News & Blog

Exosomes, PDRN, and post-procedure care. These are the hottest keywords in the global beauty market today. As K-Beauty shifts its focus from "Glass Skin" to "Recovery and Regeneration," the so-called K-Clinic category is rapidly emerging. This is more than just a trend; consumers now expect professional, clinic-level results directly from their skincare products. However, the moment these expectations are translated into marketing copy, a significant risk arises in the U.S.

"Our product is a cosmetic — it just has an SPF rating." "Anti-dandruff shampoo is regulated as a drug?" If these questions sound familiar, your facility may already be at risk. You May Be Selling a Drug Without Knowing It The FDA classifies the following products not as cosmetics, but as OTC (over-the-counter) drugs : Sunscreens with SPF claims Acne products containing salicylic acid or benzoyl peroxide Anti-dandruff shampoos containing zinc pyrithione or selenium sulfide To

On March 5th, the FDA released a significant update that carries substantial weight for the industry. The agency has finalized a rule to unify the National Drug Code (NDC)—the identification number for all drugs sold in the U.S.—from the current 10-digit format to a standardized 12-digit format. Read More : Final Rule "Revising the National Drug Code Format and Drug Label Barcode Requirements" Why FDA's NDC Matters Every product classified as a drug in the U.S. must have an

A fast-growing K-Beauty brand — call it Brand A — recently appeared in not one but two FDA public databases. First in CAERS, the FDA's cosmetics adverse event reporting system. Then in MAUDE, the medical device adverse event database. No recall. No import alert. But showing up across two separate FDA systems at the same time? That kind of thing gets noticed. Why an FDA Database Listing Is Never Just a Footnote CAERS and MAUDE are fully public. No login required. Any consumer,