The sustainability of the food chain is coming under increasing focus. Consumers are seeking out new alternative sources to traditional foods. Retailers and grocers are stocking shelves with all sorts of alternatives to many types of food, whether they be plant-based beverages or “meat” made from alternative protein sources. Not all these alternative protein foods are necessarily “new” to consumers, but there is increased demand for more sustainable foods. There is also considerable competition with traditional foods and this offers unique challenges to industry. One such challenge is ensuring that these alternative products are equally nutritious as their traditional counterparts, while providing clear and transparent labeling for the consumer when describing the product. Considering the example of alternative protein sources, industry has come under fire regarding how protein is represented in the ingredient list, in the Nutrition Facts panel, and in claims. We will look in this article at some real-world examples. We will present the requirements for protein labeling in the U.S.A. and the potential litigation risks of protein fortification and protein claims. Additionally, ways for industry to mitigate these risks will also be put in context.
Protein labeling and claims have proven problematic in recent years and there are plenty of class action lawsuits which illustrate this issue. Protein labeling brings with it its own set of issues regards nutrition labeling. We first need to consider what a protein claim really is as it requires certain obligations in the Nutrition Facts Panel. The class action lawsuits have targeted protein claims in recent years.
Most people, as consumers or as members of the food industry now know that protein is a mandatory nutrient on the Nutrition Facts Panel (NFP). It is only mandatory to include the quantitative amount of protein in the NFP.
Calculating Protein Content
When you are calculating the protein amount, you have two options based on 21 CFR 101.9. The amount is calculated based on the factor of 6.25 times the nitrogen content of the food as determined by the appropriate AOAC method. Other factors may be appropriate depending on method as defined in CFR 101.9(c)(7)(i).
Or, you can calculate the amount of protein using the protein digestibility-corrected amino acid score (PDCAAS) for use in calculating the percent Daily Value (21 CFR 101.9(c)(7)(ii).
Percent Daily Value
Most nutrients require a percent Daily Value on the NFP but what isn’t obvious is with the exception of protein. The percent daily value is mandatory only if a ‘protein claim’ is made or if the product is represented or purported to be for use by infants or children under 4 years of age.
When doing a %DV for protein you must consider the protein quality in the product.
The %DV is calculated by correcting the actual amount of protein in grams per serving by multiplying the amount by its amino acid score corrected for protein digestibility, taking that number and dividing by 50 grams (Daily Reference Value, DRV) and converting to a percent DV figure (21 CFR 101.9(c)(7)(ii)). You need to know the Protein Digestibility Corrected Amino Acid Score (PDCAAS) for your food product.
The FDA has picked up on this aspect of labelling and sent a number of warning letters in cases where food products are making protein claims BUT NOT including the percent DV in that NFP. The FDA were particularly active in the 2013 to 2015 period.
When do you need to put that percent DV for protein? When making a protein claim. A protein claim is considered when any mention of protein is made outside of the Nutrition Facts Panel. This includes nutrient content claims.
Nutrient Content Claims
- “Good Source”; “Contains”; “Provides” = 10-19% of the DV per RACC.
- “Excellent Source”; “Rich in”; “High” = 20% or more of the DV per RACC.
- “More”; “Fortified”; Enriched”; Added”; “Extra”; “Plus” = 10% or more of the DV per RACC than an appropriate reference food (only for proteins, vitamins, minerals, dietary fiber and potassium).
Quantitative claims are also ‘protein claims’ too. These may trigger the need for a percent Daily Value too in the NFP. These are ones that state “__g protein per serving”. You need to check if a disclosure statement is needed.
Whenever you make a nutrient content claim, you have to consider whether you need disclosure statements. When a claim is made on a food that contains more than 13 g total fat, 4 g saturated fat, 60 mg cholesterol, or 480 mg sodium per RACC, per labeled serving, or, for foods with small RACC, per 50 g, a disclosure statement is required as part of claim (i.e., “See nutrition information for ___ content” with the blank filled in with nutrient(s) that exceed the prescribed levels).
The disclosure statement is required on meal products that exceed 26 g total fat, 8 g saturated fat, 120 mg cholesterol, or 960 mg sodium, and on main dish products that exceed 19.5 g total fat, 6 g saturated fat, 90 mg cholesterol, or 720 mg sodium per labeled serving.
