DAIRY SOIs: FDA adopts new YOGURT standards rule, expects MILK rule next year

FDA yogurt standard of identity rule finalized; NMPF is calling it a “robust defense of dairy integrity.” IDFA is saying it is “woefully behind the times.” Frankly, it’s neither. Let’s go behind the mirror, shall we?

FDA yogurt standard of identity rule finalized. NMPF calls it a “robust defense of dairy integrity.” IDFA says it is “woefully behind the times.”

Frankly, it’s neither. Let’s go behind the mirror

By Sherry Bunting, Farmshine, July 16, 2021

WASHINGTON, D.C. — FDA’s new yogurt standard of identity was finalized this week. The final rule was published June 11 and adopted July 12, 2021 after a 30-day comment period. It was a significant part of the hearing that launched the FDA multi-year Nutrition Innovation Strategy (NIS) three years ago.

Industry compliance is set to begin Jan. 1, 2024.

Over the next 30 months, other decisions are on the to-do list for FDA before anyone can consider the yogurt rule a slam-dunk for dairy.

In fact, National Milk Producers Federation (NMPF) and International Dairy Foods Association (IDFA) responded to the new rule immediately with a little good cop / bad cop.

According to NMPF, the new rule “fits changes in yogurt-making technology.”

IDFA disagrees, and is filing a formal objection.

NMPF is calling it a “robust defense of dairy integrity.”

IDFA is saying it is “woefully behind the times.”

Frankly, it’s neither. Let’s go behind the mirror, shall we?

In the rule, yogurt is defined as: “Cream, milk, partially skimmed milk, skim milk, and the reconstituted versions of these ingredients that may be used alone or in combination as the basic dairy ingredients in yogurt manufacture.”

The rule states: “Yogurt is produced by culturing the basic dairy ingredients and any optional dairy ingredients with a characterizing lactic acid-producing bacterial culture.”

In its response, NMPF pointed to this language as “reinforcing the concept that where food comes from, and how it is made, matters.

“Logic matters. Consistency matters. That’s why the new FDA rule that defines what is and isn’t yogurt has much broader, and potentially very positive, implications in one of the most contested consumer issues of the day — the proper labeling of milk and dairy products,” NMPF states.

However, given the fact that FDA is still working on the standards of identity (SOI) for milk and dairy within its larger NIS framework, the biggest questions are still unanswered, and FDA indicated their guidance on milk and dairy SOIs won’t come until June 2022.

The yogurt rule simplifies FDA’s books and offers processors more flexibility, to a point. It revokes the previous individual SOIs for low-fat and non-fat yogurt, making one SOI for yogurt, in which low- and non-fat become labeling modifiers.

The intent of this, according to FDA, is to “modernize SOIs for technological advances while preserving the basic nature and essential characteristics.”

In the 22-page rule, FDA writes: “Any food that purports to be or is represented as yogurt, must conform to the definition standard of identity for yogurt.” — That’s the enforcement piece.

The thrust of FDA’s NIS is explained in documents as moving toward both revoking and modernizing standards so foods can compete on a nutritional basis, and to remove barriers to innovations. This includes determining how plant-based and synthetic alternatives are labeled.

New genetically-altered yeast excreting proteins are being made by companies like Perfect Day Foods, and they are pressuring FDA to designate them as dairy proteins, saying they are identical to casein and whey found in milk. They don’t want these proteins labeled as bioengineered because even though the yeast is genetically altered with bovine DNA, the protein excrement is used, not the yeast itself.

This is a bit of what’s under the surface on the dairy SOIs. 

In January 2020, IDFA had Perfect Day CEO and co-founder Ryan Pandya on an industry panel at the IDFA Dairy Forum in Arizona. During that IDFA Forum, Pandya told Food Dive in an interview that, “Every major multinational (company) is talking to us.” 

Pandya pitched the bioengineered yeast excrement to processors during the IDFA Forum, noting that they work through The Urgent Company, under the leadership of former Glanbia VP of product strategy in a business-to-business model, touting climate impact reductions by ‘partnering’ with the dairy industry to replace just 5% of dairy protein with their analog.

