The highs and lows of 2019 Cannabidiol (CBD) is both the most positive and most potentially negative issue of the year, says Steve Mister, President & CEO, Council for Responsible Nutrition (CRN). He explains: “Twenty million Americans have used dietary supplements containing CBD in the past year, according to the 2019 CRN Consumer Survey on Dietary Supplements—that’s an impactful number from any perspective. At the same time, FDA has facilitated an unregulated marketplace by not providing a legal pathway forward to market these products as dietary supplements, with all the legal requirements for safety and quality that other supplements must abide by. The agency’s inaction is creating confusion among consumers, manufacturers, marketers, and causing inconsistency in state laws. CRN urges FDA to explicitly open the dietary supplement lane to CBD and begin enforcing the whole range of dietary supplement laws and regulations that already exist against those products.”
CBD is helping to introduce a whole new consumer into the supplement marketplace, Mister adds, “and the ingredient has a lot of promise if marketed responsibly with legal claims and manufactured in a way that limits THC content, assures CBD content matches the label and removes any solvents, heavy metals and other contaminants. It has the potential to become a robust ingredient in the supplement portfolio. At the same time, incessant discussions of CBD have distracted the industry from other critical issues, like the development of a mandatory listing, assured funding of FDA and legislation to address unlawful ingredients like SARMs. These are matters that can increase confidence in the supplement market and help address the rogue players in our space. What would we have accomplished if we hadn’t spent all the time and energy on CBD?”
Daniel Fabricant, Ph.D., President and CEO, Natural Products Association (NPA), also points to the pros and cons of CBD. “The natural products industry is a promising industry that’s empowering people to engage in and support their health, which is good for Americans as well as health care costs in the system as a whole. One such item of growing interest from consumers—cannabidiol (CBD products)—is perhaps both positive and negative. CBD products appeal to millions of Americans; our recent poll showed 1 in 3 voters uses or has used a CBD product. Yet with the exception of Epidiolex, all CBD products in the U.S. are considered illegal by the federal government, and 2 out of 3 Americans aren’t clear on that. CBD is a promising new product, but we are risking another major public health crisis if Congress allows these products to go unregulated or directs FDA to go easy on illegal products flooding the market. If CBD experiences a vaping-like crisis, it’s bad for public health, bad for the benefits CBD offers and bad for the natural products industry and hemp industry’s growth and job-creating potential. NPA led a legislative effort to secure language in the FY 2020 House Agriculture Appropriations bill to appropriate $100,000 for the FDA to perform a HHE [Health Hazard Evaluation] and is leading a grassroots effort urging the Senate to act.”
Also addressing a downside of the CBD boom, Len Monheit, CEO, Trust Transparency Center (TTC), says, “With so much emphasis on CBD, all too often we have failed to learn from years of botanical expertise how to risk manage that Wild West situation. New entries and individuals have little to no institutional knowledge, seem not to care about the obvious rules (like GMPs), and are putting the entire industry at risk.”
Looking beyond CBD, Monheit points out that in 2019 there has been increased dialogue and admission that adulteration is an issue in the industry—a step that can lead to positive change. He calls out efforts like TTC’s single ingredient testing, and ABC’s BAPP program to help raise awareness and combat adulteration.
Another positive shift that has started to take place, according to Monheit: “Increased acknowledgment that the supplements part of our industry has a role to play in understanding and combating climate change.” That includes greater awareness of the benefits of regenerative agriculture.
Karen Howard, CEO and Executive Director of Organic & Natural Health Association (O&N), agrees, noting, “Industry’s increased engagement in regenerative agriculture is one that promises to serve consumers for decades to come. We’ve made significant progress on educating Congress about how grassfed is good for the family farmer, the economy, and perhaps most importantly the soil. Increasingly consumers are asking about how companies source their materials, and industry is responding. While consumers may not yet be aware they are buying collagen derived from CAFO [concentrated animal feeding operation] animals, there is a growing understanding that consumer tolerance for such product will be very low. I’m heartened we can build momentum in this area.”
The focus on sustainability has been another positive, says Michael McGuffin, President, American Herbal Products Association (AHPA). “According to HerbalGram, the U.S. retail value of herbal supplements was nearly $9 billion in 2018. This reflects a doubling of sales volume in the last decade, and, depending on the source of earlier information, a 5- to 20-fold increase in the last 25 years. The growing popularity of herbs, herbal products and herbal ingredients in products makes sustainability an issue of ever-increasing importance. AHPA recently established a Sustainability Committee to work with our members to develop solutions and best practices for herbal product companies to promote sustainability. Fortunately, the industry is generally supportive of sustainability efforts and many consumers have communicated strong support for these efforts, and will hopefully reward companies that demonstrate progress in furthering sustainability goals.” (Go here for more on sustainability.)
