To: Medical Executive Committee Boston Medical University
From: Carolyn Moore
Date: March 24, 2023
I am writing a letter in support of Michael Holick, PhD, MD from my past research and regulatory collaborations. Dr. Holick has made numerous contributions in the field of vitamin D biochemistry and photobiology. In 2001, I was the Director of Nutrition for The Minute Maid Company in Houston, Texas. The Marketing and Research Divisions of Minute Maid were interested inadding vitamin D to calcium fortified juices. However, there was a regulatory hurdle that required submitting a food additive petition to the Food and Drug Administration (FDA). Dr. Holick was identified at the time as the leading scientist in the area of vitamin D metabolism. We asked Dr. Holick to review documents being prepared to submit to the FDA to consider allowing for the addition of vitamin D to calcium fortified 100 percent juices matching current level of fortification of milk. Additional foods needed to be fortified with vitamin D. Numerous people either cannot tolerate milk due to a milk allergy or lactose intolerance (deficiency of the digestive enzyme lactase). At the time, fortified milk was the primary source of dietary vitamin Din the U.S.
Before submitting the food additive petition, Cantox Health Sciences International performed attoxicological assessment of adding vitamin D to calcium fortified juices at the proposed level {100IU/8 oz.) for the U.S. population. The level of fortification was determined to be safe.
In September, 2001 two weeks after the 9/11 tragedy, the CEO of the Minute Maid Company gave permission for a team of company scientists to meet with the FDA to discuss the proposed vitamin D food additive petition. Dr. Holick joined us as the vitamin D expert at that meeting.Mona S. Calvo PhD, Expert Regulatory View Scientist, Center for Food and Safety from the FDA, chaired the discussion and was very impressed with the case and scientific evidence presented. We were given the approval to move forward. Following the meeting, The Minute Maid Company submitted the food additive petition (FAP2A4734). In February 27, 2003 the Federal Register (68 FR 9000) issued regulations§ 172.380 (c) permitting the use of vitamin D3 in calcium fortified 100 percent fruit juices and fruit juice drinks.
While the food additive petition was under review with the FDA, Dr. Holick identified the need to determine whether vitamin D, a fat-soluble vitamin, was bioavailable in orange juice (a nonfat beverage). His research study concluded that vitamin D fortification of orange juice for 12 weeks significantly increased 25-hydroxyvitamin D concentrations (the biomarker of vitamin D nutritional status) in adults. Dr. Holick’s research was published in the American Journal of ClinicalNutrition. 2003; 77: 1478-83.
Since approval of the addition of vitamin D to juices in 2003, further updates to the FDA ruling have been made resulting in vitamin D fortification of other dairy products, fortified soy alternatives, almond beverages, and rice beverages.
Dr. Holick has a long history of providing medical care and conducting public health research as a physician and scientist. To my knowledge, he has always been an excellent scientist and made significant medical and scientific contributions by “thinking outside the box” to provide new perspectives on health issues.
Carolyn Moore, PhD, RD
Associate Professor
Department of Nutrition and Food Sciences Texas Woman’s University
Houston, Texas 77030
