’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.

Articles

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 

 in 2016 that found that drinking 8 oz of cranberry juice daily reduced the occurrence of UTIs by nearly 40% in women with recurring UTIs.

 The two-year, randomized, double-blind, placebo-controlled, multicenter study was conducted in 373 women and described by Ocean Spray as the “single largest clinical trial on cranberries of its kind.”

“With that trial published in 2016, the team at Ocean Spray started the process of submission, first by doing a thorough review of the literature with a systematic review, and then putting the dossier together,” says Khoo, who led the team. Even after the petition was submitted in September 2017 and Ocean Spray waited for FDA to do its review, at least two other positive meta-analyses on cranberries and UTIs were published, meaning the science on cranberry is even stronger now than when Ocean Spray first submitted its petition.

The reason FDA may have lowered the claim’s status to qualified status makes sense to Khoo, she says. While there have been many studies worldwide on cranberries and UTIs—and with Ocean Spray helping to provide its products and placebo beverages for ongoing trials—study protocols and materials across the spectrum of research varies, she says. “Over the years, some trials were conducted with double-blind, placebo-controlled randomized design with enough sample sizes, but others were not, and different products were being used that were not supplied by Ocean Spray. Hence, there was an array of results.”

Ultimately, the health claim win for Ocean Spray will not only strengthen the loyalty of the brand’s existing customers but also help the company capture new ones. Ocean Spray’s marketing and corporate communication teams are now deciding how to best leverage the claim in packaging and marketing. The claim can be used on many of Ocean Spray’s juices and juice cocktails, as well as Ocean Spray Cranberry + Health Juice Drinks.

The company credits many for paving the way to the health claim, including contract research organization Biofortis Research (a Mérieux NutriSciences Company), who helped assemble the scientific dossier for the petition, and attorney Sarah Roller, partner at Kelley Drye & Warren LLP, who aided the submission process. “First and foremost,” says Khoo, “we would like to acknowledge our grower owners for their continued support of the research on cranberries. We’d also like to acknowledge all the researchers at various universities and institutes who dedicate their time in this field and have continued to study the benefits of cranberries…”

“It is important to note that this research on cranberries will benefit the cranberry industry,” Khoo adds. And thanks to Ocean Spray, the new qualified health claim will benefit the entire cranberry market.

Blumberg JB et al. “Cranberries and their bioactive constituents in human health.” 

Cranberry Marketing Committee webpage. “About Cranberries.” Accessed November 25, 2020.

Zuger A. “Reputation of a Berry Is Difficult to Confirm.” 

FDA letter re: Health Claim Petition—Consumption of Cranberry Products and Reduced Risk of Recurrent Urinary Tract Infection in Healthy Women (Docket No. FDA-2018-Q-0739). Issued July 21, 2020. Accessed 

FDA website. Consumer Health Information for Better Nutrition Initiative: Task Force Final Report. Issued July 10, 2003.

FDA website. Authorized Health Claims that Meet the Significant Scientific Agreement (SSA) Standard.

Maki KC et al. “Consumption of a cranberry juice beverage lowered the number of clinical urinary tract infection episodes in women with a recent history of urinary tract infection.” 

Ocean Spray press release. “Landmark Study Suggests Cranberries Can Decrease Use of Antibiotics.” Issued June 14, 2016.

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

Nutritional Outlook’s 2020 Best of the Industry Awards, Industry Leader: Ocean Spray

Most mainstream consumers are not widely familiar with the dietary ingredient palmitoylethanolamide (PEA)—

. Chances are good, however, they might in the years ahead. PEA offers wide-reaching health benefits for humans, with a long history of scientific study to prove it.

Consumers who don’t know PEA might be surprised to learn that PEA has actually been on the research radar for quite a while. Interest in what later would be identified as PEA began prior to the 1940s when researchers realized that feeding dried egg yolk to children suffering from hemolytic streptococcal infection helped prevent them from developing rheumatic fever.