That said, McGuffin adds, “We will also need to continue to pay attention to product quality in the herbal marketplace. I think we can best summarize the current reality by acknowledging that high-quality companies make and market high-quality products, but that poor-quality companies put poor-quality products in the market. This is to some degree related to demand from some customers for cheap prices, and we as an industry need to learn how to communicate to the public that cost should almost never be the first priority in selecting health products.”
Also addressing quality, George Paraskevakos, Executive Director, IPA, talks about the state of the probiotic industry. “We have seen some interesting market shifts globally over the past 12 months. A small pull back on market growth in the U.S. probably fueled by a combination of education gaps at the HCP and consumer level and too many generic copycat products in the market. The fact still remains that the U.S. is still the biggest market globally for probiotic dietary supplements and from a consumer survey IPA conducted there was a jump in probiotic users of to 60%.” He adds that the state of the probiotics market is region specific, just like the regulatory environments around the globe—in APAC, the market is starting to experience exponential growth, and in Europe there is “a small comeback.” (For more on probiotics, see the bottom of this post.)
Focusing on omegas, Dr. Bill Harris, Chief Scientific Officer, OmegaQuant, shares, “New science on omega-3—whether low or high-dose prescription products—continue to show benefits for cardiovascular disease. REDUCE-IT, VITAL and ASCEND are the studies that keep on giving. All published about a year ago, new findings generated from these studies continue to lift omega-3s, especially with regard to heart health.” And on the negative side, Dr. Harris adds, “I think a March 2018 meta-analysis published in JAMA Cardiology cast the biggest shadow on omega-3s before these latest studies—ASCEND, VITAL & REDUCE-IT—were published. Thankfully there has not been another such negative report on this scale in a little over a year. The steady stream of positive research, especially the latest studies presented at the American Heart Association (AHA) meeting in mid-November, should boost confidence in the omega-3 category across the board.” (For more on omegas, see the bottom of this post.)
6 Top Issues for 2020
1. DSHEA 2.0 “In 1994, DSHEA struck an ideal balance between consumer safety and consumer access to a broad range of products that promote better health and wellness,” says Mister. “Twenty-five years later, the market looks much different and so does its consumer. The insurgence of online shopping has added new complexity to regulating, and we have heard many times from FDA that it does not have a clear picture of all the products on the market. So, the law must adapt accordingly. CRN believes a mandatory product listing would enhance existing regulations and increase enforcement actions against bad actors in the marketplace. Consumer safety is our number one priority, and so, as we move forward, it is critical to identify gaps in the current regulatory system and enact new ways to protect consumers and the marketplace.”A mandatory product listing, Mister continues, “is a pragmatic solution to the issue of FDA not having a clear picture of the dietary supplement marketplace. A mandatory listing would allow FDA to determine who is using a particular ingredient, what claims are being made on the label, and whether the contact information for reporting an adverse event is properly provided. CRN strongly supports FDA’s ability to better identify what products are in the marketplace and to exert regulatory enforcement against products breaking the law, which is why we are actively lobbying on Capitol Hill for the implementation of a mandatory product listing. Having successfully piloted a voluntary product listing, the Supplement OWL, CRN realizes not only the benefit a product listing would be for the agency and for consumers, but also the benefit for the participating companies who are differentiating themselves from rogue companies. We certainly don’t suggest that a mandatory listing will solve all the industry’s woes, but it will shed light on the supplement marketplace and give a new level of transparency to help our regulator and our consumers evaluate the range of products being offered for sale in the U.S.”
Dr. Fabricant offers another perspective: “Before we have any conversations about DSHEA 2.0 or ‘modernization,’ we should be talking about what the FDA can do right now. For example, the FDA doesn’t need any additional authority to create a safe level for CBD consumptions and a path for supplement makers and retailers to enter the CBD business responsibly.”
Howard’s take: “I’m not sure anyone has the stomach for a DSHEA 2.0. A major overhaul of this landmark legislation would activate the 75% of the populace using dietary supplements to ‘save their supplements,’ an unwelcome nightmare for Congress in an election year. Enter stage left, a new FDA Commissioner. Not only that, industry has done little to create a collective voice around the salient issues we face.”
Monheit sums up the differing perspectives: “While industry needs to be preparing for a DSHEA 2.0, and dialogue to better understand FDA concerns is an imperative, in the current political environment, and with the exception of provisions that may come through because of CBD, I’d not expect a DSHEA 2.0 in calendar 2020,” he says. “The grassroots side of the industry resents more oversight in the absence of a real safety concern, more rigorous thinking says we might have to prepare for product listings, and FDA has so far not used the tools available while asking for new and better tools.” There is still a significant philosophical divide, Monheit acknowledges, so there is still a long process ahead.
