by Marion Nestle

Currently browsing posts about: Health-claims

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.

Apr 16 2020

Watch out for Coronavirus frauds and unproven promises

Frauds and fraudulent information are so prevalent that the FDA says what it’s doing about them on its Coronavirus web page.

My email inbox is deluged with marketers claiming that their products boost immune systems in general, and protect against Coronavirus in particular.  Often, they cite evidence but this is highly selective and sometimes based on studies paid for by their sponsors.

The bottom line on keeping immune systems healthy?  Eat a healthful diet, don’t gain excess weight, and get plenty of physical activity.  OK, good luck doing that while you are under lockdown, but you can give it a good try.

Here are some of the items that have ended up in my inbox.

Despite FDA pronouncements, industry coalition action, the coronavirus claims warning letters keep coming:  The US Food and Drug Administration has issued an additional six warning letters in recent days on coronavirus claims. The letters coincide with an industry coalition raising a red flag on the growing flood of such claims on dietary supplement-type products….Read more

Unproven COVID-19 health claims: China’s crackdown on ads for oral sprays, probiotics and anti-hangover tea: The Chinese authorities have named and shamed a string of fake advertisement, mostly surrounding unproven COVID-19 health claims.

Consumers warned of sports nutrition products making coronavirus claimsThe European Specialist Sports Nutrition Alliance (ESSNA) has warned consumers of the increase in companies and individuals making unfounded claims in light of the current coronavirus situation….Read more

Cocoa and the coronavirus: can it boost the immune system?  Cacao beans have been consumed by humans for over 3,000 years and the ingredient is well-known for its wide range of health benefits, recent research suggests it can provide stronger protection against influenza virus infection…. Watch now [but watch critically.  If you even give this a moment’s thought….]

 

CRN UK highlights why essential nutrients have never been more essential:  The ongoing threat of coronavirus could increase the potential for deficiencies in key micronutrients supporting the immune system, according to The Council for Responsible Nutrition UK (CRN UK). Read more  [How about eating a healthy diet and getting plenty of exercise?].

Could vitamin D play a role in coronavirus resistance? Research thinks so:  Vitamin D supplements may aid in the resistance of respiratory infections such as the coronavirus or limit the severity of the illness in those infected, according to researchers. Read more.  [And what kind of research are we talking about here?  Some of it is industry-funded, as this example demonstrates (thanks to Claudia Santos for sending)].

Jun 25 2019

FDA approves qualified health claim for omega-3s

I love the FDA’s qualified health claims for food products because they are so patently ridiculous.

These are health claims so poorly supported by science that the FDA insists on a disclaimer.

What’s their point?  Companies can use them for marketing and put the disclaimer in tiny print.

The latest is the FDA’s response to a petition from the Global Organization for EPA and DHA Omega-3s, which asked the FDA to approve these health claims:

  • EPA and DHA help lower blood pressure in the general population.
  • EPA and DHA reduce BP, a risk factor for CHD (coronary heart disease).
  • EPA and DHA reduce the risk of CHD.
  • Research shows that EPA and DHA may be beneficial for moderating BP, a risk factor for CHD.
  • Convincing scientific evidence indicates that EPA and DHA help lower blood pressure in the general population, with comparable reductions to those achieved with other diet and lifestyle interventions.

Not a chance.

The FDA did its own review of the literature and quite sensibly concluded that evidence supporting such claims is too weak to take seriously.

Instead, the FDA said that

In light of the above considerations, FDA intends to consider the exercise of its enforcement discretion for the following qualified health claims [with my emphasis in red]:

