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NBJ

The NBJ Awards

The NBJ Awards

Let’s kick off 2014 on a high note. Please join NBJ in applauding our latest cohort of award winners, listed in the table stage right. We think that each of these individuals and companies is up to something special in advancing the cause of this industry we all call home.
As in year’s past, NBJ accepted open nominations at the tail end of 2013, vetted the more than 300 ideas that came our way, then went to our advisory board to narrow down to the winners. This is a process of careful consideration for us, which makes us all the more proud to announce the results and highlight the efforts you will read about throughout the issue that follows. Congratulations to everyone recognized herein. Keep it up.
2014 looks to be a year of high stakes for this industry. The debate over labeling GMOs rages on, and the call to define “natural” has taken on new urgency in light of recent lawsuits and language proffered by the Grocery Manufacturers Association to FDA. Self-directed consumer genomics hit a major road bump with the public chastisement of 23andMe, and still we quantify ourselves and our health to increasing degrees of specificity. Mainstream media and science seem to spurn supplements at new levels of vitriol, even as crowdsourced science works to chart our personal diets, our microbiomes, and the various channels by which supplementation might reach higher levels of efficacy.
There’s something quite promising for the supplements industry in the personalization of medicine. Imagine an industry less about filling micronutrient gaps—a sour proposition from the start, as any marketer will tell you—and more about optimizing nutrition in the individual that dials down the triggers to specific pre-disease states surfaced by our genomes and biomarkers. Wouldn’t that change the conversation on the nightly news and in the newspapers? Wouldn’t that change the premise of this industry forever?
From our perch, it looks a bit wild out there right now, and the systemic challenges facing us as a culture—from climate change and mass urbanization to diabesity and declining life expectancies—continue to strike a nerve of civic disquiet that’s beginning to feel largely engrained in a generation of Millennials averse to marketing and the promise of big business. On point, our industry continues to prove the value of localized, clean sourcing, and the capacity for quiet little food brands to attract significant capital from investors. It’s almost as if even big business is ready for more rapid, dramatic change in the fabrics by which we live and work, and it’s looking to us for help.
Here at NBJ, we’re excited to watch this future develop, fight the fights that need fighting to advance the possibilities of health & wellness for every one of us, and to now share a few stories with you of our allies on this front. Best of luck in 2014.

FDA slaps Star Scientific with warning letter

FDA slaps Star Scientific with warning letter

Star Scientific Inc. (NASDAQ: STSI) announced the receipt on Dec. 24, 2013, of a warning letter from the U.S. Food and Drug Administration (FDA) regarding two consumer products, Anatabloc® and CigRx®, which are marketed by the company. The letter requires the company to respond to the FDA with information and remedial steps.

Both of the company's consumer products contain anatabine, a substance naturally occurring in various plants. In the letter, the agency asserts that anatabine is a new dietary ingredient that required premarket notification to the agency. The agency also asserts that the company's products are unapproved new drugs based on statements made on the company's websites. As is typical for warning letters issued by FDA, the agency stated that the company's failure to address these alleged violations may result in regulatory action by the FDA without further notice. The company is responding to the letter and has already advised the agency that it intends to work cooperatively to resolve these issues, including undertaking a review of the company's websites.  

 

 

NBJ

Dr. Bronner's marketing consultant reflects on joining the front lines of the GMO labeling battle

Activist Adam Eidinger fights for GMO labeling and marijuana legalization

Adam Eidinger is an activist, and a good one at that. Through Mintwood, the media consultancy he founded in 2000, and public affairs for his primary client, Dr. Bronner’s Magic Soaps, Eidinger has played a foundational role in many of the pressworthy moments surrounding the consumer push for GMO labeling. Eidinger is based in Washington, DC, but NBJ corresponded with him mostly via Twitter.

 

 

nbj: How do you view the current battlefield over GMO labeling?

