Comment period for milk, dairy identity ends 8/27. Part 2 of 7/26 hearing right here

iStock-544807136.jpgBy Sherry Bunting, from Farmshine, August 17, 2018

WASHINGTON, D.C. – There are 10 days remaining for public comment on FDA standards of identity for milk and nearly 80 other dairy products, along with the other aspects at stake as FDA launched its Nutrition Innovation Strategy to determine – and stamp – healthy choices for consumers while taking steps to “modernize” standards of identity to “achieve nutritional goals.”

The daylong FDA hearing on July 26 was one of several relating to these issues on the FDA docket, and as previously reported in Farmshine, dairy has taken center stage for several reasons.

First, Scott Gottlieb, head of the FDA, responded to calls for FDA to take a closer look at the dairy industry standards of identity, especially for milk. He opened the hearing saying that the agency must first determine “how consumers understand and use the term ‘milk’ to know if the inherent differences between these products is well understood by consumers so we can understand how consumers are being misled.”

The public comments being received by FDA through August 27, are the first step in its multi-faceted approach.

Individual comments on any of these converging standards of identity issues and the Nutrition Innovation Strategy can be sent to FDA prior to the Aug. 27, 2018 deadline at the docket portal here.

Or, send to: Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20857. 

The second aspect of this brief comment period is to discuss the standards of identity more broadly.

“We want to hear about changes in science to review and update,” said Gottlieb. “We are hearing the standards of identity can cause the food industry to avoid reformulations that would reduce fat and calories. We want to gather this input and encourage out-of-the-box thinking with the bottom line helping consumers to identify healthier options.”

We covered some of the testimony at FDA’s July 26 listening session in Part One in Farmshine, Aug. 10, 2018.

Here, in Part Two, published in Farmshine August 17, 2018, are more of the elements from that hearing that are so important to know and understand…

Of particular interest on dairy product standards of identity were the hearing comments by Cary Frye, senior vice president of regulatory affairs for the International Dairy Foods Association (IDFA). She commended Commissioner Gottlieb for undertaking the Nutrition Innovation Strategy “to improve nutrition and health.”

While absolutely silent on enforcement of milk’s standard of identity, despite representing the nation’s milk and dairy food processors, Frye said, “the key area we are working on is to modernize the standards of identity for dairy products, which make up more than one-third of the 280 standards of identity currently on the FDA books.”

She said these standards “are outdated and stand in the way of innovations and novel processes. Current systems are not working and definitely need to be reformed.”

Frye noted that the cheese standards have been unchanged while ultrafiltered milk processes have been around for 20 years. “Clearly a new approach is needed for processes like this to be used to create new and healthful products.”

She said “processing milk by filtration to concentrate proteins and remove lactose is embraced around the world, but these new processes are not permitted in our dairy products with the current standards.”

Frye did, however, thank the FDA for what she described as FDA’s “recent guidance allowing ultrafiltered milk as an ingredient for cheeses.”

“But the agency needs to go further and make dairy a top priority for modernized standards of identity,” said Frye on behalf of IDFA. “We must incentify innovation. We can’t make these investments if we must petition for standards that take decades to complete.”

Along with standards, FDA wants to modernize label claims as a key element of the nutrition innovation strategy, to give consumers “quick signals” with important information on the nutritional benefits of food choices.

A key question FDA is looking at is: What claims best stimulate innovation to create products that are better choices?

Speakers at the hearing identified food trends, saying consumers are committed to a more balanced approach between nutrition and function, but also the idea of food, that it is part of how they experience life, with taste becoming more important to consumers than nutritional profile as they move away from “lowfat” foods.

(Unfortunately, this FDA strategy has not yet acknowledged there are health-related and nutritional reasons for consumers to move away from “lowfat” dogma of the past 30 to 40 years. My comment to the FDA docket will include sending by mail, a copy of The Big Fat Surprise, by Nina Teicholz, who will join me in sending copies of this book to FDA?)

As in many of these discussions, the generational shifts in food trends and choices are the most noticeable. Hearing presenters noted that millennials are pursuing “clean eating and natural foods” as more important than a nutrition-based label.

With that in mind, upholding and enforcing the current standards of identity for milk and dairy products becomes important since it is simple compared with concocted imitation formulations with long lists of ingredients unable to provide all of the nutrition milk has – naturally.

