The Participants Are:
• Jonathan Emord, Esq., President, Emord & Associates, Washington, D.C., www.emord.com
• Daniel Fabricant, PhD, President and CEO Natural Products Association (NPA), Washington, D.C., www.npanational.org
• Kurt Jetta, PhD, Executive Chairman and Founder, TABS Analytics, Shelton, CT, www.tabsanalytics.com
• Mark LeDoux, Chair and CEO, Natural Alternatives International (NAI), Carlsbad, CA, www.nai-online.com
• The Hartman Group, Bellevue, WA, www.hartman-group.com
• Randy Kreienbrink, Vice President of Marketing, BI Nutraceuticals, Long Beach, CA, www.botanicals.com
• Dan Lifton, President, Proprietary Branded Ingredients Group, Maypro, Purchase, NY, www.maypro.com
• Michael McGuffin, American Herbal Products Association (AHPA), Silver Spring, MD, www.ahpa.org
• Steve Mister, President and CEO, Council for Responsible Nutrition (CRN), Washington, D.C., www.crnusa.org
• Mintel Group, Chicago, IL, www.mintel.com
With the CBD locomotive tearing down the tracks, our panel of industry leaders and experts helps sort out everything from recent FDA guidance on probiotics, to tariffs on Chinese goods, to mass-media confusion about recent studies. And since 2018 saw the passing of Frank Murray, panelists reflect on the importance of passing the health-freedom torch to a new generation of leaders.
*We appreciate market data provided by TABS Analytics, The Hartman Group and the Mintel Group.
NIE: What do you feel were the biggest natural products industry issues of 2018, and why?
Fabricant: The Grinch that caught people off guard and has the biggest financial impact to ruin Christmas and the New Year was the tariff issue. Here is why it was so big. First, the industry expected an exclusion process for List 3, which encompasses many dietary ingredients used in dietary supplements, but it never came. NPA did manage to influence exclusions for two ingredients that are predominantly sourced in China. Second, some in the government never thought Trump would stick to his guns to keep the tariffs in place. Trump did not fold to China. Third, there are many companies who export supplements back to China as U.S. products are preferred over Chinese-manufactured products. This results in a double hit because of the Chinese tariffs on finished consumer goods. Fourth, the tariffs increase from 10 to 25 percent very soon, and that will cause pain in the industry.
Regulatory reform took center stage in 2018. The Trump administration tasked industry to identify regulations for change in the current code of federal regulations. NPA participated in that process, and we are not finished yet. There is much left to do in regulatory reform as federal agencies have only seemed to respond to the Trump regulatory reform agenda by dumping old proposed rules that have not been pulled from dusty FDA shelves for many years.
The issue that had sizzle but went out with a fizzle is CBD. Everyone has been waiting to see what Congress would do on hemp in the Farm Bill. Unfortunately, any changes on CBD in Farm Bill do not affect how FDA (U.S. Food and Drug Administration) views CBD as a dietary ingredient for use in dietary supplements. If you don’t know how FDA views CBD in dietary supplement products, just ask them.
The final big issue of 2018 centers around advocacy. How many years has it been since Tom Harkin left the Senate? He was never replaced on that side of the aisle. Now we have Senator Orrin Hatch leaving. The industry has benefited greatly from advocacy and the actions of those two members. If industry does not make advocacy and lobbying a priority in 2019, we may be in for a rude awakening over the next decade.
Mister: The biggest issue in 2018 was this exploding interest among consumers in CBD as a dietary ingredient. Every time we go to trade shows, it is the one ingredient that has the most buzz around it. Of course the problem is that currently it’s not a legal ingredient. Hopefully the Farm Bill has taken care of the DEA (Drug Enforcement Agency) problems—it will remove hemp from the definition of marijuana in the Controlled Substances Act, so that solves your problem in that hemp would no longer be a controlled substance.
But you have all of these other issues regarding FDA that you have to deal with. The first of which is this problem that if it was not marketed as a food or a supplement prior to the [epilepsy drug] clinical trials being conducted, the statute says it can’t be a supplement and it can’t be a food.
So we’ve got to address those kinds of definitional issues with FDA so that companies can really feel safe bringing it to market.
