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Industry Supports Strong Warning Label For Products With Ephedra
Washington
DC, 11 October 2002
The
Council for Responsible Nutrition (CRN), representing a substantial
segment of the dietary supplement industry, today released a letter
sent to Senator Durbin and other legislators addressing several
issues relating to ephedra-containing dietary supplements.
CRN
emphasized the industry's full support for a comprehensive mandatory
warning statement on ephedra-containing products, and noted that
such warnings have already been adopted by virtually all manufacturers.
These extensive warnings are recommended by all the trade associations
in the industry, are required by numerous states, and contain language
similar to or stronger than the wording proposed by FDA in 1997.
Synthetic
ephedrine
CRN
said the industry also supports FDA action against products with
added synthetic ephedrine, since this pharmaceutical ingredient
is not appropriate for inclusion in supplements. Ephedra contains
a mixture of naturally-occurring alkaloids, including ephedrine,
but products should not contain the synthetic drug form of the ingredient.
FDA has taken several enforcement actions against products that
violate this rule.
Marketing
ephedra as "legal high"
Members
of the dietary supplement industry have long lamented the existence
of products marketed as "street drugs" masquerading as dietary supplements
and have supported and encouraged regulatory action against them.
FDA issued a policy statement in 2000 declaring such products to
be illegal, but has taken little enforcement action in this area
until very recently.
Ephedra
for weight loss
CRN
pointed out that the use of ephedra-containing products to support
weight loss is based on numerous clinical trials demonstrating the
safety and benefit of such regimens when used appropriately in persons
without diseases or risk factors that would contraindicate the use
of ephedra. CRN contracted with Cantox Health Sciences International
for a quantitative risk assessment for ephedra and is relying on
the Cantox report as the basis for recommendations on safe dosages
and conditions of use.
Issue
of mandatory reporting
On
the question of mandatory reporting of adverse events, CRN noted
that all foods and many pharmaceutical products are currently exempt
from any requirement for mandatory reporting, except for drugs approved
on the basis of New Drug Applications. Most over-the-counter drugs,
all dietary supplements and all conventional foods including medical
foods are not required to report adverse events to FDA. While this
policy may be ripe for reconsideration, the discussion should rightfully
encompass all ingestible products currently exempt from mandatory
reporting, according to CRN.
Alternatively,
Congress and FDA could consider a narrowly targeted requirement
for a post-market surveillance system relating only to ephedra.
This would be consistent with CRN policy on ephedra and also with
previous FDA approaches to specific ingredients of potential concern,
including aspartame and olestra.
Other
regulatory concerns
According
to CRN, three immediate actions should be undertaken in response
to the concerns expressed by Senator Durbin and other legislators:
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FDA
should immediately propose a comprehensive mandatory warning
statement incorporating strong language similar to that proposed
by FDA in 1997, currently required by many states, and already
adopted by most manufacturers of ephedra-containing products.
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Congress
and FDA should consider establishing a post-market surveillance
system for ephedra-containing products, similar to the ones
previously established for other ingredients presenting potential
concerns, including aspartame and olestra. Reporting and evaluation
of adverse events should be timely and open, and reports should
be evaluated on the basis of recognized principles for assessing
causality.
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FDA
should continue and accelerate enforcement activities against
products containing synthetic ephedrine (a drug ingredient)
and against products intended for use as "street drug" alternatives.
CRN
asserted that the Dietary Supplement Health and Education Act of
1994 (DSHEA) is capable of fully protecting consumers, when it is
fully implemented and enforced. CRN requested meetings with the
legislators or their staff members to further explore cooperative
action relating to ephedra-containing dietary supplements.
About
the Council for Responsible Nutrition
The
Council for Responsible Nutrition (CRN), founded in 1973, is one
of the dietary supplement industry's leading trade associations
representing ingredient suppliers and manufacturers. CRN members
adhere to a strong code of ethics, comply with dosage limits and
manufacture dietary supplements to high quality standards under
good manufacturing practices.
Source
Council
for Responsible Nutrition (CRN).
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