‘FDA may have forgotten the standard for milk, but we haven’t’ – Part One

Dairy epicenter of broader FDA strategy

 Public comments due August 27

By Sherry Bunting, from Farmshine August 10, 2018

WASHINGTON, D.C. — While the dairy industry is focused on multiple layers to the milk and dairy standards of identity — the FDA review of these standards, and their enforcement, is couched within the broader Comprehensive Multi-Year Nutrition Innovation Strategy launched recently by the Food and Drug Administration (FDA).

Labeling and education are aspects of the strategy, along with a new FDA definition of “healthy choice” to be identified “visually” on foods that meet criteria FDA is still defining.

But the key to the strategy, according to FDA, is to “modernize” standards of identity in order to achieve specific nutrition goals the agency believes will reduce chronic diseases – namely diabetes, obesity and heart disease.

Since 80 of the 280 foods with current standards of identity are dairy foods, and many of the remaining 200 are meat products, the FDA’s noted allegiance to the low-fat dogma of the current Dietary Guidelines does not bode well for how this may all turn out.

That’s why grassroots consumers and producers NEED to get involved.

Of particular concern in a July 26 FDA hearing are regulator use of terms such as “barrier to innovation” or “reformulations of foods using science” in discussing how modernized standards of identity can help the government attain an objective of getting consumers to eat in accordance with the ways it believes will lower chronic disease.

This, despite the fact that noted scientists in the health and nutrition fields and investigative science journalists, like Nina Teicholz, author of The Big Fat Surprise, continue to point out how flawed the science has been for current dietary guidelines,  and how these flawed guidelines have actually led to epidemic rates of obesity and diabetes while doing nothing to abate heart disease and morbidity.

Teicholz observed in submitted comments that, “There is no evidence that saturated fats cause obesity. Consumption of saturated fats have declined 17% since 1970, animal fats down by 29% in same period, while obesity rates are up, so explain how saturated fats can be the cause?”

Hearings on parts of the Nutrition Innovation Strategy have already taken place prior to FDA commissioner Scott Gottlieb’s now-famous statement that “Almonds don’t lactate.” This statement propelled milk and dairy into the epicenter of the standard of identity modernization process FDA already had in motion.

A daylong FDA hearing on July 26 kicked off the standard of identity portion of the Nutrition Innovation Strategy, and two weeks prior, the administration held a listening session specifically on the labeling and regulation of new cell-cultured protein technologies — funded by billionaire investors and conventional agriculture companies — seeking to gain standardized status as ‘animal-free’ versions of various meats and dairy proteins for inclusion in products — interchangeably without notice.

The July 26 session attracted a larger than expected attendance due to the national discussion on imitation milk products, and FDA moderator Kari Barrett indicated there was a “very large webcast audience participating.”

Commissioner Gottlieb kicked it off telling how FDA has been monitoring food innovation trends and sees these trends as providing an opportunity to empower individuals to use nutrition to reduce chronic disease.

He acknowledged a “deep personal interest” in the Nutrition Innovation Strategy as he believes nutrition innovation can help solve health issues, and he believes FDA can develop a policy framework to achieve it in their regulatory role.

(However as the daylong hearing progressed, it became obvious that the notable presenters and regulators on various panels are relying heavily on the current flawed Dietary Guidelines for Americans, which themselves are in need of “modernization” due to the revelations about the poor science behind them, particularly on saturated fat).

“We want to empower consumers with innovation and facilitate industry innovation for healthier foods … to remove barriers and leverage nutrition toward these goals,” said Gottlieb, calling it one of his “top priorities.”

He reminded participants that FDA regulates 80% of the food supply with a long history of informing that regulatory process via the Dietary Guidelines for Americans.

“We want to modernize our regulatory approaches to help consumers seek healthier options,” said Gottlieb. “The historic approach (of FDA) is to set barriers. But by modernizing our framework and approach and looking at consumer trends, the food industry can provide these healthier options with foods consumers are seeking.”

The new area of focus for the agency, according to Gottlieb, will be to see the food industry “compete on the nutritional attributes of their products” within a policy framework that allows innovative reformulation.

Gottlieb also mentioned “calls for FDA to take a closer look at dairy identity,” he said. “But first we must better understand how consumers understand and use the term milk and how they are being misled.”