In fact, the January 2020 Food Dive article goes on to quote Monica Massey, an executive vice president and chief of staff for Dairy Farmers of America (DFA), as she told Pandya from the audience during the IDFA panel that she purchased the limited-edition Perfect Day ice cream last year.

“We sat down in a dairy cooperative headquarters and ate it, and I said ‘Oh, we’re screwed’ because it tasted just like ice cream,” Food Dive quotes Massey’s exchange with Pandya during the IDFA Forum. 

“In the industry we get hung up on ‘You can’t call it dairy.’ … (Perfect Day’s) not focused on the cow, you’re focused on the consumer, and we are so hellbent on focusing on the cow, the milk,” said Massey.

(Author’s note: Working for a cooperative owned by dairy farmers does kind of make it about the cows and the milk, but it can still be about the consumers, using the milk from the cows.)

An article posted publicly on the day of the new yogurt rule, July 12, gives us a good idea why IDFA is protesting the new SOI for yogurt, and why the big unanswered questions of milk and dairy identity — that the FDA expects to propose a year from now in June 2022 — are so important as the undergirding for individual SOIs like yogurt.

The July 12 article in Dairy Processing by Donna Berry (who is also a contractor on the payroll of DMI — the national dairy checkoff every dairy farmer must pay into, by law), quotes a representative of Perfect Day talking about the so-called ‘animal-free milk proteins,’ saying they are identical to casein and whey. They are excreted from microorganisms such as bacteria, yeast or fungi, that have been genetically altered with bovine DNA and are grown in fermentation vats on sugar substrate.

(The current, though unenforced, FDA SOI for milk is: “Milk is the lacteal secretion…obtained by the complete milking of one or more healthy cows.” Of course, goat milk would be a consistent qualifier in source, characteristics and nutrition, but almond, oat, soy, bioengineered yeast, are not consistent with that legal definition.)

Without FDA guidance and enforcement of real dairy SOIs for milk, and 80 other products with FDA SOIs that come from milk, what’s to stop “seamless” swapping of bioengineered yeast-excrement in place of dairy protein in standardized dairy products and no bioengineered labeling? What ensures that consumers know what they are consuming, and dairy farmers aren’t put out of business by captive supply in the market and?

Yes, deciding what is and isn’t ‘milk’ and ‘dairy’ is still a huge item on the FDA to-do list.

IDFA is protesting what it says are ‘overly prescriptive’ process requirements in the new yogurt rule they claim are “not current with today’s innovations,” such as requiring cream to be added before, not after, lactic acid fermentation to meet standardized 3.25% fat levels. (That’s a bit of a monkey wrench for Perfect Day.)

Just a few of the other things IDFA is objecting about include the requirement for yogurt that contains ‘non-nutritive’ sweeteners be labeled as ‘reduced calorie’, and how high the vitamin A and D levels are set for processors choosing to voluntarily fortify the yogurt. 

The rule does offer the industry a peek into where milk and dairy standards could be headed since former FDA Commissioner Scott Gottlieb made the now-famous “almonds don’t lactate” statement at the very same time that the FDA NIS was launched in July of 2018.

Tied-in with the NIS are the stated purposes of addressing chronic diseases like obesity and heart disease by modernizing all 280 standards of identity, updating food labeling rules to educate consumers on nutritional choices, clarifying standards for new innovations (including lookalikes), and developing a voluntary ‘healthy symbol’ for foods so consumers get a ‘quick signal’ to make choices lower in sodium, saturated fat, and calories via the Dietary Guidelines, while including the nutritional quality consumers expect.

During the FDA NIS hearings reported in Farmshine three years ago, FDA said it wanted to better understand how consumers understand the term ‘milk.’

Rob Post, with yogurt-maker Chobani, was a presenter that day, and he expressed concerns that the current yogurt standards made it difficult for Greek yogurt to be offered in schools and other institutional feeding situations to accurately quantify the protein levels. Strained Greek yogurt is 52% protein, twice that of regular yogurt, he said.

