In a June 10, 2025 update, FDA posted seven updated Warning Letters, issued between the beginning of 2025 and the present, to its online database, which stores more than 3400 such letters dating back to 2020 (1). The warnings encompassed various forms of lack of compliance in the agency’s view, including product mislabeling, false or misleading claims on packaging, and shortfalls in current good manufacturing practice (CGMP) standards found during laboratory inspections.
Highlights of five of the seven letters, the companies they were addressed to, and the significant red flags found by FDA are presented below.
American Behavioral Research Institute
Boca Raton, Fla. – Apr. 30, 2025
American Behavioral Research Institute (ABRI) was inspected in April and May 2024 relative to its capacity as the sponsor of a clinical investigation of an investigational drug, Relaxium Sleep (Protocol ABRI-002, “A Study to Evaluate the Effects of Relaxium in Subjects with Sleep Disorder”) (2). While ABRI did respond to FDA correspondence following this inspection, dated May 24, 2024, FDA said the institute failed to submit an Investigational New Drug application for the conduct of a clinical investigation, such as the one described, subject to Title 21 of the Code of Federal Regulations, part 312. However, FDA acknowledged that there may have been misrepresentation as to whether Protocol ABRI-002 was intended as a drug or a dietary supplement, and has given ABRI more time to reply.
Key Takeaways
- FDA cited CGMP violations in multiple facilities, including inadequate quality systems, lack of equipment cleaning procedures, and missing production records.
- Companies marketing unapproved or misbranded products, such as dietary supplements and topical analgesics, were warned for noncompliance with labeling and authorization rules.
- Improper or misleading promotional claims, particularly on social media, led to FDA scrutiny and warning letters regarding drug representation and investigational compliance.
Amish Origins Management
Worland, Wy. – May 29, 2025
FDA charged numerous violations with respect to pain relief creams, ointments, and sprays produced under the brand umbrella “Amish Origins Deep Penetrating” (3). The violations ranged from CGMP standards, to misbranded or unapproved new drugs marketed as external analgesics, to misbranded drugs sold as sunscreen. Among the CGMP violations were failures to conduct testing to verify the identities of certain components of drug products, notably glycerin, and to adequately prepare and perform batch production and control records, as well as quality control. FDA suggested that Amish Origins retain a consultant to address its CGMP issues, and that some of the company’s products may be classified as cosmetics, which fall under different sets of regulations.
Laboratoire Druide
Pointe-Claire, Quebec, Canada – May 29, 2025
The warning letter to this Canadian manufacturing facility also deals with CGMP violations, in this instance tied to regulations for finished pharmaceuticals; according to FDA, these products include over-the-counter drug products such as sunscreens and other skin protectants, as well as hand sanitizer (4). In addition to the same recommendations regarding a CGMP consultant and cosmetics designation made to Amish Origins, FDA said Laboratoire Druide’s quality systems were inadequate, and that the Pointe-Claire facility failed to establish, and then follow, appropriate written procedures for the cleaning and maintenance of its equipment.
Sprout Pharmaceuticals
Raleigh, NC – May 29, 2025
An Instagram post by Sprout Pharmaceuticals’ CEO, Cindy Eckert, was the impetus for this warning letter. FDA alleges that the post, which was reviewed by the agency’s Office of Prescription Drug Promotion but also received complaints through FDA’s Bad Ad Program, was false or misleading when it came to the effects of the oral tablet flibanserin, marketed as Addyi, within the meaning of the federal Food, Drug, and Cosmetic Act (FD&C Act) (5). Among other claims, the post referred to Addyi as “the sex pill for women”; while it has been indicated for treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD), it is not intended for postmenopausal women, or men, with HSDD, and is not indicated to enhance sexual performance.
Bio Wellness 444
Oldsmar, Fla. – May 30, 2025
Two products offered for purchase through Bio Wellness 444’s website and Instagram account, both varieties of vaginal douches, are available without prescriptions (6). FDA says these are unapproved new drugs that were introduced, or delivered for introduction, into interstate commerce, in violation of multiple sections of the FD&C Act. The products, labeled “Silver Bullet elite douche” and “Silver D elite douche,” contain colloidal silver intended for use in treating vaginal infections. As such, FDA said, the products would be deemed new drugs and require new drug applications, but no FDA-approved applications are currently in effect for those products. Bio Wellness 444 has been asked to respond to FDA with its plan for how to address the violations alleged.
While FDA warning letters generally do not authorize the execution of any definitive actions by the agency, they do specify actions that may be taken if FDA’s suggestions and requests are not adhered to, usually to be communicated by a company within a window of 15 business days of receipt of FDA’s letter. After that period of time, measures cited by FDA may be enacted, or further warnings can be issued.
References
1. FDA. Warning Letters. FDA.gov, last updated June 10, 2025 (accessed June 12, 2025).
2. FDA. Warning Letter—American Behavioral Research Institute, LLC. FDA.gov, last updated June 10, 2025 (accessed June 12, 2025).
3. FDA. Warning Letter—Amish Origins Management, LLC. FDA.gov, last updated June 10, 2025 (accessed June 12, 2025).
4. FDA. Warning Letter—Laboratoire Druide Inc. FDA.gov, last updated June 10, 2025 (accessed June 12, 2025).
5. FDA. Warning Letter—Sprout Pharmaceuticals, Inc. FDA.gov, last updated June 10, 2025 (accessed June 12, 2025).
6. FDA. Warning Letter—Bio Wellness 444 LLC. FDA.gov, last updated June 10, 2025 (accessed June 12, 2025).
