Medicinal mushrooms saw skyrocketing growth in 2020 during the COVID-19 pandemic. Is this the first step in their mainstream journey?

Are medicinal mushrooms on the cusp of mainstream fame?

The U.S. Department of Agriculture (USDA) has published its 

, establishing the U.S. Domestic Hemp Production Program, on October 31, 2019, and opened a 60-day public comment period that was extended until January 29, 2020. Based on comments submitted during this period, USDA made a number of changes that now appear in the final rule. 

When it comes to exceeding acceptable THC levels, called negligent violation, the final rule raises the negligence threshold from 0.5% to 1%, but limits the maximum number of negligent violations that a producer can receive in a calendar year to one. For the disposal of non-compliant, the final rule does not require using a DEA reverse distributor or law enforcements, instead expanding to disposal and remediation measures available to producers. Acceptable remediation techniques will be provided by the Agricultural Marketing Service in a separate guidance document. 

Because of the insufficient number of DEA-registered laboratories, DEA has agreed extend the enforcement flexibility to allow non-DEA registered labs to test hemp until January 1, 2021. In the meantime, DEA is processing lab registration applications quickly to get more hemp testing labs to be DEA-registered. The final rule has also extended the time window for the collection of samples before harvest from 15 days to 30 days.

During the comment period stakeholders requested that they be able to take samples from a greater part of the hemp plant or the entire plant, as well as from a smaller number of plants. The final rule, therefore, allows states and tribes to adopt a performance-based approach to sampling in their plans, but plans must be submitted to USDA for approval. Additionally, the final rule addresses the extent of tribal regulatory authority and provides that a tribe may exercise jurisdiction and therefore regulatory authority over the production of hemp throughout its territory. Essentially, the final rule does not distinguish between States and Native American Tribes, giving them equal ability to authorize and regulate the production of hemp within their jurisdiction.

“With the publication of this final rule, USDA brings to a close a full and transparent rule-making process that started with a hemp listening session in March 2019,” said USDA marketing and regulatory programs under secretary Greg Ibach, in a press release. “USDA staff have taken the information you have provided through three comment periods and from your experiences over a growing season to develop regulations that meet Congressional intent while providing a fair, consistent, science-based process for states, tribes and individual producers. USDA staff will continue to conduct education and outreach to help industry achieve compliance with the requirements.”

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Following an extended comment period, USDA made a number of revisions to rules regarding the testing, disposal, and regulation of hemp. 

USDA publishes final rule for the Domestic Hemp Production Program

BGG World (Irvine, CA) was issued a patent from the United States Patent and Trademark Office for the use of astaxanthin to support heart function during exercise (US Patent #10,827,775).

The patent is based on results from a clinical trial, sponsored by BGG, with amateur athletes preparing for a half marathon. Subjects supplementing BGG’s AstaZine natural astaxanthin experienced heart rates on average 10% lower during endurance training than the placebo group. 

According to Shawn Talbott, lead researcher of the study, “Subjects were able to perform the same amount of ‘work’ but at lower cardiovascular ‘strain’ after supplementing with astaxanthin.”

Further, lead inventor of the patent and BGG’s global chief scientific officer, Yanmei Li, PhD, said in a press release, “BGG focuses on innovation by dedicating 5% of gross revenue to R&D. As a prime example of this policy, we are one of only a very small handful of astaxanthin producers sponsoring clinical research to validate our product and have published several astaxanthin clinical studies over the last few years. This patent is another example of how BGG supports our customers through our investment in research and constant innovation; we’ve successfully opened up a whole new area of health benefits for our astaxanthin customers to focus on.”

BGG World was issued a patent from the United States Patent and Trademark Office for the use of astaxanthin to support heart function during exercise (US Patent #10,827,775).   

BGG issued patent on AstaZine natural astaxanthin for heart health

Body&Fit, Glanbia Performance Nutrition’s direct-to-consumer brand, and Lonza are collaborating to expand Body&Fit’s nutrition, supplements and dietary solutions utilizing Lonza’s Duocap capsule portfolio and specialty nutrition ingredients. 

“This collaboration with Body&Fit is a perfect showcase of our combined expertise in providing high-quality sports nutrition and dietary supplements in unique dose-delivery formats,” said Roel van de Put, business development manager for Lonza, in a press release. “We are excited to work with Body&Fit to help consumers live a fitter and healthier lifestyle with new and innovative nutrition products.”

With a capsule-in-a-capsule design, Lonza’s Duocap technology offers combined dosing of incompatible ingredients. The first two Body&Fit product utilizing Duocap technology are Beauty Skin Duo and Pro B Duo. As a way to tap into clean label trends, the products are launching using a titanium dioxide (TiO2)-free inner capsule.

“Body&Fit, just like Lonza, is constantly looking for unique solutions to bring truly innovative products to the market,” said Szabina Pál, product development manager for the tablet and capsule portfolio at Body&Fit, in a press release. “Lonza’s cutting-edge technologies, premium ingredients, and forward-thinking concepts are the perfect fit with our vision, mission, and business model. We are very excited to combine our strengths to maximize our potential.” 

Body&Fit has plans to launch three additional products for immune health, sleep, and mood and anxiety in early 2021, all featuring Lonza’s Duocap capsule technology, and a joint health and support supplement, utilizing Lonza’s TiO2-free hard capsules portfolio and its patented UC-II undenatured type II collagen ingredient. 

The two companies are also collaborating on the exclusive development of an intra-workout product featuring MuscleGuard formulation from Lonza, a unique blend that delivers pre-, intra- and post-workout support.

Body&Fit, Glanbia Performance Nutrition’s direct-to-consumer brand, and Lonza are collaborating to expand Body&Fit’s nutrition, supplements and dietary solutions utilizing Lonza’s Duocap capsule portfolio and specialty nutrition ingredients.

Lonza, Body&Fit collaborate on specialty supplements using Duocap capsule technology

The New York State Department of Health (NYSDH) recently proposed new 

which establishes requirements for licensure for extraction and manufacturing, as well as the sale of hemp-derived cannabidiol (CBD) products. As it did with proposed legislation in 

, the Council for Responsible Nutrition (CRN; Washington, D.C.) has issued 

 to the NYSDH, proposing revisions to the language that are more consistent with federal law, and prevents a patchwork of state laws.

