Regulations and protection for functional food products in the United States

In line with increasing concern and attention to health, functional foods and dietary supplements have been gaining popularity and prominence for their role in disease risk reduction and benefit to health in the recent past. Development of these food products has become a hot research area in the academia and the industry. As in the biotechnological and pharmaceutical industries, research and development of health food products are often risky and require enormous resources. In this article, the current governmental regulations and patent protection, two prime factors for paving the way for developing and marketing functional foods and dietary supplements in the United States, have been discussed. The newly reformed requirements of patenting natural matters in view of Supreme Court rulings such as Mayo, Myriad and Alice are highlighted, and we provide suggestions and advice for a better intellectual property protection for these products. (C) 2015 Elsevier Ltd. All rights reserved.