This is a story with all the important elements. It starts with a Horatio Alger-style script, one where the lead character—in this case, the dietary supplement industry—grows from humble beginnings into a $28 billion dollar industry, beloved by its audience of more than 150 million Americans who take its products every year.
 
There are multiple directors and supervising producers, including FDA and FTC, each playing an important role in how the story and its lead character develops. There’s plenty of drama, and twists and turns—fights on Capitol Hill to push back burdensome legislation that will prevent the audience from being able to purchase popular products; attempted changes in the script from the regulatory agencies; stories within the story written by the consumer press; companies buying up other companies; and contentious squabbles between competitors.
 
But there’s one thing keeping this story from reaching a happy ending—bad actors.
 
Make no mistake. Bad actors could ruin the whole thing.
 
Recently, the industry was critically reviewed in the New York Times, thanks to these bad actors, companies that are either spiking products or thumbing their noses at GMPs, selling illegal drugs wrapped in a dietary supplement label. So what’s a responsible industry to do to change the ending of our script?
 
Practicing Truthful Advertising
 
You hear about it all too often. A miracle pill, drink or some other concoction that claims to help consumers shed pounds in mere days, or perhaps pack on muscle without having to step foot in the gym. The ads might guarantee you’ll be slimmer, faster, or that the product will work 10x better than a competing product. Often the claims can’t be backed up with facts, with science or with anything other than a marketer’s desire to sell a product.
 
FTC and FDA have identified three categories of dietary supplements for which consumers should be advertising-wary: weight loss products, sexual enhancement products and bodybuilding products—and justifiably so. However, as the regulatory agencies pay close attention to these categories, consumers may get the wrong impression entirely. Many of the products in these categories have benefits, particularly when consumers’ expectations are realistic. Not all the ads are overreaching—some products do produce measurable, albeit measured, results. But along side FTC’s monitoring of these ads and taking enforcement action, the industry could use a strong dose of self-regulation.
 
Enter responsible companies supporting trade associations. In 2006 the Board of Directors of the Council for Responsible Nutrition (CRN) took a bold step by creating a program that would confront overreaching advertising head-on. It would be controversial, but also transparent, and meaningful. Through a series of multi-year grants to the National Advertising Division (NAD) of the Council of Better Business Bureaus, CRN enabled NAD to increase its efforts in monitoring dietary supplement ads to help ensure they are truthful and not misleading.
 
Ours is not the first industry to engage in self-regulatory programs, but acceptance of this program has not always been easy. Growing up never is, and let’s face it, the dietary supplement industry has grown up. In the 17 years since DSHEA was enacted, the number of companies, the consumer marketplace and the annual sales all have flourished. We’ve moved from being just the darling alternative of the health freedom crowd, to an accepted part of mainstream healthcare for two-thirds of American adults. Along with that maturity comes the need to accept responsibility for our consumers—and consumers need truthful advertising.
 
Tell the Audience Who’s Wearing the White Hat
 
The NAD initiative is simple. National in scope, it addresses both comparative and substantive advertising claims. NAD identifies questionable ads through its own monitoring process; through quarterly submissions from a CRN task force (which has even challenged advertising claims made by CRN’s own member companies), and through companies filing challenges to their competitors’ ads. The grants from CRN, which will total nearly $1.5 million over eight years, has allowed the NAD to greatly increase the number of dietary supplement cases it examines—from an average of six a year before the program started to about 30 a year currently. Although the initial grants came solely from CRN’s budget, more recently some of the grant money has been a result of a legal settlement that required restitution to consumers for false advertising. After the consumer redress was paid out, the court directed the remaining funds to support CRN’s program.
 
Aside from the challenges CRN submits in its own name, CRN has no role in determining which advertisements NAD chooses to review. Moreover, CRN does not participate in the NAD’s evaluation of the ad claims to determine whether the claims are found to be truthful and appropriately supported. Perhaps it’s the integrity of the program that has led the majority of advertisers, when provided with the NAD’s findings, to take voluntary corrective actions to either modify their advertising claims or withdraw the ad altogether. And this year the CRN/NAD initiative reached a milestone—with more than 100 cases reviewed and completed.
 
Despite the relative success of the program, there is one area that needs improvement: I’d like to persuade more companies to use the NAD to challenge their competitors’ ads that they know are too good to be true. I hear from both members and non-members alike about how important the program is, and then, in the next breath, complain about a competitor making claims that can’t possibly be true. The unspoken code of industry solidarity should take a back seat to protecting our customers from misleading claims for products that don’t work. Filing a competitive challenge is one way to help keep the industry honest.
 
It’s also important to keep in mind that just because a marketer’s ad is the subject of an NAD challenge does not mean that the company has done anything wrong. That’s another good thing about this initiative. Companies have the opportunity to prove their claims have substantiation, and have the chance to revise their ads without penalty, all before they attract the attention of FTC or a consumer lawsuit.
 
Self-regulatory programs don’t supply all the answers, and don’t claim to. But they do demonstrate that industry takes seriously its responsibility to police itself and to separate the bad actors from the good.
 