McGuffin: 2018 will likely be remembered as the year Congress de-criminalized hemp and CBD. This was a monumental step forward, but there is much work that needs to be done. Next the industry has to tackle FDA oversight. FDA has stated that CBD is not a dietary ingredient that can be sold in dietary supplements and foods.
We understand their rationale and we can dispute some of the details they’ve used to reach this conclusion, but there is also a clause in the law that allows the Secretary of Health and Human Services to simply declare an exemption to allow these products to be sold. AHPA has adopted a position to advocate FDA to encourage the HHS secretary to provide this exemption. This would allow the industry to discuss issues with regulators like possible label warnings, dosage, possible NDI (new dietary ingredient) status.
It is in the interest of consumers, FDA and the industry to have these products regulated and it makes sense to regulate them as dietary supplements which are defined in the law to include “herbs and other botanicals.” It ought to fit neatly into this class of goods. If FDA regulated these products as dietary supplements, then requirements like cGMP (current good manufacturing practice), serious adverse event reporting, drug claim limits all apply to these goods. It is an excellent regulatory model to fit hemp and CBD products.
The 2018 mid-term elections were another big story that will impact the industry. The supplement industry has been preparing for years for the retirement of our key Senatorial champions by building relationships with incoming lawmakers and educating them and their staff about supplements and how they are regulated.
Emord: The biggest issue was the widespread rise of CBD, state laws protecting CBD, and FDA and DEA angst over how to cope with the conflicting sovereigns and the rapid rise in distribution and use. The state-federal conflicts may be even more significant for defining federalism than those that arose in the 1980s and 1990s from the sagebrush rebellion, as Western states and localities battled the feds over property rights and historic rights of way over federal lands.
Lifton: I also think one of the hottest set of issues this past year revolved around hemp and CBD. While the Farm Bill just passed and this should make CBD marketers and growers very pleased indeed, the FDA has indicated that it is deferring to a patent and IND approvals that it has granted to a British pharmaceutical company for its epilepsy drug and, needless to say, it does not regard CBD products as dietary supplements. However, in the midst of all of this, a very ill-considered FDA guidance has been issued regarding probiotics and misinformation has been reported by media regarding omega-3 science.
LeDoux: I believe that, clearly, the most important issue that transpired was the imposition of tariffs on materials that come from China. Given that China has essentially dominated the supply chain space for many commodities for a variety of reasons, the impact here is substantial to the P&L of American industry using these goods. While there has been some shared “pain” with the economics of the tariffs, it is clear that the president and the USTR (U.S. Trade Representative) have every right to impose these given the history of cited abuses involving theft of intellectual property, and a litany of other issues raised by the USTR that raise to the undeniable fact that one of our largest trading partners has played fast and loose with the cost architecture of their raw materials.
Kreienbrink: Adulteration was critical, as both intentional and non-intentional adulteration is a top issue. This can only be addressed with validation and testing methods. Safety was also, and is also, a paramount issue. Suppliers must implement validated kill steps for microbes in raw ingredients. And while CBD is trending up in every industry right now, the big question moving forward is how does CBD fit into the supplement category? And, what are the legal issues surrounding the use of CBD? Also, some suggest we are seeing a stagnation of sales in the industry, especially for omega-3s, but others disagree. We do know that some of the sectors, such as omega-3s, have experienced negative press recently. How will the negative press impact future growth? And we have also seen continued consolidation of the industry.
NIE: The natural products industry lost a modern-day icon in 2018, Frank Murray. The author of More Than One Slingshot: How the Health Food Industry is Changing America (1984) and well over 50 health books, Murray fought for the passage of the Hosmer-Proxmire Vitamin Bill along with attorney Milton Bass, Clinton Ray Miller, NNFA (Natural Nutrition Food Association) President Max Huberman and others.
What health-freedom messages do we need to pass along today to the newest generation of natural products industry leaders?
Fabricant: Frank Murray was a legend to the natural products industry. He wrote the history of the Natural Products Association when it was called the NNFA. He chronicled the many battles fought by NPA with federal agencies over the past six decades. When you read More Than One Slingshot, and I urge everyone to go read it, there is one takeaway message: The health of this natural products industry is predicated on having strong advocacy and the ability to challenge agencies with sound arguments when they overstep.