Types of Class Action lawsuits
A number of plaintiffs claim that quantitative protein claims are misleading because they overstate the amount of protein in the products due to the use of the incorrect method of calculation. There are some complaints relating to a failure to include the %DV.
The main issue is that two methods are permitted by the FDA for nutrition labeling purposes. One method does not take protein digestibility into account. This is the ‘nitrogen method’. The other method does take protein digestibility into account – the PDCAAS method.
So, what is the correct method needed to generate a quantitative amount of protein for your NFP? This would also be reflected in your protein content claim outside of the NFP.
There are a lot more plant-based products on the market. Generally, plant-based proteins are lower quality proteins and would declare less protein using the PDCAAS method. these plant proteins have a lower digestibility.
One example was Hinkley versus Baker Mills, Inc.; and Kodiak Cakes, LLC Docket No. 2:21-cv-00221-BSJ (D. Utah April 2021). here, 11.5 grams of protein was measured instead of 14 grams of protein declared on the front panel which was 17% less and there was no %DV protein; which was claiming to be protein packed. They also implied that the amount could actually be lower, if the quantitative amount was based on the PDCAAS method of calculating protein.
There was Meraz vs. Purely Elizabath, LLC, Docket No.3:21-cv-04091-LB (N.D. Cal. May 2021). Here, there was 25% less protein than declared in a granola, oats and waffle/pancake mix; no %DV protein.
Then there was Brown vs Nature’s Path Foods Inc., Docket bo. 3:21-cv-05132 (ND Cal. JULY 2021). The Hemp Heart Granola product declared 10g protein per serving plus milk but testing found only 7.87g as prepared with the milk. The plaintiffs took the position that this was misleading as opposed to the granola, which on its own and without the milk, would have even less protein.
On January 11th, 2022, the FDA issued guidance to try and clarify some of these issues with regard to discrepancies and methods used to measure protein and to declare protein values. They stated:-
There are separate methods for determining the number of grams of proteins in a serving for declaration on the Nutrition facts label and for determining the percent Daily Value of protein for the Nutrition Facts label (21 CFR 101.9(c)(7)).
Which method should be used when calculating protein values for use in protein nutrient content claims?
Manufacturers can use either the nitrogen or PDCAAS methods for calculating protein content claims outside of the Nutrition Facts Panel.
Most recently in the case of Nacarino et al., vs. Kashi Co., Docket No. 3:21-cv-07036-VC (ND Cal. 2022) with Judge Chabbria presiding. The nitrogen method was used to calculate the protein without adjusting for protein quality. The plaintiff claimed this rendered the protein claim false and misleading because an incorrect higher protein value was reflected not the digestible protein. The court found that the state law claim was preempted by FDA regulations that allow protein to be calculated using that method:
“given the FDA’s express approval of the nitrogen-content method and failure to require manufacturers to adjust for protein quality when stating the amount of protein in the nutrition label, it does not make sense to read the regulations as barring manufacturers from making identifal statements elsewhere on their packaging.”
This case was dismissed on preemption grounds.
In a similar case, Chong vs. KIND LLC, Docket No.3:21 cv-04528-RS (ND Cal. 2022) [N.D. Northern District of California] presided over by Judge Seeborg. This was the same issue where a quantitative protein claim was based on the nitrogen method not the PDCAAS method.
“because plaintiffs are attempting to use state law to impose labeling requirements that go beyond what the FDA regulations require, their claims are preempted and the motion to dismiss must be granted.” The court also dismissed with prejudice the plantiff’s claims challenging the lack of a %Daily Value, based on preemption. Previously in 2021, Judge Seeborg had denied a motion to dismiss in a similar case, Minor vs. Baker Mills, Inc.
In both cases, the plaintiffs have appealed their dismissals. The opening briefs were due in June 2022.
In summary,
- Consider if protein claims are being made
- If yes, decide whether protein value will be based on nitrogen or PDCAAS method.
- Make sure protein declared in NFP matches protein in claim.
- Include %DV adjusted for protein quality, if necessary.
- For quantitative protein claim ensure amount of protein meaningful (at least 10% of 50g DRV or 5g/serving).
- Consider need for disclosure statement.
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