Navigate DSHEA, cGMP, and labeling requirements with AI-powered compliance analysis. Ensure your supplements meet all regulatory standards.
The foundational U.S. law defining dietary supplements and establishing the regulatory framework for their manufacture, labeling, and marketing.
Current Good Manufacturing Practice regulations for dietary supplements. Ensures products are manufactured consistently and meet quality standards.
New Dietary Ingredient notifications required for ingredients not marketed before October 15, 1994. Demonstrates reasonable expectation of safety.
Comprehensive labeling requirements for dietary supplements including Supplement Facts panel, ingredient lists, and required statements.
FTC and FDA requirements for truthful and non-misleading advertising of dietary supplements.
Regulatory requirements for dietary supplements in international markets including EU, Canada, and Australia.
Comprehensive analysis of supplement labels against FDA requirements, including Supplement Facts panel, claims, and required statements.
Evaluation of manufacturing documentation, SOPs, batch records, and quality systems against 21 CFR 111 requirements.
Review of scientific evidence supporting structure/function claims to assess adequacy of substantiation.
Analysis of safety data and documentation completeness for New Dietary Ingredient notifications.
"Calcium builds strong bones"
Must have substantiation, cannot claim to diagnose, treat, cure, or prevent disease
"High in Vitamin C"
Must meet specific criteria defined in 21 CFR 101.54
"Adequate calcium may reduce the risk of osteoporosis"
Must be FDA authorized or qualified with disclaimer
Upload your labels, manufacturing documentation, and claims substantiation. Receive comprehensive compliance analysis to ensure market readiness.