Awards

 Best of the Industry awards this year, we are highlighting four winners for their contributions in 2021.

Our 2021 Industry Leader is NOW, whose testing of dietary supplement products sold on Amazon.com showed how one supplement company can roll up its sleeves to try to improve the state of the market. This is the second time 

 has named NOW a Best of the Industry award winner. Back in 2011, 

 for a rapid adulteration-screening method that the company shared with the rest of the dietary supplements industry. In 2011, the company set an example; 10 years later, it continues to lead.

Our 2021 Best of the Industry Ingredient Supplier is Seraphina Therapeutics for its groundbreaking work in odd-chain fatty acids and pentadecanoic acid. Seraphina’s story shows how innovation did not take a break, even in the most challenging of times.

In the Service Provider category this year, we are awarding the Botanical Adulterants Prevention Program (BAPP). Five years ago, 

 in our Best of the Industry awards. This year, BAPP celebrates its 10

anniversary educating and warning the botanicals industry about ongoing adulteration—a role that became additionally significant during the past two tumultuous pandemic years.

Finally, we celebrate Good Catch with our 2021 Best of the Industry award for Retail Brand/Product. Within the crowded plant-based alternatives market, Good Catch stands out for pioneering plant-based seafood.

Join us in congratulating our 2021 Best of the Industry award winners. Read their stories and listen to our December episode of 

 in which we take you beyond the page with one-on-one interviews with each of our award winners.

This year marks the 10-year anniversary of 

 Best of the Industry Awards. We can’t wait to see what excellence the next 10 years bring thanks to you, companies and individuals committed to making the natural products industry bigger and better each passing year.

Ingredient Supplier: Seraphina Therapeutics

Service Provider: Botanical Adulterants Prevention Program

Articles

In Nutritional Outlook’s 2021 Best of the Industry Awards, we recognize individuals, groups, and companies whose initiatives today are helping to shape, for the better, the state of the dietary supplement and natural products industry.

Nutritional Outlook’s 2021 Best of the Industry Award Winners

Jennifer Grebow is the editor-in-chief of 

, an award-winning media-content provider in the dietary supplement and natural products market. 

, an MJH Life Sciences brand, provides insights and industry updates critical to manufacturers of dietary supplements, healthy foods, and nutritious beverages. 

 keeps industry abreast of current market trends, research updates, news, and regulatory developments. 

goes beyond the 24-hour news cycle and provides in-depth analysis to help industry players navigate the challenges and changes in the near- and long-term. 

, the largest privately held, independent, full-service medical media company in North America, dedicated to delivering trusted health care news across multiple channels.

 clicked through the endless pages of dietary supplements sold on Amazon.com and wondered just how many of those products are junk? For good reason. This past summer, U.S. FDA 

 to Amazon CEO Andy Jassy warning him that nearly 30 sexual-enhancement and weight-loss supplements sold on Amazon that FDA tested contained “undeclared and potentially harmful drug ingredients.” FDA said it was “concerned” that Amazon’s “filters” for catching unlawful products were “inadequate.”

Not all problems with supplements on Amazon rise to the level of drug spiking, but that doesn’t mean they aren’t concerning. Some products might not contain the amount of active ingredient promised—or might not even contain the ingredient 

—cheating customers paying good money for a product they’re relying on to support their health.

These problems also risk the reputation of the entire dietary supplements industry, an unfortunate reality that keeps responsible supplement brand leaders—of which there are many—up at night. But has any supplement brand actually rolled up its sleeves to find subpar products on Amazon—and then launched a public initiative to share those findings with the entire dietary supplements industry, with Amazon itself, and last, but not least, with FDA?

NOW has. Starting in 2017, the family-owned giant, now in its sixth decade manufacturing its global line of dietary supplements and other products, began testing select supplement products sold on Amazon.com. Many of those products competed with NOW’s own. The company has since tested finished supplement products in some of the most popular categories, including 

“NOW has been testing products purchased on Amazon for several years before we began this strategic program that involved making the results public,” says Dan Richard, NOW’s vice president of global sales and marketing. “We first tested a variety of products in 2017 and did our first category group of CoQ10 products in March 2018.”

The company focuses on testing products from lesser-known brands, often containing ingredients known to be pricey. “We chose categories in which the ingredients are expensive so there is more incentive for the cheaters to cheat. We chose brands that are unknowns, which we guessed would have lower quality-control systems,” says Richard. “NOW did not test larger natural brands because our experience has shown that these brands are typically made with good quality and adhere to FDA’s cGMP requirements,” he adds, referring to current good manufacturing practices.

NOW has vested interest in testing products that compete with its own. “We also chose products that NOW sells, where we saw NOW sales declining on Amazon to ‘no-name’ brands,” Richard says. “Our motive is to level the playing field with equal-quality brands competing with branding and value. We feel that NOW can win when competing fairly.”

Evening the playing field is what drove NOW’s efforts from the start. “Like many manufacturers, from time to time we do quality checks on many brands in the marketplace. It was obvious to us that many of the products sold on Amazon in the higher-priced categories, from brands no one ever heard of, could not possibly be what they claimed on the label. It was also clear many of them were not following the cGMPs as required by law,” Richard explains. “It was enraging, really, to see these unknown brands cheating customers and taking sales from legitimate brands that invest in quality and regulatory compliance. After several rounds of testing just to satisfy our curiosity confirmed our worst suspicions, we decided to strategically test more products in specific categories and share the results with the industry, Amazon, and FDA.”

Once products are purchased from Amazon, they’re tested for content, potency, contaminants and heavy metals, labeling accuracy, and more. In addition to testing in its own laboratories, NOW sends samples to reputable third-party labs such as Eurofins and the University of Georgia’s Center for Applied Isotope Studies to ensure results are not biased.

“One of the important elements of competent testing is that the results are reproducible and can be confirmed,” Richard explains. “Although the industry is well aware of the excellence of NOW’s in-house labs, having confirmation from another well-respected lab removed the potential for questioning the accuracy of the results we publicized.” Not only that, “Additionally, Amazon told NOW that only third-party assays would be considered for action. They felt that in-house labs could not be independent, which may be fair,” he says.

Outsourcing also ensures testing is done by the right experts. Curcumin, for instance, has become a red-hot ingredient, with economic adulteration giving rise to synthetic curcumin adulteration. To test for the presence of synthetic additives, NOW sent curcumin product samples to the University of Georgia’s Center for Applied Isotope Studies for radiocarbon testing. The Center found that 4 out of 23 non-NOW samples tested were spiked with synthetic material. Says Richard: “In the case of checking curcumin to see if it is from turmeric or a synthetic substitution, radiocarbon testing is the method used. It’s highly specialized equipment, and the University of Georgia’s Center for Applied Isotope Studies has experience testing curcumin to determine origin. This is an extra test beyond normal quality control; most brands would only test curcumin/turmeric for potency, not to confirm the source. Because this is a known problem in the industry, quality brands should be testing to confirm their products are not spiked with synthetics.”

After NOW shared such negative findings with both Amazon and FDA, weak reaction from those corners drove NOW to report the results publicly in the hopes of spurring a stronger response.

“We were very frustrated that Amazon would not take any action given that we supplied detailed information on quality lapses,” Richard says. “We also submitted the test results to FDA, and that also didn’t seem to lead to any actions or enforcement. I checked some products that I put in one-star reviews [for], with details on who I am and what the product tested at, to warn potential buyers. These are still selling today on Amazon, so that’s unfortunate.”

