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It’s pretty depressing to watch what’s happening to the gains in food and nutrition policy so hard won in the last few years.

Nothing but bad news:

Menu labeling:  The FDA is submitting interim final rules, a tactic to delay implementation of menu labeling, which was supposed to start on May 5.  Why?  The National Association of Convenience Stores and the National Grocers Association filed a petition asking for the delay.   Pizza sellers have been lobbying like mad to avoid having to post calories.

Food labels (calories, added sugars): As the Washington Post puts it, the food industry is counting on the current administration to back off on anything that might help us all make better food choices.  At least 17 food industry groups have asked for a delay in the compliance date for new food labels—for three years.  Why?  They are a burden to industry.  The soon-to-be FDA Commissioner, Scott Gottlieb, said this about food labels:

As a general matter, I support providing clear, accurate, and understandable information to American consumers to help inform healthy dietary choices,” Gottlieb wrote, according to documents obtained by The Washington Post. “ … However, I am mindful of the unique challenges that developing and communicating such information can pose, particularly on small, independent businesses.”

Definition of dietary fiber: The American Bakers Association wants the FDA to take back its new, stricter definition of dietary fiber, (it excludes synthetic fiber) due to go into effect in July 2018.

School meals: The USDA says it is about to announce new school meal “flexibility” (translation: rollback of nutrition standards).

The score: Big business 4, public health 0

Happy May Day.

For further reading:

• Vox’s Julia Belluz reviews these issues, but also comments on Michelle Obama’s enduring legacy.
• Politico summarizes USDA’s proposed actions.

Addition: It gets worse.  Politico reports that the congressional spending bill:

Contains a rider blocking funds from being used to work on “any regulations applicable to food manufacturers for population-wide sodium reduction actions or to develop, issue, promote or advance final guidance applicable to food manufacturers for long term population-wide sodium reduction actions until the date on which a dietary reference intake report with respect to sodium is completed.”

Politico also points out that the previous draft of the appropriation bill merely encouraged FDA to delay its salt reduction proposal until the reference intake report is updated (this, by the way, will take years).

More documents:

• USDA’ proclamation on school meals
• CSPI’s press release
• Background: the letter from Senator Pat Roberts (R-KS) requesting these changes
• The FY2017 omnibus spending bill that includes the school lunch changes
• RWJ Foundation’s statement

Rolling back nutrition standards #1: Added Sugars

The new administration is hard at work undoing the gains of the last one.

In my post on the nominee for FDA Commissioner, Scott Gottlieb, I noted that he’d been saying nothing about food.  Now he is.

He told Congress this week that he’s open to “pushing back the Nutrition Facts label update deadline [of July 2018] to align it with USDA’s coming GMO labeling regulation.”

The Center for Science in the Public Interest (CSPI) has plenty say about this.  As it explains, the food industry wants the

deadline to be pushed back to align with the USDA’s coming GMO disclosure regulation — a measure that isn’t likely to kick in for a few years (at least)… Gottlieb suggested during the hearing that he may be open to aligning the deadlines…You want to try to consolidate the label changes when you’re making label changes as a matter of public health, he said, adding that requiring companies to update their labels repeatedly is costly.

But wait!  Doesn’t this sound just like what food company leaders said in March in a letter to HHS Secretary Tom Price?

On behalf of the food and beverage industry, we are writing to express our concern with the current compliance deadline of July 2018 for the Nutrition Facts and Serving Size (NFL) rules and to request extending the deadline to May 2021.

May 2021?  Let’s hope we all live that long.

Reminder: Everyone would be healthier eating less sugar.

Rolling back nutrition standards #2: School food

According to Politico, Senate Agriculture Chairman Pat Roberts wants the USDA to undo the school meal nutrition standards put in place by the Obama administration.  In a letter to the USDA Acting Deputy Secretary, Roberts said:

I urge you to act administratively and provide immediate relief from certain egregious aspects of the standards, particularly in regards to the rapidly approaching sodium limits and the dairy and whole grain requirements,..After providing immediate relief, I urge you to provide long-term flexibility and certainty for our schools, our food service directors, and other stakeholders.

Reminder: the school nutrition standards are working just fine.

