Warning letter · FDA Warning Letters

Gluten Free Remedies LLC: FDA Warning Letter 687832 (Apr 15, 2025)

Agency action: Apr 15, 2025Record ID: fda_warning_-c7a2b87d582b689b
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What happened

Original notice title

Gluten Free Remedies LLC MARCS-CMS 687832, April 15, 2025

From the archived source record

Food and Drug Administration _____________________ 1 This warning letter does not address whether sulbutiamine can be lawfully marketed in dietary supplements as a non-dietary ingredient.

What the official notice says to do

Check the original notice for the instructions that apply to the named product, company, and affected lots.

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Status and source details

Status recorded in the archive
No closeout listed in FDA table
Source checked
Jul 16, 2026
Record revision
2aedb88d9f7b

This is a dated record. Its current status may have changed since the source was captured. A record applies to its stated scope; it is not a safety rating for every product from a company.

Sources, dates, and coverage →

What is affected

Product
Dietary Supplement/Misbranded
Company
Gluten Free Remedies LLC
Lot / identifier
The source does not specify this field.
Market / distribution
The source does not specify this field.