Richard recounts some of the problems NOW’s testing uncovered. “Our initial red flag was seeing CoQ10 in 400-mg potencies in dry capsules. Our experience showed that CoQ10 is too sticky to fit 400 mg in a dry capsule with normal encapsulation machines. That’s why we suspected foul play as well as pricing that looked too good to be true.”

“I think the worst we found,” he continues, “was zero potency found with a 400 mg CoQ10 label claim. That is seriously negligent and hard to believe.” It also seriously risks the consumer. “It is well known that many cardiologists recommend CoQ10 400 mg to their patients, so this failure could lead to a very dangerous problem,” Richard points out.

In fact, “All of the expensive ingredients are candidates for quality problems from these no-name brands,” he says. “We have also found items as simple as zinc oxide with under 5% labeled potency, so it’s buyer beware for unknown brands.”

He adds: “Products made with ingredients that are expensive and therefore have a higher price tag are the ones less likely to meet label claims. Cheaters are less likely to put effort into making a low-quality vitamin D even though it’s a popular product, because it isn’t an expensive ingredient. Conversely, cheaters will cheat in various ways even to save a small amount. We did find several brands that labeled products in vegetarian capsules that we tested and found to be gelatin/animal capsules.”

NOW conducts extensive testing on its own products in its in-house lab. Photo from NOW.

Not all test results are as bad. Richard reports that results from glutathione testing the company shared this October actually “were pretty good.” He comments: “This was really a surprise, a good surprise, and demonstrates progress in cleaning up products sold on Amazon.”

NOW hopes Amazon can progress in cleaning up its supplements marketplace. The wheels may be turning. Last December, Amazon launched 

 sold on its site. Supplement marketers must now submit a certificate of analysis and/or third-party certification from reputed third-party certifiers before they can retail on Amazon. This November, Amazon also announced it will require marketers to submit a “valid good manufacturing practice (GMP) certificate issued by an accredited third-party certification body.” It also strengthened rules for high-risk categories like sexual-enhancement and weight-management supplements.

Was it NOW’s public reports that motivated Amazon to toughen up? Or was it FDA’s letter? It could have been both. “We have been providing the test results to Amazon but not gotten direct feedback from them,” says Richard. “While we have no direct statement from Amazon [linking] NOW making the appalling testing results public and the stricter requirements for sellers being instituted, the timing certainly suggests a strong correlation.” Last December, NOW 

 for Amazon’s stricter supplement policies.

For now, says Richard, NOW will continue testing products bought on Amazon and sharing the results with everyone. “We do plan to resume testing products we purchase on Amazon in the new year with different products we suspect are likely to be problematic. We may phase out of this as Amazon’s new quality program leads to positive actions.”

NOW also always includes its own products among those tested from Amazon. “A NOW product is included as a benchmark of what the product test results in the category should look like,” says Richard. “We purchased our own brand from Amazon and tested internally and externally to be consistent with other brands’ testing.” As a testament to NOW’s quality control, “We have not found our own products below label potency in any of our Amazon tests,” he says, noting that the company always comprehensively tests both its raw materials and finished products—conducting approximately 16,000 tests every month—including high-performance liquid chromatography potency verification, “exhaustive” microbial and heavy metal testing, and pesticides and steroids screening. “NOW does such extensive testing that we would find any quality problems before the products left the manufacturing facility,” he declares.

Still, as a result of its initiative, NOW has found at least one area where it may change its practices or products. But it’s not due to poor performance. Richard explains: “When we tested ALA products, it raised the question if we were putting too much overage in our product. NOW adds 5% overage generally, and we formulate our blends to use the most conservative calculations. If ALA purity is 96%-99%, we will formulate to assume 96% is the purity even if we test it higher, meaning we ‘double-add’ overage. There is also some variance with encapsulation to allow some higher and some lower levels. Because of this test, we are reviewing our retained samples to see if NOW should reduce our overage from normal 5% down to 3% for this particular product.”

Richard says NOW has received positive industry feedback for its work. And what of the companies whose negative results NOW broadcasted? “We expected to get pushback, and in fact made sure the NOW board of directors understood that this program could result in legal action against us,” Richard says. But so far it hasn’t. “The fact that this has not happened may mean that the brands we tested could not disprove our findings,” he surmises. “We did have one company contact us about how their product was labeled ambiguously, and we had a friendly exchange,” he adds. “The product was still mislabeled as our test results show zero detectable CoQ10.”

“Some competitors were concerned there would be a negative impact,” he continues, “and others pushed back about the requirements, but far more were pleased to see these bad practices highlighted…A lot of smaller brands and retailers were very happy that NOW was taking this on for the industry.”

Of course, not every supplement sold on Amazon is bad. A good number of respectable companies like NOW sell products online. Not all lesser-known brands are bad, either. Still, Richard points out, “Well-known brands have a reputation to protect, are generally honest, and have quality checks and balances to comply with cGMPs. No one is perfect, but it’s apparent that larger brands that have stood the test of time tend to pass most quality checks.”

The fact is that Amazon needs stronger scrutiny. “Sellers on Amazon can quickly jump into the market and sell a lot of product if they know how to market,” Richard says. “So many marketing brands have launched and stayed exclusively on Amazon because it can be easier to build a brand there.” It’s even easier to get away with selling subpar products online than in brick-and-mortar, he points out, because “physical store brands must be more legitimate in order for chain stores to invest their shelf space into that brand.”

Would NOW ever extend its testing to other online platforms or marketplaces besides Amazon? Not yet. Says Richard: “Only Amazon sells enough product to have such a great effect. eBay would be another platform to investigate, but it would be a much harder search and the impact not nearly as far reaching.”

By exposing those who dare to sell low-quality supplements, NOW is doing what it can to help improve the supplements market. NOW’s leadership and dedication to industry excellence is why 

 named the company this year’s Best of the Industry award winner in the Industry Leader category.

“We want a level playing field, and it’s better for NOW when we are not competing with far lower prices that are only possible because the products are very low quality,” Richard concludes. “We all stand to lose when consumer confidence in our industry’s products is undermined by products that do not deliver the expected benefits, so we benefit from removing all those bad products from the market and preventing new ones from using the same tricks.”

Hear bonus interviews with our award winners on The Nutritional Outlook Podcast!

NOW shows how an industry leader can expose bad products in the dietary supplement market, raise public awareness, and make a difference.

Nutritional Outlook’s 2021 Best of the Industry Awards, Industry Leader: NOW

Founded by the husband-and-wife team of Eric and Stephanie Venn-Watson, San Diego, CA–based Seraphina Therapeutics has played a central role in the scientific investigation and now commercialization of pentadecanoic acid, an odd-chain fatty acid that the scientific literature shows meets the criteria for being an essential fatty acid. Pentadecanoic acid is an odd-chain saturated fatty acid with 15 carbons (C15:0) that is naturally present in foods such as whole-fat dairy, but has found itself removed from our diets for the last four decades over fears of saturated fats in general. This decision may have resulted in higher risk of type 2 diabetes, coronary heart disease, chronic inflammation, and obesity globally. C15:0 is a key nutrient with the potential to support global health. Seraphina Therapeutics has commercialized it as the ingredient FA15, and as a finished product called Fatty15. The company has not only taken on the mantle of bringing a completely novel nutrient to market, but a larger ambition of correcting a major nutrient deficiency.

