In June 2026, the U.S. Food and Drug Administration (FDA) issued a Warning Letter to Huons Co., Ltd. following an inspection of its sterile injectable manufacturing facility in Jecheon, South Korea. While Warning Letters are not uncommon in the pharmaceutical industry, this case stands out because it goes far beyond isolated documentation issues. The FDA concluded that the company's manufacturing systems, laboratory controls, and quality oversight failed to comply with Curren

You can no longer approach the FDA without an eSTAR. To launch a medical device in the U.S., entering the FDA’s gateway is an absolute necessity. For most companies, the preferred route is the 510(k), or Premarket Notification process. While primarily designed for Class II (moderate-risk) devices, it also applies to certain low-risk or high-risk devices depending on their unique technical characteristics. In fact, the vast majority of medical devices entering the U.S. market

The First New FDA Sunscreen Ingredient Addition in More Than 20 Years The U.S. Food and Drug Administration (FDA) has added bemotrizinol to the list of permitted sunscreen active ingredients, marking the first new FDA sunscreen ingredient addition to the OTC sunscreen monograph since the late 1990s. The decision represents an important regulatory milestone for the U.S. sunscreen industry and may create new opportunities for product innovation in the years ahead. What Is Bemot

Last May, the FDA officially announced a recall of a kimchi brand sold in the U.S. The product itself wasn't the problem. What triggered the recall was a single missing line on the label — the anchovies used in the product weren't declared as an allergen the way FDA requires. Over 32 million Americans live with food allergies. And undeclared allergens are one of the violations the FDA treats most seriously. U.S. Allergen Rules Are Stricter Than Most Brands Expect The FDA reco

The BIO International Convention, taking place in San Diego from June 22–25, is one of the world's leading events for the biotechnology and life sciences industry. Every year, the convention brings together biotechnology companies, pharmaceutical developers, investors, research institutions, manufacturers, and regulatory experts from around the globe to explore partnerships, investment opportunities, and commercialization strategies. For companies developing innovative health

Lately, the FDA has been issuing a wave of Warning Letters to OTC sunscreen manufacturers. Korean manufacturers are no exception. Across all these letters, the core issue remains exactly the same: It’s not just about a faulty product; the entire manufacturing quality system is failing to function. In South Korea, sunscreen is classified as a "functional cosmetic." Because of this, many brands and manufacturers mistakenly assume: "We passed the SPF testing, so we should be fin

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