I just received this invitation:

Save The Date

FDA invites our Constituent Update subscribers to Save the Date for the

FDA Public Meeting on the Use of the Term “Healthy” in the Labeling of Human Food

Thursday, March 9, 2017 (8:30 AM‐5:30 PM)

Hilton Washington DC/Rockville Hotel

 1750 Rockville Pike

Rockville, Maryland 20852

This refers to FDA’s “public process to redefine the healthy” nutrient content claim for food labeling.”

This involved opening its proposals up for public comment, extending the comment period until April 26 this year., and holding this public meeting “to facilitate further dialogue on this topic.”

This all came about as a result of the KIND company’s petition to FDA to advertise its nut-grain-and chocolate bars as “healthy,” even though the nuts and chocolate have more fat than is allowed in the FDA’s current definition.  The FDA agreed that KIND could use the term.

The irony is that this enormous effort applies to processed food products.  OK, some are more processed than others, but eating whole, relatively unprocessed foods is what’s really healthy.

This is about how food companies can market products.  It is not about health.

FDA has produced these documents:

• Guidance for Industry: Use of the Term “Healthy” in the Labeling of Human Food Products
• Constituent Update: FDA to Redefine “Healthy” Claim for Food Labeling

Last week I posted this about Canada’s new food label:

• A Canadian study shows that two-thirds of packaged foods sold in Canada have added sugar.
• Canada’s new food label is causing a fuss over the sugar listing because it (a) does not distinguish between intrinsic and added sugars, and (b) sets 100 grams per day as the standard amount.  Looks like the Canadian sugar lobby won this one.

I received a note from a reader who sent an article from the Canada Gazette giving some of the background for these decisions.

The government did a cost-benefit analysis of the then-proposed label:

Costs were estimated based on the inclusion of all regulatory options that were presented during consultations (i.e. the U.S. approach for added sugar, mandatory inclusion of vitamin D in the NFt). Stakeholders indicated that the cost would be a maximum of $727.1 million and with the removal of outliers, $598 million. However, the decision to use a Daily Value approach for sugars instead of added sugars would significantly lower these costs…The coming-into-force period of 5 years was chosen to minimize the cost of implementing the proposed amendments.

How did the Daily Value get to be 100 grams per day, twice the U.S. Daily Value of 50 grams?  All it says is:

A DV of 100 g is being proposed for sugar, and the declaration of the % DV for sugar in the NFt would be mandated for all foods.

Food industry politics in action!

Just in the nick of time, the FDA has released rules on labeling added sugars.  and re-adjusting serving sizes, documents aimed at helping food manufacturers prepare for the sweeping update to Nutrition Facts labels set for 2018.

The FDA also released draft guidance for complying with the rules.  Here is one example from this Q and A:

7. How should I calculate the amount of added sugars in a fruit juice blend containing the juices of multiple fruits that have not been reconstituted to 100 percent (full-strength)?

If the juice blend is reconstituted such that the sugar concentration is less than what would be expected in the same amount of the same type of single strength juice (e.g., less than 100% juice), the added sugar declaration would be zero. If the juice blend is reconstituted such that the sugar concentration is greater than what would be expected in the same amount of the same type of single strength juice, the amount of sugar that is in excess of what would be expected in the same amount of the same type of single strength juice must be declared as added sugars on the label.

A separate draft guidance explains changes in serving sizes that also go into effect.

When does all this happen?  The rules became final in May but they do not have to be implemented until July 26, 2018.  Businesses with annual food sales below $10 million get an additional year to comply.

The elephant in the room?  Will the new administration step in and repeal the whole thing?

The relevant documents

• Draft Guidance for Industry: Questions and Answers on the Nutrition and Supplement Facts Labels Related to the Compliance Date, Added Sugars, and Declaration of Quantitative Amounts of Vitamins and Minerals
• Federal Register Notice for the Draft Guidance on Questions and Answers
• Draft Guidance for Industry: Reference Amounts Customarily Consumed: List of Products for Each Product Category
• Federal Register Notice for the Draft Guidance on Reference Amounts
• Changes to the Nutrition Facts Label

This is one of FoodNavigator-USA’s special edition collections of articles on similar themes, in this case food labeling and lawsuits over labeling issues.  These are a quick way to get up to speed on what’s happening from a food industry perspective .  FoodNavigator introduces this collection:

Food and beverage companies have faced a tsunami of false advertising lawsuits over the past five years. But how big of an issue is this for the industry, who has been targeted, and what strategies are working, both for plaintiffs and defendants in these cases? In this special edition, we also look into labeling issues and trends, from healthy, Paleo and grass-fed claims to NuTek’s potassium salt petition.