Among the revisions suggested by CRN are more detailed definitions that offer clarity and are consistent with the 2018 Farm Bill. For example, CRN asks that the NYSDH, in line with the 2018 Farm Bill, define hemp-derived CBD as containing no more than 0.3% THC by dry weight. NYSDH fails to make this distinction throughout its proposed regulation. In its definition of “Broad spectrum,” NYSHD writes: “Broad spectrum means a concentrate extracted from hemp containing multiple cannabinoids, but where all Δ9-Tetrahydrocannabinol (THC) has been removed.”

CRN asks that the definition be revised to: “Broad spectrum means an extract from hemp containing multiple cannabinoids, but where all Δ9-Tetrahydrocannabinol (THC) has been removed to non-detectable levels to be in compliance with the United States Department of Agriculture 0.3% THC limit for raw flower and finished products.”

Similarly, NYSDH defined “hemp extract” to mean “all derivatives, extracts, cannabinoids, isomers, acids, salts of isomers derived from hemp and used for human consumption, with a Δ9-Tetrahydrocannabinol concentration of not more than an amount determined by the department.”

Again, CRN asks that NYSDH include the 0.3% THC threshold with the following revision: “Hemp extract means any derivative, extract, cannabinoid, isomer, acid, salt of isomer derived from hemp and used for human consumption, with a Δ9-Tetrahydrocannabinol. concentration of not more than an amount determined by the department, provided the amount is not less than 0.3% on a dry weight basis.”

The rationale for this inclusion is that the threshold of 0.3% is set by the 2018 Farm Bill and consistent with federal law, and prevents the state from setting a lower threshold which would create a burdensome patchwork of regulations. This is important because as more states issue their own regulation to make up for a lack of federal regulation, it would hurt industry if manufacturers and extractors had to meet different requirements throughout the nation. This would be expensive for business owners, and would create less choice for consumers as brand owners avoid commerce with certain jurisdictions.

CRN hopes that states deviate as little as possible from the federal frameworks established in the 2018 Farm Bill, the Dietary Supplement Health and Education Act of 1994 as well as the Federal Food, Drug & Cosmetic Act so that there is a seamless transition to inevitable federal regulation. CRN hopes this will be accomplished through legislation, specifically, 

H.R. 8179, the Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act of 2020

As it advocates for this important piece of legislation and more consistent regulation between states, CRN has recently expressed frustration with the U.S. Food and Drug Administration (FDA) for a complete lack of progress in developing a regulatory pathway for hemp-derived CBD. For example, a recent 

 issued by the Agency expressed a need for better data, so that they may better understand the use and safety of CBD products. CRN argues that FDA’s quest for information on these products does not have to preclude federal regulation in the meantime.

“[The notice] tries to excuse the agency’s inaction by decrying a lack of data — even as FDA has blocked the New Dietary Ingredient (NDI) route for CBD supplements by declining to review them, and done little that might incentivize data to be presented or invested in research of its own,” says Steve Mister, president and CEO of CRN, in a statement. “But more troubling is that FDA’s essay on data quality misses the point entirely – and fundamentally misunderstands how DSHEA works. As a botanical, under DSHEA, the presumption in the law actually runs the other way. Put plainly, consumers should have access to CBD dietary supplement products absent some reason shown why they should not. FDA could fix this problem today by exercising authority it is clearly given in the law, and immediately enforcing the full array of FDA dietary supplement regulations on the CBD dietary supplement industry.”

The New York State Department of Health recently proposed new cannabinoid hemp regulation which establishes requirements for licensure for extraction and manufacturing, as well as the sale of hemp-derived cannabidiol (CBD) products. 

NY State Department of Health proposes new hemp-derived CBD regulation, CRN responds

COVID-19 has taught us so much already, such as: 1) handwashing really does work, 2) masks save lives, and 3) it doesn’t hurt to keep more toilet paper on hand than you think you’ll actually need.

But one of the lessons that’s stuck most with the health-and-wellness community isn’t just the fact that health is inextricably related to nutrition, but that the way we “do” healthcare in the United States quite simply doesn’t work.

That’s certainly the lesson that Paul Schulick, founder and CEO, For The Biome (Dummerston, VT), takes from all this. “People are looking for immune support and preventative measures beyond social distancing and future vaccines,” he points out, “but our conventional healthcare system is only offering band-aid solutions, for the most part.”

No wonder, then, that the public’s growing skeptical of it. And no wonder that they’re also adopting what Schulick considers “the natural response”—namely, “looking to ‘alternative’ wellness practices.”

Topping that list of alternatives are functional mushrooms, which were attracting attention even before COVID gave a new shine to their relevance. And while mushrooms haven’t fully hit the mainstream yet, Schulick believes, “The more people react to our antiquated and ineffective healthcare system, the more the health benefits of mushrooms will resonate.”

Mushrooms began resonating with health-minded consumers several years ago, according to Jacob Knepper, data product manager, SPINS LLC (Chicago), “when they jumped to prominence as a key part of the adaptogenic movement centered on physical and mental stress management.”

Once shoppers wrapped their heads around the functional fungi’s basics, he continues, they started catching on to mushrooms’ “more holistic benefits,” including blood-sugar and immunity support. By the time the pandemic hit, “mushrooms were already on a steep upward trajectory in both food and beverage applications, and in vitamins and supplements.”

Concerns surrounding COVID-19 have since steepened that trajectory, and mushrooms are now “being catapulted into the spotlight and are likely seeing accelerated growth patterns and product innovation compared to what we may have otherwise seen,” Knepper concludes.

To quantify those observations, he cites SPINS data showing that for the 52 weeks ending October 4, 2020, growth in functional mushroom ingredients was up 49.9% across the board.

“The data suggest that more shoppers are turning to mushrooms in the form of supplements, as these products have grown 63.5% to $30,857,134 over the same time period,” Knepper notes. And zeroing in on the all-important early-COVID stockpiling days, he says the numbers there reflect “a huge spike for these products” during March 2020, when sales reached $5,940,387 over the four weeks to March 22—a 152% increase compared to the same period the previous year.

In retrospect, any observer of the pandemic’s cultural effects could have seen those sales coming, given how handily mushrooms’ functions fit our anxious moment.