“We have methodically removed and lowered C15:0 levels in our diets population-wide across the globe, and so the big hypothesis that we’re chasing here is that we have created population-wide C15:0 deficiencies that are the cause of the rise of heart disease and diabetes and liver disease, and what keeps Eric and me and the Seraphina team going every day is that we have the opportunity to fix, to restore, C15:0 in a vegan-friendly, sustainable way, and hopefully reverse this increase in diseases that impact all of us every day,” says Stephanie Venn-Watson, DVM, MPH, Seraphina’s CEO.

Stephanie is a veterinary epidemiologist by training who has worked for the Centers for Disease Control and Prevention to help investigate outbreaks, as well as for the World Health Organization to help install disease surveillance systems all over the world. Eric Venn-Watson, MD, MBA, Seraphina Therapeutics’ COO, is a physician and U.S. Navy veteran who was deployed multiple times to places like Afghanistan, Iraq, and East Africa, where he was tasked with “creating medical systems where none existed and taking care of people in very austere environments.” Eric went on to use the skills he developed in the military to get his MBA and become an entrepreneur, starting successful companies such as a medical device company called XpandOrtho, which created a device to improve total knee replacements.

Both Stephanie and Eric have a great deal of experience in creating solutions, so it’s no surprise that when they discovered the therapeutic potential for C15:0, they took action. “With both Eric and I coming from long careers in civil and military service, it instilled in us that if you are going to make a discovery, you need to translate it, and it needs to be meaningful, or you leave it and move on to something else,” says Stephanie.

Stephanie first learned about the potential health implications of C15:0 when she was recruited by the U.S. Navy Marine Mammal Program 20 years ago to help start and lead a clinical research program to improve the health and welfare of Navy dolphins. There, she explains, she “was able to bring the passion and excitement for pattern recognition to look at improving dolphin health, the same way we look at improving global public health. I came to understand that the Navy dolphins live 50% longer than dolphins in the wild because the Navy takes really good care of them. As the dolphins get older, like people, some but not all develop chronic aging–associated conditions like high cholesterol, and chronic inflammation, and even the full suite of changes in the brain consistent with Alzheimer’s disease.”

In short, mammals with the same healthcare and diets were seeing different health outcomes. But why? To determine this, Stephanie applied advanced metabolomics on the serum of what she called an “unprecedented longitudinal cohort of long-lived, large-brained mammals” to discover which small molecules in their serum were predictive of healthy aging dolphins. As it happened, higher serum C15:0 levels were associated with better health outcomes in the dolphins.

The quality of the population cannot be overstated, as it lends immense credence to the results Stephanie found. “It’s a really healthy population of animals,” states Eric. “They see their doctor every day, get routine labs, they don’t smoke and don’t eat fatty foods. It would be very hard to recreate something on the human side that would be as healthy as this population. So that really allows us to get through all the white noise of drinking coffee and other things, and use these advanced technologies like metabolomics, lipidomics, and genomics to understand what molecules are beneficial and which are essential.”

“The sole intent was to improve the dolphins’ health, and it was through understanding and improving this incredible population that we came to understand the parallels between aging dolphins and aging people,” says Stephanie. “And that opened up this incredible world where not only can we help dolphins, but we can help people, too, and that’s where C15:0 came from.”

“When we really came to understand that C15:0 is not only an active and beneficial fatty acid, but met the criteria of being essential, it changed from exciting research to a moral obligation to get the science out and move quickly to be able to help improve global health,” says Stephanie. Being scientists and medical professionals, credibility, and therefore scientific substantiation, were paramount to the Venn-Watsons. Eight studies were conducted over three years, and the results were published in 

. It was in this study that Seraphina Therapeutics made the case for C15:0 to be an essential fatty acid.

The results showed that C15:0 attenuated inflammation, anemia, dyslipidemia, and fibrosis 

, potentially by binding to key metabolic regulators such as peroxisome proliferator-activated receptors (PPARs), as well as repairing mitochondrial function. The study argues that the odd-chain saturated fatty acid is essential because C15:0 is not made endogenously in the body, and lower intakes and blood concentration are associated with higher mortality and poorer physiological states, while supplementation has demonstrated activities and efficacy that parallel associated health benefits in humans.

. Seraphina recently announced an upcoming randomized, double-blind, single-center, controlled study that will investigate whether supplementation with C15:0 will reduce the risk of metabolic syndrome in young adults. This study is being led by Jeffrey Schwimmer, MD, from the University of California, San Diego, who is a pediatric gastroenterologist at the Rady Children’s Hospital. The interest in C15:0 also extends well beyond Seraphina Therapeutics.

“When you look at the peer-reviewed scientific literature, an average of 2.4 peer-review papers are on C15:0 over the last seven years. This year alone, and we’re not done yet, there have been at least 18 independent peer-reviewed published papers on the benefits of C15:0,” says Stephanie. “And this is coming from folks like Harvard, Johns Hopkins, and Cambridge, and many of them are these large, longitudinal studies showing that people who have higher C15:0 blood levels, or in their diet, are less likely to develop type 2 diabetes, heart disease, and heart failure, and are even less likely to die during the study period.”

All this will only contribute to the credibility of C15:0 as an essential fatty acid and as FA15 as an ingredient for supplementation and food fortification.

Seraphina Therapeutics co-founders: Stephanie Venn-Watson, CEO, and Eric Venn-Watson, COO. Photo from Seraphina Therapeutics.

Seraphina Therapeutics launched its finished-product brand Fatty15 in January 2021 to serve as an ambassador for its FA15 ingredient and spread the word of C15:0. Fatty15 is sold directly to consumers with a subscription program that helps determine customer retention. Despite being a product that is novel and largely unknown, Fatty15 has been immensely successful.

“We sold out within six weeks,” says Eric. “Then we scaled up production to one ton and now have the supplies to continue to sell. Right now, we have almost 4,000 subscribers, and they’re staying. We have retention rates of over 90% per month, which is incredible, and part of the reason for this is people are seeing both near-term and long-term effects. People are feeling better, they’re sleeping better, they have more energy, they’re snacking less, and it’s amazing to hear from our customers because they’re becoming incredible advocates.”

The direct-to-consumer model is a great resource for Seraphina as it grows, serving not only as a proof of concept but also building a consumer base that will buy other products featuring FA15 down the road. These consumers also serve as an anecdotal research population, offering insights about C15:0’s benefits. With a recent 

self-GRAS (Generally Recognized as Safe) affirmation

, FA15 can now be used in food and beverage products. Seraphina Therapeutics touts FA15 as highly pure, tasteless, scentless, and vegan-friendly, making it a versatile ingredient for food and beverage formulators.

“We advertise our ingredient as being over 98% pure. But if you look at our recent batches, the last two were 99.8% and 99.7%, so it is an extremely pure ingredient. That’s our promise to customers on the supplement and the food ingredient side, that we will provide the purest, most bioavailable ingredient that we can,” says Eric. “So, the GRAS status was important to further our research and our safety studies, and everything we’ve done is accessible to everybody. The plan now is to start getting that [knowledge] out to the world of food and beverage.”

Compared to other essential fatty acids such as omega-3 fatty acids, for example, FA15 is not susceptible to the same challenges as fish oil, such as lipid peroxidation, poor organoleptic properties, or large dosage sizes, says Stephanie.