Self-regulation is a cornerstone of a mature industry that cares about its consumers. In an age of underfunded government agencies, it is imperative that the industry take a leading role in holding itself accountable to the public and its consumers. If responsible companies do not take center stage to lead these efforts, then a legitimate fear exists that consumers will be “duped” by misleading advertising. If that happens, the integrity of the entire industry is at stake and the hard work of so many could be overshadowed.
 
Separate the Heroes & Villains
 
The NAD initiative is not the only area where the industry has helped to elevate the marketplace. In late 2010, CRN, along with the other four dietary supplement trade associations, joined together with FDA to help rid the market of illegal drug products masquerading as dietary supplements.
 
These products pose a danger to consumers and they tarnish the reputation of the legitimate supplement industry. FDA’s concern focuses on three categories of products that may be particularly susceptible to adulteration: weight loss, sexual enhancement and body building, i.e., categories that often target consumers looking for a quick fix. As an industry, we strongly supported FDA’s flexing of its regulatory muscle, and appreciated the opportunity to further separate the responsible players in these categories from the criminals. This action sent a message to bad actors—“We won’t sit idly by and allow you to highjack our industry.”
 
Unfortunately, Dr. Joshua Sharfstein left FDA shortly after this cooperative effort was announced, and recent FDA activity on the issue has been limited to warning letters, but no further collaboration with responsible industry. We would very much like to see FDA focus its efforts in this area; a few high level enforcement steps and heavy sanctions should help chill the environment for companies that too easily ignore warning letters alone. The New York Times wouldn’t publish articles like the one I referred to earlier if companies were not selling products containing prescription drugs and misleading consumers into thinking they are getting “all natural” supplements. That is a frightening scenario for our consumers and the future of our industry.
 
At the same time, though, we are seeing the fruits of our efforts to strengthen regulation in other areas. With a reporting of post-market surveillance now firmly in place for serious adverse events, the industry has a good track record, one that supports product safety. Good Manufacturing Practices (GMPs) are now in effect for all companies, large and small. The result here is not as good as for AERs.
 
FDA inspections have turned up an unacceptable number of companies with an alarming number of deficiencies. I’m not talking about a disagreement with the inspector about what type of identity testing to conduct on a particular ingredient—there are still companies that are not testing their incoming ingredients at all. The GMP rules assure consumers they can have confidence in our manufacturing, so we need to boost compliance. In fact, CRN is planning an industry-wide webinar to address this problem. For some it may be a refresher, for other companies, perhaps a wake-up call.
 
We must also continue to work with Congress to shape the laws that will foster continued growth in the industry and protect consumers. Last year, Congress passed and the President signed into law the Food Safety Modernization Act (FSMA), which gives FDA the additional tools needed to help protect public health in the area of food safety. FSMA requires biennial registration of all food manufacturing facilities, provides FDA with new authority to mandate food recalls, requires companies to develop food safety plans (particularly ingredient suppliers that are not subject to the more stringent supplement GMPs), and enhances public health by adopting a risk-based approach to inspection.
 
Resist Re-writes That Would Doom the Play
 
No account of the dietary supplement industry would be complete these days without mentioning FDA’s New Dietary Ingredient (NDI) draft guidance released in July. When DSHEA was enacted in 1994, one of the core tenets was to presume the safety of ingredients already on the market, but to hold new dietary ingredients that would enter the market after 1994 to a higher standard. But FDA was never very clear about what that standard would be, and quite frankly, the industry doesn’t have a good track record with meeting FDA’s expectations.
 
Less than one-third of NDI notices are accepted. So we asked FDA to explain the criteria it is using. Unfortunately the first draft FDA delivered bears little resemblance to the requirements the industry agreed to in 1994. CRN and the other industry trade associations have grave concerns about the content of this draft guidance, and we will raise our voices strongly and cohesively to protect industry from a document that is overreaching and contravenes the original intent of the law.
 
A transparent and reasonable NDI process would encourage more companies to file their NDI notifications, alert FDA to new ingredients in the marketplace, and provide a measure of safety in these new products. But the current approach is burdensome, daunting and unworkable for both industry and the agency. I am hopeful FDA will negotiate, compromise and come back with a guidance that is attainable, appropriate and embraceable by industry.
 
Plotting the Happy Ending
 
What can we do to change the next chapter of the supplement industry’s story? How can we work together to ensure the bad actors don’t rewrite the script to jeopardize a strong future filled with healthy consumers who view dietary supplements as an essential choice for good health? We can take responsibility for the products we manufacture and market. We can make sure our ads and product claims are truthful and not misleading. We can make sure we’re monitoring our supply chain from top to bottom. We can redouble our commitment to comply with existing laws. We can urge FDA and FTC to use their limited budgets and overburdened staffs in effective and cost-efficient ways. We can’t pick the cast of players who will appear in this drama, but we certainly can influence the direction of the script.              
 
About the author: Steve Mister is the president and CEO of the Council for Responsible Nutrition (CRN), Washington, D.C. For more information, www.crnusa.org.