“Lead, not follow” are words that exemplify all four of 

’s 2019 Best of the Industry award winners. The individuals and companies we’re recognizing this year are at the helm, whether of an entire segment of the market they represent or as stewards of a new ingredient.

Our industry leader is Michael McGuffin of the American Herbal Products Association who this year celebrates his 20

 anniversary as association president. Under Michael’s tenure-and even before that, when he served on the association’s board of trustees-AHPA has been a leading influence and guiding hand in shaping the safe, responsible, and prosperous herb commerce market that so many consumers rely on today. With Michael at the lead, AHPA’s influence extends beyond the herbal community; AHPA has been promoting the interests of the entire dietary supplement industry for decades.

OmegaQuant has likewise served as a key advocate for the omega-3 industry. The company and its leader, William Harris, PhD, have been key messengers about the importance of the Omega-3 Index, a measure of a person’s omega-3 status that serves as a risk indicator for developing cardiovascular disease. Harris and his colleagues were not only the earliest proponents of the Omega-3 Index, which is increasingly recognized by researchers as a reliable metric, but OmegaQuant’s Omega-3 Index test kits have given consumers a tangible, practical way to test their own Omega-3 levels and have helped spread awareness about low omega-3 intake and the importance of supplementation. For this reason, we’ve selected OmegaQuant as this year’s retail brand/product leader.

Two of our other company winners are ingredient suppliers embarking on new ground. The first is ChromaDex, who is creating a market for its Niagen nicotinamide riboside ingredient, which in November the European Commission approved as a novel food. Perfect Day is another ingredient supplier, one that has created an innovative non-animal, flora-based dairy protein that offers the best of both worlds: the enjoyment of a dairy product without sustainability drawbacks attached.

’s 2019 Best of the Industry award winners!

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In Nutritional Outlook's 2019 Best of the Industry Awards, we are recognizing individuals, groups, and companies whose initiatives today may help shape, for the better, the state of the dietary supplement and food and beverage industries for years to come.

Nutritional Outlook’s 2019 Best of the Industry Award Winners

The American Herbal Products Association (AHPA; Silver Spring, MD) has been the chief U.S. trade association for the herbal products industry for nearly four decades. More than half of the association’s existence has been led by AHPA’s current president, Michael McGuffin. This year, McGuffin celebrates his 20

 is honored to recognize his longstanding work on behalf of the industry by naming him our 2019 Industry Leader.

McGuffin’s dedication to “health, herbs, and good food” is personal and far-reaching. His journey began long before he joined AHPA. “Before moving to California in 1973, I had made a few gallons of sassafras tea during my youth in pre-paved Maryland suburbs. And though I’d eaten wild ‘poke salat’ as a kid, I gained my first appreciation of proper plant identification by mistaking the toxic 

 in a Venice alley as a Western cousin of poke,” he tells 

In 1974, McGuffin cofounded a retail store called Venice Fruit Tramps-an “accidental collective,” he calls it-selling fresh produce and bulk herbs on California’s Venice Boardwalk. In 1979, McGuffin and a business partner, Janet Zand, who is a now a doctor of naturopathy and oriental medicine, and a board-certified acupuncturist, took their “combined fortune of $2200” to build an herbal tincture manufacturing and marketing firm called McZand Herbal. In 1985, McZand Herbal became a member of the recently formed American Herbal Products Association. (The association was founded in 1982.)

In 1990, McGuffin was elected to AHPA’s board of trustees. “In late 1989, I was contacted by Shel Weinberg of Trout Lake Farm to solicit my candidacy for an open board seat,” McGuffin says. “When I told Shel I was just too busy with my company to take on a volunteer role, he replied: ‘We’re all too busy, Michael. But it’s your turn.’ This message somehow resonated with me, and I was elected to AHPA’s board of trustees in 1990 and served there until I was hired as AHPA’s president in 1999.”

Twenty years later, McGuffin and AHPA are a leading voice not only for the herbal products industry but for the entire dietary supplement industry, helping to shape the regulatory environment and the multibillion-dollar market for these products.

More importantly, AHPA’s work has benefitted the growing number of consumers relying on natural products and herbal remedies for healthcare. “This really is my life’s work,” McGuffin says. “I think there is a tendency for trade associations to be thought of as only advocating for industry. That isn’t true, at least not for AHPA. We’re doing this for consumers and my fellow American citizens who want to use herbs without undue legal obstructions. That’s why I have devoted my life to advocating for ready, informed access to herbal products in a regulatory framework that protects public health and simultaneously ensures the right to make personal healthcare choices.”

One would be hard-pressed to find a regulatory issue related to the herbal and dietary supplement industry in which AHPA’s voice isn’t heard.

In the early days, even before McGuffin came on board, AHPA had begun speaking out to protect the herbal category. McGuffin says, “For example, in 1983 AHPA went on record as supporting the efforts of the Fmali Herb Company in its lawsuit against FDA in response to FDA’s refusal to allow import of an herbal product containing schizandra seed 

and other herbal ingredients with a long history of human consumption in Asia. This enforcement position was based on that agency’s interpretation of the 1958 food additive amendments to federal law as disallowing consideration of food use outside of the U.S. as relevant to a food’s history of use. Fmali eventually won this case on appeal, which had ramifications for the entire food industry.”

That was just the beginning. During McGuffin’s presidency, another key win was the association’s push for the USDA’s National Organic Program (NOP) to allow supplement products to be labeled as “organic” and to carry the USDA Organic seal. At the time in 2005, the NOP was only granting use of the seal to conventional food products. AHPA was also involved when FDA was establishing its 2006 law for serious adverse event reporting (AERs).

AHPA’s advocacy has not only helped the herbal products industry but the larger dietary supplement industry as well. The association has been one of the leaders in conversations with regulators, including through public comments submitted to federal and state agencies. Notably, AHPA submitted more than 400 pages of comments regarding regulations proposed under the Food Safety Modernization Act (FSMA), as well as voluminous comments regarding FDA’s new dietary ingredient (NDI) draft guidance (both the initial draft in 2011 and the revised draft in 2016). This year alone, AHPA submitted comments to regulators expressing its opinion on topics ranging from FDA’s intention to revamp dietary supplement regulations, tariffs on herbal ingredients during the current U.S.-China trade war, crop-grouping regulations under the purview of the U.S. Environmental Protection Agency, and even a matter as specific as the use of dairy names for plant-based products.

