supplement quality is a question of commitment."
with Loren D.
30 July 2001
no individual represents the dietary supplement industry more effectively
than Loren D. Israelsen. As an attorney, policy maker and
corporate leader, Israelsen has served as president of Nature's
Way, Issues manager for dietary supplements to the Trans-Atlantic
Business Dialogue (TABD), and advisor to the federal Office of Dietary
Supplements. His work as executive director of the Utah Natural
Products Alliance was instrumental in the introduction and passage
of the Dietary Supplement Health and Education Act (DSHEA) of 1994.
is a frequent lecturer on policy and commercial issues affecting
dietary supplements and has published numerous articles in the field.
He currently serves as president of the LDI Group, a strategic consulting
firm with clients in the functional food, pharmaceutical and dietary
response to a request by SupplementQuality.com editor Wyn
Snow for his thinking on the major issues facing the supplement
industry today, Israelsen commented via phone and email. In this
important interview, he focuses on efficacy research, health claims,
safety, product quality, and global harmonization of government
One important challenge facing the supplement industry is proving
the effectiveness of products. What do you see as the best means
of conducting further research?
Proving efficacy for dietary supplements is complicated by the
fact that they are made up of a variety of differing chemical
compounds. The gold standard in research, of course, is the placebo-controlled,
crossover double-blind study, which was principally designed to
test single chemical entities against placebo.
many of our most important supplement products do not behave in
the body like single chemical entities, which is one of the virtues
of supplements. The diverse nature of plant extracts, even within
the same species, makes it considerably more difficult to assess
their effectiveness in controlled studies.
diverse biochemistry is also one of the criticisms of supplements.
How, for example, would one test the anti-cancer effects of antioxidants
or the energizing effects of Siberian ginseng using placebo controls
in a study population of 200 people? This is obviously difficult
to do and historically has not been done for both economic and
common sense reasons.
is why bibliographic, open studies and traditional wisdom are
widely relied on by sellers and users of dietary supplements.
It is also the basis of a different approach to regulating and
approving botanicals as drugs in Western Europe, Asia and elsewhere.
The US is singularly unreceptive to accepting non-double-blind
evidence as the basis of efficacy for botanicals and other dietary
will be little important privately funded research on dietary
supplements until there are financial rewards -- such as drug
exclusivity, patents or reimbursement. It appears the most effective
way to conduct significant new research is to get the government
to pay for it, as we now see at the National Institutes for Health
(NIH) with St. John's wort and several other botanicals. If these
studies are positive, it will be a major boost for the industry
and the studied dietary ingredient. If they are negative or inconclusive,
there will be the sound of air escaping from the tires of the
I am enticed by these pivotal NIH studies, this approach is really
risky. Typically, it takes several studies to reach consensus
on the true utility and safety of any substance, especially in
the natural products arena.
see a great need to create research incentives for dietary supplements.
Until this happens, there will be very little new news on the
efficacy of this class of products.
Much research about supplements is characterized as "flawed" by
the medical community. Is this just smoke or is much of the extensive
research truly inadequate? (There are upwards of 400,000 titles
in the IBIDS database (International Bibliographic Information on
Dietary Supplements), created and maintained by the federal Office
of Dietary Supplements.)
To most doctors, any study is flawed if it is not a placebo-controlled,
crossover, double-blind study. Current medical science discounts
bibliographic, personal case reports or observational studies
as nothing more than anecdotal.
don't question the statistical power of the double-blind study,
but I do question its relevance when such studies are used as
the basis for approving drugs that will be used by millions of
men, women and children of all ages, races and with broad genetic
differentiation. This is partly why a number of drugs are withdrawn
from the market, because they have proven to be very dangerous
when placed in a broader genetic population.
is why many consumers take comfort in using supplements that have
long human experience even though double-blind studies are absent.
Doctors have been sold on a specific style of research as the
only credible one, while most lay persons are sold on what they
sense, feel and gain from shared experience with others.
What about communicating the results of existing research?
The best way to communicate the results of existing research is
to put it in front of people's faces -- on the label. Of course,
we are now talking about drug claims, not nutrient or structure/function
claims. We have reached a plateau on label claims. Structure/function
claims were a rising tide phenomenon. The public is now much more
aware of the general use of many botanicals and other supplements,
but generically so. Few consumers can tell which product is a
useful one and which one is a phony. There is a lot of room to
improve the present situation with respect to claims and research
incentives for supplements.