Adam Eidinger: We are still in the early phases of a fight that was barely on the public’s radar in 2011.  Today it’s an issue that has touched millions of Americans due to initiatives, protests and media coverage, but also because many brands have decided to distinguish themselves as non-GMO in the marketplace. I believe that FDA will soon act and require food labels to disclose whether there are genetically engineered ingredients in the foods for sale at grocery stores.

The silver lining behind the losses in California and Washington is that people are starting to learn more about where their food is coming from and how it was produced. They’re demanding more transparency. The ballot initiatives have only galvanized the public’s support for honest food labels. The processed food industry is losing its public relations battle because they’re spending millions to keep Americans in the dark. Consumers now understand that if GMOs were 100% safe, then there should be nothing to hide and companies should be proud that they use GE ingredients.

There is also greater awareness about income inequality in America, yet Monsanto and other purveyors of GM crops have people at the top making tens of millions of dollars per year. When they talk about feeding the world, it’s really about feeding their profits. There are many issues with food today, not just labeling, but all of them are tied to larger social issues and the values of the people eating the food.

nbj: Can you describe the master strategy? Does more transparency equal change?

Eidinger: Yes. In the case of food, I think GMO labeling awakens you to the type of agriculture behind the food going into your mouth. You are what you eat, so the knowledge that weed killer—including chemicals similar to Agent Orange—could be in your food if it says x, y or z on the label means you might avoid it or not feed it to your kids.

I know I can avoid any food with artificial flavors or colors because it’s labeled. Some people apparently like food coloring, and it’s your right to eat it and make it in America to this day. Just don’t hide the fact that the ingredient is artificial on the label. GMO technology is like that. It’s not a natural food process, yet it’s hidden, oftentimes under the laughable banner of “all natural.” The public wants to know what they are buying, especially if it’s not natural, such as plants that were designed in a lab. I told Monsanto in our meeting last October that if GMO foods are so great, people will keep buying them, but they first must be transparent with their customers all the way down the supply chain.

American food labels are not very transparent and through increased disclosure consumers would benefit. So, yes, increased transparency does equal change. Disclosing the country of origin, the caloric content, and even the U.S. patent numbers that were used to create the ingredients—all of these are forms of increased transparency.

nbj: What are the next steps on the GMO front?

Eidinger: We had big protests at the Monsanto shareholder meeting on January 28 and at the FDA on January 10. In the spring, there will be large protests in May. We will be keeping an eye on a sneak attack by the Grocery Manufacturers Association in Congress pushing voluntary labels that do not provide consumers with meaningful information.

Intitiating action

nbj: What is the role of the stunt in this day and age?

Eidinger: We only win when there is mass agreement and awareness of the issue, and politicians held accountable to do something to fix the issue. Protests need to be strategic, not vanity projects. They need to be provocative, evoke outrage, and even create confusion to gain attention. Stunts have to be peaceful or they will backfire. Making lifelong friendships through a demonstration is one of the best benefits from modern-day activism.  A successful action is the sort of thing that converts armchair activists into missionaries for any movement.  I learned this from David Bronner when he suggested I organize a walk from New York City to the White House in the fall of 2011 for GMO labeling. We walked 317 miles in 16 days for the Right2Know March and today, those 50 or so marchers are all over the world leading the fight to label GMO foods in their own communities.  It starts with a stunt and ends with politicians writing new laws, if you’re lucky.

nbj: How do you get a specific message heard in DC?

Eidinger: The only way for our message to rise above so many other issues is to be firm and persistent. The day after President Obama signed the “Monsanto Protection Act,” we were outside the White House protesting and that evening the Daily Show with Jon Stewart lampooned Congress for an obvious handout to the biotechnology industry. The ire from this act resulted in the two Marches Against Monsanto, which took place last year in May and October and featured an estimated three million people around the world taking to the streets demanding change. Thousands of new friendships were forged and the movement has grown to the point where we have CNN and MSNBC covering the protests.  Right now, there are two bills in the 113th Congress dealing with GMO labeling and they wouldn’t exist if it weren’t for the passionate activism of many concerned Americans.

nbj: How do you vet a client? What makes a good cause for you?

