Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
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Talk to a SpecialistTalk to a SpecialistBased on limited metadata, Bioactive C60/FullerLifeC60 LLC, a company marketing C60 products, received an FDA Warning Letter on March 30, 2020, for violations related to drug classification and/or marketing. Without access to the complete warning letter, the specific nature of the regulatory violations cannot be determined, though the letter's issuance suggests the FDA identified concerns regarding product claims, manufacturing, or regulatory compliance within the drug product category. The warning was issued by the FDA's drug regulatory division, indicating the agency determined these products were being marketed as drugs without appropriate approval or were otherwise in violation of drug regulations.