After all, as Susan E. Hirsch, formulation manager, Gaia Herbs (Brevard, NC), points out, “People are concerned about their health, the health of their family and friends, and adaptations to new ways of living and working—in some cases managing homeschooling on top of everything else. People have also reported trouble staying focused with all the new distractions they’re dealing with. This new reality has dramatically increased levels of ongoing stress and anxiousness, and these conditions can easily lead to other issues, including sleep and digestive challenges.”

And immunity challenges. “People are becoming more aware of chronic stress’s impact on the immune system,” notes Schulick. “It’s like turbulence for your immune response and accelerates its deficiency and deterioration. You’re much more vulnerable to infection when chronic stress goes unchecked.”

Which is where mushrooms come in. Not only are they safe to take on a daily basis, Schulick says; they’re packed with protective terpenoids and beta-glucans that “‘train’ and rehabilitate the immune system, modulating pro- and anti-inflammatory cytokines to help support what we call ‘a wiser immune system’ that responds more precisely while helping the body adapt to stress,” he explains.

Scientists are fast at work figuring out why. “Virtually every day,” Schulick says, “more research is being published on mushrooms, focusing on their ability to help alleviate human suffering.”

Brien Quirk, director of R&D, Draco Natural Products (San Jose, CA), notes that a number of current studies examine mushrooms’ antiviral properties against influenza, which he says “is even more of a concern while we’re dealing with COVID.” To understand how mushrooms effect their antiviral benefits, it helps to understand the pathways whereby flu viruses make us sick in the first place.

One such pathway involves the glycoprotein hemagglutinin (H), a large sugar-binding lectin that sits outside viral particles and helps bind them to new host cells. Another involves the enzyme neuraminidase (N), which eases viral particles’ transit through the respiratory tract mucus membrane and helps release “flu-virus offspring” from infected cells “so that they can disseminate to infect other cells,” as Quirk explains. (When we see seasonal flus named with HN numbers, like H1N1, those numbers reference the particular strain of hemagglutinin and neuraminidase involved.)

So where do mushrooms come in? Aside from their general immune-boosting properties, they help block these two pathways. In fact, Quirk says, “Many immune-support medicinal mushrooms have been found to inhibit the neuraminidase pathway, which is the same mechanism Tamiflu uses.”

For example, reishi, maitake, shiitake, cordyceps, and 

 all display this capacity, with a recent study on reishi (genus 

) finding inhibitory effects for two of its triterpenoids—ganoderic acid T-Q and TR—against neuraminidases in the H5N1 and H1N1 virus strains.

Another study involving influenza virus type A (serotype H1N1) found that oyster mushroom, enokitake, and turkey tail all provided effective inhibition against the pathway, as well.

 “Turkey tail was even noted to have a high therapeutic index and was suggested as a promising new antiviral agent against some flu strains,” Quirk adds.

And while conceding that none of these fungi will likely prevent the flu or its more serious complications, Quirk believes that “they may be able to help the body improve its defense based on a combination of their immune support and other bioactive effects.”

Whether consumers are familiar with the research or not, their demand for mushrooms is strong enough for Quirk and others to notice. For example, reishi “is almost always the top request,” he says, with lion’s mane—which, like reishi, has purported cognitive, mood, and immune benefits—coming in a close second. “Others we frequently see requested are chaga, 

Jonathan Fitzpatrick, product manager at Gaia Herbs, notes that 

was scoring a search-popularity ranking close to 100 in Google Trends this past autumn, “which means that the term is receiving the highest active search interest level possible.”

And Schulick says that his company has its eye on chaga. “It’s been used for centuries in TCM”—Traditional Chinese Medicine—he notes, “and is known as the ‘king of medicinal mushrooms’ for good reason.”

Case in point: Recent research apparently shows that chaga can inhibit RNA and DNA viruses 

. “The antiviral and anti-inflammatory benefits are quite remarkable,” Schulick says. “In fact, a research paper released this past August focused on the virome-modulating and anti-inflammatory effects of mushrooms and herbs on SARS-CoV-2 infection and stated that ‘one of the potential candidates against the SARS-CoV-2 virus may be 

 The study went on to highlight chaga’s ‘powerful enzymatic system and strong system of defense,’ which has been shown to inhibit pro-inflammatory cytokines associated with COVID-19 and help prevent a ‘cytokine storm’ from overwhelming the immune system.”

Worth noting, Schulick adds, is that these benefits manifest most strongly in high-grade, quality chaga grown specifically on birch trees. “This is because chaga extracts betulinic acid from the birch tree, a key immune-modulating compound and signaling molecule that helps support the resilience of the immune system,” he says. And not surprisingly, this is the chaga his company includes in two of its new immune products.

Similarly, Fitzpatrick notes that another trend in the mushroom space is a preference for extracts from the fruiting-body—the above-ground portion of the fungi that we can see—over those from the underground mycelia network grown on grain. Here, too, Gaia Herbs uses only fruiting-body extracts, as these “contain the most active beneficial constituents”—in particular, the beta-glucans that research associates with immune health and overall wellness, Fitzpatrick says.

Sevanti Mehta, president, Unibar Corp. (Houston), is also excited about mushroom beta-glucans and notes that the company’s Maitake Pt78 mushroom ingredient “delivers a unique and powerful source of immune support by providing the body with essential beta-glucans,” he says. “At a time when everyone has immune health on the mind and when interest in medicinal mushrooms has grown, it was clear that we needed to launch this clinically studied maitake extract to provide an option that can deliver optimal support to the immune system and promote enhanced cellular function.”

Consumers are finding ingredients like Maitake Pt78 and others in products across the board: foods, supplements, beverage mixes—even cosmetics.

To help formulate the latter, Quirk notes that Draco supplies the BioReishi brand of reishi extract, which is standardized to beta-glucans and has moisturizing, anti-inflammatory, and purported skin-healing benefits.

Adds Schulick of For The Biome, “Four of our seven skincare products contain mushrooms as a key ingredient. And as I mentioned, chaga will be featured in two of our upcoming immune formulas set to launch this December,” the month this article was written.