Eidinger: I’m not taking new clients because I have the best client ever and I dedicate myself to projects that match their specific needs.  Essentially there has to be synergy with all the existing projects I work on.  A good cause is usually one that’s underrepresented in the media and the public’s mind that, if addressed, somehow advances more freedom and a better quality of life for everyone.

nbj: What is the role of civil disobedience in our society?

Eidinger: To speak truth to power. Next.

nbj: How has this role changed in the modern era of fragmented media and short attention spans?

Eidinger: I think civil disobedience is happening less, but then something like Occupy Wall Street happens and it’s so amazingly unsustainable, yet goes on for months. I think it’s easier than ever to stage a protest and broadcast the demonstration to the whole planet. So make the most of it. With the help of professional stand-up comic Elizabeth Croydon, I’m going to be hosting a comedy telethon for legalizing marijuana in the District of Columbia from my living room on March 15. Zero cost, besides internet connection! We have more tools now than ever before, but it still boils down to personal relationships. Trust, friendship and camaraderie are still needed to have a successful protest.

nbj: Will we see another Occupy soon?

Eidinger: I hope so. But we must not forget that Occupy is a tactic first, and a branded form of activism second. To stop business as usual, it has been the tactic of activists to occupy a space in order to have their message heard. The branded Occupy was an amalgamation of different issues that was very successful in showing that inequality is alive in America and people need to come together to fix the issue.

I know the first Occupiers very well, the ones who started the camp out in Zuccotti Park in New York. If they say we’re doing it again, I’m in! In the meantime, I’m focused on organizing with activists at Occupy-Monsanto.com.

Defining moments

nbj: Please describe a few of your proudest professional moments.

Eidinger: I’ve been involved with so many issues over the years, but here are a couple that I am the most proud of:

  • Knowing that our protests forever opened the World Bank meetings to the public.
  • Forcing the Metropolitan Police Department and the U.S. Capitol Police to rewrite guidelines for police conduct during demonstrations in Washington, DC.
  • Cover of the Washington Post Magazine, even if the article is a hit job.
  • Getting Monsanto to have for the first time an audio broadcast for anyone to hear.
  • Using money from a lawsuit against the DC government to organize a 100,000-person anti-war concert on the National Mall with some of my favorite bands.

nbj: Who was your hero when you were a kid? Who’s your hero now?

Eidinger: Superman and Franco Harris, the Pittsburgh Steeler. My hero today is Ai Weiwei.

nbj: Have you ever read an entire Bronner label in one sitting?

Eidinger: I’ve read it and lived it. On the pump soap label, which is written by Dr. Bronner’s grandsons David and Michael, it talks about what our generation is doing to implement his “All-One” ideals. This includes organic farming and fair trade, which is about “sharing the profits with the workers and the earth from which you made them.” Dr. Bronner calls this “Constructive Capitalism,” and I’m all about that. I believe that CEOs should think about capping their pay and using the extra money to lift up those at the bottom of their companies.

NBJ

Thorne Research bets on personalized medicine technology and wins Nutrition Business Journal Investment in the Future Award

Thorne Research bets on personalized medicine technology and wins Nutrition Business Journal Investment in the Future Award

