Vol. II pg. 190 Dr. Blackburn
"I want to see whether if we vote for any of these levels, recommended
levels that have come down 10-fold in 2 days, or in 10 months [since the
1995 working group meeting], down to 2 milligrams, what we're really doing,
and I think only the people from the industry can tell us. Then if we know
what we're doing, then we go ahead and do it. If we reduced it to those
kind of doses with these kind of restrictions and this sort of quality
control, is there going to be any market and are we banning the drug for
use as a good supplement, in which case we might as well go and vote that
But, the banning of ephedra herb products
is not possible under DSHEA because the FDA has only very poor quality
and unconvincing evidence that using ephedra herb products per label instructions
poses a substantial and unreasonable risk to those using it. It cannot
meet its burden to prove these alleged risks. Hence, the FDA now wants
to reduce the permitted label single dose and permitted label total daily
dose and permitted label number of days of use so that none of the benefits
of using ephedra will be obtainable by consumers, thereby causing these
troublesome (to the FDA) products to dissappear from the market.
This is a ban by the back door.
Vol. II pg. 209 Dr. Jasinski
"...my view is that you're probably going to wind up with a dose of
no more than 40 to 60 milligrams of total ephedrine alkaloids per day.
The reason for this, just doing this and coming back again, from being
a pharmacologist and a clinical psychopharmacologist and looking at this
in terms of what we know about ephedrine, we know that from studies which
have been done over the last couple of years that you can take anhydrous
caffeine and give it to people and get amphetamine-, cocaine-like effects,
maximizing at about 200 milligrams, between 100 and 200 milligrams."
Right. Note that the FDA approved dose of
caffeine in OTCs like NoDoz is 100 mg. to 200 mg. An unwanted overstimulating
effect would be particularly noticeable to an adult who had not experienced
coffee before, just as most adults in the U.S. probably have not experienced
ephedra herb before. However, in the U.S., most adults already have
tried coffee and, if they had an unpleasant reaction, avoid it.
Vol. II pg. 210 Dr. Jasinski
"...somewhere about 2.5 milligrams of amphetamine...is equivalent to
about 10 to 15 milligrams, 12.5 milligrams, of ephedrine. So one would
look at this to keep it in this dose range of what people are using as
the average or maximum sort of caffeine dose."
Vol. II pg. 221 Dr. Ricaurte
"I think it's telling that just from October '95 until here we are
8, 9, 10 months later, we've already gone from an estimated safety level
down 10-fold, and I'm not quite sure on what basis we're doing this."
Vol. II pg. 222 Dr. Ricaurte
"With the issue of a margin of safety, I'm left at somewhat of a loss
because for a margin of safety you really have to have some indication
and what I've heard this afternoon is that all purported purposes of use
are being taken off the table and it leaves you with, well, what the heck
are we going to use this for. If there's no clear answer to that, then
the margin of safety, quite frankly, has to go to infinity because you
can't do a risk/benefit when we don't have a perceived benefit." (emphasis
The FDA has made this conclusion inevitable
by requiring that the committee disregard any evidence concerning the efficacy
of ephedra for those purposes for which it is being most widely sold: weight
loss and energy. When you cannot consider any benefit, then of course
even small risks will seem unacceptable.
Vol. II pg. 222 Dr. Ricaurte
"Question number 3 [the possibility 'of significant harm' and 'serious
adverse effect in at least one individual']--I'm not sure that there's
many compounds that can satisfy that requirement, so the answer is, no,
I can't, but I'm not sure that it's entirely a fair question with regard
to the ephedra alkaloid per se."
And it is not the definition of harm mandated
in DSHEA, either.
Vol. I pg. 145 Mr. Israelson
"... the standard you are asking us to look at is significant harm,
which has two sub-definitions, I'm just curious how you arrived at that
definition, specifically in its two subparts, which is different from the
statutory definition within the law." (emphasis added)
Because FDA has chosen to charge the Committee
with a definition of harm contrary to that intended by Congress, FDA must
withdraw the Rule, re-convene the Committee, reach a new conclusion that
fits within the ambit of Congress's will, and re-propose a new Rule.
Vol. II pg. 231 Dr. Ziment
"So my recommendation is that ephedrine, as such, has always been prescribed
by orthodox physicians in a dose of about--a minimal dose of 15 milligrams
3 times a day for adults and proportionately less for children. That should
be the baseline dose for the orthodox, and I believe it's safe even if
used for a prolonged period of time because I certainly used it that way.
I've looked at the literature and I don't see much evidence that that dosage
Vol. II pg. 236 Dr. Wang
"What margin of safety? What I did is just took a 10-fold safety factor
from the OTC maximum level per day basis for, again, ephedrine alkaloid."
It would be interesting to consider what would
be left on the market if all products had to be taken on the basis of a
10-fold safety factor. Oxygen, water, sugar, and total daily caloric
intake all fail the tenfold safety test. DSHEA does not authorize
the FDA to impose a 10X safety margin, either.
