The Regulatory Challenges of Placing Dietary Ingredients on the European and US Market

Abstract

The DSHEA is 30 years old and its place in providing legitimate protections for public health through relevant agency oversight has created a patchwork of legal and scientific requirements. In contrast, the European Union has rules on supplements and permitted ingredients. Given the context of a global supply chain for food ingredients any conflict between the legality of ingredients between the U.S/EU can inhibit the economic viability of international trade. The purpose of this review is to contrast these different systems of legislative oversight. The analysis of both markets demonstrates a fragmentation in what are considered legal food ingredients between country wide harmonization and state rules and related interpretation. There are many commonalities in this regard between the U.S/EU, from borderline medicinal classifications to their resultant preclusion from food use. However, the codified legal system existing within the EU and excessive guidance can be viewed as time consuming and inflexible, especially for placing new ingredients on the market. The US in contrast is in a holding pattern for legislative interpretation regarding NDIs, GRAS and possible drug preclusion laws. As we hit the anniversary of the DSHEA recent commentary from U.S./EU central authorities point to increased international co-operation in ingredient safety assessments but whether this results in friction-free access between markets is to be determined.

Keywords:

• Dietary supplements
• EFSA
• Europe
• European Commission
• FDA
• USA

Disclosure statement

Both authors represent clients within the function food and nutrition industry.

Correction Statement

This article has been corrected with minor changes. These changes do not impact the academic content of the article.

Additional information

Funding

The author(s) reported there is no funding associated with the work featured in this article.

Notes on contributors

M. J. Tallon

Dr Mark Tallon is a nutritional biochemist and food lawyer and managing partner at the Legal Products Group Ltd a European food law firm.

D. S. Kalman

Dr Douglas Kalman is a Clinical Associate Professor in the Dr. Kiran C. Patel College of Osteopathic Medicine at Nova Southeastern University, Ft. Lauderdale, Fl. Dr. Kalman is the cofounder of Substantiation Sciences, Inc, a nutrition centric consultancy.