Students of the supplement industry—especially the rarefied airs of its professional lines and practitioner sales channel—should begin to take careful notes on Thorne Research. Since the June 2010 transaction with Diversified Natural Products that shifted management of the company from its original, charismatic and contentious founders—Al and Kelly Czap—to new CEO Paul Jacobson, Thorne has gone on an investment spree that’s raised more than a few eyebrows.
In May of 2011, the company began to drop hints of its new strategic direction with the announcement of Health Elements, a joint venture developed with Integrative Health Resources to bring more technology into the industry. A month later, Thorne announced a minority investment by Helsinn Group, the Swiss pharma company, that led to the subsequent launch of Oncoqol, a line of cancer support products.
Next came an exclusivity agreement with Indena in October 2011 to jointly develop botanical products, and news of a dedicated product set—originally called Thorne Performance but about to launch as ThorneFX—targeting sports nutrition. In April 2013, Thorne landed another joint venture with YouCare Pharmaceutical Group in China, and followed that up with TruCardia, a cardiovascular line developed with Dr. Mark Houston of the Hypertension Institute in Nashville.
Last but not least, Thorne ended 2013 with its acquisition of WellnessFX—last year’s winner of an NBJ Innovation Award—and its most brazen play yet into the burgeoning field of personalized medicine and quantified health.
So what ties this story together? Long-term strategy. “Back in 2010, we looked at the industry from both a defensive and offensive standpoint,” says Jacobson, a former partner at Goldman Sachs. “We looked at the major pain points—quality control on the defensive side, and efficacy on the offensive side. Then we set about building a company to try and solve one of those two problems—either raising the level of quality in the products, or pushing more and more to find ways to prove their efficacy. A third priority from the beginning has been to expand our business into the MD channel.”
Says Will McCamy, formerly of Metagenics and Xymogen and now Thorne’s President: “I’m going on 20 years in the practitioner space and we just refuse to be another one of these me-too companies that swaps out shelf space for products—my CoQ10’s better than yours, my multi’s better than yours. We want to provide innovative solutions that differentiate us in the eyes of the doctor.”
Thorne has a longstanding reputation as one of the highest quality manufacturers in the business, but it’s quickly obtaining
a new reputation as one of the most aggressive operators and innovative partners as well. With more than $20 million now invested in new lines of business, Thorne has a lot riding on its new strategy, but, as they say, to the victor go the spoils. Who else is this well positioned to bridge from supplements to pharma, from natural medicine to conventional, from one-size-fits-all to n=1?
“Thorne is very strong among naturopaths,” says McCamy, “and we’ve always maintained our commitment to that core customer, but we just won’t cow tow to this notion that we’re selling out by partnering with pharma. The only way this type of medicine will be validated and accepted more globally is if we bring into the arenas where people are big doubters. Two of the hardest disciplines to get on your side are cardiology and oncology. We’re going toe-to-toe there to make an impact.”
There’s no more promising path to efficacy than personalized medicine. Here’s what Jim Kean of WellnessFX, the Silicon Valley startup bringing dashboard diagnostics to a screen near you, has to say about the new Thorne: “Much of the supplement industry is not mentally prepared for the level of investment and commitment that will be required to provide consumer engagement in a scalable, regulation-compliant manner. The management of Thorne shared this vision with us, of what could be if we combined our health services delivery platform with their leading-edge product line.”
In the wake of these joint ventures and partnerships, what’s next for Thorne? Not surprisingly, it’s time to implement and get that $20 million to market. “This is a year for execution,” says Jacobson. “We put
the pieces in place that would land us in an industry leadership position, and now we need to execute.” With TruCardia
and ThorneFX set to launch this month, plus WellnessFX now in the mix with a growing and meaningful consumer-facing business, it’s time to watch the master plan unfold.

Indian gooseberry helps hearts

Indian gooseberry helps hearts

A clinical study on a patented Phyllanthus emblica extract, commonly known as Indian gooseberry, published online in Phytomedicine, showed that Indian gooseberry caused a significant decrease in platelet aggregation. In a 10 day study, Indian gooseberry (500 mg twice daily) reduced platelet aggregation by over 36 percent, compared to 50 percent by Clopidrogel (75 mg once daily) and 51 percent by Aspirin (75 mg once daily). However, when Indian gooseberry was taken in conjunction with Clopidrogel or Aspirin, the inhibition of platelet aggregation increased only marginally to 53 percent and 56 percent, respectively. Bleeding and clotting times were not significantly affected by Indian gooseberry when used alone or in conjunction with either Clopidrogel or Aspirin.

