FDA cosmetic + telehealth prescriber licensure per state, what do I need?

Two regulatory tracks, depending on product mix:

FDA cosmetic (for grooming products without health claims):

• Cosmetics don’t need pre-market FDA approval but claims must be truthful + not drug claims. “Softens skin” is fine; “treats acne” turns it into a drug requiring full FDA approval.
• Labelling rules: ingredient list in descending order, net weight, manufacturer / distributor name, warnings if applicable.
• MoCRA (Modernization of Cosmetics Regulation Act, effective 2024) requires FDA registration of cosmetic facilities + product listings + adverse-event reporting. Most contract manufacturers handle the registration; the brand handles the product listings.

Telehealth prescriber licensure (for hair loss / ED / skincare prescription products):

• State-by-state licensure, the prescriber must be licensed in the state of the patient at the time of consultation. The prescriber-network handles this (Wheel, SteadyMD, OpenLoop). Not your problem to track.
• Asynchronous vs synchronous rules. Some states (Indiana, Louisiana, Arkansas) require live video consult for first prescription; most allow async after the first. The prescriber-network routes accordingly.
• Controlled substances, Schedule II, V (e.g. testosterone replacement therapy, GLP-1) have stricter rules. Most men’s grooming brands stay out of CS land. Hims does TRT in selected states with extra licensure.
• HIPAA applies to all health data. BAA with prescriber-network + pharmacy. Magento stores prescription state (status, refill count) but not full medical history.

DSHEA (Dietary Supplement Health and Education Act) applies if you sell supplements (e.g. Beardbrand Boost multivitamin, Hims hair gummies). Structure / function claims OK, disease claims not.

The pattern: hire a regulatory consultant (~$5k for full audit, $2k retainer) at the start; build with compliance in mind, not retro-fitted later. Retrofit is 5× the cost.