To the new generation of the industry who were not around in those landmark fights of the 1960s through the drafting of the Dietary Supplement Health and Education Act of 1994, the old guard set the bar and made the industry viable today. Will the Millennial generation of natural products leaders study history and reinvest in advocacy? Time will tell.
What folks can do in the interim is engage in the process now. They can go to www.npanational.org/advocacy/ pac/ for more information and to contribute that way. They can write their Congressperson. We have “oven-hot, ready-to-go” letters on a number of iss-ues on www.saveoursupplements.org. The advantage here is that the letters get past email filters to reach Congressional staff.
Mister: It was the Proxmire Amendment that led to the creation of CRN. So that issue in particular is very near and dear to us. It was at that moment that some of the members of industry decided that they couldn’t just continue to say no to all regulation, and that there had to be some kind of legal framework in order for the industry to flourish. It couldn’t just continue as a Wild West. And it was those companies that started CRN. The last 45 years is history.
And regarding history, and as we look back at those people, I think it’s important to remember that we are the stewards of that message today, and that there are all these new threats to consumer’s ability to access these kinds of products. Sometimes these threats or challenges come in the form of state attorneys general. Or maybe the FDA, or maybe the state legislatures. But there are threats and we’ve got to always be diligent. And to continue that legacy of making sure consumers have access to these products to stay healthy. Yet, this is not a health care system that necessarily rewards people for staying healthy in the first place. And so we need to be sure to protect that right for consumers who want to be actively involved in their own health care before they get sick.
Emord: Although the United States Court of Appeals for the D.C. Circuit held in the 1999 landmark case of Pearson v. Shalala that FDA censorship of nutrient-disease relationship claims is unconstitutional under the First Amendment, the FDA remains in the business of prior restraint and censorship, failing to implement the constitutional mandate of that case. Complacency in the face of FDA’s effective licensing regime for nutrient-disease claims maintains a chronic state of suppression, denying manufacturers and consumers alike the freedom to exchange vital health information needed for informed choice in the market.
Present and future generations must maintain the legal and political fight against the censorship or, in the face of complacency, we are likely to see FDA become even more suppressive of nutrient-disease information.
Lifton: While we do need to remind today’s—and tomorrow’s—industry leaders about the health-freedom battles that have been fought, we need to also make sure that we don’t encourage an “us versus them” knee-jerk response to every question about science, efficacy, safety and quality that emerges. By leading with science, leaders will always be in a strong position.
LeDoux: With a new administration focused on removing some of the regulatory burdens imposed by prior administrations, we need to maintain a careful watch on actions taken by various agencies. Furthermore, we need to stress that advocacy remains a vital component for the simple fact that Congress and the agencies have the authority to change our landscape very quickly, and often in punitive ways. We also need to continue to invest in primary research and publication of findings that bolster our point of view.
NIE: 2018 witnessed a number of studies and reviews that were seized on by the mainstream media as “Aha!” moments, supposed proof that specific nutrients or foods may not be as great as Americans thought they were, case in point “The Vitamin D and Omega-3 Trial (VITAL),” initial results for which were recently published online in The New England Journal of Medicine.
But, the media coverage largely missed the fact that the findings showed a 30 percent reduction in heart attacks in the fish oil group and a 40 percent reduction in people who seldomly eat fish.
Is there a message here for our industry and for companies that formulate and market omega-3s?
Mister: The VITAL Trial really underscores some important points: the importance for industry to monitor these studies as they come out and then engaging with them. So for example, when you peel back the first layer of headlines around the VITAL Trial, you do find significant reductions in heart attack. So the industry has to engage and be critical about how these studies get reported if what’s really there is being glossed over. The second thing is for the industry to get more engaged in helping to design and conduct the research.
All of this being said, we need to be careful that we don’t let any one study distract us from the whole body of research. For example, the U.S. Preventative Services Task Force has looked at vitamin D and calcium and finds real benefits for older Americans in helping to prevent falls and fractures in the first place.
Fabricant: The message to consumers of omega-3s and the industry is to remember “totality of the evidence.” One study does not negate all other studies that came before it. It is one data point. The totality of the evidence is overwhelmingly in favor of omega-3 consumption. Who eats fish on a daily basis? Omega-3s should be part of WIC (Women, Infants and Children). There should also be HSA (health savings account) coverage for omega-3s as there should for other supplements.