With McGuffin as its head, the association regularly engages with federal agencies, including FDA, the FTC, USDA, the U.S. Department of Commerce, and the U.S. Fish & Wildlife Service. AHPA actively monitors government activity at the state level as well, stepping in when issues and legislation could negatively impact herbal commerce. It has, for instance, been a leading participant in regulatory issues involving California’s Proposition 65 law. The association also extends its representation abroad via its International Committee, which works to ensure responsible international commerce of herbal products. AHPA is also an active member of the International Alliance of Dietary/Food Supplements Associations (IADSA) and regularly updates AHPA’s membership on international regulatory developments. McGuffin himself has served as an industry representative for groups such as FDA’s Food Advisory Committee Working Group on Good Manufacturing Practices for Dietary Supplements (1998-1999) and California’s Office of Environmental Health Hazard Analysis Food Warning Workgroup (2008-2010).

AHPA is also an active presence on Capitol Hill. In addition to its own lobbying work, AHPA is one of the associations that participates in the annual Day on the Hill event during which associations share education about the benefits of dietary and herbal supplements, alongside industry concerns, with lawmakers.

On the scientific front, AHPA’s chief science officer, Holly Johnson, PhD, and AHPA’s science staff participate in organizations such as the U.S. Pharmacopeia, the American Herbal Pharmacopeia, AOAC International, NSF International, and the National Institutes of Health, communicating on matters of research and natural product standards. McGuffin himself has been published in scholarly and scientific journals.

It’s hard to separate AHPA’s achievements from McGuffin’s own; they are one and the same. McGuffin attributes the association’s accomplishments to its members.

“One of AHPA’s strengths, reflected in the breadth and diversity of our membership, is the ability to connect many industry leaders to address the many, evolving issues and opportunities we encounter,” he says. “[W]e focus this combined experience and expertise, both through active engagement with regulatory working groups and with other authoritative bodies, such as the U.S. Pharmacopeia, AOAC International, and NSF International, and through submission of comments during rulemaking procedures.” Under McGuffin’s stewardship, AHPA’s Board of Trustees has grown nearly 40%.

“I would like to be able to report that our positions are always embraced by regulators, but of course it would be unrealistic to have any such expectation!” says McGuffin. “But we have had important influence on many and diverse regulations adopted by federal agencies and occasionally by states. And we maximize opportunities for such outcomes by first engaging with our members and then communicating to regulators with as much clarity as we can. Importantly, we have also built and continue to maintain respectful relationships with government agencies, even when we disagree with them.”

Click here to read our full interview with Michael McGuffin

AHPA will always serve first and foremost as a resource for its members-nearly 400 companies, including growers, processors, manufacturers, and marketers of herbs and herbal products (foods, dietary supplements, cosmetics, and non-prescription drugs).

AHPA’s educational and technical tools for its members are vast, including the association’s 

, created in 2005, which helps the entire supplements industry by providing a searchable repository of new dietary ingredient notifications submitted to FDA. During McGuffin’s presidency, AHPA’s board has adopted nearly 30 trade requirements or guidance policies to help promote responsible herb commerce and, in AHPA’s words, “represent meaningful self-regulation for the herbal products industry.” During McGuffin’s tenure, the association also issued second editions of its 

 (an incorporated reference in FDA’s labeling rules for herbal supplements) and 

-both key industry primers, with McGuffin serving as managing editor. It also regularly hosts in-person events and webcasts on regulatory and technical issues, and keeps its membership informed through newsletters and e-mail alerts.

McGuffin also ensures that the association monitors the current market, keeping its eye on which herbal categories are growing and in need of guidance and exchange of information. Under McGuffin’s watch, the association has created additional committees reflecting some of the most active herbal markets in the past 20 years: Sports Nutrition, Cannabis, Ayurvedic Products, Chinese Herbal Products, Analytical Labs, Tea & Infusion Products, and Sustainability. Says McGuffin: “It is important to remember that the herbal products industry is not monolithic. We see emerging niche interests, expertise, and needs. In order to serve the many and diverse needs of the industry, it has been vital for AHPA to tap the experts in various of these niches, and we do that by chartering committees that serve these separate and specific segments.”

AHPA serves a unique function that no other trade association does. Says McGuffin, “I am probably biased, but...I certainly think there would be a void of leadership for the herbal community without AHPA. There are other herb-focused organizations-the American Herbal Pharmacopoeia, the American Botanical Council, the American Herbalist Guild-and each of these also plays important roles in service to the herbal community. But AHPA plays a different role than any of these, as we have come to be relied on to serve the interests of the trade and to be the primary resource for industry advocacy. There are also several trade associations and other organizations that focus exclusively on the supplement and natural product markets-the Council for Responsible Nutrition, the Natural Products Association, and the United Natural Products Alliance-and each of these also makes significant contributions. But AHPA is again unique among these with the focused expertise of both our staff and our membership on the unique needs of the herbal products sector of the trade.”

According to the American Botanical Council’s (Austin, TX) journal 

, 2018 marked the U.S. herbal supplement market’s strongest year of sales growth yet-9.4% in 2018 to $8.8 billion. This means that U.S. herbal supplement sales are the strongest since McGuffin became AHPA’s president. AHPA’s guidance, both within and outside of the industry, will remain invaluable as this category increasingly goes mainstream and encounters more regulatory pressure and criticism. As AHPA continually monitors media coverage, it will continue to disseminate accurate information and correct misinformation. One pressing example of how AHPA’s voice is especially valued today is in the emerging hemp cannabidiol (CBD) market. To this end, AHPA has hosted both in-depth in-person and online events to bring regulators and stakeholders closer together and to help the industry navigate the waters to ensure a responsible market. With more than 40 years of experience with herbal product regulation and what McGuffin calls a “decade of engagement with this controversial herb,” AHPA is an authoritative figure on Capitol Hill, urging FDA to create a lawful pathway to market for CBD products.

In looking back on his 20 years of AHPA leadership, McGuffin says, “I have been a member of the natural products industry for nearly 45 years, and the bulk of my education has come from on-the-job experience. This experience in the industry and at AHPA has provided me with a valuable understanding of the distinct, but compatible, needs that individual businesses and the broader industry require to succeed.”

We turned to an equally respected authority in the herbal community to offer a few words about McGuffin’s many contributions. Mark Blumenthal, founder and executive director of the American Botanical Council, shared these words with us:

to be acknowledging Michael McGuffin for his immeasurable contributions to the American herb and dietary supplement industries. Everyone in the U.S. herb industry owes a profound and genuine debt of gratitude and appreciation to him for his strategic contributions to the overall industry. This debt applies to 

companies that sell botanical ingredients, whether or not they are members of AHPA-whether they consider themselves ‘herb’ companies or simply dietary supplement companies that happen to sell herbal ingredients as part of their product line.

