Looking back at the last 20 years, I feel like the dietary supplement industry has matured from an unruly child with neglectful parents and a “Why follow the rules if no one else does?” attitude to a mostly mature young adult, still finding its way but on the right path with as much hope as opportunity for improvement. We’ve also seen advances in technology impact the world of dietary supplement testing-sometimes not for the better.

Back in 1998, Alkemist Labs had a handful of clients who were big companies trying to do things right-although what that meant was not yet very well defined. Good Manufacturing Practices (cGMPs) were specified under the Dietary Supplement Health and Education Act of 1994 (DSHEA), but it would be a ridiculous number of years later until the FDA outlined just what those cGMPs were in the agency’s eyes. During those gray years, cGMPs came up as fuel for prosecution only when there was a serious event. Although there weren’t a lot of them yet, companies who either had big enough liability or who were owned by other companies in better regulated industries relied on our services to limit their liability. Alkemist survived those years, but had some memorable times. With gas tanks nearly empty, we limped into the bank to make anemic deposits and robbed Peter to pay Paul, and then paid Peter back with a loan from Paul. It was a long, dry, dusty road ahead for the next 10 years, with a few ups and many downs. We do not miss those times at all. 

When FDA finally spelled out its cGMPs regulations, the industry realized that complying with the cGMPs was the right thing to do-or, at least, the smart thing to do. Fortunately, Alkemist Labs had become known as being a very proficient testing lab, and companies serious about botanical identity came calling.

This year, thanks to continuous improvement in industry compliance with cGMPs, Alkemist Labs is celebrating its 20

 year in business and growing faster than ever. Things are great and are getting even better. The industry has more players, more complicated formulas, and more adherence to federal regulations. We see more companies committed to doing things right, investing in reference standards, working through discrepancies to get real answers, and focusing on more than just getting a cheap price when sourcing ingredients.

Still, we have work to do. There are those who still abuse the vaguely written cGMPs, which state that a scientifically valid method must be used to test the identity of all incoming raw ingredients. These companies do the least amount of quality control possible. 

Shiny balls will also come and go. Technologically speaking, DNA testing has been a disruptive, shiny ball that some have tried to apply before it was fit for purpose; as a result, those who overstate the accuracy and applications for DNA testing have created a brouhaha of biblical proportions. While DNA testing will eventually be fit for some purposes, the “oldie but goodie,” tried-and-true technique of HPTLC (high-performance thin-layer chromatography) is still the most trustworthy and accurate method available for testing plant identity.

! I look forward to the journey as both our companies head towards our 30s. 

Elan Sudberg is CEO of Alkemist Labs (Costa Mesa, CA), a passionatwely committed contract testing laboratory specializing in plant authentication, botanical ingredient identification, and quantitative analytical services to the food and beverage, nutraceutical, and cosmeceutical industries. 

Is 2017 a Better Year for Dietary Supplements than 1998?

Articles

How dietary supplement testing changed over two decades

Dietary Supplement Testing, Then and Now

Although I can’t quite believe that it’s been 20 years since 

launched, and nearly 30 years since I joined the natural products industry, looking at how much the industry has evolved confirms it: today’s natural products industry is quite different than it once was. Much has changed, particularly in the tools people use to get and give information. And yet, in other ways some things have not changed at all. 

Let’s take a trip back and remember the state of the industry when 

 was launched. Twenty years ago, we were still sorting out how the industry should and would operate under the Dietary Supplement Health and Education Act (DSHEA). It would be many years before FDA actually provided guidance on how the agency intended to implement the law. 

Large companies in the OTC sector saw opportunity and begun entering our space, bringing a more sophisticated approach to manufacturing and product testing, among other practices. Many existing companies were acquired or flooded with investment dollars. The mass market started to look like a much more viable sales channel for nutritional products. The number of product offerings grew and would continue to escalate. The range of quality variables expanded, the supply chain got longer and more complicated, and those willing to cheat found a lot of new and creative ways to do so. 

The number of ingredient companies actually investing in science was still small; yet, the number of those claiming to invest in science was growing. Healthy-lifestyle consumers shopped at health food stores, and that relatively small constituency brought its values into the store when choosing products. Whole Foods and Fresh Fields “super naturals” chains had recently disrupted the health food channel dramatically, and were converting new shoppers.