There were also no adverse effects or bleeding events reported. An area of concern is the inhibition of platelet aggregation greater than 50 percent which is strongly correlated with bleeding events. Indian gooseberry alone produced only 27 percent and 36 percent inhibition of platelet aggregation in single dose and multiple dose studies respectively, compared to 47 percent and 50 percent for Clopidrogel and 46 percent and 51 percent for Aspirin.

This study was a randomized open label crossover study that included 10 patients with type II diabetes. Patients were evaluated both after a single dose and then with multiple doses over a 10-day period. In the single dose study, the patients were given either a dose of 500 mg of Indian gooseberry or 75 mg Clopidogrel or 75 mg Ecosprin (enteric-coated aspirin). The combination doses were 500 mg Indian gooseberry with 75 mg Clopidogrel or 500 mg Indian gooseberry with 75 mg Ecosprin. After the single dose study and wash out period, patients received the combinations for 10 days. Platelet aggregation was measured at baseline and at four hours after treatment. Bleeding and clotting times were also recorded.

"The results illustrate how Indian gooseberry may provide benefits for healthy blood circulation and heart health through reduced platelet aggregation," said Sanni Raju, Ph.D., R.Ph., chairman and CEO of Natreon. "The study was done in type 2 diabetes patients that are at a higher risk for abnormal platelet function. We're very pleased with the positive results and with growing scientific support for Indian gooseberry, we're excited about the heart health benefits it offers to dietary supplement manufacturers seeking to introduce new products or differentiate existing brands in the category," said Dr. Raju.

New JAMA study reinforces vitamin E safety

New JAMA study reinforces vitamin E safety

In response to a study, “Effect of Vitamin E and Memantine on Functional Decline in Alzheimer Disease,” published in the Journal of the American Medical Association (JAMA), the Council for Responsible Nutrition (CRN), the leading trade association representing the dietary supplement industry, issued the following statement:

Statement by Duffy MacKay, N.D., vice president, scientific and regulatory affairs, CRN:

“This study is significant as it presents strong data on the safety of vitamin E, at high doses, and dismisses previous questions raised about the safety of this essential nutrient. The authors stated, ‘In contrast to the conclusion drawn from a 2005 meta-analysis of vitamin E, which showed that high-dose vitamin E (≥400 IU/d) may increase the risk of all-cause mortality, we found no significant increase in mortality with vitamin E.’ This new study demonstrates that scientists seeking to slam the door on vitamins, and new vitamin research, is the antithesis of what science is all about.

“In addition to confirming the safety of vitamin E, this study, one of the largest and longest treatment trials in patients with mild to moderate Alzheimer’s disease, found 2000 IU/daily of vitamin E compared with placebo resulted in slower functional decline in these patients. These results point to a powerful role of integrating proper nutrition into disease management, and provide hope for Alzheimer’s patients and their care givers. However, the dietary supplement industry should be reminded that dietary supplements cannot be marketed or sold to consumers as a disease treatment, and we recommend that those suffering with Alzheimer’s disease rely on the advice of a trusted doctor as to the appropriate treatment plan. Self-dosing at the levels studied in this trial are not recommended. 

“It is commendable that aspects of this study ‘reflect the best in trials of Alzheimer disease therapy,’ as noted in an accompanying editorial, though we still encourage more research to further assess the role vitamin E plays in both the prevention and treatment of this very complicated disease.”

 

NBJ

Alkemist Labs, Navitas Naturals & Boulder Brands win Nutrition Business Journal Growth Awards

Alkemist Labs, Navitas Naturals & Boulder Brands win Nutrition Business Journal Growth Awards

One company was born in a 750-square-foot house in the shadow of the famous Hollywood sign. Another was launched by a teenager with a fascination with plants. The third started out as nothing more than idea—but an idea backed by $100 million and an entrepreneur with a sterling reputation.
Despite these vastly different origins, all three winners of this year’s NBJ Growth Awards have demonstrated an ability to create something out of nothing and usher it to market with great success. Here are their stories.