Michael’s impact goes well beyond the U.S. market; it also includes benefits to foreign companies, whether they manufacture their own herbal products that they’re selling in the U.S. or whether they are botanical ingredient suppliers trying to sell to U.S. manufacturers. Either way, Michael’s excellent work for over 20 years as president of AHPA has helped to create a strong and stable American herb industry where many businesses have been able to flourish due to his efforts. Under his tireless and strategic leadership, AHPA has grown to be a major trade association dealing with many different issues on numerous fronts; AHPA is very possibly the most significant trade association dedicated to botanicals in the entire world.

As one of the founders of AHPA in 1982, I know that none of us ever envisioned the size and complexity of the modern herbal industry, and by extension, the various communities of industry and non-industry stakeholders with which Michael has so deftly worked and supported. Michael has worked very strategically and has mastered many key areas of the herb industry, including the compelling areas of standardizing botanical nomenclature for herbs sold in the U.S.; providing guidance to companies on issues of safety labeling; exerting leadership on the intricacies of GMPs, California’s Proposition 65, adverse event reporting; and so much more. His deep knowledge of government regulations and energetic efforts in submitting public comments to various agencies is well-known and highly respected, including within the government agencies themselves.

Smith T et al. “Herbal supplement sales in US increase by 9.4% in 2018.” 

McGuffin celebrates his 20th year as the renowned president of the American Herbal Products Association.

Nutritional Outlook’s 2019 Best of the Industry Awards, Industry Leader: Michael McGuffin

Establishing oneself as a category leader with a relatively new ingredient is no easy task, but ChromaDex (Los Angeles), with its novel vitamin B3 formulation-nicotinamide riboside (NR), branded Niagen-has done just that.

NR was discovered by Charles Brenner, PhD, now chief scientific advisor for ChromaDex, in 2004 while he was a researcher at the Geisel School of Medicine at Dartmouth College. In 2011, ChromaDex acquired the exclusive patents for the ingredient from Dartmouth College, Cornell University, and Washington University. In a relatively short amount of time, NR has accumulated a robust library of clinical research, with continued interest from scientists.

“There are 43 human clinical trials currently registered on ClinicalTrials.gov, six of which have now led to peer-reviewed publications. This is an unprecedented number of clinical trials for this type of supplement,” explains Rob Fried, CEO of ChromaDex, to 

 “Scientists approach ChromaDex all the time seeking new research opportunities, and we are happy to partner with them to further understand the full potential of NR. We are committed to be the best in the industry by having a brand that’s trusted because of our science, our quality, and our safety. Research is a big part of that. We would not put a product on the market unless we had conducted rigorous testing not only on safety but also on efficacy.”

Why all this interest? NR is a highly efficient precursor to nicotinamide adenine dinucleotide (NAD+), an essential coenzyme and regulator of cellular metabolism that plays an important role in the production of cellular adenosine triphosphate (ATP). ATP, generated by our mitochondria, is a major energy carrier in our cells.

“Because declining NAD+ levels have been associated with aging and a variety of age-associated conditions (i.e., metabolic disease, diabetes, Alzheimer’s disease, hearing loss, cognitive loss), we anticipate that these would be targets for NR’s therapeutic benefit theoretically, and researchers are pursuing that potential,” says Fried.

The therapeutic potential for NR is huge, and ChromaDex’s dedication to science and product integrity in past years, this year, and beyond is a testament to its commitment to improving consumer health. That is why ChromaDex is being recognized by 

Before Brenner discovered NR (nicotinamide riboside), a form of vitamin B3, as a nutrient that can boost NAD+ levels, nicotinic acid and nicotinamide, also in the B3 family, had been the only known vitamin precursors of NAD+ since the 1930s.

Fast forward to 2019, and the scientific literature on NR continues to grow. A recent randomized, double-blind, placebo-controlled, parallel-arm study published in 

 found that, compared to placebo, subjects taking 100 mg, 300 mg, or 1000 mg of ChromaDex’s brand name NR ingredient Niagen daily for eight weeks experienced an increase in whole-blood NAD+ levels of 22%, 51%, and 142%, respectively.

 There were no reports of flushing, a side effect of taking nicotinic acid, or significant adverse events, supporting the establishment of a tolerable upper intake limit for Niagen of 1 g, which was found to be safe and bioavailable. The recommended daily dose of Niagen is 300 mg.

“We believe NR is the best way to safely and efficiently elevate NAD+ levels, and its NAD-boosting properties have been validated in multiple published human trials,” says Fried. “First, it boosts levels of NAD+, supporting the same cellular energy production pathway as industry standards like CoQ10. Second, cells can also convert NAD+ to NADP (nicotinamide adenine dinucleotide phosphate), which functions in the same way as the antioxidant glutathione. Finally, NAD+ acts as a cellular signal, activating cellular processes that support mitochondrial efficiency for improved energy production. Essentially, Niagen feeds the organic surge already occurring within the body by bolstering our mitochondria to promote healthy aging at the cellular level.”

Interest in cellular health, mitochondrial health, and so-called antiaging products is huge. For example, mitochondrial health made it into SPINS’ “

,” a report in which the market research firm compared growing interest in mitochondrial health to early-stage interest in trending topics such as the microbiome and the endocannabinoid system.

“Mitochondrial health has surpassed the ‘trend’ category and become an important focus beyond early adopters,” explains Fried. “The NAD+ market has exploded. Awareness of NAD+ and its impact on cellular health has hit a tipping point-from the biochemistry and nutrition communities to the general population. ChromaDex has been at the vanguard of NAD+ and cellular health research for many years.”

Not only is ChromaDex a supplier of NR, but the firm also has its own finished supplement brand called Tru Niagen, in the form of capsules. It launched in September of 2017 and is sold directly to consumers. ChromaDex has expanded retail distribution of the product to Hong Kong, Singapore, New Zealand, and, most recently, Canada. The expansion into Canada also coincided with the launch of Tru Niagen stick packs for the consumer market, and the Tru Niagen powder is also available in full tubs for professional sports teams.

“There are a number of reasons why we opted to create our own consumer brand. The first was economic-it’s expensive to make NR, so by vertically integrating we’re able to reduce our cost basis,” explains Fried. “The second was that several of the companies to whom we were supplying NR were being quite irresponsible in their manufacturing processes, as well as with the messages they were using with consumers. By creating our own brand, we can ensure that consumers receive accurate information and a safe and effective product. We recognize the importance of this molecule and take our responsibility as stewards of NR seriously.”

Speaking of stewardship: not only is Niagen generally recognized as safe (GRAS) and the only NR ingredient with a new dietary ingredient (NDI) notification, but in November the European Commission approved NR as a novel food at a daily adult serving of 300 mg. “We are pleased to be extending our global footprint into Europe,” said Fried in a press release. “We are committed to offering Tru Niagen to health-conscious people worldwide.”