Gaia’s Hirsch is bullish on the potential of mushroom-herb blends, which she credits for helping to “push mushrooms into the spotlight.” Within Gaia’s line of such blends, “my personal go-to and one of my favorite products is our Immune Shine Mushroom & Herbs powder,” she says, which combines adaptogenic mushrooms like maitake and chaga with elderberry, ginger, and astragalus. “I use it in my daily morning routine, as it helps me stay healthy and supports my immune health.”

At SPINS, Knepper’s seen “major increases” for mushrooms in the food supplements category, where mushroom wellness shots and powders generated growth of more than 400% relative to the previous year for the 52 weeks ending October 4, 2020.

Outside of supplements, functional mushrooms gained traction in food and beverages, with the emphasis on beverages and especially beverage mixes. “This segment has grown to about $12 million, with a very healthy growth rate of 22%,” Knepper notes. “Shelf-stable coffee beans, grounds, and instant mixes are definitely a hot category within the segment, too, where functional mushrooms products are up 43% compared to the previous 52 weeks.”

Even snack and indulgent categories are seeing mushroom action—ice cream, chips, jerky. “Thanks to a favorable taste and texture profile to go along with their holistic wellness benefits,” Knepper says, “functional mushrooms should continue to see an increased presence across a number of food categories as a highlighted functional ingredient.”

And experts agree, a presence in the food space is the ticket that any mushroom needs to officially go mainstream.

As Quirk says, “When we start seeing more instant-food-based medicinal mushrooms in grocery stores—much as we now see products with goji berries, stevia, and monkfruit—we’ll know that it’s gone full mainstream.”

Fitzpatrick looks forward to mushrooms’ colonization of platforms ranging from gummies and chewables to effervescents, syrups, herbal shots, and even infused lollipops. “It’ll be exciting to see all the ways that mushrooms will be introduced in new and approachable formats,” he says.

But Schulick is holding off on declaring mainstream certification just yet. “From my perspective, mushrooms aren’t even close to being fairly mainstream,” he says. “Their popularity in America is nothing like in Asia or even some European countries when it comes to appreciation and understanding of what they have to offer. I look at the future of mushrooms using the practice of acupuncture as an analogy: If we touch the right points with just the right people, their popularity could go viral overnight. Pun intended.”

And now could be the right time for that to happen. “If we don’t make major modifications to our lifestyles, the viral upheaval that SARS-CoV-2 caused will be just the tip of the iceberg,” Schulick predicts. “To overcome what’s ahead, people will need to remain proactive regarding holistic wellness. In conclusion, all pointers suggest that mushrooms will continue to mushroom.”

Zhu Q et al. “Inhibition of neuraminidase by 

 triterpenoids and implications for neuraminidase inhibitor design.” 

Krupodorova T et al. “Antiviral activity of 

 mycelia against influenza type A (serotype H1N1) and herpes simplex virus type 2 in cell culture.” 

Shahzad F et al. “The antiviral, anti-inflammatory effects of natural medicinal herbs and mushrooms and SARS-CoV-2 infection.” 

The Ninth Circuit Court of Appeals upheld a previous decision of the U.S. District Court of the Northern District of California in favor of the defendants: Target Corporation, International Vitamin Corporation, and Perrigo Company of Southern California Inc. The plaintiff challenged the labeling of the dietary supplement biotin, which stated that the supplement “helps support healthy hair and skin.” The Ninth Circuit Court of Appeals ruled that the plaintiff’s state law claims were preempted by the Federal Food, Drug, and Cosmetic Act (FDCA), which under 21 U.S.C. § 343(r)(6)(B) authorizes statements such as disease claims and structure/function claims. In the case of the biotic product, the court ruled that the challenged claim met the criteria for a permissible structure/function claim.

“The defendants met the first requirement for its structure/function claim because it had substantiation that biotin ‘helps support healthy hair and skin,’ and that statement was truthful and not misleading. Manufacturers may make structure/function claims about a nutrients’ general role on the human body without disclosing whether the product will provide a health benefit to each consumer,” stated the 

. “Second, the biotin product label had the appropriate disclosures. Third, the biotin product label did not claim to treat diseases. Because the structure/function claim about biotin met the FDCA’s requirements, plaintiff’s state law claims amounted to an imposition of different standards from the FDCA.”

The Council for Responsible Nutrition (CRN; Washington, D.C.) praised the decision, which protects both industry and consumers by maintaining the federal framework. “We applaud this decision as it protects both industry and consumers by maintaining the federal framework, allowing dietary supplement manufacturers to disseminate information about how nutrients affect the health and function of the body and empowering consumers to make informed choices about nutrition,” said Megan Olsen, vice president and associate general counsel for CRN, in a statement. “CRN submitted an 

 in support of product claims surrounding biotin in April 2020. CRN recognizes the importance of filing these amicus briefs on behalf of industry to protect the federal standards that are in place and prevent private actors from overhauling this carefully crafted framework and creating a patchwork of conflicting substantiation standards inconsistent with the federal system.”

The Ninth Circuit Court of Appeals upholds ruling that federal dietary supplement framework preempts state law in case against biotin claims.

Court of Appeals upholds ruling that federal dietary supplement framework preempts state law

The Natural Products Association (NPA; Washington, D.C.) has sent a letter to governors from all 50 states urging them to declare health food stores essential. This would ensure that millions of Americans continue to have access to dietary supplements to support their health, and ensure access to vaccines for those working at natural health stores as front-line workers.

“There is uncertainty right now created by individual interpretations on whether health and nutrition stores have been deemed essential retail establishments,” said Daniel Fabricant, president and CEO of NPA, in his 

. “For the millions of people who rely on stores that retail dietary supplements this uncertainty is troubling and could cause such stores to close unnecessarily, and not allow their front-line workers to have access to vaccination per schedule 1C of the COVID-19 vaccination disbursement.”

Dietary supplement manufacturers are referred to as essential in the latest CISA guidance (version 4.0), says Fabricant in his letter, therefore it would be consistent with existing policy to classify health food stores as essential, and therefore the whole supply chain would have access to vaccination.

“I believe that this issue could be simply resolved if the interpretation on retail storefronts by all local jurisdictions was coordinated with the federal guidelines thus putting all health and nutrition stores on par with grocery and drug stores as essential businesses,” explains Fabricant in his letter. “The majority of states (47) deemed all health and nutrition stores on par with grocery and drug stores as essential businesses during the spring of 2020, thus the vaccination scheduling of these essential workers would also be consistent with precedent.”

