Princeton, NJ – Charles B. Simone, M.D., a medical oncologist, immunologist and radiation oncologist at the Simone Protective Cancer Institute, continues to be a leader in health care matters and Food and Drug Administration reform. In 1993 he was called upon to write the language that led to the compromise in the US Senate and finally the House ensuring that all Americans have free access to food supplements – the Dietary Supplement, Health and Education Act of 1994 (DSHEA).

Wins Landmark Case Against FDA

Charles B. Simone, M.D. was again called upon to help Emord and Associates win a landmark case against the Food and Drug Administration. On January 15, 1999, the United States Court of Appeals for the D.C. Circuit ruled as invalid the FDA's interpretation of the term "significant scientific agreement" for pre-screening nutrient-disease relationship claims of nutritional supplements - [Pearson v Shalala]. The Court found that the FDA’s interpretation of the term "significant scientific agreement" has been "arbitrary and capricious" and "in violation of the Administrative Procedure Act."

FDA Violates First and Fifth Amendments

The Court also held that FDA's four sub-regulations [21 C.F.R. § 101.71(a), (c), (e); and § 101.79(c)(2)(i)(G)] as invalid and in violation of the First and Fifth Amendments to the United States Constitution. The First, because producers of dietary supplements are assertedly subject to a ‘prior restraint’ on their protected speech the labeling of products. The Fifth, because the agency’s approach is so vague as to deprive the producers of liberty (and property) without due process.

The U S Court of Appeals further stated: "It simply will not do for a government agency to declare - without explanation - that a proposed course of private action is not approved. The agency must articulate a satisfactory explanation for its action. To refuse to define the criteria it is applying is equivalent to simply saying no without explanation. Accordingly, on remand, the FDA must explain what it means by ‘significant scientific agreement’ or, at minimum, what it does not mean."