What about the ruling by the federal Food and Drug Administration
(FDA) on the health claim for saw palmetto? (A petitioner sought
to use a claim supported by approximately two dozen research studies
that saw palmetto is effective for easing symptoms of benign prostatic
hyperplasia or hypertrophy (BPH) disease, which is a non-cancerous
growth in the prostate gland. Roughly 80% of men over the age of
40 have urination problems caused by BPH.)
The FDA's denial of the saw palmetto/BPH health claim petition
is no surprise. There are lots of reasons for this. Saw palmetto
is not a nutrient -- which is a critical precondition for a health
claim. The proposed claim is a chronic treatment and not a prevention
claim, which is also a novel aspect and which the FDA is resisting.
Nobody eats saw palmetto as a food or food ingredient, so it is
not eligible for the generally recognized as safe (GRAS)
food ingredient category.
saw palmetto be approved as drug? In my opinion, the answer is
yes. Will the FDA do this? I hope so, as it is probably the best
product we have with respect to the risk/benefit equation for
a condition that is non-malignant, self treatable and chronic.
It fills a therapeutic gap for many men who don't need to rely
on a prescription drug for early stage BPH. If the FDA refuses
to accept saw palmetto as a legitimate treatment for BPH, it will
be time to go see the Congress again.
What about the herbal new-drug guidelines published by the FDA?
Do you see this having any effect on the marketing of herbal products?
(Only products approved as drugs by the FDA are allowed to make
The FDA published a guidance for botanical new drugs to clarify
what it expects of a plant drug. There is nothing really new or
different in this document except to formalize a heretofore unwritten
set of views and policies within the FDA.
will be no immediate effect on the present herbal market because
of this new guidance, but if a botanical new drug application
is approved by the FDA for an important product (such as ginkgo
or St. John's wort), this would be big news and would likely give
the whole herbal category a big boost due to the halo effect.
Another big challenge facing the supplement industry is supplement
safety. We keep seeing headlines whose underlying message is: "Supplements
are dangerous and unregulated."
Proof of safety is really an equation:
= Benefits - Risks
of our industry accept the risks and deny the benefits, which
equals unsafe in their minds. The Dietary Supplement Health
and Education Act (DSHEA) of 1994 defines a safety standard for
supplements, which assumes a higher benefits factor and relatively
low risk factor. This is why our critics don't like DSHEA. It
is the risk factor!
How best can the industry address issues like the controversy over
identifying the specific risks of using ephedra products? (For
the most part, industry spokespersons state that ephedra is safe
when used as directed. The FDA and some people in the medical community
believe that ephedra is dangerous and has caused severe side effects,
even several deaths.)
Naturally, the risk-to-benefit ratio among various supplements
is different. Ephedra is chemically and pharmacologically active
and has a higher risk factor, but to many users, it also has a
very high benefit factor (energy gain and weight loss).
risk-to-benefit ratios always mean controversy. Americans are
disserved when we treat all supplements as having the same levels
of risks and benefits, because they do not. Clearly, some supplements
require special labeling, controlled potencies, limits on how
long they are used, etc. DSHEA allows for all of this.
Similar controversies have occurred with chaparral and comfrey;
kava is looming on the horizon. Are questions about high risk factor
supplements best addressed on a product-by-product basis? Would
it be better to create a new category for "potentially hazardous
botanicals"? Or would this undermine the status of all botanicals?
Creating a separate category for potentially hazardous botanicals
isn't necessary. Such products have been and will be dealt with
on a case-by-case basis with existing law and regulations (comfrey,
chaparral, aristolochic acid, and GBL are good examples).
Another big challenge facing the supplement industry is a perception
on the part of both the public and media of serious gaps in the
quality of dietary supplements. ConsumerLab's testing program addresses
one corner of the "do the contents match the label" issue. What
more needs to be done industrywide?
Dietary supplement quality is a question of commitment. We know
what it takes to make a properly sourced, tested and manufactured
supplement. The problem lies in our apparent inability to hold
ourselves, as an industry, to a high common standard.
is a matter of resolve and self-governance. To the extent that
bad products (defined as failure to meet label claims) are available
to consumers, we are all diminished as an industry. As we have
seen in ongoing exposés focused on quality failures, tragically
DSHEA is blamed for this. As a result, we are in danger of losing
our most important success, because we apparently cannot behave
FDA has failed to inspect facilities or bring appropriate enforcement
cases when and where they should. Most of the industry's trade
associations have urged the FDA to do so. The FDA claims they
don't have the money to do it. In response, the industry's trade
associations have urged Congress to allocate monies for specific
enforcement activities to address this problem. The industry has
also urged speedy publication of proposed good manufacturing practice
(GMP) regulations. So far, we wait in vain.
