by Marion Nestle

Currently browsing posts about: Health-claims

Mar 12 2024

FDA allows health claim on yogurts, sugary and not

The FDA Announces Qualified Health Claim for Yogurt and Reduced Risk of Type 2 Diabetes.

FDA intends to consider exercising its enforcement discretion for the following qualified health claims:

“Eating yogurt regularly, at least 2 cups (3 servings) per week, may reduce the risk of type 2 diabetes. FDA has concluded that there is limited information supporting this claim.”

“Eating yogurt regularly, at least 2 cups (3 servings) per week, may reduce the risk of type 2 diabetes according to limited scientific evidence.”

FDA intends to consider exercising enforcement discretion for the above qualified health claims for when all other factors for enforcement discretion identified in Section IV of this letter are met.

All I can do is laugh.  As I told CNN,

Qualified Health Claims are ridiculous on their face.

Why would any sensible person think that all you have to do to prevent type 2 diabetes is eat 2 cups of yogurt a week?…All we can hope is that the yogurt is at least unsweetened, but since it’s really hard to find unsweetened yogurt [in small cups], this is telling people who want to avoid type 2 diabetes that sweetened yogurts are good for them…According to the FDA’s review of the studies, the amount of sugar in the yogurt made no difference to the results…Therefore, according to the FDA, sugar is a non-issue.”

The reason for my amusement?  Limited evidence.  Translation: if you want to believe this, go ahead, but it’s not on the basis of compelling evidence.

Take a look at the Danone petition.  The company asked for—and got—the qualified claim on the basis of observational evidence along with consumption data indicating that Americans currently do not eat much yogurt.

Given this low consumption, such a QHC is important to encourage food companies to increase yogurt in the food supply and inform consumers of current evidence in order to help them make informed choices.

It’s not that the FDA is ignoring the sugar issue despite its allowing the claim no matter how much sugar the yogurt contains.  In its letter of acceptance of Danone’s petition, the FDA said,

we are concerned that the use of a qualified health claim on yogurts that contain a significant amount of added sugars could contribute empty calories to the diet. The Dietary Guidelines for Americans, 2020-2025 recommend limiting added sugars to less than 10 percent of total calories and note that added sugars account on average for almost 270 calories, or more than 13 percent of total calories per day in the U.S. population.

…Consequently, while there is currently no disqualifying level for added sugars, given that Americans are exceeding recommended limits on added sugars, and some yogurts on the market are high in added sugars, FDA encourages careful consideration of whether to use the claim on products that could contribute significant amounts of added sugars to the diet.

Is this a warning to Danone to avoid using the claim on sugary yogurts?  We shall have to wait and see.

In the meantime, Danone is delighted: Danone North America Announces the FDA’s Decision on Their Petition for the First-Ever Qualified Health Claim for Yogurt, Linking This Dairy Aisle Staple to a Reduced Risk of Type 2 Diabetes

In response to efforts led by Danone North America, the new claim states that “eating yogurt regularly, at least 2 cups (3 servings) per week” may reduce the risk of developing type 2 diabetes, a condition 1.4 million Americans are diagnosed with every year.

Qualified Health Claims are about selling food products, not science.

Apr 7 2023

Weekend reading: The FDA on food label dietary guidance statements

Press release: FDA Works to Further Improve Nutrition, Reduce Diet-Related Chronic Disease with Dietary Guidance Statements on Food Labels

The draft guidance provides the agency’s thinking about the use of such statements, including recommendations that products contain a meaningful amount of the food, or category of foods, that is the subject of the statement, and that they also not exceed certain amounts of saturated fat, sodium and added sugars.

Translation: The idea here is to make sure that packages making health claims can back them up, or disclose relevant information.  This will automatically eliminate health claims from lots of products (see post on “healthy”).

The FDA is proposing something like this.

 

Here are the relevant documents:

This is all open for public comment now.  Here’s where to submit comments.

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Mar 15 2023

FDA allows health claim for cocoa flavanols, sort of

Here’s what the FDA is doing these days.

To  my astonishment, the FDA says it will allow a health claim for cocoa flavanols and reduced risk of cardiovascular disease.

OK, it’s a qualified health claim, but still.  The whole thing is absurd.

