Depilatories & Other Cosmetic or Toilet Preparations (NESOI)

Depilatory creams that work by chemically breaking down hair protein (typically using thioglycolate compounds) are generally regulated by FDA as cosmetics because they act on the hair shaft rather than a body function. However, if a product makes claims that go beyond hair removal — such as skin-conditioning drug claims — FDA may treat it as a drug. Importers should review label claims carefully and consult regulatory counsel if the product's positioning is ambiguous.

Contact lens solutions are regulated by FDA as Class II or Class III medical devices, requiring 510(k) clearance or premarket approval and device establishment registration. This is a fundamentally different regulatory pathway from cosmetics, even though both products may classify under 3307900000. Importers must ensure the foreign manufacturer is registered with FDA and that the specific product has the required clearance before US entry.