Ten Years Later: Now What?
Nutrition Business Journal, excerpted with permission.
30 June 2004
by Loren Israelsen and Thomas
Note by Wyn Snow:
Years of DSHEA: Law At Risk In Today's Political Climate
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
the past decade,
press increasingly described supplements as "unregulated"
-- which is untrue;
manufacturers used the new law as an opportunity to market
dubious products and make exaggerated and false advertising
have struggled with issues of quality;
appeared in the media that bottle contents didn't always
match the label;
did not establish new GMP regulations required by DSHEA,
and was woefully slow to enforce existing law.
initial strong growth at the beginning of the decade, consumer
confidence has now waned and sales have slumped.
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 aboundand the FDA's new
proposed final rule for GMP regulations are far more stringent
than the industry's original proposals of 1995.
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
four key issues in the debate about DSHEA
the most vital provisions of DSHEA
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
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).
now enter 2004a 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.
year's article identified five key realities:
Defense of an ideological DSHEA will not save the supplement industry.
Discipline, not regulation, will sustain the market.
Popular political support has eroded.
Too many companies compete for too few customers.
Negative media is a symptom, not the problem.
five core realities remain central to the future of the supplement
the past year, the industry has started to take action steps to
bolster DSHEA and address fundamental concernsincluding:
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.)
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.
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.
Challenge of 2004
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 2004all the groundwork has been laid.
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.
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"
From HistoryWhat Goes Around Comes Around
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.
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.
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.
DSHEA: What Is The Plan?
numerous initiatives are underway to protect DSHEA, we believe three
core strategies are needed to defend this landmark legislation:
resolve the four biggest controversies within the DSHEA debate;
and protect the most important provisions of DSHEA;
#1: Resolve Major Controversies
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.]
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.]
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.]
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."
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
#2: Identify And Protect The Most Important Provisions Of DSHEA
believe that three fundamental and critical provisions of DSHEA
must be preserved:
definition of dietary supplements,
provision that dietary supplements are not food additives, and
FDA has the burden-of-proof to show a product is unsafe before
it can remove it from the market.
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.
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.
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 safeeither
from centuries of use by indigenous peoples or through the fact
that they are derived from food.]
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.
note: Consumers who wish to write their Senators and Representatives
are well advised to focus on preserving these core provisions of
#3: Restore Public Confidence
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).
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
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 samethe appearance
that FDA "lacks authority" to regulate this industrya myth
and misconception that may be partly resolved by FDA's recent ban
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.
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.
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.
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.
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.
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.
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!
Israelsen and Thomas D. Aarts. "DSHEA Ten Years Later: Now
What?" Excerpted with permission of Nutrition Business Journal,
San Diego, CA.