 In 1954, those same researchers discovered that a lipid fraction in egg yolk had anti-inflammatory properties and that similar anti-inflammatory fractions were present in peanut oil and soy lecithin.

 In 1957, researchers identified this lipid fraction as palmitoylethanolamide (PEA).

 Over the next decades, through animal and human clinical studies, scientists learned more about the anti-inflammatory activities and numerous health benefits of PEA.

In 1970, PEA was introduced commercially to the world as a cold-and-flu remedy called Impulsin in the Czech Republic (Czechoslovakia back then).

 Today, PEA is available in the global market as both a food supplement/dietary supplement ingredient, as well as one for topical and veterinary use.

 Its best-known benefits are its anti-inflammatory and pain-relieving properties.

What is PEA, and what makes it so exciting in terms of what it can offer human health? As Gencor explains, PEA is a fatty acid amide produced endogenously by the body. It exerts its benefits via multiple mechanisms. First and foremost, it is an agonist that binds to peroxisome proliferator-activated receptors (PPARα), thereby helping to promote PPARα’s anti-inflammatory and related painkilling effects. PEA is also thought to inhibit degranulation of the mast cells, or immune cells, which ultimately keeps the body from producing pro-inflammatory mediators like TNFα and cytokines. PEA also alleviates pain by activating the transient receptor potential vanilloid type 1 (TRPV1). Finally, research suggests a beneficial relationship between PEA and the endocannabinoid system. This interplay with the endocannabinoid system (ECS) is of high interest especially these days as research on the ECS and cannabinoids grows. Although PEA is part of the endocannabinoid system, it does not bind to the classically known cannabinoid receptors CB1 and CB2; however, it may indirectly activate these receptors by participating in the “entourage effect,” working synergistically with cannabinoids and ultimately influencing physiological outcomes of the ECS. It has also been shown to activate the GPR55 cannabinoid receptors, which are involved in immunomodulatory functions.

The body itself produces PEA, and PEA is used locally by every tissue in the body. Simply put, the body makes PEA when pain and inflammation occurs. Most importantly, PEA’s action is rapid, which is one of its most valued attributes as an anti-inflammatory and pain reliever.

“Because it is locally produced and is the first responder to any threats to the body, it is fast acting,” explains R.V. Venkatesh, managing director, Gencor (Irvine, CA). “PEA,” he says, “is the body’s first responder to any injuries, inflammation, stresses, pains, infections, etc.”

If the body produces PEA on its own, is there a need to supplement with PEA as a dietary ingredient? Venkatesh explains. “PEA is produced endogenously and used up quickly and on demand by the body. Its action peaks in two hours, which is why it’s fast acting. Once it is depleted, the body takes time to produce it again. That is why supplementing with exogenous PEA helps maintain normal healthy tissue levels of PEA.” Moreover, he says, although PEA is naturally present in such foods as egg yolk, soy, peanuts, and alfalfa, getting enough PEA from these foods usually requires a high intake, “well above what these foods can provide as part of normal daily consumption. This is why supplementation with PEA helps to maintain healthy tissue and levels of PEA.”

Gencor first started its work with PEA eight years ago. Gencor’s branded PEA ingredient, Levagen, launched in 2015 in the U.S. and Canada. The first product to include Levagen was brought to market in 2015 by GNC, which at the time held an exclusive, first-right-of-use license on the ingredient in certain countries. Once that agreement expired, 

To be clear, Levagen is not the first nor the only PEA dietary ingredient on the market. However, Gencor is bringing PEA to market with a splash, armed with impressive human clinical research showing how its proprietary ingredient specifically has a multitude of health applications. In short, it is likely Gencor will play an important role in renewing and raising the profile of an ingredient with such promising benefits.

The first human clinical study Gencor published on Levagen, published in 2019, was conducted in 111 adults experiencing mild-to-moderate knee osteoarthritis.

 Results showed that the ingredient helped relieve pain and other symptoms associated with knee osteoarthritis.

In 2020, Gencor announced the publication of a new study on Levagen—this time on exercise recovery.

