FDA Issues Warning Letters Alleging Unapproved New Drug Status and CGMP Non-Compliance
By Alvin J. Lorman, AAHP Counsel
The Food and Drug Administration (FDA) has issued two Warning Letters that should be of intertest to all manufacturers and distributors of homeopathic drugs.
The first, addressed to StellaLife, Inc., a distributor of homeopathic oral care products, claims that the company’s VEGA Oral Care Recovery Kit, VEGA Oral Care Peppermint Gel, VEGA Oral Care Spearmint Rinse, VEGA Oral Care Peppermint Rinse, and VEGA Oral Care Coconut Rinse are unapproved new drugs. FDA said in the Sept. 16, 2025 letter (available here: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/stellalife-inc-712804-09162025) that the company’s
“…homeopathic drug products are especially concerning from a public health perspective because they are marketed for use in vulnerable populations, i.e., children and patients at high risk for developing an infection, such as those with open oral wounds or postoral surgery. Use of your products in these populations is even more concerning because some of your products have been recalled due to microbial contamination. Introduction of certain types of bacteria to the disrupted oral mucosa in patients with oral disease, undergoing dental surgical procedures, or with compromised immune systems could lead to bacteremia and sepsis. (Footnote omitted; emphasis added.)”
In a footnote, FDA noted that “your contract drug manufacturer HomeoCare Laboratories, Inc. voluntarily recalled several lots of StellaLife Homeopathic Drug products due to concerns with microbial contamination in June 2023 and June 2024.”
FDA’s assertions of unapproved new drug status were based on the agency’s review of the company’s website and social media accounts, including Facebook, Instagram, and YouTube. That review was likely the result of the previous recalls. Some of the claims cited by FDA include:
“Natural relief for dental surgeries . . . mouth ulcers . . . mucositis, thrush, lesions.”
“Doctors have found it effective in managing . . . mucositis.”
“The patented rinse supports healing after dental treatment. It is part of oral hygiene to moisturize dry mouth and kill bacteria that cause periodontal disease.”
“It has been helping patients with dry mouth symptoms, including patients who experience xerostomia caused by radiation therapy to the head and neck.”
The company was asked to provide a written response within 15 working days of the letter (due October 7).
An Aug. 11, 2025, Warning Letter to Everlaan Organics, Inc. dba Maple Organics involves allopathic OTC drugs and was based on FDA’s review of records submitted in response to a Sept. 4, 2024 request for records and other information pursuant to section 704(a)(4) of the FD&C Act, and subsequent correspondence. (The Warning Letter is available at https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/everlaan-organics-inc-dba-maple-organics-707956-08112025). FDA’s actions, based solely on company records and correspondence, demonstrate the importance of proper recordkeeping as well as proper procedures.
While not involving homeopathic drugs, the Warning Letter is of particular interest because of the granularity of the alleged CGMP violations based solely on a review of company records. Among the FDA allegations are the following:
“Your firm failed to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release (21 CFR 211.165(a)) …. In response to our initial request, you state that you “identify all items via receiving practices” and provided a receiving procedure. However, the procedure did not specify chemical identity testing for incoming components. You also did not provide your incoming component testing data for the most recent batches shipped to the United States when asked by FDA subsequently.
Your firm failed to conduct at least one test to verify the identity of each component of a drug product (21 CFR 211.84(d)(1)) …. [Y]ou state that you “identify all items via receiving practices” and provided a receiving procedure. However, the procedure did not specify chemical identity testing for incoming components.
The records and information you provided did not demonstrate that you have an adequate stability program for the OTC drug products you manufacture. You provided a stability test procedure that only discussed accelerated stability testing but did not include long-term stability testing. In lieu of stability data, you provided a cost estimate from a contract testing laboratory outlining the various stability tests to be performed. We note that one of your microbiological test references USP <2021>, which is intended for evaluating nutritional supplements, and not drug products.
The batch records you provided in response to our request for records lacked adequate production details regarding significant manufacturing steps, including, but not limited to, identity of major equipment and lines, in-process controls, yield, and container closures.
The records and information you provided demonstrate that your quality unit (QU) did not effectively exercise its responsibilities to oversee the quality of your drug manufacturing operations. Specifically, your QU did not adequately exercise its authority in the approval or rejection of components, approval or rejection of finished drug products, batch record review, establishment and implementation of an adequate stability study program, and performance of adequate process validation.”
The company informed FDA that it planned to cease production and instead employ a contract manufacturer. FDA’s Warning Letter noted that the prospective contract manufacturing facility was placed on Import Alert 66-40 for failure to comply with CGMP requirements. “Accordingly, drugs manufactured at the prospective CMO are considered adulterated and thus should not be used for the manufacture of drugs for the United States market,” FDA said.