Understanding the New Bioengineered Disclosure - CSPI Newsroom

USDA Symbol for foods with bioengineered ingredient (left); USDA Symbol for foods with ingredients derived from bioengineering (right).

When you go to the grocery store, have you noticed foods with messaging like “no GMOs” or “contains bioengineered ingredients” on the packaging? Most likely, you have seen a range of ways food manufacturers have chosen to share (or not share) this information. But starting January 1, 2022, USDA regulations specify how foods sold in the United States that are bioengineered or contain bioengineered ingredients must disclose that information to consumers. In this blog, I will break down the history and major components of this new requirement.

Background

In July 2016, President Obama signed the National Bioengineered Food Disclosure Law (NBFDL), requiring food manufacturers to disclose the presence of bioengineered foods and ingredients. A “bioengineered” plant or animal has had a new gene inserted into it to give it a useful trait. GMO papayas, for example, have been given a gene that makes them resistant to the ringspot virus.  “Bioengineering” is a synonym for the more familiar terms “GMOs,” “genetically modified”, and “genetically engineered.”  A bioengineered food or ingredient must contain some of the newly introduced DNA.  According to the National Academy of Sciences and the FDA, bioengineered foods are safe to eat and pose no risk to your health.

The Required Disclosure

The NBFDL and USDA’s regulations require all foods and ingredients that have modified DNA to make a disclosure using one of four methods of the food manufacturer’s choice.  First, the food product can include the words “this is a bioengineered food” or “contains bioengineered ingredients” on the food product packaging near the ingredient list.  Second, the food product can include the “bioengineered” symbol that USDA created in that same location. The third option is to put the disclosure online. The food manufacturer includes a QR code on the food package that takes you to an online webpage with the disclosure information (after you scan it with your smartphone camera).  Finally, the food manufacturer can include a phone number on the package, which the consumer can call or text and receive the information about bioengineered content.

These last two options are the reason the requirement is considered a disclosure rather than labeling.  For all the disclosure options, the food manufacturer need not identify the specific engineered ingredient, so the consumer does not know which of the many ingredients in the product are bioengineered, only that the food contains at least one bioengineered ingredient. (CSPI’s position is that food manufacturers should be able to substitute the more familiar terms for “bioengineered” in the disclosure and identify the specific bioengineered ingredients in a product.)

Example of bioengineered disclosure on the food package (above).

Example of product with electronic disclosure (above). Scanning the QR code with a cellphone takes the consumer to disclosure (below).

Food Manufacturers May Disclose “Derived From” Ingredients

If one or more of a food’s ingredients comes from a bioengineered plant, but the ingredients themselves contain no DNA from that plant, the label may carry a “derived from bioengineering” disclosure, but it does not have to. This would apply to ingredients made from a bioengineered plant that are so highly processed that none of the plant’s modified DNA remains. Some example ingredients include corn or canola oil, sugar, or high fructose corn syrup.  In 2018, the Center for Science in the Public Interest—and even some food companies—urged the USDA to make “derived” disclosures mandatory, but the Trump Administration declined to do so. (CSPI’s position is that we support the “derived from” distinction but that the requirement for those foods should be mandatory not voluntary.)

Exemptions From Disclosure

The law and regulations identify several exemptions from disclosure.  These include restaurant food, foods produced by very small manufacturers, and products from animals that were fed bioengineered crops.  Probably the most important exemption for consumers is the exemption for food products that contain meat, poultry, and/or eggs.  The new disclosure rules don’t cover products that list meat, poultry, or eggs as their first ingredient (or their second ingredient after water, stock, or broth) because those product labels are regulated by other USDA statutes.  However, all food products with meat, poultry, or eggs as the second ingredient (or third where broth or water is the first ingredient) do require disclosure if they contain a bioengineered ingredient.  This also means that if, in the future, we have bioengineered meat, poultry, or eggs, and they are the main ingredient in a food, there will be no disclosure requirement.

Non-GMO Disclosures

The law and regulations do not regulate claims asserting that the product is free of GMOs.  Consequently, any food manufacturer can set its own standard for what constitutes a non-GMO food and claim their product meets that standard.  The Non-GMO Project is a non-profit organization verifying products that meet its non-GMO standard.  However, they also verify products that don’t have a GMO counterpart, such as unseasoned almonds or orange juice (there are no engineered almonds or oranges produced anywhere in the world).  One way to avoid bioengineered ingredients is to purchase foods with the USDA “organic” symbol as that government program does not allow the use of bioengineered seeds, animals, or ingredients.  (CSPI’s position is that USDA should have established a definition of what constitutes a “non-GMO” food.)

The Bottom Line

• GMO (bioengineered) foods currently available are safe. According to the National Academy of Sciences and the FDA, eating them poses no risk to your health.
• Many foods will now have to disclose that they contain “bioengineered” ingredients. The disclosure may be on the package or require going to a website or making a telephone call. The disclosure won’t tell you which ingredients are bioengineered.
• Disclosing “derived from” ingredients is voluntary. Oils, sugars, etc., made from bioengineered plants don’t have to be disclosed if no modified DNA remains in the ingredients, but a manufacturer may choose to do so.
• Restaurants, “very small” companies, most alcohol, and foods with meat, poultry, or eggs as a major ingredient aren’t required to disclose bioengineered ingredients. The disclosures are required on supplements.

USDA's List of Bioengineered Foods

Alfalfa

Apple (Arctic varieties)

Canola

Corn

Cotton

Eggplant (BARI Bt Begun varieties)

Papaya (ringspot virus-resistant varities)

Pineapple (pink flesh varities)

Potato

Salmon (AquAdvantage)

Soybean

Squash (summer)

Sugarbeet

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Valentine's Day Gift Guide: Specialty Ingredients From Around The World - Forbes

Is Vanilla a Sustainable Beauty Ingredient? Environmental and Ethical Concerns - Treehugger

Long before reaching European elites in the 1500s, the creeping vine of vanilla grew wild in tropical forests across Mesoamerica. Nowadays, the majority of the world’s vanilla is grown on the small island of Madagascar and sold to a wide range of beauty and cosmetic brands around the world. 

However, the rising demand for vanilla poses several social and environmental concerns, including cases of child labor, deforestation, and the exploitation of farmers.

Did You Know?

Around 80% of the world's vanilla, commonly known as Bourbon vanilla, is produced in Madagascar, while smaller producers can be found in Indonesia, Mexico, Tahiti, and China. The scents and flavors vary from country to country, depending on the quality of soils, climate, curing methods, and species. 

How Is Vanilla Made?

Hand pollination of a vanilla plant. Aldo Pavan / Getty Images

Nearly all of the vanilla produced commercially today is hand-pollinated using a technique invented in the 1840s. It can take up to five years from planting the vine to producing vanilla extract. 

The traditional, “natural” vanilla extract is generally produced by copping and percolating vanilla beans in steel containers with alcohol and water. It is kept in a cool place for 48 hours before it is filtered and stored.