 (This study was done on Levagen+, Gencor’s enhanced-dispersibility version of Levagen introduced in 2018.) Following acute and intense exercise, Levagen+ was not found to reduce pain and localized swelling in subjects by reducing pro-inflammatory intramuscular enzymes and cytokines (possibly, the researchers said, due to the “volume of exercise and/or the acute supplementation protocol used”); but, they noted, Levagen+ “was, however, able to reduce myoglobin and increase protein kinase B phosphorylation following exercise.” Protein kinase B plays a key role in muscle building. Myoglobin is a marker for muscle damage, and results showing reduced myoglobin levels indicate a subsequent reduction in muscle damage. The intervention also showed increased lactate levels and therefore an increased exercise threshold. Said the researchers: “Taken together, these results may indicate that PEA supplementation is able to aid in muscle recovery from repeat bouts of exercise performed within three hours.”

The researchers added: “To our knowledge, this is the first study to examine the effects of PEA supplementation on recovery from muscle-damaging exercise.”

These studies are only the start for Gencor. Venkatesh advises that a study on Levagen+ and short-term joint pain is currently being submitted for peer-review publication, this time “focusing on any joint in the body, instead of solely the knee,” and demonstrating that Levagen+ relieved discomfort quickly. He says this study would again be a first for PEA, noting that “Nobody else has done short-term joint-pain studies on all joints for nutraceutical applications.”

Another completed Levagen+ study currently being submitted for peer-review publication compared the effects of Levagen+ and ibuprofen for resolving headaches—again, a first, says Venkatesh—and showing Levagen+ to be as effective, and even faster acting, compared to 400 mg of ibuprofen, he says. This would open Levagen+ up for headache-related products in certain countries. “In Australia and India, we are allowed to make analgesic and pain-relief claims for Levagen+. This is a huge market, and we are working to tap into it,” says Venkatesh.

Then there is sleep. A recently completed study found that Levagen+ significantly reduced the time taken for subjects to get to sleep at night, Venkatesh says—once again, a first for PEA, he adds. This paper will be submitted for peer-review as well.

The company has many other Levagen+ studies in progress, some of which will be completed soon, including trials on seasonal allergies, migraines, cold-and-flu symptoms, the microbiome, and menstrual pain.

The goal, Venkatesh says, is to do more research in healthy subjects. “Most of the research on PEA has been done on diseased patients in the past, as the product was more focused and launched as a food for special medical purposes in Europe as an adjunct to pharmaceutical treatment,” he says. “We have started a lot of work on clinical studies on healthy human subjects in nutraceutical areas.”

Most studies now center on Levagen+, introduced in 2018, which is the cold-water-dispersible version of Levagen that Gencor developed with its sister company, Pharmako Biotechnologies (Cromer, Australia), using Pharmako’s LipiSperse lipid-dispersion technology. Levagen+ stands out in the PEA market because of its enhanced solubility and thus broader product-application potential and absorption in the body. For instance, unlike Levagen which is suited for tablets and capsules, Levagen+ can also go into effervescents, powders, gummies, and more. Generally with PEA, due to its lipophilic nature and thus insolubility in water, “The challenge for PEA has been poor absorption and bioavailability, which is well documented,” Venkatesh points out.

Like for Levagen’s other claims, Gencor has research to back claims about improved absorption and solubility. This year, a pharmacokinetic study was published in the 

Journal of Nutraceuticals and Food Science

 confirming that LipiSperse increased the absorption of PEA in Levagen+ above standard PEA formulations—by up to 1.75 times.

“This was a groundbreaking study,” Venkatesh says. “Levagen+ is the only PEA ingredient in the world that has demonstrated increased bioavailability compared to standard PEA, in a human pharmacokinetic study, which has been peer-reviewed and published….There have been no other pharmacokinetic studies done on PEA showing increased absorption with any other delivery form or system.”

