’s Organic For Pets 300mg CBD” product is an unapproved new animal drug that is unsafe under section 512(a) of the FD&C Act, 21 U.S.C. 360b(a), and adulterated under section 501(a)(5) of the FD&C Act, 21 U.S.C. 351(a)(5). As explained further below, introducing or delivering these products for introduction into interstate commerce violates the FD&C Act. You can find the FD&C Act and FDA regulations through links on FDA’s home page at www.fda.gov. You can find specific information about how FDA regulates CBD at https://www.fda.gov/news-events/public-health-focus/fda-regulation-cannabis-and-cannabis-derived-products-including-cannabidiol-cbd. See more …
  • March 1, 2021 – Cannafyl
    Unapproved New Animal Drugs: “This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address https://cannafyl.com in November 2020 and has determined that you take orders there for various human and animal products, all of which you promote as products containing cannabidiol (CBD). We have also reviewed your social media websites at www.facebook.com/cannafyl, https://twitter.com/cannafyl, and www.instagram.com/cannafylcbd/; these websites direct consumers to your website https://cannafyl.com to purchase your products. In addition, the FDA has observed that your website offers CBD-containing products for sale in the United States and that these products are intended to mitigate, prevent, treat, diagnose, or cure COVID-191 in people. The claims on your website and social media websites establish that all strengths and varieties of your “Balance CBD Drops,”2 “Relief CBD Drops,”3 “Relax CBD Drops,”4 and “Relief CBD Salve”5 (hereinafter all referred to as “your CBD-containing products for humans”) are unapproved new drugs sold in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. 355(a) and 331(d). Furthermore, your CBD-containing products for humans are misbranded drugs under section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1). In addition, your “Pet CBD Drops”6 is an unapproved new animal drug that is unsafe under section 512(a) of the FD&C Act, 21 U.S.C. 360b(a), and is adulterated under section 501(a)(5) of the FD&C Act, 21 U.S.C. 351(a)(5). During our review of your website, https://cannafyl.com, and your social media websites, www.facebook.com/cannafyl, https://twitter.com/cannafyl, and www.instagram.com/cannafylcbd/, FDA determined that your firm is marketing the unapproved new animal drug “Pet CBD Drops.” Based on our review of your website and social media websites, your “Pet CBD Drops” is a drug under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in animals and/or intended to affect the structure or any function of the body of an animal. Further, as discussed below, this product is an unapproved new animal drug and marketing it violates the FD&C Act. Examples of claims observed on your website https://cannafyl.com, and your social media websites, www.facebook.com/cannafyl, https://twitter.com/cannafyl, and www.instagram.com/cannafylcbd/ that establish the intended use of your “Pet CBD Drops” as a drug include, but are not limited to, the following:” See more …
  • December 22, 2020 – NextL3vel Services Group, LLC dba This Stuff Is Good For You
    Unapproved New Animal Drugs & 301(ll) and Adulterated Animal Foods: “During our review of your firm’s website, www.thisstuffisgoodforyou.com, and your social media sites, https://www.instagram.com/tsigfy and https://www.facebook.com/tsigfy/, FDA determined that your firm is marketing the unapproved new animal drugs reLeaves 40mg CBD Pet Shampoo, reLeaves Full-Spectrum CBD Dried Dog Treat Cookies (all strengths), reLeaves CBD Broad Spectrum Tincture (all varieties), and reLeaves CBD Full Spectrum Tincture (all varieties). Based on our review of your websites, your products reLeaves 40mg CBD Pet Shampoo, reLeaves Full-Spectrum CBD Dried Dog Treat Cookies (all strengths), reLeaves CBD Broad Spectrum Tincture (all varieties), and reLeaves CBD Full Spectrum Tincture (all varieties) are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in animals and/or intended to affect the structure or any function of the body of an animal. Further, as discussed below, these products are unapproved new animal drugs and marketing them violates the FD&C Act. Examples of claims observed on your website www.thisstuffisgoodforyou.com and social media site https://www.instagram.com/tsigfy that show the intended uses of your products as drugs include, but are not limited to, the following:” See more …
  • December 22, 2020 – G&L Wellness, LLC
    Unapproved New Animal Drugs: “During our review of your firm’s website www.glwellness.net, FDA determined that your firm is marketing the unapproved new animal drug “C BETTER DAILY Pet Formula.” Based on our review of your website, your “C BETTER DAILY Pet Formula” product is a drug under section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in animals. Further, as discussed below, this product is an unapproved new animal drug and marketing it violates the FD&C Act. Examples of claims observed on your website www.glwellness.net that establish the intended uses of this product include, but may not be limited to, the following:” See more …