He asked for a better process that keeps pace with innovation, but he was very quick to defend the current definition of milk and dairy — and its enforcement.

“It’s important to have options,” said Post. “But words matter to consumers and dairy means something specific. It means nutrient dense, minimal processing. It is important that this standard is preserved. Standards are important because they assure the consistency of the product, its authenticity and nutrition.”

Meanwhile, FDA’s new yogurt rule “expands the allowable ingredients in yogurt, including sweeteners such as agave, and reconstituted forms of basic dairy ingredients.”

This simpler, more flexible statement means ultrafiltered (UF) milk solids and even dry milk protein concentrate, can be used in formulation as ‘optional functional dairy ingredients.’ As milk-derived ingredients, these examples don’t reconstitute to the properties of the basic ingredients listed in the yogurt SOI, and must be labeled. 

The new rule also “establishes a minimum amount of live and active cultures yogurt must contain to bear the optional labeling statement ‘contains live and active cultures’ or similar statement.” And, if the yogurt is treated for extended shelf life in a way that inactivates viable microorganisms, the yogurt must now include a statement ‘does not contain live and active cultures’ on the label. 

“The final rule is already out of date before it takes effect,” wrote Joseph Scimeca, Ph.D., senior vice president of regulatory and scientific affairs for IDFA in a statement. “For the most part, FDA relied on comments submitted 12 or more years ago to formulate its final rule — as if technology has not progressed or as if the yogurt making process itself has been trapped in amber like a prehistoric fossil.”

Scimeca added that the yogurt rule is “woefully behind the times and doesn’t match the reality of today’s food processing environment or the expectations of consumers.”

On the other hand, there were numerous industry comments seeking a more traditional rule in terms of milk and cream vs. ‘milk-derived’ or ‘reconstituted’. 

FDA responded in the rule, stating: “Technological advances in food science and technology allow for a wider range of milk-derived ingredients developed with advances in membrane processing technology in the dairy industry. The final rule permits the use of emulsifiers and preservatives to prevent separation, improve stability and texture, and extend the shelf-life of yogurt.”

While the rule, in effect, “permits optional functional dairy ingredients,” and “modernizes the yogurt standard to allow for technological advances,” it also requires the 3.25% milkfat and 8.25% solids not fat threshold at a point in the process before bulky flavorings are added. That’s helpful.

Calling the new rule “a robust defense of standards of identity,” NMPF cited its citizen’s petition filed with FDA in 2019, saying: “With the yogurt rule complete, our petition should be answerable in much less than 21 years.”

FDA’s NIS is also reviewing and updating its own “general principles for food standards of identity.” The seed inside the core of this huge apple.

“We are continuing our efforts to revoke or amend certain standards of identity — from frozen cherry pie and French dressing to yogurt — especially when the standard of identity is inconsistent with modern manufacturing processes or creates barriers to innovation,” states FDA about its process.

As pieces, like this yogurt rule drift out of that process, a thought emerges: FDA is cleaning its books full of hundreds of SOIs to consolidate and simplify them — before tackling the really big questions of legally defining what the broader SOIs will be.

Still on deck are the all-important SOIs defining and enforcing core milk and dairy terms, even as pressure from plant-based, cell-cultured, yeast-cultured and other lookalikes push for SOIs that simply set nutritional standards for analogs to meet. 

How will fake milk, fake meat be labeled and regulated?

Say, what? New twist on standards of identity: How will fake milk and fake meat be labeled and regulated?

cows.jpg

In a time when many people have lost their connection to the values and sustainability of the circle of life, cattle have been getting an undeserved bad rap on everything from diet to environment to compassion. On all three counts, the anti-animal agenda lies behind the false narrative that is leading us down a dishonest path to more fake concoctions of ill-fated science fueling profits at the expense of our physical and emotional health and the health of the planet. Fake meat and fake milk are funded by billionaires, genetically engineered by USDA, initiated as the brain children of Silicon Valley techies, with partnership from the biggest names in corporate agriculture. Noble goals of ending hunger are the defense, but it’s difficult to believe that when we have surplus dairy and meat protein produced naturally with the real problem of hunger coming down to distribution and waste. This so-called solution has the potential to quietly dictate food choices, markets and livelihoods.