Vol. II pg. 249 Dr. Jasinski
"Thirdly, I think there is a telling point which was made that you
have to be very cautious. I have been both historically and been involved
in people that have made decisions that have driven things underground.
I think what amazed me is watching the anabolic steroids of people passing
laws because they got concerned about athletes using these. We have now
a whole underground economy with anabolic steroids being imported which
are being used which are less pure than those which were manufactured as
pharmaceuticals coming in, and that's creating public health problems and
Remember that Dr. Jasinski is an expert on
drug abuse. Heed his warning.
Vol. II pg. 249 Dr. Jasinski
"And I would think it would be better to encourage industry to come
in with a position which they can defend on what they're going to do voluntarily
and that this would be legitimate to set the standards. It would be much
better than trying to impose a policy."
Far better, and far more effective.
The FDA seems to think that if it makes a rule and points enough guns at
enough people, any rule will work. This one won't. It will
cause far more harm than it prevents, an all too common result at the FDA.
Vol. II pg. 250 Dr. Croom
"We've got to find a better way, I would say, to come together and
talk about how do we impact the public health because there are benefits
coming here and not just risk..."
Vol. II pg. 255 Dr. Dentali
"When I came here, I understood that my mission is the common-sense
one, is to reduce the risk with these products. So when I got the updated
version of the adverse events, I wanted to do a rigorous analysis of those,
particularly with respect to the October  recommendations.
For me, that would be to look at the adverse reactions that are consistent
with ephedrine use and to eliminate the ones that are not, to look at ones
that are consistent with the levels of ephedrine that were recommended
in October or that were proposed by a few members and eliminate those that
were not, to look at the ones that were combined with other known stimulants
and eliminate those reports, to look at the ones that were resulting from
clear abuse and to eliminate those, to look at the ones that were made
with only the herb and the herb extract and to include those and exclude
all the others, and to exclude the ones that were resulting from chronic
use. And I feel that that wasn't done and I feel that that was very
important for me to be able to have a handle on beginning to look at the
risk as it was presented to me regarding the adverse effects for us to
determine for traditional use and traditional forms what is the danger
of using this botanical."
A very cogent objection.
Vol. II pg. 262 Dr. Ricaurte
"So the pendulum has swung from one extreme of being very cynical to
trying to regard this as a product, a dietary ingredient that should be
used by consumers and not be over-regulated, not be in a position where
the FDA or the medical profession or the scientific advisory group is put
into a position of over-regulating something that adult Americans may wish
to use under safe conditions. Those have not been defined."
Vol. II pg. 262 Dr. Ricaurte
"I think as long as the concern for some of the use is misuse and abuse,
I find it somewhat, again, disingenuous to make recommendations, well,
we're going to limit the dose from 20 down to 10 or down to 5. As a consumer,
I don't have to be particularly adept in mathematics to realize that if
now the tablet or capsule or a spoonful contains only 5 milligrams, I take
2 or I take 3 or I take 4. So the dose considerations and frequency of
use suggestions, while I recognize that they're well-intended and I appreciate
what the efforts are in terms of looking at the reality of the use of the
product by a population of individuals who may be predisposed to misusing
or abusing the product, I don't think those are particularly effective
They are worse than ineffective; they will
substantially increase the risk of harm by destroying the integrity and
credibility of all the label instructions and warnings on ephedra dietary
Vol. II pg. 265 Mr. Israelson
"...I share the view that has been expressed that if you ban this product,
you'll drive it underground and create a bigger problem."
Vol. II pg. 270 Dr. Woosley
"...as I think you pointed out, Dr. Ricaurte, there is no risk/benefit
ratio you can establish when you don't have a known benefit..."
There are benefits known to the Committee;
the FDA just refuses to allow the Committee to consider them, thereby guaranteeing
a proposed Rule that is not based on reason or evidence.
Vol. II pg. 274 Dr. Inchiosa
"...in the experiences in Ohio, the Canadian study, even the information
collected was that young people who are abusing the drug largely get it
from ephedrine hydrochloride from over-the-counter preparations. I heard
that statement made that a large number of the use by young and abuse by
young was from over-the-counter preparations, not the difficult process
of extracting something from a nutritive supplement."
Vol. II pg. 197 Dr. Kessler
"It's [the judgment on a safe level of ephedrine] based on the record
before individuals. We have alot of different individuals with a lot of
different expertise. We'll take that into account. For some, it'll be the
information that has been presented over the last two days. For some,
it'll be information that has been presented both in the working group
and over the last two days. For others, they certainly can draw upon the
literature that they're familiar with and their own expertise, but
it's the record before them as has been presented. I think that the starting
base is over the last two days, certainly."
But the data supplied over the last two days
is of very poor quality and, as admitted by Dr. Love, has not yet
been peer reviewed. Moreover, vital OTC adverse event safety data
has been expressly removed by the FDA.
