Addressing the Regulatory Gaps in Labeling Novel Ingredients

A recently filed class action lawsuit against David Protein has opened up discussions on the regulation of novel ingredients and how they are presented in functional foods. The lawsuit claims that third-party laboratory testing revealed the calories and fat content of the David Protein protein bars to be much higher than stated on the labels. In response to the lawsuit, David Protein argued that the testing method used by the plaintiffs is inappropriate for ingredients like fat substitute esterified propoxylated glycerol (EPG), also noting 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 second part of this interview, Harrison discusses how current nutrition labeling rules lag far behind nutritional science, the benefits of forward-thinking approaches to regulation, and guardrails for marketing claims.

Catch up with the first part of this interview here.

Transcript

Erin McEvoy: So if this case does set a precedent regarding how fat and calorie content must be verified and displayed on a label, what shifts do you anticipate in how the industry handles novel ingredients in functional foods?

Todd Harrison: I think what it really means is that somebody needs to file a Citizen Petition with FDA if they have ingredients that are novel, and we know they act differently in the body. Then we need to have the nutrition labeling regulations evolve. For instance, we know that FDA, with the sugar alcohols – erythritol, I think only there's like zero grams, it has zero calories. But maltitol, mannitol, they have more calories. So we actually need to evolve our regulations and ensure that when we learn that a new ingredient has less calories than what they are declared to be, then we need to ensure regulations are also issued at the same time to take that into account, because that's the only way you're going to be able to deal with this in the future.

In other words, there is a failure on the agency's part to keep up with these regulations. Or one could say maybe it's a failure on the industry's part for not petitioning the agency. But David Protein should not be paying the price for that.

McEvoy: Definitely interesting. So for companies currently developing high protein snacks or supplements, what are some of the top red flags in marketing copy and labeling that you're seeing?

Harrison: Well I think that when you're developing unique proteins or anything like that, you got to make sure what they're delivering – especially branched-chained amino acids, they have calories. So if you have four grams of BCAAs, that's calories. So there's no exception in the regulations not to declare them. But all BCAAs may not be four calories, maybe one BCAA per gram may only have one calorie or two calories, but we need to make those determinations. And I don't think FDA has done that. I think what we have to figure out as we come up with novel contents, novel protein peptides that are GRAS, not ones that are not GRAS, we need to figure out, really, what those calories are, what they're equivalent to, and then make sure that changes are made to the regulations. Or just amend the regulations, specifically say the deal with novel proteins and novel ingredients, and understand that as we develop these ingredients, they may have different caloric values. We're stuck in this idea that everything is a carb, a protein, and a fat. Well, not all dietary fibers are – insoluble dietary fibers have no calories, but soluble fibers actually do have calories. So again, where is that line? And yet the regulations don't really seem to understand all that.

McEvoy: Do you foresee any place where regulations and science will eventually be on par with each other? Or is it always going to be – regulations are always going to be a little bit behind science?

Harrison: I think regulation will always be a lot behind science. And I think that's the difficult part, especially in nutritional science. The only way we're going to do that is if we make the regulations more open ended. One easy fix, I think, is, “or any other validated method of determining the caloric intake.” So if the regulations had just said, “or any other validated method,” that would probably have taken care of the David Protein part, because the method that's been valid, consistently 0.7 calories have been validated over and over and over in all these GRAS notices. So clearly, somebody's come up with these numbers have that have been proved over and over and over. So by small changes in regulations that looks forward rather than backwards.

Again when you make things so structurally and so absolute, you leave doors open, and we shouldn't do that. We have to understand science evolves. Nutrition has really evolved in last 50 years, 60 years. And what we know today about nutritional science is far, far ahead of ourselves than we knew in 1970s. If in 1970s I told you that 80% of chronic diseases was caused by poor diet, you would have laughed at me. What we know today is that 80% of chronic diseases are related to bad nutrition, but yet a whole regulatory and statutory scheme has failed to realize that. So what's important is that we build regulations that have flexibility and not be so monochromatic.