According to the Food and Drug Administration (FDA) flavoring law, vanilla extract should contain at least 13.35 ounces of vanilla beans in every gallon of spirit for the product to be considered a pure vanilla extract.

Around 6 pounds of green vanilla beans are needed to produce 1 pound of processed vanilla, making it one of the most expensive and difficult spices to harvest in the world.

Nowadays, less than 1% of the total global market in vanilla flavor is actually sourced from vanilla beans, as most brands and products use artificial vanilla extract. The artificial extract contains synthetically prepared products like guaiacol from wood pulp, petroleum, and other chemicals. 

This technique comes from early 19th century scientists who discovered how to derive vanillin, the dominant component of vanilla flavoring, from less expensive sources. These include eugenol, a chemical compound found in clove oil, and lignin, which is found in plants, wood pulp, and even animal feces. 

Synthethic Vanilla

Vanillin is the primary component of the vanilla bean extract. Because of the scarcity and cost of natural vanilla, vanillin is now synthetically prepared using its predominant natural compounds. Look for eugenol, lignin, safrole, or guaiacol to identify synthetic vanilla in ingredients lists

Environmental Impact

Deforestation 

There are several environmental concerns surrounding vanilla production, mainly related to deforestation and biodiversity loss. 

In Madagascar, the rising demand from global markets is forcing farmers to clear forests to make new fields. As a result, the island lost about one-fifth of its tree cover between 2001 and 2018, according to Global Forest Watch, which uses satellite imagery to detect deforestation.

The destruction of Madagascar’s forests is especially worrying, as they are home to 107 species of lemurs, a forest-dwelling primate found nowhere else on Earth. Nearly a third of them are now critically endangered, and most of the rest are considered threatened, largely because of deforestation in recent decades.

Climate Change

Most of Madagascar’s vanilla is grown in the Sava region, a northeastern tropical forest area which usually experiences high annual levels of rainfall, ideal conditions for the vanilla plant. But climate change has created additional challenges for farmers in recent years. 

Extreme weather events are recurring, affecting their delicate crops and causing prices to surge on global markets. In 2017, Tropical Storm Enawo damaged about 30% of the island's vanilla production, sending prices soaring from $60 to about $400-$450 per kilogram in four years. 

Can Vanilla Be Ethically Sourced?

Pierre-Yves Babelon / Getty Images

Income Insecurity

Despite producing the second most expensive spice in the world after saffron, most vanilla farmers have to live on less than $2 per day. But their income security is even more complicated by the fact that vanilla production can be subject to weather conditions and variable demands from global markets, and it doesn’t provide a steady income throughout the year. 

Producers sell most of their harvests between May and September and often run out of savings by the following March or April. And as Rajao Jean, president of a farmers association in the Sava Region, told The Guardian, a single bad harvest can force farmers to sell land, animals, and possessions in an attempt to pay off their debt. 

Child Labor

In order to accelerate production and make ends meet, Malagasy farmers often employ children to plant, harvest, and sell vanilla beans. According to Fair Labor, approximately 20,000 children aged between 12 and 17 work in vanilla production in the Sava region of Madagascar, and children make up nearly 32% of the overall workforce. 

The organization conducted interviews with 80 children, aged between 9 and 15 years old, and nearly all of them confirmed they help their parents in vanilla fields outside of school hours. Boys as young as 12 years old were reported to be transporting heavy loads of vanilla beans and using knives and machetes during the production process.

“Vanilla Wars”

Known as the “vanilla wars,” the high economic value of vanilla has recently made farmers a target for crimes and thefts. 

In the village of Anjahana, on the outskirts of Madagascar's capital Antananarivo, extrajudicial killings related to vanilla have made headline news. According to a report in The Guardian, alleged gangsters sent farmers advance warning of raids demanding vanilla, but were rounded up and killed by local farmers. Such events have been reported in most of the key growing regions, and local communities have called for protection from armed police. 

Is Vanilla Cruelty Free?

The vast majority of the world’s vanilla doesn’t come in contact with animals, which means most of the vanilla we consume is cruelty free. However, the perfume-making industry has long used a chemical compound called castoreum, which comes from the anal glands of beavers and produces a musky vanilla scent due to the beaver’s unique diet of leaves and bark.

While castoreum was commonly used until the 20th century, the chemical compound is now banned in the perfume-making process. According to Fenaroli’s Handbook of Flavor Ingredients, castoreum production still occurs, but it is rather small—about 132 kilograms (292 pounds) yearly. 

Look out for castoreum in the ingredient list to make sure your vanilla-scented beauty products are not derived from animals.

Sustainable Vanilla Alternatives 

In order to ensure brands and companies source their vanilla responsibly, the IDH Sustainable Vanilla Initiative joined forces with 28 companies, including Unilever, Symrise, and Givaudan. Their aim is to promote the long-term supply of high-quality, natural vanilla that is produced in a socially, environmentally, and economically sustainable way. 

The organization is working to grow the supply and market for sustainable and traceable vanilla, improve and sustain vanilla households' incomes, and address the concerns regarding child labor in vanilla production.

In 2017, another solidarity sourcing project called Livelihoods Fund was launched with the fragrance house Mane in Madagascar, alongside conservation organization Fanamby and the local farming communities. Luxury fashion house Armani, which uses Bourbon vanilla in many of its perfumes, has played a crucial role in developing this project. 

The brands are taking action on the ground to develop a sustainable, traceable, high-quality supply chain, which respects the integrity of natural ecosystems and contributes to improving the quality of life for farming communities in Madagascar.

Frequently Asked Questions

• Vanilla extract and vanilla flavor are both made with real vanilla beans. The difference between the two is that vanilla flavor is not made with alcohol and therefore cannot be labeled as extract.

• Most of the vanilla extracts, including artificial ones, are suitable for vegans. However, some perfume brands still use castoreum to reproduce vanilla scents, a chemical compound which comes from the beaver’s anal glands. Look at your beauty products’ ingredients lists and be sure to avoid castoreum if you prefer vegan options.

• There are several environmental concerns related to vanilla, which include deforestation, erosion of soil, and biodiversity loss.

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'The Pioneer Woman' Ree Drummond Crab Cakes and 5-Ingredient Remoulade Recipe - Showbiz Cheat Sheet

The Pioneer Woman has a new recipe that will help you freshen up your dinner menu. Ree Drummond’s latest cooking demonstration features crab cakes. She also prepares a delicious five-ingredient remoulade. You’ll certainly wow your guests with this elegant dish. Here’s how to make this meal.

The Pioneer Woman Ree Drummond’s crab cakes

The Pioneer Woman Ree Drummond | Nathan Congleton/NBC/NBCU Photo Bank via Getty Images

Drummond admits she never makes crab cakes, but she wanted to show home cooks how to prepare them. She promises her crab cakes are “amazing.”

Drummond starts by making the crab mixture. She mixes mayonnaise and lemon zest. Then, she adds seafood seasoning. Drummond says it’s OK to use the seasoning you like best. “You can use whatever seasoning you want—chili powder, paprika, garlic powder—whatever you want,” says the Food Network star on The Pioneer Woman show.

