David Protein Bars: How to Avoid Misbranding and Litigation
Are Your Calories Accurate? Labeling Risks Explained
With recent attention on David protein bars, calorie calculations are under a microscope. People are actually looking at labels, doing the math, and asking questions. This is not a recall issue, it is a misbranding issue under the FD&C Act. Your label needs to be truthful and not misleading, and if your calorie count cannot be supported or does not make sense to the consumer, that is where risk starts to build. Even if the calories are technically correct, the consumer can still be misled, and that responsibility falls on the brand.
Why Calorie Accuracy Matters for Label Compliance
Calories matter more right now because consumers are actually paying attention.
People are reading labels, doing the math, and questioning when something does not line up with what they expect. And under the FD&C Act, it is not just about whether your number is technically allowed, it is about whether your label is truthful and not misleading to a reasonable consumer.
Ingredients like allulose or EPG do not contribute calories the way most people expect. So you end up with a product that looks like it should be one calorie number, and it comes in much lower. To a consumer, that can feel like magic, or worse, like something is off.
If the way you are calculating calories is not obvious, and the ingredient story is not clear, that gap creates confusion. And right now, that confusion is turning into scrutiny.
We have not done a great job as an industry explaining that there are multiple ways to calculate calories, or why certain ingredients behave differently. So even when a label is technically compliant, if it does not make sense to the person reading it, it starts to look misleading.
FDA-Approved Methods for Calorie Calculations
One of the biggest misconceptions I see is that there is one “correct” way to calculate calories.
There isn’t.
Under 21 CFR 101.9, FDA allows multiple methods, which is helpful, but also where a lot of confusion comes in because different methods can give you different calorie results for the exact same formula.
And that is exactly why the David protein bar situation is getting so much attention right now.
The method may very well be compliant, but if someone applies a different method, like bomb calorimetry, it can produce a higher number. To a consumer, that looks like something does not add up, even if both approaches are grounded in science.
So now it is not just about whether your numbers are technically correct. It is about whether they make sense, how they are interpreted, and how you explain them if someone questions them.
David likely has a leg to stand on. The method is more than likely compliant, but what matters is how clearly they can explain their methodology and how it does not mislead the consumer. If your numbers are ever challenged, you need to be able to show exactly what you did, why you did it, and how it aligns with FDA regulations.
Have the receipts.
1. The Standard 4-4-9 Calorie Method
Most people are familiar with the general factors:
4 calories per gram of carbohydrate
4 calories per gram of protein
9 calories per gram of fat
It is simple, widely used, and easy to apply, especially for consumers who are tracking calories, but it is based on averages, not exact values, but not every ingredient behaves the same way in the body. Some are not fully digested, some are absorbed differently, and because of that, some contribute fewer calories than those standard factors assume.
That is why a lot of newer products, especially those using alternative sweeteners or fat substitutes, do not rely solely on this method. These ingredients are outliers, and forcing them into a 4-4-9 calculation does not reflect what is actually happening.
2. Using Ingredient-Specific Calorie Factors (Atwater-Based Methods)
FDA allows the use of more specific calorie factors for certain ingredients, which is the most important method for new and novel ingredients.
It’s important to understand how each ingredient contributes to total calories, and that means getting the right data from your suppliers. Typically, that looks like requesting 100 g nutrition for each raw material, then using those values to calculate your finished product based on the actual inclusion levels.
It is more manual, but these calculations will align properly with how the ingredients function in the body.
And again, this is where documentation matters. You need to be able to show your inputs, your calculations, and how you arrived at your final number.
3. Bomb Calorimetry, Laboratory Methods, and Calorie Determination
Larger brands, or dietary supplement companies that are already doing finished product testing, may also use lab analysis to measure calories.
On the surface, this feels like the most accurate option, but this is where people get tripped up.
Bomb calorimetry measures total energy released when a product is burned. It does not measure what the human body actually absorbs, and for labeling purposes, that distinction matters.
Ingredients like allulose, certain sugar alcohols, or fat substitutes like EPG are not fully digested or absorbed. So even though they release energy in a lab setting, they do not contribute that same level of calories in the body. If you rely on bomb calorimetry for a product that uses these types of ingredients, you are likely going to overstate the calorie count.
This is why FDA allows different calculation methods, including adjusted and ingredient-specific factors, to account for these differences.
We need to think about what the consumer actually needs to know.
Calorie labeling is not about total energy, it is about the amount the body can actually process and use. If that is not clear, even a technically compliant label can feel misleading.
And that is what we are seeing play out with David.
So What Can We Do?
We know this is an issue now, so what can we do? Here are some statements you may place on the label to explain a lower than expected calories when using ingredients that are not digested fully.
- Calorie values reflect how ingredients are metabolized, not just their total energy content.
- Some ingredients in this product are not fully digested by the body, which means they contribute fewer calories than traditional ingredients.
- The calorie count reflects metabolizable energy, which may be lower for ingredients that are not fully absorbed by the body.
Final Thoughts on Calorie Labeling Compliance
Calorie calculations are not just math. They are a regulatory decision and a communication decision.
The FDA gives you flexibility, but that flexibility comes with responsibility. Unfortunately, this flexibility is not being relayed to the consumers properly and the consumer questions are turning into lawsuits.
If you want a second set of eyes on your Nutrition Facts panel or your calculation method, reach out. I’m happy to walk through it with you.
Happy labeling,
Lauren
