Currently browsing posts about: Health-claims

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 claims:  The 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)].

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.

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

• And now the food lawsuits… General Mills sued over glyphosate residue post Monsanto $289m verdict: Monsanto has just been ordered to pay $289m in damages to a man who alleged its glyphosate-based herbicide caused his cancer (a ruling it is appealing). But what, if anything, does this verdict mean for food companies manufacturing products containing trace levels of glyphosate?.. Read
• Nestlé USA lawsuit highlights confusion over Non-GMO claims, say attorneys: A lawsuit alleging that Nestlé USA is misleading shoppers with its ‘No GMO Ingredients’ seal is unlikely to make much progress, predict legal experts, but it does highlight the confusion surrounding Non-GMO claims given that the standards underpinning them can differ from one product to another… Read
• The Non-GMO Project may emerge as the big winner from federal GMO labeling legislation: The Non-GMO Project will “only become more relevant” as mandatory GMO labeling kicks in, in part because its scope could be so narrow that consumers will not simply be able to assume that anything without a bioengineered label is automatically Non-GMO, says executive director Megan Westgate… Read

Warnings about chemicals in foods

• ‘Significant increase’ in Prop 65 notices over lead, acrylamide, and cadmium in 2017/18, says Perkins Coie: There has been a significant increase in food and beverage Prop 65 actions in the past five years, with particularly strong growth in notices relating to lead, acrylamide and cadmium, according to new data compiled by attorneys at Perkins Coie… Read
• Amended Prop 65 regulations likely to prompt a significant uptick in litigation, predict attorneys: Amendments to Prop 65 – which requires firms selling products in California to provide warnings if their products expose consumers to 900+ chemicals linked to cancer or reproductive toxicity – will likely trigger a sharp rise in litigation as manufacturers struggle to get to grips with the new rules, predict attorneys… Read

Compliance with labeling and health claims requirements

• RXBAR sued over minimalist labels, ingredients declaration; but case is a stretch, say legal experts: ‘We tell you what’s on the inside on the outside’ protein bar brand RXBAR has been hit with a proposed class action lawsuit* by the same law firms challenging the minimalist ingredients declarations of fellow bar brand That’s It.**.. Read
• Halo Top routinely under-fills its pints, alleges lawsuit, ‘dramatically so, at times…’: A month after being hit with a lawsuit alleging it made false and misleading representations about its light ice cream, Halo Top has been targeted again, this time with a proposed class action alleging it routinely under-fills its pints, “and has been doing this for years.”.. Read
• ‘No reliable scientific evidence’ supports Trader Joe’s alkaline water claims, alleges lawsuit: “There is no greater benefit to ingesting Trader Joe’s alkaline water than ingesting an equivalent bottled water or tap water,” argues a lawsuit alleging Trader Joe’s is duping shoppers into paying over the odds for the water, although legal experts predict that proving Trader Joe’s is making false implied health benefit claims will be “close to impossible.”.. Read
• Plant-based ‘milk’ row heats up as FDA commissioner says ‘public health concerns’ inform the agency’s renewed interest in dairy standards of identity: The war of words over labeling conventions for plant-based ‘milk’ intensified this week as FDA commissioner Dr Scott Gottlieb indicated that a “a new compliance policy” may be on the cards as the agency hosted a public meeting on its nutrition innovation strategy… Read
• Do consumers expect kombucha to contain live organisms? Court gives green light to lawsuit: Do consumers expect products labeled as ‘kombucha’ to contain live organisms, even if they don’t make any claims to this effect? Maybe, according to a court filing in a case that could have broader ramifications for the burgeoning category going forward, say attorneys… Read
• How much sugar do consumers expect in a ‘lightly sweetened’ cereal? Judge certifies classes in Kellogg added sugar case:  If up to 40% of the calories in breakfast cereals are from added sugar, and brands describe them as ‘lightly sweetened,’ are they misleading shoppers? Perhaps, says a federal judge who has just certified three classes of consumers in a false advertising lawsuit vs Kellogg, which is now heading into mediation… Read
• Tofurky CEO: It’s not the role of lawmakers to choose winners or losers in any given industry: As long as protein products are safe and shoppers are not being misled, it’s not the role of lawmakers to write new labeling laws favoring one production method over another, says the CEO of plant-based meat brand Tofurky, which is challenging a Missouri law* limiting the term ‘meat’ to slaughtered livestock or poultry… Read
• Clif Bar fires back at ‘absurd’ lawsuit: Consumers expect energy bars to contain sugar: Clif Bar has hit back at allegations made in a recent lawsuit* that it is duping consumers by presenting bars that are “loaded with sugar” as wholesome and nutritious, and urged the judge to toss the “absurd” and “implausible” case… Read

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

• LaCroix ingredients: Lawsuit alleges “all natural” claim is false: LaCroix 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

• Article about the five most active lawsuits

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.