“From a dosing side, FA15 offers similar benefits but at much lower doses,” says Eric. “We’re looking at a hundred milligrams per our very small size-two capsule, and then using that same dose or less, potentially, in a food ingredient.”

Stephanie and Eric see a great deal of potential in food and beverage fortification, particularly where C15:0 is lacking. “Of particular near-term interest includes foods that have typically had C15:0 in them, like whole-fat dairy, and to look at the rise in the market of non-dairy alternatives,” says Stephanie. “Milk alternatives, for example—oat milks, soy milks, and others—are completely devoid of C15:0. People choosing plant-based milks, or meats, could benefit from having those products fortified with FA15.”

Seraphina Therapeutics is not interested in being a one-trick pony, and while the company is a thought leader and innovator, it will only be a matter of time before other companies follow its lead. With more and more companies applying the same advanced technologies like metabolomics, which have become rather accessible and affordable, Stephanie says that it’s a wonderful moment for new discoveries in nutrition, and that Seraphina Therapeutics will not be alone in forging new ground. Seraphina’s advantage is having access to the advanced technologies as well as the Navy dolphin population and 50 years’ worth of longitudinal serum samples collected throughout their lifetime. As a result, Seraphina Therapeutics has 200 molecules, of which C15:0 was one, to study and potentially commercialize.

“The data from these populations are so clean that it’s like finding a needle in a needle stack when you’re looking for important molecules. We’ve taken those molecules, and we’ve run most of them now through cell-based studies to look for not just associations with better health but with direct activities that support them,” explains Stephanie. “We’ve had an amazingly high positive hit rate on that batch of molecules. [Seraphina Therapeutics] and also Seraphina’s parent company, Epitracker, have been funded by the Department of Defense to basically rinse, wash, repeat what we did for C15:0 for the next molecules.”

The goal with the new batch of molecules is to look for broad benefits that can support the health of a large population, says Stephanie. “The biggest win for nutrition and for public health is to find something generic that’s essential, that has these widespread benefits,” she explains. “However, we’re also working on finding molecules that may be more targeted towards liver health or brain health. In the nearest term, we have three molecules that we are actively working on and pursuing, and we hope to be able to share new information on the next exciting discovery in the coming six months.”

Despite making a big splash, the story has only just begun for Seraphina Therapeutics. We won’t know the true impact of C15:0 until there is widespread adoption of the odd-chain fatty acid through supplements and food, which will take time in our saturated and competitive nutrition space. In the meantime, the scientific literature continues to grow, and Seraphina Therapeutics will continue to innovate by analyzing the therapeutic potential of hundreds of molecules. Put quite simply by Eric, “There’s a lot to do.”

With the discovery and commercialization of what may be a new essential fatty acid, Seraphina Therapeutics is poised to become a leader in developing scientifically substantiated nutritional solutions.

Nutritional Outlook’s 2021 Best of the Industry Awards, Ingredient Supplier: Seraphina Therapeutics

Adulteration in commerce is an age-old problem, one that never has and likely never will go away.

“Adulteration and fraud in the food, spice, and botanical drug market is not new; it has been going on for literally thousands of years,” say the American Botanical Council’s (ABC; Austin, TX) Chief Science Officer Stefan Gafner and Founder and Executive Director Mark Blumenthal. “It’s a truism that some people cheat and do not respect the implicit and explicit rules of society and commerce.”

Adulteration wears many faces in the botanical products market today. It often takes the form of economic adulteration when fraudsters substitute authentic botanical ingredients with cheaper imposters. Plenty of factors contribute to adulteration: the globalization of commerce, the rise of e-commerce, and supply chain turmoil caused by natural disasters and a global pandemic.

It’s pretty bleak. But for every bad actor looking to cheat the market, there is a good actor standing up for legitimate trade. In the botanicals world, that entity is the ABC-AHP-NCNPR Botanical Adulterants Prevention Program (BAPP), whose mission is to “educate members of the herbal and dietary supplement industry about ingredient and product adulteration.”

Since it started 10 years ago, BAPP has been a partnership among three nonprofit-organizations: the American Botanical Council, the American Herbal Pharmacopoeia (AHP; Scotts Valley, CA), and the University of Mississippi’s National Center for Natural Products Research (NCNPR; University, MS).

On BAPP’s 10-year milestone this year, “The term 

 is not what I would use for the BAPP anniversary,” say Gafner, who serves as technical director of BAPP, and Blumenthal, BAPP’s founder and director. “All of the BAPP partners are in this to improve the quality of herbal dietary supplements for the benefit of the consumer. We might celebrate on the day that adulteration is no longer an issue and BAPP is no longer needed.”

BAPP is still very much needed. BAPP researches and tracks adulteration in the global botanicals market. It reports those findings to those inside the botanicals industry and outside the industry (regulators, the media, the public).

From BAPP, we learn that most adulteration occurring in the botanicals space is still economic fraud. The good news is it’s largely not fraud that presents a public health concern; the bad news is this may be of small comfort to consumers hoping to derive health benefits from a botanical product. “In our experience, there appears to be a greater number of cases of adulteration where the type of adulteration is based on the addition of undisclosed, lower-cost ingredients that not only provides an economic benefit to the seller of the fraudulent material but is also designed to fool the prevalent analytical methods being used in industry analytical laboratories,” Gafner and Blumenthal report. “Such adulteration would almost always be in the form of extracts.”

The adulteration landscape evolves over time, making BAPP’s monitoring vital. For instance, say Gafner and Blumenthal, “One of the unfortunate trends is the occurrence of herbal extract fortification with highly enriched fractions or isolates made by fermentation or chemical synthesis. While this type of adulteration has been around for a while in the essential oil industry, it hasn’t been very common in herbal dietary supplement ingredients to our knowledge.” Adulteration with synthetic ingredients isn’t always surprising either. By now, it’s an “obvious problem” in the turmeric/curcumin market, for instance. But this is not the only adulteration incident that is hard to uncover. For instance, animal-derived fatty acids can be used to adulterate “saw palmetto” berry extracts, a practice Gafner and Blumenthal say is “difficult to detect” using common analytical methods, though it can be done.

“Another issue that we noticed more frequently,” Gafner and Blumenthal add, “is the admixture of different plant parts to an ingredient. This was first reported from goldenseal and Asian ginseng, where undeclared extracts of the leaves or aerial parts were added to root extracts. In the past five years, the same type of adulteration has been reported for ashwagandha roots and more recently also for eleuthero roots.” It’s the transparency that matters here, Gafner and Blumenthal point out. It’s not considered adulteration if a company discloses, both on the certificate of analysis and the finished product label, that it’s added botanical materials from another part of the same plant. “So, for example,” they say, “a ginseng root extract with a relatively high level of ginsenosides that also contains transparently labeled ginseng leaf extract is not adulteration so long as the leaf material’s addition is transparent.”

adulteration, it is a problem. What BAPP brings to the table is an arsenal of educational tools aimed at helping the public understand how, when, and where adulteration can happen—and, most importantly, how to detect and fight it.

The company’s resources include its Botanical Adulterants Prevention Bulletins and Botanical Adulteration Reports providing detailed information on plant-specific adulteration observed in the market. BAPP also circulates its Botanical Adulterants Monitor newsletter containing timely news, science updates, industry alerts, and regulatory alerts, using information gathered from “other published sources in the global medicinal plant literature, as well as reports of relevant regulatory activity internationally,” Gafner and Blumenthal explain.