The industry went from having three trade magazines focused primarily on natural channel retailers in the early 1990s, to eight that addressed specific aspects of the broader industry by the end of that decade. E-mail was becoming a more common way to communicate, but communication was still mostly done via phone and fax. And the name 

 still largely referred to either a river or a legendary female warrior; few had heard of the small Internet start-up bookseller in Seattle.

Then, as now, the trade publications were a powerful conduit to reach a B2B audience and convey your message, but the proliferation of content marketing options in 2017 presents remarkable opportunities. For brands and ingredient companies who want natural-channel retailers to know about and sell their offerings, several trade publications target that audience. For ingredient companies and service providers, there are many options to tell your story via PR and advertising. Companies that invested in publishing books on the research behind their products were rare 20 years ago; today, producing seminars, infographics, and e-books is a common component of marketing programs.

How consumers get their information, and the volume of information they access, has changed dramatically since 1998. It’s no surprise that “transparency” is both a call to action and a marketing tool, given how informed consumers can be today. Company websites have to be optimized for mobile devices. Social media programs are key to consumer marketing as well as monitoring for potential PR problems and addressing any that occur. And forget using mainstream media to reach consumers; they’ll just throw the term 

 into the copy, even if they do agree to write about your products. Bloggers and social media are today’s avenue to reach consumers who may be interested in your products.

What has not changed-and is more important than ever, given consumers’ broad access to information today-is the importance of the substance behind products, research to prove efficacy claims, and company-demonstrated best practices. Consumers want to believe in the values of a company before giving their loyalty to a brand, and that’s one important practice that is now mainstream.  

Suzanne Shelton is managing partner of The Shelton Group (Chicago). The Shelton Group specializes in marketing and PR services for product manufacturers and ingredient suppliers in the natural products industry.

A longtime natural products marketing expert reminisces on the evolution of the natural products arena.

The Evolution of the Natural Products Market

By John R. Endres, ND, Chief Scientific Officer, AIBMR Life Sciences

Over the past 20 years, the dietary supplements industry and FDA have learned how to work together to achieve the common goal of regulatory compliance to ensure that products are safe for consumers. My company, AIBMR, is approaching its 40

 year as a scientific and regulatory consultant serving the natural products industry. I myself have had the mere pleasure of being part of this industry for 11 years. As we have worked together with our industry clients on regulatory compliance, we have experienced firsthand the benefits that come from working closely with FDA. 

First, however, consider all the regulatory changes that have taken place in the 20 years that 

 has been publishing, and consider how the natural products industry’s relationship with FDA has had to evolve over that time. When 

 first published in 1998, the Dietary Supplement Health and Education Act of 1994 (DSHEA) was only an infant at four years old. At the same time, as a result of scrutiny from public interest groups, FDA’s Office of Food Additive Safety finalized the proposed GRAS rule that went into effect in April 1997. Later, in 2007, FDA established Good Manufacturing Practices (GMPs) for dietary supplements. And just six months after the Food Safety Modernization Act (FSMA) was signed into law by President Obama in 2011, FDA issued the first of two draft guidance documents to help our industry understand how to properly prepare and submit a New Dietary Ingredient notification (NDIN); just last August, FDA issued its revised second NDI draft guidance. 

Clearly, a lot has changed at FDA in the past 20 years. In fact, FDA’s dietary supplement division isn’t even a division anymore within FDA’s Center for Food Safety and Applied Nutrition; in 2015, the division became a full-fledged office, the Office of Dietary Supplement Programs.

It has taken time for the industry to digest and to understand FDA’s complicated set of regulations, and during that time, we have been honored to be able to provide guidance to industry on how to navigate the regulatory waters. And, while the regulatory realm may be second nature for us, we still continue to learn as new challenges present themselves. 

An important lesson that AIBMR likes to communicate is that FDA is not the enemy. In most cases, FDA has been extremely helpful in terms of its availability, spirit of cooperation, and willingness to offer advice. For example, GRAS pre-notification meetings we have facilitated in person in College Park, MD, between GRAS notifiers and the agency have tended to result in enhanced cooperation between the two parties that FDA has ultimately said helps make the GRAS process more efficient by reducing the agency’s questions on the back end. These hour-long meetings are generally attended by 10–12 FDA senior staff, perhaps including the division director as well as senior supervisory toxicologists, chemists, and microbiologists.