With Gencor’s own research adding to the existing human clinical research that’s already been done on PEA—Venkatesh estimates there are more than 50 published human clinical studies on PEA—“the research on PEA for human health is very strong,” he says. Given how long the ingredient has been researched, “it is one of the most studied products found in the industry,” he adds. PEA has also been found to be safe and without adverse effects, he adds.

Backed by its existing and ongoing research, Gencor is positioning Levagen+ especially for multiple markets within nutraceuticals, including pain and inflammation reduction, reduction of allergies, enhanced sleep, increased calmness and reduced anxiety, immune support, microbiome support, and neuroprotective support.

What products might we see with Levagen and Levagen+ in the future? Only time will tell, but the ingredients are likely to gain more attention as more products hit the market and as Gencor works on expanding its regulatory approvals throughout the world. Gencor’s proprietary PEA ingredients already hold GRAS self-determination in the U.S., as well as approval as a food supplement in Europe, Australia, India, Brazil, Canada, and South Africa. (Venkatesh points out that PEA alone does not require a New Dietary Ingredient notification in the U.S. or a Novel Food application because it has historically existed as a common dietary ingredient in the food supply. It has also not been previously sold or investigated as a drug substance in the U.S. and thus does not run up against any Investigational New Drug challenges.)

There are already numerous products with Levagen and Levagen+ on the market. Just this year, English retailer Holland & Barrett International launched a unique 

 featuring Levagen, and CBD leader CV Sciences this year introduced a 

 featuring Levagen, with interest stemming from immune-related research already done on PEA.

Products like these two are being marketed as alternatives to the phytocannabinoid CBD. Gencor points out that PEA has some unique attributes that cannabinoids do not. While both act through the endocannabinoid system, Venkatesh explains that “CBD is an endocannabinoid that is supplemented externally. It is not endogenous to your body. That’s one of the key reasons why we compare PEA to CBD; it is something your body is used to producing and processing, while also providing the same, and in many cases greater, benefits.” PEA, as it already exists legally in the market, does not face the same regulatory hurdles CBD currently faces, especially in the U.S., and it currently has a much richer history of published research as well as established dosages—and it is well characterized.

By targeting many of these high-profile nutraceutical spaces, PEA is poised to become better known and more widely used, driven in large part by the work Gencor did in 2020 and that the company says it will continue to do. Says Venkatesh: “We have been instrumental in bringing more attention to PEA in the dietary supplement market with our manufacturing, science, and delivery technologies.”

Coburn AF et al. “The prophylactic use of sulfanilamide in streptococcal respiratory infections, with especial reference to rheumatic fever.” 

 vol. 18, no. 1 (January 1939): 147–155

Coburn AF et al. “The effect of egg yolk in diets on anaphlyactic arthritis (passive arthus phenomenon) in the guinea pig.” 

vol. 100, no. 5 (October 31, 1954): 425-435

Kuehl Jr. FA et al. “The identification of N-(2-hydroxyethyl)- palmitamide as a naturally occurring anti-inflammatory agent.” 

Journal of the American Chemical Society, 

vol. 79, no. 20 (October 1, 1957): 5577–5578

Keppel Hesselink JM. “Evolution in pharmacologic thinking around the natural analgesic palmitoylethanolamide: from nonspecific resistance to PPAR-α agonist and effective nutraceutical.” 

Gabrielsson L. “Palmitoylethanolamide for the treatment of pain: pharmacokinetics, safety and efficacy.” 

British Journal of Clinical Pharmacology, 

Musella A et al. “A novel crosstalk within the endocannabinoid system controls GABA transmission in the striatum.” 

Steels E et al. “A double-blind randomized placebo controlled study assessing safety, tolerability and efficacy of palmitoylethanolamide for symptoms of knee osteoarthritis.” 

Mallard A et al. “The effect of orally dosed Levagen+ (palmitoylethanolamide) on exercise recovery in healthy males—a double-blind, randomized, placebo-controlled study.” 

Briskey D et al. “Increased absorption of palmitoylethanolamide using a novel dispersion technology system (LipiSperse®).” 