  • April 20, 2020 – Homero Corp dba Natures CBD Oil Distribution
    Unapproved New Animal Drugs: “During our review of your firm’s website www.naturescbdoil.com, FDA determined that your firm is marketing CBD-containing products for dogs and cats that are unapproved new animal drugs: “Natures Pet CBD,” “CBD Drops Small Dog,” “CBD Drops Large Dog,” “CBD Drops Medium Dog,” and “CBD Drops Cat Formula.” Based on our review of your website, your CBD-containing products for dogs and cats are drugs under section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in animals. Further, as discussed below, these products are unapproved new animal drugs and marketing them violates the FD&C Act. Examples of claims observed on your website www.naturescbdoil.com that show the intended use of your products for dogs and cats as drugs include, but may not be limited to, the following:” See more …

See more …

  • October 29, 2019 – Dr Jen Hartley/Healing Artistry, LLC
    Unapproved New Animal Drugs: “On your website page for your “Colloidal Silver” product, you promote it for use in humans and animals. Specifically, you state, “It can be used internally or externally, for all ages and even the family pet,” and “…add it to the doggie water bowl.” FDA has determined that your firm’s “Colloidal Silver” is a drug under section 201(g)(1) of the FD&C Act, 21 U.S.C. § 321(g)(1), because it is 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 man or other animals. Examples of claims from the website that establish the intended use of “Colloidal Silver” include, but are not limited to, the following:” See more …
  • September 23, 2019 – Natural Wonder Products Corp
    Unapproved New Animal Drugs: “This letter concerns your firm’s marketing of products for the treatment of disease in pets, including but not limited to, Daily Sure Multi-Herbal, Denta Sure, Adadren, Arthridia, C-Care, Cataractin, CortiQuel, Detox, Blood-Sugar Balance, Number 2, Ear Mist,  Heart Hardy, SoothAway, Immune, KC Cat Cough, KC for Kennel Cough, K9 Calm, PV for Canine Parvovirus, Tidy Tears, ThyroPaws, TSH, Number 1, FourGuard, and FlexaSure.  The U.S. Food and Drug Administration (FDA) has reviewed your websites at various internet addresses where you promote and sell these products.  These internet addresses include, but are not limited to:  www.natural-wonder-pets.com and www.natural-wonder-remedies.com.  We have determined that these products are intended for use in the mitigation, treatment, or prevention of diseases in animals, which makes them drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) [21 U.S.C. § 321(g)(1)(B)].  Further, as discussed below, these products are unapproved new animal drugs and your marketing of them violates the FD&C Act. Statements on your website that show these intended uses of your products include, but are not limited to, the following:” See more …
  • July 22, 2019 – Curaleaf, Inc.
    Unapproved New Animal Drugs: FDA issued a Warning Letter to Curaleaf, Inc. of Wakefield, Massachusetts, for illegally selling unapproved products containing cannabidiol (CBD) online with unsubstantiated claims that the products treat cancer, Alzheimer’s disease, opioid withdrawal, pain and pet anxiety, among other diseases and conditions. As described in the warning letter, the company used product web pages, its online store and social media websites to make unfounded claims about more than a dozen different CBD products. Examples of the unsupported and unapproved claims made by the company include:
    • “CBD has been demonstrated to have properties that counteract the growth of [and/or] spread of cancer.”
    • “CBD was effective in killing human breast cancer cells.”
    • “CBD has also been shown to be effective in treating Parkinson’s disease.”
    • “CBD has been linked to the effective treatment of Alzheimer’s disease …”
    • “CBD is being adopted more and more as a natural alternative to pharmaceutical-grade treatments for depression and anxiety.”
    • “CBD can also be used in conjunction with opioid medications to reduce the severity of opioid-related withdrawal and lessen the buildup of tolerance.”
    • “CBD oil is becoming a popular, all-natural source of relief used to address the symptoms of many common conditions such as chronic pain, anxiety … ADHD.”
    • “What are the benefits of CBD oil? … Some of the most researched and well-supported hemp oil uses include … Anxiety, depression, post-traumatic stress disorders, and even schizophrenia … Chronic pain from fibromyalgia, slipped spinal discs … Eating disorders and addiction … “
    • “[V]ets will prescribe puppy Xanax to pet owners which can help in certain instances but is not necessarily a desirable medication to give to your dog continually. Whereas CBD oil is natural and offers similar results without the use of chemicals.”