2. Trade wars/tariffs “While we share the Administration’s goal to help American jobs and businesses, we have been clear about our view during public hearings and comments that these tariffs would cause significant harm to our industry’s ability to innovate, grow, and meet consumer demand for natural products,” says Dr. Fabricant. “We are happy with the outcome so far during the exclusion process, and we look forward to working with the Administration in the coming months. Without exemptions, these tariffs will increase costs on small businesses and the majority of Americans who rely on dietary supplements to support their healthy lifestyles.”
CRN is also working on this issue, Mister says. “CRN is working to pressure the Administration to remove the China tariffs and to help our members seeking specific exemptions from the tariffs. The China tariffs are doubly detrimental to this industry because the raw materials are taxed on their way to the U.S. from China, and those finished goods get hit again with retaliatory tariffs as the goods head back to China. To help draw awareness to the effects the tariffs have on the U.S. dietary supplement industry, CRN collaborated with the U.S. Chamber of Commerce to create an industry spotlight piece, which brings attention to the impact the Chinese tariffs could have on cost for manufacturers of dietary supplements.”
There will be an end to the trade war between China and the United States, forecasts Scott Steinford, Founder, Trust Transparency Center. “When and what the result will be is the remaining question. The impact has already been felt with many ingredients. Few of the dietary supplement ingredients coming from China have been taxed as part of the tariff proposal. However, the sentiment of the Chinese suppliers towards the U.S. has become strained, and pricing has seen increases built on the mere threat of tariffs as well as nationalistic pride. When the trade war does end, the results of the tension on both sides will likely linger much longer.”
3. Adulteration concerns “Adulteration is going to remain a focus for the industry, particularly when it comes to product crossing borders,” says Howard. “This would be a place where FDA enforcement could have a huge impact. The rules are on the books and O&N is committed to transparency and traceability of all ingredients, domestic or foreign. Consumers are becoming increasingly aware of the risks for heavy metals, for which our research partner GrassrootsHealth now has a test and research protocol.”
Dr. Fabricant maintains that the FDA “has neglected a series of its enforcement obligations over the past several years, meaning unsafe and untested dietary supplement ingredients are being imported to the U.S. and reaching store shelves. Adulterated ingredients that have not completed the New Dietary Ingredient notification process are entering our country at an alarming rate, and it’s been roughly six years since the FDA provided any sort of dietary supplement import alert. This puts American consumers at risk and compliant U.S. supplement-makers at a terrible disadvantage.”
Monheit’s view: “Many in the industry still duck and hide and refuse to admit that adulteration and products not meeting label claim is a huge issue. There are signs though that this issue is taking the stage that it ought to. Products are being called out, companies are following enhanced protocols for the detection of adulterants, pressure is being brought to bear on both ingredients suppliers as well as contract manufacturers. This is all good.” Ridding the market of adulterated products masquerading as dietary supplements is one of CRN’s top initiatives and will continue to be in 2020, says Mister. “Combatting this egregious issue requires more than just defending the mainstream industry, which is why CRN is actively educating consumers, engaging stakeholders, and working with Congress to enact real solutions.”
4. The pathway forward on CBD “CBD is a promising new product but we are risking another major public health crisis if Congress allows these products to go unregulated or directs FDA to go easy on illegal products flooding the market,” Dr. Fabricant stresses. He adds that NPA led a legislative effort to secure language in the FY 2020 House Agriculture Appropriations bill to appropriate $100,000 for the FDA to perform a HHE and is leading a grassroots effort urging the Senate to act.
CRN’s position on CBD has been clear, says Mister. “We expect the FDA to use its discretion under DSHEA to create a regulatory pathway to market for supplements containing CBD and to use the full range of tools available to it to enforce the legal requirements against companies that don’t honor these requirements. We know there are responsible marketers of CBD products, which is why we opened up our membership to CBD companies that market hemp-derived CBD and whole spectrum hemp extract in food and dietary supplements. CRN is poised to be the leading voice for these companies in the industry as we move forward in creating a regulatory path to market.”
TTC’s Monheit stresses how serious this all is: “I said some months ago that this was really going to end up all about safety, and naively suggested at an executive meeting that industry should get ahead of the issue and write a massive NDI submission covering a variety of cannabinol processes and concentrations/doses/applications. I was told that this would never happen due to IP and other competitive concerns. The issue is still safety, and we are one SAER [Serious Adverse Event Report] away from losing total control of the process and narrative. Recent FDA talk suggests we are moving further away from a lane for food/bev/supplements—which would be unfortunate and an oversight nightmare.”