  • Consuming EPA and DHA combined may help lower blood pressure in the general population and reduce the risk of hypertension. However, FDA has concluded that the evidence is inconsistent and inconclusive. One serving of [name of the food or dietary supplement] provides [ ] gram(s) of EPA and DHA.
  • Consuming EPA and DHA combined may reduce blood pressure and reduce the risk of hypertension, a risk factor for CHD (coronary heart disease). However, FDA has concluded that the evidence is inconsistent and inconclusive. One serving of [name of the food or dietary supplement] provides [ ] gram(s) of EPA and DHA.
  • Consuming EPA and DHA combined may reduce the risk of CHD (coronary heart disease) by lowering blood pressure. However, FDA has concluded that the evidence is inconsistent and inconclusive. One serving of [name of the food or dietary supplement] provides [ ] gram(s) of EPA and DHA.
  • Consuming EPA and DHA combined may reduce the risk of CHD (coronary heart disease) by reducing the risk of hypertension. However, FDA has concluded that the evidence is inconsistent and inconclusive. One serving of [name of the food or dietary supplement] provides [ ] gram(s) of EPA and DHA.
  • Research shows that consuming EPA and DHA combined may be beneficial for moderating blood pressure, a risk factor for CHD (coronary heart disease). However, FDA has concluded that the evidence is inconsistent and inconclusive. One serving of [name of the food or dietary supplement] provides [ ] gram(s) of EPA and DHA.

In order to use these claims, the products would have to contain at least 0.8 g EPA and DHA (combined total).

Absurd as all this may seem, the approval of qualified claims is considered a win for the omega 3 industry.

Why does the FDA allow such claims?  Because Congress said it had to permit claims even if evidence was insufficient to back them up [but see below].

Sigh.

Correction: A Twitter correspondent, Ilene Heller (@foodcop819), reminds me that the courts, not Congress, forced the FDA to allow qualified health claims on First Amendment grounds.  In 1990, Congress forced the FDA to allow health claims in general as part of the nutrition labeling act.  In 1994, Congress passed the dietary supplement act that essentially deregulated these products and allowed “structure/function” claims for them.  Food companies wanted to use them too.  Whenever the FDA objected that science didn’t support the claims, supplement companies took the FDA to court.  In 2003, the FDA gave up: We have lost 8 of 10 First Amendment decisions, and doing business the way we were doing it was unsustainable” (New York Times, July 6, 2003).  The so-called qualified health claims are the absurd result.

Oct 18 2018

Who is suing whom? Food politics lawsuits

FoodNavigator-USA has collected its recent articles on food industry lawsuits.  As it puts it,

There have been hundreds of class action lawsuits directed against food and beverage companies in the past five years, spanning everything from added sugar, ‘natural’ and ‘healthy’ claims, to glyphosate residues, and alkaline water claims. We take a look at some high profile cases, some emerging hot topics from Non GMO claims to a new wave of kombucha lawsuits, and what’s coming up from the FDA, from plant-based ‘milk’ labeling guidance to a fresh look at ‘healthy’ and ‘natural’ labeling.

I’ve organized these into categories.

GMOs

Warnings about chemicals in foods

Compliance with labeling and health claims requirements

And here’s a more recent one from CBS News:

  • LaCroix ingredients: Lawsuit alleges “all natural” claim is falseLaCroix sparkling water is facing a lawsuit alleging its claims of “all natural” and “100 percent natural” are misleading because…”Testing reveals that LaCroix contains a number of artificial ingredients, including linalool, which is used in cockroach insecticide.”

And here’s one more from CSPI (an October 24 addition):

  • CSPI sues Jamba Juice: its juices, CSPI charges, are made from cheap concentrates as well as fresh fruit.

Addition, December 11

May 16 2018

Should organic eggs be labeled “healthy?” Their producers think so.

You have to have some sympathy for egg producers.  Egg consumption has been declining for years.

Egg producers blame the decline on cholesterol concerns; eggs are by far the largest dietary source of cholesterol.

Now Pete and Gerry’s Organic Eggs is petitioning the FDA to forget about cholesterol and update its definition of “healthy” so the company can advertise its eggs as “healthy.”

FDA Commissioner Scott Gottlieb said in a speech last month that the FDA would be updating the definition.

I, of course, think “healthy” is a slippery slope best avoided, and that Congress never should have allowed health claims on foods in the first place.,

But too late for that.

I don’t envy the FDA’s challenge here.  The petition is based on the dietary guidelines, but what the guidelines say about dietary cholesterol, and therefore eggs, is extremely confusing.

As I explained in a previous post, the guidelines no longer recommend a cap on dietary cholesterol of 300 mg/day (the equivalent of 1.5 eggs), but do say that people should eat as little cholesterol as possible.

Good luck on this one.