From our perspective, maintaining this open dialogue with FDA is partly why our process has resulted in a high degree of success; it helps companies to understand questions and concerns that FDA might have on the front end, and it allows the agency the opportunity to preemptively provide very valuable advice. 

The industry as a whole has realized over the past 20 years that it needs to self-regulate-that is, to move closer to full compliance with GMPs, label claims, and submitting NDINs and obtaining GRAS notifications when necessary. I believe that the majority of industry companies are chiefly trying to do the right thing and appreciates any help they can get to be completely compliant with FDA regulations. Companies that are unwilling or unable to comply will eventually be pushed out of business if they haven’t already been. 

FDA has been very active and helpful-both the Office of Dietary Supplement Programs and the Office of Food Additive Safety-with giving presentations and participating in Q&A sessions at industry tradeshows (e.g., SupplySide West, Natural Products Expo, the Institute of Food Technologists’ Annual Meeting and Food Expo) and trade association meetings (e.g, the Council for Responsible Nutrition, the Natural Products Association, the United Natural Products Alliance, the American Herbal Products Association, etc.). 

The future is bright as the industry continues to grow. Although we face many challenges, working together with FDA to make sure consumers are assured safe products to support their health is part of what will enable our industry to remain successful for many years to come. 

John R. Endres, ND, is chief scientific officer at AIBMR Life Sciences (Seattle), a leading natural products and functional ingredients consulting firm. 

Industry and FDA share the same goal: to ensure a safe dietary supplements marketplace. 

FDA: Friend, Not Foe to Dietary Supplement Industry

By Steve Mister, President and CEO, Council for Responsible Nutrition

If today’s supplement marketers and consumers could time travel back to 1998, they’d see a very different dietary supplement marketplace: the aisle would be much smaller, brand selection would be narrower, delivery forms like gummies and gels wouldn’t be on the shelves, some of today’s “hot” specialty ingredients would barely be noticed-think protein and probiotics. But in other respects, we’d see familiarity: multivitamins would still be prominent, consumers would be asking about unnecessary chemicals, and supplement users would want assurances of safety on the label. For the past 20 years, as the U.S. population has grown, the percentage of U.S. consumers who take supplements has steadily increased. At the same time, the types of supplements consumers use have grown, too: while the multivitamin is still the most popular supplement, users have expanded into CoQ10, fiber, omega-3s, and various herbals. The U.S. supplements market now touts over 170 million users and is $41 billion strong.

The industry itself has changed, too. The infusion of capital; investments from food, pharma, and packaged goods companies; new regulatory requirements like GMPs and adverse-event reporting; and even emerging research supporting new benefits for old ingredients have all contributed to a more mature, more responsible and robust collection of manufacturers and marketers to greet a new generation of supplement consumers.

Credit for the market expansion starts with the passage of the Dietary Supplement Health and Education Act (DSHEA) in 1994. Contrary to critics’ revisionist history of DSHEA serving as a form of industry deregulation, the fact is that DSHEA actually added consumer-safety provisions and conferred new authority on FDA to regulate supplements. Not only that, DSHEA defined the supplement category. In turn, the law provided more certainty for manufacturers, a roadmap for labeling, and a clearer path to industry growth. One can argue about which came first-consumer demand for a wider variety of products, or marketers who saw an opportunity to create consumer demand. Regardless, today’s consumers crave both tried and true vitamins, as well as niche categories, new ingredients, and products segmented to their personal demographics. They have the clarity and certainty that DSHEA provides to thank.

Today, supplements are mainstream healthcare, no longer referred to as “alternative” or “fringe.” Along with our traditional consumers are soccer moms, millennials, more health-conscious men, and thriving baby boomers who want to maintain their active lifestyles. The steady growth of positive science continues to demonstrate both the need to fill nutritional gaps due to poor eating and the array of health benefits supplements provide. Healthcare practitioners recommend them; online influencers tout them. While health food stores still do a robust business, supplements are even more widely accessible today, from the big box stores to supermarket chains, from healthcare practitioners’ offices to direct sellers, from the online retail portals to gyms and yoga studios.

Consumer attitudes toward supplements are evolving, too. Today’s consumers are more proactive about their health, looking to focus on prevention. Distrust of large institutions makes them want to take more control of their healthcare decisions. They’re seeking products by condition, in addition to seeking to fill nutrient gaps. They’re relying more on digital media and online social communities for recommendations. Millennials, as well as boomers, seek assurances of quality and safety at the same time they shop across channels for value and for companies whose brands they align with. 