The footprint of Niagen is likely to grow even larger, considering a global commercial license and supply agreement deal ChromaDex signed with NestlÃ© Health Science at the end of 2018. This agreement provides NestlÃ© Health Science the exclusive right to include Tru Niagen in its branded medical nutrition portfolio and co-exclusive rights to include Tru Niagen in certain products within the consumer health category. The territories in the agreement include North America, Europe, Latin America, Australia, Japan, and New Zealand.

“We like the idea of combining NR with other complementary ingredients and are looking to implement more product concepts in that arena,” says Fried. To that end, the collaboration with NestlÃ© Health Science will fuse ChromaDex’s revolutionary science with NestlÃ©’s robust creative portfolio, he adds.

With such impressive growth and huge long-term potential, ChromaDex is bound to push the cellular health category to great heights.

Brenner C et al. “Discoveries of nicotinamide riboside as a nutrient and conserved NRK genes establish a Press-Handler independent route to NAD+ in fungi and humans.” 

Conze D et al. “Safety and metabolism of long-term administration of NIAGEN (nicotinamide riboside chloride) in a randomized, double-blind, placebo-controlled clinical trial of healthy overweight adults.” 

SPINS. “Top 10 Trend Predictions for 2019.” Published on January 10, 2019.

ChromaDex is pushing the boundaries of the cellular health and “antiaging” category with its groundbreaking ingredient, Niagen, and robust research.

Nutritional Outlook’s 2019 Best of the Industry Awards, Ingredient Supplier: ChromaDex

One of the leading criticisms of animal proteins is that their production is not environmentally friendly. Carbon emissions, waste byproducts, and high water and land usage-not to mention animal welfare-are all considered drawbacks of the dairy production process. And still, people love dairy protein. Consumers like its clean, neutral, milky flavor/texture, and food, beverage, and dietary supplement makers love that dairy proteins’ organoleptic properties ease formulating. Plant proteins are proposed as an earth-friendlier option to dairy proteins, but the fact is that many plant proteins’ grassy or beany flavors can run astray of the dairy protein experience that consumers like and, more importantly, are used to. But what if you could have both? What if you could have a dairy protein that tastes delicious but that can also be produced without harming the welfare of animals or the planet? Sounds like a dream come true? Thanks to a startup ingredient supplier called Perfect Day (Emeryville, CA), this solution now exists.

Perfect Day has devised a way to produce dairy proteins using microbial fermentation. Perfect Day was founded in 2014 by Ryan Pandya and Perumal Gandhi. Both became vegan as adolescents, driven by their concerns about animal welfare and the environmental unsustainability of producing and consuming animal products. Even as committed vegans, however, they still hated the taste and texture of the non-dairy protein products available at the time, and they sorely missed the dairy products they had loved. When the two met, “what we didn’t realize at the time was that we were both vegans but not exactly happy with the options that were out there,” Pandya says.

In 2014, Pandya had just started his career as a biomedical scientist in the U.S. Gandhi, meanwhile, was in India working as a research assistant. Prior to that, he had studied biomedical engineering at The State University of New York at Stony Brook, working in the lab of associate professor David A. Rubenstein, PhD, to develop tissue scaffolds. A mutual friend, Isha Datar, the executive director of a nonprofit research institute called New Harvest, introduced Pandya and Gandhi via e-mail. New Harvest funds research focusing on “cellular agriculture”-processes to “make animal products-without animals.” Shortly after they met, Pandya and Gandhi set out to find a way to make non-animal dairy proteins. They decided to turn their focus to dairy products first-and the milk proteins within, specifically whey and casein-for one simple reason: they both loved dairy.

Shortly after founding Perfect Day in 2014, the two worked with a team of scientists, engineers, chefs, and food developers to improve and perfect the fermentation process ultimately used to produce Perfect Day proteins. Perfect Day owns the patent to its process.

The process works like this. The company uses a microflora from the 

 genus, a genus commonly used in the bioproducts industry to produce protein. (“

 produces a lot of protein naturally and is one of the top performers in the bioproducts industry,” Pandya says.) Perfect Day harnessed this ability to create milk proteins in microflora. Using what it says are common tools of biology, the company inserts the genetic information responsible in cows for making specific milk proteins (casein and whey) into the microflora so that the flora can produce the proteins via fermentation in tanks instead. “We call this flora-based dairy protein, since it comes from flora instead of animals,” the company says. “By combining the milk protein genes with 

 we successfully domesticated the world’s first dairy-producing flora.”

The company uses this process to create vegan, lactose-free, hormone- and antibiotic-free dairy proteins that it says formulate with just as much ease as conventional dairy proteins and that sidestep the sustainability negatives of dairy protein. Nutritionally and organoleptically, Perfect Day’s non-animal dairy protein is a match with conventional animal protein, including amino acid profile, offering consumers the same clean, appealing taste as dairy protein, the company says.

“We’re the only company doing flora-based dairy,” Pandya says. “There are a few other companies using a similar model using fermentation to create ingredients and products, but Perfect Day is the first to bring a product to market for people to actually taste, and to use the term 

 to try to educate consumers on this new category.”

This past summer, as Pandya mentioned, Perfect Day gave customers a taste of its flora-based protein in the form of a test-run, limited-edition, 

 sold through the company’s website only. By combining the flora-based protein with water, non-lactose sugars, and plant-based fats in the same proportions as found in cow’s milk, the company was able to create the animal-free milk with which to formulate the ice cream.

“The first product we chose to launch, back in July, was ice cream made from our animal-free milk base,” says Pandya. “The protein is what enabled it to have that creamy texture and mouthfeel. Those who have tasted our ice cream note that it lacks the iciness or chalkiness of many plant-based ice creams, and brings the experience in line with what you’d expect from a premium ice cream made with cow’s milk.”

Consumer appreciation for this innovation is high: the test-run ice cream sold out on Perfect Day’s website in 

“We were thrilled by the overwhelming response to our limited release,” says Gandhi. “There was so much buzz and excitement amongst our community of supporters, and we are still riding the wave from that initial launch.”

Companies, both finished-product brands and ingredient firms, are also interested in the possibilities Perfect Day offers. The flora-based dairy proteins can be used in many ways, not only to produce the same dairy-based foods we know and love (milk, cheese, yogurt) but also, potentially, products like dietary supplements. “Because it’s the same kind of protein that food makers are already familiar with, it’s simple to use flora-based dairy protein in exactly the same ways you’d use dairy protein from cow’s milk,” the company says.