5. The Amazon Effect “I’m curious about how long Amazon can sustain its market position when it comes to dietary supplements,” Howard shares. “As we found in our testing of CBD products, Amazon’s #1 seller did indeed have CBD in it (albeit an ineffective amount) despite the fact they have a policy of not selling CBD. Combine that with the fact that there are thousands of CBD products for sale on the site, in clear violation of that policy. Early indicators are that many are hemp seed oil. Is that consumer fraud? It feels like it.
“Already,” Howard continued, “Amazon has had to refund a customer for the counterfeit supplements she bought. In Pennsylvania, a federal appeals court has ruled that Amazon can be held liable for dangerous or defective products or defective products sold online, stating Amazon ‘enables third-party vendors to conceal themselves from the customers injured by defective products with no direct recourse.’ Companies traditionally defend themselves using the 1996 Communications Decency Act. In this case, the first of its kind, a defective dog leash injury resulted in permanent blindness. More than half of all goods sold on Amazon are through these third party sellers. It’s possible the courts could end up reigning in the King of Commerce. Only time will tell.”
Steinford notes: “The fast-emerging realization that Amazon has a counterfeit problem is real. Independent retailers have the unique opportunity to remind consumers that personal health is not to be left to chance. You can return a defective blow-dryer that you purchased from Amazon but that return policy does no good if the ingredients in the dietary supplement you purchased are fraudulent or non-existent. Quality, service and value are the continuing attributes the dietary supplement industry seeks to underscore as the cornerstones for our success.” The Amazon Effect on the dietary supplement category, Steinford maintains, can be overcome.
“Consumer behavior and the accompanying approach from retailers will always be evolving, and as a member-driven organization, NPA seeks to support independent retailers as well as others in the industry,” says Dr. Fabricant. “There’s real value for American consumers in finding a local retailer in their community and building relationships with its owners and employees. While it’s great for people to be able to secure natural products with the click of a button, independent retailers and small businesses are essential in maintaining access and choice for natural products consumers.”
6. M&As “There is still a huge appetite for acquisitions across the space, in all ingredients, contract services and brands,” says Monheit. “Many of the best (biggest or most obvious) targets have been snapped up, so it’s getting a bit tougher and more speculative. Look for deeper or earlier plays, and companies with technology (a platform, data or other related value) to be sought after, and any aspects of personalization or the microbiome to be hot.”
“In our industry this seems to be the order of the day,” says IPA’s Paraskevakos. “It’s a sellers’ market as everyone is looking to acquire. We are reducing the number of players and opting for size when it comes to probiotic players.”
Dr. Fabricant adds, “Our industry continues to grow because more and more people are turning to natural products to support their health, and they are looking for natural ingredients in things like cosmetics and homecare products. We look forward to seeing more growth in the coming year as our industry continues to provide the American people with the natural products they use each and every day.”
7 Trends for 2020
1. A return to holistic wellness: “U.S. sales data indicate a broad—and broadening—acceptance by American consumers of herbal supplements,” says McGuffin. “This should not be too surprising though. From a historical perspective, use of botanicals has almost always been the norm, rather than the exception. It was only in our recent history that we abandoned this norm, and what we are witnessing now may just be a correction to our culture’s blind embrace of modernity in the early- to mid-20th century. We are now witnessing a resurgent and growing focus on healthy living and holistic wellness as a way for consumers to take responsibility for their healthcare and improve quality of life, and herbs are just one part of this overall trend. And I see nothing to indicate that these trends are going to slow any time soon.”2. Phytocannabinoids beyond CBD: “We are already seeing the rebranding of CBD in the marketplace, necessitated by a growing legal consensus CBD in itself will migrate to a strict pharmaceutical definition, further kindled by the fact credit card processors are playing jury and judge on the topic by inferring language like ‘full spectrum hemp’ is code for CBD,” says Howard. “With this change will come new formulations, perhaps with a broader array of phytocannabinoids.” She also suggests that the growing body of science will inspire product development that can “knock the knock-offs out the back door.” At the end of December 2020, Howard forecasts, “I expect quality hemp-derived products created by conscientious companies to fill retailer shelves.”