Today’s supplement consumers also insist on transparency and demand accountability, so industry has responded with “clean labels;” allergy-free, non-GMO, and third-party-certified products; and resources like the industry’s new Supplement OWL product registry. All these factors give consumers more confidence in dietary supplements than ever. When 

 anniversary, I hope we’ll be able to say we met-even exceeded-consumer expectations. 

Steve Mister is the president and CEO of the Council for Responsible Nutrition (CRN; Washington, DC), the leading trade association for the dietary supplement and functional food industry.

Two decades later, supplement users seek choice, take control.

An Evolving Consumer Landscape for Dietary Supplements

By Bob Sanders, Executive Vice President, Healthcare Practice Leader, IRI 

Armed with the confidence that comes from their Internet-driven research on the benefits of dietary supplements, today’s consumers have gone after their health and wellness goals with a targeted approach that has changed the face of the supplements market in the past two decades. Today, consumers seek solutions, and not necessarily product categories, which has blurred category lines and opened up opportunities for key, sought-after benefits like immunity, pain relief, and memory, for example. 

Diet and supplementation have spurred a hybrid approach combining the benefits of traditional pills and delivery methods with foods and now popular smoothies or shakes to combat chronic ailments and conditions. While 37% of Americans say that food is just as powerful as medicine and that they intentionally eat products such as kale and spinach with known health benefits, nutritionals and supplements will continue to play a critical role because most Americans also say that eating the recommended dietary allowance of a nutrient is often impractical, unhealthy, and expensive to do, according to IRI’s 2017 Self-Care Study. Combined with healthy diets, supplements contribute to consumers’ efforts to seek solutions and drive the self-care movement. 

Most notable in the evolution of supplements throughout the past two decades is their mainstream appeal; no longer are these products just the territory of health food stores. Today’s nutritionals, including vitamins, minerals, herbals, and other supplements, are widely distributed through online and brick-and-mortar retailers, and they’re increasingly sought after by various demographics. 

According to IRI’s 2017 Self-Care Study, 85% of Americans say that they continue to engage in self-care activities at a similar level compared with the year prior. Some 15% say they are doing more. Specific to supplements, 22% of respondents say they take more supplements than they did a year ago. 

Millennials, in particular, have embraced supplements and are buying and taking more than generations before them. Today’s younger generation of adults is using supplements in daily living and before and after exercising, and they’re honing in on specific products to help them meet their health and fitness goals. This has been a huge mindset shift from the 30-somethings of 20 years ago. Twenty years ago, for instance, by no means could marketers have convinced the 30-something generation to take supplements, while today, this group demonstrates great engagement, potential, and spending power in this space. They’re learning about supplements and their value online, and they’re buying niche products as they work to take control of their health and fitness as well as actively stave off any signs of aging. 

Ready-to-drink smoothies have also captured a lot of attention in the past decade, delivering benefits in a convenient, on-the-go format, positioned as the perfect complement to today’s busy lifestyles. Smoothies also allow for inclusion of specific value-added ingredients and removal of others, such as gluten or dairy, as consumers address their unique health goals. 

Natural and organic ingredients are also popular, and they reflect a much more globally inspired marketplace than in decades past. Twenty years ago, hot ingredients were antioxidants, vitamins E and C, beta-carotene, and herbals such as ginseng and ginkgo, while today, hot ingredients better reflect our diverse, global ingredient world (think cumin, maca, turmeric, and protein-rich options as well). 

As the blurring of nutritional lines continues, it will be harder to differentiate which categories and nutritional benefits are considered mainstream. For instance, consumers may indeed perceive nutritional shakes such as Boost and Ensure as very viable alternatives to meet nutritional needs. In years past, this benefit was only associated with the traditional vitamin supplement category. 

The supplements market has grown dramatically, reaching nearly all consumer groups and delivering products in a global marketplace. Self-care is the consumer behavior shift, and health and wellness is the outcome. It is clear that consumers wish to increasingly control their long-term health, and they will seek a much broader, blurred solution set to meet these needs.     

Bob Sanders is executive vice president, Healthcare Practice Leader, at IRI (Chicago). IRI is a leading provider of big data, predictive analytics, and forward-looking insights that help CPG, OTC healthcare, retailers, and media companies to grow their businesses. 