Next, Drummond adds one beaten egg, parsley, panko crumbs (as a binder), Dijon mustard, and lump crab meat. She says it’s OK to use whatever form of crab meat you can find, even if it’s canned.

Making the crab cakes

Ree Drummond | Tyler Essary/NBC/NBCU Photo Bank via Getty Images

“Canned is fine, fresh is fine, frozen is fine, depending on your locale,” says Drummond. “You can use anything you want.” Drummond likes that you can take a canned ingredient and transform it into a dinner that has an impressive presentation. “It’s really refreshing that you can take something like canned lump crab meat and turn it into something so elegant,” says Drummond. She also likes that she doesn’t have to fry the crab cakes in a skillet. Instead, they’re broiled in the oven.

For the next step, Drummond mixes the ingredients. Then she forms the mixture into cakes and places them on a buttered sheet pan. Each crab cake mix is about 1/3 cup in size. Drummond says small measuring cups are helpful because they assist with forming the shape of each crab cake.

Drummond then brushes the tops of each cake with melted butter. “That way, when they’re under the broiler, they’ll get extra brown and have that delicious flavor of butter when we pull them out,” explains Drummond. Drummond preheats the broiler and cooks the crab cakes until the tops are brown.

On The Pioneer Woman website, contributors Erin Merhar and Kara Zauberman say the key to making top-notch crab cakes is to pay attention to how much crab meat and filling you include. You don’t want to use too much of one ingredient and not enough of the other.

“The key to an authentic crab cake recipe is the ratio of crabmeat to filling,” they explain. “It should be packed with juicy crab and spices but not weighed down by breadcrumbs or fillers.”

Ree Drummond’s 5-ingredient remoulade

Next, Drummond makes the remoulade. She says remoulade is just a sauce that’s served with crab cakes. She mixes mayonnaise, chopped capers, lemon juice, garlic salt, and pepper. “And that is the five-ingredient remoulade,” says Drummond.

Once the crab cakes are done, Drummond places them on a platter. She says the butter helps create a golden-brown color on the tops of the crab cakes. The broiler also helps add a bit of crunch. Drummond describes these crab cakes as “gorgeous, easy, simple, beautiful.” Once the crab cakes are arranged on a platter, she sprinkles parsley on top. You can see the complete ingredients and directions here.

RELATED: ‘The Pioneer Woman’: Funniest Things Ree Drummond Said About Food

Follow Sheiresa Ngo on Twitter.

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Plant-based: Mitigating against ingredient bottlenecks to disrupt 6% of global meat market - FoodNavigator.com

Breakthrough ingredient for plant-based chocolate? Palsgaard highlights high-performing lecithin replacement - FoodNavigator-USA.com

More consumers are looking for plant-based credentials in the chocolate aisle and brands in the category have responded accordingly with vegan and dairy-free chocolate products. Globally, the sector recorded a 24% compound annual growth rate for 2018 to 2020 with North America accounting for 21% of new plant-based chocolate launches, according to Innova Market Insights data.

And while there is clearly a lot of activity and consumer demand for chocolate products made without dairy, formulations have typically relied heavily on costly cocoa butter used in combination with lecithin, which has functional limitations, noted Palsgaard.

Dairy-free chocolate challenges

Removing milk fat to create a dairy-free version of chocolate is not an easy task, explained Arne Pendersen, regional application manager, bakery & confectionery, Palsgaard.

"When making plant-based chocolates you typically need to replace the milk components with other sugar and protein sources to get the milky-like appearance and mouthfeel," ​Pedersen told FoodNavigator-USA.

"Typically, these replacements will absorb more of the fat than the milk components with a resulting higher viscosity of the liquid chocolate and a more dry mouthfeel in the finished product. To avoid this, it is common to add 2 – 3% more cocoa butter to the recipe, which is very costly. Instead of adding more of the expensive cocoa butter, a replacement of lecithin with Palsgaard AMP 4455 will do the job.​"​

To put the cost savings into perspective, for a medium-sized manufacturer producing 10,000 MT of chocolate a year, switching to AMP 445 and in the processing cutting down on the amount of cocoa butter used translates to savings of €700,000 (US$790,000), according to Palsgaard. 

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Plant-based: Mitigating against ingredient bottlenecks to disrupt 6% of global meat market - FoodQualityNews.com

Is NAC SOL? | Immunity ingredient of the year is … - Natural Products INSIDER

N-acetyl cysteine has been a beloved ingredient for detox (and, yes, hangovers) since 1991—three years before DSHEA was passed with its “grandfathered” ingredients proviso. Still, the FDA says it approved it as a drug back in 1963 so it must be taken off the market. Amazon abided. But really now, a half-century later? Seriously?

Speaking of the FDA, regulatory guru Asa Waldstein tells you the No. 1 reason why you don’t want a Warning Letter. Hint: Follow the money.

Also this episode, get a tutorial on the ingredient of the year in the immune-health category, as voted on by a panel of judges at SupplySide West 2021 in Las Vegas last October. Differentiate your brand in the marketplace by using this gatekeeper branded ingredient that activates other immune cells.

Guests this week:

• The Co-Factors: Todd Runestad & Ola Lessard
• Law Dog Josh Long, Informa Legal Editor
• Asa Waldstein from Supplement Advisory Group
• Danielle Citrolo, PharmD, vice president of scientific and regulatory affairs at Kyowa Hakko US

For additional epsiodes, visit the Insider in the Afternoon home page.

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This Secret Ingredient Can Take Your Deviled Eggs Up A Notch - Tasting Table

The first step to adding butter to your deviled eggs is to make sure you're actually using butter. Because the whole point of the addition is to maximize the structural integrity of the egg mixture, margarine or other plant-based butter alternatives don't substitute well for the real thing. According to Eat This, Not That, the water content in margarine is a lot higher than that of butter, and that means the consistency is literally watered down. Vegan butter isn't much different. As My Recipes explains, vegan butter is simply a type of margarine made only with plant-based ingredients, but both are still majority oil and water.

Provided that you're using actual butter, Taste of Home recommends a ratio of two tablespoons per batch of deviled eggs. Softened butter is best because it blends better with the rest of the ingredients without the risk of any curdling. Per Taste of Home's instructions, simply combine the egg yolks, mayonnaise, and mustard as you normally would in a standard recipe, then add the softened butter. Since there's just a couple tablespoons of it, the butter only serves to amplify the original flavors of the deviled eggs instead of overpowering them, and, of course, they'll also hold up much better when you're ready to serve them.

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Cocaine was the secret ingredient in pig-to-human heart transplant - New York Post

The organ used during the groundbreaking pig-to-human heart transplant that took place earlier this month got a boost from an unlikely drug: cocaine.

Now, doctors hope to see more of the party drug in transplant hospitals.

Dr. Muhammad Mohiuddin, director of xenotransplantation — which refers to the process of transferring an animal organ into a human — at the University of Maryland Medical Center, spoke to Vice News about his historic work on a 57-year-old patient who became the host of a genetically modified pig heart.