Hearing presenters also acknowledged that the declines in consumption of meat and dairy over the past 40 years have just begun to “shift back the other way.” People are returning to the fresh perimeter of the grocery store.

(Again, no mystery here, FDA needs to read the book: The Big Fat Surprise)

With millennial food choices driven by a so-called “return to purity,” my thoughts as I listened to the July 26 FDA Nutrition Innovation Strategy hearing is this: Will FDA move incrementally toward giving consumers what they want, while slipping into that desired food the science and innovation the FDA and food industry believe consumers need… in order to “get” the FDA ‘healthy choice’ stamp – however that is ultimately defined in this multi-year strategy and however it is ultimately designed for packaging?

These are big things to watch and participate in.

This is not to say that some new standards aren’t needed. Rob Post for Chobani, testified that they produce a nutrient dense, healthy, strained Greek yogurt, but because no standard of identity exists for this type of yogurt, they are challenged to have standardized nutrition profiles “that account for the 52% protein content in Greek yogurt” when used in institutional feeding programs like the National School Lunch Program.

“Today’s consumers have evolving demands and a new set of food values,” said Post. “Health is important, but so are other values and drivers.”

Others noted that the current standards of identity “do not allow lower salt content for cheese.”

This could be an issue when it comes to nutritional cheese getting a ‘healthy choice’ FDA stamp in the future, if such stamps are based on what are now questionable low-salt directives for healthy eating.

“Standards are important because they assure the consistency of the product, its authenticity and nutrition,” said Post.

Laura MacCleery, Policy Director, Center for Science in the Public Interest testified that, “Americans overconsume saturated fat.” They are among the contingent of wanting to work on labeling to steer consumers away from saturated fat.

Meanwhile, the American Heart Association testified to FDA that they want the standards of identity “modernized to improve the nutritional value of food by reducing both sodium and saturated fat.”

On the flipside, members of the dairy processing industry said they are looking for standards to be modernized to abolish the milk fat minimums and allow lower sodium on natural cheeses that currently have rigid standards of identity. Dairy processors testified that this is necessary to conform to the nutritional focal points of this discussion – salt and fat – that are still based on current dietary guidelines.

Will FDA grant these wishes and will we see lowfat and low salt cheeses introduced as “the real thing” because the standard has changed based on a dietary guideline many in the scientific community are already saying is a flawed guideline?

You can see the intertwined dilemma this FDA Nutrition Innovation Strategy could spawn.

Taste is king, according to the food processors speaking about low salt claims. They said they go ahead and formulate low salt varieties, they just are not always advertising it on the packaging space.

Will modernization of standards of identity low-salt and low-fat our food – our cheese for example — without our knowing it or being able to choose? Do we care if that happens as long as it tastes good? And how is that happening? With milk protein concentrates, given FDA’s already loosened grip on allowable ingredients in cheese standards of identity?

A representative for Great Lakes Cheese spoke up to say that, “Consumer transparency around label claims and that presents a huge consumer perception issue. We are interested in experimenting to reduce sodium in cheeses, but without having to put a flag saying so on our product.”

Without a change in standards, a low salt or low fat cheese would have to be labeled that way. If the fat and salt standards are abolished, no ‘flag’ is needed and consumers won’t know the fat or salt is lowered – it just may taste different.

One question asked was “If our goal is to impact consumer behavior, how do we empower consumers to look for better choices by looking to the nutrition facts instead of making changes to do it for them (with modernized standards and healthy-choice stamps)?”

Part of this process is FDA’s work to “update” the definition of “healthy” as a “voluntary” claim. What kind of symbol should be used, should it be by food group.

“What’s healthy and not healthy shifts over time, and it’s not the same for everyone. If you’re putting a stamp on something today, you may have to take it off at some time down the road,” said one hearing participant.

Dieticians were on the side of “one size doesn’t fit all” when it comes to using FDA-sanctioned ‘healthy’ stamps or symbols on food labels. They preferred to see a focus on foods and food patterns more than specific nutrients.

In fact, one anonymous dietician has already commented on the public document online to say they have spent 30 years with government food programs and this is his or her observation over those 30 years: “We have done a great disservice to the public in trying to get people to eat 6 to 12 servings of carbohydrates per day while subsisting on a lowfat diet.”