The Natural Products Association has sent a letter to governors from all 50 states urging them to declare health food stores essential. 

NPA urges governors of all 50 states to declare health food store essential

TA Associates (Mumbai, India), a global growth private equity firm, acquired a significant stake in OmniActive Health Technologies (Morristown, NJ). Sanjaya Mariwala, founder and executive chairman of OmniActive, has also increased his personal holding. Financial terms of the transaction were not disclosed.

“We are pleased to welcome TA Associates as a strategic investor and partner for the next phase of OmniActive’s growth journey,” Mariwala said in a press release. “We believe that TA has deep capabilities and experience investing in companies focused on nutritional ingredients, and shares OmniActive’s vision of bringing innovative, natural and science‐based solutions to our customers and end consumers. We intend to leverage our strong management capabilities and TA’s distinctive M&A sourcing engine to drive programmatic M&A and in‐licensing to continuously deliver innovation to our customers.”

“We believe that the nutritional ingredients space will see strong growth over the next decade,” said Naresh Patwari, a director at TA Associates Advisory Private Limited, in a press release. “OmniActive has built a strong reputation and deep customer relationships by focusing on natural, R&D-led innovative ingredients. We look forward to working together with Mariwala and the OmniActive management team to further accelerate the growth in this business through organic levers and M&A.”

“We believe that TA’s global healthcare experience will be valuable in supporting OmniActive’s next phase of growth through continued organic growth and strategic acquisitions,” added Jim Hamilton, CEO of OmniActive. “OmniActive has been growing at an accelerated pace, driven by a portfolio of branded, innovative natural products with clinically supported health benefits, and we are excited to continue this growth journey and supporting our customers with TA as our new equity partner.”

TA Associates, a global growth private equity firm, acquired a significant stake in OmniActive Health Technologies. Sanjaya Mariwala, founder and executive chairman of OmniActive, has also increased his personal holding.

TA Associates acquires large stake in OmniActive Health Technologies 

Researchers with the Fatty Acid Research Institute, in collaboration with Cedars-Sinai Medical Center in Los Angeles, CA, recently posted the results of a pilot study

 which found a potential link between low Omega-3 Index levels and mortality from COVID-19 infection. The study included 100 patients admitted into the hospital with COVID-19, whose blood samples were analyzed for omega-3 levels, and grouped into four quartiles based on Omega-3 Index.

There was one death in the top quartile (Omega-3 Index >5.7%), and 13 deaths in in the lower three quartiles (Omega-3 Index <5.7%). In age-and-sex adjusted regression analyses, patients in the highest quartile were 75% less likely to die compared those in the lower three quartiles, meaning the relative risk of death was four times higher in those with a lower Omega-3 Index compared to those with higher levels.

“While not meeting standard statistical significance thresholds, this pilot study – along with multiple lines of evidence regarding the anti-inflammatory effects of EPA and DHA – strongly suggests that these nutritionally available marine fatty acids may help reduce risk for adverse outcomes in COVID-19 patients. Larger studies are clearly needed to confirm these preliminary findings,” said Arash Asher, MD, the lead author on this study, in a press release.

An omega-3 expert not involved with the trial, James H. O’Keefe, Jr., MD, director of Preventive Cardiology, Saint Luke’s Mid America Heart Institute (Kansas City, MO) observed in a press release, “An excessive inflammatory response, referred to as a ‘cytokine storm,’ is a fundamental mediator of severe COVID-19 illness. Omega-3 fatty acids (DHA and EPA) have potent anti-inflammatory activities, and this pilot study provides suggestive evidence that these fatty acids may dampen COVID-19’s cytokine storm.”

The research team is currently seeking funding to expand upon the preliminary observations found in the pilot study.

Asher A et al. “Blood omega-3 fatty acid and death from COVID-19: a pilot study.” 

, Published online ahead of print on January 8, 2021

Researchers with the Fatty Acid Research Institute, in collaboration with Cedars-Sinai Medical Center in Los Angeles, CA, recently posted the results of a pilot study which found a potential link between low Omega-3 Index levels and mortality from COVID-19 infection. 

Pilot study finds potential link between omega-3 levels and COVID-19 mortality

SweeGen (Rancho Santa Margarita, CA) has successfully scaled up production of Bestevia Rebaudioside N (Reb N) to begin commercialization. The ingredient’s unique sensory profile makes it particularly attractive for beverage applications.

“Bestevia Reb N has a unique sweet profile that helps us create solutions that have a taste profile closer to both full-calorie and high intensity sweeteners,” said Shari Mahon, senior vice president of global application technology, in a press release. “Our solutions are one of the most unique and tailored in the industry because of our access to the widest range of Rebs for sugar reduction.”

SweeGen’s Bestevia Reb N is produced using a patented bioconversion technology developed by Conagen, a biotech innovator of sustainable ingredients. “The introduction of Reb N is another great example of how Conagen’s deep expertise in bioconversion technology enables the creation of unique stevia sweeteners,” said Conagen’s vice president of innovation, Casey Lippmeier, PhD. “With such a wide range of next generation stevia offerings now available, we will see a new level of innovation in better-for-you products that was previously considered impossible.”

SweeGen adds Bestevia Reb N to its portfolio of stevia sweeteners.

SweeGen adds Rebaudioside N to its line of stevia ingredients

DuPont Nutrition & Biosciences (Madison, WI) launched Howaru Calm, a probiotic aimed to support consumer’s response to stress. Prior to launch, Howaru Calm’s featured strain, 

 Lpc-37, was tested to ensure quality, efficacy, and performance. According to DuPont, in a recent clinical study, participants consumed the strain daily for five weeks before undergoing an acute stress test called The Trier Social Stress Test. Researchers measured subjects’ mood, stress, and anxiety levels in response to the five-week intervention with Lpc-37, their perceived and physiological response to the acute stress test at the end of the study, and their overall mood, health and well-being throughout the study.

