The US regulatory environment has evolved substantially since the federal government first started to regulating food production and drug development. The initial regulatory policy enacted by the US dates to 1906 with the Pure Food and Drug Act, which was spurred on by Upton Sinclair’s book The Jungle. The Jungle created an intense focus on the quality of food after Sinclair’s book highlighted the shortcomings of the meatpacking industry in Chicago, IL, US. While the Pure Food and Drug Act was the first step toward pushing manufactures to create safe and effective products, the Act only required manufactures to accurately list product ingredients.2 The 1938 Food, Drug and Cosmetic Act later required drugs to be non toxic and the 1962 Kefauver-Harris Drug Amendments required drugs to be efficacious.