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News / Insights
News & Blog
Regulatory updates. Practical perspectives.
A clearer view of what comes next.
Blog: Blog2


A Kimchi Brand Just Got Recalled. The Culprit? Anchovies.
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
Provision Consulting Group
Jun 153 min read


KOTRA x Provision Consulting Group to Support Korean Companies at BIO International Convention San Diego
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
Provision Consulting Group
Jun 112 min read


The FDA is Cracking Down on Sunscreen Factories—Is Yours Truly Ready?
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
Provision Consulting Group
Jun 14 min read


FDA-Compliant, Yet Still Sued? The Labeling Risks U.S.-Bound Brands Often Miss
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
Provision Consulting Group
May 154 min read
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