Pandya adds, “While our current focus is on whey protein, we’re committed to developing all major milk protein fractions, because the fermentation process is surprisingly simple. We combine our microflora with plant-based sugar and put it through fermentation. Afterward, we filter out the flora and remaining sugar and dry the protein into a powder that can be implemented into all sorts of products.”

In November 2018, Perfect Day and the Archer Daniels Midland Co. (ADM; Chicago) signed a joint agreement to develop and commercialize animal-free dairy proteins. (“These animal-free dairy proteins will be the first in the world to be produced at large scale via fermentation instead of using farmed animals, which have historically been the only way to produce dairy proteins,” the companies’ press release states.)

“We are working with ADM to optimize and scale up the production of our protein,” says Gandhi. “ADM has been a leader in plant proteins for many, many years, and working with them has and will enable us to propel this source of dairy protein that can lead to endless opportunities for food innovators and consumers.”

And it’s likely just the beginning. Perfect Day says that as of October 2019, it has received $62.5 million in funding. (It currently employs just over 70 people.) Says Pandya, “While we cannot share specific details about the number of requests [we’ve received] to partner, we have been overwhelmed by the positive response and are excited for what’s to come in the near future.” The company says interest is coming from “some of the most well-known food and dairy companies in the world,” as well as from smaller food makers and even culinary chefs.

Education will still be needed to introduce flora-based protein to consumers, the company says. To those who question the naturalness of a Perfect Day protein, the company points out that the fermentation techniques used to create Perfect Day’s dairy proteins are the same as those used for more than half a century to create ingredients like vitamins, probiotics, and natural flavors. “Fermentation is natural,” the company says. “It’s been used for centuries to preserve and improve foods.”

Says Gandhi: “We, at Perfect Day, are dedicated to transparency, and we truly believe in educating consumers about this new category: flora-based foods. On our website and in our external communications, we include a breakdown of how the fermentation process works and how our protein is created. As we work with partners and continue to work through educating consumers on this category, we’re constantly assessing receptiveness and overall understanding of this category so that we can continue to share a clear message.”

Perfect Day is also communicating with the U.S. FDA regarding its proteins’ status as generally recognized as safe (GRAS). A third-party assessment affirmed the flora-based protein as GRAS. Says Pandya: “We submitted the GRAS filing for our non-animal whey protein to FDA in April 2019. Since 2014, we have been briefing the FDA on our process and discussing labeling for clear consumer communication.”

Milk made from non-animal dairy protein does not fall under FDA’s legal definition of 

which FDA defines as “the lacteal secretion, practically free from colostrum, obtained by the complete milking of one or more healthy cows.” Keeping these regulatory definitions in mind, Perfect Day says, “We have referred to our protein on packaging as ‘non-animal whey protein.’” (It adds: “There is precedent in the dairy industry and with the FDA for similar nomenclature as ‘non-animal rennet,’ a common component in cheesemaking. Non-animal rennet is also made through microflora fermentation.”)

“We are the first and only company scaling flora-based dairy, so we are on a mission to educate consumers on this new category and ensure we are working closely with the FDA,” the company says.

And, at the end of the day, Perfect Day’s proteins are all about expanding the options for consumers.

“Consumers want choices, and we recognize that there is no single type of protein that will satisfy every consumer,” says Pandya. “Our goal is to enable food makers to offer a new choice: products that not only taste great but that are also nutritious, sustainable, and humane. We are expanding the total ‘protein pie,’ so to speak, by providing food companies with a third, flora-based protein option.”

When will the first commercial foods be available featuring Perfect Day’s flora-based protein? “Given the timelines of our brand partners, we expect to be able to launch the first commercial product(s) within the next year,” says Pandya. The good news for consumers? Soon, very soon, you will be able to have your dairy proteins and eat sustainably, too.

Perfect Day is offering consumers and companies a new choice: non-animal, flora-based dairy protein.

Nutritional Outlook’s 2019 Best of the Industry Awards, Ingredient Supplier: Perfect Day

The omega-3 category has had its highs and lows over the years. Occasional bad press has hurt public opinion about the benefits of omega-3 EPA and DHA supplements, affecting sales, but the category always seems to bounce back. That’s probably because omega-3s remain among the most well researched and recognized nutrients on the market. 

 have demonstrated the role of EPA and DHA in the health of our heart, eyes, and brain, as well as the healthy development of fetuses and children in utero and after birth.

One company working to keep omega-3s at the forefront of consumer attention is OmegaQuant, based in Sioux Falls, SD. The company provides simple at-home kits for consumers to test their Omega-3 Index-a measure of the level of omega-3 EPA and DHA fatty acids in red blood cells. This Index number can help to indicate one’s risk for cardiovascular disease and allows people to take preventative action by either eating more fish and foods rich in omega-3 fatty acids or taking omega-3 dietary supplements. 

 provide users with everything they need to administer testing. Via a simple finger stick, consumers send back a drop of blood for analysis. OmegaQuant also provides fatty acid analytical services for researchers.

More than 200 clinical studies have utilized the Omega-3 Index methodology, and OmegaQuant continues to study the Omega-3 Index and build its library of research validating the role of omega-3s in our health, especially cardiovascular health. By providing this reliable scientific metric for gauging omega-3 status as it relates to heart health, OmegaQuant is empowering consumers and giving dietary supplement brands the ability to more effectively market their products. That is why OmegaQuant is recognized as the Best of the Industry this year.

 century was a very important moment for omega-3 research. In 1999, the landmark GISSI-Prevenzione trial found omega-3 supplementation significantly reduced the risk of death, cardiovascular death, non-fatal myocardial infarction, and stroke.

 In 2002, expanded analysis of the study results showed just how fast omega-3s’ effects occurred (in as little as three months) and hypothesized that the effects were due to a reduced risk of arrhythmia.

 Meanwhile, confronted with the recent revelations about omega-3s and heart health, William S. Harris, PhD, president and CEO of OmegaQuant, and his colleague, a German cardiologist named Clemens von Schacky, MD, pondered whether omega-3 EPA and DHA levels in the blood could be a risk factor for sudden cardiac death.

In 2004, Harris and von Schacky published a paper proposing that a person’s Omega-3 Index can be a new means of measuring the risk of cardiovascular death.

More specifically, the paper posits that the fatty acid composition of red blood cells, dubbed the Omega-3 Index, reflects long-term intakes of omega-3 EPA and DHA and can indicate risk of coronary heart disease death. They concluded that an Omega-3 Index of greater than 8% was associated with the greatest cardioprotection, while an index less than 4% was associated with the least.