• FOOD LITIGATION 101: Are you up to speed?  There have been hundreds of class action lawsuits directed against food and beverage companies in recent years over everything from evaporated cane juice to Non-GMO claims. But has the false advertising litigation trend peaked, and if not, what are the new areas of vulnerability for food companies? .. Read
• More farm-related claims to appear on pack, Innova Market Insights forecasts: Now that clean label has moved on from being a trend to becoming “the new rules of the game,” Innova Market Insights predicts more brands will rely on ‘farm to fork’ claims and bucolic imagery as a differentiator… Read
• Paleo certification requests have doubled annually, scheme embraced by ‘household names,’ says Paleo Foundation: Demand for Paleo-certified products are on the rise. But is the diet – and the certification scheme – based on sound science? We chat with Paleo’s critics and proponents to get the inside scoop… Read
• Dairy from cows fed GM feed is not ‘all-natural’, alleges lawsuit vs Dannon – but will it fly?  Has the FDA’s probe into ‘natural’ claims on food labels put a stop to the tidal wave of false advertising lawsuits engulfing food manufacturers? Not if a new complaint against Dannon is anything to go by, which also delves into the thorny issue of GMOs, another area currently being scrutinized by regulators. .. Read
• Future of Nutrition Facts, menu labeling & food safety are unclear under Trump, CSPI says: While President-elect Trump’s position on food policy is relatively unclear still, changes to the exhaustively researched and intensely debated Nutrition Facts label, menu labeling rule and food safety regulations could all be on the chopping block under the new administration, warns a top nutrition policy expert… Read
• Comments in FDA docket reveals consumers’ shifting perceptions of ‘healthy’: If the FDA’s decision to wade into the ‘natural’ debate seemed like an act of sadomasochism, its decision to re-examine the criteria underpinning ‘healthy’ claims on food labels looks set to be equally painful, judging by the first wave of public comments filed in the docket… Read
• FDA hints at how conventional foods can make structure/function claims: For the first time, FDA weighs in on what marketers must have on hand to support claims about conventional foods’ direct impact on consumers’ bodies. .. Read
• Soup-To-Nuts Podcast:The rise & future potential of grass fed claims: Grass-fed claims on products are a beacon for consumers who are health-conscious, want minimally processed food and care about animal welfare, and as such manufacturers increasingly are using them on products across categories and channels to drive up sales sharply… Listen now
• ProTings closes $1.2m financing round, changes name to Protes after spat with Original Tings: Brooklyn-based pea protein chip pioneer Proformance Foods has closed a $1.2m financing round led by a leading CPG company, and changed its brand name from ProTings to Protes following a trademark dispute with B&G Foods, which owns the Original Tings brand… Read
• Vox Pop: Consumers had this to say about GMO labeling…On the heels of President Barack Obama signing into law a federal bill requiring the disclosure of genetically modified organisms (GMOs) on packaged food and beverage products, we at Beverage Daily and FoodNavigator-USA asked consumers at a downtown Chicago farmers market what they thought of GMOs… Watch now
• Are ‘GMO-free’ (as opposed to ‘non-GMO’) claims legally defensible? As the Non-GMO Project states on its website, ‘GMO-free’ claims are “not legally or scientifically defensible due to limitations of testing methodology” coupled with cross-contamination risks. In future, however, that could change as testing methods become more sophisticated, predicts Clear Labs, a Californian start-up which recently hit the headlines after identifying human and rat DNA in hamburgers [albeit within safe parameters]… Read
• Label Insight: Your SmartLabel landing pages could become more important than your website or facebook pages: While the SmartLabel initiative has been dismissed by some as an elaborate conspiracy by big food companies to avoid mandatory on-pack GMO labeling statements, it will ultimately have far broader significance – and potentially a huge impact on how consumers view all food and beverage products – predicts product data and image platform Label Insight… Read
• House approves federal GMO labeling bill that nullifies Vermont law: The US House of Representatives has voted to pass a federal GMO labeling bill (306:117 votes) that would pre-empt and nullify all state-led GMO labeling laws including the one that has just come into effect in Vermont. .. Read
• Hampton Creek to settle worker classification lawsuit: Just Mayo maker Hampton Creek – one of a growing number of food companies sued for allegedly misclassifying workers as independent contractors as opposed to employees – is settling its case in order to avoid the hassle and expense of protracted litigation, court documents show… Read
• Kellogg, Post & General Mills urge courts to toss ‘meritless’ sugar lawsuits: Kellogg, General Mills and Post Foods have urged the courts to ditch high-profile lawsuits over the sugar content in their cereals, on the grounds that their claims are pre-empted by federal law and that no reasonable consumer would find their labels to be false or misleading… Read
• Dole Foods 9th Circuit ruling reignites all-natural lawsuit, ’emboldens plaintiff’s bar’: The Ninth Circuit Court of Appeals has reversed (in part) a lower court’s ruling that Dole Foods’ ‘all natural fruit’ labeling likely isn’t deceptive, resurrecting a four-year-old lawsuit, and giving fresh ammunition to plaintiff’s attorneys pursuing ‘all-natural’ cases… Read
• Parties clash over Welch’s ‘made with real fruit’ fruit snack label claims: Reasonable consumers may well be misled by the packaging of Welch’s fruit snacks, a magistrate judge has concluded, prompting a lengthy rebuttal from the defendants in court documents filed this month. .. Read
• Shoppers aren’t confused by our labels, Chobani tells court: ‘Plaintiffs count on a consumer who is a veritable fool’: A false advertising lawsuit alleging that Chobani’s labels are confusing and deceptive, paints American consumers as credulous fools unable to apply common sense when they go shopping, argues the yogurt maker in court documents urging the judge to toss the case… Read
• GMA to FDA: Sodium reduction guidance must be re-worded or industry will face a tidal wave of ‘frivolous litigation’: Two years isn’t enough time for food manufacturers to make the kind of reductions in sodium that the FDA is asking for, says the Grocery Manufacturers Association (GMA), which also urges the agency to tweak the wording of its guidance in order to avoid “a wave of frivolous litigation.”.. Read
• American Bakers Association backs ‘potassium salt’ petition: It sounds more clean label: The American Bakers Association (ABA) has joined the CSPI, Unilever, and other food manufacturers in voicing its support for a citizen’s petition asking the FDA to permit ‘potassium salt’ as an alternate name for potassium chloride on food labels, while the Salt Institute remains resolutely opposed… Read