Compared to placebo, those taking the probiotic strain reported a significant reduction in perceived stress after five weeks of intervention. “Too much stress, or daily chronic stress has become more prevalent in today’s society and can seriously impact our mental and physical well-being and overall health,” said Elaine Patterson, PhD, senior R&D scientist, DuPont Nutrition & Biosciences, in a press release. “Over the last few years, we have been investigating the links between the gut microbiota and brain health —the so-called microbiota-gut-brain axis. During these investigations, our focus was on discovering a natural probiotic solution targeting brain health, more specifically mood, stress and anxiety. We are proud to finally share the fruits of our innovation and have developed a product that helps consumers target stress at the source so they can prioritize both their mental and physical health.”

“In the last five years, the industry has seen a 34 percent global increase of new probiotic supplements that help stabilize mood and combat stress, as consumers have begun to recognize the critical impact the gut has on the brain,” said Stephanie Udell, global marketing leader, DuPont Nutrition & Biosciences, in a press release. “By launching Howaru Calm, we’re allowing dietary supplement manufacturers to develop an efficacious end-product that satisfies market demand for probiotic supplements aimed at reducing stress and promoting mental well-being.”

DuPont Nutrition & Biosciences launched Howaru Calm, a probiotic aimed to support consumer’s response to stress. 

DuPont Nutrition & Biosciences launches Howaru Calm probiotic to support stress

Qualitas Health (Houston, TX), DBA iwi, has secured $10 million in venture funds at a $73 million post-money valuation. Iwi is known for its high absorption polar lipid EPA derived from algae. The investment round was led by foodTech investor PeakBridge VC, Malta, together with Arancia Group, a privately owned Mexico-based food ingredient/food service conglomerate, Minrav (the company’s largest investor) and additional private investors. Additional convertible notes held by Minrav Holdings, Sasa, Trucent and other single investors are converted to equity. The investment will help accelerate customer acquisition and commercialization of the company’s unique plant-based protein, as well as deepen the clinical science and intellectual property to accelerate its expansion into additional geographies.

Iwi employs a unique process that relies on saltwater, utilizing the sun as the main source of energy, placing zero strain on the natural ecosystem. This allows iwi to cleanly cultivate immense amounts of the ancient sea vegetable 

, an algae that contains all the essential amino acids, plus vitamins, minerals, chlorophyll, and essential fatty acids, particularly omega-3.

“This investment will be instrumental to accelerating growth in 2021 as iwi advances to the industrial pilot stage of our unique plant-based protein, start the regulatory process, and conduct additional clinical studies,” said Miguel Calatayud, CEO of Qualitas Health, in a press release. “This uniquely sourced, complete plant protein will be ready for commercialization in 2022.”

Qualitas currently has 15 supplement SKUs of its high-absorption omega-3 under its iwi brand in the U.S., including soft gels and functional gummies. Iwi has also built a strong direct-to-consumer platform, and has an additional presence in more than 5,000 US retailer outlets.

“Qualitas ticks all the boxes for meeting our investment criteria,” explained Nadav Berger, co-founder and managing partner of PeakBridge, in a press release. “It has strong intellectual property, proven scaling capabilities, and tremendous sustainability impact — all of which give iwi a unique edge within the plant-based nutrition industry. We welcome Qualitas and its new and existing investors to the PeakBridge family.”

“PeakBridge is far more than a VC fund,” added Yoni Glickman, chairman of Qualitas. “PeakBridge, together with our additional new investors, brings decades of knowledge, expertise, and food industry networking, and Arancia is an industry leader with a long heritage of operational excellence and innovation. They also add significant value to our company. We warmly welcome our new partners and look forward to executing our ambitious plans together.”

The investment will help accelerate customer acquisition and commercialization of the company’s unique plant-based protein, as well as deepen the clinical science and intellectual property to accelerate its expansion into additional geographies.


Qualitas Health secures $10 million in venture funds to commercialize new plant protein

Debbie Wildrick Consulting will be leading AIDP Inc.’s (City of Industry, CA) beverage and natural food expansion efforts. Wildrick has 40 years of sales, marketing, and operations in the food and beverage industry with a focus on the functional beverage sector. Wildrick has a particular interest in understanding functional ingredients and how they align with current and future health and wellness trends.

“AIDP is delighted to be working with Debbie Wildrick,” said Mark Thurston, president of AIDP, in a press release. “As a leader in functional ingredients for supplements and other wellness products, we see tremendous potential for our ingredients in the beverage and functional food categories. With Debbie’s direction we look forward to accelerating our growth in functional beverages.”

“The goals are to be able to align extensive knowledge of new and trending ingredients with the needs of the consumer and to advise on creating new and functional products thereby building sales and profits” said Wildrick in a press release. “Working with AIDP offers a unique opportunity to learn about trending and emerging early-stage ingredients.”

Debbie Wildrick Consulting will be leading AIDP Inc.’s functional beverage and natural food expansion efforts. 

Debbie Wildrick to lead AIDP’s functional beverage and natural food expansion efforts

Sorghum cultivars are being intensively studied for their potential as a biofuel source because of their high biomass yield and sugar production. The sugars produced by sorghum give it an economical advantage over starch-based crops for biofuel use. Sorghum is also drought resistant and salt tolerant, making it possible to grown on marginal land, another advantage.

Fun fact! Sorghum cultivars are being intensively studied for their potential as a biofuel source because of their high biomass yield and sugar production. The sugars produced by sorghum give it an economical advantage over starch-based crops for biofuel use. Sorghum is also drought resistant and salt tolerant, making it possible to grown on marginal land, another advantage. 

Sorghum biofuel?

AIDP Inc. (City of Industry, CA) has entered into an exclusive sales distribution agreement for Functional Fungi organic mushroom nutraceuticals. Functional Fungi offers a full line of certified organic, multi-patented mushroom powders which are produced in its U.S.-based, large scale indoor growing, drying, and manufacturing operation.

The firm’s mushrooms are grown utilizing multiple patented and patent-pending processes that include the use of high antioxidant (anthocyanin) substrate, and purple corn. Compare this to other brands that use inert or nutrient poor substrates such as oat, rice, millet, and sawdust. Functional Fungi’s cultivation technology creates U.S. grown single-species mushroom powders and custom blends.