Qualified health claims are just that; they have to include the qualifier which usually says there’s no or not much research to back up the claim.

The FDA gives several examples of what it will allow.  Here are two:

  • “Cocoa flavanols in high flavanol cocoa powder may reduce the risk of cardiovascular disease, although the FDA has concluded that there is very limited scientific evidence for this claim.”
  • “Very limited scientific evidence suggests that consuming cocoa flavanols in high flavanol cocoa powder, which contains at least 4% of naturally conserved cocoa flavanols, may reduce the risk of cardiovascular disease.”

The FDA also says:

This qualified health claim only applies specifically to cocoa flavanols in high flavanol cocoa powder and foods that contain high flavanol cocoa powder. The claim does not apply to regular cocoa powder, foods containing regular cocoa powder, or other food products made from cacao beans, such as chocolate.

Not that anyone can tell the difference.

This silliness came about because  of a petition from the chocolate company, Barry Callebaut AG in Switzerland.

My surprise was that Callebaut was behind the petition, not Mars.

Mars, after all, has been funding this kind of research for years (see my industry-funded study of the week from March 2022).

I can’t wait to see how Callebaut or Mars will use this claim.  I haven’t seen it anywhere yet.  Let me know if you do.

Feb 15 2023

More on what the FDA is doing about food and nutrition

Last week I did a post on the FDA’s reorganization.   I should have made one other point: the long-standing inadequacy of FDA funding.  For decades, Congress has assigned tasks to the FDA but provided inadequate funding to do those tasks adequately (hence 1% of imported foods are inspected).  Congress also assigns the funding for specific purposes.

Yes, FDA ought to be doing more, but it is not up to the agency to decide how to deploy its funds.

One more point: For long-standing historical reasons, FDA funding comes from congressional Agriculture committees, even though it is an agency of the Public Health Service.  That is one reason why USDA’s food safety programs are funded at so much higher a level than FDA’s.

With that said, the FDA has come out with some recent initiatives of interest.

I.  Front-of-Package labels.  The FDA is proposing to research a front-of-package symbol: “an easy-to-understand, standardized system that is 1) mandatory, 2) nutrient-specific, 3) includes calories, and is 4) interpretive with respect to the levels of added sugars, sodium, and saturated fat per serving.”

It is doing this in response to a petition from the Center for Science in the Public Interest.

The comments that have come in so far are here.

It is examining the use of front-of-pack symbols in other countries.

It also plans to conduct research on consumer understanding of multiple designs.  Here are the prototype packages on which the designs will be tested.

None of these is likely to be as effective as the ones used in other countries.

Here is one of the better options, in my opinion.

To file comments, go here.  It’s important to do this because the Consumer Brand Association (formerly the Grocery Manufacturers Association) and other industry groups are unlikely to accept any labeling scheme that might discourage you from buying a product.

II.  Qualified health claim: cocoa flavanols.  The FDA has approved a qualified health claim for cocoa flavanols and reduced risk of cardiovascular disease.

This was in response to a petition from the Swiss chocolate company, Barry Callebaut.

Here’s what the FDA will allow.  Yes, this is absurd (look at what the FDA has to go through to get to this), but companies must think statements like this will sell their products.

  • “Cocoa flavanols in high flavanol cocoa powder may reduce the risk of cardiovascular disease, although FDA has concluded that there is very limited scientific evidence for this claim.”
  • “Cocoa flavanols in high flavanol cocoa powder may reduce the risk of cardiovascular disease. FDA has concluded that there is very limited scientific evidence for this claim.”
  • “Very limited scientific evidence suggests that consuming cocoa flavanols in high flavanol cocoa powder, which contains at least 4% of naturally conserved cocoa flavanols, may reduce the risk of cardiovascular disease.”
  • “Very limited scientific evidence suggests that consuming cocoa flavanols in high flavanol cocoa powder, which contains at least 4% of naturally conserved cocoa flavanols, may reduce the risk of cardiovascular disease. This product contains at least 4% of naturally conserved cocoa flavanols. See nutrition information for_____ and other nutrients.”

III.  GRAS panels.  The FDA has issued final guidance on best practices for panels deciding which ingredients can be Generally Recognized as Safe.

