Case on Responding to a Data Submission Order from the Korea Food and Drug Administration

1. The Client's Situation

The Korea Food and Drug Administration gave the client advance notice of a disposition suspending advertising operations regarding a violation of the Cosmetics Act in connection with a product the client manufactured and sold. After consulting with our law firm, the client submitted its opinion to the effect that (1) the product in question carried no possibility of being mistaken or confused for a pharmaceutical, and (2) it had complied with all of the Guidelines on the Management of Cosmetics Labeling and Advertising and the regulations on substantiation. Thereafter, the Korea Food and Drug Administration instructed the client to additionally submit the substantiation materials attached to the previously submitted opinion, the test methods of the human application test, and substantiation materials regarding the advertising content.

Your Legal Team reviewed the substantiation materials and report content delivered by the client to confirm whether the above materials conformed to the documents additionally requested by the Korea Food and Drug Administration. We also presented a strategy whereby, for a portion involving a simple clerical error by the clinical company, it would be advisable to obtain a confirmation letter from that company to provide an explanation.

As a result, the client was able to appropriately respond not only to the advance notice of the administrative disposition by the Korea Food and Drug Administration, but also to the follow-up instruction to submit additional materials.