The immediate response to the article was “exceedingly quiet,” says Harris, but this eventually changed. “It was like a seed planted in a field that only slowly began to emerge from the dirt and grow and grow,” he says. “I think the watershed event for the test was probably our first publication using the test in the Framingham Cohort

. Being associated with that well-respected study gave it more legitimacy than anything we’d done before.”

Since then, the Omega-3 Index has been making its way into more and 

. “The logic of the red blood cell membrane serving as a repository for EPA and DHA and thus a marker for omega-3 status of other tissues has been compelling,” says Harris. He explains that omega-3 EPA and DHA levels in red blood cells remain more stable over time compared to plasma-based samples. “Plasma levels can go up immediately after a big salmon meal, but red blood cell levels don’t. In other words, the red blood cell is not artificially influenced by a one-time load of omega-3, while plasma is.”

This makes the Omega-3 Index a better long-term measure of omega-3 status. Harris compares it to HbA1c testing for diabetes, which is preferred to plasma glucose testing. This is because HbA1c is red blood cell–based and a much more stable long-term marker of glucose status than plasma glucose, which can fluctuate.

The challenge remains to get broader acceptance of the Omega-3 Index from physicians. “Detractors [of the Omega-3 Index] are typically physicians who are not experts in the field who read only headlines of studies and who think there’s nothing to the omega-3 story,” says Harris. “They obviously see no value in measuring omega-3 status. If they knew that the Omega-3 Index is considered a superior marker of risk for heart disease and death than cholesterol, they might change their minds.”

 found that in a head-to-head comparison between the Omega-3 Index and total cholesterol as a predictor of cardiovascular disease and mortality, the Omega-3 Index was significantly associated with total cardiovascular disease, coronary heart disease, and any mortality, while cholesterol was not significantly associated with any of these.

This is why OmegaQuant exists, Harris says. It gives people greater control and knowledge of their own health. “We realized that the medical community was going to be slow to take up the Omega-3 Index test, and that insurance companies-because it’s ‘new’-would not be paying for it,” says Harris. “The movement toward self-healthcare and personalized nutrition also pointed us to consumers.”

, allowing expecting mothers to monitor their omega-3 DHA level, which has a profound effect on the development of the baby before and after birth. Recent research has found that supplementation with omega-3s is associated with a significantly reduced risk of preterm birth. One 

meta-analysis of 70 randomized controlled trials found that preterm birth (<37 weeks gestation) and very preterm birth (<34 weeks gestation) were reduced by 11% and 42%, respectively, when women took omega-3 supplements.

Another study found the risk of early preterm birth was ten times higher among women with an EPA and DHA omega-3 concentration less than 1.6% of total blood plasma.

 Using this data, OmegaQuant converted EPA and DHA plasma levels to red blood cell DHA levels and determined that pregnant women would need at least 5% DHA content in red blood cells to prevent early preterm birth. In a proposal of this prenatal DHA test published in 

 Harris and OmegaQuant’s research associate, Kristina Harris Jackson, PhD, RD, determined that 70% of women of childbearing age are below the 5% DHA cutoff.

OmegaQuant is also giving researchers a more reliable way to study omega-3 supplementation with its recently devised Omega-3 Calculator. The Omega-3 Calculator is an attempt to model the effects of omega-3 supplementation on the Omega-3 Index. In a study published in 

The American Journal of Clinical Nutrition, 

Harris and Jackson, along with other researchers, created a model equation that estimated the final Omega-3 Index of a population based on the dosage of omega-3 EPA and DHA and baseline Omega-3 Index.

For example, a population with a baseline Omega-3 Index of 4.9% that is given 840 mg EPA and DHA per day for 13 weeks, as a 1-g ethyl ester capsule, would reach an Omega-3 Index of about 6.5%. Using this equation, one can also calculate the approximate dosage necessary to achieve a mean Omega-3 Index of 8% in 13 weeks. 

, for a population with a baseline Omega-3 Index of 2%, 2200 mg of EPA and DHA is required, while for those with a baseline Omega-3 Index of 4% and 6%, 1500 mg and 750 mg of EPA and DHA is required, respectively.

“[The Omega-3 Calculator] makes it easier for researchers to select a dose that will give them a cardioprotective Omega-3 Index. The old way was just to give one capsule and see what happens (or doesn’t happen!), without any concern for the right dose,” explains Harris. “The calculator, imperfect as it may be because of unknown factors that cause the Omega-3 Index response to fish oil supplementation to vary from person to person, really should be used for groups, not individuals.”

When OmegaQuant launched in 2009, the science behind the Omega-3 Index test was well-established, but getting the Omega-3 Index tests in the hands of consumers was the real challenge, says Harris. “Implementing the logistics was not difficult; the difficulty was in marketing and education,” he says. “We’ve done a 

 and for ‘influencers’ over the years, and will no doubt keep that up.”

The Omega-3 Index can also be an invaluable tool for finished product manufacturers. For example, supplements brand MegaRed recently did a campaign that tested the Omega-3 Index of 234 individuals in and around Newport, RI, a coastal city with easy access to seafood. Results showed that the 96% of Newport-area residents were below the target Omega-3 Index range of 8%, with an average score of 5.2%. The campaign highlighted the importance of supplementation even for those who live in a place where seafood consumption is an everyday part of life.

magazine recently recognized the company in its 2019 

 the company has grown 177% in three years. One can only hope that OmegaQuant’s continued growth reflects greater consumer awareness of the benefits of omega-3 supplementation and the importance of the Omega-3 Index.

Decker KJ. “Omega-3 market in 2019.” 

 vol. 22, no. 7 (September 2019): 86-90. Accessed at: 

www.nutritionaloutlook.com/article/omega-3-market-2019

“Dietary supplementation with n-3 polyunsaturated fatty acids and vitamin E after myocardial infarction: results of the GISSI-Prevenzione trial. Gruppo Italiano per lo Studio della Sopravvivenza nell’Infarto miocardico.” 

vol. 354, no. 9177 (August 7, 1999): 447-455

Marchioli R et al. “Early protection against sudden death by n-3 polyunsaturated fatty acids after myocardial infarction: time-course analysis of the results of the Gruppo Italiano per lo Studio della Sopravvivenza nell’Infarto Miocardico (GISSI)-Prevenzione.” 

vol. 105, no. 16 (April 23, 2002): 1897-1903

Harris WS et al. “The Omega-3 Index: a new risk factor for death from coronary heart disease?” 

Harris WS et al. “Changes in erythrocyte membrane trans and marine fatty acids between 1999 and 2006 in older Americans.” 

Harris WS et al. “Erythrocyte long-chain omega-3 fatty acid levels are inversely associated with mortality and with incident cardiovascular disease: The Framingham Heart Study.” 

