Read the record in context: An FDA warning letter describes the agency’s position at the time of the letter and gives the recipient an opportunity to respond. It is not a court judgment, product review, recall, or permanent verdict on a company. Later interaction may change the status of issues described. Check the original letter and FDA for newer records.
This FDA CBD warning-letter index organizes recent agency letters involving CBD and other cannabis-derived products. Search the page by firm name, state, year, or product area, then open the original FDA record. A letter can reveal dated regulatory concerns, but it does not prove the present quality, safety, legality, or performance of every product sold under a brand name.
What This Warning-Letter Index Includes
- Firm names exactly as displayed in FDA’s cannabis-derived product list
- Letter issue dates shown in the individual FDA records
- State information displayed in the FDA index when available
- Broad product areas taken from the letter page
- Direct links to the original FDA letters
The current release covers FDA’s 2024 and 2025 cannabis-derived product entries. It is a curated access layer, not a full export of all FDA warning letters or a market-wide estimate.
2025 FDA Cannabis-Derived Product Warning Letters
| Firm | State | Letter Date | Product Area | Original Record |
|---|---|---|---|---|
| Trew Balance | AZ | August 25, 2025 | Drugs | FDA letter 709880 |
| TKO Distribution, LLC | FL | April 17, 2025 | Food and beverages | FDA letter 696557 |
| Latro Inc. | CA | March 25, 2025 | Food and beverages | FDA letter 698196 |
| Bailey’s Wellness, LLC dba Bailey’s CBD | Not listed | April 7, 2025 | Animal and veterinary; drugs | FDA letter 701066 |
| Holista LLC dba HolistaPet | Not listed | April 7, 2025 | Animal and veterinary; drugs | FDA letter 699082 |
| House of Alchemy LLC dba CBD Dog Health; Hamet & Love LLC dba MycoDog | Not listed | April 7, 2025 | Animal and veterinary; drugs | FDA letter 701064 |
| Pico IV Inc. | CA | March 6, 2025 | Drugs | FDA letter 700591 |
2024 FDA Cannabis-Derived Product Warning Letters
| Firm | State | Letter Date | Original Record |
|---|---|---|---|
| Anne’s Daye Ltd dba Tampon Innovations | Not listed | December 17, 2024 | FDA letter 696362 |
| Root Bioscience Brands, LLC dba Naternal | NC | August 30, 2024 | FDA letter 673646 |
| White Label Leaf, LLC / Flying Monkey US, LLC | FL | July 11, 2024 | FDA letter 681493 |
| Hippy Mood | PA | July 15, 2024 | FDA letter 677031 |
| Earthly Hemps | FL | July 15, 2024 | FDA letter 674916 |
| Mary Jane’s Bakery Co. LLC | FL | July 15, 2024 | FDA letter 678010 |
| Life Leaf Medical CBD Center | SC | July 15, 2024 | FDA letter 674917 |
| GrowGod LLC | CA | July 15, 2024 | FDA letter 674690 |
| Shamrockshrooms.com | Not listed | July 15, 2024 | FDA letter 675517 |
How to Read a Warning Letter
- Confirm the firm and date. Similar brand names can refer to different entities, and a letter is a dated record.
- Read the product and claims named in the letter. Do not extend the agency’s statements to every item the firm has ever sold.
- Separate the alleged violations. A letter may discuss unapproved-drug claims, food-additive issues, animal products, manufacturing, route of administration, labeling, or several categories.
- Check for a response or closeout record. FDA notes that later interaction may change the regulatory status of issues described.
- Check recalls separately. A warning letter is not the same as a recall, seizure, injunction, consent decree, or court judgment.
- Check current product evidence. Use the exact package, batch COA, seller terms, and current claims rather than treating a dated letter as a product review.
What the Index Can and Cannot Tell You
| The Index Can Show | The Index Cannot Prove |
|---|---|
| That FDA issued a named letter on a named date | That every present product from the firm has the same issue |
| The products, claims, and legal provisions discussed in the record | That the agency’s allegations were tested in court |
| The issuing FDA office and referenced product area | That a product is safe, effective, accurately labeled, or lawful in a state |
| Whether the FDA page displays a response or closeout link | That no other federal, state, or private action exists |
Use the CBD buying checklist for product-level evidence and How to Report a CBD Product Problem when you have a reaction, quality concern, deceptive claim, refund issue, or billing dispute.
Source and Update Method
CBDCafe.org checks FDA’s dedicated cannabis-derived warning-letter page, then opens each individual record to verify the firm, issue date, identifier, and product area. Entries are not removed because a seller’s site changes. A correction or closeout record is added when FDA publishes one.
- FDA: Warning Letters for Cannabis-Derived Products
- FDA: Search All Warning Letters and Read the Status Notice
- FDA: Regulation of Cannabis and Cannabis-Derived Products, Including CBD
Coverage: FDA cannabis-derived product index entries for 2024 and 2025. Fact checked: September 5, 2026. FDA’s dedicated cannabis-derived warning-letter page still shows 2025 as its newest year in this check. Refresh when FDA adds a cannabis-derived product letter, response, or closeout record.