LeDoux: The message here is that industry involved in various segments of primary research needs to get the word out through peer review published studies demonstrating the value propositions of the underlying premise of the research, namely, that it is difficult, if not impossible, to achieve appropriate levels of nutrient intake through the “normal” American diet. If that were not the case, why would be seeing the extraordinary rise in type II diabetes and morbid obesity showing up at alarming levels in our society?
McGuffin: We always have to remain vigilant of industry critics who will stretch the truth and ignore facts to misrepresent the dietary supplement industry in order to support their agenda. Media outlets often quote these critics without providing additional context. Fortunately, most consumers trust their brand, so these companies are in a good position to set the record straight.
Emord: The elephant in the dietary supplement tent has always been the pharmaceutical industry, which pokes its head in whenever a supplement shows promise as a disease risk reduction agent (for example [drug makers’] NSAIDs successfully blocking glucosamine and chondroitin sulfate/ osteoarthritis risk reduction claims).
FDA is the pharmaceutical industry’s handmaiden. That industry has tremendous suasion over the agency, the Congress and the media. The dietary supplement industry must call out the misleading reports and conflicts of interest held by “expert” observers in the pocket of drug companies, who frequently skew scientific reporting to benefit those from whom they receive support.
Lifton: It is hard to imagine a category that has stronger science behind it than marine oils. Omega-3s are also an area that has experienced exponential advances in harvesting, processing and extraction technologies, especially in the category of krill oil. The American public is a lot more savvy than the nay-sayers believe, as they don’t automatically swallow these sour “pills” of unwarranted skepticism.
NIE: And regarding guidances, the FDA also came out with a guidance on probiotics, what it termed its “Policy Regarding Quantitative Labeling of Dietary Supplements Containing Live Microbials.”
However, while quantitative (or volume-based measures) for nutrients, they do not work for probiotics, where colony forming unit (CFU) is the scientifically accepted unit of measure for probiotics. Labeling live microbial dietary ingredients in CFUs gives consumers information regarding the levels of viable microorganisms in the product throughout its shelf life.
Agreed? What should be the next steps for developers or marketers of probiotics? Just wait and see?
Lifton: The problem with the “Draft Guidance for Industry: Policy Regarding Quantitative Labeling of Dietary Supplements Containing Live Microbials” is the new recommendation that the label has to also list the quantitative amount by weight. While it applies to other supplements, weight does not correlate with the number of viable microorganisms in a probiotic supplement. It isn’t even possible to accurately or reliably list both weight and CFUs for these products. The FDA should consider removing this provision before its starts exercising any “enforcement discretion” regarding probiotics, as this would unfortunately foist an impossible burden on manufacturers and confuse consumers more just as they were beginning to get used to comparing products partly based on CFU levels.
Mister: CRN has been pushing the FDA for some time to revise its requirements for how you label probiotics. Because what is important to consumers is “how many of these organisms are alive at the point at which they are being used,” because they have to be alive to work. And so we petitioned the FDA to allow us to use “colony forming units” as the basis of measurement. But what we got was about half of the right answer. The FDA’s response allows us to put CFU on the label, but it does not excuse companies from also listing the weight of the ingredient, which is completely irrelevant to the consumer. Unlike vitamins and minerals and many other nutrients—where you’re looking for a mg serving—what consumers care about, when it comes to probiotics, is “how many live organisms are in the bottle.” So we have reached back to the agency with a second round of comments, trying to clarify with them that CFU should be the sole unit of measure [for probiotics].
NIE: In the meantime, the FDA has tentatively concluded that vinpocetine is neither a true dietary ingredient nor a true dietary supplement, claiming that it is synthetically produced. In 2016, the FDA opened a comment period soliciting responses to these conclusions. On November 7, 2018, an FDA press officer wrote that, “The FDA has not reached a final position on vinpocetine’s regulatory status, and we are continuing to consider the more than 800 comments received on our Federal Register notice.”
Any speculation about this, or the larger picture of the FDA going back and questioning the status of ingredients that have been on the market for 10, 15 or 20 years?
