In order to make a protein content claim on a food, the law requires its label to list the percentage of quality protein. However, measuring quality protein requires the determination of protein digestibility in sacrificed rats. This is the only FDA regulation requiring animal testing for a food product label. Compliance with the law creates a dilemma for food manufacturers desiring a clean label concerning ethical animal treatment. David Plank, Managing Principal, WRSS Food & Nutrition Insights and Senior Research Fellow, University of Minnesota, Dept. of Food Science & Nutrition, spoke on “Ethical Analysis and Labeling for Protein Claims” at the 2023 Clean Label Conference. He presented the financial risks of not complying with the existing regulations and a new method that accurately determines rat digestibility without using animals.
Communicating the protein content of a formulated food or beverage to consumers is often crucial for commercial success. When making a protein label claim, regulations require analytical protein content and protein quality determinations. This can be expensive and time-consuming and also requires animal sacrifice. “This is not what you’d want for an aspirational clean label product,” said Plank. He delved into common industry misbranding errors; the current state of protein analysis; and the progress toward non-animal (in vitro) testing.
Label Claims and Analysis Needed
Protein content claims like “Contains xx Grams Protein” are popular. Plank explained that grams of protein is the amount of “Crude” protein. Its determination is straightforward and relatively inexpensive. When proteins are added to fortified or fabricated foods, they are considered Class 1 nutrients and must be present at 100% or more of their declared label value. (21 CFR 101.9(g)(3))
In contrast, a protein’s % Daily Value (DV) is based on the amount of Quality Protein in a product. The “standard adult” must have 50g of Quality (not Crude) Protein per day to reach 100% of the DV of protein in their diet. Thus, if 20g of Quality Protein is declared on
the label and divided by 50g, the product has 40% DV. (20g/50g = 40%). Quality Protein is defined as having a PDCAAS (Protein Digestibility Corrected Amino Acid Score) of 1.0. Few single-plant sources have PDCAAS values this high. It is not uncommon for smaller
manufacturers to confuse Crude Protein with Quality Protein in calculations—resulting in inaccurately high %DVs on labels.
Any protein claim outside of the Nutrition Facts Label must include the labeling of the protein’s % DV, which requires a PDCAAS determination. Although some manufacturers disagree, a consensus among larger manufacturers and legal experts is that making a protein content claim outside the Nutrition Facts Label also implies a “Good Source of Protein” in consumers’ minds. For a “Good Source of Protein” claim, regulations require the product to have at least 5g of Quality Protein/serving (i.e., 10% DV), stated Plank. Therein lies the challenge.
PDCAAS Analysis Issues & An Alternative
Protein labeling errors are common. Requirements are often poorly understood, and some manufacturers follow competitors’ labeling mistakes. True compliance is expensive and time-consuming, Plank pointed out. And the current analytical method may be contrary to the ethics of manufacturers or their clients.
The usual method to quantify PDCAAS Protein Quality includes analysis of the amino acids in the food product and calculating the limiting amino acid relative to the 1991 FAO Complete Protein amino acid profile. Lastly, the protein’s digestibility in rats must be determined since this value is multiplied by the limiting amino acid value to calculate PDCAAS.
This involves measuring a sample’s total nitrogen, amino acid profile, fat, sugars, etc., which the animal is fed over weeks. The rats’ food intake, body weight and fecal nitrogen are also measured during this time. The animals are then sacrificed. Typically, five rats per sample plus controls are needed, said Plank.
An in vitro method under development and informally named “ASAP-Quality” is based on enzymatic analysis. It eliminates the need for animal testing (US Pat No. 9,738,920). Numerous technical challenges are being overcome, including the need to compensate for individual amino acid reactivity, preventing the enzymes used for digestion from interfering with measurements, and not inactivating the enzymes prematurely. As adaptations have been made to the analysis protocol, the method produces results increasingly similar to the current FDA-approved analysis.
The next steps toward FDA regulatory approval include launching an improved equation; conducting an AOAC collaborative study; and recruiting international participation from academia, industry and government agency labs. Then a much desired “AOAC First Action Status” should be obtained, followed by a Citizen Petition to the FDA, said Plank.
Companies currently using the in vitro test include those with animal testing bans, those who want to comply with the law using an ethical test for clean labels, and/or those who want to reduce class action risk at low cost.
“Ethical Analysis and Labeling for Protein Claims,” David Plank, Managing Principal, WRSS Food & Nutrition Insights/Senior Research Fellow, University of Minnesota, Dept. of Food Science & Nutrition, https://www.wrssfni.com
Caption for Feature Rate Image: Efforts to obtain an FDA-approved Protein Quality method to replace one requiring the use of animals are advancing toward FDA approval. Crucially, the gap between the test results of the traditional analysis and the new protocol is closing.
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