I am at a loss to explain why the industry has been so tolerant
of shoddy products. As always, this appears to be an 80/20 (perhaps
90/10) rule. Most companies make a real effort to sell a quality
product and for the most part do so. Those that can't or don't
meet basic standards of quality should be drummed out of the industry
as fast as possible.
of supplement regulations
The global economy is bringing new challenges to the dietary supplement
industry. The various nations of the international community maintain
separate regulatory environments for supplements. In particular,
DSHEA has allowed Americans a higher degree of health freedom than
our European counterparts.
to harmonize regulations internationally focus on the Codex Alimentarius
(of the World Health Organization), as well as other organizations,
such as the Trans-Atlantic Business Dialogue (TABD). You are involved
in some of the ongoing harmonization discussions. What do you see
approaching on this horizon?
Globalization is a fact, and it is going on as we speak. Harmonization
is a result of globalization, and so the question is, what countries
and what organizations will set the agenda for the rest of the
has become the battle cry for those opposing both globalization
and harmonization, fearing that DSHEA will be displaced by international
treaties to which the US is a party. The supplement industry as
a whole opposes a "Codex-style" framework for dietary supplements.
Collective efforts to oppose the present Codex initiatives are
working. The Transatlantic Business Dialogue (TABD) is a useful
effort in this respect, as is the work of the International Alliance
of Dietary Supplement Associations (IADSA).
always, international initiatives require a lot of time and patience.
Fortunately, there are a lot of skilled and committed people in
the US and Europe working to identify and resolve threats created
by Codex and other initiatives that would move us in the direction
of unnecessary and unwanted regulation.
The TABD is encouraging US and European regulatory bodies to develop
standards for "safe upper dosage limits", which it intends to promote
as maximum dosage levels for supplements. However, a fair amount
of scientific controversy surrounds the question of how to determine
what these safe upper limits and maximum dosage levels should be.
(For further details, see SQ's interview
with Robert Reynolds and story on RDAs
and Safe Upper Levels.)
Safe upper limits is a big issue. Both the US and European dietary
supplement groups are very conscious of finding the right upper
limits, meaning maximum potencies that are safe. The key issue
is not to approach this from a minimum-nutritional-needs perspective.
That is the thinking we are opposed to.
The World Trade Organization (WTO) is another potential influence
on the harmonization of supplement regulations. The WTO has international
jurisdiction in resolving regulatory disputes between countries
that have signed various free-trade treaties. Is this a threat to
This issue involves treaty obligations that flow from the fact
that the US is a signator country to WTO agreements. I have asked
a lot of people about the commitments of the US with respect to
domestic laws (like DSHEA) and national commitment to the WTO
-- which may be inconsistent with DSHEA. I have not yet gotten
a good answer, and so I remain concerned about this specific issue.
remarks shine a spotlight on ways that industrywide quality standards
might solve several problems that have undermined consumer confidence
in supplements and flattened industry growth. More directly, his
comments bear on key issues relating to safety, efficacy and overall
most reliable method of drumming shoddy products out of the industry
under a self-regulation model is to create a clear means for consumers
to distinguish good from bad. Underwriters Laboratories (the familiar
UL symbol) have done this for a host of electrical and other products.
ConsumerLab and others are doing something similar for supplements
by putting a quality seal on the label of approved products. Other
industries have established self-regulatory bodies that debate quality
issues and establish quality standards. Why not supplements?
Israelsen points out, the industry's failure to govern itself puts
DSHEA at risk. If new legislation were to be passed into law that
authorizes the FDA to pre-screen new supplement products, it well
might create gridlock for product development, drive prices of new
products through the roof, and make it more difficult for consumers
to get full, accurate information about supplement health benefits.
companies, trade organizations, and the FDA have come together to
develop rigorous test methods for botanical materials at the Institute
for Nutraceutical Advancement. Surely a similar umbrella organization
can be formed to hammer out ongoing consensus on standards for product
quality, efficacy research, safety issues and appropriate label
warnings for individual supplements.
needed is leadership -- for individual consumers, industry leaders
and health care providers to come forward and say, "Let's get this