3. Personalized nutrition: CRN is following this trend closely, says Mister. “Consumer interest is not the only driving force behind this trend; emerging science is fostering the industry’s ability to better support individualized nutrition needs through the creation of products and services that meet the individual needs of the consumer. People intuitively understand that everyone’s nutritional needs are different, driven by a range of factors like lifestyle, dietary habits, and genetics. As the science of personalized nutrition evolves and helps us fine tune the balance of supplements that’s just right for that individual, the potential for greater health will follow. ”
4. Microbiome & -biotics: “We’re already seeing it—the emergence of the ‘microbiome’ as a recognized, if poorly understood term with retailers, consumers and others,” says Monheit. “2020 will see increased awareness and use, products developed to get the microbiome ‘in order,’ and brands talking about their microbiome set in the same way as they talk now about their digestive health offerings. It may not be 2020, but it won’t be too long before we see stores taking a small corner and creating a ‘microbiome zone’ with apps, online resources, products and experts offering insights on how to create and maintain a healthy microbiome. This will then lead to increasing popularity of prebiotics and synbiotics.”
Paraskevakos also sees this emerging trend. “A significant area where companies are working and researching is the other ‘biotic’ segments such as parabiotic, eubiotic, psychobiotic, etc. The research is starting to report interesting results. As a differentiator companies are also investing heavily into dose delivery research in a vast array of applications. With a different dose delivery and more targeted condition specific formulas companies are looking to introduce new and novel products.”
5. Access and savings: Dr. Fabricant notes that 2019 brought good things for the prospect of HSAs and FSAs being modernized to include supplements as medical expenses. “Earlier this month we worked with several U.S. Senators and Congressmen who called on the IRS to allow Americans this cost savings when they use supplements to support their health. I’m hopeful 2020 will be the year this gets done. I also see 2019 as the year CBD gained overwhelming visibility having been used by 1 in 3 people, and I’m hopeful we’ll be able to look back on 2020 as the year we set strong consumer safety standards for CBD allowing it to continue in popularity but without any further health tragedies from bad actors making tainted products labeled as CBD. Additionally, we look forward to working with the Dr. Stephen Hahn if confirmed as FDA Commissioner.”
6. Healthy aging: “There will be an increasing consumer interest in all natural-health products that address aging, mobility, and cosmetic issues as we all slide into our older years,” says WholeFoods Magazine legal columnist Scott C. Tips.
7. Omegas re-emerging: Chris Gearheart, Director - Member Communications & Engagement at GOED, notes that there’s a lot of energy in the omega-3 space. In 2019, he reports, “The U.S. FDA granted a Qualified Health Claim to EPA and DHA products allowing marketers to connect EPA and DHA consumption to improved blood pressure outcomes using specific language. We’re keeping a close eye on how this new communications tool plays out during 2020 and beyond in the U.S. market.” What’s more, he says, “GOED worked on a meta-analysis during 2019 that we hope will positively impact conversations about omega-3s dosage when published in 2020.” And Dr. Harris points out that there has been “increased awareness and uptake of our prenatal DHA test, our mother’s milk DHA test, and beginning in 2020, our new dried blood spot based vitamin D test.”
6 Concerns for the future
1. Regulatory creep. “I am concerned about the tendency for ‘regulatory creep’ that seems to come naturally to many government agencies, and an apparent drift by some such agencies toward less transparent communications with the trade and the public,” says McGuffin.”Of equal concern is that some in the trade are taking positions in support of increasing agencies’ regulatory authority without clearly articulating how increased authority would benefit consumers or the trade, or would at least hold out the promise of fixing specifically identified problems. As an example, I recently heard a representative of a key regulator defend a controversial position taken by the agency in a light-hearted manner. The representative rhetorically asked why industry would expect the regulator to take a different position, observing that by their nature regulators love to regulate. Although this response seemed tongue in cheek, I believe it also reflected a basic truth about how some regulators view their roles and functions. Nevertheless, I continue to believe that resisting the regulatory drift implied by this reply best serves the interests of the trade and our consumers. I acknowledge that exceptional cases in which increased regulation can help deliver clear benefits and solve identified problems can arise, and I take pride in AHPA’s track record of supporting improvements to the regulatory framework in these cases. AHPA’s support of the Dietary Supplement and Nonprescription Drug Consumer Protection Act serves as but one example.”2. Synthetic biology. Howard calls out the proliferation of ingredients grown in vats of GMO yeast as a major concern that is threatening the integrity of our supply chain. “No longer limited to Franken Fish, factory-derived ingredients are getting into food and supplements. Flavors, astaxanthin, and cannabis are already on the market. Yes, it is complicated, and yes we are challenged in our ability to test for these properties. However, that is no excuse for brands that must demand source documentation that clearly identifies the origins of ingredients. As for that pesky testing issue, progress is being made. Global Molecular ID is HRI Labs’ newest testing technique. It’s like using the Hubble Telescope instead of binoculars. Super-high resolution identifies a constellation of micronutrients not previously detectable. Instead of total polyphenols, you can measure 500 different polyphenols. I would hope companies avail themselves of this opportunity before consumers stand up and demand the information. Wearing blindfolds should be reserved for Pin the Tail on the Donkey.”