The heart was developed by lab company Revivicor, tweaked so that its DNA would be more amenable to a human host, then fortified with the party drug by Swedish medical tech company XVIVO, before traveling to the US.

Usually, transplant organs originate from much shorter distances as they deteriorate within a few hours outside of the body.

The 57-year-old patient of the first successful pig heart xenotransplantation is now recovering.

University of Maryland School of Medicine

Mohiuddin explained how cocaine was used in a mixture among hormones, including cortisol and adrenaline, that keep the live tissue from spoiling during its long journey overseas to Maryland, but the proprietary solution raised flags with drug enforcement officials in the US, where cocaine has never before been used in this setting.

“The cocaine name pops out because everybody thinks, ’Oh my God, what is cocaine doing in here?’ ” Mohiuddin told the outlet.

Doctors hope to see more of the party drug in transplant hospitals: “It will be a great advance if this process is approved by the regulatory agencies.”

University of Maryland School of Medicine

Medical researchers aren’t clear on the mechanisms behind the amphetamine’s efficacy, but Mohiuddin wasn’t concerned with the “why” at the time, as the cocaine and hormone blend had bested the alternatives.

“When we were not using this solution, we were getting failures within 48 hours. But when we started using this and infusing the heart with this solution, the heart became well preserved and started beating very well,” he said. 

A tedious permit process with the US Drug Enforcement Administration ensued. “It’s a bit of a hassle but it’s a routine procedure when importing controlled substances,” said Mohiuddin. 

The doctor encouraged further research on the use of cocaine in transplantation protocol in the US. “It will be a great advance if this process is approved by the regulatory agencies,” he said.

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Tate & Lyle's insight into global consumer ingredient perception - BakeryAndSnacks.com

“55% of global consumers say they expect snacks to offer a nutritional boost, so manufacturers must keep this in mind when formulating new snacks in the coming months, whether it is reducing calories or enriching products with functional ingredients,”​ said Greet Vandeputte, category development manager for Bakery and Taste & Lyle Europe.

According to the company’s Global Consumer Ingredient Perception Research – conducted across 14 countries in 2020 – 46% of consumers said they snacked more during the pandemic, while six in ten (58%) believe their snacking habits will continue even after the pandemic ends.

“Although the ingredients are an important factor, taste is still the dominant factor impacting buying behaviour. The Tate & Lyle team is working closely with a number of manufacturers to help them achieve these goals with our broad portfolio of ingredients solutions.”​

Sugar reduction

Vandeputte said consumers are looking for ways to get healthy and stay healthy.

“One recommendation to achieve better health is to reduce the amount of sugar in their diet. However, consumers are torn between reducing sugar and maintaining a great taste experience.​

“Many sweeteners are significantly sweeter than sucrose, so they are used at very low levels. But these options generally only provide sweetness without the other functional attributes of sucrose. This can impact the appearance, texture and mouthfeel of baked snacks, so may require a complete recipe change to compensate for this.”​

Tate & Lyle produces a soluble fibre solution, along with a range of texturants and functional clean label starches that help to build back mouthfeel and body often missing from reduced calorie baked snacks.

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APIs: The secret ingredient for a big tech leap - McKinsey

In 2017, Emirates NBD Group, a leading banking group in the Middle East, North Africa, and Turkey (MENAT), was confronted with an ever-increasing demand from customers to provide innovative digital products and services in a highly competitive market. At that time, the banking group had strong business ideas for thriving even as its competition increased, but its IT delivery had reached capacity, so it couldn’t put all its ideas into practice. So the company decided to execute a complete overhaul of its IT infrastructure and parallel functions.

In this interview with McKinsey’s Henning Soller and Timo Mauerhoefer, Emirates NBD’s Neeraj Makin, group head of international and group strategy, and Saud Al Dhawyani, chief technology officer, explain how the bank designed, fast-tracked, and implemented its IT transformation by using application programming interfaces (APIs) to simultaneously accelerate technical modernization and enable new business ideas over time.

McKinsey: Tell us what inspired Emirates NBD Group to undertake its IT transformation in 2017.

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Neeraj Makin: We operate in very competitive markets and were faced with an increasing demand for digital solutions for our customers. Although, at the time, we were regarded in the region as a leader in digital solutions and technology, our technology was complex.

We had multiple different technology stacks, and the integration among our IT platforms was complicated, which slowed us down and made any changes to our technology very expensive. Our core IT platforms were not aligned across our different locations, causing redundant work. Top management was unsure whether these locations would stay profitable.

Moreover, we had outsourced a lot of key IT capabilities, such as our IT engineers. In this setup, we couldn’t react to the increasing demand for digital solutions, such as end-to-end digital customer journeys, let alone leverage innovative banking technology, such as advanced-analytics-based product offerings. We concluded that we needed to transform our technology to outperform our competition and stay a leader in digital and technology.

McKinsey: How is your transformation different from other companies’ technology transformations?

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Saud Al Dhawyani: One key difference was that we changed everything within IT in parallel. While many organizations focus on, for instance, a core-banking-system migration or push cloud adoption or experiment with agile teams, we decided that to conduct a true quantum leap, we needed to pull every lever within IT and fully transform our core technology.

We upgraded our IT architecture by modernizing key IT platforms and simplifying their integration. We optimized our IT infrastructure by building the first private-cloud platform in the region, and we modernized our organizational structure, which enabled an agile operating model. But we didn’t stop there. Building on the revamp of our core technology, we developed new digital capabilities, such as robotics, smart automation, and advanced analytics, to generate the full business value of our transformation.

Changing basically all elements of IT in parallel is a complex effort, which is the reason why many other organizations sequence the initiatives over a longer period. However, in light of increasing competition, we needed to be fast and complete our transformation within four years. To change our IT estate in parallel, we had to carefully design a modular architecture with separate layers and decouple our core platforms in the initial stages via APIs.

Given the complexity of this transformation, we knew that we would need to significantly upgrade and exchange our existing talent—this is another key difference from other transformations. We didn’t start any technical initiative until we had a critical mass of new and upskilled talent in place.

McKinsey: What role do APIs play at Emirates NBD?

Saud Al Dhawyani: In 2017, before we launched our technology transformation, we had few unstandardized APIs. Today, APIs are at the core of our IT architecture and play a significant role in our digital strategy. Our strategy is built around three key elements that are central to our API-centric architecture (exhibit).

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The first element is called Sahab, meaning “cloud.” It is a fully automated private-cloud platform that is the foundational platform on which all our applications operate. The second we call Bawaba, meaning “gate.” This is our groupwide API platform, which manages more than 800 microservices and connects our channels, applications, and data platform. It also includes our developer portal. Third is our enterprise-data platform, which we call Manara, meaning “lighthouse.” Manara enables real-time data exchange among applications, a key feature that we didn’t have in the past.

With this drastic shift to APIs, we have significantly increased our delivery effectiveness and efficiency. For instance, the productivity of our agile squads rose dramatically after we launched our internal developer portal, which allows users to easily search for and manage all our APIs. This significantly reduces the integration efforts among different teams and applications and decreases the duplication of functionalities by enabling reuse at scale.

