The Hidden Labeling Risks American Beauty and Inner Beauty Brands Are Missing When preparing to enter the US market, most brands fixate on FDA registration and MoCRA compliance. Once the ingredient list is formatted according to regulation and the label design is set, it is easy to assume you’re in the clear. However, a significant portion of the lawsuits that actually threaten brands in the US market do not originate from the FDA. Instead, they stem from class-action lawsuit

A patient arrives in the ER. The medical team needs to quickly identify an implant placed years ago. Or a recall notice lands at a hospital — and no one can immediately tell whether the devices on the shelf are affected. This isn't hypothetical. It happens. The FDA's answer to this problem looks, on the surface, like just another barcode requirement. But it's something much bigger: the UDI (Unique Device Identification) system. And for any company selling — or planning to sel

Same ingredients, same formula—so why does the FDA interpret them differently? We break down why your MoCRA listing is a strategic baseline, not just a registration form.

Longevity: Shifting the Language of Beauty In the U.S. beauty market this year, the term "anti-aging" is rapidly fading from brand vocabularies. In its place, "Longevity" has taken center stage. Longevity is no longer just about living longer; it’s about "how long one can maintain a state of peak health." This encompasses an entire lifestyle—from exercise, sleep, and diet to stress management and skincare—aimed at slowing down aging at a cellular level. With Mintel identifyin

We're proud to share that ' Magnif's make p:rem' , a K-Beauty client of PCG, has officially launched at Sephora — one of the world's most selective beauty retailers. This is more than an expansion of distribution channels. It's proof that when exceptional product quality meets a solid regulatory foundation, even the biggest doors in global beauty can open. Who Is Brand 'make p:rem', a brand by Magnif'? Magnif’s make p:rem is a clean beauty skincare brand that has built its re

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,