Are you up-to-date on Section 912 and the potential threat to food innovation? Tucked into a law recently passed by Congress is a little known prohibition that represents a shift in the dividing line between foods and drugs, and threatens to present significant hurdles for anyone involved in product development.
The provision, known as Section 912, is now in effect and prohibits the addition to a food of an approved drug. It also prohibits the addition of a drug for which substantial clinical trials have been executed and made public. Food manufacturers must look at Section 912 closely to determine how it could affect their existing portfolios and their product development strategy.
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Dr David H Bechtel, CFS
VP NJ Office
Cantox US Inc
Diane Barber McColl
Hyman, Phelps & McNamara PC
Diane B. McColl is a principal at Hyman, Phelps & McNamara P.C., a law firm that specializes in the regulation of foods, drugs, medical devices and cosmetics. She received a B.S. in Pharmacy cum laude from the University of South Carolina in 1976. Ms. McColl practiced pharmacy in Tennessee and South Carolina until 1984, when she earned a law degree from the University of Carolina. Ms. McColl was a member of the Order of Wig and Robe and associate editor-in-chief of the South Carolina Law Review. She joined Hyman, Phelps & McNamara in 1989. Ms. McColl is admitted to the bars of Texas and the District of Columbia. She sits on the Council of the International Society of Regulatory Toxicology and Pharmacology, and is a professional member of the Institute of Food Technologists. With more than 20 years experience, Ms. McColl’s practice focuses on food law, with an emphasis on issues surrounding the development of new food ingredients.
Ashley Roberts PHD
VP Food & Nutrition Grp
Dr. Roberts is an accomplished Regulatory Toxicologist with extensive knowledge in both European and international regulatory affairs, and has considerable experience in designing, conducting and reporting pre-clinical and clinical research studies. During his time in industry and academia, he has published a number of papers in peer-reviewed journals primarily in the area related to mechanisms of toxicity and pre-clinical/clinical pharmacokinetics. Dr. Roberts received his B.Sc. with honours in biochemistry from the University of London and a Ph.D. in clinical pharmacology toxicology from the University of Southampton. Following his Ph.D., he completed a post-doctoral fellowship in metabolism and pharmacokinetics also from the University of Southampton. Dr. Roberts is based in Cantox’s Mississauga office as the Vice President, Food and Nutrition Group providing advice and assistance to our international clients with issues that are scientific, regulatory and toxicological in nature, as well as assisting clients wishing to design and develop scientific research programmes and for those developing regulatory strategies for food additives.
Deputy Director for Regulatory Affairs
Michael M. Landa is the Deputy Director for Regulatory Affairs, Center for Food Safety and Applied Nutrition, U. S. Food and Drug Administration. He has held that position since August 2004. Previously, he was Deputy Chief Counsel, FDA (2000-2004), and was in the private practice of food and drug law in Washington, D.C. (1993-1999).
Mr. Landa also served as a staff attorney in FDA’s Office of the Chief Counsel (1979-1993). Mr. Landa holds a BA from Columbia College (1971), a JD from the University of Virginia (1975), and an LL.M. from New York University (1978), where he was the Food and Drug Law Institute Fellow during the 1977-78 academic year.