Journal of Nutraceuticals and Food Science. 

The company is carving out its own stake in the PEA market in a big way: with heavy investment in research and development.

Nutritional Outlook’s 2020 Best of the Industry Awards, Ingredient Supplier: Gencor

When discussing the success of Alkemist Labs (Garden Grove, CA), its CEO Elan Sudberg likes to invoke the Old Testament story of David and Goliath, driving home the industry dynamics between boutique, family-owned testing laboratories such as Alkemist, and the giants that dominate the industry. These Goliaths, as Sudberg likes to call them, have a wealth of resources that allows them to offer a huge array of services while also undercutting their more modest competitors on price. Of course, to Sudberg, Alkemist is David in this analogy, thriving despite seemingly insurmountable challenges because Alkemist is great at what it does, prioritizing quality over quantity with a service-oriented approach that benefits its clients.

“Starting a lab requires some of the most expensive equipment as well as highest-paid employees, which would give any entrepreneur pause. The global testing arena is composed of many little labs of varying proficiency and a handful of Goliaths buying up the little labs. Even 24 years ago this was true. Still, we are here, and we owe that to tenacity, foresight, and a little crazy,” says Sudberg.

Alkemist Labs was originally founded in the early 1980s by Sidney Sudberg, Elan’s father and current Chief Scientific Officer of the company, as the manufacturing division of Cooperative Healing Arts. At Cooperative Healing Arts, patients would see a chiropractor, receive allergy testing and live blood cell analysis, and get prescribed herbal tinctures by practitioners. Alkemist Pharmaceuticals produced high-quality tinctures for these practitioners. Eventually in 1996, major problems with adulteration led the U.S. FDA to offer manufacturers courses in microscopy and high-performance thin-layer chromatography (HPTLC) to help them self-regulate. Alkemist began using these methods for quality control, rejecting adulterated materials they received—and vendors took notice. From there, Alkemist Labs was born.

“We found a niche early on, dug our heels in, and have remained the plant analysis lab,” says Sudberg. “Most other labs uninspiringly and with no personal touch offered every service under the sun while we evolved into the friendly experts we are. We’ve also had a loyal core group of clients through the years, really the best of the best in the industry, and they’ve provided some stability.”

Specializing in botanical identity testing and phytochemical potency testing, Alkemist only believes in using fit-for-purpose technology such as microscopy and HPTLC. These tried-and-true methods have remained a constant in the industry while other methods and plug-and-play devices Sudberg calls “tricorders” come and go with little success. This insistence on using validated methods and an emphasis on good company culture has helped Alkemist build its reputation these 24 years as a trusted testing partner and a company with ethical business practices.

“We began the company with culture in mind and have always desired to create an entity that we would want to work for, and a management style that we would want to serve alongside. Over that time, critical issues have boiled over, like equality and justice, and we take those opportunities to get introspective and to look at our own organization to assess if we are being beyond fair and equitable,” explains Sudberg. “This attention to traditionally not-profit-making details has built a culture in which our loyal, hardworking team truly cares about our product. Couple that with our unmatched expertise in plant analysis, and the other labs can’t touch us.”

With its superb reputation, Alkemist is working hard to push transparency in the industry and demonstrate the importance of botanical testing by bringing to light unethical practices that could hurt stakeholders and put consumers in danger. For example, in May of this year, Alkemist raised the flag that suppliers of so-called 

elderberry extracts were circulating doctored lab reports

. These practices are likely motivated by the unprecedented demand brought on by the COVID-19 pandemic for immune health ingredients such as elderberry. Problems like this are not particularly new, but when they crop up every so often, they reinforce the importance of testing and transparency.

“We have been pushing the transparency envelope since inception and after two decades are finally seeing the needle moving in the direction to best support the consumer. I’ve been encouraging companies to make their test results public, and we’re starting to see that happen,” says Sudberg. “If you’re using an excellent lab to confirm you are producing high-quality products, that information should be a marketing asset, not sitting in a drawer waiting for your next FDA inspection.”

