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Editorials

DSHEA Ten Years Later: Now What?

Source: Nutrition Business Journal, excerpted with permission.
30 June 2004
by Loren Israelsen and Thomas D. Aarts

Editor's Note by Wyn Snow:

Ten Years of DSHEA: Law At Risk In Today's Political Climate

Ten years ago, the Dietary Supplement Health and Education Act (DSHEA) established new guidelines for the dietary supplement industry. The new law nurtured a brief golden age where it was easier for consumers to purchase supplements and easier for manufacturers to bring new products to market. Sales rose dramatically.

Over the past decade,

  • the press increasingly described supplements as "unregulated" -- which is untrue;
  • unscrupulous manufacturers used the new law as an opportunity to market dubious products and make exaggerated and false advertising claims;
  • manufacturers have struggled with issues of quality;
  • reports appeared in the media that bottle contents didn't always match the label;
  • FDA did not establish new GMP regulations required by DSHEA, and was woefully slow to enforce existing law.

After initial strong growth at the beginning of the decade, consumer confidence has now waned and sales have slumped.

The controversy over ephedra tarred the herbal products industry with widespread public perception that herbs are dangerous, despite extensive evidence that most herbs are quite safe. Calls for increased regulation abound—and the FDA's new proposed final rule for GMP regulations are far more stringent than the industry's original proposals of 1995.

A year ago, Israelsen and Aarts called for supplement executives to take a hard look in the mirror and fix the problems plaguing the industry. They now call for executives to take a three-pronged approach:

  • resolve four key issues in the debate about DSHEA
  • protect the most vital provisions of DSHEA
  • restore consumer confidence

The following is excerpted from "DSHEA Ten Years Later: Now What?" by Loren Israelsen and Thomas D. Aarts. We have paraphrased some of their industry-specific language, while doing our best to preserve the arguments and intent of the original, which appeared in the Nutrition Business Journal in January 2004.

 

Exactly one year ago, we argued that leaders in the dietary supplement (DS) industry must address the reality of a post-DSHEA world by looking in the mirror and taking more responsibility for self-governance (NBJ Executive Review Issue; Dec 2002).

We now enter 2004—a presidential election year, an Olympic year, and the 10th anniversary of DSHEA (the Dietary Supplement Health and Education Act of 1994)—a make or break year for the industry.

Review of 2003

Last year's article identified five key realities:

1. Defense of an ideological DSHEA will not save the supplement industry.

2. Discipline, not regulation, will sustain the market.

3. Popular political support has eroded.

4. Too many companies compete for too few customers.

5. Negative media is a symptom, not the problem.

All five core realities remain central to the future of the supplement sector.

In the past year, the industry has started to take action steps to bolster DSHEA and address fundamental concerns—including:

The industry has begun to cooperate with the FTC to pursue rogue companies whose business practices, if unchecked, would result in the continued erosion of the industry's reputation with regulators, politicians and most importantly, consumers. (A complete summary of FTC actions is available at www.ftc.gov/bcp/reports/dietadvertisingcases.htm.)

Five industry trade associations recently issued a joint press release supporting S.1780 (Biden/Hatch Bill), which would treat androstenedione and similar chemicals as controlled substances.

Pro-active approaches to the media: In September 2003, top leaders from The Dietary Supplement Education Alliance (DSEA) met with senior health editors from The New York Times to voice their concern over biased media coverage in the Times and other publications. These editors have agreed to push for increased objectivity when reporting on the supplement industry.

The Challenge of 2004

The stars are aligned for a highly focused assault on DSHEA intended to result in its amendment or, possibly, its repeal. Most congressional insiders and advisers agree that if DSHEA is to be changed, it will happen in 2004—all the groundwork has been laid.

For example, hearings have been held, zeroing in on the industry's gross failures and abuses (ephedra, andro, Internet claims). Powerful members of the House and Senate (of both parties) are now calling for the repeal or amendment of DSHEA. FDA press releases are being coordinated with media exposZs clearly timed to affect both congressional and public opinion about DSHEA.