The key is that many of these materials, especially the longer reports and guides, go through many layers of peer review to ensure their reliability.

“It always starts with an extensive literature search, since all our documents are based to a large extent on published data,” Gafner and Blumenthal explain. “We sometimes add in quotes from industry experts in areas where data are unavailable, especially pricing of ingredients, but we are really cautious about using personal communications in support of adulteration, as we have to avoid publishing any BAPP documents based on hearsay or the sole opinion or view of one expert. If we get industry data, we ask our BAPP experts to review them and verify the accuracy of the data. Once we have chosen an author, this author is in charge of writing the first draft. If there are questions (and there always are), we reach out to experts in the field to help us get the answers.”

Additional reviews are conducted by botanical experts such as Dr. Ikhlas Khan of NCNPR, Roy Upton of AHP, and Steven Foster and John Cardellina. “Eventually, we send each document to experts of the ingredient in question, but also to experts within our BAPP supporters, usually [approximately] 30-40 individuals per document,” Gafner and Blumenthal add. After compiling and addressing the feedback, ABC staff, such as ABC’s Special Projects Director Gayle Engels, then finalize the draft. As a final step, the publication’s layout is done by ABC’s Art Director Matt Magruder. The entire process is labor and time intensive.

Another key BAPP production is its Laboratory Guidance Documents. In essence, these guides provide industry with the “how” to detect adulteration. The documents, which are also peer reviewed, educate readers about current analytical methods for testing for adulteration.

Test methods need to keep up with the adulteration they’re meant to catch. “Adulteration is a bit of a cat-and-mouse game,” Gafner and Blumenthal explain. “The fraudsters try to come up with ways to avoid detection of adulteration by a quality control laboratory using common and prevalent analytical methods. In many instances, as analytical methods get better to find adulterated ingredients, the fraudsters come up with new ways to adulterate (e.g., by manipulating botanical extracts in various ways), making it even more difficult to detect adulterated material. It is important for the quality control groups to be aware of the analytical methods that are easily fooled and replace them with assays that are more specific (i.e., better able to distinguish between the genuine ingredient and its adulterants).”

As of November 2021, BAPP has produced 67 peer-reviewed publications, with more to come. One doesn’t have to imagine how much better equipped the industry is to combat adulteration with these tools in hand.

BAPP’s publications have grown in stature over time—so much so that they are their own standalone publications and no longer just part of ABC’s esteemed 

 journal. They are released in their own electronic versions and exist as standalone publications on the BAPP website. These resources also have global reach, with Gafner and Blumenthal noting that most Botanical Adulterants Prevention Bulletins and Laboratory Guidance Documents can be viewed via ResearchGate by scientists worldwide. BAPP publications have also been translated into Chinese, they’re told. Moreover, Gafner and Blumenthal often speak about global adulteration at international conferences, spreading the word.

The Botanical Adulterants Prevention Bulletins are usually published first “to document and provide confirmation of the available data on adulteration of a specific botanical ingredient,” they say. A Laboratory Guidance Document will be published on the ingredient after that with more information on corresponding analytical methods. BAPP also expanded the supply chain and ingredient market information in the Bulletins “since this appears to be helpful in providing greater understanding of the adulteration issues for many ingredients.”

BAPP has turned the spotlight on herbal supplement and food ingredients like pomegranate, 

boswellia, ashwagandha, grape seed extract, cranberry, 

 ginseng, and many more. This past year, BAPP also made sure to include elderberry, whose adulteration risk rose during the COVID-19 pandemic.

During the pandemic, BAPP warned the public about potential increases in economic adulteration due to supply chain problems, supply shortages, and price increases. “In April 2020 as the pandemic was just in its initial stages, ABC and BAPP sent out a notice to all ABC members, BAPP supporters, and the botanical industry in general, cautioning all responsible players that the increased consumer demand for herbs and other dietary supplements coupled with predicted supply chain shortages and delays would most likely result in the presence in the global market of additional quantities of adulterated, fraudulent botanical ingredients,” say Gafner and Blumenthal. “ABC suggested that responsible players increase their identity testing programs to help ensure that they were sourcing authentic material.”

BAPP doesn’t come by these findings easily. After all, there isn’t always a clear starting point or an easy source of information when one is trying to unmask hidden fraud in the market. For instance, they say, “The information gathering of adulteration isn’t any different during a pandemic than in other times. However, there aren’t any publicly available data on specific topics (e.g., the ingredients for which the pandemic has led to a supply shortage).”

That’s when BAPP and its partners’ diligent research and outreach come into play. “In the case of elder berry,” they continue, “BAPP has initiated a request for information from contract analytical laboratories, reputable suppliers, and manufacturers of elder berry ingredients. For other plants, such as ashwagandha roots, forsythia fruits (which is in high demand in the traditional Chinese Medicine community), or the mushroom category (e.g., reishi mushrooms), which have seen large increases in sales compared to previous years, we don’t have much information. We know that several academic groups are investigating the quality of elder berry products on the market, but these data have yet to be published.”

For what it’s worth, there is no clear consensus yet on just how the pandemic impacted botanical adulteration. “We are not able to determine at this time whether the incidence of adulteration (i.e., the frequency) or the type of adulteration has increased during the pandemic,” say Gafner and Blumenthal.

There’s also no clear answer as to what the extent of adulteration has been. “Michal Ichim published a series of papers

 in which he and his co-authors attempted to find an answer to this question,” they point out. “One of the papers reviewed publications using genetic methods to detect botanical ingredient adulteration, while the second reviewed botanical microscopy, and the third chemical methods. Interestingly, the same percentage of adulterated materials (27%) was reported in the review paper on genetic authentication as in the paper on chromatographic and spectroscopic authentication, contrary to 41% adulteration reported when botanical ingredients were assessed by microscopy.”

BAPP is always cautious when drawing conclusions about adulteration, because there’s not always a clear explanation for why it’s happening.

“One of the challenges in the interpretation of the results, especially when evaluating the percentage of adulterated ingredients, is the variability in the definitions among authors of exactly what constitutes adulteration, and the changes over time in the criteria for adulteration,” Gafner and Blumenthal explain. “Taking ginkgo leaf extract as an example, for which we have a large number of published data, the earliest report of ginkgo leaf extract adulteration in 2003 noticed that one out of 10 commercial samples was fortified with rutin. A 2005 paper reported fortification with quercetin in addition to rutin, eventually leading to the establishment of quercetin/kaempferol ratio specifications for the detection of adulteration. The possibility of using Japanese sophora extract (which contains some of these compounds) as an adulterant was mentioned for the first time in a 2010 paper, leading to further method developments for ginkgo leaf extract analysis and the proposal to use genistein as a marker compound for adulteration with Japanese sophora in 2014, adding another albeit controversial criterion to determine adulteration of ginkgo leaf extracts. While the reported adulteration rate of ginkgo products is generally below 50% prior to 2014, a number of subsequent papers reported that 72%-88% of commercial samples analyzed by the researchers were adulterated. It is not clear if this change is due to an increase in adulteration, an expansion of the number of criteria and target analytes to detect adulteration, or an improvement in the analytical methods to detect adulteration. In short, we don’t really have a reliable baseline or comprehensive enough data to answer this question.”

