Dedicated compliance flows for FDA special-regulation categories (not general food / cosmetic)
These categories are regulated specially in the U.S. and cannot use general food or cosmetic review paths. Select the corresponding flow below for a 4-layer AI review.
Sunscreen (with SPF claims)
Products with SPF are classified as OTC drugs in the U.S. and must follow 21 CFR 201.327 Monograph + 21 CFR 211 drug cGMP + Drug Facts panel.
Canned, acidified, aseptic, retort pouch foods
Hermetically sealed foods with pH > 4.6 + aw > 0.85 are LACF (21 CFR 113); acidified foods fall under 21 CFR 114. Failing to file FCE/SID triggers Import Alert 22-04 detention.
Nutrition management for specific diseases
4 legal tests (enteral tube feeding + physician supervision + specific disease + unique nutritional requirements). Most 'health food' products disguised as medical foods receive Warning Letters.
💡 Not sure which category fits your product?
First run afood revieworcosmetic review— L1 will automatically tell you whether your product falls into a specialty category and recommend the dedicated flow.