I am late getting to the FDA’s July announcement of the release of its work plan for the next ten years, Foods and Veterinary Medicine (FVM) Program’s Strategic Plan for fiscal years 2016-2025.

The FDA organized the plan under goals for:

• Food safety
• Nutrition
• Animal health
• Organizational excellence

The FDA based the plan on basic principles:

1. Public health is the first priority
2. Partnerships are the key to success
3. Scientific expertise and research are the foundation
4. The program is committed to operating openly and transparently

Comments can be submitted on the strategic plan at any time.  Instructions for how to do so are here.

One possibility is to ask for further details.  The plan does not say how the FDA will accomplish the objectives, how much it will cost to achieve them, or whether it has adequate funding for everything it does (hint: it doesn’t).

Some of what it wants to do is puzzling.  For example, one Nutrition objective is this:

2.1: Provide and support accurate and useful nutrition information and education so consumers can choose healthier diets consistent with the Dietary Guidelines for Americans and other evidence-based recommendations.

I assume this refers to Nutrition Facts labels and menu labels, but one of its sub-objectives is:

Strategy 2.1d: Promote collaboration with stakeholders, including industry, consumer, and public health groups, to enhance consumer nutrition education directed towards age and demographic groups with specific needs.

I wish the report said more about this.  Surely the FDA is not suggesting that the food industry take responsibility for nutrition education?  I hope not.

The documents:

• Federal Register Notice
• FDA Home Page for the Plan
• The Strategic Plan for 2016-2015
• Blog: Charting a Path Forward on Food Safety, Nutrition and Animal Health

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