Vol. II pg. 204 Dr. Chassy
"We are talking about a dietary supplement which I as a consumer, when
I walk into a store that sells these products, have every reason to believe
are at least as safe as the foods in my diet that I mean to supplement
and so I would hold them up to a very high standard of expected safety."
As we have shown, ephedra herb dietary supplements
are already much safer than foods in common form. The bottom line
is that consumers have unrealistic beliefs about the presumed safety of
foods and need badly to be educated about that. Educating consumers
about the risks of foods is of far greater importance than that of dietary
supplements, on the basis of the record, yet the FDA has done a very poor
job of providing needed information on food risks to consumers.
Vol. II pg. 157 Dr. Jasinski
"...the critical question has been the relationships of these deaths
and your data and the particular interpretation versus the interpretations
we've heard, and there has been a conflict."
"...and the essence of the scientific culture is we have peer review."
Vol. II pg. 158 Dr. Jasinski
"My question is have you prepared a report on your data, how you collected
it, how you interpreted it and what conclusions you've made, and have you
submitted this to internal review within the agency or outside the agency?
And, similarly, have you taken the report from this ad hoc committee and
submitted it to a peer review?" (emphasis added)
Vol. II pg. 158 Dr. Love
"We, of course, intend to do that, but we were analyzing this data
even over the weekend to supply the information to you at this committee
meeting here." (emphasis added)
They were in such a tight schedule that they
didn't have time to do the internal review or submit the data and their
conclusions to peer review. So they just rushed into the meeting
without that. Where is that peer review that they intended to do?
Vol. II pg. 248 Dr. Jasinski
"...I have been disturbed to some extent by what is really the lack
of either scientific scholarship or scientific quality through all of this.
...it's like the question I asked Dr. Love in terms of did she write a
report, was it reviewed, was it peer reviewed, making this available before
you start getting these discussions." (emphasis added)
Vol. II pg. 26 Mr. Betz
"...although I pointed out last time [meeting in 1995] that these three
products contain absolutely no ephedrine alkaloids, they're still in the
report as part of this larger report."
The report that the FDA provided to
the Committee was carefully purged of data pertaining to OTC drugs containing
the same ephedra alkaloids as the dietary supplements, but apparently little
or no care was taken to remove adverse reaction reports for dietary supplements
that contained no ephedra alkaloids whatsoever. The FDA's report
would never pass peer review. It must be noted that the FDA report
as given to the Committee would not meet the Supreme Court's Daubert criteria
for weeding out junk science.
Vol. II pg. 53 Mr. Shapiro
"...it has also been widely reported that the individual [college student
who died in Florida] ignored clear warnings on the product and took at
least twice the daily dose all at once. Those same reports indicate that
his companions all took three times the daily dose without incident. In
addition, according to the police report, cannabis and another product,
Nexus, consisting of the herb kava-kava were found in the hotel room."
"It is noteworthy that the autopsy report contains no findings at all relating
to the presence of other substances such as cannabis, cocaine, amphetamines
or barbiturates. It appears that no tests were performed for the presence
of these and other substances which is most certainly very strange."
"Yesterday, Dr. Love said that the tests were performed. If so, the results
were not made a part of the autopsy report." (emphasis added)
"The Ad Hoc Committee on the Safety of Ma Huang submitted to you as
part of their package the declaration of Dr. Joseph Brazelica, a toxicologist,
which sets forthe many deficiencies in the autopsy report and concludes:
'That it is not possible to determine from the report of autopsy to a reasonable
degree scientific certainty that the cause of death was the ingestion of
some quantity of a product containing ephedrine.'" (emphasis added)
Vol. II pg. 110 Dr. Askew
"Clarification of the autopsy." (This refers to the autopsy mentioned
earlier in which there was some question as to what the coroner found in
the consumer's bloodstream.)
Vol. II pg. 110 Dr. Love
"The clarification of the autopsy report is that information on the
consumer's negative ethanol and cannabis levels are in the record."
Vol. II pg. 147 Dr. Love
Dr. Love clarifies the Florida autopsy report, which found ephedrine
alkaloids and caffeine positive, while a long list of others tested for
were negative, including cocaine, amphetamines, strychnine, cardioregulatory
drugs, and others.
Vol. I pg. 229 Dr. Fukagawa
"...in letters that we've received from Mr. Appler from the Ad Hoc
Committee on the Safety of Ma Huang and from Mr. Shapiro at Bass and Ulman,
who also referred to the 20 year old from Florida, suggest that his situation
was perhaps not as clear-cut with the presence of other compounds in his
hotel rooms etc., and the lack of toxicological reports or analyses."
Vol. I pg. 229 Dr. Love
"Actually all of his blood levels for anything else were negative,
and the coroner directly attributed it to the use of this product."
"Now, where is the exception is this is the highest level of ephedrine
alkaloids that we have analyzed in any product." (emphasis added)
Why didn't the FDA show the autopsy report?