By Sherry Bunting, updated since first published in Farmshine, November 21, 2018

WASHINGTON, D.C. –  “Dairy reinvented: Sustainable. Kind. Delicious,” is the tagline of Perfect Day’s website.

“Better meat, better world” are the words that jump from the Memphis Meats website.

To be more specific, Perfect Day’s mission is to “create a better way to make dairy protein, the same nutritious protein found in cow’s milk…without the help of a single cow.”

Meanwhile, at Memphis Meats, their mission is “To bring delicious and healthy meat to your table by harvesting it from cells instead of animals… feel good about how it’s made because we strive to make it better for you… and the world.”

On the fake meat side, Memphis Meats received Series A funding from four sources in August 2017: venture capitalist DFJ, billionaire investors Bill Gates and Richard Branson, and Cargill. In January of 2018, Tyson came on board as an investor.

On the fake dairy side, Perfect Day received its Series A funding from Singapore and Hong Kong venture capital and investment companies that have relationships with some of the largest food and beverage companies and brands in the world, according to a company news release. In addition, Continental Grain was part of the early investment, and in November 2018, Perfect Day announced a partnership with Archer Daniels Midland (ADM).

The big question, at present, is how will these proteins be regulated and labeled?

The discussion is converging with FDA’s nutrition innovation strategy and modernization of standards of identity (especially dairy standards of identity), along with parallel hearings and comment periods on how to regulate and label the ‘meat’ version of lab-created cellular proteins.

Make no mistake about it folks: Both of these processes involve genetic engineering start-to-finish.

Perfect Day (fake milk protein), for example, sources yeast from USDA research labs that has been “genetically-altered” to include bovine protein stimulators and synthesizers.

Memphis Meats (fake meat) uses animal cells, mainly bovine and poultry, from cell banks that have been edited to grow only desired muscle cells — separate from their whole-animal source.

The fake dairy protein would be the end-product of the fermentation of the genetically-altered yeast, while the fake meat protein would be the protein blobs that grow from the genetically-edited cells, using neonatal bovine serum — or a plant chemical substitute that is under development — as a growth “on” button.

Both systems would require energy feed sources, using a sugar and/or starch substrate to feed the growth.

Both processes would produce waste streams.

The dairy version are grown in fermentation vats. The meat version in bioreactor towers.

While opinions vary on how quickly these technologies can scale, it is clear that the technologies are well-funded, and that agriculture’s top-tier food supply-chain processors and distributors are partnering.

We must continue to let FDA and USDA know what farmers and consumers — the two ends of the supply chain that need to be talking to each other — feel about the potential of these technologies to create captive-supply market control using interchangeable proteins in common manufactured dairy products or as protein enhancements for plant-based beverages, as well as to stretch boneless beef and poultry products with fake counterparts, namely as ground beef, hamburger, meatballs and chicken tenders and nuggets.

In a press release Friday, November 16, the U.S. Food and Drug Administration (FDA) and U.S. Department of Agriculture (USDA) announced that they will “jointly oversee the production of cell-cultured food products derived from livestock and poultry.”

There has been no similar FDA PMO-regultory process established for the fake milk proteins.

USDA and FDA had a public meeting in July and October to discuss the use of bovine and poultry “cell lines” to develop these cell-cultured, lab-created foods.

In fact, meat industry stakeholders shared their perspectives on the regulation that is needed to “foster these innovative food products and maintain the highest standards of public health,” said FDA commissioner Scott Gottlieb in an official FDA statement in November.

USDA and FDA announced their “agreement on a joint regulatory framework wherein FDA oversees cell collection, cell banks and cell growth and differentiation. A transition from FDA to USDA oversight will occur during the cell harvest stage. USDA will then oversee the production and labeling of food products derived from the cells of livestock and poultry.”

