Improving Regulatory Decisions through Targeted Research: A Case Study Concerning Amino Acids

Abstract

This paper argues that the EU regulatory practice in the food area may be unnecessarily applying the Precautionary Principle by focussing on upper intake limits for naturally occurring nutrients, while not controlling the quality of the ingredients used in commercial products even though precedents of public health issues arising from adulterated ingredients do exist. Risk governance depends heavily on expert evidence and the case of amino acid supplements is used to document an industry-supported effort to strengthen the science database and thus enhance the regulatory process: Thus ensuring that amino acid use in the EU is safely and proportionately regulated. Scientific work conducted in the last decade by the not-for-profit association, the International Council on Amino Acid Science (ICAAS) is used as a simple case study highlighting the role of proactive clinical research in an era characterized by precaution in risk management, and by the escalating costs of scientific research, and the growing influence of the internet.

Detection of impurities in dietary supplements containing l-tryptophan

“…The aim of this study was to build upon the peer-reviewed literature (Rogers and Smriga 2012) by evaluating the total impurities in commercially available Trp supplements, which were chosen to represent dietary supplement products manufactured in the US, EU and Japan The impurity peaks detected from 0 to 11 min were integrated and designed as the "before Trp peak" area. The peaks detected after Trp (from 14 to 40 min) were integrated as the "after Trp peak" area and available by e-commerce globally.…”

“…The aim of this study was to build upon the peer-reviewed literature (Rogers and Smriga 2012 ) by evaluating the total impurities in commercially available Trp supplements, which were chosen to represent dietary supplement products manufactured in the US, EU and Japan and available by e-commerce globally. The study utilized an HPLC methodology described in the FCC monograph (12th edition) and assessed the presence of EBT using LC–MS.…”

“…Although the evaluated Trp-containing products represent a small segment of commercial products (NIH 2021 ) the results point towards a need to improve the enforcement of purity standards for Trp and other functional ingredients in dietary supplements (Rogers and Smriga 2012 ). Alas, many national authorities regulate ingredients in dietary supplements only by establishing maximum limits on daily intake (Smriga 2020 ).…”

Analytical Chemistry of Impurities in Amino Acids Used as Nutrients: Recommendations for Regulatory Risk Management

“…Safety evaluation of “new dietary ingredients” to be used in dietary supplements should be conducted in a comparable manner to the GRAS determination of novel food ingredients. Due to their long history of safe use, proteinogenic amino acids are frequently used as dietary supplements without federal supervision of the dosing, formulation, or purity standards [ 7 ].…”

“…Utilizing the case of amino-acid-containing products, we argue that controlling the purity of nutrients in dietary supplements and foods is the key enforceable factor in preventing adverse effects [ 6 , 7 , 8 ]. To do so, we briefly review the current regulatory status of proteinogenic amino acids, and the analytical methods applied for the evaluation of their purity.…”