Gottlieb acknowledged the “proliferation of beverages calling themselves milk” and said the FDA is being questioned about its enforcement of milk’s standard of identity.

“The challenge is that we can’t unilaterally change if we have been historically enforcing it a certain way,” he said.  “That’s what we are starting, a conversation. We are meeting with interested stakeholders and will post a definition later this summer or early fall with specific questions for feedback and then revisit our enforcement.”

The next steps after comments, feedback and proposed definitions for milk will be to provide the industry with guidance on labeling, and then compliance.

“In the meantime, we will take steps on labels where there is a high likelihood of consumers being misled in cases where public health is affected,” Gottlieb said.

In total, the FDA has 280 standards of identity on the books “created when our grandparents were younger than me,” he said. “We want to hear about the changes in science to review so that we can update these standards.”

He gave the example of standards of identity being modernized with industry and consumer input “to reduce fat and calories.”

He said that FDA wants “to gather input and encourage out-of-the-box thinking” so that the standards are not so rigid as to “cause the industry to avoid reformulations that would reduce fat and calories.

“We need diverse opinions,” said Gottlieb, “but the bottom line (of the Nutrition Innovation Strategy) is for consumers to identify healthier options.”

He said that, “Disparities in diet contribute to disparities in health… modernizing standards and label claims are a key element of our strategy to give consumers quick signals with important information on nutritional benefits and provide incentives for industry to innovate for foods with more healthful attributes.”

Expert panelists, like David Portalatin, vice president and food industry advisor, The NPD Group, testified about consumer trends: “Our data suggest that plant-based protein alternatives are increasing very rapidly, and a large percentage of these consumers are not vegan.”

“Protein is the number one thing consumers seem to want to add to their diets, and we’ve seen a proliferation of ways to add it, and consumers say ‘yes’ I’ll try that,’” said Portalatin about the renewed interest in high protein diets. “When we invest in new stuff, we buy it, we are not a meat-avoidance society.”

He noted that according to survey data, 84% of people reporting they are consuming plant-based alternatives while they are not vegan or vegetarian. “There are a lot of us trying these alternatives,” said Portalatin.

He also mentioned that the interest consumers have in purchasing “low-fat” foods is declining, that people want real food – as it is – and want to control their intake of fat by portion size.

FDA hearing graph

David Portalatin said that in addition to more protein and fewer concerns among consumers about fat, consumers aso want more calcium, iron, Vit. A and antioxidants. Milk contains all and is a big source all but iron, while beef is a big source of the iron. A recent study showed that milk and other dairy foods are “densely packed” with antioxidants delivered in a more soluble way via the protein and fat found naturally in milk —  the very fat that FDA and the food police want people to eat less of and the very protein that some experts at the hearing said consumers want more of, but are not deficient in. In other words, consumers are going one way with their diets (away from flawed guidelines that have led to chronic illness) while the government may use this nutrition strategy to shepherd consumers back into the flawed guidelines obedience flock they are just now breaking free of. Screenshot by Sherry Bunting during FDA hearing webcast 

Interestingly, the four areas consumers are trying to improve their diets are found in the combination of real milk and beef in the diet.

The American Heart Association had a representative during the open comment time telling FDA they “want the standards of identity to be modernized to improve the nutritional value of food by reducing sodium and saturated fat.” (More on this in a future part of this series).

While he noted that generational cohorts are the biggest drivers of change, the renewed interest in high protein diets is, in his opinion, not necessary since “American diets are certainly not deficient in protein,” in Portalatin’s opinion.

He and other panelists tended to lump this high protein diet preference with a return to higher fat in the diet. Not one panelist recognized the revelations about low-fat dogma of 40 years contributing to the very chronic diseases the FDA strategy seeks to prevent. Every indication from this hearing is that FDA will fall in line with the Dietary Guidelines Advisory Committee in continuing to tweak all kinds of rules and regulations to get Americans to eat less fat — unconsciously — through modernized standards and reformulated foods.

The Good Food Institute — an organization representing plant-based and cell-culture imitation meat and dairy products — had legal representatives testifying on July 26 that, “FDA’s practice for the last decade or more in its guidance for ‘milk’ is that we could use the term ‘milk’ with appropriate modifiers, like almondmilk. The same has been true of butter, such as cashewbutter.”

The Good Food Institute insisted that when their foods can use a standardized term with a modifier, it allows their new – and they say healthier (but are they?) – products come to market more easily. “If that changes, it will make it harder for newer and healthier foods to come to market,” they said.