3. Getting too comfortable. “My greatest concern is complacency,” says Mister. “When the market is growing, consumer confidence is high, ominous regulation seems far off and opportunities for an easy payday abound, it’s easy for companies to ‘pocket some of their winnings’ and defer their trade association engagement. But trade associations, like CRN, are an insurance policy. As the New York AG situation taught us four years ago, you never know when the next existential crisis will arise. To be prepared for these kinds of threats, an industry needs to support and cultivate its trade association, cultivating relationships with regulatory and potential allies. I worry that the success of the industry and the promise of CBD deters companies from planning ahead.”
4. Low-quality products. “We’ve had an acknowledged black opaque box in the middle of our supply chains forever,” says Monheit. “It’s Contract Manufacturing and to a certain extent all contract services including analytical labs. While some of these service providers are world class with a focus on quality and sourcing, many are low barrier to entry operations that reverse engineer leading products at a fraction of the cost, taking every shortcut imaginable. Brands don’t know what they don’t know, especially Internet (entry) brands, don’t know the questions they should ask of these service providers and since they’re startups, the minimums are quite attractive. This is an industry Achilles heel, we saw it with curcumin and astaxanthin products that we at TTC tested, and it’s a huge concern.”
“I always have concerns regarding products which do not meet the highest level of quality,” says Paraskevakos. “Products which might leave consumers unhappy about the probiotics they purchase as they feel no benefits. With the growth of a sector brings opportunity and many players migrating towards it; this does not necessarily mean products which meet the highest standards—IPA is working very diligently to remedy this, with all the best practice and guidelines we are working on and for the industry we hope to take care of these type issue.”
5. Leadership changes. “With the departure of our longtime champion Senator Orrin Hatch, party change in the House of Representatives, and 100+ new Members of Congress, 2019 was all about building relationships,” says Dr. Fabricant. “I’m proud to say that this year at Natural Products Day we demonstrated yet again that we are hands down the strongest advocacy force in the industry. In light of persistent consumer-safety issues like the need for FDA to set level for CBD products and gaps in new dietary ingredient enforcement, it will be especially important for us to stay vigilant and maintain our relationships with elected officials.”
6. The economy. “As increased regulation and tightening of the dietary-supplement industry takes hold, supplements have steadily increased in cost to the consumer,” says Tips. “Any major economic downturn—which will happen—will very negatively impact retail store sales and hence manufacturing and distribution. Most likely, we will start to witness a collapse of negative-interest bonds in 2020 that will continue at least into 2025. At its peak, this will severely strain the economy if not crash it. Witness, too, that the latest forecast from the Atlanta Fed is projecting a fourth quarter 2019 growth rate of just 0.3 percent and you can see the looming problem as the U.S. economy struggles right now to avoid slipping into negative GDP growth. Dietary supplements are about protecting and advancing optimal health. However, when customers are in a financial crisis, they think simply of surviving and supplement and other whole-food purchases become of secondary importance. On the other hand, the aging portion of the population will place critical emphasis on maintaining their mobility and memory, and certain dietary supplements offer the best solution to that problem. The elderly and their informed caregivers will pay almost anything, even in a financial crisis, to stay mobile and mentally active.”
4 bright spots for 2020
1. Transparency: “Retailers, and consumers, are being heard,” says Howard. “I never thought I would be happy about a proliferation of new seals, and yet I am heartened at the transformation that is occurring in the industry. Granted, it can be confusing. That said, it’s encouraging to know that the pioneering work around glyphosate testing is leading to a new pesticide testing (and perhaps a pesticide-free seal) as we prepare for the inevitable disappearance of glyphosate in exchange for its ‘new and better’ replacements. Regenerative is going through its growing pains while Biodynamic is seeing a rise in popularity after enjoying enormous success in Europe. As organic struggles to maintain its integrity in the face of ‘technology,’ the American Grassfed Association label gains traction and people (aka retailers) continue to explore what it takes to certify an egg. The motivator? Consumers who demand transparency and a commitment to the planet as part of what defines a healthy lifestyle. We’ve a way to go, but I like where we are starting as an industry.”2. Communication and cooperation: “Thinking ahead to 2020, CRN is looking forward to continuing to build and grow its relationship with retailers,” says Mister. “Earlier this year, CRN began a new initiative, The Retailer Relations Forum, to do just that. The Forum was created to help CRN members protect and grow their business with retailers. We recognize how important it is for executives in the industry to stay up-to-date with retailers’ priorities, initiatives and expectations for the dietary supplement and functional food categories. Providing insights from retailers to our members (like their expectations for their vendors and their aspirations for their supplement aisles) and promoting the responsible initiatives of CRN to them in return, will not only generate new and grow existing business, but it will also help consumers achieve better health and wellness through safe and quality dietary supplement products.”