“We are excited to add the line of Functional Fungi to the AIDP portfolio. This trending ingredient has a wide range of applications for our customers,” said Mark Thurston, president of AIDP, in a press release. “Functional Fungi provides the highest quality, organic mushroom powders in a wide variety of historically proven strains.”

“AIDP is the perfect partner for Functional Fungi,” added Jordan Rubin, head of formulation, in a press release. “AIDP customers align with Functional Fungi and have a great opportunity to include them in supplement, beverage and functional food formulations.”

Mushrooms offer a number of benefits, including immune-boosting compounds such as beta-glucans, polysaccharides, and prebiotics.

AIDP Inc. has entered into an exclusive sales distribution agreement for Functional Fungi organic mushroom nutraceuticals. 

AIDP now exclusive distributor of organic mushroom powder from Functional Fungi

Aker BioMarine has entered into its first pharmaceutical agreement with serial biotech entrepreneur Michael Davidson, MD, and his wholly owned company Medical Food Solutions Research. The agreement is for the development of pharmaceutical therapies for brain and eye health based on Aker’s 

Under the terms of the new agreement, a new company will be established to develop the therapies, with Aker retaining 50% of the company’s shares and granting it an exclusive license under its intellectual property. This license will be limited in scope to the distinct products and therapies the new company will develop. In exchange for the license, Aker will receive milestone payments and double-digit royalties from commercial sales of the therapies. For these therapies, Aker will supply the LPC products. To bolster these efforts, the new company will seek $30 million from external investors for early clinical trails to obtain proof of concept therapies.

The therapies will seek to treat Alzheimer’s Disease, gestational diabetes, dry age-related macular degeneration, dry eye syndrome, and Stargardt’s juvenile blindness. “These are all diseases where there is no effective method of treatment available today, and which are having big impact on the life quality of those affected,” said Davidson, in a press release. “By using the breakthrough discovery of LPC showing how EPA/DHA can effectively be delivered to the brain and eyes combined with the knowledge of EPA/DHA’s role in these diseases, gives us great confidence in the opportunities that lie within the use of Lysoveta for development of treatments towards these diseases.”

“This collaboration merges Dr. Davidson’s experience and track record from successful drug developments with Aker BioMarine’s IP and unique position for production and processing of LPC-EPA/DHA, and creates a strong basis for the development of new products within the pharmaceutical sphere,” said Matts Johansen, CEO, Aker BioMarine, in a press release. “The agreement with Dr. Davidson is an important step to position Aker BioMarine as a global leader in development and commercialization in the LPC space.”

The agreement is for the development of pharmaceutical therapies for brain and eye health based on Aker’s Lysoveta LPC-bound EPA and DHA. 

Aker BioMarine signs first pharmaceutical agreement for therapies based on Lysoveta

Healright (Orlando, FL) has launched healright.com, the exclusive platform to deliver its micronutrient bars directly to consumers. The patent-pending micronutrient and fiber formula found in Healright bars was scientifically developed and clinically tested in a 15-year collaborative project with Children’s Hospital Oakland Research Institute (CHORI), now a part of UCSF Benioff Children's Hospital Oakland, and the United States Department of Agriculture (USDA). The core formula was shown in published 

 to improve a wide range of biomarkers linked to metabolic health and lower risk of chronic disease. Improvements included cholesterol, triglycerides, inflammation, insulin resistance, and even modest weight loss in just 8-weeks.

“This bar, with its 15 vitamins, 15 minerals, insoluble and soluble fibers, is uniquely positioned to provide positive health outcomes by addressing micronutrient deficiencies that are linked to a range of chronic illnesses,” said Bruce N. Ames, PhD a U.S. National Medal of Science recipient and senior scientist at UCSF Benioff Children’s Hospital Oakland (now retired), who led the team that developed the CHORI-bar.

“In addition to restoring vitamin and mineral adequacy, the second major goal informing the product development was very simple: Keep the gut as strong as Healright Launches Page 2 possible,” explained another key member of the original research team, Mark Shigenaga, PhD. “Proper feeding of the gut wall is very important because not only does it make it stronger, but these nutrients help power the gut’s immune system needed to support a healthy microbiome. So, by providing those types of nutrients in the bar, you're helping to boost the physical strength and immunologic fitness of the GI tract, all of which is important for overall health.”

Healright Micronutrient Bars can be purchased as part of a subscription program, available in five flavors including Lemon Blueberry, Peanut Butter Banana, Chocolate Cherry Pomegranate, Caramel Apple Fig, and Dark Chocolate Blueberry. Each bar also contains essential vitamins and minerals, omega-3 fatty acids, soluble fiber, insoluble fiber, fermentable fiber, and high polyphenol-containing foods.

Healright has launched healright.com, the exclusive platform to deliver its micronutrient bars directly to consumers. 

Clinically tested micronutrient bars sold by Healright through subscription platform

The U.S. dietary supplement, functional food, and natural products industries face a number of regulatory uncertainties as 2021 kicks off with a new U.S. administration, an ongoing global pandemic, and more. We asked industry associations and group leaders to discuss the possibilities.

 What impact could the new U.S. administration have on the dietary supplement industry?

Christine Burdick-Bell, Steering Committee Chair, Dietary Supplements Quality Collaborative (DSQC):

Former Food and Drug Administration (FDA) Commissioner Scott Gottlieb and the outgoing administration rightly recognized that Congress last updated the Dietary Supplement Health and Education Act (DSHEA) 25 years ago. While we are unable to predict the priorities of the agency until the new FDA commissioner is confirmed by the Senate, the 

Dietary Supplements Quality Collaborative (DSQC)

 is hopeful the incoming new administration will also recognize the need to modernize the legal and regulatory framework to both preserve consumer access and increase consumer safety. Because 

from $4 billion with roughly 4,000 products to $40 billion with over 50,000 products over the past 25 years, it is imperative 

 safety, advance transparency, and begin to embrace new and innovative mechanisms that ensure greater supplement quality.

As history shows, Democratic administrations tend to favor a more robust regulatory environment, and we anticipate the FDA as well as the Federal Trade Commission (FTC) to increase regulatory oversight and enforcement. Additional regulatory oversight could be favorable to both consumers and responsible actors within the industry, although the overall impact of that oversight will largely depend on the modifications that the agencies make first and the methods they will use to implement their actions.

