Assessing progress since 2002, envisioning more progress for 2020

[Editor’s note: This guest editorial is based on a similar piece published in the July 2011 issue of Nutrition Business Journal.¹ It has been slightly expanded and edited, and references have been added. The views contained herein are those of the author’s and do not necessarily reflect the views or policies of HerbalGram or the American Botanical Council.]

Leaders of the nutrition industry (paticularly the herb and dietary supplement segment of the industry) should reconsider simply predicting or preparing for the future. Rather, they ought to articulate an idealized vision that can be utilized to create a plan from which to work backward.

The Past

This editorial is the third in a series addressing the state of the dietary supplement industry in a post-DSHEA* world. The first editorial, written with industry veteran Loren Israelsen (NBJ December 2002;² HerbalGram 2003³), urged company leaders to resist taking a reactive stance and focusing all of their energies on defending DSHEA—an outcome that cannot be guaranteed. Instead, we encouraged the supplement industry to take responsibility for its own future by self-regulating in the absence of US Food and Drug Administration (FDA) enforcement of existing laws—proving by our own hand that the industry is not unregulated. This did, in fact, happen, with many self-policing initiatives and more effective communication with the regulatory agencies (FDA and Federal Trade Commission [FTC]) and the US Congress. The industry faced many of the same problems it does today, such as overcrowding and dilution of its ideals and, therefore, erosion of consumer trust in the pursuit of the dollar—a sad truth that kick-started the disintegration of popular support almost a decade ago and damaged the public’s perception of the industry.

A year later, Mr. Israelsen and I addressed the signature issues that demanded attention: The myth that our industry is unregulated; the obstacle of drugs posing as dietary supplements; and the lack of adequate quality and safety standards (NBJ, December 2003⁴). Since that article, the myth of an unregulated industry—perpetuated in large part by the availability of ephedra (Ephedra sinica, Ephedraceae) at that time—has been partially resolved. The ephedra ban robbed industry foes of their tallest lightning rod. On its heels, the steroid precursor ban (2004) went some way toward putting to rest the “drugs as dietary supplements” issue and addressed concerns regarding drug spiking.

Today, we are still dealing with product adulteration issues that are driven by economic opportunitism and greed, and, in some cases, vague testing and analysis protocols that enable this practice to occur. To address this issue, the American Botanical Council (ABC) has teamed up with several notable academic and nonprofit groups, including the American Herbal Pharmacopoeia (AHP) and the University of Mississippi, as well as numerous third-party analytical labs, to document and confirm the level of adulteration of various botanical ingredients and publish the results in a series of white papers. These reports are to be aggregated in a database on the ABC website. (ABC is also publishing a primer on solvents used in botanical extracts.)

On the question of protecting the most important provisions of DSHEA as outlined in the 2003 article—that is, (a) definition of dietary supplements, (b) supplements are not food additives, and (c) the burden-of-proof issue—I believe that the industry has made some progress. There are more executives and leaders who understand the importance of DSHEA’s core elements. Moreover, the trade associations are larger, well-run, and communicating more effectively both with each other and the government (on political and regulatory matters).

In 2001, the Dietary Supplement Education Association (DSEA) was formed with the mission to educate the public about the positive aspects of dietary supplements. This group eventually merged with the Natural Products Foundation (NPF), the nonprofit foundation of the Natural Products Association. Before that, DSEA helped to fund and broadcast the results of the Lewin Group Study, which documented concrete savings in healthcare costs associated with 5 supplements. The first two—calcium and folic acid—demonstrated combined savings of over $14 billion over 5 years, while omega-3 supplements, glucosamine, and saw palmetto (Serenoa repens, Arecaceae) showed substantial promise for improving health and quality of life.

Since Congress received the results of this study on September 22, 2004, growing numbers of consumers have taken calcium and folic acid, so the actual savings could be even higher. Moreover, the consumption of omega-3 supplements has increased dramatically, with consumers now spending over $1 billion dollars on omega-3’s, saving billions in healthcare costs. Specifically reducing those costs are omega-3’s consumed for the prevention of cardiovascular disease. In 2005, The Center for Disease Control and Prevention (CDC) estimated that at least 84,000 heart disease-related deaths per year can be prevented with the consumption of omega-3 supplements.