Monheit also points to having more voices in the conversation. “Our natural products and specifically the supplements portion of it is finally starting to catch up with other sectors with an increase in women in leadership, but also as voices. That’s great and encouraging. In another view, industry’s relationship, in general, and the stability of the FDA as it affects supplements is good. Finally, for retailers, there’s so much consumer confusion in key categories (CBD, curcumin, microbiome) that there’s so much ability for retailers to differentiate and really make themselves category experts who know their stuff in these areas and build solid consumer communities and devoted following.”
3. Safety and standards: “AHPA this year published an article that evaluated all of the recalls reported by FDA to date in 2019 for any FDA-regulated products,” says McGuffin. “Not surprisingly, what we found was that less than 2% of the more than 800 such recalls were associated with any dietary supplement product. We intend to continue this focus on getting factual information to the trade, as well as to consumers and government officials, and we hope to continue to change the narrative with the addition of such important data. We have already heard from some of our most staunch Congressional critics that they no longer give much attention to our products and don’t now have much concern for our category. It’s unlikely though that critics of supplements, or of any industry that challenges the status quo, will ever completely disappear, so AHPA continues to monitor media coverage of the industry and actively responds to inaccurate or misleading coverage.”
Dr. Fabricant’s POV: “At a time when Americans are increasingly suffering from preventable chronic conditions associated with unhealthy diets, NPA is supporting the advancement of food and dietary supplement standards worldwide in an official observer capacity during upcoming Codex Alimentarius Commission meetings. Recognition as a Codex Alimentarius Observer means NPA will have the opportunity to contribute expertise, comments and recommendations to advance health standards worldwide. We also look forward to continued work with the Supplement Safety & Compliance Initiative (SSCI) which brings some of the largest retailers, raw material manufacturers and suppliers, dietary supplement manufacturers and other stakeholders together to recognize and ensure common safety standards throughout the supply chain to enhance consumer safety.”
4. Purpose and Resilience: “The whole-food industry’s inherent resilience and ability to adapt to market conditions and consumer needs is definitely a bright spot,” says Tips. “And I see this positive attribute of the industry as continuing into the foreseeable future. Good times or bad times, the talented and bright people driving our industry will ensure that there is always a bright spot.” WF
A Closer Look at Probiotics
“CRN will continue to keep its finger on the pulse of the probiotics sector in 2020,” says Steve Mister. “The growing category has strong scientific research and incredible product innovation, but it continues to be subject to lack of clarity in labeling--or at risk of restrictive regulations or requirements. In 2018, FDA announced its intent to exercise enforcement discretion to allow supplement companies to use colony forming units (CFUs) when declaring the quantity of live microbials on a Supplement Facts label. This was a positive step in the industry as CFU is the scientifically accepted unit of measure for probiotics, and labeling live microbial dietary ingredients in CFUs gives consumers the most accurate information possible to the viable microorganisms present in the product throughout shelf life.”
That said, Mister continues, “The Guidance still states that the label must list the quantitative amount by weight, as required by current regulation. Over the past several years, CRN has advocated that a measure of live organisms present in probiotics is a more meaningful way to compare products than metric weight, and we continue to urge FDA on this issue. CRN submitted comments on the Draft Guidance back in 2018 and also sent a letter to FDA in August of 2019 requesting FDA to eliminate the condition that live microbial quantity must be listed in terms of weight. There has been no updates from FDA since the last Guidance, but we remain optimistic as we enter into 2020.”
IPA’s George Paraskevakos notes that probiotics will be more closely considered in the new DSHEA. “IPA has requested we visit a pre-approval approach including a master file system and an exempt list of strains, but more importantly have a consortium for probiotic safety formed including relevant probiotic stakeholders.”
In terms of the science on probiotics, Paraskevakos says, “As you know the science cycle and research takes some time before we start seeing any results. I believe we will begin to see most of the brain gut research initiated from the last two years. We also began seeing sports application research coming out and I also believe many of these strains will be tied into weight management and metabolic syndrome type applications. These scientifically justified applications will be a breath of fresh air to applied specific probiotic products versus the generic type ‘copy cat’ probiotics.”
A Closer Look at Omegas
Looking back, GOED’s Chris Gearheart says, “2019 showed us that that there’s a lot of energy in the omega-3 space.” He points to the following 3 topics of interest:
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Health claims: “The FDA granted a Qualified Health Claim to EPA and DHA products, allowing marketers to connect EPA and DHA consumption to improved blood pressure outcomes using specific language. We’re keeping a close eye on how this new communications tool plays out during 2020 and beyond in the U.S. market.”
