We were just notified that as of Monday April 12, 2004 we will
no longer be able to sell the WDC or WBG 1 and 2 until they are reformulated.
You can order them on Friday April 9, 2004 and still receive them. Please make
sure all orders are in before noon so that they can be shipped out on Friday
otherwise we will be unable to ship them on Monday.
Questions and Answers about FDA's Actions on Dietary
Supplements Containing Ephedrine Alkaloids
February 6, 2004
What did FDA do today?
FDA published a final rule concluding that dietary supplements
containing ephedrine alkaloids (ephedra) present an unreasonable risk of illness
or injury under conditions of use suggested or recommended in the labeling,
or if the labeling is silent, under ordinary conditions of use, and are therefore
adulterated under Section 402(f)(l)(A) of the Federal Food, Drug, and Cosmetic
How is this different than what was announced on December
On December 30, 2003, FDA issued a consumer alert on dietary
supplements containing ephedrine alkaloids. The purpose of the consumer alert
was to let consumers know as quickly as possible about FDA's determination.
In addition, FDA sent letters to manufacturers who market such supplements,
stating that FDA was preparing to issue a final rule declaring that such products
present unreasonable risks. The purpose of the letters was to advise such manufacturers
and distributors that when the rule becomes effective (60 days after publication),
FDA may take enforcement action against them or the products if they do not
cease distribution of the products.
Today, FDA is issuing a final regulation declaring that dietary
supplements containing ephedrine alkaloids are adulterated because they present
an unreasonable risk.
What do the firms that received the letters have to
They have to take steps to ensure that they will be in compliance
with the regulation once it becomes effective. We hope that many responsible
firms will stop marketing dietary supplements containing ephedrine alkaloids
right away, as a number of companies have done already. We want to be clear,
however, that all firms will have to comply with the new regulation upon its
effective date in 60 days. Firms that fail to cease distribution of their products
by the effective date of the rule will face the possibility of FDA enforcement
action without further notice.
Are you prohibiting the sale of ephedra?
That is, essentially, what the rule will do. The rule concludes
that dietary supplements containing ephedrine alkaloids present an unreasonable
risk to the public health and are adulterated under Section 402(f)(1)(A) of
the FD&C Act.
Why didn't FDA reach this conclusion sooner?
The law that governs how FDA can regulate dietary supplements,
the Dietary Supplement Health and Education Act (DSHEA), requires FDA to bear
the burden in determining that a lawfully marketed dietary supplement presents
a significant or unreasonable risk and should be removed from the market. In
contrast to drugs, which must be proven safe and effective to be marketed, DSHEA
requires FDA to develop evidence after the supplements are already on the market
that a dietary supplement presents an "unreasonable risk of illness or
injury." FDA has no authority to require any studies of safety or effectiveness
for dietary supplements. FDA first proposed regulating ephedra in 1997, but
commenters including the U.S. General Accounting Office generally believed that
FDA had not developed sufficient evidence for certain actions proposed. We were
determined to make our current decisions based upon the best available scientific
In large part this came from the recent RAND analysis and a
careful review of the Boozer et al. 6-month clinical study [which were not available
to us until the last several months]. Earlier this year, the Agency published
a Federal Register (FR) notice reopening the comment period on its 1997 proposed
rule on dietary supplements containing ephedrine alkaloids to seek comment on
new scientific evidence about the risks of these products and on a proposed
warning statement for the labels of these products.
The FR announcement also sought comments on whether, in light
of current information, FDA should determine that dietary supplements containing
ephedrine alkaloids present a significant or unreasonable risk of illness or
injury under the conditions of use recommended or suggested in labeling, or
under ordinary conditions of use if the labeling is silent. In order to make
the determination regarding unreasonable risk, FDA had to examine the best available
scientific evidence and take it into account in assessing whether the product's
known or reasonably likely risks outweigh its known or reasonably likely benefits.
We sought comment from health professionals, the supplement
industry, and the general public on any additional data on ephedra's safety,
so that FDA could acquire the most complete picture possible of the product's
potential risks, as a basis for appropriate regulatory action.
What has FDA been doing to meet the requirements to
take action under the dietary supplement law?
FDA has gone to great lengths to obtain and review all of the
relevant scientific evidence on ephedra, as well as adverse event information,
even though FDA's legal authorities to obtain this information are limited.
FDA's analysis of the scientific evidence includes: a comprehensive evaluation
of the scientific literature through 2002 conducted by the RAND Corporation;
and evaluation of adverse event reports. FDA also reopened the 1997 proposed
rule (see above Q&A) for comment in March 2003, soon after the release of
an agency "white paper" outlining the types of evidence and the legal
standards that the agency was considering as a basis for further action. FDA
has since received and reviewed tens of thousands of comments, and will include
its formal evaluation of all relevant comments in the final rule. Completing
a major new rule on a never-before used legal standard with limited agency authorities
and a significant burden of proof is difficult and time-consuming. FDA has worked
as quickly as possible to complete the rule in a way that will stand up in court
and thus will provide lasting protection for the public health.
What have you been doing in the meantime to protect
the public health?
While we have been preparing our forthcoming rule, we have been
very active in protecting the public health through a series of high profile
enforcement actions aimed at addressing a real public health danger. In conjunction
with FDA's enforcement actions and other public activities involving ephedra,
entire categories of ephedra products have been withdrawn from the market, and
many manufacturers have withdrawn as well. Enforcement actions include inspections
that resulted in voluntary compliance, voluntary recalls, warning letters, seizures
and injunctions, and joint enforcement actions with FTC and DOJ. (More detail
on these actions can be found at http://www.fda.gov/ola/2003/dietarysupplements1028.html.