As healthcare costs and related personal bankruptcies approach staggering numbers, some industry leaders have proposed that we update the Lewin Study, adding several additional supplements such as vitamin D3, vitamin K, and magnesium, among others. I concur. I believe that certain nutritional ingredients, whether delivered in supplement or food form, can help mitigate healthcare costs from diseases associated with the Western diet. These supplements can counterbalance the perverse incentives in the current healthcare system for quick fixes and sick-care solutions.

On the question of restoring public confidence, the industry, through the Council for Responsible Nutrition (CRN), has implemented and funded an industry self-policing initiative in partnership with the Better Business Bureau’s National Advertising Division program with enforcement teeth from the FTC if companies do not comply. This allows the members of industry to self-police its peers on erroneous, unsubstantiated, and/or illegal claims. This program has helped to raise the bar on trade and consumer advertising practices and reduce the frequency of inappropriate ads. Similar activities have been conducted by the NPF in the domain of monitoring advertising for dietary supplements and communicating with advertisers to help improve the veracity of claims.

Finally, the industry has made a concerted effort to communicate to the media and the public that we are, in fact, a regulated industry. Last year, several industry leaders charged CRN with creating a summary document entitled “Does DSHEA Give FDA Adequate Authority over Dietary Supplements?” The report cites FDA commissioners verbatim confirming that DSHEA does provide the adequate authority to regulate dietary supplements. (This document and a full history of all regulations passed on the dietary supplements industry from 1994 to 2010 are available at the NewHope360.com website.⁵) These 2 documents were used extensively by trade associations and industry leaders to help dismantle the myth of an “unregulated industry” in the minds of regulators, government officials, and consumers. In addition, in 2001, ABC published an extensive article on the “myth of the unregulated industry” documenting the various authorities of FDA and FTC.⁶ A revision is expected to be published in HerbalGram in the coming months.⁷

The Future

In this third article, I want to front-engineer our path to progress by creating an “idealized redesign” of the entire supplement industry. The goal is not to plan away from a current or forecasted state, but to plan toward a desired state. It has been well documented that, when an organization or industry has a clearly articulated vision, it will move towards that vision in better concert. There is perhaps no better example of this strategy than when John F. Kennedy articulated in 1962 his vision of putting a man on the moon by the end of the decade.

Followers of systems theory will recognize this approach as the work of Russell Ackoff, PhD.8 In his approach to interactive planning—starting in the future and working back to the present—Ackoff seeks to stimulate imaginative and creative solutions. One of the key challenges for the supplement industry over the past 2 decades has been the disambiguation of its stakeholders across many product segments, business sectors, links in the value chain, as well as shifting overlaps with the pharmaceutical, food, beauty, and fitness industries. Many believe that without a more coordinated and constructive dialogue between these stakeholders, progress toward a unified goal will be slow.

For several years at the annual Nutrition Business Journal CEO Summit (www.nbjsummit.com), industry leaders have gathered to discuss key issues and challenges. At this annual meeting, we host the heads of the 4 trade associations (most other industries have fewer than 4 associations, which is another challenge facing this industry—i.e., the proliferation of trade groups with multiple agendas) as well as the CEOs from many of the top natural ingredient suppliers and nutrition and dietary supplement manufacturing and marketing companies.

The organic industry demonstrated what is possible when leaders collaborate on a common vision—a federal standard of organic foods, which propelled organics to double-digit growth rates. In a commercial context, a similar dynamic led to the creation of Whole Foods Market. A handful of entrepreneurs got together to create a vision for the marketing and retail of natural and organic foods, supplements, and personal care products to the public in a large-format store. This vision led to dramatic category growth in super natural foods stores, and brought dramatic numbers of new consumers into the marketplace.