Mr. Prochnow said that this data was not in the autopsy report.
Vol. II pg. 65 Dr. Calvin McCausland from Enrich International, Orem,
"...if you look at the 20-year old in Florida and the autopsy report,
you will find reasonable doubt. That reasonable doubt has been spelled
out by Dr. Borzelica, from the Medical College of Virginia and it's in
those three volumes that you have before you." "There are other deaths
that have been listed that have reasonable doubt. They took ephedrine a
week before, reportedly. There is none in the tissues of the autopsy. Reasonable
Vol. I pg. 59 Michael Davidson, M.D.
Dr. Davidson's qualifications and his review of the adverse event reports
on behalf of the NNFA. See Adverse Event Clinical Summaries at Tab
F referred to by Dr. Davidson. He reviewed the case files underlying
191 of these adverse event summaries. Of these 191 case files, he
categorized 84 of the events to be serious and 107 not to be serious. "Of
the 84 serious events, I found that 13 were not related to ephedra. I classified
eight as unknown for lack of information. Thirty-four were remotely related;
22 were possibly related, and seven were probably related."
pg. 61 "Six deaths were possibly associated with ephedra. In two cases,
not enough information was provided to consider an assessment. Two deaths
were related to consumption of toxic doses of ephedra." "Of the six
deaths possibly associated with ephedra, three were due to sudden death
and cardiac abnormalities were present on autopsy in all three individuals.
Two of the possibly associated deaths were due to strokes. One of these
deaths was due to a strong [stroke?] that occurred in an obese individual
male who was using multiple other supplements and who had basilar artery
atherosclerosis on autopsy. Another was a fatal stroke that occurred in
a 44 year old female due to a left internal carotid artery occlusion. She
had a very strong family history of strokes. The sixth possibly associated
individual whose death was from a seizure was also on phenteramine, Apidex,
a prescription drug for weight loss. All of these six possibly associated
deaths occurred on the high dose ephedra products." [How high?]
"There were ten cases of non-fatal myocardial
infarction. Of these ten cases, four, in my judgement, were not related
to ephedra. In another three reports, there was not enough information
provided to make an assessment. In three cases of myocardial infarction,
a possible association with ephedra exists. In all three of these reports,
post-myocardial infarction angiograms revealed normal coronary arteries.
All three individuals were consuming high-dose ephedra in combination with
There were 17 reports of non-fatal strokes.
Three cases were unrelated or remotely related to ephedra-containing products.
In four additional cases, not enough information was available for me to
make an evaluation. In the remaining ten cases, a possible association
with ephedra products exists.
In four of the ten possibly associated cases,
these individuals had significant hypertension of hyperlipidemia diagnosed
prior to the stroke. One case involved a male with a dilated left ventricle
as a possible source of emboli. The remaining five cases involve premenopausal
women. At least two of these women were on oral contraceptives. One of
these was noted to be a cigarette smoker and the other was diagnosed as
having a positive lupus inhibitor. In the three remaining possibly associated
cases, oral contraceptive use is unknown and one was a cigarette smoker,
and one of these women was on the product for over a year before she suffered
as intracerebral hemorrhage. All but one of these stroke patients--the
exception being the woman with a positive lupus inhibitor--were on the
high-dose ephedra containing products.
There were 16 reports of seizures. Of these
cases, the majority of seizures occurred in individuals with either a history
of seizures or an abnormal EEG on follow-up. As I am not a neurologist,
I made only a limited evaluation of these cases.
In summary, with the exception of two cases
of toxic exposure to ephedrine, there appears to be only infrequent possible
associations of ephedra-containing products with severe adverse reactions.
These infrequent possible associations are characterized by coronary or
cerebral thrombosis and seizures.
Of the 105 non-serious adverse events that
I reviewed, these are characterized by increases in blood pressure, tachycardia,
nervousness, and dizziness. These symptoms are expected potential side
effects of ephedra-containing products. These side effects appear to be
dose-related, occurring in greater frequency in the high-dose ephedra-containing
To test the hypothesis that low-dose ephedra
products below 15 mg. per dose, which is the recommended dose of the working
panel, do not have a significant rate of adverse events, I reviewed the
adverse events associated with the ephedra product containing less than
15 mg. per dose. These products account for over one-third of all
the ephedra-containing products, but only approximately 7% of the adverse
events. Of these 42 adverse events on low-dose products, there were
only two serious events that were possibly related to the product.
I mentioned one was the young woman who had a stroke who also had a positive
lupus inhibitor, and the other was a 55 year old female who had a seizure.
Based on my medical review of the ephedra
adverse event reports, I have the following opinions:
Number one, last year's  recommendation
of the ephedra working group and those of the dietary supplement trade
associations are appropriate. The two main issues that appear to affect
adverse reactions are the dose of the ephedra and the quality assurance
of the product.