    • “For dogs experiencing pain, spasms, anxiety, nausea or inflammation often associated with cancer treatments, CBD (aka cannabidiol) may be a source of much-needed relief 
      See more …
  • June 7, 2019 – Earthworks Health
    Unapproved New Animal Drugs: “FDA also reviewed your website at www.earthworkshealth.com for your product 100% Diatomaceous Earth and Natural Dog Treats. The claims on your website establish these products are intended for use in the cure, mitigation, treatment, or prevention of diseases in animals, which makes them drugs under section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)]. Further, as discussed below, these products are unapproved new animal drug and introducing or delivering this product for introduction into interstate commerce violates the Act. Examples of some of the claims that provide evidence that your products are intended for use as animal drugs are identified below.Diatomaceous Earth for Dogs:
    Website https://www.earthworkshealth.com/diatomaceous-earth-for-dogs/
    “…many feel the presence is DE in the dog helps with parasite control and other toxins removed from the digestive tract…”
    “Reported in scientific literature to absorb methyl mercury, e-coli, endotoxins, viruses, organophosphate pesticide residues, drug residues, and protein, perhaps even the proteinaceous toxins produced by some intestinal infections. Therefore reducing chances of intestinal disease.”
    “Reported in scientific literature to kill parasites like whip worms, roundworm, pin worm, and tapeworm.”
    “Reports of arthritic pain relief.”
    See more
  • April 23, 2019 – Newton Laboratories Inc dba Newton Homeopathics
    Unapproved New Animal Drug Violations    : “Your firm manufactures and distributes new animal drugs, as defined by section 201(v) of the FD&C Act, [21 U.S.C. 321(v)]. As discussed below, they are not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing. Therefore, these products are unsafe within the meaning of section 512(a) of the FD&C Act, [21 U.S.C. 360b(a)], and adulterated under section 501(a)(5) of the FD&C Act [21 U.S.C. 351(a)(5)]. We reviewed your April 19, 2018, response in detail. During our inspection, our investigators observed specific violations including, but not limited to, the following.1. Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192). You manufacture various homeopathic drug products marketed direct to consumers for potentially vulnerable patient populations including pediatric patients. You failed to thoroughly investigate microbial results outside of established limits received from your contract laboratory for samples of (b)(4) water and finished products. Instead, you had new samples tested by your contract laboratory. For example:” See more …
  • March 28, 2019 – Advanced Spine and Pain, LLC
    Unapproved New Animal Drug: “Based on our review of your websites, your “CBD for Dogs” product is a drug under section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in animals. Because your “CBD for Dogs” product is intended to cure, mitigate, treat, or prevent disease in animals, it is a drug within the meaning of section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B).  Moreover, this product is a new animal drug, as defined by section 201(v) of the FD&C Act, 21 U.S.C. 321(v), because it is not generally recognized among experts qualified by scientific training and experience to evaluate the safety and effectiveness of animal drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling. It is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing under sections 512, 571, and 572 of the FD&C Act, 21 U.S.C. 360b, 360ccc, and 360ccc-1.  Therefore, this product is unsafe under section 512(a) of the FD&C Act, 21 U.S.C. 360b(a), and adulterated under section 501(a)(5) of the FD&C Act, 21 U.S.C. 351(a)(5). The introduction or delivery for introduction into interstate commerce of this adulterated drug violates section 301(a) of the FD&C Act, 21 U.S.C. 331(a).Examples of claims observed on your website that show the intended uses of your “CBD for Dogs” product include, but may not be limited to, the following:On your website www.relievuscbdoil.com: Webpage titled – “Indications”
    • “Here you can find a list of indications that we can treat with our hemp oil products . . . Anxiety . . . Chronic Inflammation . . . Cancer Pain . . . Chronic Pain . . .”