Taking this concept to the next level, at the end of 2019 Alkemist unveiled its Next Generation Transparency initiative which provides 

consumer-friendly certificates of analysis

 for botanical testing. So, not only is Alkemist encouraging its clients to share their lab data, it is also making those lab reports comprehensible to the everyday shopper. What’s clear is that customers want to make educated decisions. That’s why third-party certifications have become so popular. However, even those have limitations, says Sudberg.

“Third-party certifications and seals are a dime a dozen these days, especially when some companies just concoct their own. While some require audits, others don’t, and I am not sure the discerning consumers are guided by them,” he explains. “Frankly, I don’t think those certifications or seals go far enough for the next-generation consumer. Younger consumers of herbs, of which there are many, are not satisfied with ‘just trust me on this,’ which in a way is what a seal says. Our efforts are to make transparent the actual test results for the ingredients in the product in hand, which is why our consumer version of a certificate of analysis explains what we tested for and what we found, so you don’t need a chemistry degree to read it.”

If you’re asking yourself whether anyone will bother to make this sort of effort toward consumer transparency, especially when it isn’t required, Sudberg has some news. “I am excited to state that I have one of the biggest players in the industry beginning to post our Consumer-Friendly Certificates of Analysis on their website for the raw ingredients going into their finished product,” he says. “It has not been announced just yet so I can’t share who, but I assure you it will not only turn heads but set the standard for Next Generation Transparency. It will raise the bar exponentially for those seeking to sell substandard products.”

It only takes one person to make a difference, to become the benchmark and set the stage for others. By reaching a major industry player, Alkemist might have changed the way transparency will be viewed going forward. While consumers are rapidly educating themselves, the consumer-friendly certificates of analysis extend this knowledge even further, giving them more autonomy and control over what they put in their bodies. While this may not be as popular of an idea in the industry as we wish it were, the more companies that share their certificates of analysis puts more pressure on others to do the same.

Having spent 24 years establishing itself as the go-to independent lab for botanical identity and potency testing, Alkemist Labs is finally comfortable expanding its service offerings. Much of this is due to demand from its existing customers.

“For years we have been leaving the other required tests—pesticide analysis, heavy metals analysis, and microbial analysis—‘on the table,’ and that work has gone to other labs. After years of our best clients, who send us plants for ID and potency testing daily, begging us to tool up so they don’t have to use a Goliath lab, we have finally begun another round of tooling up to be more full-service starting in 2021,” says Sudberg. “We also plan to expand our Next Generation Transparency efforts, and you will soon see the Alkemist logo as a trusted symbol of quality and ingredient integrity on the labels of the best of the best.”

Growing a small business takes patience and vision, which Alkemist has in spades—the patience to understand one’s limitations and the vision to take those limitations and make them a virtue. Alkemist Labs is already pushing the envelope, but now the time has come to push the envelope even further and go toe-to-toe with the Goliaths. As our 2020 Best of the Industry Service Provider, Alkemist Labs represents where our industry started, how far it has come, and the potential for growth that still exists.

“For us, the last two years have been about settling into a facility nearly four times larger than our previous one and fine-tuning our call to action around transparency in lab testing,” says Sudberg. “Now we are able to respond to the needs of our clients to expand the scope of services. We’re well positioned for this, with a very solid client base and an amazing staff.”

The boutique, family-owned laboratory has taken on industry Goliaths, powered by “tenacity, foresight, and a little crazy.”

Nutritional Outlook’s 2020 Best of the Industry Awards, Service Provider: Alkemist Labs

As a leader in the hemp-derived-CBD space, CV Sciences (San Diego, CA) has used its resources to create a market for and lend credibility to a burgeoning product category. In 2018, 

 for achieving the first Generally Recognized as Safe self-determination for a full-spectrum, hemp-derived cannabidiol (CBD) ingredient. This required commissioning a battery of toxicology studies, the first published toxicology studies on hemp extracts since 1981. Now, 

 is recognizing the firm’s efforts to secure a mainstream audience—sometimes without using CBD at all. It’s a strategy that not only benefits CV Sciences but also sets the stage for other CBD brands to enter the mass market.