Support for BAPP’s nonprofit work has grown over the years. In the beginning, say Gafner and Blumenthal, some were worried about how BAPP’s findings would make the industry look. “There was a good amount of skepticism from parts of the herbal dietary supplement industry at the start of the program with concerns that BAPP bringing some of the adulteration issues to prominence may make the whole industry look bad,” they say. The prospect of reducing adulteration undoubtedly wins out, however, given that “responsible suppliers have struggled with unfair competition from low-cost adulterated ingredients for far too long, and saw BAPP as a means to explain quality differences among brands and emphasize the importance of the authenticity of botanical ingredients.”

Gafner and Blumenthal note that, “To date, BAPP has been financially supported and/or publicly endorsed by over 200 entities.” This includes both members of the U.S. and international medicinal plant industry, including ingredient suppliers and product manufacturers, as well as third-party labs, trade associations, professional research and clinician organizations, research centers, and more. They add that “BAPP’s financial support has been relatively stable over the past five years, after substantial growth during the initial five years. Most responsible industry members that support BAPP continue to do so, although there have been some companies that have dropped their support, for a number of reasons. This is to be expected as numerous companies have had changes in ownership and/or management, some of which may not understand the vital importance of supporting such a unique research and educational international program like BAPP.”

They conclude: “BAPP would not be possible without the generous financial support of companies representing dietary supplement ingredient suppliers, manufacturers, trade associations, contract analytical laboratories, and analytical instrument manufacturers.”

BAPP has also expanded its partnerships with other education and resource providers. In 2021, ABC and BAPP signed a 

 with the International Association for the Advancement of High Performance Thin Layer Chromatography (HPTLC Association) in Switzerland so that ABC members and visitors to BAPP’s website can access the HPTLC Association’s research, analytical, and educational content, including its extensive Methods Collection for identifying herbal ingredients.

“One of the main positive outcomes of these partnerships is the exchange of information,” Gafner and Blumenthal say. “You mentioned the partnership with the HPTLC Association, which has a large collection of methods to identify botanical ingredients, and to detect adulteration by HPTLC. Raising the awareness of this resource may prompt some in the industry to have a look at the collection and possibly add some of these methods to their quality control protocol. Another example is the 2019 workshop on botanical ingredient adulteration which BAPP organized as part of the 67

 Annual Conference of the Society for Medicinal Plant and Natural Product Research (GA), which was held in Innsbruck, Austria. Sometimes, collaborations with research centers cumulate in the development of a new method to detect adulteration of a specific botanical ingredient. An example is the 2021 publication

 of a NMR method to detect the adulteration of turmeric extracts. Again, this should benefit industry, especially for botanicals for which authentication is difficult and methods are scarce.”

And always, at the core, is the hard work of BAPP’s collaborators. Gafner and Blumenthal note that BAPP “has had active participation from several expert colleagues and industry members who volunteered to write some of the documents we published. And we had 181 different peer-reviewers (excluding BAPP management) from the herbal dietary supplement industry, contract analytical laboratories, academia, government, trade organizations, and the nonprofit sector over the years in the U.S. and internationally for the Bulletins and Laboratory Guidance Documents. Some of these reviewers have looked at over 20 documents in the past 10 years, and some of our documents have had up to 29 peer reviewers’ input from these experts.”

“ABC and BAPP’s partners are truly grateful for the wide range of support, recognition, and endorsement that BAPP has received and continues to receive across such a broad spectrum of the responsible elements of the herb and dietary supplement industry and the extended research and integrative healthcare communities,” they say.

So, BAPP provides a wealth of information. How companies choose to use that information to protect themselves and their customers is up to them. Have many companies changed their practices based on tips from BAPP? In February 2020, BAPP sent a survey to ABC members to gauge BAPP’s effect. “Approximately half (50) of the 103 respondents were industry members, with others being healthcare professionals, from academia, consultants, or respondents who declined to provide such information. Based on the feedback from the industry members, 24 companies implemented new quality control measures, 18 changed suppliers, and 15 changed ingredient specifications based on input from BAPP,” say Gafner and Blumenthal. At the very end of the chain, “Consumers benefit from improved measures by having access to products that have gone through a more robust quality control system.”

“Using BAPP information doesn’t necessarily mean that the product quality has improved (especially since our industry supporters already are among the best in town),” they add, “but we certainly hope that it ultimately leads to better products on the market.”

Adulteration will exist as long as there is a propensity to defraud the market for money. There will never not be a need for BAPP. 

 in its Best of the Industry awards in 2016; in 2021, we again salute BAPP’s service for the past decade as a lookout for the botanicals market, the industry, and consumers.

“In general and historically, adulteration has always been part of commerce…Unfortunately, it is predictable that it will continue, despite our best efforts,” say Gafner and Blumenthal. “The best we can do is try to ensure that responsible, ethical members of the industries that utilize botanical ingredients know about BAPP, know about the free access to all of BAPP’s extensive library of publications on adulteration, and will use BAPP publications to help ensure that they are not victimized by the unscrupulous sellers of fraudulent ingredients. So, as far as we’re concerned, this creates a form of ‘job security’ for all of us at BAPP, because as much as we produce high-quality, reliable information for the use of industry members and others, the fact remains that someone will still try to cheat, and people cannot let down their guard. After all, the herbal products industry is about providing healthful products for consumers to help them improve and maintain their health, naturally.”­

Botanical Adulterants Prevention Program website

Chemical authentication of botanical ingredients: A review of commercial herbal products

The untargeted capability of NMR helps recognizing nefarious adulteration in natural products

BAPP’s crucial mission, warning the botanicals market about adulteration, reaches its 10th year.

Nutritional Outlook’s 2021 Best of the Industry Awards, Service Provider: Botanical Adulterants Prevention Program

Plant-based crab-free cakes. Photo from Gathered Foods.

Consumers are actively seeking plant-based alternatives to their favorite poultry, beef, dairy,

 seafood products. Plant-based seafood is a small but growing member of the plant-based product segment. One company leading the charge for plant-based seafood is Good Catch Foods, a subsidiary of Gathered Foods. Good Catch offers a suite of finished products that includes plant-based tuna, fish sticks, fish fillets, crab cakes, fish burgers, and fish cakes, all made with the company’s proprietary blend of six legumes—peas, chickpeas, lentils, soy, fava beans, and navy beans—that help create the ideal taste, texture, and protein content consumers are looking for.

According to data published by the Plant Based Foods Association, in 2020 plant-based meats—the second largest plant-based category—grew 45%, up $962 million, compared to the previous year, with plant-based meat accounting for 2.7% of retail packaged meat sales. This growth was twice as fast as that of conventional meat. Refrigerated plant-based meat grew 75% in 2020, and frozen plant-based meat grew 30%.

Within the plant-based meat market, plant-based seafood accounted for $12 million in sales in 2020, growing 23% over the previous year.

There is a lot of hype around certain plant-based meats, focused on burgers and milk alternatives, so plant-based seafood has some work to do when it comes to consumer awareness. What’s unique about Gathered Foods’ approach to evangelizing plant-based seafood is that it is actively expanding into food service to reach as many consumers as possible, making its products more accessible and relatable to everyday people.

“We know that curating the taste experience is absolutely paramount to success, especially when you have something that’s new,” explains Christine Mei, CEO of Gathered Foods. “Our consumers are typically millennial flexitarians; they’re food explorers, they’re adventurous, they’re experiential foodies that want to learn and discover new things. Also, they’re awfully health conscious, they’re transparency seekers, they’re altruistic, but ultimately, if you present the consumer with something that’s new, the best way to be able to compel them to enjoy the experience is to curate this experience.”