Middleton P et al. “Omega-3 fatty acid addition during pregnancy.” 

Cochrane Database of Systematic Reviews. 

Olsen SF et al. “Plasma concentrations of long chain omega-3 fatty acids in early and mid-pregnancy and risk of early preterm birth.” 

Jackson KH et al. “A prenatal DHA test to help identify women at increased risk for early preterm birth: a proposal.” 

Walker RE et al. “Predicting the effects of supplemental EPA and DHA on the omega-3 index.” 

vol. 110, no. 4, (October 1, 2019): 1034-1040

Krawiec S. “Recent study devises ‘omega-3 calculator’ to help researcher determine proper EPA and DHA doses.” 

 Published on August 28, 2019. Accessed at: 

www.nutritionaloutlook.com/omega-3/recent-study-devises-omega-3-calculator-help-researcher-determine-proper-epa-and-dha-doses

OmegaQuant is giving consumers a way to measure omega-3 content-and a reason to take supplements.

 Nutritional Outlook’s 2019 Best of the Industry Awards, Retail Brand/Product: OmegaQuant

's 2018 Best of the Industry Awards, we are recognizing individuals, groups, and companies whose initiatives today may help shape, for the better, the state of the dietary supplement and food and beverage industries for years to come.

First, there is CV Sciences, a company doing its best to establish a responsible presence in the midst of the mushrooming CBD market. As more CBD players, delivery forms, and product claims fly about the market-with little guidance, it seems-CV Sciences is staying grounded and, in a historical move, has become the first CBD nutraceutical firm to achieve a Generally Recognized as Safe (GRAS) self-determination for its proprietary, natural, CBD-rich hemp extract. This GRAS self-determination now sets the bar in the CBD market and an example for other CBD firms to follow, and there is no telling how this GRAS self-determination could pave tomorrow’s road to a better regulatory environment for CBD supplements and food.

Ardent Mills is another company laying a path forward for the markets it serves. Its new business unit, The Annex by Ardent Mills, is committed to increasing the supply of ancient and heirloom grains in North America through its grower relationships and taking an end-to-end look at the supply chain, helping formulators by providing innovative new grain formats and guidance. Altogether, the ability to source grains domestically and from more regions of North America will help companies as they face growing demand for these grains in healthy foods and beverages.

We are also recognizing two new initiatives, the Supplement Safety Compliance Initiative (SSCI) and the Global Retailer and Manufacturer Alliance (GRMA), for the work they are doing to, if all goes well, increase the level of industry self-regulation and quality control. While these initiatives are still in their infancy, their achievements so far in bringing together stakeholders throughout industries will help companies and retailers ensure that the quality standards and the benchmarking of those standards at the end of the day secure a safer, higher-quality product market for consumers.

And then there is Senator Orrin Hatch, whose support of dietary supplements has been the industry’s foundation-past, present, and future. The industry owes much of its existence today to Senator Hatch’s contributions. As Senator Hatch retires his congressional seat at the end of year, industry leaders remember his support and his friendship.

Ingredient Supplier: The Annex by Ardent Mills

Industry Leader: Supplement Safety Compliance Initiative

Industry Leader: Global Retailer and Manufacturer Alliance

In Nutritional Outlook's 2018 Best of the Industry Awards, we are recognizing individuals, groups, and companies whose initiatives today may help shape, for the better, the state of the dietary supplement and food and beverage industries for years to come.

Nutritional Outlook’s 2018 Best of the Industry Award Winners

There are few figures more revered in the dietary supplement industry than Senator Orrin Grant Hatch, the Republican senator who has represented the state of Utah since 1977 and championed dietary supplements throughout his career, most notably with his most seminal contribution: the passage of the Dietary Supplement Health and Education Act of 1994 (DSHEA). Introduced by Senator Hatch in 1993 and co-sponsored by Democratic Senator Tom Harkin of Iowa, DSHEA laid the foundation for what the dietary supplement industry has become today.

“The Dietary Supplement Health and Education Act was the watershed event that created the modern dietary supplement industry by finally creating a regulatory home that included, for the first time, a legal definition for this category of products within foods,” explains Frank Lampe, vice president, communications and industry relations, United Natural Products Alliance. “It established a regulatory structure and good manufacturing practices and also provided the U.S. Food and Drug Administration with abundant power to enforce the new law through a defined safety standard and authorities. The law explicitly allowed certain third-party literature to be provided in conjunction with a sale and for statements of nutritional support, or structure function claims. Additionally, the law also established the Office of Dietary Supplements at the National Institutes of Health, to foster independent scientific research about the benefits of supplements.”

DSHEA enabled the growth and prosperity of dietary supplements as an industry as well as a resource consumers rely on to live a healthy lifestyle. “Today, more than 170 million Americans take dietary supplements each year,” says Mike Greene, senior vice president, government relations, the Council for Responsible Nutrition. “The dietary supplement industry provides 750,000 good paying jobs in the United States, and with national sales just under $50 billion, the industry continues to thrive and grow.”

Providing some historical context, Daniel Fabricant, PhD, CEO and president of the Natural Products Association, explains that prior to DSHEA, the U.S. Food and Drug Administration treated dietary supplements as food additives, making ingredients subject to extensive toxicological testing despite most of the ingredients in question having precedent as a food. This was under a new FDA policy bolstered by the passage of the Nutrition Education Labeling Act in 1990, which considered any non-vitamin or mineral dietary supplements to be food additives, not food, as they had been regulated as since the passage of the Federal Food, Drug, and Cosmetic Act in 1938.

At the same time, there was a self-care movement in which more and more people were taking supplements. Senator Hatch was one of them. Beyond his responsibility to Utah, which has a high concentration of dietary supplement manufacturers, he cared about the products and the people taking them. “He took the products, believed in the products. It was the way he stayed healthy,” says Fabricant. “Senator Hatch was a boxer at a young age. He was athletic, very much interested in health.”

“He clearly understands how [supplements] support the wellbeing of millions of Americans and how important broad access to the products is for those consumers,” says Lampe. This, too, is one of DSHEA’s most important achievements, beyond helping manufacturers. “Its importance cannot possibly be overstated as it ensured that consumers had broad access to safe and reliable products” by enabling the industry to innovate responsibly, Lampe explains. “Instead of assuming all companies are making unsafe products, the law operates on the assumption that most products are safe, and the burden of proof is on the agency to prove otherwise.”

It’s also important to note, in these currently polarizing political times, that DSHEA was created under bipartisan leadership, showcasing the senator’s gift of reaching across the aisle.