Examples of prominent FDA enforcement and outreach activities
in this area include:
· In October 2001, FDA brought a seizure action against
$2.8 million worth of finished drug products containing synthetic ephedrine
hydrochloride that were labeled as dietary supplements. United States v. 1009
Cases . . . E'ola International AMP II, No. 2:01CV - 820C (D. Utah filed Oct.
22, 2001). As a result of this seizure, in 2002, the manufacturer signed a consent
decree agreeing to the condemnation and destruction of the seized products and
prohibiting it from manufacturing or distributing violative ephedrine hydrochloride
products. In other actions, we have sent warning letters to multiple firms that
were marketing products containing synthetic ephedrine alkaloids as dietary
supplements, resulting in the removal of the illegal products from the marketplace.
· On February 28, 2003, based on the conclusions from
the RAND study, FDA warned 26 firms to cease making unsubstantiated claims that
ephedrine-containing dietary supplements enhance athletic performance. Since
performance enhancement was one of the two principal ways in which ephedra has
been marketed, the impact of these warning letters has been substantial. These
firms have generally complied with our letters. FDA continues to monitor them
to ensure they comply with the law, and will take further enforcement actions
· On March 31, 2003, FDA took enforcement action against
firms marketing dietary supplements containing ephedrine alkaloids as street
drug alternative products. FDA sent warning letters to eight firms. The majority
of the firms stopped selling these products or removed the street drug alternative
claims for these products.
In addition to the above enforcement actions:
· FDA has also taken new steps to educate the public
about dietary supplements containing ephedra. In February 2003, in proposing
a warning label and possible further regulatory action for ephedra products,
FDA described adverse events that have been associated with ephedra and particular
risks faced by persons with certain medical conditions.
· On March 7, 2003, FDA announced proposed rules to
establish Good Manufacturing Practices for all dietary supplements. FDA's proposed
rule is intended to reduce risks associated with adulterated or misbranded dietary
supplement products. FDA solicited comments from the public and industry on
this proposal. Written comments were received until August 11, 2003, and FDA
expects to finalize the rule in the coming year.
Other examples of FDA's continued outreach efforts to promote
the safe use of dietary supplements include:
· Expanded use of our Web site to communicate critical
information and useful strategies about dietary supplements to industry and
consumers. Examples include FDA Talk Papers, articles in the FDA Consumer magazine,
Fact sheets, etc. Other examples of these materials include CFSAN's "Overview
of Dietary Supplements" and "Tips for the Savvy Supplement User."
Industry has access to guidance documents, such as FDA's "Statement of
Identity, Nutrition Labeling, and Ingredient Labeling of Dietary Supplements
Small Entity Compliance Guide," which discusses compliance with the Agency's
regulations implementing DSHEA's labeling provisions.
· FDA continues to work closely with other Federal and
state entities including FTC, DEA, Customs, etc. involved in combating health
fraud. An example is our joint FDA/FTC project entitled, "Operation Cure-All",
which is aimed at halting the Internet promotion of products, including dietary
supplements, that make false or misleading disease claims. This year, FDA has
issued more warning letters for misleading and unsubstantiated claims involving
dietary supplements, including misleading claims about ephedra products, than
in prior years.
In conjunction with all of these actions, ephedra use by consumers
has declined significantly, and many firms have reduced their marketing of ephedra-containing
Why a rule?
The agency chose to do a rule in this case because it the most
efficient and powerful way to achieve successful enforcement of this provision
against numerous companies. It will apply to all types of currently-marketed
dietary supplements containing ephedrine alkaloids, not individual products.
What types of enforcement actions are possible?
FDA has a variety of enforcement possibilities including seizure
of the product, injunction against the manufacturers and distributors of such
products, and criminal prosecution of violators.
Is this rule final? Why wait 60 days?
The rule as published will be a final rule. In accordance with
5 U.S.C.801-808, the rule will become effective 60 days after publication so
as to allow for congressional review.
Why does FDA believe "Imminent Hazard" hasn't
been met in this case?
FDA is confident that it has a clear legal basis for taking
effective action to protect consumers under the "unreasonable risk"
standard. FDA does not believe that it is necessary to look to other authorities
to take the action that it has taken today.
How did FDA arrive at this final rule?
Through a series of actions. In 1997, FDA first proposed a rule
on dietary supplements containing ephedra including a warning statement on these
products. It was modified in 2000. Since publication of this proposal, new scientific
evidence has come to light. To solicit comments on this new evidence as well
as on a proposed warning statement, in February 2003 FDA published a Federal
Register notice outlining FDA's concerns and reopening the comment period. The
final rule comes as a result of public comments, literature review, adverse
event reports, scientific studies and information sent to the docket.
What types of products are subject to the rule?
The rule applies to all dietary supplements that contain a source
of ephedrine alkaloids, such as ephedra, Ma huang, Sida cordifolia and pinellia.
Are all products containing ephedra affected?
Essentially all currently marketed dietary supplements that
contain ephedrine alkaloids will be affected by the rule. The scope of the rule
does not pertain to traditional Chinese herbal remedies. It generally doesn't
apply to products like herbal teas that are regulated as conventional foods.
Ephedra is not Generally Recognized as Safe (GRAS) for foods and not approved
for use as a food additive.
What about Dietary Supplements that are considered ephedra
The FDA is aware of dietary supplements that are marketed as
substitutes for dietary supplements containing ephedrine alkaloids. It is not
clear how widely they are available. To the extent that these products are brought
to our attention, we will evaluate them in the same manner as all other dietary