by Marion Nestle

Currently browsing posts about: Health-claims

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.”

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.

Sep 28 2016

What does “healthy” mean (on food labels)?

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:

Aug 8 2016

Food products with health claims: only marginally better (no surprise)

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.
May 11 2016

Healthy? Natural? It’s up to the FDA.

The terms “healthy” and “natural” help to sell food products.  They are about marketing, not health.

This makes life difficult for the FDA, which has the unenviable job of defining what the terms mean on food labels.

In a victory for the maker of KIND bars, the FDA has just said that the bars can be advertised as healthy—and that the agency will be revisiting its long-standing definition of the term.  This is what that definition says now:

You may use the term “healthy” or related terms as an implied nutrient content claim on the label or in labeling of a food that is useful in creating a diet that is consistent with dietary recommendations if the food meets the conditions for total fat, saturated fat, cholesterol, and other nutrients…In addition, the food must comply with definitions and declaration requirements for any specific NCCs [Nutrient Content Claims].

The chronology :

As reported by Food-Navigator-USA (in a remarkably thorough account of these events),

Dr. Susan Mayne, Director of the Center for Food Safety and Applied Nutrition at the FDA, said: We do not object to the specific statement that you would like to place on your bar wrappers, on the condition that there will be no other nutrition-related statement, such as express or implied nutrient content claims, on the same panel of the label…We agree with you that our regulations concerning nutrient content claims are due for a reevaluation in light of evolving nutrition research.”

What this sounds like is that FDA will be soliciting comments on the meaning of “healthy.”   It also sounds like the FDA agrees that fat is not an appropriate criterion.  But will the FDA set a limit on sugars?  KIND bars are sweetened.

This looks like the FDA will request comments as the start of its interminable rulemaking process.

In the meantime, here’s the Wall Street Journal’s video explanation of the absurdity of the current rules.

Natural

The FDA is further along in that process for “Natural.  The comment period closed and Politico Pro Morning Agriculture reports that more than 5000 came in.  These have not yet been posted, but Morning Ag has some.  It says opinions vary.  Widely.

  • FDA should prohibit using the term.
  • Acceptable post-harvest processing and production methods [including GMOs]
  • No chemicals, no additives, and no kitchen chemistry
  • Some forms of processing can be used – and indeed may be necessary.
  • ‘Natural’ means that this product contains no artificial or synthetic ingredients.

I’ve commented many times in the past on the ongoing debates about “natural.”

I repeat: When it comes to food labels, “healthy” and “natural” are marketing terms.  Their purpose is to sell food products.

Caveat emptor.

Feb 19 2016

Food-Navigator USA’s collection on health & wellness

Health and wellness and terms like natural and organic help food manufacturers sell products.  Food-Navigator-USA.com offers this collection of its articles addressing the question, “What does health & wellness mean to consumers today? We ask what Americans now expect of the food industry, and which innovative firms are best placed to meet their evolving needs.”

  • Mushrooms: The go-to ingredient for 2016?: Mushrooms will feature more prominently in plant- and meat-based dishes in 2016, predicts the Mushroom Council, which says domestic production and value are at an all-time high, while ‘blended’ burgers, meatballs and tacos combining ground meat and chopped mushrooms are gaining significant traction in the foodservice market… Read
  • How ‘progressive consumers’ are redefining health and wellness… and is fat really back?: While cynics observe that biodynamic cane sugar is still sugar, and gourmet Himalayan pink salt is still good old sodium chloride, it’s a fact that trends which might seem to have niche appeal are increasingly heading to the mainstream, and that a small, but increasingly influential group of what Hartman Group calls ‘progressive consumers’ is now redefining food culture. .. Read
  • Marketing Health: Will the healthier option still be the pricier one?: Forget dieting or “cheat days.” Some food industry observers believe the general populace is more concerned for their holistic health, and the CPG industry is taking the hint. By 2020, opening a bag of chips guilt-free doesn’t have to mean splurging more at the “healthy food” part of store shelves… Read
  • C-stores offer growth opportunity for better-for-you brands: Convenience stores, often considered a destination for indulgent, unhealthy snacks, could offer a new growth opportunity for better-for-you brands as the channel’s core audience begins shifting slightly towards more health-conscious shoppers, according to research from the Hudson Institute and Natural Marketing Institute… Read