These are the telltale signs of a full-scale assault on DSHEA in the next Congress. A powerful congressional veteran, John Dingell (D-MI), is quoted as saying, "I would like to repeal the whole sorry mess" [DSHEA].

Learning From History—What Goes Around Comes Around

Contrary to industry mythology, in 1994 DSHEA did not pass by a unanimous vote on the floor of the House and the Senate. No floor vote on DSHEA was ever held in the House. In fact, the House version of DSHEA never even made it out of committee. DSHEA became law because of a "perfect storm" confluence of political forces.

The Gingrich New Deal Republicans were about to sweep out the old line House Democrats who were holding up DSHEA, which caused the Democrats to unload the DSHEA issue at the very last minute to save their jobs. In the Senate, Senator Orrin Hatch (R-UT) was able to hold off a last minute attempt to derail DSHEA as it was coming up for unanimous consent vote in the closing minutes of the 1994 Senate session. Literally, DSHEA was a political "Hail Mary" of unprecedented proportions. Frantic last-minute deal making resulted in the addition of the structure/function claim disclaimer, among other things.

Over the past 10 years, the industry has lulled itself into believing that DSHEA was an overwhelming political victory (which it was) because it was unanimously voted for by the Congress (which it wasn't). The core enemies of DSHEA remain in Congress and now wait their turn to "take care of business" with respect to DSHEA in 2004. Just as DSHEA was created by last minute deals, it could easily be changed by this same and largely mysterious political process.

Defending DSHEA: What Is The Plan?

Although numerous initiatives are underway to protect DSHEA, we believe three core strategies are needed to defend this landmark legislation:

  • proactively resolve the four biggest controversies within the DSHEA debate;
  • identify and protect the most important provisions of DSHEA;
  • restore consumer confidence.

Strategy #1: Resolve Major Controversies

[Editor's note: This next section paraphrases the authors' views on the four biggest controversies, and includes their impact on consumers. If you prefer, read the authors' full text of Strategy #1.]

1. Ephedra: The authors recommend that industry stop fighting the FDA's stance on banning ephedra. Congressional sentiment is strongly opposed to ephedra, and the ephedra controversy has created a "distorted looking glass" that is tainting other herbs and supplements. [Editor's note: This taint means that the media casts a jaundiced eye on all supplements, so consumers now hold a distorted view of their safety and effectiveness. If Congress does act to regulate supplements more stringently, consumers are likely to lose access to many valuable nutrients and herbs, and innovation in the field will become stifled.]

2. Drugs posing as supplements: Here, the authors recommend supporting the Anabolic Steroid Control Act of 2003. This legislation would categorize steroid precursors as drugs, thereby removing them from the supplement market and also removing all possibility of scandals and consequent bad press during the 2004 Olympic games in September. [Editor's note: Also, many adolescents are using these precursors, despite strong warnings from the government and medical authorities not to do so.]

3. Quality: The authors call for an economic analysis of the impact on small business of the FDA's proposed good manufacturing practices (GMP) regulation "in order to demonstrate FDA's utter failure to correctly assess the economic impact of the GMP rule on the supplement industry. This analysis should clearly articulate consumers' loss of access to products that would result from soaring costs to produce small lot and specialty products."

4. Safety: "The time has come for industry to support measures that provide FDA and qualified health professionals with pertinent information on Adverse Event Reports. For supplements to become more fully accepted by the general public, there must be ways to help ensure confidence in their overall safety. This means, at least in part, developing a process of monitoring cases of adverse responses to some supplements and provide a pro-active way of dealing with this issue."

Strategy #2: Identify And Protect The Most Important Provisions Of DSHEA

We believe that three fundamental and critical provisions of DSHEA must be preserved:

  • the definition of dietary supplements,
  • the provision that dietary supplements are not food additives, and
  • the FDA has the burden-of-proof to show a product is unsafe before it can remove it from the market.

These are the "operating system" of DSHEA. Without these provisions, there would not be much of an industry to operate, just as a computer cannot function without an operating system.

The first two provisions make it possible to sell dietary supplements in the marketplace and remove one of the key strategies that FDA has used in the past to over-regulate supplements. The third provision is procedural from a legal perspective, but is at the heart of DSHEA and can make or break the industry if it goes the wrong way.