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:

• Commissioner Speech: https://www.fda.gov/NewsEvents/Speeches/ucm603057.htm
• FDA Nutrition Innovation Strategy: https://www.fda.gov/Food/LabelingNutrition/ucm602651.htm

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.

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

• FDA Response to Petition for a Qualified Health Claim for Macadamia Nuts and Reduced Risk of Coronary Heart Disease
• Questions and Answers: Qualified Health Claims in Food Labeling
• Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health Claims
• Qualified Health Claims: Letters of Enforcement Discretion

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

As it promised in response to a petition from the KIND fruit-and-nut bar company (as I discussed in a previous post), the FDA is now asking for public comment on what “healthy” means on food package labels.

You might think that any food minimally processed from the plant, tree, animal, bird, or fish would qualify.

But “healthy” is a marketing term for processed food products (not foods).  

As Politico Morning Agriculture reminds us, things got complicated when KIND, which makes products from whole nuts, said its bars deserved to be called “healthy.”

In 2015, KIND received a warning letter from FDA arguing the company violated federal rules by using “healthy” on its packages. KIND then petitioned the agency, and, after an exchange about why the current definition is outdated, FDA decided to reverse course. For example, it requires that a food be low-fat to be labeled “healthy,” a standard that a nut-based bar doesn’t meet, while products like fat-free puddings do.

The FDA’s rules now say:

The term “healthy” and related terms (“health,” “healthful,” “healthfully,” “healthfulness,” “healthier,” “healthiest,” “healthily” and “healthiness”) may be used if the food meets the following requirements: 21 CFR 101.65(d)(2)

OK.  I know you can’t read this (you can look for it here). The point is that to qualify as “healthy,” a product has to be low in fat, saturated fat, and cholesterol; relatively low in sodium; and contain at least 10% of the Daily Value per serving for vitamins A or C, calcium, iron, protein, or fiber (with some exceptions).  There are also rules for levels of nutrients added in fortification.

The FDA wants input on whether all of this makes sense in the light of the 2015 Dietary Guidelines and the KIND petition.

In its inimitable FDA-speak:

While FDA is considering how to redefine the term “healthy” as a nutrient content claim, food manufacturers can continue to use the term “healthy” on foods that meet the current regulatory definition. FDA is also issuing a guidance document stating that FDA does not intend to enforce the regulatory requirements for products that use the term if certain criteria described in the guidance document are met.

If I correctly understand the meaning of “does not intend to enforce the regulatory requirements,” the FDA, while waiting for your comments, will allow manufacturers to call products “healthy” as long as the products:

(1) Predominantly contain mono and polyunsaturated fats regardless of total fat content; or

(2) Contain at least ten percent of the Daily Value (DV) per serving of potassium or vitamin D.

In other words, if your food product is made with a low saturated fat oil and contains potassium or vitamin D, it is by definition “healthy.”

Correction, September 29: An FDA official wrote to say that I didn’t quite get this right.  

Actually, if a food exceeds the low fat requirement currently in our definition, we will not take any enforcement or compliance action as long as the food meets all of the other requirements in the definition, namely that it is low in saturated fat, cannot exceed the specified levels of cholesterol and sodium, and contains at least 10 percent of the daily value for beneficial nutrients.  

Second, we are not saying that foods must contain potassium or vitamin D to be labeled as “healthy.”  We are simply indicating that potassium and vitamin D can be substituted for the beneficial nutrients now listed in the current regulations, in line with the new Nutrition Facts label regulations.

My apologies to the FDA for misunderstanding the notice.

The FDA’s request is good news for KIND bars.

But it smacks of “nutritionism”—the use of these two single nutrients (as well as others on the short list of beneficial nutrients) as indicators of quality in processed food products (and don’t get me started on vitamin D, which is a hormone, not a vitamin, and best obtained by getting outside in the sun once in a while).

Understand: this effort is not about semantics; it is about marketing.

Would you like to weigh in on what you think qualifies a food as “healthy?”  Here’s how:

• Federal Register Notice for the Guidance for Industry 
• Federal Register Notice for the Request for Information
• Guidance for Industry: Use of the Term “Healthy” in the Labeling of Human Food Products
• Blog: Making Sure ‘Healthy’ Means What It Says on Food Packages
• “Healthy” on Food Labeling 

A recent study did something useful.  It examined the nutritional quality of more than 2000 foods with or without health-related claims.

As compared with food products without health claims, foods with health claims had, on average, per serving:

• 29 fewer calories
• 3 grams less sugar
• 2 grams less saturated fat
• 842 mg less sodium
• 0.8 grams more fiber

The authors conclude:

Foods carrying health-related claims have marginally better nutrition profiles than those that do not carry claims…It is unclear whether these relatively small differences have significant impacts on health.

Unclear?  Most of these are barely measurable.  Only the sodium reduction might help.

This study confirms the following:

• Health claims on food packages are not about health; they are about marketing.
• Just because a food product is slightly better for you does not necessarily mean that it is a good choice.