Gearheart outlined the following for WholeFoods Magazine readers:
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The new claim applies to products that provide at least 800 mg of EPA and DHA per day. The FDA also updated its upper limit of allowable EPA and DHA in dietary supplements from 3 grams/day to 5 grams/day in products on which a company is making the claim.
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The new language:
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“Consuming EPA and DHA combined may help lower blood pressure in the general population and reduce the risk of hypertension. However, FDA has concluded that the evidence is inconsistent and inconclusive. One serving of [name of the food or dietary supplement] provides [ ] gram(s) of EPA and DHA.
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Consuming EPA and DHA combined may reduce blood pressure and reduce the risk of hypertension, a risk factor for CHD (coronary heart disease). However, FDA has concluded that the evidence is inconsistent and inconclusive. One serving of [name of the food or dietary supplement] provides [ ] gram(s) of EPA and DHA.
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Consuming EPA and DHA combined may reduce the risk of CHD (coronary heart disease) by lowering blood pressure. However, FDA has concluded that the evidence is inconsistent and inconclusive. One serving of [name of the food or dietary supplement] provides [ ] gram(s) of EPA and DHA.
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Consuming EPA and DHA combined may reduce the risk of CHD (coronary heart disease) by reducing the risk of hypertension. However, FDA has concluded that the evidence is inconsistent and inconclusive. One serving of [name of the food or dietary supplement] provides [ ] gram(s) of EPA and DHA.
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Research shows that consuming EPA and DHA combined may be beneficial for moderating blood pressure, a risk factor for CHD (coronary heart disease). However, FDA has concluded that the evidence is inconsistent and inconclusive. One serving of [name of the food or dietary supplement] provides [ ] gram(s) of EPA and DHA.”
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2. Media coverage: “Mainstream media headlines both amplifying and casting doubt on the benefits of omega-3 consumption captured the attention of millions of readers,” says Gearheart. He calls out:
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A story from the New York Times titled “Why Children (and Pregnant Women) May Want to Eat More Fish” argued that eating fish may make children smarter, but another story, “Should I Take Fish Oil?” suggested that supplementation is unnecessary if consumers “just eat a fish once in a while” and that more omega-3s didn’t necessarily contribute to better health.
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Consumers also saw media coverage of a meta-analysis from Dr. JoAnn Mason, the lead investigator of the VITamin D and OmegA-3 TriaL (VITAL), concluding that EPA and DHA supplementation lowered cardiovascular disease risk.
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The Mayo Clinic Proceedings published a scientific review of the literature of omega-3s and cardiovascular health that reported, “taking an omega-3 product that supplies between 500 to 4,000 mg per day of EPA+DHA appears to be an effective, safe, and affordable strategy for improving long-term cardiovascular health.”
3) Science: “GOED worked on a meta-analysis during 2019 that we hope will positively impact conversations about omega-3s dosage when published in 2020."
These topics and others will be the focus of the biennial GOED Exchange event for omega-3 professionals, Gearheart shares. It will be held February 4-6, 2020 in Barcelona, Spain.
Also spotlighting the science, Dr. William Harris says, “In the omega-3 space, additional favorable effects of Vascepa (reported at AHA Nov 2019) and the papers to be published from them in 2020 will continue a good drum-beat for omega-3s,” says Dr. William Harris. “In addition, in November of 2020 the results of the STRENGTH study (larger than REDUCE IT with a product containing 4 grams of EPA+DHA) will be reported. By all accounts, it should be positive.” To that he adds: In August we made the Inc. 5000 list, which was a first for us. We believe that recognition is a sign that the market is primed and ready for personalized testing like the Omega-3 Index.” He adds that with a 50% expansion in analytical capacity, OmegaQuant is “well-situated to handle the anticipated increases in volume. I’m also excited to see increased awareness and uptake of our prenatal DHA test, our mother’s milk DHA test, and beginning in 2020, our new dried blood spot based vitamin D test.”
One thing to watch, Dr. Harris adds: “On the one hand, we see omega-3 testing rising to prominence, not only for industry but also researchers, clinicians and the public. In August, we published a paper that underlines the need for such testing at all levels to ensure people are taking enough of the right omega-3s, namely EPA and DHA. On the other hand, with rising popularity of omega-3 testing you will get companies using unstandardized tests that might be more widely promoted and that produce numbers that have a questionable relationship to the Omega-3 Index. Ultimately, this could end up confusing consumers. The Omega-3 Index from OmegaQuant has been standardized over time through its use in hundreds of clinical studies. (Learn more here.)