    On your website www.relievuscbdoil.com: Webpage titled – “Health Benefits” See more …

  • March 27, 2019 – Catnip Cocktail
    Unapproved New Animal Drug: “This letter concerns your marketing of the veterinary product “Catnip Cocktail” for use in dogs and cats. The U.S. Food and Drug Administration (FDA) reviewed your websites, www.buycatnipcocktail.com and www.catnipcocktail.com where you promote and sell this product. You market your product for the following intended uses: “The ultimate mood enhancer”; “Helpful pain relieving properties”; “… anxiety relief…”. We also reviewed the label affixed to your product stating: “This product is intended solely for the treatment of anxiety in cats and dogs.” Based on our review, we determined that your product is intended for use in the mitigation, treatment, or prevention of diseases in animals and to affect the structure or function of the body of animals, which makes it a drug under section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) [21 U.S.C. § 321(g)(1)]. Moreover, this product is a new animal drug, as defined by section 201(v) of the FD&C Act, [21 U.S.C. § 321(v)], because it is not generally recognized among experts qualified by scientific training and experience to evaluate the safety and effectiveness of animal drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling. It is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing under sections 512, 571, and 572 of the FD&C Act [21 U.S.C. §§ 360b, 360ccc, and 360ccc-1], respectively. Therefore, the product is unsafe within the meaning of section 512(a) of the FD&C Act, [21 U.S.C. § 360b(a)], and adulterated under section 501(a)(5) of the FD&C Act [21 U.S.C. § 351(a)(5)]. The introduction or delivery for introduction into interstate commerce of this product therefore violates section 301(a) of the FDCA.
    See more …
  • March 7, 2019 – Flea Assassin, LLC
    Unapproved New Animal Drugs: “This letter concerns your firm’s marketing of veterinary products under the Flea Assassin, brand name for the “treatment” of disease in dogs and cats, including all dosage forms of: Flea Assassin Nitenpyram and Flea Assassin Lufenuron. The U.S. Food and Drug Administration (FDA) reviewed your website, www.fleaassassin.com, where you promote and sell these products. Based on this review, we determined that your products are intended for use in the mitigation, treatment, or prevention of diseases in animals, which makes them drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) [21 U.S.C. § 321(g)(1)(B)]. Further, as discussed below, these products are unapproved new animal drugs and your marketing of them violates the FD&C Act. Statements on your website and product labeling that show the violative intended uses of your products include, but are not limited to, the following:” See more …
  • March 19, 2019 – IMedDo
    Unapproved New Animal Drugs: “This is to advise you that the Food and Drug Administration (FDA) reviewed your web site at the Internet address http://www.imeddo.com/ in October 2018 and has determined that you take orders there for the products NeuSilver™ Colloidal Silver by iMedDo (NeuSilver™) and NeuKids™ lower dose silver for pets and children (NeuKids™). The claims on your website establish that the products are drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 321(g)(1)(B)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease in humans or animals. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act. Because your NeuSilver™ and NeuKids™ products are intended to cure, mitigate, treat, or prevent diseases in animals, they are drugs within the meaning of section 201(g)(1)(B) of the Act, [21 U.S.C. § 321 (g)(1)(B)]. Moreover, these products are new animal drugs, as defined by section 201(v) of the Act, [21 U.S.C. 321(v)], because they are not generally recognized among experts qualified by scientific training and experience to evaluate the safety and effectiveness of animal drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling. They are not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing under sections 512, 571, and 572 of the Act [21 U.S.C. 360b, 360ccc, and 360ccc-1]. Therefore, these products are unsafe within the meaning of section 512(a) of the Act [21 U.S.C. 360b(a)] and adulterated under section 501(a)(5) of the Act [21 U.S.C. 351(a)(5)]. The introduction or delivery for introduction into interstate commerce of these adulterated drugs violates section 301(a) of the Act [21 U.S.C. 331(a)].Examples of some of the website claims that provide evidence that NeuSilver™ and NeuKids™ lower dose silver for pets and children are intended for use in animals as drugs include, but are not limited to the following:” See more …
  • January 31, 2019 – Bimeda Incorporated
    Unapproved New Animal Drugs: “This letter concerns your firm’s marketing of the products Polyglycan®, Polyglycan®–SA, and Polyglycan®–HV, and A-CYST®. The U.S. Food and Drug Administration (FDA or we) reviewed your Polyglycan® product label and your website in October, 2018, at the internet address www.bimedaus.com where you promote these products and sell these products to distributors. The product label and claims on your website establish that these products are intended for use in the mitigation, treatment, or prevention of diseases in animals and/or to affect the structure or function of the body of animals, which makes them drugs under section 201(g)(1)(B) and 201(g)(1)(C) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) [21 U.S.C. § 321(g)(1)(B) and 321(g)(1)(C)]. As discussed below, these products are unapproved new animal drugs and your marketing of them violates the FD&C Act. As explained further below, under section 301(a) of the FD&C Act [21 U.S.C. § 331(a)], the introduction or delivery for introduction into interstate commerce of any drug that is adulterated violates the FD&C Act. Statements on your Polyglycan® product label and website that establish these intended uses of your products include, but are not limited to, the following:” See more …
  • November 8, 2018 – Guardian Pet Products Inc.