APIs were crucial for our transformation because they allowed us to modularize our IT estate and modernize some of our core IT platforms, such as our payments hub and trade-finance IT platform. We now have almost the same “code base” for all entities and locations and can add new functionalities efficiently. This also makes us more flexible in our international markets, where our growth was historically limited by our technology capabilities.

A specific example of how our API-based architecture directly creates business value is through our retail assets. Using APIs, we will be able to access and integrate different back-end capabilities and information to provide an easy way for our customers to use our key retail products and services, such as loans, cards, and mortgages, in a self-service way online. APIs now allow us to instantly offer credit cards to our customers, whereas, before, that process required lots of manual checks and reviews. Through our modular architecture, our retail assets will also be available for all our legal entities and locations.

From a business perspective, APIs enabled several strategic business initiatives. In 2019, we launched WhatsApp Banking for our customers in a matter of weeks. Today, we have 100,000 subscribed users for Emirates NBD and 50,000 for Emirates Islamic, and we have seen around a million interactions in the past 12 months. We now also have a dedicated ecosystem and API team that identifies new business opportunities enabled by making our data, products, and services available via APIs.

What’s new in banking API programs

McKinsey: Can you give us an example?

Neeraj Makin: Sure. We are collaborating with the Department of Economy and Tourism (DET) on a blockchain project to source licensing information. While blockchain is the underlying platform that provides a single source of truth of verified companies as well as of individual data and documents, we can interact with it through the APIs we build on Bawaba. These APIs allow our small and medium-size enterprises and corporate clients to consume this capability as a service. This aligns with our philosophy of building once, while the APIs enable reusability.

We also supported noqodi, a leading provider of online technology solutions in the Arab world, with real-time transaction-processing capabilities to enable operational efficiency when paying its merchants and clients. We implemented three key services leveraging our APIs on Bawaba. First, fund transfer, which allows customers to transfer money between Emirates NBD accounts locally and internationally. Second, transaction history, which gives customers access to a list of recent transactions. And third, transaction-status inquiry, through which customers can obtain recent details of a single transaction.

McKinsey: How did you approach your API transformation?

Saud Al Dhawyani: We started by designing our target architecture blueprint based on the three core platforms. We aimed for an approach to integrate these platforms through APIs and to standardize our management of APIs for two main reasons: first, to avoid creating a complex integration, or “spaghetti architecture,” as we had in the past, and second, to be more flexible and able to extend our technology by providing certain platforms a faster, more efficient way to exchange information and data, or by integrating new solutions from third parties, such as fintechs.

To prioritize our APIs, we structured the existing services we had on our enterprise service bus (ESB) in standard banking domains, such as customer and product. We also prioritized certain nonbanking APIs as “common” or “channel engagement,” such as campaigns, offers, and optical character recognition (OCR) functionalities.

We then prioritized the services based on relevance for our transformation—that is, when we would need to decouple each IT platform to drive the modernization—as well as on their level of complexity. Based on these criteria, we could better understand what the overall effort of “API-zing” our IT architecture would be. Then we started to outline the operating model and governance, in addition to detailing the API taxonomy, standards, and guidelines. Last, we decided on the technology solution for the API management platform and other relevant components and started the first proof of concept.

McKinsey: How did you build momentum at that stage?

Saud Al Dhawyani: We outlined the importance and potential of APIs for both technology and business to our management and dedicated a significant part of the budget to it. We had initial funding that was sufficient to lay the technological foundation, define the required standards and policies, and migrate all our services from the legacy ESB to microservices accessible via our standard APIs. We now have roughly 800 microservices available.

This foundation allowed us to establish three agile squads that worked only on building APIs in the different domains. We kick-started our API effort by running several API awareness sessions in IT, and we also spread awareness among our business colleagues to help our employees understand the opportunities.

To drive API adoption, it was crucial to implement a user-friendly developer portal with good documentation and sufficient search functionalities. We looked for best practices across the globe. Moreover, we invested in training our developers to familiarize them with the developer portal and with the API guidelines and standards right from the beginning. We wanted to lay the right foundations so we could easily scale when the time was right.

After initial small successes with the internal use cases and some external ones, the business demand grew significantly. They wanted additional APIs—and they wanted them quickly, so we created an agile budgeting and prioritization process to cater to the increased demand.

McKinsey: What were the biggest challenges?

Saud Al Dhawyani: One of our biggest challenges was to get the right talent to drive our API approach. Completely redesigning the integration architecture, setting up an API management platform and developer portal, and continuously prioritizing the initial API backlog are very complex tasks. On the one hand, we needed experienced engineers who knew the technological details, and on the other hand, we needed experienced product owners to ensure a laser focus on the right priorities.

In the beginning, there were several concerns about being able to build up the required talent in Dubai, since tech talent is not readily available. However, we managed to do it through a balanced combination of hiring and developing our existing talent. One key element to our success was establishing dedicated learning journeys for the different roles we needed with a combination of internal and external courses as well as certification programs.

Later on in our journey, we faced the challenge of increasing the productivity of our agile API squads. When we started, it was acceptable for our teams to deliver one API in two-to-three-week sprints. However, to follow our road map, we needed to increase our productivity dramatically. We leveraged DevOps automation tools to optimize the integration and maintain continuous deployment and delivery and doubled our API output.

McKinsey: Is there anything you would do differently if you were starting again?

Saud Al Dhawyani: Although our approach of clustering and prioritizing the existing ESB services was a good starting point to limit our initial scope, I would not follow this approach without restrictions. I would instead spend more time detailing the target design of the domains and evaluate in more detail which APIs enable the highest business value—though this certainly doesn’t mean a reduction in IT integration costs. I would also leverage existing frameworks, such as the Banking Industry Architecture Network (BIAN), as much as possible to better identify and prioritize the APIs that have higher business value.

McKinsey: What are the benefits of your API efforts? How do you quantify them?

Neeraj Makin: We have enabled several strategic business initiatives as a result. One example is our digital onboarding, which is available on mobile phones for self-service and via tablet for assistance in our branches. We have onboarded more than 100,000 customers with our new process, doing up to 85 percent with straight-through processing in less than ten minutes.

We have also implemented several successful data and analytics use cases that drive our business performance. For instance, through our API-based architecture, we were able to launch a new corporate and institutional banking portal—we call it Business Online—which is fueled by real-time data. With this tool, we can offer our corporate clients an instant overview of their payments, open letters of credits, and more—a service that is unparalleled in the region.

McKinsey: What key success factors should other organizations look for when embarking on their own API journeys?

Neeraj Makin: When reflecting on the API transformation of Emirates NBD, we can clearly see three success factors. The first is to define a clear API strategy, aiming to maximize the number of APIs as fast as possible and drive adoption with a user-friendly API developer portal. Second, be sure to build the right technology environments in order to effectively scale and maximize the team’s productivity—for example, through implementing cloud or DevOps. With traditional nonautomated infrastructure setups, it is difficult to realize the benefits of APIs. Finally, there’s talent. Having the right engineers and product owners is key to scaling an API-driven ecosystem. That requires a balanced combination of hiring new members and upskilling existing employees.