The proposal to lower the ephedra alkaloid
content to 60 mg. per day with 15 mg. of ephedra per dose, expressed as
ephedrine equivalents, provides a margin of safety based on the fact that
the vast majority of both serious and non-serious adverse reactions occurred
with products that exceeded these dosage thresholds.
Improved good manufacturing practices and
quality assurance will provide dosing consistency within product batches.
Because dosing consistency is important, I would add to the recommendation
that products that can be easily mis-dosed not be permitted. (emphasis
The ephedra working group also recommended
very appropriate warnings and labeling instructions. I would also include
on the label cautions against the use by smokers, those taking oral contraceptives,
and those with a history of cardiovascular or seizure disorders.
Vol. II pg. 107 Dr. Georgitis
"Dr. Love, I have a question for you, in terms of the serious aadverse
events below the median value of 20 milligrams per serving of the ephedrine
alkaloids, do you have a percentage as to how many of those out of the
total adverse events?
Vol. II pg. 107 Dr. Love
"We haven't expressed our data in that form because, of course, we
have only a relatively few samples where we've been able to collect the
sample that the consumer was using at the time of the injury and be able
to analyze that." (emphasis added)
This is clearly a very important question
concerning how the numbers of reports of adverse events related to the
amount of ephedrine actually consumed. Here, the FDA admits that
it doesn't know that. This is a very poor reflection on the follow-up
of the FDA after receiving such reports.
Vol. II pg. 108 Dr. Kessler (to Dr. Love)
"...you asked for relatively clean cases that didn't have a lot of
confounding factors--where you have a medical examiner, where you have
a sample--could you just go through those cases and at what levels you
saw significant adverse reactions?
Vol. II pg. 108 Dr. Love
"Well, unfortunately, I don't have all the data in hand here,
but there are a number including very recent cases for which we yet don't
have all information on how the consumer used the product but a more recent
death, again, it appears to be a cardiomyopathy case. The total alkaloids
in that case are 10 milligrams, total alkaloid. As I stated a death from
what appears to be long-term use of a product containing 10 milligrams
of total ephedrine alkaloids."
The FDA here mentions a single case of what
"appears" to be long-term use of a product containing 10 milligrams of
total ephedrine alkaloids. No information is provided on what else the
individual was taking or how the FDA knows how much of the product the
individual was using, or how often.
Vol. II pg. 109 Dr. Kessler (to Dr. Love)
"And just go through that case. I mean just so we have some--I mean
the best data that we have."
Vol. II pg. 109 Dr. Love
"Well, as I stated I don't have all those details."
Vol. II pg. >
This is a shockingly small amount of total information on what is supposed
to be their best or one of the best cases providing evidence concerning
adverse reactions versus dose.
Vol. I pg. 228 Dr. Chassy
"I'm trying to get at something that gives us some feel for where we
begin to see a dose-response correlation, because as it stands now, you
have effects all across the board. But you do have fewer products with
very high amounts of ephedrine alkaloids in them, and where you have fewer
of those products on the market, you seem to have around the same number
of cases of adverse effects reported, which suggests that there is a dose-response
Vol. I pg. 234 Dr. Jasinski
"...you're showing this increase [in relative incidence], and how much
of this increase is actually an increasing showing that we're getting a
growing public health problem that's going to project, or how much of this
increase is related to the change in the way you've done things in publicizing
this and asking people to report in?"
Indeed, the FDA's publicity concerning the
adverse events reports they received in which injuries were associated
with (but not necessarily caused by) the use of ephedra alkaloid containing
dietary supplements has resulted in reports on CNN and a recommendation
not to use ma huang in the July 1997 Reader's Digest (pg. 85). The
FDA's warnings have also appeared repeatedly on network TV. There
has been no similar FDA publicity during this period concerning adverse
events reports the FDA has received for ephedra alkaloid (ephedrine, pseudoephedrine,
or phenylpropanolamine) containing OTC products.
Vol. II pg. 277 Mr. Guzewich
"...I want compliment Dr. Love on what she's trying to do in running
a surveillance program. I've been doing that for 16 years for food-borne
disease. It's not an easy task and she has a very difficult and often
thankless job, and you're reporting for poor quality data and when
it's the only data you can get ahold of and you're trying to make decisions
on that kind of data..."
Yes, the data are poor quality, and the FDA
cannot improve the quality of these data by dumping them into the lap of
a hapless committee, which is then told to ignore any benefits of the products.
Moreover, the FDA failed to present the committee with other available
and important information. The FDA could have prepared a report on
the adverse events and had the data peer-reviewed, but it did not.
The FDA should have had data available on the spontaneous occurrence of
MIs and strokes and seizures in the population using the ephedra products,
but did not. The FDA should have had data available on the
occurence of adverse side effects in the OTC ephedrine containing drugs
for comparison, but they did not.