    Unapproved New Animal Drugs: “This letter concerns your firm’s marketing of veterinary products under the Guardian Pet Products and PetStar Product name for the “treatment” of disease in dogs and cats, including all dosage forms of: Guardian with Nitenpyram and PetStar Nitenpyram. The U.S. Food and Drug Administration (FDA) has reviewed your websites at: www.theguardianpets.com and www.petstarpets.com, where you promote and sell these products, as well as your product labeling. We have determined that your products are intended for use in the mitigation, treatment, or prevention of diseases in animals, which makes them drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) [21 U.S.C. § 321(g)(1)(B)].  Further, as discussed below, these products are unapproved new animal drugs and your marketing of them violates the FD&C Act. Statements and testimonials on your website and product labeling show these intended uses of your products include, but are not limited to, the following:” See more …
  • October 17, 2018 — No More Fleas Please, Inc.
    Unapproved New Animal Drugs: “This letter concerns your firm’s marketing of veterinary products under the Queen City Animals brand name for the “treatment” of disease in dogs and cats, including all dosage forms of the following Queen City Animals products: Liquid Vanilla Flavored Wormer (Pyrantal Pamoate), Praziquantel Tapeworm Dewormer Capsules, Nitenpyram Flea Killing Capsules, and Lufenuron Flea Controlling Capsules. The U.S. Food and Drug Administration (FDA) reviewed your website (www.nomorefleasplease.com), where you promote and sell these products, as well as your product labeling.  Based on the information we obtained from the website and labeling, we have determined that your products are intended for use in the mitigation, treatment, or prevention of diseases in animals, which makes them drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) [21 U.S.C. § 321(g)(1)(B)]. Further, as discussed below, these products are unapproved new animal drugs and your marketing of them violates the FD&C Act. Statements on your website and product labeling that show these intended uses of your products include, but are not limited to, the following:” See more …
  • August 31, 2018 – Independent Nutrition, Inc.
    Unapproved New Animal Drugs: “FDA reviewed your product labels collected during the inspection for the companion animal products CranUTi and Horse Calm. The claims on the product labels establish that these products are intended for use in the cure, mitigation, treatment, or prevention of disease in animals, which makes them drugs under section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)]. Further, as discussed below, these products are unapproved new animal drugs and introducing or delivering these products for introduction into interstate commerce violates the Act. Because your CranUTI and Horse Calm products are intended to cure, mitigate, treat, or prevent disease in animals, they are drugs within the meaning of section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)]. Moreover, these products are new animal drugs, as defined by section 201(v) of the Act [21 U.S.C. § 321(v)], because they are not generally recognized among experts qualified by scientific training and experience to evaluate the safety and effectiveness of animal drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling. They are not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing under sections 512, 571, and 572 of the Act [21 U.S.C. §§ 360b, 360ccc, and 360ccc-1]. Therefore, these products are unsafe within the meaning of section 512(a) of the Act [21 U.S.C. § 360b(a)], and adulterated under section 501(a)(5) of the Act [21 U.S.C. § 351(a)(5)]. The introduction or delivery for introduction into interstate commerce of these adulterated drugs violates section 301(a) of the Act [21 U.S.C. § 331(a)]. Examples of some of the claims on your product labels that provide evidence that your products are intended for use as animal drugs are listed below:” See more …
  • August 24, 2018 – Viero Resources
    Unapproved New Animal Drugs: “In addition, claims on your product labels and the website (www.canineactiv.com) establish that your CanineActiv Safe Pain Relief and CanineActiv HP products are drugs under section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)] because they are intended for use in the cure, mitigation, treatment, or prevention of diseases in animals. Further, as discussed below, these products are unapproved new animal drugs and introducing or delivering these products for introduction into interstate commerce for such uses violates the Act. Your products are not generally recognized among experts qualified by scientific training and experience to evaluate the safety and effectiveness of animal drugs, as safe and effective for the above referenced uses. These products are not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing under sections 512, 571, and 572 of the Act [21 U.S.C. §§ 360b, 360ccc, and 360ccc-1]. Therefore, these products are unsafe within the meaning of section 512(a) of the Act, [21 U.S.C. § 360b(a)], and adulterated under section 501(a)(5) of the Act [21 U.S.C. § 351(a)(5)]. The introduction or delivery for introduction into interstate commerce of these adulterated new animal drugs violates section 301(a) of the Act [21 U.S.C. § 331(a)]. An example of a claim on the label for your product, Canine Activ Medium 25-65 lbs, that provides evidence that this product is intended for use as a drug includes:” See more …