This lays out the guidelines for

  • Identifying GRAS panel members who have appropriate and balanced expertise.
  • Steps to reduce the risk of bias, or the appearance of bias, that may affect the credibility of the GRAS panel’s report, including assessing potential GRAS panel members for conflict of interest and the appearance of conflict of interest.
  • Limiting the data and information provided to a GRAS panel to publicly available information.

A lot of this is headache-inducing.  FDA rulemaking takes forever.  Can’t wait to see how all this turns out.

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Oct 11 2022

More on FDA’s proposed definition of “healthy”

Last week, STAT News asked if I would write something about the FDA’s definition of “Healthy” for them.  I agreed because I was planning a blog post on it anyway (posted here).

I wrote a draft and had a great time working with a STAT editor, Patrick Skerritt, to fill in some missing pieces.  Here’s how it came out (with a couple of after-the-fact embellishments).

First Opinion: FDA’s plan to define ‘healthy’ for food packaging: Better than the existing labeling anarchy, but do we really need it?   STATNews, Oct. 7, 2022

The FDA has announced the set of rules it proposes to enforce for manufacturers to claim that a food product is “healthy.” The proposed rules are a lot better than the labeling anarchy that currently exists. But here’s my bottom line: health claims are not about health. They are about selling food products.

The FDA says that a “healthy” product must meet two requirements: It must contain a meaningful amount of food, and it must not contain more than certain upper limits for saturated fat, sodium, and added sugars.

To illustrate the “healthy” claim, the FDA is also researching a symbol that food makers can use, and might be testing examples like these.

[Source: https://www.regulations.gov/document/FDA-2021-N-0336-0003]

Doing all this, the FDA says, would align “healthy” with the 2020-2025 Dietary Guidelines for Americans and with the Nutrition Facts label that is printed on food packages.

This action is the latest in the FDA’s attempts to simplify food label information so it’s easier for consumers to identify healthier food choices. It is also an attempt to head off what food companies most definitely do not want: warning labels like those used in ChileBrazil, and several other countries. These have been shown to discourage purchases of ultra-processed “junk” foods, just as they were supposed to, a message understood even by children or adults who cannot read. No wonder food manufacturers will do anything to prevent their use.

If we must have health claims on food packages, the FDA’s proposals are pretty good. They require any product labeled “healthy” to contain some real food (as opposed to a collection of chemical ingredients or, as author Michael Pollan calls them, “food-like objects”), and for the first time they include limits on sugars.

Here’s an example given by the FDA: To qualify for the “healthy” claim, a breakfast cereal serving would need to contain at least three-quarters of an ounce of whole grains and could contain no more than one gram of saturated fat, 230 milligrams of sodium and 2.5 grams of added sugars.

These proposed rules would exclude almost all cereals marketed to children.

But do Americans really need health claims on food products? You might think that any relatively unprocessed food from a plant or animal ought to qualify as healthy without needing FDA approval, and you would be right. But health claims aren’t about health. They are meant to get people to buy food products, not real foods like fruit, vegetables, grains, nuts, meat, poultry, dairy, eggs, or fish.

Food companies love the term “healthy” because it gets people to buy food products.

 

The history of “healthy”

How did we get to where the FDA needs to require a product to contain real food to be considered “healthy”? Blame KIND bars.

In 2015, KIND (then a small private company, but now owned by Mars) advertised its bars as healthy because they contained whole foods like grains and nuts. But nuts have more fat than the FDA allowed at the time for products to be labeled as “healthy.” The FDA warned KIND that its bars violated the rules for health claims.

KIND fought back. It filed a citizens’ petition arguing that even though nuts are higher in fat than the FDA allowed, they are healthy. The FDA could hardly argue otherwise — of course nuts are healthy — and it backed off. It permitted KIND to use the term and said it would revisit its long-standing definition of “healthy.” That was good news for KIND.

At the time, the FDA’s definition of “healthy” set upper limits for fat, saturated fat, sodium, and cholesterol; required at least minimal amounts of one or more vitamins or minerals; and said nothing about sugars. So the new FDA proposals break new ground in simplifying the nutritional criteria and in putting a limit on sugars.