Vol. II pg. 282 Mr. Guzewich
"...sophisticated choices about products that might be at risk to them,
I think, is more than we can reasonably expect consumers to have to assess
when they choose between different bottles on the shelf. Therefore, consumers
should be able to purchase a product in the market and find it safe at
normal use, and even at abused levels..." (emphasis added)
More and better information on labels and
in labeling and other methods of education for consumers so that they can
make choices is a far better and safer choice, in our opinions, than to
treat consumers as unmitigated idiots that must have decisions made for
them by committees assembled by the FDA and given by the FDA poor quality
data and unreasonable limitations (eg., do not consider any benefits) to
make decisions for them. The final point made by Mr. Guzewich, that
a product in the market should be safe at virtually any dose is impractical
and ridiculous. Consumers must be expected to assume some personal
responsibility for their use of products, at least extending to their compliance
with label instructions. Moreover, DSHEA requires that dietary supplement
products not be unreasonably unsafe when used as directed, not to be safe
no matter how badly abused.
Vol. II pg. 285 Dr. Chassy
"Several [committee members] have noted the quality of the data, and
without blaming the FDA staff in any way because they are to be commended,
they need to build a cause-and-effect relationship, however hard that may
be. I think they especially need to do it because DSHEA sets us in a situation
where they [FDA] may find themselves in court being asked to bear the burden
of proof that the ephedra alkaloids have done damage in a specific case,
and they may find themselves doing that again and again and again."
The above comment speaks for itself.
FDA data from this Committee meeting would never meet the Supreme Court's
Daubert criteria for weeding out junk science. Because of this, FDA
must withdraw the Rule, re-convene the Committee, provide sound peer reviewed
data to the Committee members in advance, reach a new conclusion that fits
within the ambit of Congress's will, and re-propose a new Rule.
It doesn't seem that the thousands of pages
of materials that the FDA presumably distributed to each of the committee
members before the meeting were actually read by most of them, judging
by the questions asked of the FDA during the meeting. These questions
included what are the background numbers of cardiac deaths and seizures
among the population using ephedrine-containing dietary supplements and
what were the levels of adverse reports for OTC products containing similar
amounts of ephedrine as ephedrine-containing dietary supplements).
The answers to these questions are key information
in interpreting the meaning of the adverse reports. Yet, at the meeting,
Dr. Love (FDA) did not have this information. Either the committee
members did not do their homework or the FDA did not have key information
available either before or at the meeting or both.
.fo Version of 14 August, 1997, 12:13 AM PDT;
SPECIFIC PROPOSAL FOR A CONSTITUTIONALLY ACCEPTABLE
The FDA cannot ignore the limits placed on
it by the First Amendment of the U.S. Constitution. We have discussed
these limitations at some length (often quoting Supreme Court Justices)
in a prior section on general labeling considerations. The FDA has
no constitutional authority to prohibit statements that are true and not
misleading. The FDA does have the authority to prohibit statements
that are false or misleading, and to require reasonable disclosure of hazards
on the labels and labeling of dietary supplements sold in interstate commerce.
This discussion considers the application of these limits and powers to
a specific product.
Commenters Pearson & Shaw license formulations
containing approximately 1.8 grams of ground ephedra herb per one tablespoon
serving (the amount of ephedra herb being adjusted on the basis of herb
lot analyses so that one tablespoon of product contains a total of 20 mg.
of ephedra alkaloids). No ephedra extracts are used in this product,
there is no caffeine or other methylxanthines, and it contains no synthetic
ephedrine, pseudoephedrine, or phenylpropanolamine.
Since whole ground herb is used rather than
an instantly soluble ephedra alkaloid extract, blood levels of the alkaloids
increase much more slowly as the ground herb slowly releases its alkaloids,
thereby providing a time-release effect and reducing the risk of adverse
effects in sensitive individuals.
Products containing real ephedra herb when
ingested are pharmacokinetically substantially different from products
containing ephedra alkaloid extracts; regulating them in an identical manner
is arbitrary, capricious, and contrary to fact.
With a one tablespoon serving, this product
contains approximately 1.8 grams of ephedra herb (adjusted to standardize
the amount of ephedra alkaloids) per serving of tea, quite conservative
compared to the traditional tea serving of 1.5 to 9 grams (usually 5 to
6 gm.) of ephedra herb referred to on page 20 of the proposed Rule.
On the basis of the FDA's proposed Rule, we
propose the following new label for this product:
NOTICE: CONTAINS EPHEDRA HERB WHICH CONTAINS EPHEDRINE ALKALOIDS.
FDA MANDATED SERVING SIZE:: 1 TEASPOON (contains 6.7 mg. total ephedra
alkaloids). The FDA believes that a serving size of 8 mg. or more would
present an unreasonable risk of injury or illness. Taking more than
this recommended serving may cause heart attack, stroke, seizure, or death.
