by Marion Nestle

Currently browsing posts about: Health-claims

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.

Apr 3 2018

FDA says public health matters, promises to consider nutrition issues

Last week, FDA Commissioner Scott Gottlieb spoke at the National Food Policy Conference in Washington, DC where he announced FDA’s Nutrition Innovation Strategy.

His speech, Reducing the Burden of Chronic Disease, specifies five areas that FDA intends to consider (meaning, at best, proposing suggestions for public comment and going through FDA’s interminable rulemaking process):

  • Modernizing health claims
  • Modernizing ingredient labels
  • Modernizing standards of identity
  • Implementing the Nutrition Facts Label and Menu Labeling
  • Reducing sodium

The documents:

My immediate reactions: sounds good, but short on commitment.

I was impressed that Gottlieb focused on public health and prevention:

We can’t lose site of the public health basics – better diet, more exercise, and smoking prevention and cessation…The public health gains of such efforts would almost certainly dwarf any single medical innovation or intervention we could discover.

Yes!

I was particularly interested in two initiatives under consideration:

Front-of-package icon for “healthy”

This is to be based on a food-based definition that focuses on the healthful attributes of a food product—not, apparently, on its content of sugar, salt, or saturated fat.  Only healthful attributes?

This sounds like a highly pro-industry position, since research on front-of-package labeling is pretty clear that warning labels about unhealthful attributes (salt, sugar, saturated fat) are most effective in discouraging purchases of “ultraprocessed” foods.  The warning labels used in Chile, for example, are proving to be highly effective.

Gottlieb did not mention the the FDA-sponsored reports on front-of-package labeling performed by the Institute of Medicine early on in the Obama administration.  Those were serious attempts to develop an effective front-of-package labeling system that identified nutrients to be avoided.  The FDA seems to have forgotten about those reports.

Reduce sodium

This is the item that got the most attention.  Gottlieb said: “There remains no single more effective public health action related to nutrition than the reduction of sodium in the diet.”

OK, but if that’s true, how about ensuring that food companies gradually reduce sodium in their products, as was done in the UK.  No such luck.  Instead: “I’m committed to advancing the short‐term voluntary sodium targets” (my emphasis).

I suppose “voluntary” could work, but if sodium reduction isn’t across the board, companies will have little incentive to risk changing their formulas.

In short, Gottlieb’s words reflect modern public health thinking the good news) and it’s great that FDA is considering taking these actions (also good news).  Now, let’s see what the agency actually does.

 

Aug 7 2017

FDA allows Macadamia Nuts health claim: will they use this?

Since I don’t want to be accused of making things up, I herewith reprint the FDA notice in its entirety.

FDA Completes Review of Qualified Health Claim Petition for Macadamia Nuts and the Risk of Coronary Heart Disease

July 24, 2017

After conducting a systematic review of the available scientific data, the U.S. Food and Drug Administration now intends to exercise enforcement discretion over the use of a qualified health claim characterizing the relationship between consumption of macadamia nuts and reduced risk of coronary heart disease. The claim, which manufacturers can use immediately, reads:

“Supportive but not conclusive research shows that eating 1.5 ounces per day of macadamia nuts, as part of a diet low in saturated fat and cholesterol and not resulting in increased intake of saturated fat or calories may reduce the risk of coronary heart disease. See nutrition information for fat [and calorie] content.”

The qualified health claim was in response to a petition filed by Royal Hawaiian Macadamia Nut, Inc. Qualified health claims are supported by scientific evidence, but do not meet the more rigorous “significant scientific agreement” standard required for an authorized FDA health claim. As such, they must be accompanied by a disclaimer or other qualifying language so that the level of scientific evidence supporting the claim is accurately communicated.

For More Information

For the record, I love macadamia nuts.  Will this sell them?  Can’t wait to see.