 

Front-of-package symbols

These, too, have a long history with the FDA. In the early 1990s, when the agency was writing the rules for Nutrition Facts labels on food products, it tested public understanding of several prototype designs. As it happened, nobody could understand any of the samples very well, so the FDA picked the one that was the least poorly understood. Soon afterward, food companies and health organizations developed symbols that would allow buyers to recognize at a glance which products were supposed to be good for them.

By 2010, more than 20 such symbols were on food packages. The FDA commissioned the Institute of Medicine to do studies of front-of-package labeling. The Institute’s first report on the subject examined the strengths and weaknesses of all of the symbols cluttering up the labels of processed foods, and recommended that the FDA develop a single symbol that would cover just calories, saturated fat, trans fat, and sodium. Why not sugars too? The Institute said calories took care of them.

But the Institute’s second report did include sugars. It recommended a front-of-package labeling system that would give food products zero, one, two, or three stars (or check marks) depending on how little they had of the undesirable nutrients.

This idea so alarmed food manufacturers that they quickly developed the Facts Up Front labeling system in use today.

This, in my view, is so obfuscating that nobody pays any attention to it. But this scheme, coupled with industry pushback, was all it took to get the FDA to drop the entire idea of a symbol that would tell people what not to eat.

Here we are a decade later with the FDA’s current proposal. This plan is strong enough to exclude huge swaths of supermarket products from self-identifying as “healthy.” Products bearing the “healthy” symbol will have to contain real food and be low in saturated fat, salt, and sugar, as called for by federal dietary guidelines.

The new rules won’t stop “healthy” products from being loaded with additives and artificial sweeteners. And the FDA won’t require warning labels for unhealthy products, which work better than other symbols. But these proposals are a marked improvement over the current situation.

And the FDA might do more. It could look into the idea of warning labels. It already promises to make a decision about the other ambiguous marketing term, “natural.” A decision on that one can’t come soon enough.

As for “healthy,” the FDA is seeking feedback on its proposals. Instructions for filing comments, which can be made until Dec. 28, 2022, are at Food Labeling: Nutrient Content Claims; Definition of Term “Healthy.

I can’t wait to see what companies wanting to sell ultra-processed food products as “healthy” will have to say about this.

Marion Nestle is professor emerita of nutrition, food studies, and public health at New York University, author of the Food Politics blog, and author of the new memoir, “Slow Cooked: An Unexpected Life in Food Politics” (University of California Press, October 2022).

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Dec 8 2021

The FDA plans to define “healthy”

Healthy food? What’s that?

The FDA is working on a definition of “healthy” on food labels.

Blame KIND bars for all this.

The chronology of this saga.

2015: KIND puts the word “Healthy” on the labels of its whole-food bars.  FDA issues warning letter to KIND because its labels do not meet the requirements to make health claims.

2016: FDA reconsiders, says KIND can use “healthy.”   FDA issues request for information and comments on Guidance for Industry: Use of the Term “Healthy” in the Labeling of Human Food Products.

2017: FDA says it will reevaluate use of the term; holds public meeting on how to redefine the term “healthy” as a nutrient content claim.

2018: FDA’s Nutrition Innovation Strategy includes defining the term.

Healthy” is one claim that the FDA believes is ready for change, and we have already signaled our intention to update the criteria for this claim. The Agency is considering how to depict “healthy” on the package so that consumers can easily find it. Similarly, the FDA has also received requests for clarity on the use of “natural” in labeling. Just like other claims made on products regulated by FDA, we believe the “natural” claim must be true and based in science.

2019: The FDA proposes, and OMB approves, focus group review of a “healthy” icon on food packages.

As one of the methods for achieving this step of the Action Plan, the FDA is exploring the development of a graphic symbol to help consumers identify packaged food products that would meet an FDA definition for “healthy.” The symbol would be voluntary, allowing packaged food companies to place it on their products if the products meet the FDA definition of “healthy.”

2021: FDA again sends proposal to redefine “healthy to OMB, and announces further research on developing a ‘healthy” icon.

