Evidence map›Paper›PMID 41625198›Full record

ArticleCurrent developments in nutrition2026

Eliminate the In Vivo Digestibility Requirement for Protein Content Claims in North America to Align Consumer Purchasing Behavior with Dietary Guidelines.

Joseph Manuppello, Christopher D Gardner, Anna Herby, Elaine S Krul, Christopher Pf Marinangeli, Amanda Gomes Almeida Sá, Mingyang Song

Abstract readCase Reports
In one paragraph

Article in Current developments in nutrition, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Joseph ManuppelloPhysicians Committee for Responsible Medicine, Washington, DC, United States.
Christopher D GardnerStanford Prevention Research Center, Department of Medicine, School of Medicine, Stanford University, Palo Alto, CA, United States.
Anna HerbyPhysicians Committee for Responsible Medicine, Washington, DC, United States.
Elaine S KrulEKSci, Limited Liability Company (LLC), St. Louis, MO, United States.
Christopher Pf MarinangeliProtein Industries Canada, Centre for Regulatory Research and Innovation, Regina, Canada.
Amanda Gomes Almeida SáDepartment of Food and Human Nutritional Sciences, Richardson Centre for Food Technology and Research, University of Manitoba, Winnipeg, MB, Canada.
Mingyang SongDepartments of Epidemiology and Nutrition, Harvard T.H. Chan School of Public Health, Boston, MA, United States.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

A roundtable discussion, held on 10 December, 2024, addressed requirements for protein quality assessment in United States and Canadian food labeling regulations, focusing on concerns with the protein digestibility-corrected amino acid score (PDCAAS), which includes an in vivo rat assay to determine true fecal protein digestibility. Because animal proteins tend to score higher, the PDCAAS disadvantages nonanimal foods in substantiating protein content claims despite dietary guidelines recommending increased intake of plant proteins. In addition, the use of animal testing raises ethical concerns for some consumers. Roundtable participants weighed the benefits and costs of requiring the PDCAAS and discussed alternative regulatory approaches to better promote human health, prevent chronic disease, replace animal testing, and support sustainable food production. Options included relying solely on the amount of protein per serving, correcting only for the amino acid score, using fixed coefficients of digestibility or in vitro assays to determine digestibility, and incorporating measures that reflect human health outcomes and environmental impact. Several in vitro methods, such as the pH-drop and pH-stat methods, were identified as promising candidates for regulatory acceptance. The consensus was that for foods that do not address special needs, relying solely on the amount of protein to substantiate content claims is appropriate for populations who already consume protein in excess of reference values from varied sources. This approach, already used in other high-income jurisdictions, allows more plant-based foods to qualify for protein claims while avoiding animal testing. Moving away from the in vivo derived PDCAAS would reduce existing regulatory barriers, better align with current dietary guidelines, and promote increased intake of plant-based foods, thereby improving public health and sustainability.

Indexed as

3Rsamino acidsanimal testing alternativesdietary proteindigestibilityfood regulationsin vitro techniquesPDCAASplant-basedprotein quality

Identifiers

PMID41625198
PMCPMC12854027

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.