DSHEA is far from the only contribution Senator Hatch has made to the industry. He has consistently demonstrated his commitment to defending the rights of both dietary supplement manufacturers and consumers. His commitment led to the achievement of other supplement-related policies, including the release of Good Manufacturing Practices for dietary supplements (cGMPs), serious adverse event reporting, and the Designer Anabolic Steroid Control Act (DASCA).

“Ten years after DSHEA became law, many in the industry were concerned that FDA was not implementing or enforcing the law,” explains Greene. “GMPs for dietary supplements had yet to be finalized or promulgated, and in the wake of FDA banning ephedra, there were growing concerns about the safety of dietary supplements. Senator Hatch called on FDA to release GMP [regulations], and passed legislation, supported by many stakeholders, including the industry, that would require serious adverse event reporting for dietary supplement (and non-prescription drug) manufacturers.”

Ironically, the adverse event reporting law saw some resistance from industry companies, says Fabricant. “There were a number of companies at that time in 2006 that thought it was a terrible idea, and a lot of those companies were in Utah,” he explains. “They thought this was going to be hung around their necks like an albatross, and that wasn’t the case at all.”

Once again, Senator Hatch brought people together to compromise. “Senator Hatch really worked with people on both sides of the aisle-people like Dick Durbin, who has been a critic of the industry, and Joe Biden, who at the time was a critic of the industry,” says Fabricant. “He brought them over to the table, brought the OTC folks to the table, and brought the dietary supplement industry people who were opposed, and got it done.”

As bad actors began selling falsely marketed dietary supplements spiked with anabolic steroids, Senator Hatch took additional action to protect consumers and the reputation of the dietary supplement industry by introducing the Designer Anabolic Steroid Control Act alongside Democratic Senator Sheldon Whitehouse of Rhode Island. This legislation provided the Drug Enforcement Agency the authority to remove designer anabolic steroids from the market and stop them from being added to sports nutrition products.

A similar sentiment shared by many involved in the dietary supplement industry is that no one can replace a champion such as Senator Hatch. His support was singular. “It will be impossible to replace the experience, knowledge, and love that Senator Hatch has for the dietary supplement industry,” says Greene. “But we can continue to make new friends and build alliances.”

Indeed, there do remain friends to the industry within Congress, as is demonstrated by the nearly 50-member bipartisan Dietary Supplement Caucus. So, while no one can replace him, one can hope that there will be those who follow his example.

Myers S. “The Importance of DSHEA: Past, Present and Future.” 

www.naturalproductsinsider.com/regulatory/importance-dshea-past-present-and-future

As Senator Hatch retires his congressional seat this year, industry leaders reflect on how his support paved the road to today’s dietary supplement industry.

Nutritional Outlook’s 2018 Best of the Industry Awards, Industry Leader: Senator Orrin Hatch

These days in the dietary supplement industry, no one, it seems, can get away from the topic of CBD. Hemp-derived cannabidiol (CBD) has taken the industry by storm, with more products and players popping up in the market every day and multitudes of questions raised at industry events: Is it legal? Are firms selling CBD taking a risk? And what about that Investigational New Drug (IND) application belonging to CBD drug firm GW Pharmaceuticals, which many cite as the primary reason FDA still says products containing CBD are not an authorized dietary supplement ingredient?

All are worthy questions, but one of the most salient questions is whether or not CBD is actually safe for human consumption. One hemp-derived-CBD company, CV Sciences (San Diego, CA), has taken a leadership role in demonstrating the safety of its ingredient and trying to chart a responsible path to market. In September, CV Sciences announced a monumental achievement: it now has a Generally Recognized as Safe (GRAS) self-determination for its proprietary hemp extract used to make the products in the company’s bestselling PlusCBD Oil Gold Formula consumer product line. This GRAS self-determination stems from a battery of toxicology studies commissioned by the company on its ingredient. These studies, conducted by scientific and regulatory consultant AIBMR Life Sciences (Seattle, WA), are said to be the first published toxicology studies since 1981

 on a hemp extract that contains naturally occurring CBD. CV Sciences’ ingredient is a hemp extract comprising a full spectrum of naturally occurring phytocannabinoids, including CBD, as well as fatty acids, terpenes, plant sterols, and vitamin E in all of its isomers. It is produced via supercritical CO

 extraction of the aerial parts of the hemp plant 

 and contains approximately 25% CBD overall.

At this point, it should be mentioned that in March of this year, leading hemp foods brand Manitoba Harvest announced an industry-first GRAS self-determination for the company’s hemp seeds, hemp oil, and hemp protein powder products for foods, with the company submitting its GRAS notification to FDA. There is a marked difference, however, between Manitoba Harvest’s products-seeds, oil, and protein powder-and what CV Sciences has obtained a GRAS determination for: a CBD-rich, full-spectrum hemp extract. In short, CV Sciences’ GRAS self-determination represents

 GRAS assessment of its kind to be performed on a hemp extract containing naturally occurring CBD. In fact, the toxicology studies done on CV Sciences’ Gold Formula CBD are “not only the first peer-reviewed toxicology work published on a hemp extract since 1981 but the first toxicology work published on a natural CBD-containing extract ever,” says Stuart Tomc, vice president of human nutrition for PlusCBD Oil.

John Endres, chief scientific officer for AIBMR Life Sciences, the company that placed, monitored, and published the OECD- (Organisation for Economic Co-operation and Development) and FDA-compliant toxicology studies as well as the GRAS self-determination for CV Sciences, explains the five tests included in the toxicology study, which is now published in the

 These tests include: 1) an AMES bacterial reverse mutation test (testing for mutagenicity), 2) an 

 mammalian chromosomal aberration test (testing for clastogenicity, or chromosomal damage), 3) an 

 mouse micronucleus test (testing for genotoxicity), 4) a 14-day repeated-dose oral toxicity study in rats (a range-finding study to narrow the dosage range, with researchers testing extreme dosages of 1000, 2000, and 4000 mg/kg body weight per day), and finally, and most critically, 5) a pivotal 90-day repeated-dose oral toxicity study in rats. These are standard tests for determining the safety of consumption of a food ingredient, says Endres, who was the studies’ monitoring scientist.

CV Sciences’ hemp extract was determined to be non-mutagenic, non-clastogenic, and non-genotoxic. In the 90-day repeated-dose test, the researchers determined a No-Observed Adverse-Effect Level (NOAEL) to be 100 mg/kg body weight per day for male rats and 360 mg/kg body weight per day for female rats. Abiding by the more conservative of the two doses, the NOAEL coming out of these rat studies was therefore concluded as 100 mg/kg body weight per day. After dividing that number by a 100-fold uncertainty factor (to account for the differences between rats and humans), the NOAEL for 

CV Sciences is leading the CBD industry with a monumental GRAS self-determination.