Disease claims have long been a thorn in the U.S. dietary supplement industry’s side—and recently that thorn has grown more painful. Just this week, the U.S. Food and Drug Administration (FDA) instructed U.S. Marshals to seize supplement products from two different companies because the products’ labels carried disease claims.
Although the majority of supplement marketers operating today stay within the limits of the structure/function claims allowed by the Dietary Supplement Health and Education Act (DSHEA), some do not—and as any supplement trade association executive will tell you, those marketers crossing the claims line threaten the reputation and prosperity of all supplement brands.
“When a company makes outrageous claims for a product, that can color consumer impressions of all our claims,” says Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN).
The FDA and the Federal Trade Commission (FTC) work in unison to monitor the claims made for dietary supplement companies. But with limited budgets and a host of other industries under their regulatory umbrellas, the agencies can only do so much when it comes to cracking down on illegal supplement claims.
That’s why CRN and the National Products Association (NPA) are both working to eliminate unlawful supplement claims through their own separate programs. But just how successful are these and other ad-monitoring initiatives, and what’s required for industry self-regulation to be successful in this day and age?
In 2006, CRN began funding the work of the National Advertising Division (NAD) of the Council of Better Business Bureaus, with the goal of enabling NAD to expand its review of supplement advertising. NAD is the advertising industry’s self-regulatory forum. Through its work, it requests substantiation for claims made by a wide range of companies for a wide range of products.
Multi-year grants from CRN have enabled NAD to hire an additional attorney who is solely focused on the supplement category. Since 2006, NAD has reviewed the advertising in more than 100 supplement-related cases.
Through the National Products Foundation (NPF), the NPA operates the Truth in Advertising campaign. The program is designed to identify advertising that crosses the line into disease claims. Once identified, such claims are brought to the attention of the marketer or manufacturer through warning letters.
“The goal is a level playing field for the responsible core of the industry, as well as making sure fringe companies aren’t misleading consumers,” says NPF Executive Director Deb Knowles.
Although CRN’s annual supplement usage survey shows that consumer confidence in dietary supplements has remained stable over the last several years, Mister acknowledges that many consumers still harbor a healthy dose of disbelief when it comes to supplement advertising. “We still see a lot of skepticism,” he says.
That’s not difficult to believe when you take a look at some of the claims being made every day by supplement companies. In a recent case, U.S. Marshals—at the request of the FDA—seized elderberry juice products from Wyldewood Cellars Inc. because the company refused to cease claiming that the product could cure, treat and prevent numerous diseases, including AIDS, diabetes and flu.
As the head of the standards group at New Hope Natural Media (NewHope360.com’s parent company), Don McLemore experiences the benefits of industry self regulation every day. The role of New Hope’s standards program is to ensure all advertising in New Hope publications and products exhibited at the company’s shows comply with federal labeling regulations. Those companies whose products don't pass the standards test are provided guidance on how to comply, which they must do before they can advertise or exhibit the products in question.
“Self regulation is crucial to ensuring the accuracy of information about product claims and safety,” McLemore says. “Such a mechanism is necessary to promote the responsible growth of the natural products industry and will ultimately lead to consumer confidence in natural products.”
Of course, when one talks about industry self regulation, the question often comes up: but does it really work?
In some industries, the answer seems to be not very well (just look at what happened following the deregulation of the financial industry). But for the dietary supplement industry, CRN’s Mister argues that self policing is making a difference.
In nearly every supplement advertising case NAD has reviewed since 2006, the group has pinpointed wording or other aspects of a company’s supplement advertising that is in conflict with current supplement regulation. And according to Mister, this NAD guidance more often than not leads to a company changing the advertising in question to better align with the rules of DSHEA.
“The nice thing about this program is that it is not like litigation or having the FTC come in with a subpoena,” Mister says. “The NAD is truth seeking. They will look at an ad and say, ‘We think that these claims are fine, but these other claims need some attention.’”
Through its Truth in Advertising program, the NPF sent more than 70 warning letters and worked on some 100 supplement advertising cases over the last 12 months. The group reports that 65 percent of these cases have led to companies addressing their advertising issues with NPF’s legal advisory council.
But what if a company refuses to comply? Both CRN and NAD understand that self policing can go only so far; so if an advertiser chooses to ignore their warnings and guidance, they will turn those companies over to the regulatory authorities.
“We don’t have a badge or a gun; we can’t make someone come to the table,” Mister says. “For those companies that will not engage in the process, we go to the FTC.”
In May, NPF representatives met with Richard Cleland, associate director of the FTC’s advertising division; and Gary Coody, FDA’s health fraud coordinator, to ask the agencies to take action against 13 supplement advertisers that had failed to amend their marketing materials after being contacted by NPF’s Truth in Advertising program. “Both agencies advised us that they would review the material we provided,” says attorney Marc Ullman, chairman of the NPF Legal Advisory Council.
Cases referred to the FTC or FDA may never be reviewed by a government agency. However, according to Mister, many of the high-profile supplement advertising cases that resulted in significant fines or other penalties originated through industry self-policing programs such as CRN’s NAD initiative.
Case in point is Airborne Health, which agreed to pay $30 million in fines in 2008 to settle FTC charges of false advertising for a product marketed as a cold and flu prevention supplement. “That started as an NAD case and eventually the FTC got involved,” Mister says.
Programs such as CRN’s NAD initiative also provide supplement companies with a vehicle for bringing scrutiny to a competitor’s advertising. Although NAD chooses many of the cases it will review, companies can pay to submit what Mister calls a “competitive challenge” to the group. In these situations, both the challenger and the challenged are allowed to submit data for the NAD review.
Around 25 percent of the cases NAD has reviewed were submitted by another company. Submitting a challenge costs $3,500. “That may sound expensive,” Mister says, “but if you think about what it would cost to bring a false advertising claim against a competitor, $3,500 wouldn’t even get you in door of a court room. We think this is a very reasonable way to call out your competitor.”
So what’s likely to bring an advertisement to the attention of NAD, NPF’s Truth in Advertising program or New Hope's standards group?
Words such as “cure,” “treat” or “prevent” followed by a specific disease state like cancer, heart disease or arthritis are immediate red flags.
Supplement advertisers also routinely get “called out” for making claims without any having any finished product data, Mister says. “These companies may have a study on an individual ingredient, but that study may not even represent the same dose found in the finished product,” he adds. “That is a problem we see over and over again.”
Using words the “clinically proven gets a lot of people in trouble” as well, Mister says. That’s because the NAD views the word “clinically proven” as meaning “beyond a shadow of a doubt” and therefore requires clinical studies to substantiate the claim, he explains.
Using specific claims such as “drop 7 pounds in 14 days” or “Product X works three times faster than Product Y” can also be problematic. “If you make that type of specific claims, you’d better have the data to substantiate it,” Mister says.
As New Hope’s McLemore sees it, “The success of self-regulation is dependent upon a spirit of cooperation between industry manufacturers, distributors, brokers and retailers.”
In addition, for industry self regulatory to be effective, McLemore says it should:
For the most part, companies welcome self-policing initiatives such as New Hope’s standards program or NPF’s Truth in Advertising campaign because they provide often much-needed guidance in an area that can be tricky to navigate.
Says McLemore: “Most of the natural product marketers, particularly those who may not completely understand the regulatory climate with respect to labeling claims and ingredient safety, appreciate resources that offer them an opportunity to successfully market their products within regulatory compliance.”