Interest in plant-based alternatives is at an all-time high, but not everyone may be willing to take the risk of purchasing an entire box of plant-based crab cakes if they don’t understand the potential for taste and texture. “We’ve already had some really good lessons and experiences with food service partners over the last year and a half, reinforcing that you have to meet the consumers where they are, where they are trying to discover new foods, and where they are trying to have new experiences,” says Mei. Consumers have to be inspired to take the leap.

Christine Mei, CEO, Gathered Foods. Photo from Gathered Foods.

Widespread adoption of novel, plant-based alternatives to well-loved food is not achieved by virtue alone. Taste is paramount. It’s therefore no surprise that Good Catch was co-founded by Chef Chad Sarno, a pioneer of plant-based cooking who has launched restaurants in Istanbul, Munich, London, and Belgrade, and served as vice president of plant-based education at Rouxbe Cooking School as well as global wellness coordinator, media spokesperson, and R&D chef for Whole Foods Market. Sarno has also written and contributed to numerous cookbooks dedicated to plant-based and health-conscious cooking.

It is this chef-driven focus on great taste and texture, and a quality culinary experience, that makes Gathered Foods so well suited to partnering with food service providers. “The opportunity for us when we approach food service partners is, because we have clear culinary expertise, we can look at their menus, and we curate a menu suggestion that is customized to what they serve,” explains Mei. “So, we work with those food service partners and their chefs or their culinary teams to come up with something that is customized for them. And that’s the fun of it, to unleash culinary creativity.”

Plant-based tuna hoagies. Photo from Gathered Foods.

Currently, Good Catch’s food service partners include Bareburger (New York City), Champs Diner (Brooklyn, NY), Daily Veg (Newark, DE), Honeybee Burger (Santa Monica, CA), Malibu’s Burgers (Oakland, CA), Pause…itively Vegan (Deerfield Beach, FL), and Veggie Grill (CA, MA, NY, OR, WA). Additionally, Whole Foods Market now stocks a plant-based tuna salad made by Good Catch in the prepared foods section of its store in ten states. Recently, in July of 2021, Good Catch entered into a partnership with Long John Silver’s, the nation’s largest quick-serve seafood food chain, which offered Good Catch’s Plant-Based Bread Fish-Free Fillet and the Plant-Based Breaded Crab-Free Cake in five locations in California and Georgia, for a limited time. That, too, was successful, and Mei reports that the two companies are working together on next steps.

“We do reach a range of food service partners, from fast food to casual dining to fine dining,” says Mei. “Our goal is not to just be a limited-time offer, and we’ve actually had some really good experiences of migrating from limited-time offers to a permanent placement on the menu.”

Once consumers are inspired by their experience of eating Good Catch plant-based seafood in a restaurant, the brand also provides further support for those buying products at retail by offering recipes on its website as well as its YouTube channel, with additional instruction for some recipes. This is important because plant-based options are often presented in formats such as frozen foods that most people may associate with convenient, no-effort meals. Good Catch wants consumers to understand that, with some creativity and effort, they can elevate plant-based seafood to be a rewarding culinary experience.

“We offer that creativity so you don’t have to just think of it on your own, if you want some guidance,” says Mei. “Again, this is about curating that taste experience. We can curate it at the food service establishment, and if you want to recreate it yourself or want to experiment, but need a little bit of inspiration, we have ways to be able to help you get on your way.”

There are many strategies consumers take to reduce their negative environmental impact on the planet. One of them is either completely removing animal-based foods from their diet or restricting the amount of meat or dairy they eat. Others remove red meat and poultry but continue to eat fish. For those who eat fish, the story of commercial fishing’s impact on marine life may be overshadowed by the environmental impacts and welfare concerns of animal agriculture. However, both animal agriculture and commercial fishing have a significant impact on our planet.

“One of the shocking facts, at least for me, is realizing that 40% of the fish that are caught worldwide is bycatch. Eight hundred dolphins, whales, and porpoises are killed from fishing every day. Hundreds of thousands of sea turtles are caught as bycatch every year,” says Mei. “And when I think about the over-exploitation of fishing resources, that’s another huge issue. There is going to be a significant reduction in the population of some species of fish in the next several years. Oceans and sea life really need some attention. And we have got to align all kinds of interested parties to really have a commitment to a new approach to seafood. That’s really needed to allow fish to remain in the ocean.”

Even major brands associated with fish see the writing on the wall. For example, in March of 2020, Gathered Foods and Bumble Bee Foods (San Diego, CA), one of North America’s largest seafood companies, entered into a joint distribution venture.

“What binds us together is the genuine ambition to be purposefully sustainable. We each do it in our own different and respective ways, but the end goal, quite frankly, is still the same: to nurture healthy oceans,” explains Mei. “We have to raise awareness, we have to reduce harm, and we have to preserve our environmental resources.”

The partnership was also strategic for Gathered Foods because as a mission-based startup, it had limited access and points of distribution. “We’re not huge, and so by forming a partnership with a company like Bumble Bee, we can reach far more consumers who want seafood alternative products,” says Mei. “It’s been pretty exciting to pair up with Bumble Bee because they are taking a bold step for the industry, but together we’re also providing choice for consumers—and, ultimately, it is about choice.”

Plant-based fish burger. Photo from Gathered Foods.

Gathered Foods and Good Catch are poised for immense growth as the desire for plant-based alternatives climbs. By driving distribution through both retail and food service channels, Gathered Foods is making huge progress in enlightening a diverse set of consumers about the culinary possibilities of plant-based foods, specifically the emerging category of plant-based seafood, and contributing to their growing acceptance.

“Our mission at Gathered Foods is really about positive disruption,” says Mei. “We’re specifically focused on propelling change with craveable plant-based food solutions, and it’s primarily because we’re united by the love of really good food, plant-based eating, and animal welfare. That’s the combination that enables us to really stay focused and committed to raising consciousness, reducing harm, and preserving environmental resources, all while delivering a great culinary experience.”

As a leader in the plant-based seafood space, Gathered Foods anticipates continued innovation. “There are two to three hundred species that live in the ocean, and we are looking to leverage our technical and culinary innovations to deliver plant-based solutions to support ocean health,” states Mei. “That is the front and center priority for us. In order to do that, we really want to make Good Catch more accessible, more available. We want that full range of consumers, from vegans to flexitarians, to experience Good Catch.”

Leader in the small, but growing, plant-based seafood space, Good Catch Foods is making the category more accessible through its aggressive expansion into food service.


Nutritional Outlook’s 2021 Best of the Industry Awards, Retail Brand/Product: Good Catch Foods

’s editors, with input from our editorial advisory board, surveyed the landscape of natural products industry excellence in 2020, four leaders stood out for achievements that not only elevated their own businesses but that will likely positively and significantly influence the natural product, dietary supplement, and food and beverage industries in the years ahead.

Our industry leader this year is Ocean Spray, who after petitioning FDA for a cranberry health claim in 2017 finally saw the fruits of its labor realized when in July of this year, FDA indicated that it will exercise enforcement discretion for a qualified health claim linking select cranberry products with a reduced risk of recurrent urinary tract infections. This new qualified health claim will not only benefit Ocean Spray and the rest of the cranberry market but will also be a valuable touchstone for cranberry consumers, new and old, searching for validated health support.

