Corey Hilmas, MD PhD

Chief Regulatory Officer

Dr. Corey Hilmas is a respected scientist, medical doctor, former U.S. federal food regulator, and dad to three amazing kids. After having completed his medical degree and doctorate in toxicology and working as a principal investigator at a large research institute, he was employed on behalf of the US government at US FDA. He served as a toxicologist for NDI notifications and branch chief within the Division of Dietary Supplement Programs (today the Office of Dietary Supplement Programs). In addition to his expertise in food safety/toxicology, setting structure function claim policy, labeling, GMPs and health fraud, he served as an expert witness for FDA, DOJ and AUSA. He helped revamp the FDA’s food inspector training program (Memphis, TN) for dietary supplement manufacturers and distributors and trained over 500 inspectors. During his time at FDA, their small Division of Dietary Supplement Programs led all of FDA in final agency actions and produced over 450 warning letters. He has reviewed over 90,000 dietary supplement labels for claims and misbranding that were collected as part of certificate of free sale applications, 30-day notices, misbranding reviews, requests for labeling exemptions, GMP inspections, health fraud alerts, FDA DO queries, DIOP investigations, and other enforcement activities.

As a recognized regulatory expert with intimate knowledge of the dietary supplement industry, Dr. Hilmas has made significant contributions toward building and re-shaping the global food regulatory landscape after leaving FDA through drafting over 70 comments to US federal and state agencies, as well as global food health directorates on topics ranging from soy to supplements and cannabis to China’s overhaul of their Food Safety Program through his work with the largest US trade association representing conventional foods and dietary supplements. He has also worked with venerable organizations like AOAC to spearhead progress in developing new analytical methods for foods. Today, Dr. Hilmas heads up KGK Science’s Client Services Division, which encompasses KGK Science’s Research, Regulatory, and Preclinical Services Branches. KGK Client Services helps research and regulatory clients gain market access and distinction in the North American sector through supporting GRAS, NDIs, protocols, manuscripts, consulting advice, labeling reviews, structure function claim substantiation files, citizen petitions, and a myriad of other regulatory work products. Dr. Hilmas also serves as co-chair of the International Probiotics Association’s Regulatory Committee and remains actively involved with the Consumer Healthcare Products Association’s scientific and regulatory committees.

Dr. Hilmas is a well-traveled and decorated civil servant. He was the recipient of FDA’s prestigious Award of Merit from former FDA Commissioner Margaret Hamburg for expert witness trial work on behalf of FDA, DOJ and AUSA; an Excellence in Federal Career Bronze Award for Outstanding Performance for US Government; four military commendations awards; Commander’s Award for Civilian Service; and 12 FDA Awards for enforcement initiatives.