A participant from the Edge dairy farmer cooperative of 800 members in the Midwest (formerly Dairy Business Association Cooperative based in Wisconsin) said that, “Accurate labeling is the first step in FDA’s enforcement of existing standards for milk, cheese, yogurt. High nutrition and taste have come to be expected,” he said.

“Inaccurate labeling is not fair to farmers and their investment or to customers who may have been misled. We’re encouraged by FDA’s announcement and we encourage innovation in the dairy case to keep up with changing wants and needs with options for healthy products, but most people under-consume dairy products. We must have the flexibility to make what competes and to label innovative foods made with milk.”

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There’s a war to win for our health and our dairy producers

NinaTeicholz0181Learn, then comment! Deadline: March 30!

By Sherry Bunting, Farmshine March 2, 2018

STATE COLLEGE, Pa. – Never did Nina Teicholz envision herself talking about nutrition to groups of dairy and livestock producers and hearing how important it was to them to hear that the work they care deeply about and the product they produce is good, great, healthy, in its full-fat form after decades of being maligned by flawed advice for a low fat or fat free diet.

Nina Teicholz-27“Not only has this advice been bad for people, it is especially bad for children,” said Teicholz as she told her story of a decade of investigation met by intimidation uncovering stories of a scientist who bullied others who had alternative hypotheses and a powerful nutrition elite still controlling the food supply through their grip on Dietary Guidelines.

The author of New York Times best seller The Big Fat Surprise has not only challenged but also disproved the anti-fat dogma of 40 years and revealed the politics that have overshadowed the science in the confusing world of diets and nutrition.

In fact, she says, the power of an elite class of experts who control nutrition guidelines that in turn control the food supply is still strong and very tough to overcome – even when the evidence is not on their side.

imagesTeicholz’s Big Fat Surprise has had a ripple effect in the food industry among consumers since 2014,but the dietary elites have challenged her each step of the way.

And there’s a lot of war left to be fought for what is right.

This is especially true when it comes to the milk the USDA prohibits from being served in the National School Lunch program or through Women, Infants and Children (WIC) programs.

The intimidation that Teicholz and others have endured shows just how much is at stake and just how tough the politics are in trumping the science. With a steady drumbeat of proof, one would think the bad advice could be easily overturned, but the work is hard and it needs to continue, Teicholz indicates.

(Not only are the flawed guidelines affecting health, but also reverberating in their economic effects on family farms across the country, in part aided by the dairy industry accepting a role in working alongside former first lady Michelle Obama when it came to school meals, allowing her to deal the final blow to milk in school, while accepted yogurt on the plate as a compromise.)

Nina Teicholz kicked off the 2018 Pennsylvania Dairy Summit last Wednesday, Feb. 21 here in State College, treating nearly 500 dairy producers and industry representatives to an inside look at her 10 years of investigative journalism on this topic that began when her editor assigned her a piece on defining trans fats.

Little did she know then where this would lead her today. Who would have thought that the former vegetarian from Berkley, California and New York City would end up uncovering what may be the biggest nutritional tragedy done to consumers and dairy and livestock producers, worldwide.

She told Summit attendees that she began to suspect a problem when her initial inquiries started revealing a pattern of resistance.

“That’s where my deep dive into the world of fats began,” said Teicholz. “The fats we obsess about that have made us all crazy over what kind to eat and how much.”

She started hearing about scientists getting “visits” and papers being yanked from scientific journals. She started feeling the intimidation, herself, as she widened her investigative scope, reading scientific papers and seeking interviews with scientific experts at some of America’s most trusted universities and institutions.

“I would be interviewing scientists at top universities and they would hang up on me,” Teicholz revealed. “I thought, am I investigating the mob? What’s going on?”

Her deep dive into fats took her through a decade of work reading thousands of scientific papers and doing hundreds of interviews to write a book investigating the research on all fats in the diet.

“Every idea has a beginning, like an acorn to a tree,” said Teicholz, “and this had its beginning when President Eisenhower had a heart attack. This is when the concern about heart disease rose out of nowhere to be labeled the nation’s leading killer.”

Many ideas of causes were initially looked at, and then University of Minnesota physiology scientist Ancel Keys posited the cholesterol theory, that like hot oil down a cold stove pipe, would clog arteries and cause heart attacks.

Through her research, Teicholz discovered that so in love was Keys with his own theory that colleagues described his approach to the work of others as “bullying.”

