# In vitro protein digestibility to replace in vivo digestibility for purposes of nutrient content claim substantiation in North America's context

## TL;DR

This paper proposes using in vitro methods to assess protein digestibility instead of animal testing to support protein content claims in North America.

## Contribution

It outlines a pathway for validating in vitro methods through collaborative studies for regulatory acceptance.

## Key findings

- Current in vivo methods hinder innovation in protein food development.
- Collaborative studies are needed to validate in vitro methods for regulatory approval.
- A consultative process will ensure the program meets its goals.

## Abstract

The reliance by North American regulatory authorities on in vivo rodent bioassays—Protein Correct-Amino Acid Score (PDCAAS) in the U.S. and Protein Efficiency Ratio (PER) in Canada—to measure the protein quality for protein content claim substantiation represents a major barrier for innovation in the development and marketing of protein foods. Although FAO in 2013 proposed a new method (Digestible Indispensable Amino Acid Score, DIAAS), it is still not used for protein content claim substantiation in any jurisdiction. Together with public health efforts to increase the consumption of plant-based foods, removing hurdles is key to incentivizing the food industry to measure protein digestibility in making food formulation decisions as well as in claiming protein content on product labels. To address this issue, a pathway has been proposed to position alternative methods for in vitro protein digestibility in collaborative studies to generate the data necessary for method approval by a certifying body. The latter is critical to the potential recognition of these methods by both Health Canada and the US FDA. The purpose of this article is to briefly summarize the state-of-the-art in the field, to inform the research community of next steps, and to describe the path engaging collaborative laboratories in a proficiency test as the first step in moving forward toward acceptance of in vitro digestibility methods. Throughout, a consultative and iterative process will be utilized to ensure the program goals are met. Success will be achieved when the proposed path results in the acceptance of an in vitro methods for protein digestibility used for PDCAAS determinations, which will enable increased protein analyses and improved nutrition labeling of protein foods.