Alkemist Labs     
Elan Sudberg was a 17-year-old kid, pressing herbs after school to make tinctures for his father’s chiropractic practice, when he sensed a change in how the federal government viewed botanicals. The year was 1997, and FDA would soon mandate certain GMPs for the then largely unregulated herbal industry.
“The FDA was waking up, and making quality control a bigger deal,” he says. His father Sidney Sudberg—an acupuncturist and chiropractor—signed up for some FDA classes in identity testing and brought home a thick stack of books with a microscope for his inquisitive son. Soon the two transformed one treatment room of Dad’s chiropractic office into a laboratory, where Elan spent afternoons poring over plant cells under a microscope, helping the company’s first clients confirm their botanicals were what they thought they were.
Alkemist Labs was born. “We quickly built up a reputation for doing low-tech, but very necessary identity testing,” says Elan. Seventeen years later, the Costa Mesa Calif.-based contract testing laboratory has expanded to include a staff of 20, a 6,000-square-foot lab facility, and an herbarium bursting with 15,000 plant specimens. Its revenue topped $3 million in 2013, according to company CEO Elan, and it is poised to hit $4 million in 2014. But while revenue has grown consistently in recent years, the company’s focus has remained narrow.
 “All we do is test plants and vitamins,” he says, noting that, because the company doesn’t sell ingredients or finished products, it’s never in the awkward position of competing with its clients. “No one does what we do as well as we do it.”
After graduating from high school, Elan began pursuing a chemistry degree from California State University Long Beach but with a flourishing business, it took him nearly a decade to graduate. Meanwhile, he and his father cashed in their life’s savings to buy equipment. “That was unfortunately not enough to buy a bunch of fancy equipment, so we just kept it simple and stuck to identity testing,” Elan says, noting that they did not test for things like pesticides and heavy metals.
That narrow focus became a blessing when an adulterated herb started sickening people in Australia in 2006. When the government there began requiring identity testing, Alkemist Labs was one of few companies in the world to do that, and only that. Revenue spiked 300% in 2006. The next year, when the FDA issued its long-awaited Good Manufacturing Practices rules, Alkemist revenue spiked another 100%. The company has grown 30% annually ever since, Elan says.
Today Alkemist has expanded its offering to include not only identity testing of single botanicals but also potency testing and testing of multi-ingredient finished products. In 2014, it will begin testing fish oils. For some symbolism of just how much Alkemist has matured in 17 years while still sticking to its roots, the company just rolled out its new logo—an old-fashioned beaker tucked inside a sleek molecular hexagon.

 