As FDA and USDA are “actively refining the technical details of the framework,” some of the aspects of the framework are said to include robust collaboration and information-sharing between the two agencies to allow each to carry out our respective roles.

The well-funded startups and their lobbying organization Good Food Institute (a misnomer in this author’s opinion) had pushed for FDA to control labeling and inspection knowing that if USDA were in charge, their efforts to scale production would be slowed.

In view of this joint approach between FDA and USDA, the original public comment period about cell-cultured ‘meat’ had been extended to December 26, 2018. Comments can be seen at the FDA docket at https://www.regulations.gov/document?D=FSIS-2018-0036-0001  and there are thoughts that this comment period could be extended again as has the dairy standards of identity comment period.

Meanwhile, on the lab-created ‘dairy’ protein front, Perfect Day, a Silicon-Valley startup, announced in a press release in November that it has formed a partnership with ADM, an agricultural processor and food ingredient provider with a mission of plant-to-plate collaboration throughout the food industry.

In fact, ADM will provide facilities for scaling this technology as part of the deal.

This partnership is billed as “teaming up” to begin supplying “the world’s first animal-free dairy proteins to the food industry in 2019,” according to Perfect Day.

“Animal-free dairy proteins will not only offer consumers the option to have a lactose-free, animal-free alternative to conventional animal-based dairy, but also provide a portfolio of nutritious and functional, high-purity proteins with similar taste and nutrition profile of dairy proteins for a wide range of food and beverage applications,” Perfect Day said in their press release.

Meanwhile, the FDA has extended — yet again — its invitation for information specifically on “the use of names of dairy foods in the labeling of plant-based products.” So far, 10,043 comments (as of December 28, 2018) have been received on this docket. To comment by the new deadline of January 28, 2019, go to the docket online at https://www.regulations.gov/docket?D=FDA-2018-N-3522.

Dairy checkoff-funded DMI completed a survey of consumers recently showing that 73% are confused about the differences in nutrition between real dairy milk and plant-based alternatives calling themselves ‘milk.’

Other surveys show that more than half of U.S. consumers want healthy foods with ‘clean’ labels having few ingredients and limited or no processing.

It would seem that these findings, among others, would indicate clearly to FDA and USDA that consumers want no more monkey-business when it comes to their food, that they want to see clarity in the enforcement of milk and dairy standards of identity, and that they want to be informed about look-alike ingredients made in laboratories instead of in the time-honored land-and-animal care-taking profession of dairy and livestock farmers and ranchers.

One thing to keep in mind when commenting is to highlight the fact that over half of U.S. consumers want food that does not have a long list of additives and that is minimally processed.

That, on top of nutritional differences and new unproven processes, are enough reason to aggressively label any food containing either the fake dairy or fake meat protein because standards of identity are in place not just for health and safety but also to prevent fraudulent misleading of consumers.

Consumers should know what they are buying and be able to choose food based on their beliefs about what is a better world, not someone else defining what is kind and good and sustainable for them and not using the government’s currently flawed dietary guidelines to decide for consumers what is deemed “healthy.”

Let FDA and USDA know that we as consumers and farmers want clear labeling if these technologies are going to scale into our food system. We want the fake versions to have all of the inspection rigor that real dairy and meat proteins are subjected to.

Above all, we do not want the government quietly removing — via its one-size-fits-all nutrition innovation strategy — our ability to choose foods and production methods with which we want to nourish our bodies and on which we wish to spend our hard-earned money.

This may come down to a battle between fake animal protein ingredients funded by billionaires aligned with Silicon Valley startups and partnered by the biggest names in corporate agriculture vs. a collaboration between individual farmers and ranchers who are the backbone of our nation, the stewards of land and livestock, along with the public at-large, the consumers who are confused by the lines that are blurring.

Now, more than ever, both ends of the supply chain — farmers / ranchers and consumers — need to engage with each other directly — and not through the industry-scripted mouthpieces.

Stay tuned.

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