McGuffin: AHPA recommended the Secretary of Health and Human Services consider initiating rulemaking to declare vinpocetine to be a lawful dietary ingredient in comments submitted to the FDA. AHPA also strongly encouraged FDA to clarify that if vinpocetine is either found to be currently in the market as a food ingredient or comes to be included as a food ingredient in the future, the ingredient would therefore qualify as a dietary ingredient. AHPA contends that vinpocetine’s use as food was possibly overlooked or that it could come into use as a food in the future.
AHPA also noted that Congress provided the Secretary of HHS with authority to create exceptions to normal exclusions from the definition of a dietary supplement. Although this authority has not been used in the 22 years since this statutory provision was established, it should be assumed that the Congress foresaw that there might be circumstances in which it would be appropriate for the Secretary HHS to undertake the described regulatory steps to create such an exception.
Fabricant: We met with FDA over the summer and an FDA official stated that a final position on vinpocetine would move forward in the fall. Interestingly, neither the vinpocetine administrative proceeding nor the NDI final guidance showed up on the OMB OIRA Fall 2018 Unified Agenda for rules and guidance. We need Congress to place pressure on FDA to withdraw the vinpocetine administrative proceeding. It is causing confusion in the marketplace and more importantly, it sets a dangerous new precedence, outside of Administrative Procedures Act, to allow the Agency to re-review any New Dietary Ingredient. NPA will continue to deal with the vinpocetine issue in 2019. Hopefully, regulatory reform will root it out of the federal register.
Emord: The DSHEA (Dietary Supplement Health and Education Act of 1994) specifically contemplates synthetic analogues as within the definition of dietary supplements. In this instance, as in many others, FDA endeavors to chip away at the plain and intended meaning of DSHEA so that it may avoid constraints that were meant to limit its power to constrain the availability of these products.
NIE: What calls-to-action or general market comments do you have? What predictions do you have for the natural products industry for 2019?
Emord: The industry should embrace a more aggressive agenda against agency efforts to take away constitutional and statutory protections that enable supplement products to be marketed and claims to be made about them. Without constant vigilance in defense of those freedoms, they may well be lost.
Mister: We think the Supplement OWL (Online Wellness Library) dietary supplement registry is a very important piece for industry to demonstrate that we can regulate ourselves. If we don’t continue to build this and demonstrate a level of transparency around our products that the OWL provides, we might very well find ourselves in a situation where regulators are calling for some sort of mandatory listing process at FDA. And I think we would all rather be able to do this on a voluntary basis rather than it coming from the FDA [as a mandate].
Second, we are going to see changes in the Supplement Facts labels over the next year because there’s a deadline of January 2020 for those changes.
And, it can’t be overstated that CBD will be a very big part of the environment in 2019, and trying to knock down some of these regulatory obstacles for companies so that they can lawfully market CBD products as supplements is going to be a big part of the year as well.
McGuffin: 2019 presents good opportunities to build new relationships with incoming lawmakers and work to educate their staff about the benefits of herbal products and how they are regulated in the U.S. to ensure safety and quality. Bolstered by increasing consumer confidence in natural products like herbal supplements, the industry continues to build on it’s reputation of being responsible. This is having many beneficial effects on the industry including increased collaboration with FDA.
At several events in 2018, FDA officials recognized that the majority of the dietary supplement industry are responsible firms that share the same goals as FDA. Responsible dietary supplement firms today are looking for ways not just to comply with the law’s requirements, but to set higher standards for themselves and to hold the entire industry to those standards. We expect this collaboration between FDA and the supplement industry to increase in 2019 and beyond. This will ultimately benefit consumers, the industry and federal regulators.”
Kreienbrink: We need an increase in self-policing by supplement manufacturers to continue to sift out the bad characters. The 2019 market will be flat with the exception of CBD and hemp-related products.
Lifton: Every day, consumers are showing legislators, the media and manufacturers that taking dietary supplements is important to them—as a nutritional “insurance policy” and to tackle health issues linked to age, sex or activity levels. Legislators need to remember that, and agencies charged with implementing the will of the American people need to remember that and to also make sure that consumers have access to more information, not less, regarding products and ingredients they consume for health and wellness. NIE