Superfoods pioneers

Navitas Naturals      
Step into a natural foods retailer, gourmet specialty store, or even some large, conventional supermarkets today and you’ll find shelves of exotic nutrient-dense “superfoods”—from organic cacao snacks and chia seeds to wheatgrass powder for build-your-own smoothies. Propelled by rising interest in smoothies, growing demand from foodies with an experimental streak, and frequent shout-outs by Dr. Oz, superfoods remain a strong and growing category.
That wasn’t true a decade ago. “People had just begun to talk about superfoods,” recalls Zach Adelman, the 43-year-old CEO and founder of superfoods category leader Navitas Naturals. “In 2003, it was just me and my website. I was knocking on doors trying to convince retailers to put products on the shelf. It was really hard.”
The Canadian-born entrepreneur was living in a 750-square-foot bungalow at the base of Beachwood Canyon, the road leading to the fabled “Hollywood” sign. He had just left an international arts and crafts business and was looking for a new opportunity when a friend from Australia called and asked him if he’d heard of a Peruvian root called maca.
Adelman and his then-partner pulled together $90,000 to launch Navitas Naturals and sell a maca powder or capsule supplement called Maca Power online out of his home office. Several times a year he would travel to remote and rugged areas of Peru to check on suppliers. The first few years were slow going, but as word of the purported benefits of maca spread, other companies reached out to Adelman. He had his own brand in mind, but selling raw materials gave him a jumpstart to expand to a bigger space and venture into other superfoods.
“People wanted more access to things like high quality cacao and goji berries,” he says. So he expanded his line, rented a 10 by 10 booth at Expo West, and crossed his fingers.
Fast forward to 2013 and Navitas Naturals boasts 75 employees and a glistening 26,000-square-foot headquarters in Novato, Calif., complete with a kitchen studio producing recipe videos. It has largely left the ingredient business to focus on its own brands, pushing 80 SKUs sold in 4,000 retail stores, including mainstream retailers HEB, Giant Eagle, and Kroger subsidiary Harris Teeter. Adelman’s Australian partner exited the business and Adelman now runs the company with partner Wesley Crain.
In 2013, the company did roughly $35 million in business, up 50% over 2012, he says. “We hope to grow at that same pace in 2014.” The company’s early core products (cacao, goji berry, acai berry and chia) remain its top sellers, but it has branched into the exotic in recent years, rolling out snack packs of dragonfruit (a night-blooming cactus from Thailand), and nori powder (a nutrient-packed seaweed used in smoothies).
All products are 100% organic and verified non-GMO by the Non-GMO Project. Adelman hopes to expand further into the snack-food aisle, with stand-up chews and healthy chips derived from plants from as far away as Columbia, China and Paraguay.
“People are becoming more and more aware of the unique ingredients they can put in their food to boost nutrition,” he says. “We will continue to bring these interesting indigenous foods from around the world to store shelves in the U.S.”
 

Natural goes big

Boulder Brands       
In the beginning, Boulder Brands was nothing more than an idea. “The major food companies had fundamentally corrupted the food chain over the previous 30 years. We wanted to start from scratch and create a company focused on getting the bad stuff out and the good stuff back in,” says CEO and co-founder Steve Hughes.
With that vision in mind, and a stellar track record from leadership stints at Celestial Seasonings, Con Agra and Tropicana, Hughes took a novel tack at getting the business off the ground. He and partner Jim Lewis created a Special Purpose Acquisition Company—a rare venture that enables public investors to sink money into a private-equity-type deal with the promise that if nothing comes of it in a few years, they get their money back. They took their presentation on the road in December, 2005, and swiftly raised $100 million.
“There were not a lot of medium-sized public companies that were high growth and high margin in the health and wellness space at the time,” says Hughes, who vowed to build one. “We did what we set out to do.”
Today, the Boulder-based company (Nasdaq: BDBD) is among the largest natural consumer packaged goods producers in the country, with revenues hovering around $465 million, up from $365 million in 2012, organic growth in the high teens, and impressive profitability (17.5% EBITDA). With its December purchase of Boulder-based burrito-maker Evol Foods for $48 million in cash, the company is now home to six successful brands, including two gluten-free leaders: Glutino, bought for $66 million in 2011, and Udi’s, acquired for $125 million in 2012. In the average U.S. grocery store, Boulder Brands now has 38 items on the shelf.

The company started its acquisition spree in 2006 with the unlikely purchase of New Jersey-based Smart Balance, maker of better-for-you spreads and butter alternatives, for $465 million. At first glance, a mainstream spreadable butter may have seemed like a departure from its natural products mission, but Hughes says the company did precisely what he set out to do. “We were part of a movement that drove trans fats out of the spreads category, and now the federal government is poised to ban trans fats completely,” he says. “That really illustrates what we are about.”
Going forward, Hughes intends to combine the company’s strength in the gluten-free category and its pure and simple focus to launch products and make much-needed inroads in a long-stagnant packaged frozen foods category. “The pure-and-simple frozen space could be a big opportunity for us this year,” he says. Hughes also hopes to make the company’s brands more broadly available. “Our big focus is to get these ideas that have proven themselves in the natural space, and spread them into all of the channels they should be in.”