“They described him as very charismatic and able to debate an idea to death. And, yes, a bully,” she said. “Once he was able to get his idea implemented into the American Heart Association, it was on.”

By 1960 he was on the nutrition committee and by 1961, “that acorn had grown into a giant oak tree of the advice leading to what we have today. The world transitioned from saturated to unsaturated fats,” said Teicholz. “But rarely do checks for common sense happen in the world of nutrition. Keys became ‘Mr. Cholesterol’ on the cover of Time Magazine with just one study.”

This study was not a randomized controlled study, but rather a series of contacts in seven countries relating diets to disease in middle-aged men.

Teicholz spent six months studying the Keys’ study. While it involved seven countries, the study looked only at the diets of middle-aged men and created this “big bang” theory. His study had been funded by the National Institutes of Health (NIH).

“But what happened is that Keys already had his idea. He loved his idea, and he set out to find what he found,” said Teicholz.

She outlined the numerous problems with the Keys study. It did not include countries with high consumption of fats and low rates of heart disease, which would have destroyed his hypothesis. He went to countries that were ravaged by war, not the countries that were eating well.

“And his star subjects were on the island of Crete, mainly hard-working peasants he worked with for three months one of which was during Lent, where he clearly undercounted the amount of fat these people ate,” Teicholz observed.

What was mind-boggling for Teicholz as she went through the record is that absolutely none of this theory — or the 40 years of advice that followed — is based on randomized controlled clinical trials.

“The government and the American Heart Association understood the evidence was weak, so the NIH funded a study to follow people through their death to set out to prove Keys’ theory this way,” she said.

Meanwhile it was being treated as gospel.

After more than a decade and following 75,655 men and women for one to 12 years, some of them with controlled in-patient diets, “The results showed no effect of saturated fats on cardiac mortality or total mortality!”

In fact, there was no effect whether subjects consumed 18% of their dietary calories in fat or 6%.

At the same time, Teicholz reports that people in the study, who had replaced fats with soy and margarine, had higher rates of cancer.

So, by this time in the presentation, it’s hard to keep the hair from standing up on your neck, and Teicholz asks the question: Why is this advice still around? Why is it still controlling food programs and markets?

“The politics explain so much more than the science,” she said. There is a small group of nutrition aristocrats controlling who they invite to lead panels or grant appearances, and they sit on editorial boards of medical journals and control these institutions.

“This is still true today,” said Teicholz, noting how an invitation for her to join a panel at an international conference was later withdrawn because the other people on the panel were key members of the U.S. Dietary Guidelines committee.

“This relative small (but obviously powerful) group does not include critics. They are the reason why we still have these ideas even if they are wrong,” said Teicholz.

An educated writer and scientist herself, Teicholz understands that scientists are trained to discover for themselves, but selective bias crept into nutrition the moment Ancel Keys at the University of Minnesota, fell in love with his own hypothesis.

Nina Teicholz-25A colleague of Keys had done research with 5000 people around the same time, but it didn’t see the light of day. This Minnesota Coronary Survey found no difference from fat in the diet between treatment and control. It is the biggest and most well controlled study of its time but was not published for 16 years!

Teicholz explained further that when the competing research was ultimately published, long after the Keys hyposthesis had grown into an oak with roots, it was only published in an out-of-the-way journal.

Meanwhile, it was the 1980s and Senator George McGovern initiated the Dietary Goals report, written by staffers with no background in nutrition, some of them vegans. This formed the basis for the food pyramid.

From that point forward, Teicholz showed graphs of the increase in obesity and diabetes. But as a science-minded journalist, she reminded her audience that the graph, by itself, didn’t show causation. However, other studies have proved causation, and she shared those as well.

In fact, studies have been showing that Americans really have been following the flawed dietary guidelines and that while consumption of full fat dairy is down, and pounds of fruits and vegetables up 20 and 30%, along with grains and cereals up 30%, obesity and diabetes has risen exponentially.

Nina Teicholz-29“We follow the guidelines and eat more calories, but all of those extra calories are coming from the increase in carbs,” said Teicholz.

So the third rail some say we dare not touch is that the hallmark recommendation of 60 minutes of exercise — meant to accompany the promotion of a low fat diet – was touched by Teicholz during her presentation.