Nutrient Content Claims, Definition of Term: Healthy: The proposed rule would update the definition for the implied nutrient content claim “healthy,” and would revise the requirements for when the claim “healthy” can be voluntarily used in the labeling of human food products. In a separate but related action, on 7 May 2021 the FDA issued a notice in the Federal Register announcing that it is conducting preliminary quantitative consumer research on symbols that could be used in the future to convey the “healthy” claim on packaged foods.

The FDA has not said what definition it is considering.  I can think of three possible options:

  • Nutrient-based: Below some level of sugar, salt, calories, or whatever
  • Food-based: Must contain a fruit, vegetable, or whole grain
  • Process-based: Must be unprocessed, processed, or minimally processed; cannot be ultra-processed

Anything other than process-based is too easy for food companies to game.

Center for Science in the Public Interest has plenty of concerns.

Allowing some products to carry a ‘healthy’ claim because they contain a minimal amount of a fruit, vegetable, or other recommended food would just make it easier for veggie chips and ‘fruit’ snacks to compete with fresh fruits and vegetables…No matter how FDA defines the term, consumers should realize that manufacturers will mostly be interested in using ‘healthy’ for marketing purposes—to sell you more processed food that you may not need.

The voluntary nature of the “healthy” symbol also raises questions.  If a food label does not use the symbol, how will anyone know if it’s not there because the product does not meet the definition of “healthy” or if its maker just chose not to use the symbol?

On “healthy,” whether word or symbol: stay tuned.

Aug 3 2020

Dubious health claim of the week: cranberries and UTIs

The FDA has just announced a Qualified Health Claim for Certain Cranberry Products and Urinary Tract Infections.

The U.S. Food and Drug Administration announced today in a letter of enforcement discretion that it does not intend to object to the use of certain qualified health claims regarding consuming certain cranberry products and a reduced risk of recurrent urinary tract infection (UTI) in healthy women.

Huh?

The FDA does not exactly approve health claims that are not backed up by scientific evidence.  It just doesn’t object to them.

This one, no surprise, comes in response to a request by Ocean Spray Cranberries, Inc, which would love to be able to market its products as helping to prevent UTIs (which lots of people believe).

Here’s what the FDA says about the science.

After reviewing the petition and other evidence related to the proposed health claim, the FDA determined that the scientific evidence supporting the claim did not meet the “significant scientific agreement” standard required for an authorized health claim.

Hence, the Qualified health claim.

If Ocean Spray wants to use the claim, it has to put atatements like these on the label:

  • For cranberry juice beverages: “Consuming one serving (8 oz) each day of a cranberry juice beverage may help reduce the risk of recurrent urinary tract infection (UTI) in healthy women. FDA has concluded that the scientific evidence supporting this claim is limited and inconsistent.”
  • For cranberry dietary supplements: “Consuming 500 mg each day of cranberry dietary supplement may help reduce the risk of recurrent urinary tract infection (UTI) in healthy women. FDA has concluded that there is limited scientific evidence supporting this claim.”

Why does Ocean Spray want this?  Because believers will ignore the FDA disclaimers.  Ocean spray says:

To that end, Ocean Spray will use its medical attributes in the place they matter most–running a campaign on the WebMD site later this year. “We’re going to be all over WebMD,” he said, noting that the connection between cranberry juice and urinary tract health is the fifth most discussed topic on the influential health site.

Qualified health claims are about marketing, not science.

But I know how you feel.  UTIs are awful.  If all it takes is cranberry juice….

Jul 24 2020

Weekend reading: health claims in food advertising.

Chefs Best has issued a short, handy guide to making health claims in advertising that will stand up to the Federal Trade Commission’s scrutiny.

The guide divides advertising claims into three categories.

How can you tell if your claim is OK?

First, consult with competent legal counsel. The FTC advertising substantiation policy states, “Objective claims
for products represent, explicitly or by implication, that the advertiser has a reasonable basis supporting these
claims”. It goes on to state, a “reasonable basis” means “objective evidence that supports the claim” and “at a
minimum, an advertiser must have the level of evidence that it says it has.” “If the ad is not specific, the FTC looks
at several factors to determine what level of proof is necessary, including what experts in the field think is needed
to support the claim.”

Good luck with that.  The FTC generally goes along with what the FDA says about health claims.

As for those of us who are the target of health claims: it’s best to remember that health claims are about marketing, not health.