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FDA questions: supplements, cosmetics and device listings
Resolve common document misunderstandings using the actual claims and product category.
Applicable route
Does a food registration number make a supplement FDA approved? No. FDA does not approve dietary supplements for safety and effectiveness before sale; other safety, ingredient and labeling duties still apply. Identify the actual composition and claims rather than assuming ordinary-food paperwork resolves every supplement requirement.
Records and action
Does cosmetic listing approve a cream? No. Check whether the claims or intended use bring another regulatory branch into scope. Does device listing replace a required premarket decision? No. Registration, listing, clearance and approval describe different records and must be checked separately.
Example and boundaries
Example: an online seller asks for a cosmetic exemption letter from FDA. FDA's September 2026 clarification says it does not issue such verification documents. Document the actual exemption analysis and discuss the platform's evidence request without fabricating a government letter. Kayra can explain the gap, not invent agency proof.
Tell us what you need and our specialists will contact you.
Provide the product branch, actual facility and specific record to be prepared. Kayra can scope preparation ; no agency decision or US-agent appointment is established here.