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.
π‘ Not sure which category fits your product?
First run afood revieworcosmetic reviewβ L1 will automatically tell you whether your product falls into a specialty category and recommend the dedicated flow.