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Collagen remains a superstar in 2022: 2022 Ingredient trends for food, drinks, dietary supplements, and natural products - Nutritional Outlook

Any way you slice it, collagen sales are stellar. Collagen companies are now striding confidently—and excitedly—into 2022.

Per SPINS multioutlet channel tracking, powered by IRI, collagen ingredient sales in the U.S. mainstream supplements market grew a whopping 56% in the year ending October 31, 2021, reaching $241 million compared to $154 million a year ago. Collagen now ranks #23 on the list of 25 bestselling mainstream functional ingredients.

Meanwhile, per SPINS natural enhanced channel tracking, collagen ingredient sales in the U.S. natural supplements channel grew 7% in the year ending October 31, 2021, reaching $67 million compared to $63 million a year ago. Collagen now ranks #2 on the list of 25 bestselling functional ingredients in the natural channel.

“Conservatively,” says Angie Rimel, marketing communications manager, North America, Gelita (Sioux City, IA), “2021 should see sales of collagen-based supplements at nearly $250 million, more than triple compared to 2016. Collagen peptides have been widely recognized as one of the hottest ingredients in modern times.”

Lindsey Toth, associate director, global marketing, Lonza Capsules & Health Ingredients (Morristown, NJ), points to a Forbes article published last year¹, noting, “The global collagen market more than doubled in size from $3.5 billion in 2018 to $8.36 billion in 2020 and is expected to reach $16.7 billion by 2028.”

Collagen secured an enthusiastic audience amidst the pandemic. Says Rimel: “Although the market growth had cooled for a bit during the early days of the pandemic, the momentum of this market is back on pace to continue dominance in the arena of active ingredients.”

Indeed, “With so many unknowns over the past two years, healthy daily rhythms can provide a sense of stability, familiarity, and comfort—not to mention tangible physiological benefits,” says Liz Clarke, CFS, technical marketing manager, Nitta Gelatin North America (Morrisville, NC). “While immunity superstars like vitamins C and D, zinc, and elderberry saw huge spikes in sales, we saw a milder, but similar pattern of use, with collagen-containing products during the same period of late 2020 to late 2021.”

Each year, interest expands beyond collagen’s origins in skincare and beauty. After all, one of collagen’s strongest characteristics, and what will drive the ingredient going forward, is the fact that the one ingredient has so many overarching benefits. This gives companies considerable latitude to innovate products that address multiple health concerns at once.

“One major reason for growing collagen sales is consumer interest in supplement solutions that offer multiple, complementary benefits,” says Lonza’s Toth.

Combination health-benefit products are taking the market by storm and attracting new users. Nutrition brand Bulletproof, for instance, last year launched five new collagen-based need-state products, including a Sleep Collagen Protein drink mix combining collagen protein with melatonin, chamomile, and magnesium, and a Complete Daily Energy Collagen Protein mix marrying collagen protein, essential amino acids, medium-chain triglyceride (MCT) oil, and a blend of ginseng, magnesium, and cordyceps. “We created our targeted collagen line that gives all the benefits of a collagen supplement with added functional ingredients,” says Shenoa Riegel, brand manager, Bulletproof. “Our Sleep Collagen is a great pre-bedtime routine, and Energy Collagen is great for a boost of energy to start the day.”

She adds, “We see functional ingredients coupled with collagen for a specific need state as an integral part of what is helping grow collagen interest now and in the future.”

Jim Burkett, president of the brand Great Lakes Wellness, says, “Gut health has been a hot topic of discussion.” His company recently introduced its Daily Digestion Collagen Peptides, a quick-dissolving drink mix containing collagen peptides and 5 billion CFU of branded probiotic strain Bacillus subtilis DE111, plus prebiotic fiber and vitamin C (to support collagen production).

Lonza’s Toth highlights collagen’s complementary presence in bone health products. “Bone and joint health typically go hand-in-hand for consumers, as they are both key to mobility; bone brings structural integrity to the body, while joints enable movement. However, the ingredients that address each one are very different—undenatured type II collagen for cartilage, and calcium and vitamins D and K for bone health, to take a few examples. For consumer convenience, developing combination products using formulation expertise and innovative capsule technology helps bridge this gap and address multiple health concerns while also driving market growth.”

The fact that collagen is so friendly to work with—including in food and drinks—enables lots of innovation. “Collagen peptides allow for a wide range of formulations—for example, powder, gel, gummies, concentrated shots, near-waters and bars, and inclusion in everyday foods such as yogurt,” says Gelita’s Rimel.

“Collagen peptides,” she explains, “are versatile and easy to use. They have a neutral taste and can be incorporated into a diverse range of products. Additionally, they have high heat and acid stability, low viscosity, and no precipitation or clumping. They also offer fast absorption and good bioavailability, and are free from fat and cholesterol.”

Riegel says Bulletproof “continues to see a preference for healthy drink options among consumers,” and that single-use packets and bars provide travel-friendly options for customers on the go.

Plant-based cream and creamers are also hot categories for collagen, adds Haleigh Resetar, corporate communications specialist, SPINS.

All these product types give consumers many ways to adopt a collagen product into their daily diet. “People are creatures of habit and need products that fit into their already established routines,” says Burkett at Great Lakes Wellness. “Collagen powder is a popular choice as it can be added into morning cups of coffee, smoothies at the gym, or even oatmeal. Stick formats make on-the-go collagen consumption easy and convenient, as do gummies. New flavors are catching the eye of consumers as well, bringing a fruity or sweet twist to their daily water intake. We’ll see the continued development of products that target specific needs and are easy and convenient for consumers—from quick-dissolving tablets to other flavor combinations.”

“Consumers are searching for products that will help them age the way they like to age,” he adds. “Collagen can also target multiple areas of wellness at the same time, rather than using multiple products to get the whole package, or they can opt for collagen that targets exactly what they want.”

Two of consumers’ primary goals for collagen supplementation are beauty and joint support. These are firmly established as collagen’s strongest categories.

“Beauty applications remain the top application for collagen. In the U.S., skin and beauty is the main purchasing driver for almost half of collagen users,” says Jaume Reguant, healthcare director, Bioiberica (Barcelona, Spain), citing 2021 consumer survey data from Ingredient Transparency Center (ITC).

Collagen’s growth in the U.S. hair, skin, and nails supplement market was impressive last year. Per SPINS tracking, within the mainstream multioutlet hair, skin, and nails supplement sector in the U.S., collagen was the second-highest-selling ingredient, growing an incredible 61% in sales the year ending October 31, 2021, reaching $122 million compared to just $76 million the year prior. Over in the natural-channel hair, skin, and nails supplement market in the U.S., collagen was the number-one-selling ingredient, reaching $22 million.