NBJ

Jay Udani and Medicus Research bring solid science to supplement studies

Jay Udanis Medicus Researchbrings pharmaceutical protocol to supplement studies

In the oft-maligned dietary supplement industry, research is painted as the antidote to skepticism. But not all research is created equally, says Jay Udani, MD, CEO of California-based Medicus Research.
“The industry is often characterized in the media as non-scientific. The problem is that the people who are investing in the research are doing it wrong,” he says. “If you run a study for dietary supplements in the same way as a pharmaceutical study—just dropping it into the same template and expecting it to work—you are less likely to see positive results.”
Thirteen years ago, the board-certified internist, trained at Cedars-Sinai Medical Center in Beverly Hills, set out to fill a void in an industry that, he says, still severely lacked scientific backing. “At that time, what passed for a clinical trial was two rats in Siberia,” he jokes. “People were using pirated third-party research.”
He had his own private practice and conducted research for pharmaceutical companies. When a supplement company asked him to conduct a clinical trial for them, he said, “Sure, send me the protocol, and they said ‘What protocol?’ The companies in this industry—unlike pharma companies—didn’t have, and still don’t have, the in-house capacity to design a clinical trial.”
In 2001, Udani launched Medicus Research with two goals: It would provide a full-service “end to end” contract research organization which would design clinical trials, recruit and see patients, execute studies and navigate regulatory hoops. It would also usher in a new research paradigm better suited to the dietary supplement industry and, as a result, more likely to produce relevant results.
“Jay is working on providing the hard evidence everyone is asking for, and doing it in a way that recognizes the subtleties and complexities of studying natural products,” says Loren Israelsen, president of the United Natural Products Alliance.  

Udani says that natural compounds aimed at subtly supporting wellness in a healthy or at-risk population cannot be studied in the same way as powerful drugs designed to cure the sick. Even if a dietary supplement trial showed swift and specific action in treating a disease, regulatory guidelines prohibit companies from marketing it that way.
His three-pronged Udani Theory of Natural Product Clinical Trial Design takes a different approach. It starts with a healthy or at-risk population, rather than a diseased one (like people with achy joints, rather than osteoarthritis), applies a consistent stressor (like a stair step machine set on a specific resistance), and looks for end-points that both regulatory bodies and consumers can understand and find relevant.

 

Published Results

Udani’s team recently published a study in Journal of Alternative and Complementary Medicine looking at 55 healthy subjects screened to be sure they did not have osteoarthritis. Those who took Interhealth Nutraceutical’s UC II collagen-based joint health supplement for 17 weeks could exercise longer on a stair stepper without experiencing joint discomfort and had less pain afterward. The study was presented at the Scripps Natural Supplement Conference in San Diego and received a first place award for quality research.
Udani has also been lauded for using innovative technology to make supplement research more thorough. Because trial subjects must often be monitored for long periods of time to see the subtle effects of natural products, and because compliance is critical, Udani’s company SysteMedicus developed a novel technological platform called eCompliance that uses tablets and smartphone apps to keep track of patients remotely. The technology can get informed consent, collect video of subjects taking their pills regularly, gather diary entries, etc. This allows more frequent tracking of a larger study population at an affordable cost, according to Udani.
One recent study, published in the Nutrition Journal looked at 157 subjects over 120 days to test whether a Garden of Life EPA supplement improved omega-3 fatty acid status in healthy adults. (It did.) “These people never walked through our doors but we were able to do a proper informed consent online and have ongoing communication with them both online and by phone,” says Udani. “We showed that the future of clinical trials involves use of technology.”
In 2013 alone, Medicus Research conducted roughly 70 trials, and had 8 studies published in peer reviewed journals. With federal regulators, lawmakers and the media increasingly questioning the efficacy and safety of dietary supplements, he could face a busy 2014. “You can be assured there will be quite a show in 2014,” says Israelsen. “We have to put our best efforts forward on research and that is where Jay comes in. He’s making a vital contribution to the industry.”