PMS4PMS, LLC
FDA issued a warning letter to PMS4PMS, LLC (Clarence, NY) after a November 2024 inspection found significant CGMP violations and determined that their 'Comforté® Menstrual Cramp RELIEF CREAM' is an unapproved new drug and misbranded product. The product's labeling includes menstrual cramp relief indications not covered under OTC monograph M017 for external analgesics, making it a new drug marketed without an approved application. FDA also cited failures in release testing, stability programs, and quality unit oversight. The company is required to respond within 15 working days, and failure to comply may result in seizure, injunction, or withholding of export certificates and new application approvals.
Flagged claims (6)
Temporary relief of monthly feminine discomfort
The natural plant extracts in this cream help to temporarily relieve pain associated with menstrual cramps.
We believe in the power of plants and their therapeutic properties to offer solutions for menstrual discomforts.
Uses: Temporarily relieves minor pain associated with cramps
apply and massage Comforté® cream to the lower abdomen from hip to hip and to your lower back if you are experiencing discomfort there too.
Menstrual Cramp RELIEF CREAM
Required actions (5)
After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any violations and to prevent their recurrence.
Correct any violations promptly. Failure to promptly and adequately address this matter may result in regulatory or legal action without further notice including, without limitation, seizure and injunction.
Failure to promptly and adequately address this matter may result in regulatory or legal action without further notice including, without limitation, seizure and injunction.
If you plan to resume any manufacturing operations regulated under the FD&C Act, notify this office before resuming your drug manufacturing operations.
We may re-inspect to verify that you have completed corrective actions to address any violations.
Does your site contain similar claims?
The free site audit scans your whole site against every entry in this Atlas. Most nutrition / supplements sites match 3-6 patterns.
Run my free site auditWorried about one specific page, ad, or email? Paste it into the free Claim Checker and see what the FDA and FTC would flag, with the precedent next to each one. No email required.
Check specific copy in the Claim Checker