  • July 18, 2018 – Hawaiian Organic Noni, LLC
    Unapproved New Animal Drugs: “The United States Food and Drug Administration (FDA) inspected your facility located at #3 Larsens Beach Rd. Anahola, Hawaii, from August 15, 2017 through August 21, 2017. As part of the inspection FDA collected finished product labeling, including product labels and brochures, for your Hawaiian Organic Noni products. FDA reviewed the finished product labeling and also reviewed your website at the Internet address https://www.realnoni.com in May and July 2018.  FDA has determined that you take orders at this Internet address for your Hawaiian Organic Noni Fruit Leather, Hawaiian Organic Noni Banana Fruit Leather, Hawaiian Organic Noni Lavender Lotion, Hawaiian Organic Noni BioBandage, Pet Noni Fruit Leather, Pets Noni Lavender Lotion, and Pets Noni BioBandage products. The claims on your product labels, product brochures, and website establish that these products are drugs under sections 201(g)(1)(B) and/or 201(g)(1)(C) of the Federal Food, Drug and Cosmetic Act (the Act),[ 21 U.S.C. § 321(g)(1)(B) and/or  § 321(g)(1)(C)], because they are intended for use in the cure, mitigation, treatment, or prevention of disease in humans or other animals and/or to affect the structure or function of the body of man or other animals. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act. Examples of some of the website claims that provide evidence that your products are intended for use as drugs in animals include:” See more …
  • July 3, 2018 – AniCell Biotech
    Unapproved New Animal Drugs: “The U.S. Food and Drug Administration (FDA) inspected your facility located at 145 S 79th St. Chandler, AZ, from September 11, 2017 through September 13, 2017. After a review of the establishment inspection report, and a subsequent review of information provided on your website at the internet address: www.anicellbiotech.com, we have determined that you are marketing unapproved new animal drugs. All of the cell-based, regenerative therapy products that AniCell Biotech markets are intended for use in the mitigation, treatment, or prevention of disease in animals, which makes them drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) [21 U.S.C. § 321(g)(1)(B)]. Further, as discussed below, your products are unapproved new animal drugs and your marketing of them violates the FD&C Act. Statements on your website that show these intended uses of your products include, but are not limited to, the following:” See more …
  • May 17, 2018 – Silver Armor, Inc.
    Unapproved New Animal Drugs: ”
    The U.S. Food and Drug Administration (FDA) conducted an inspection of your facility located at 300 Willow Bend Rd., Suite 19, Peachtree City, GA 30269 from October 31 through November 11, 2017. Based on the inspection, a review of the product labels and promotional literature collected, and a review of your website, www.silver-armor.com, we have identified serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations.  As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act. Moreover, your website and promotional brochures indicate your Silver Armor brand Immune Support and Protection products are also intended for use in the cure, mitigation, treatment, or prevention of diseases in animals. For example, your website at http://www.silver-armor.com/benefits states: “Animals, Give 1 – 2 oz for daily immune support or 2 – 4 oz every 4 hours for illness. Use for eyes, ears, nose, skin, on wounds and bedding.” Your brochure entitled “Next Generation Natural Health” states the following regarding use of your Silver Armor brand Immune Support and Protection products: “Silver helps to destroy bacterial, fungal and viral infections in cats and dogs just as well as it does in human beings.” Because your Silver Armor brand Immune Support and Protection products are intended to cure, mitigate, treat, or prevent diseases in animals, they are drugs within the meaning of section 201(g)(1)(B) of the Act, [21 U.S.C. § 321 (g)(1)(B)]. The products are not generally recognized as safe and effective for the above referenced uses; therefore, they are “new animal drugs” as defined by section 201(v) of the Act, [21 U.S.C. § 321(v)], They are not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing under sections 512, 571, and 572 of the Act [21 U.S.C. §§ 360b, 360ccc, and 360ccc-1]. Therefore, these products are unsafe within the meaning of section 512(a) of the Act, [21 U.S.C. § 360b(a)], and adulterated under section 501(a)(5) of the Act [21 U.S.C. § 351(a)(5)]. The introduction or delivery for introduction into interstate commerce of these adulterated drugs violates section 301(a) of the Act [21 U.S.C. § 331(a)].” See more …