A representative for Dairy Farmers of America spoke during the open comment time saying that, “The current standard for milk should be enforced as it is. The plethora of products are borrowing the dairy industry’s nutrition profile, and those products may not be as nutritional or wholesome with FDA not enforcing the standard.”

From the Academy of Nutritionists and Dieticians, Jeannie Blankenship, said their professional members will have to “translate” whatever FDA decides on these things. “Consumers must be able to readily understand,” she said. “People with food allergies and intolerances use these standardized terms in a different manner than the general population.”

North Carolina Ag Commissioner Joe Reardon cited the standard of identity defines milk as a lacteal secretion of the mammary gland. “Plant-based beverages do not meet that definition,” he said. “If milk is on the label, then milk should be in the product. Without enforcement of this simple standard, then all standards of identity are compromised.”

He and others made it clear they are not advocating for these plant-based beverages to be removed from the market.

“We recognize they are a vital option for many consumers; however, they should be labeled correctly, without the term ‘milk,’” said Reardon. “North Carolina and other states stand ready and willing to assist FDA to enforce this standard and for the industry to come into compliance. We have heard here all day about the importance of a label, but without truth in labeling, none of the other matters.”

Kim Bremmer FDA Hearing (1).jpg

Kim Bremmer testified to FDA on behalf of the American Dairy Coalition about enforcement of the definition of milk. Photo provided by ADC

Speaking for the American Dairy Coalition, which recently started an Integrity Initiative, Kim Bremmer, a dairy producer from Wisconsin said “You play a vital role in giving consumers the information to make choices. Nutrition matters. I see tens of thousands of consumers in my speaking and the vast amount think some of these beverages have cow’s milk in them, and most believe they are as nutritional as milk, and they aren’t. The play on words is misleading.”

Bremmer described cow’s milk as a powerhouse of nutrition with crucial nutrients for cellular function. “No other drink packs this nutrition. There’s no comparison,” she said, explaining what she sees and hears when fourth-graders visit her farm and she watches the children connect the dots to realize the almondmilk they may be drinking at home, isn’t milk at all.

“One in five people are food insecure and one out of 10 adolescent girl are deficient in calcium. We have a problem. We must protect the integrity and identity of milk because nutrition matters,” said Bremmer.

Rob Post from Chobani was there to talk about getting a standard of identity for Greek yogurt so that schools and other institutional feeding situations could accurately quantify the protein levels. As it is now, they are standardized at the regular yogurt levels of protein even though strained Greek yogurts are 52% protein — twice that of regular yogurt.

While he said standards of identity have not kept pace with new food innovations, and he wants to see a better process, he was quick to defend the current definition of milk and dairy — and its enforcement — saying that, “It’s important to have options, but words matter to consumers and dairy means something specific. It means nutrient dense, minimal processing. It is important that this standard is preserved,” said Post.

From National Milk Producers Federation (NMPF), Tom Balmer noted that the issue comes down to “safeguarding the standards to help maintain honesty in the markets.”

“Milk, yogurt, cheese, butter. Standardized dairy terms are being coopted by others as purely a marketing gimmick, while these products lack the nutrients and attributes of dairy,” said Balmer.

“Consumers don’t realize they are being shortchanged. It’s hard to talk about ‘modernizing’ standards when current standards are not enforced. FDA may have forgotten the standard for milk, but we haven’t. Enforce the current standards and stop the confusing and deceitful marketing practices.”

International Dairy Foods Association (IDFA), representing milk and dairy processors, was mum on milk, but touted an array of expanded and modernized standards they want to see for many dairy standards. More on that in part two.

The American Dairy Coalition is urging the FDA to stop allowing the wrongful use of the word “milk” on non-milk, plant-based alternative products labels. To sign the ADC Milk Integrity Initiative petition, it is available online at http://www.americandairycoalitioninc.com/the-integrity-initiative.html

Public comments can be sent to FDA prior to the Aug. 27, 2018 deadline at the docket portal at https://www.regulations.gov/docket?D=FDA-2018-N-2381.

Or, send to: Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852

All submissions received must include the Docket No. FDA– 2018–N–2381 for ‘‘FDA’s Comprehensive, Multi-Year Nutrition Innovation Strategy.’’

Look for part 2 this week.

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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.