An idealized vision can inspire people to move in the same direction. Shared visions often materialize at a time of crisis, as in the early ’90s when the industry fell under siege, but this is hardly a requirement. Rather than wait passively for the next crisis to occur, it would behoove us to pick points of commonality now, and rally behind them in a meaningful way. Lester Crawford, former FDA commissioner, once said that he had never dealt with so many factions within one industry, and that nutrition was shooting itself in the foot by not creating one strong, centralized voice. I have long believed that an industry that supports as many trade associations and segments as ours would benefit from a “federation” of associations and leaders that convenes on a regular basis.

I would like to propose the beginnings of an idealized, unified vision that articulates this voice. This vision should address how companies will act, as well as define our relationships with consumers, healthcare providers, regulators, retailers, investors, and the media.

The Vision

Ten years from now, I believe the following attributes will be used to describe our industry:

• The dietary supplements industry will be self-policing, so that any company that makes non-defendable claims or sells tainted products will be drummed out of the industry;
• The term “unregulated industry” will no longer be front-of-mind for consumers, healthcare providers, regulators, and the media. Perception will improve so that dietary supplements are viewed as safe, effective, and contributory to the health of the population.
• The medical establishment will move toward an integrative approach as described by Andrew Weil, MD, (see Focus Q&A with Dr. Weil, NBJ, June/July 2009⁹) Conventional and integrative healthcare providers will accept key nutraceutical products as alternatives to drugs or will integrate them into pharmaceutical treatments to prevent disease, so that people can live healthier lives with less disease and lower costs.
• For example, physicians will prescribe products like probiotics after prescribing antibiotics, red yeast rice (Monascus purpureus, Monascaceae) and diet changes in lieu of statin drugs, and fish oil for heart health and possibly for arthritis.
• Healthcare reform will move from access to prevention, and more government resources will be applied to nutrient research so that Alzheimer’s disease, various cancers, heart disease, and other conditions can be postponed or even prevented.
• Intellectual property laws will be changed so that qualified nutraceutical products will receive legal protection, providing incentives for people to invest in proprietary nutrient solutions.
• Consumers will take ownership of their own health, make conscious connections between diet and disease, and thus make healthier choices that lead to prevention.
• Schools will no longer sell soft drinks or high-sugar drinks of any kind, but will offer healthy, nutritious food choices that significantly decrease childhood obesity.

This is just the beginning. It’s my personal vision of how we can define this industry for a future full of promise and progress. In the coming months, I plan to reach out to industry stakeholders, including politicians, regulators, and consumers, to ask for their feedback and their own idealized visions.

----------------Thomas Aarts is Co-Founder of Nutrition Business Journal and now principal Co-Founder of Nutrition Capital Network. He is also a co-chair of the NBJ Newport Summit, the premier executive retreat for the nutrition industry (www.nbjsummit.com). Tom can be reached at: mailto:tom@nutritionbusiness.com.

References

1. Aarts T. Ten Years from Now, What Should the Nutrition Industry Look Like? Nutr Bus J. July, 2011:9-10.
2. Aarts T, Israelsen LD. Industry Needs to Re-think DSHEA. Nutr Bus J. December 2002. Pages 10-11.
3. Israelsen LD, Aarts T. Industry Needs to Re-think DSHEA. HerbalGram. 2003; 58:59-61.
4. Aarts T. Israelsen LD. DSHEA Ten Years Later. Nutr Bus J. December 2003. Pages 29-31.
5. Powers, A. A timeline of regulation in the dietary supplement industry: 1994-2011. Available at: http://newhope360.com/regulation-and-legislation/timeline-regulation-dietary-supplement-industry-1994-2011. Accessed July 22, 2011.
6. Soller RW. Regulation in the Herb Market: The Myth of the “Unregulated Industry”. HerbalGram. 2000;49:64-67.
7. Soller RW, Bayne HJ, Shaheen C. The Regulated Dietary Supplement Industry: Myths of an Unregulated Industry Dispelled. HerbalGram 2011 (in press).
8. Ackoff R.L. Creating the Corporate Future (Canada: John Wiley & Sons, Inc., 1981).
9. Aarts T, Israelsen LD, Weil AT. Q&A: We need to create a completely new culture of health and medicine. Nutr Bus J. June/July 2009.