“CV Sciences’ business strategy includes developing products that maximize consumer access to high-quality hemp-derived CBD products that are supported by independent lab tests verifying purity, strength, and composition,” says CV Sciences CEO Joseph Dowling. The foundation of this goal is the firm’s flagship PlusCBD line of full-spectrum, hemp-derived CBD products. With capsules, tinctures, and balms of varying strengths and price points, PlusCBD offers consumers reliable and trustworthy sources of CBD in a market that is increasingly saturated and unpredictable. However, foundations need to be built upon.

“Our experience has taught us that a singular brand is not elastic enough to meet the growing demand for CBD from diverse consumers across many sales channels,” Dowling explains. “In order to expand consumer access and meet consumers where they are, we launched 

, our line of THC-remediated CBD products.”

Happy Lane expands CV Sciences’ reach into the convenience retail channel, introducing hemp-derived CBD products to shoppers who may be uncomfortable with the thought of consuming tetrahydrocannabinol (THC), no matter how miniscule the amount. “Happy Lane products are made with the same rigorous manufacturing and testing standards CV Sciences is known for; however, unlike the European hemp sourced for PlusCBD, Happy Lane products are made from hemp grown in Kentucky. We pass the cost savings of growing hemp in the U.S. to consumers,” says Dowling.

Despite the market success hemp-derived CBD has experienced so far, widespread consumer recognition is not achieved within a single product category. In order to develop a relationship with a wider base of consumers, it was important for CV Sciences to diversify its portfolio. This is particularly important because outside of cosmetic products, mainstream retailers are still uneasy with stocking hemp-derived CBD in dietary supplement or functional food formats. For this reason, CV Sciences debuted its 

 lines of immune health products. The new products do not contain any hemp-derived CBD.

“A third tier of our business plan is to use brand awareness, reputation, and retail relationships to introduce non-CBD dietary supplements,” says Dowling. “CV Defense provides daily immune fortification with palmitoylethanolamide (PEA), organic reishi extract, and vitamins and minerals. CV Acute provides short-term, high-intensity immune support in a liquid herbal form. CV Acute is a 21

-century version of a time-tested Traditional Chinese Medicine (TCM) formula that has been extensively used and studied for respiratory immune support.”

The exclusion of CBD from the new line also acknowledges the limits of CBD, or at the very least the limits of our current scientific knowledge about the compound—a move that takes integrity. “As a science-based organization, we have always had concerns about companies that add CBD to condition-specific products without any scientific rationale for including CBD in those products,” explains Duffy MacKay, ND, senior vice president, scientific and regulatory affairs. “To us, including CBD in products without any scientific basis is gimmicky and creates a reputation risk for the category.”

Launching entire product lines is no small task, especially during a pandemic. Nor do things always happen as planned. While COVID-19 set some roadblocks, it also created urgency. “When Expo West was cancelled in March 2020 due to COVID-19, we had just wrapped up our plans for refreshing the PlusCBD line and were well into the research and development for our next phase of product innovation,” says Dowling. “The day after COVID-19 shut down California, where CV Sciences is headquartered, a few members of our team were sitting in the office and looking out at empty parking lots as far as the eye could see. This stark sight made us realize that we had to move quickly to protect the health of our employees, families, and customers.

“As we surged forward with product development, our scientific committee keyed into the immune-fortification power of PEA, an endocannabinoid-like molecule, for what would become CV Defense. In addition, we identified a strong partner with an impressive TCM formula—backed by science and regulatory work—for what would become CV Acute. The CV Sciences team worked around the clock, overcoming many obstacles and challenges brought on by the pandemic, to successfully launch our first two non-CBD products for immune support.”

