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Fibromyalgia Treatment Group, LLC received an FDA Warning Letter in August 2021 regarding drugs marketed for fibromyalgia treatment that were found to violate new drug and misbranding regulations. Based on the limited metadata available, the violations appear to involve either unapproved new drug products or products with labeling and marketing claims that do not comply with FDA requirements. The warning was issued by the Division of Human and Animal Food Operations West VI, which covers FDA's Western region regulatory oversight.