Credit goes to the growth of ingestible beauty. “The nutricosmetics market—whether we call it ‘edible’ or ‘beauty-from-within’—has experienced substantial growth over the last five years in sales volume,” says Sid Hulse, vice president of product development, PLT Health Solutions (Morristown, NJ). “What was once a strong business in Asia—particularly Japan and Korea—has now become a global phenomenon.”

Joint health is collagen’s second-highest seller. “In fact,” Bioiberica’s Reguant says, “collagen is currently driving growth of the joint health category, which has historically been dominated by ingredients such as glucosamine and chondroitin.”

Interest in collagen for joint health may have also shot up as the pandemic adversely impacted routines and mobility. “The pandemic affected consumers in a huge number of ways, including how they move and how their joints feel,” Lonza’s Toth points out. “Lockdowns and gym closures disrupted exercise routines, while at-risk individuals have avoided leaving the house. Many people who were once very active have lost some joint flexibility and mobility, while pandemic-related weight gain has become common in the U.S. and Europe—another major cause of joint health issues.” Joint health will continue being a leading concern. “Joint health remains a key driver of the collagen market—it has long been a major consumer priority,” she says.

Tangential health concerns are also getting swept up in the enthusiasm for collagen. For instance, joint health relates to sports performance and active nutrition, and here, collagen is growing its name, especially as more consumers seek to increase their level of exercise during the pandemic, Toth says.

Performance nutrition is one of collagen’s top-growing categories, Resetar at SPINS confirms. “In the performance nutrition category, the top subcategories include postworkout, preworkout, and hydration and electrolyte,” Resetar adds. “We can expect to see shoppers interested in exercise and nutrition to be pushing this ingredient forward in innovation. The expanded role of collagen for joint support and performance opened new categories for the ingredient.” Gelita’s Rimel highlights her own company’s body-toning collagen peptides as playing in this space.

Cognition is another emerging focus. “Another collagen application with potentially enormous benefits is brain health,” says Abdul Alkayali, vice president of sales and marketing, Certified Nutraceuticals Inc. (Pauma Valley, CA). “The approximately 100 billion neurons in our brains rely on neurotransmitters made of essential amino acids to enable thinking and memory.” Jellyfish collagen, he says, offers not only these amino acids but also macronutrients and calcium-binding proteins.

Stress relief is another area to explore. “Stress manifests itself in different ways, both mentally and physically,” says Nitta Gelatin’s Clarke. “We’re hearing so many accounts of self-care routines featuring collagen peptides addressing both the physical and mental manifestations of stress, allowing consumers to both look and feel their best.”

And then there’s immune health. Gelita’s Rimel says, “The fact that [specific collagen] peptides also contribute to immune function is a fairly new discovery.”

Witnessing consumers’ growing interest in these other health benefits of collagen is gratifying to ingredient suppliers who have been investing in collagen research.

The public’s growing focus on holistic health, particularly during the pandemic, bodes well for the enduring appeal of a multifunctional ingredient like collagen. “The growth of collagen can be attributed to many factors, including changes in health focus from immunity to strengthening the overall wellness of the entire body,” says Resetar at SPINS. “The pandemic opened the eyes of consumers in terms of looking at their health in its entirety. It started with consumers looking at introducing supplements that promoted immunity, and from there shoppers started to take a closer look at how they were treating the rest of their body. Shoppers want to take care of their body from the inside out, and through branding and marketing of collagen products, consumers learned of its benefits both inside and outside the body. This corresponds to the growing trend of increased health and beauty from within.”

And this is why beauty-from-within products like collagen are outperforming the market. Says Hulse at PLT Health Solutions, “If you’ve seen the sales volumes for the traditional cosmetics market since early 2020, not only hasn’t there been any growth, but sales are also dramatically lower. This is not the case in the nutricosmetics beauty market, which tends to focus more on health as a driver than just appearance.”

The result is that nearly all collagen businesses interviewed here report skyrocketing, double-digit sales gains last year. And the good times will continue. “When it’s continuing to do well in the natural channel, that’s why I’m comfortable saying that it’s going to continue to have growth in the conventional channel as well,” says Scott Dicker, senior market insights analyst at SPINS. Will sales plateau? “At some point, yes,” he says. “I don’t predict 2022 is the year, though.”

For one thing, collagen’s audience continues to grow. “Traditionally, the age-related decline of function or appearance was the primary driver of collagen demand. Today, we’re seeing more interest in collagen from consumers of all ages,” says Certified Nutraceuticals’ Alkayali. “Younger and middle-aged consumers are supplementing with collagen products to maintain joint health and function in hopes of preventing the mobility and pain issues plaguing the older generation. Similarly, younger consumers are turning to beauty products with collagen to help maintain and enhance beauty.”

Burkett at Great Lakes Wellness agrees. “All ages and backgrounds are turning to collagen. It comes in a wide range of flavors for easy integration. Social media is huge and an easy avenue for sharing products and results over time between friends, family, and followers. Younger generations are also turning to collagen as they are seeing the results from Gen X and the Boomers.”

Toth says Lonza has been doing studies on its ingredient to demonstrate joint-health benefits not just in older populations but in healthy, younger subjects as well.

And Reguant at Bioiberica says, “Over the past few years, we have seen a steady increase in the number of consumers taking a daily dose of collagen—up 8% in the U.S. between 2019 and 2021,” he says, again citing ITC survey data. “What’s more,” he continues, “almost half of regular collagen users say they have increased their intake over the past year, suggesting there is a growing loyal base of consumers that are seeing the benefits and wanting more.”

The science is also strengthening. “Collagen ingredient technologies are evolving by leaps and bounds,” says Nitta Gelatin’s Clarke, noting that “researchers continue to gain more in-depth understanding of collagen peptides’ mechanisms of actions within the body…” She adds: “Even over the past few years, we’ve seen the general tone of skepticism transition into genuine interest, and support, by the wider scientific community.”

Collagen also lets companies check off the boxes important to today’s shoppers. For instance, says Hulse at PLT Health Solutions, “We find that ‘origin story’ is increasingly something that consumer products companies want to share with consumers. Consumers want to know about sustainability, non-GMO certification, fair trade, traceability, and more when they go to select a beauty-from-within product containing collagen.”

Certain consumers prefer non-bovine and non-animal-based collagen sources, Hulse adds. Burkett says Great Lakes Wellness launched its Daily Marine Collagen Peptides product last year for its pescatarian and flexitarian customers “so they can still reap the benefits of collagen in a format that isn’t from bovine sources.”

“The collagen source can…be a key purchase influencer,” agrees Bioiberica’s Reguant. “There has been a slight increase in the number of collagen users looking for ‘grass-fed’ or ‘fair trade–sourced’ collagen. In the U.S., egg-sourced collagen is the most popular choice for regular collagen users, although the overall split across different sources (vegetarian, marine, chicken, egg, and bovine collagen) remains fairly even.”

Educating the industry and consumers about the differences between collagen ingredients will be key to protecting the category’s longevity. After all, collagen is not a singular ingredient but rather a broad category. As Certified Nutraceuticals’ Alkayali points out, “There are 28 different types of collagen.”