Our winner in the retail brand/product category is CV Sciences, who in 2020 set the stage for how a hemp-derived-CBD company can not only position itself for mainstream success but also charter a new course outside of the CBD category itself—an important path that CBD companies may need to head down as the CBD market becomes increasingly crowded.

In the supplier category, we are awarding Gencor for the headway it’s made in carving out its own stake in the palmitoylethanolamide (PEA) market. Armed with heavy investment in research and development, and putting the full weight of scientific substantiation behind its own branded ingredient, the company will play a leading role in raising the credibility of PEA and drawing industry and consumer attention to PEA, an ingredient with so many promising benefits across the health and wellness spectrum.

Finally, our service provider of the year is Alkemist Labs, who is not only standing tall among larger labs but who in the past year also exemplified its ingenuity and forward-thinking with a consumer-friendly certificate of analysis that will ultimately raise the level of transparency along the supply chain, all the way down to the consumer. The need for best-in-class quality control and transparency has never been higher in this industry, and Alkemist is playing a leading role in showing the industry one way to achieve it.

I hope you will congratulate me in saluting all four of this year’s winners. We hope you’ll agree with us that these companies not only represent excellence but the pursuit of a better path forward for the natural products industry.

In Nutritional Outlook’s 2020 Best of the Industry Awards, we recognize individuals, groups, and companies whose initiatives today are helping to shape, for the better, the state of the dietary supplement and natural products industry.

Nutritional Outlook’s 2020 Best of the Industry Award Winners

Cranberries have long enjoyed a rare perch, embraced by natural-channel shoppers and mainstream customers alike as a natural health remedy. In the U.S., use of the polyphenol-rich American cranberry species 

 dates back centuries to when Native Americans used cranberries for medicinal purposes and sailors used cranberries to prevent scurvy.

 centuries, cranberries have been studied for their health-promoting phytochemical constituents—one of the most researched being A-type proanthocyanidins (PACs) and their ability to prevent urinary tract infections (UTIs).

While consumer lore has long touted the benefits of drinking cranberry juice for helping to ward off UTIs, scientists are working to substantiate that belief. The conclusions drawn from cranberry studies vary

, and new human clinical trials continually add to the literature. In 2020, the health legitimacy of cranberries got a definitive, dramatic lift in the U.S. in the form of a landmark qualified health claim. Spearheading this feat was the company who put cranberry products on the retail map: Ocean Spray (Lakeville, MA).

 that moving forward it will exercise enforcement discretion for product claims linking a reduced risk of recurrent UTIs in healthy women with consumption of cranberry juice beverages containing at least 27% cranberry juice—such as many commercially available cranberry cocktails in the supermarket—as well as consumption of dietary supplements containing at least 500 mg of cranberry fruit powder (100% fruit).

“The FDA’s announcement of a qualified health claim is fantastic news for Ocean Spray,” says Christina Khoo, director of emerging science, nutrition, and regulatory affairs for Ocean Spray. “Cranberries are one of only a handful of ingredients to obtain this stamp of approval from the FDA since 2003 when qualified health claims were instituted as part of the Consumer Health Information for Better Nutrition Initiative.” This FDA initiative aims to “provide more and better information to consumers about the health and nutritional benefits of their products”—including through qualified health claims.

A qualified health claim does not rise to the full strength of an FDA authorized health claim. While both types of claims describe the relationship between a substance and a disease or health-related condition, authorized health claims are allowed to simply state “that a food or food component may reduce the risk of a disease or a health-related condition.”

 By contrast, qualified health claims are claims deemed by FDA to be “supported by scientific evidence, but do not meet the more rigorous ‘significant scientific agreement’ standard required for an authorized health claim.” Instead, qualified claims must include “qualifying language to accurately communicate to consumers the level of scientific evidence supporting the claim.”

FDA does not “approve” qualified health claims, but companies can petition the agency to exercise enforcement discretion when a qualified health claim is used on packaging and in marketing. FDA will review the petition and then, if its opinion of the claim is positive, issue a letter to the company indicating that it will not object to the qualified claim when used, as long as its usage meets the agency’s requirements. This is what FDA did in the case of Ocean Spray. On September 8, 2017, Ocean Spray initially submitted a petition to FDA for an authorized health claim linking cranberries to prevention of UTIs. In February 2018, FDA instead filed the petition as a qualified health claim and in July 2020 said it would exercise enforcement discretion over the qualified health claim.

Even as a qualified health claim, this claim is a milestone achievement. “Cranberries are now the only food with an approved qualified health claim for reducing an infectious disease, UTIs,” says Khoo.

She also points out that a qualified health claim is superior to the structure/function claims more common in the food and supplements markets. “A structure/function claim explains how a nutrient might help improve a normal structure or function of the body (e.g., “calcium helps build strong bones”). The qualified health claim FDA has announced permits Ocean Spray to say a bit more by informing consumers that the scientific evidence, while still characterized by FDA as limited and inconsistent, demonstrates that covered cranberry products ‘may help reduce the risk of recurrent UTIs in healthy women.’”

She continues: “The qualified health claim is a huge achievement for Ocean Spray and for cranberries. We are proud that the cumulative research conducted over many years allowed us to have the first qualified health claim for a food to help address combating an infectious disease.”

With this new qualified health claim in hand, cranberry beverages that meet FDA’s content threshold requirement can feature a product claim like: “Limited and inconsistent scientific evidence shows that by consuming one serving (8 oz) each day of a cranberry juice beverage, healthy women who have had a urinary tract infection (UTI) may reduce their risk of recurrent UTI.” For cranberry supplements, the claim would look something like: “Limited scientific evidence shows that by consuming 500 mg each day of cranberry dietary supplement, healthy women who have had a urinary tract infection (UTI) may reduce their risk of recurrent UTI.” Notably, FDA says these claims are not allowed on other conventional foods made from or containing cranberries such as dried cranberries or cranberry sauce.

When asked if Ocean Spray was disappointed that FDA did not award an authorized claim, Khoo says no. “We are not disappointed that a full, authorized health claim was not provided. Nutrition research on food is hard to do as we typically cannot control food intake or other environmental influences. We are proud that the cumulative research conducted over many years by qualified researchers conducting well-designed studies allows us to have the first qualified health claim for a food to help address a recurring infection. It is great recognition of the benefits of this superfruit and the bioactive components such as polyphenols and phenolic acids that are present in abundance in this fruit.”

The health claim points to how cranberries have influenced—and will continue to influence—the urinary tract health landscape. For instance, says Khoo, “It is likely that there will be more studies on cranberries, and there should be, as the issue of antibiotic resistance continues to grow.” Antibiotics are commonly prescribed by medical practitioners for UTI treatment, and cranberries can play a bigger role as a natural preventative. By doing so, they may also help address rising healthcare costs. Khoo notes that the World Health Organization reports UTI-related healthcare costs eclipse $1 billion annually.

Most importantly, cranberries can make a difference to consumer health. While “our internal experts would be the first to state that cranberry products are not a treatment for UTI,” says Khoo, when it comes those who suffer the common problem of recurrent UTIs “if cranberry products can help increase the time between episodes or prevent it altogether, it would be incredibly beneficial and improve the quality of life for them.”

Research on cranberries and their UTI benefits continues to emerge, directly and indirectly helped along by Ocean Spray. For instance, one of the studies substantiating the company’s health claim petition was Ocean Spray’s own large-scale clinical trial published in the 

The company’s landmark cranberry health claim win will benefit consumers and the industry at large.