TRADITIONAL SERVING SIZE: 1 TABLESPOON (contains 20 mg. total ephedra
alkaloids from approximately 1.8 grams of herb). This serving size is NOT
approved by the FDA.
DIRECTIONS: Add 4 ounces of hot or cold water to one serving of mix.
Stir briskly and drink. DO NOT EXCEED THREE SERVINGS A DAY!
On the first day, drink one-half serving before breakfast. For the next
two days, drink one serving before breakfast. For the next three days,
drink a second serving before lunch. From then on, drink a third serving
one hour before dinner. Do not take more than one serving within a 6 hour
period. Keep in a cool, dry place. Keep lid tightly closed when not in
FDA MANDATED INSTRUCTIONS: Consult a health care provider before use.
Do not use this product for more than 7 days. Risk of adverse reactions
increases with duration of use. Starting and stopping use may increase
risk of adverse reactions.
WARNING: KEEP OUT OF REACH OF CHILDREN. NOT FOR SALE TO OR USE BY PERSONS
UNDER THE AGE OF 18. DO NOT EXCEED RECOMMENDED SERVING SIZE OR FREQUENCY.
May cause insomnia in sensitive individuals, especially if taken too soon
before bedtime. Consult your physician before use if you are taking asthma
medications, decongestants, anorectic (appetite suppressing) drugs, antidepressants,
or cardiovascular medications. Use of caffeine containing beverages may
increase the stimulating effects of this product. Do not use this tea if
you are pregnant or lactating, if you have high blood pressure or cardiovascular
disease (especially stroke or cardiac arrhythmia) or a family history of
these disorders, diabetes, difficulty in urination due to prostrate enlargement,
seizure disorder, glaucoma, hyperthyroidism, or psychiatric disease.
Do not drink this tea within 14 days after taking MAO (monoamine oxidase)
inhibitor drugs. Stop use and call your health care professional if dizziness,
headache, heart palpitations, or tingling sensations occur. Stop use or
reduce serving size if sleeplessness, tremors, nausea, or nervousness occurs.
Stop use if symptoms of allergy to this product develop.
Note that these instructions increase the serving
size from the initial one-half of 6.7/20. mg. ephedra alkaloids once per
day to the final 6.7/20 mg. three times per day over a period of seven
days. This schedule is designed to reduce the incidence of adverse
effects by allowing the development of tolerance to the CNS and cardiovascular
effects of the ephedra alkaloids.
The Caution on page 43 of the proposed Rule
has been modified in several respects:
1) "Warning" is used rather than
"Caution," as is tentatively proposed by the FDA.
2) Rather than "Seek advice from
a health care practitioner if you are pregnant or nursing or if you are
at risk or are being treated for high blood pressure, heart, heart, thyroid
or psychiatric disease, diabetes, seizure disorder, stroke, or difficulty
in urination due to prostrate enlargement." these and other conditions
are all listed as "Do not use if..." absolutely contraindicated conditions.
We do not believe that these conditions should be required as absolute
contraindications (rather than checking first with your doctor), as we
have expressed it, but the stronger form of warning we have used should
not be prohibited. It would be arbitrary, capricious, and not in the public
interest for the FDA to standardize the warning in such a way as to prevent
the listing of additional contraindications or to prevent contraindications
from being listed as absolute rather than relative. FDA should require
a minimum list of contraindications but must never prohibit additional
or stronger contraindications than their minimum required list. For
example, rather than "Consult your health care professional before use
if you are taking an MAO inhibitor or any other prescription drug." we
believe that we should be permitted a label warning that taking an MAO
inhibitor within the last 14 days is an absolute contraindication.
3) "Taking more than the recommended
amount will not necessarily increase benefits." has not been used because
it is both weak and lacks credibility. Worse yet, this lack of credibility
may tend to reduce the credibility of the other warning statements.
Instead, we have used the FDA's much stronger warning: "The FDA believes
that a serving size of 8 mg. or more would present an unreasonable risk
of injury or illness. Taking more than this recommended serving may
cause heart attack, stroke, seizure, or death." We do not believe
that this stronger warning should be required, but the FDA should not prohibit
a stronger warning than the one that is proposed.
4) We have not instructed the user
to consult with their health care professional if they are taking any prescription
drug. Such consultations may easily cost $50 or more; people will
generally ignore this warning. It is unreasonable to expect customers
to take this action; they simply won't do it. It is unwise to put
a warning on the label that one knows will be generally disregarded, for
such warnings promote a general disregard for other far more important
warnings. As an alternative to this ineffective warning, we believe
that we should be allowed to say "Consult your physician before use if
you are taking asthma medications, decongestants, anorectic (appetite suppressing)
drugs, antidepressants, or cardiovascular medications." If the FDA
Rule requires the label to carry "Consult your health care practitioner
before use if you are taking an MAO inhibitor or any other prescription
drug," this statement will be prefixed with the truthful non-misleading
"FDA mandated Warning:", which is protected speech under the First Amendment.
