Warning Letters
Learn about the types of warning letters on FDA's website.
- Matters described in FDA warning letters may have been subject to subsequent interaction between FDA and the letter recipient that may have changed the regulatory status of issues discussed in the letter.
- To obtain additional available information, contact FDA. Requests to FDA for agency records should be sent to: Food and Drug Administration Division of Freedom of Information (HFI-35), 5630 Fishers Lane, Rockville, MD 20857. Instructions for how to submit an FOI request can be found at How to Make a FOIA Request.
- Frequently requested records may be accessed on the Reading Room page.
| Posted Date | Letter Issue Date | Company Name | Issuing Office | Subject | Response Letter | Closeout Letter | Excerpt |
|---|---|---|---|---|---|---|---|
| Bailey’s Wellness, LLC dba Bailey’s CBD | Center for Veterinary Medicine | Unapproved New Animal Drug Products | … Bailey’s Wellness, LLC dba Bailey’s CBD … WARNING LETTER April 7, 2025 RE: 701066 Dear John V. … those that you promote as products containing cannabidiol (CBD). We have also reviewed your social media webpages at … your social media webpages establish that your products, Hemp Pellets for Horses and Livestock, also referred to as … | ||||
| House of Alchemy LLC dba CBD Dog Health Hamet & Love LLC dba MycoDog | Center for Veterinary Medicine | Unapproved New Animal Drug Products | … House of Alchemy LLC dba CBD Dog Health Hamet & Love LLC dba MycoDog … WARNING LETTER … those that you promote as products containing cannabidiol (CBD). We have also reviewed your website … in a January 3, 2025 blog post titled “Full Spectrum Hemp Extract: The Complete Package,” on your website, … | ||||
| Holista LLC dba HolistaPet | Center for Veterinary Medicine | Unapproved New Animal Drug Products | … those that you promote as products containing cannabidiol (CBD). We have also reviewed your website at the Internet … media webpages establish that your products, including CBD Pellets for Horses (all flavors), CBD Oil for Horses, CBD … the claim, “Aside from horses, you can also use these CBD hemp pellets for many different species, including donkeys, … | ||||
| Pico IV Inc. | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded | … offers “Pico IV,” an intravenous form of cannabidiol (CBD). We have also reviewed your social media websites at … marketing material found on your website states that “CBD, and other cannabinoids, are considered dietary … of your health journey. #CBD #PICOIV #Health #Wellness #Hemp #HolisticHealth #IV #CBDIV #CBDInfusion #Intravenous … | ||||
| Anne’s Daye Ltd dba Tampon Innovations | Center for Devices and Radiological Health | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device | … (FDA) determined that your firm manufactures Cannabinoid (CBD) coated tampons (“CBD Daye Tampons”) and vaginal microbiome screening kits. … o “She found it interesting that industrial hemp has two main properties - its extracts act as a pain … | ||||
| Root Bioscience Brands, LLC dba Naternal | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded | … which you represent contain, in part, cannabidiol (CBD), cannabigerol (CBG), and cannabinol (CBN). The claims on your website establish that your products, CBD Oils, 1 Move CBD+CBG Oil, Rest CBD+CBN Oil, Nurture Broad … and 331(d). FDA has also determined that your Naternal Hemp Extract Oil for Pets (300mg, 600mg, and 1200mg) 2 … | ||||
| East Fork Cultivars | Office of Unapproved Drugs and Labeling Compliance | Finished Pharmaceuticals/Unapproved New Drug/Misbranded | … Cultivars … WARNING LETTER December 22, 2023 East Fork Hemp, LLC 6258 SE Foster Rd Portland, Oregon 97206 RE: # … which you promote as products containing cannabidiol (CBD). 1 We also reviewed your social media websites at … products. The claims on your websites establish that your CBD products including, but not limited to, all strengths and … | ||||
| GCHNC LLC dba Hemp XR/Gate City Hemp dba Hemp XR/Allaziya Enterprises, LLC dba Hemp XR | Center for Food Safety and Applied Nutrition (CFSAN) | Premarket Approval/Adulterated | … GCHNC LLC dba Hemp XR/Gate City Hemp dba Hemp XR/Allaziya Enterprises, LLC … Delta-8 tetrahydrocannabinol (THC) or cannabidiol (CBD). FDA has determined that your Far Out Candy 500MG Delta … Delta 8 Gummies, Hemp XR Delta 8 Honey 500 MG, and Hemp XR CBD Honey 500 MG products are adulterated under section … | ||||
| Discover Health, LLC d/b/a Discover CBD and Strain Snobs | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drugs/Animal Drugs/Human Foods/Animal Foods/Adulterated/Misbranded | … Discover Health, LLC d/b/a Discover CBD and Strain Snobs … WARNING LETTER November 16, 2023 RE: … note that your firm is the U.S. distributor for the Active CBD Oil brand of various products, which you represent … your CBD products “Active CBD Oil Capsules Gold Label Hemp Supplement,” “Active CBD Oil Full Spectrum CBD … | ||||
| Koi CBD, LLC | Division of Human and Animal Food Operations West V | Adulterated Human Foods/Misbranded | … Koi CBD, LLC … WARNING LETTER WL 651252 Dear Mr. Ridenour: This … tetrahydrocannabinol (THC). FDA also inspected your Koi CBD facility, which distributes human food products … that your products, Koi brand “Delta 8 Gummies” and Hemp Living brand “Pot Rocks,” are adulterated under section … |