Unfortunately, people might be unaware of the differences—the efficacy, dosage, and benefits—between collagen types. It also doesn’t help that manufacturers looking to capitalize on the collagen trend—but who are unwilling to pay the price for a clinically proven, high-quality, often branded, ingredient—can take advantage of a general lack of knowledge.

Suhail Ishaq, president, BioCell Technology LLC (Irvine, CA), says, “There’s two different dynamics happening in the industry. Some that are purely cost-driven—contract manufacturers who are just riding on the coattails of the success in the category and saying, ‘Hey, collagen is hot. Just come out with a product.’ And when they see how much [branded ingredients like] Verisol or BioCell Collagen cost, they’re, like, ‘Oh, well, you know what? We can find some cheap stuff, and consumers don’t know. We’ll just call it collagen on the label and just start marketing it.’ You have those players who are just price-driven and who have no sense of real caring for quality and integrity. And then you have the other players who are, like, ‘No, hey, we really want to make sure we can deliver products that are effective, that we can really stand behind.’”

“That’s, I think, where the industry needs more stewardship,” he continues, “because there’s extreme over-generalization that’s happening in the category.” Fortunately, he believes this will cease over time as more people learn about collagen types.

Nitta Gelatin’s Clarke hopes likewise. “Branded, clinically substantiated collagen peptides are primed for major growth as we move past demand for generic collagen ingredients,” she believes.

As consumers get serious about collagen, they also may be willing to pay more for a better-quality product. “Indeed, research shows that ‘quality’ is the major factor driving price premium for branded ingredients, with over a quarter of collagen users willing to pay a premium of over 20%,” says Reguant at Bioiberica.

“We expect that collagen sales will continue on an upward trajectory as more brands and consumers come to understand the various types of collagen available and the different benefits of each,” says Lonza’s Toth.

Collagen sales will continue forging ahead even as these best practices take hold, with collagen companies reaping the rewards as they learn how to position their products to meet the growing demand.

“We can tell who’s winning and losing” in the collagen market, says Douglas Jones, BioCell Technology’s global sales and marketing manager. “We’ve got a couple of customers that are just hitting this thing out of the ballpark” with their product positioning—such as by branding their products more strongly to play up their collagen ingredients, as well as strengthening their marketing around structure-function claims and highlighting clinical studies on proprietary, branded ingredients.

Hulse at PLT Health Solutions states, “Quality science allows messaging that consumers will trust…Healthy solutions backed by trustworthy clinical science and delivered in product forms that delight the consumer are where today’s edible beauty market is going.”

As collagen goes from strength to strength, its stage continues to grow, and its star continues to rise. “When you look at retailers like CVS and Target who have created beauty-from-within departments in their cosmetic aisles,” says Jones, “…you know you’ve transitioned right when you’ve got your own section in Target.”

Reference

1. Robert Y. “Here’s Why Wellness Brands Are Investing into Collagen.” Forbes. Published November 15, 2021.

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CRN presses FDA again on NAC ingredient's legal status in newly filed comments - Nutritional Outlook

The Council for Responsible Nutrition (CRN; Washington, DC) yesterday filed new comments with FDA over whether the agency can continue to try to lawfully ban the ingredient N-acetyl-L-cysteine (NAC) from use in dietary supplements. These comments follow a letter CRN sent to FDA on January 4, 2022, as well as a citizen petition CRN sent FDA in June 2021. CRN says FDA continues to fail to address the key question the association has asked the agency to answer: whether NAC can be legally banned as a dietary supplement ingredient under the Federal Food, Drug, and Cosmetic Act’s (FD&C Act) drug preclusion clause.

Dietary supplement associations, including CRN, the Natural Products Association (NPA; Washington, DC), and the American Herbal Products Association (AHPA; Silver Spring, MD), either filed citizen petitions or comments with FDA last year over NAC. This came after, in July 2020, FDA unexpectedly sent warning letters to some companies selling NAC dietary supplements, telling them that NAC is not legally allowed in dietary supplements. Despite the agency’s own previous position allowing NAC as a supplement ingredient, including in its favorable review of prior NAC structure-function claims notifications for supplements, the FDA warning letters sent in July 2020 stated that NAC is now illegal for use in supplements under the FD&C Act’s “drug exclusion provision” (Section 201(ff)(3)(B)(i)) because it had been approved as a new drug in 1963. In response to this turn of opinion by FDA, several supplement sellers, including Amazon.com, subsequently began preemptively removing NAC supplements from retail.

CRN’s citizen petition in June 2021, another citizen petition NPA filed separately in August 2021, plus comments on these petitions filed by the American Herbal Products Association (AHPA; Silver Spring, MD) here and here pointed out key reasons why the drug exclusion clause cannot be applied to disallow NAC as a supplement ingredient. Those reasons include the fact that there is evidence that NAC was sold as a supplement before NAC was approved as a drug, and that the NAC drug’s approval date isn’t adequately proven. For more background on those arguments, click here.

But the top argument industry leaders are making to FDA is that the FD&C Act’s drug preclusion clause cannot be applied retroactively to delegitimize dietary supplement ingredients that were already on the market before the drug preclusion provision became law.

CRN says this is the key question FDA needs to answer and that the agency has repeatedly failed to answer. Instead, in response to CRN’s citizen petition, in November 2021 FDA sent CRN a “tentative response,” not addressing CRN’s questions about FDA’s legal reasons for trying to apply the drug exclusion clause to NAC retroactively but rather asking for more evidence to show that NAC supplements were on the market before NAC became a drug. CRN says this evidence was already provided to the agency, and, moreover, that it’s extraneous because the heart of the issue is whether FDA can apply the drug exclusion clause to NAC at all.

Following the “tentative response” FDA sent to CRN in November, the association sent another letter to the agency on January 4, 2022, again asking the agency to answer its legal question. Failing adequate response from FDA, on January 25, 2022, CRN filed official comments with the agency demanding a response.

CRN’s new comments strongly ask the agency to “provide a substantive response addressing CRN’s legal concerns within 30 days,” meaning by February 24, 2022.

In addition, as it did in its January 4, 2022, letter to FDA, CRN asked the agency not to review the citizen petitions filed by CRN and NPA together. CRN states that while it is asking solely for FDA to reverse its position on NAC due to the agency’s wrongful application of the drug exclusion clause, NPA asks for that but also requests, as an alternative, that FDA use its rulemaking authority to allow NAC to remain a legal dietary ingredient.

CRN’s newly filed comments state: “CRN reiterates that it is inappropriate for FDA to review the two citizen petitions concurrently, as they request different actions from the Agency. Further, by introducing concurrent review, FDA appears to be disregarding the legal challenges to the NAC position raised by CRN, and intimating that it has declined CRN’s request for legal review without the Agency actually formally stating this.”

CRN’s newly filed comments are the latest development in the industry’s fight with FDA over NAC. In December, following its citizen petition, NPA additionally sued FDA over NAC.

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CRN presses FDA again on NAC ingredient's legal status in newly filed comments - Nutritional Outlook
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