Legal Insights on Measuring Calories, Functional Food Labeling, and FDA Regulation

In early 2026, a lawsuit filed against David Protein alleges that the company mislead consumers on the amount of fat and calories in their protein bars. Filed on behalf of three consumers, the lawsuit claims that third-party laboratory testing, revealed the calories and fat content of the bars to be much higher than stated on the labels.

In a written response to the lawsuit, David Protein stated it stands behind its labeling, explaining that bomb calorimetry, the method used by the plaintiffs, is inappropriate for ingredients like fat substitute esterified propoxylated glycerol (EPG). The company also added that the Food and Drug Administration (FDA) permits six different calorie calculation methods specifically to account for non-bioavailable ingredients.

For more insight on this case, Nutritional Outlook sat down with Todd Harrison, Co-Chair of the FDA Group at Venable LLP. In the first part of this interview, Harrison discusses the discrepancies in methods of testing, the reach of FDA regulation, and the weight of Generally Recognized as Safe (GRAS) notices.

Continue the conversation with the second part of this interview.

Transcript

Erin McEvoy: Hello everyone, I'm here with Todd Harrison, Co-Chair of Venable LLP’s FDA group, here to explore more on the recent lawsuit involving David Protein bars, the allegations of fat and protein content being much higher than stated on the labels, and the role of the fat substitute ingredient esterified propoxylated glycerol or EPG. Thank you for joining us today, Todd.

Todd Harrison: Thanks for having me.

McEvoy: Pleasure is all mine. So diving right in, a recurring theme in this case is how a reasonable consumer interprets label claims. Considering a typical consumer's understanding of nutrition fact labels, how is the court likely to view the discrepancy between the various FDA-approved calculation methods for measuring total fat and calorie content in the protein bars?

Harrison: I think the way the court is going to look at it is they're going to be concerned that FDA has set out a very specific way of calculating calories, and they're going to see that the bomb calorimetry is probably the gold standard of how you're supposed to do it. So there's a good chance a court would want to say that it is false and misleading. However, I think that's the wrong decision, if it goes down that road. In fact, I think that the court should defer and dismiss the case preemption, that this is an FDA concern because the regulations have failed to stay with the times, that bomb calorimetry is not the appropriate measure here, and the regulations do not reflect the appropriate means of determining calories for these type of products.

McEvoy: So in his response to the lawsuit, David Protein’s CEO states that, “FDA has reviewed multiple GRAS notices over more than a decade that have recognized that EPG contributes only 0.7 kcal per gram—compared with 9 kcal per gram for conventional fats.” How definitive are GRAS notices when it comes to labeling?

Harrison: Unfortunately, GRAS notices don't have—they're just notices. GRAS notices don't have any effect of the law, in fact. GRAS notices are simply what we call “Have a nice life” letters. FDA comes back, they have no objection, we know unless something comes up, we're not going to come back to you. So they're not definitive, unfortunately. The definitive part is the regulations. And in this instance, the regulations have not kept up with the GRAS notices and what we know about these ingredients.

McEvoy: Does a GRAS conclusion on safety automatically translate to a legally defensible value for a nutrition facts panel?

Harrison: Plaintiff attorneys are going to argue no. As a defense attorney, I would argue it should, and I would say that's why the court needs to dismiss this case, and that this should remain in FDA’s jurisdiction. It should be FDA has primary jurisdiction here, and FDA should make this decision and that the case is preempted by FDA. In essence, what we have, there's no private right of action under the Federal Food Drug and Cosmetic Act. And in essence, you, plaintiff, are attempting to enforce the Federal Food, Drug and Cosmetic Act and its regulations, and therefore you're preempted. And if I was a judge, I would dismiss it.