This article is the third in a series addressing the state of the dietary supplement industry in a post- DSHEA world. The first article, written with Loren Israelsen of the United Natural Products Alliance and published in December 2002 inside the pages of Nutrition Business Journal, urged companies to resist their reactive stance in defending DSHEA, and instead focus greater energies on self-regulation. We encouraged the supplement industry to take responsibility for its own future, proving by our own proverbial hand that this industry is well-regulated. Thanks to self-policing initiatives and more effective communication between the industry and FDA, FTC and Congress, I believe this has happened.
In December 2003, Mr. Israelsen and I surfaced again with another editorial in NBJ that addressed the signature issues of the day: the lingering myth that our industry is unregulated, the scourge of drugs posing as dietary supplements, and our lack of quality and safety standards. Since that article appeared, the ephedra ban and the steroid precursor ban went some signifcant measure toward debunking this myth. The ephedra ban, in particular, robbed industry foes of their tallest lightning rod, while the ban on steroid precursors began to seriously address concerns over drug spiking.
We are still dealing with adulteration issues today, driven largely by economic opportunity and vague testing and analysis protocols. To address this issue more pointedly, the American Botanical Council is working with several groups, including the American Herbal Pharmacopoeia, to provide a series of reports on adulterants in botanical materials. The reports from this project will publish over the next few years, with the first white paper on solvents to come out this year.
On the question of protecting the most important provisions of DSHEA outlined in our second article—a definition of dietary supplements, distinguishing between supplements and food additives, and the burden-of-proof problem—I believe that the industry has been even more successful. There are now more executives and leaders who understand the importance of DSHEA’s core provisions. Our leading trade associations have grown larger and more effective at communicating with each other and the government.
In 2001, the Dietary Supplement Education Association (DSEA) was formed with a stated mission to educate the public about the positive aspects of dietary supplements. This group eventually merged with the Natural Products Foundation, but before that it did help to fund and broadcast the results of the Lewin Group Study, which documented concrete savings in healthcare costs associated with five supplements. The first two—calcium & folic acid— demonstrated combined savings of over $14 billion over five years, while omega- 3 supplements, glucosamine and saw palmetto showed substantial promise for improving health and quality of life.
Since Congress heard the results of this study in September 2004, growing numbers of consumers have taken to calcium and folic acid, so the actual savings could be even higher. Moreover, the consumption of omega-3s has increased dramatically, with consumers now spending over $1 billion annually on omega-3 supplements in hopes of preventing cardiovascular disease. In 2005, the Centers for Disease Control estimated that at least 84,000 heart-disease-related deaths each year could be prevented with omega-3s.
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 sickcare solutions.
On the question of restoring public confidence, the Council for Responsible Nutrition (CRN) has implemented and funded a successful industry self-policing initiative in partnership with the Better Business Bureau’s National Advertising Division. With enforcement teeth provided by FTC, the program allows industry to self-regulate its peers over erroneous and illegal claims. This single intitative has unquestionably raised the bar and helped to weed out many bad apples.
Finally, the industry has made a concerted effort to communicate to the media and the general public that we are, in fact, a regulated industry. Last year, at the annual NBJ Summit, 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, on the record, that DSHEA does provide the adequate authority to regulate dietary supplements. Another document that came out of that Summit was a brief timeline, drafted by Al Powers of NOW Foods, of all regulatory acts and developments intersecting with the supplement industry from 1994 to 2011.
These two documents were used extensively by trade associations and industry leaders to help explode the myth of an unregulated industry in the minds of regulators, government officials and consumers. Changing existing mindsets is a challenging endeavor, and much more is left to do on this front.
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 forecast state, but to plan toward a desired state. It has been well documented that, when an 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 Dr. Russell Ackoff. 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 two decades has been the disambiguation of its stakeholders across many product segments, business sectors, links in the value chain, and shifting overlaps with the pharmaceutical, food, beauty and fi tness industries. Many believe that without a more coordinated and constructive dialogue between these stakeholders, progress will be slow.
At the NBJ Summit, industry leaders gather to discuss key issues and challenges. I am fortunate enough to co-chair this event, where we host executives from the four leading trade associations, as well as CEOs from leading nutrition industry companies. This is the perfect venue to shape and promote the coordination that leads to real growth.
The organic industry demonstrated what is possible when leaders get together and agree on a common vision—a federal standard for 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 & organic foods, supplements and personal care products to the public in a largeformat store. This vision led to dramatic category growth in super natural foods stores, and brought dramatic numbers of new consumers into the space.
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 90’s 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 get 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 put forward the beginnings of an idealized vision that articulates this voice. This vision should address how companies will act, as well as defi ne our relationship with consumers, healthcare providers, regulators, retailers and investors.
Ten years from now, I believe the following attributes will be used to describe our industry:
The nutrition industry will be self-policing, so that any company that makes non-defensible claims or sells tainted products will be drummed out by the industry itself.
The term “unregulated industry” will no longer be front of mind for consumers, doctors, 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 towards an integrative approach [See NBJ’s June 2009 Q&A with Andrew Weil]. Doctors will accept key nutraceutical products as alternatives to drugs, or in concert with drugs, to prevent disease and reduce healthcare costs. For example, doctors will prescribe products like probiotics after courses of antibiotics, red yeast rice and diet changes in lieu of statin drugs, and fish oil for heart health and arthritis.
Healthcare reform will move from access to prevention, and more government resources will be applied to nutrient research so that Alzheimer’s disease, cancer, heart disease, and a wide host of conditions can be postponed or even prevented outright.
Intellectual property laws will change so that qualified nutraceutical products receive legal protection, providing incentives for companies 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 sugary sodas, milks or juices, 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 defi ne 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 co-chair of the NBJ Summit. He is also a founding principal at Nutrition Capital Network and managing director of Nutrition Business Advisors. You can reach him at [email protected].