[Editor's note: Drugs must prove they are safe before they can be marketed. This is sensible because most drugs become toxic at intakes only a little higher than the effective dosage level. However, the vast majority of dietary supplements are already known to be safe—either from centuries of use by indigenous peoples or through the fact that they are derived from food.]

Some of the sophisticated attacks on DSHEA have targeted these core provisions because the opposition knows that this is where the "rubber hits the road." It would take only a few sentences to turn DSHEA from a useful law into a predatory policy that the industry would abhor.

[Editor's note: Consumers who wish to write their Senators and Representatives are well advised to focus on preserving these core provisions of DSHEA.]

Strategy #3: Restore Public Confidence

The next step is to restore public confidence in the safety and benefits of dietary supplements through adopting quality standards, certification programs, and appropriate, truthful claims management. Here, "public confidence" needs to include not just consumers, but also health professionals, congressional members, and regulators. Industry executives should fully support any efforts toward adopting certification standards (such as NSF and USP).

Along these lines, the American Botanical Council's new Safety Labeling Program, which provides enhanced safety information for product labeling, can help reduce the incidence of potential adverse events to safe herbal products on the market-even though it is widely known that most popular herbs are not associated with any serious adverse effects.

At present, there is an internal enforcement vacuum. The FDA still falls short of taking appropriate enforcement action in the face of clear violations of current law. Whether for lack of enforcement budget or lack of will, the effect is the same—the appearance that FDA "lacks authority" to regulate this industry—a myth and misconception that may be partly resolved by FDA's recent ban on ephedra.

However, invisible Internet marketers of supplements (and their excessive claims) are challenging for anyone to find and discipline. Who then is the sheriff in town? Until the FTC gains ground on these rogue marketers, industry leaders should continue to do everything possible to help identify these players to the FTC and continue to draw a line between the responsible and fringe players in the industry.

On the retail front, the major retailers exercise strong gatekeeper power. They decide what goes on their shelves and hold the greatest buying power in the value chain. The post-DSHEA era will see a new cooperation between these retailers, trade associations and industry leaders. Such programs should include adherence to trade policies (labeling practices, ingredient safety, dosage limits, and the like) in choosing which products to accept and place on their shelves.

A retailer peer group is being formed to explore ways to realize this gatekeeper function. Clearly, it should not be the ongoing task of retailers to pass judgment on product safety or legitimacy. However, as an interim step, this could and should be an effective tool to ensure that products of questionable quality do not reach the shelves.

Another gatekeeper is the media. In other industries, the media has standards that companies must follow. Publishers, conference organizers and associations do not accept advertisers or exhibitors who fall short of these standards. New Hope Natural Media has an extensive standards policy and practices program for the industry's two largest trade shows. Trade and consumer publishing executives and, more importantly, infomercial companies should meet to set minimum standards for investigating whether advertising claims are legitimate and whether products are in compliance with government regulation.

Next Steps

All political efforts should be focused on these and directly related objectives. It is not helpful or productive to scare consumers through "the government is trying to take away your vitamins" campaigns or to support extremist calls to abolish the FDA. Also, it is extraordinarily destructive to personalize regulatory issues. In 1994, there were unfortunate personal attacks made against members of Congress and their families by overzealous members of our industry; these attacks nearly derailed DSHEA for which we are still paying politically.

After years of skirmishing, the dietary supplement industry will likely face the first true assault on DSHEA in 2004. Our best defense must be a clear and focused offense to address "tipping point issues" that have become symbolic of the public debate about whether DSHEA is bad law. These issues include resolution of ephedra, andro, and the twin issues of quality and safety.

Industry executives must be prepared to spend time and money on DSHEA defense and industry self-regulation issues at levels not seen since the 1992-94 DSHEA campaign. Failure to do so could be the most expensive decision the industry ever makes!

Source

Loren Israelsen and Thomas D. Aarts. "DSHEA Ten Years Later: Now What?" Excerpted with permission of Nutrition Business Journal, San Diego, CA.end-of-story

 

   
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