Health Claims on Food Labels (in USA)

Did you know that up until 2003, the FDA (Food and Drug Administration) would make food manufacturers show significant scientific evidence of any health claim they wanted to put onto their product labels?  Yes, I said "up until 2003" because after that, things got stupid and crazy.  Once again we get to see evidence that these manufacturers, those with the "deep pockets", get to play havoc with the public's psyche.

Before 2003, if a food label read "Diets low in sodium may reduce the risk of high blood pressure" we would have known that this couldn't have been published on the label without having enough scientific evidence to back it up - the FDA wouldn't have allowed it. Back then, if there was a claim on something, it came with scientific baggage.

Okay, let's get clear first on what exactly is a "health claim".  According to the FDA, a health claim is: "any claim made on the label or in labeling of a food, including a dietary supplement, that expressly or by implication, including “third party” references, written statements (e.g., a brand name including a term such as “heart”), symbols (e.g., a heart symbol), or vignettes, characterizes the relationship of any substance to a disease or health-related condition. Implied health claims include those statements, symbols, vignettes, or other forms of communication that suggest, within the context in which they are presented, that a relationship exists between the presence or level of a substance in the food and a disease or health-related condition (see 21 CFR 101.14(a)(1)).
Further, health claims are limited to claims about disease risk reduction, and cannot be claims about the diagnosis, cure, mitigation, or treatment of disease. Health claims are required to be reviewed and evaluated by FDA prior to use. An example of an authorized health claim, is: 'Three grams of soluble fiber from oatmeal daily in a diet low in saturated fat and cholesterol may reduce the risk of heart disease. This cereal has 2 grams per serving.'"


Yes, well...it all started with supplements and then the GMA (Grocery Manufacturers Association) decided that they didn't want to be left out in the cold so they challenged the FDA saying that if they didn't get the same treatment that was allotted to the supplements industry in the Pearson ruling that they would also take the FDA to court.  The gist of the argument was that the GMA should be allowed to inform their consumers of possible benefits.  The court ruling read, "Holding only the highest scientific standard for claims interferes with commercial free speech".

In order to accomplish this, while still letting the public know what their stance was on the particular health claim, there was devised a plan...a letter grading policy.  Have you heard about it?  I hadn't until recently because, basically, if I saw a product that read "...has been shown to lower cholesterol", I was assuming it had been scientifically proven and okayed by the FDA.  As far as I can tell, there's no actual letter grade printed on packages but it's the way a claim is worded that's supposed to tell us what the grading is. Uh...what?

Do you know what the grading policy is exactly? Here's an ABC/Health News article from that time that excitedly shares the information and cites a lot of experts that were excited for the change and those that were not. I have to side with the "were not" ones, especially when they said that consumers wouldn't pay attention to the letter grades but just the health claim. Really?  You think??  Let's face it, as human nature goes, we're far too busy to read the nutrition label AND follow up on the health claim grade too, right?

In case you do want to know but only want the highlights, the grading policy goes like this:
Grade A: High: Significant scientific agreement - no disclaimer needed.
Grade B: Moderate: Evidence is supportive but not conclusive - must have this statement after the health claim: "Although there is scientific evidence supporting this claim, the evidence is not conclusive."
Grade C: Low: Evidence is limited & not conclusive - must contain this statement: "Some scientific evidence suggests [enter health claim here]. However, FDA has determined that this evidence is limited and not conclusive."
Grade D: Very low: Little scientific evidence supporting this claim - must have this statement: "Very limited and preliminary scientific research suggests [enter health claim here].  FDA concludes that there is little scientific evidence supporting this claim."

Okay, so I just checked out my box of Kashi Lean cereal and snapped a picture of their health claim:

So it says "25 grams of soy protein a day, as part of a diet low in saturated fat and cholesterol, may reduce the risk of heart disease."  There's none of those other disclaimers on there so we can assume that this health claim has an "A" grade, meaning there's "significant scientific agreement" to their claim! Whew! That's good to know, 'cause I just had some for a snack :-D   I was looking for a different claim but couldn't find any in my pantry - guess that's what I get for buying healthy foods.

Besides these "health claims" on packages, there are other claims that are completely different categories - nutrient claims and structure-function claims.


Nutrient claims are those phrases like "good source of fiber" or "rich in calcium" or "low in sodium" because they single out a particular nutrient to focus on for marketing purposes (of course).  It works though, doesn't it?  If you know that eating more fiber helps you lose weight and lower your risk for heart disease, when you see that tag "good source of fiber" or "high in fiber", you'll be tempted to grab it, won't you? Still, these have to meet FDA definitions, and let me tell you that there are A LOT of definition guidelines for these claims!  Let's take my fiber example - "good source of fiber"...in order to claim that on the package the product must provide between 10% - 19% of the Daily Value for fiber, per serving.   But change the claim to "high in fiber" and then the product needs to be 20% or more of the Daily Value for fiber per serving (this goes for the words "rich in" and "excellent source" interchangeably).  Ya, words - who knew that just changing the words "good source" to "high" would mean a difference in the amounts of a particular nutrient?  Oh, and just so you know, the words "fat-free" aren't 100% true -- something can say that it's "fat-free" and still contain up to .5grams of fat per serving...eat 5 servings and that's 2.5 grams of fat...not that it's all that much, but fat is fat, is fat... If you want more information on the wordings and what you're really getting, you can go to the FDA labeling website by clicking here.

Structure-function claims are the most unusual of the lot - hold on to your hats for this one -- they can be made WITHOUT any FDA approval!  These claims can be made WITHOUT any proof - none, zip, nada!   The only requirement is that the claim cannot mention a disease.  Look at the following statements:
A) "May reduce the risk of heart disease."
B) "Promotes a healthy heart."
Statement (A) is definitely a health claim whereas statement (B) is a structure-function claim - can you tell the difference?  If you saw statement (B) on a box of cereal, would your thought be "This might prevent me from having a heart attack - I think I'll buy it"?  Or would it be "Huh, there's no actual health claim here maybe I should look for a cereal that does have an actual heart disease prevention health claim"?  Honestly, consumers don't usually know that there's a difference.  I sure as heck didn't know.  Here's the link to the FDA's information on structure-function claims if you want more information.

So, now that I've shared all of this information with you, what are you going to do with it?  I hope you share it with those who are close to you.  There's more to reading labels than just reading the nutrition panel and, as much as I hate to think about it this way, there are big, money-making food manufacturers out there to make even more money and to trick you into buying their products by using the laws to their advantage.  Make an effort to beat them at their game by getting educated on what it is you're putting into your body because food, whether you want to think of it that way or not, is a chemical - and there are bad chemicals and there are good chemicals (there are some that are the Switzerland of chemicals but that's another story) so fuel your body with "premium unleaded" food instead of "regular" almost-food products.



Hahaha!  Here's MY disclaimer now:
All information on this blog is my own pursuit of information on the road to getting my BS in Nutrition Science and as a mode of studying.  Most information and data was taken from my textbook "Understanding Normal and Clinical Nutrition" by Rolfes, Pinna, & Whitney, ISBN-13: 978-0-495-55646-6

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