Daniel Fabricant, PhD, Executive Director and CEO

Natural Products Association (NPA; Washington, DC):

We’re very hopeful that a new administration is interested in keeping FDA accountable specific to dietary supplements. We understand that COVID is still a big part of their lift; still, there needs to be better accounting of actions (warning letters, legal actions, inspections, etc.) and specific outcomes tied to those actions. E.g., If a firm has been inspected twice and is OAI (Official Action Indicated) both times, what is the plan to bring those companies into compliance?

Loren Israelsen, President, and Larisa Pavlick, Vice President of Global Regulatory and Compliance, United Natural Products Alliance (UNPA; Salt Lake City, UT):

Currently the nation and the world are focused on COVID-19. We believe the new administration will likely continue to focus on slowing the pandemic, drug approvals, and vaccine distribution. The likelihood that food and supplements will be a priority to the new administration is unlikely until we see improvement with the global pandemic.

At the time of preparing this article, the Georgia runoff elections had not occurred, and therefore the impact of the new Congress and administration had not been fully understood or realized. Once we see the results of these runoff elections, and their impact on the Hill, we can make better predictions. However, with any new president, we will see appointments to many key positions, including the secretary of Health and Human Services (HHS) and the FDA commissioner.

 reported President-elect Biden’s selection of Xavier Becerra, currently attorney general of California, as nominee for secretary of Health and Human Services. This comes as quite a surprise to UNPA, as Mr. Becerra’s background is legal and legislative. Traditionally the secretary of HHS would bring a medical or healthcare background. Why is this of importance? Because this would likely make the selection of an FDA commissioner even more important—i.e., someone with deep FDA experience—if the HHS secretary has little experience working with FDA.

The FDA commissioner appointment is expected to be made quickly due to the current health crisis around COVID-19; however, it will likely occur weeks after President-elect Biden takes office. As a previous barometer, during the past two administrations, the new commissioner was nominated in May.

After the key positions are filled, we feel the FDA’s top priorities will likely be focused on Emergency Use Authorizations and continued efforts related to the vaccine for COVID-19.

By the second half of 2021, pending improvements with the current pandemic, we might anticipate attention to the modernization of the Dietary Supplement Health and Education Act (DSHEA) of 1994, potential legislation for hemp-derived cannabidiol (CBD) as a dietary supplement, emphasis on pesticide use in food, and for continued discussions on the labeling for added sugars in foods. These predictions are based on topics of interest in the final 2020 Congressional action on budget/COVID approved by Congress on December 21, 2020, and the FY2021 Appropriations Conference Report.

 and MSN, per the FDA policy until the new commissioner is appointed, all duties and responsibilities will be conducted by an acting commissioner. Within FDA policies, the acting commissioner will be held by the deputy commissioner for Food Policy and Response. This position is currently held by Frank Yiannas.

Mr. Yiannas is from industry, and he is not from the FDA. He brings a needed industry perspective to the table, which we welcome. He was formerly with Walmart as the vice president of food safety (10 years), and prior to Walmart was the director of safety and health for Walt Disney World Co. for 19 years. He is highly respected by the industry for his background and education. Mr. Yiannas has experience with food safety, Hazard Analysis Critical Control Point (HACCP), traceability, and outbreak response.* We predict any FDA attention during Mr. Yiannas’s time as acting commissioner will be focused on these areas of expertise. 

Michael McGuffin, President, American Herbal Products Association (AHPA; Silver Spring, MD):

Every regulated industry recognizes the need for increased vigilance whenever the Democrats are in charge of the White House and both Houses of Congress. The Democrats are more prone to propose new regulations since they are, as a rule, more protective of consumers and more willing to place more burdens on industry if they think that supports consumers.

Focused just on the history of food and drug law, the last time the Democrats were in charge of all the levers of government the Congress passed the Food Safety Modernization Act in 2010 (signed into law in January 2011). This law is, in FDA’s words, “the largest overhaul of the nation’s food safety system since the Federal Food, Drug and Cosmetics Act of 1938.” It completely changed the way foods are regulated and moved FDA’s authority all the way back to the farms on which produce is grown.

Looking forward and focused just on dietary supplements, FDA has made it clear it wants to require mandatory product registration for all dietary supplement products. The agency frames this interest in the context of solving the international problem of drug-spiked products that masquerade as dietary supplements, at least in the U.S. So it’s likely that FDA will be working with the Congress to try to gain support for this new authority.

Of peripheral interest is that Senator Richard Durbin (D-IL) and Representative Rosa DeLauro (D-CT)—both Democrats and both dietary supplement critics—have regularly introduced legislation since 1999 that would redefine FDA as the “Federal Drug Agency” and create a new federal agency to oversee all food operations—now split between FDA and USDA. It will be interesting to see if this idea gains more support in the current Congress—and if it does, where supplements would fit in the envisioned new structure.

Steve Mister, President and CEO, Council for Responsible Nutrition (CRN; Washington, DC):

CRN is optimistic about working with the new administration. We especially look forward to the appointment of the new FDA commissioner to further strengthen the dietary supplement industry and to modernize FDA’s oversight of these products. It will be critical that the new commissioner maintain the balance DSHEA struck in 1994 between preserving consumer access and assuring consumer safety. This balance, along with FDA’s regulatory oversight, has helped the industry to grow and has built the vibrant marketplace that exists today.

John P. Troup, PhD, Vice President, Scientific Affairs and Dietary Supplements, Consumer Healthcare Products Association (CHPA; Washington, DC):

Things are at a turning point for dietary supplements. The 25

anniversary of DSHEA has come and gone, but the momentum behind DSHEA modernization is ongoing and must continue into the next term. CHPA looks forward to working with the Biden administration on ensuring the country has a modernized regulatory system overseeing the rapidly expanding dietary supplements category. This is an important public health issue that transcends political parties and election results. CHPA has observed firsthand with OTC monograph reform that FDA and Congress are able to jointly tackle comprehensive legislation addressing important regulatory matters, despite which party is in the White House or holds majority in Congress. We’re hopeful that we will see sustained momentum behind dietary supplements regulatory and legislative efforts over the next few years.

Dietary supplement industry associations and leaders share 2021 regulatory predictions.

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