  • October 4, 2017 – Vet Cellect Bio Products, LLC
    Unapproved New Animal Drugs: “This letter concerns your firm’s marketing of your cell-based, regenerative therapy product ExCellR8™. The U.S. Food and Drug Administration (FDA) has reviewed your website at the internet address www.vetcellect.com, where you promote and sell the product ExCellR8™. We have determined that ExCellR8™ is intended for use in the mitigation, treatment, or prevention of diseases in animals, which makes it a drug under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) [21 U.S.C. § 321(g)(1)(B)]. Further, as discussed below, ExCellR8™ is an unapproved new animal drug and your marketing of ExCellR8™ violates the FD&C Act. Because ExCellR8™ is intended to prevent, mitigate or treat diseases in animals, ExCellR8™ is a drug within the meaning of section 201(g)(1)(B) of the FD&C Act, [21 U.S.C. § 321 (g)(1)(B)]. Moreover, ExCellR8™ is a new animal drug, as defined by section 201(v) of the FD&C Act, [21 U.S.C. § 321(v)], because ExCellR8™ is not generally recognized among experts qualified by scientific training and experience to evaluate the safety and effectiveness of animal drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling. ExCellR8™ is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing under sections 512, 571, and 572 of the FD&C Act [21 U.S.C. §§ 360b, 360ccc, and 360ccc-1]. Therefore, ExCellR8™ is unsafe within the meaning of section 512(a) of the FD&C Act, [21 U.S.C. § 360b(a)], and adulterated under section 501(a)(5) of the FD&C Act [21 U.S.C. § 351(a)(5)].Statements on your website that show these intended uses of your products include, but are not limited to, the following:
    “ExCellR8™ Equine Topical Cream is indicated for the control of irritation and inflammation associated with over exertion, injury or osteoarthritis in tarsal, carpal, metacarpophalangeal, metatarsophalangeal and proximal interphalangeal (hock, knee, fetlock and pastern) joints in horses.”
    “Given the inherent anti-inflammatory and all-natural properties of its acellular derivatives, ExCellR8™ can promote natural equine health through regimented daily maintenance applications.”
    “At Vet Cellect, our focus is on a new strategy for treatment, involving non-invasive products that may help support healthy joint and cartilage function.”
    “Stem cells are a powerful tools for treating common injuries that result from athletic endeavor, resulting in high morbidity and often compromising an equine athlete’s performance.”
    “At Vet Cellect, we believe in providing practical products and services based on the transformative potential of regenerative stem cell treatments and medicines.”
    “We’re not only in the business of treating horses, we are also involved in the everyday care of these incredible animals.” See more …
  • June 29, 2017 – Evanger’s Dog & Cat Food Company, Inc. – FDA inspected Evanger’s low-acid canned food manufacturing facility in response to a consumer complaint of five dogs becoming sick, with one of the dogs dying, after consuming “Evanger’s Hunk of Beef in Au Jus” chunk meat product. As a result of inspectional evidence collected during the investigation, including supplier traceback, facility inspection, and samples collected by FDA, they found serious violations of the Federal Food, Drug, and Cosmetic Act and its implementing regulations.
  • September 22, 2014 – Young Living – FDA reviewed websites and social media accounts for Young Living products marketed as human dietary supplements.  They found many examples of  drug claims on websites and social media as cited in the warning letter.  The social media accounts reviewed by FDA were Facebook.com, Twitter.com and Pinterest.com.
  • July 28, 2011 –HBB, LLC dba Baked World – FDA warned this company that its human product “Lazy Larry” (formerly “Lazy Cakes”) brownies are adulterated because they contain melatonin, an unapproved food additive.  The product, although the package says it is a dietary supplement, is represented for use as a conventional food.  Any substance added to a conventional food must be used in accordance with a food additive regulation or be GRAS according to 21 CFR 170.30(g).  Melatonin, FDA pointed out in the letter to HBB, is not a food additive nor considered GRAS.