Today’s consumers have gone after their health and wellness goals with a targeted approach that has changed the face of the supplements market in the past two decades.

Consumers Redefining Dietary Supplement Categories

Quinoa-arguably one of the superfood trend’s earliest poster children-has gone from being a niche health-food ingredient to a true staple of the North American diet. As it happens, North Americans consume more than half of the global production of quinoa, as was reported last October in the 

 But in spite of quinoa’s undeniable popularity in North America, the crop is almost never grown here.

The reasons North America–grown quinoa is so rare are myriad: excessive heat or cold conditions found in much of North America can kill the crop, and the cost of infrastructure to switch to growing quinoa crops proves too great for many North American farmers who have traditionally grown soybeans or corn. The transportation equipment required for quinoa, for example, is different than the equipment needed for other crops. In addition, though quinoa is a resilient crop, it cannot survive in regions that are too hot or too moist, which is why it’s typically been grown in the arid climates of South American countries like Bolivia, Peru, and Chile for millennia.

“If you look at quinoa, there are distinct differences in growing regions,” says Daniel LaFaver, manager of specialty grains at Bridgewell Food Products (Clackamas, OR). “In the Bolivian Highlands, the berries are larger and more flavorful. The overall presentation of the product is better-it’s a better-tasting product as compared to some of the lower elevations that quinoa grows in.” LaFaver says that the key struggle in growing quinoa in North America is finding enough arable acres that are high and dry enough to achieve the best flavor and color profiles. In general, he says, when you take a crop out of its native growing region, there are going to be challenges. 

Typically, even when quinoa is successfully grown in North America, scalability is an issue. But at least one company is looking to change that. 

With demand for quinoa showing no signs of slowing, grains manufacturers like Ardent Mills (Denver) are finding new growing solutions to ensure price predictability and keep up with the persistent demand. Earlier this year, Ardent Mills introduced what it says is “the first major, scalable quinoa grown in North America.” Ardent Mills Great Plains Quinoa is the product of a partnership between the flour-milling company and family farmers like Joe Dutcheshen, who has been evaluating different varieties of South American quinoa seeds on his farm for the past 25 years. Shrene White, director of specialty/risk for Ardent Mills, says that while the quinoa plant is highly sensitive to climate conditions, Ardent Mills has found a solution. “The cool and dry climates of Alberta and Northern Saskatchewan are ideal growing areas for North American quinoa,” she says. 

To achieve the scale required to have a viable North American quinoa farm, Ardent Mills says it is highly selective both in its partnerships with farmers and in determining the best growing locations. In addition, great care is taken to ensure that the scale of the operation increases appropriately and sustainably. “Our farmers are carefully vetted before being allowed entry into the quinoa program,” White says. “Crop rotation is considered due to its seed size and its gluten-free status. Quinoa should not follow a crop rotation of canola or wheat. As a farmer enters into the quinoa-growing program, they start small-usually about 50 acres. Once it is determined that their land and location is suitable for growing quinoa and that this will be a successful rotation for him or her, they will increase acres and add the quinoa into their rotation plan.” In addition, the company says that it can offer up to a two-year price guarantee, as its Great Plains Quinoa is traceable back to the farm. 

This price-predictable, scalable quinoa model seems to have come at the right time. Zachery Sanders, marketing director for Ardent Mills, tells 

 that from 2012 to 2016, sales of products containing quinoa grew over 700% and reached half a billion dollars (per Nielsen). Innova Market Insights reports that new product launches containing quinoa continue to grow every year. From 2013 to 2014, for example, Innova observed a 55% surge in product launch activity. At this point, quinoa’s popularity seems a given, but in a crowded market, manufacturers will continue to look for new supply channels. 

Every year, the United States imports around 40% of the global quinoa output, says White. As demand for quinoa continues to grow in the North American market, it is increasingly important for companies to find mainstream, scalable solutions to navigate the growing pains.

5 Plant Protein Ingredients for Food and Drink

Quinoa-now a staple of the North American diet-is rarely ever grown here. Here’s what one company is doing to change that. 

Is North American Quinoa Finally Here?

Slideshows

In celebration of Nutritional Outlook’s 20th anniversary, dietary supplement leaders share their views on how the industry has changed over the past two decades.