The kicker is that Americans are not getting fat because they don’t exercise enough, she said. Not one study could show where this 60-minutes of exercise and a lowfat diet actually helped.

Nina Teicholz-30“We cannot exercise ourselves out of a bad diet,” said Teicholz. “Is it our own fault or is it the advice we have been given? I’m here to tell you that saturated fats do not cause cardiovascular death, and Canada is already working to remove the percent of fat requirement from their guidelines.”

In fact, Teicholz cited the work of Salin Ysuf, a leading cardiology specialist. His work showed that patients who ate the least amounts of fat had the highest risk of stroke and those who ate more, lived longer.

“We are in the midst of a paradigm change,” she said. “Cholesterol in the diet has not been proven to increase blood cholesterol. Eating egg whites instead of eggs has accomplished nothing.”

In a small step in 2013, the American Heart Association dropped its caps on cholesterol and this also occurred in the 2015 Dietary Guidelines. However, the recognition that a low fat diet doesn’t work has not made it to the dietary guidelines elite, and the next cycle to change them doesn’t happen until 2020.

“Fat is not making you fat,” said Teicholz. “It’s like a tragic horror movie. The truth is the fat we eat is not the fat we get.”

So what does cause disease? Teicholz explained the carb insulin hypothesis, where carbs become like glue in the bloodstream, and the body has to secrete insulin, a hormone, so the body socks this away as fat. She explained that not all carbs have the same effect and that gaining and losing weight also has a hormonal aspect being found as a key culprit in obesity and diabetes.

“There is a growing drumbeat of positive research coming out showing that whole dairy, full fat dairy, is good for cardio risk factors and that there should be no caps on cholesterol in the diet; however, the caps on saturated fat remain,” she said.

The reason the Dietary Guidelines are so powerful is that they control so much of what we think about what we are eating, according to Teicholz. She noted that soy milk has been allowed as a replacement for dairy milk in the Dietary Guidelines.

This is huge because these guidelines dictate what schools can serve, the WIC program and so many other aspects of nutrition where the government is involved.

“The Dietary Guidelines for Americans have huge control over the food supply, and trying to change them is so difficult because those in charge are so incredibly powerful,” said Teicholz.

This is why she has initiated the Nutrition Coalition to fight for our diets. Her aim is to have evidence-based Dietary Guidelines, and to see an end to the promotion of 60 minutes of exercise and a low fat, low sodium diet as what’s good for our children.

“This advice has not worked for people, and especially not for kids,” said Teicholz. At best, the 60 minutes of exercise is disingenuous when accompanied by low fat, high carb dietary advice, and at worst, the promotion of low fat and fat free is harmful.

Alas, her attempts so far, including a piece in a British medical journal about changing the flawed Dietary Guidelines was met with a petition signed by 180 nutrition aristocrats on the Dietary Guidelines committee, who demanded a retraction of Teicholz’s paper.

“It took them a year to put it out, but the BMC did their review and stood up strong for my paper,” she said. “This shows us just how much is at stake and how tough the politics are in this field of nutrition.”

Learn more about Teicholz’s work and the Nutrition Coalition she founded as well as how to comment by March 30, 2018 on issues to review in the Dietary Guidelines Advisory Committee’s next 5-year review for the 2020-2025 guidelines.
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To read other agmoos articles / columns authored by Sherry Bunting on the School lunch program and dietary guidelines from the past several years, here is a link: https://agmoos.com/2015/04/24/nutrition-politics-kids-and-cattle-caught-in-the-crossfire/

About Nina Teicholz: Nina is an investigative journalist and author of the International (and New York Times) bestseller, The Big Fat Surprise (Simon & Schuster). The Economist named it No. 1 science book of 2014, and it was also named a 2014 *Best Book* by the Wall Street Journal, Forbes, Mother Jones, and Library Journal. The Big Fat Surprise has upended the conventional wisdom on dietary fat and challenged the very core of our nutrition policy. A review of the book in the American Journal of Clinical Nutrition said, “This book should be read by every nutritional science professional.”

Before taking a deep dive into researching nutrition science for nearly a decade, Teicholz was a reporter for National Public Radio and also contributed to many publications, including the Wall Street Journal, New York Times, Washington Post, The New Yorker, and The Economist. She attended Yale and Stanford where she studied biology and majored in American Studies. She has a master’s degree from Oxford University and resides in New York City.