Operating a company in the CBD space is complicated enough without a global pandemic, but CV Sciences has demonstrated a great deal of flexibility in adapting to certain business realities while continuing to develop new products and bring them to market. This is a testament to the company’s wherewithal and the dedication of its staff.

“Due to the restrictions and challenges brought on by the pandemic, CV Sciences has made significant operational changes to protect the health and safety of our employees, their families, and our customers,” says Dowling. “During the pandemic, we have continued to operate as an essential business. This would not have been possible without the incredible staff in our warehouses, lab, and elsewhere whose work kept the lights on and ensured orders were fulfilled during the most uncertain times.”

CV Sciences’ ability to work efficiently and strategically under pressure has fortified the brand’s position in the market, making up for deficiencies caused by the pandemic. For example, when the pandemic forced authorities to mandate closures of non-essential businesses and eventually limited in-store shopping, e-commerce experienced exceptional demand. This forced many companies to change their approach and shift resources to e-commerce. For CV Sciences, this also presented a major opportunity to help meet demand in the immune space to which consumers were clamoring as well as expand the brand’s online presence.

“We shifted our sales focus from in-store to in-home. E-commerce is a highly competitive space that consumers are relying on more than ever to get the products they need safely and without interruption,” explains Dowling. “Marketing CBD online has a host of inherent challenges, the greatest being that Amazon and other large online retailers heavily restrict the marketing and sale of CBD. Introducing CV Immunity, our line of non-CBD immune products, has allowed us to expand our online presence through new opportunities and partnerships.”

 on the subject of CBD, and while the wait is certainly not over, some slow progress is being made by FDA and Congress. For example, FDA is currently conducting a 

 of the CBD marketplace to determine the extent of adulteration and mislabeling, and a bipartisan bill called “

The Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act of 2020

” was introduced in September by congressmen Morgan Griffith (R-VA) and Kurt Schrader (D-OR). The bill would make hemp, CBD from hemp, and other ingredients derived from hemp lawful under the Federal Food, Drug, and Cosmetic Act.

With a new presidential administration on the way and the continuing COVID-19 pandemic, it’s unclear if and when Congress will vote on the bill or how many revisions the bill will undergo until then, but one thing industry and regulators can agree on is that the current situation is unsustainable. “We have been optimistic about the regulatory future of CBD since FDA Commissioner Dr. Stephen Hahn was quoted in February 2020 as saying it would be ‘a fool’s game’ to keep consumers away from CBD,” says MacKay.

In the meantime, CV Sciences’ hard work helps provide the space some stability while the powers that be catch up to the rest of us. CBD will continue to grow no matter what, but brands like CV Sciences provide a high benchmark for quality that consumers will be attracted to and that other manufacturers will have to strive to. The success of high-quality products such as PlusCBD will only help the industry at large because of the credibility they lend. The success of CV Defense and CV Acute will lend name recognition to the brand outside its usual marketplace and will serve as a gateway for mainstream consumers to the CBD space. And products will continue to launch.

“CV Sciences plans to expand its CBD and non-CBD offerings with innovative products. Our experienced team of nutrition industry executives is working closely with our medical advisory board on several exciting projects that will advance CV Sciences’ position as the most reliable and trusted CBD manufacturer for all sales channels,” says Dowling. “At the same time, we are working on improving our e-commerce operations to improve the online shopping and education experience.”

Education will play a huge role in CBD’s mainstream success. Hemp’s relationship to marijuana can make consumers nervous, but with the right guidance, their concerns can be put to ease. “CV Sciences continues to expand its mindshare and education offerings with a YouTube channel that goes outside the bounds of our products,” says Dowling. “YouTube is where we let our talented staff explore the human condition with topics that span traditional healing to the latest science on psychedelics. We think the CV Sciences community will see tremendous value in this content for expanding their health horizons.”

CV Sciences is paving the way to hemp-derived-CBD’s mainstream success.

Nutritional Outlook’s 2020 Best of the Industry Awards, Retail Brand & Product: CV Sciences

“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!

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.

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