5) Users of ephedra dietary supplements
should not be instructed to call a physician if "sleeplessness, tremors,
nausea, or nervousness occur," since these are not likely to be precursor
symptoms of a potentially serious or life-threatening adverse reaction.
Instead, they should be instructed to "stop use or reduce serving size."
If users are instructed to make an expensive call to their doctor because
of a minor matter like temporary insomnia, they are less likely to call
their doctor when "dizziness, headache, heart palpitations, or tingling
sensations occur," which may be symptoms of far more serious problems such
as hypertension, stroke, or a potentially serious cardiac arrhythmia.
There is a very real cost to diluting major warnings with minor warnings.
If the FDA's Rule requires the label to carry their preferred warning,
it will be prefixed with the truthful non-misleading "FDA mandated Warning:",
which is protected speech under the First Amendment.
6) The split label: This
label identifies FDA mandated information as such. This label contains
two different serving sizes, one mandated by the FDA and identified as
such, and an alternate serving size that provides a traditional amount
of ephedra herb per serving.
Identifying FDA mandated information as such
is truthful and non-misleading. Indeed, without such identification,
the customer would be misled into believing that the product manufacturer
voluntarily agreed with this information and had voluntarily placed it
on the label. FDA has no constitutional authority to prohibit the
truthful identification of the FDA as the source of this information and
its mandatory nature.
The FDA mandated serving size is one teaspoon
containing 6.7 mg. ephedra alkaloids. This serving size is clearly
identified as being recommended by the FDA. Moreover, the FDA's reasons
are clearly and forthrightly stated, "The FDA believes that a serving size
of 8 mg. or larger would present an unreasonable risk of injury or illness.
Taking more than this recommended serving may cause heart attack, stroke,
seizure, or death." This is the strongest warning regarding serving
size that the FDA has proposed in the Rule. If this were the only
serving size described on the label, we believe the FDA would have no objections.
The traditional serving size is one tablespoon
containing 20 mg. of ephedra alkaloids. It is in fact at the low
end of the traditional ephedra herb dosage range. The statement that
this is a traditional serving size is truthful and non-misleading; the
FDA has no constitutional authority to prohibit it. An FDA prohibition
of this traditional serving size statement would be a content based prior
restraint caused by FDA's not wanting people to know this information.
The FDA doesn't want people to know this information, because if they learn
of it, people may not behave the way the FDA wants; customers may choose
to take the larger servings rather than the FDA's preferred smaller ones.
The First Amendment prohibits the manipulation of consumer behavior by
restricting the communication of truthful, non-misleading information.
Quotes from the U.S. Supreme Court decision in 44 Liquormart v. Rhode
Island (1996 WL 241709 (U.S.))
"...a State's paternalistic assumption that
the public will use truthful, non-misleading commercial information unwisely
cannot justify a decision to suppress it." (at 8)
"It is precisely this kind of choice, between
the dangers of suppressing information, and the dangers of its misuse
if it is freely available, that the First Amendment makes for us." (quoting
from Pittsburgh Press Co. v. Pittsburgh Comm'n on Human Relations, 413
U.S. 376, 93 S.Ct. 2553, 37 L.Ed.2d. 770 (1973)
"In case after case following Virginia Pharmacy
Bd., the Court, and individual Members of the Court, have continued to
stress the importance of ... the impropriety of manipulating consumer choices
or public opinion through the suppression of accurate 'commercial' information..."
(J. Thomas, concurring, at 21)
The First Amendment of the US Constitution
absolutely prohibits the FDA from banning labeling that is neither misleading
nor deceptive. Indeed, Pearson & Shaw, et. al, have a First Amendment
lawsuit against the FDA Commissioner before the U.S. District Court for
the District of D.C. at this very moment. (Civil Action No. 95-1865
(EGS), District Court for the District of Columbia) If the FDA proceeds
with its proposed Rule, it is likely to be sued again.
Note, too, that this product does not describe
any non-traditional uses (or indeed, any uses at all) on the label or labeling.
Nearly all customers of this product use it before meals to help satisfy
appetite (the reason most foods are eaten) as an adjunct to their own personal
weight loss or weight maintenance program.
In addition to considering the constitutional
issues that an FDA attempt to ban this label would raise, we suggest that
the FDA consider the pragmatic public health value of allowing the vendor
to provide a maximum serving size that is likely to be heeded. The
FDA's serving size is so small that consumers will generally ignore the
FDA's dose limitation. This is especially likely for the many millions
of people who have had prior experience with ephedra herb products.
Without an alternate serving size that is more
likely to be heeded by the consumer, the consumer may take unnecessary
risks. The consumer will know that the FDA has radically reduced
the dose of the supplement, so they will take more -- perhaps far too much
more than needed to compensate for FDA's dosage reduction.
For the sake of both liberty and government
legitimacy under the constitution, FDA must not attempt to prohibit ephedra
dietary supplement labels from displaying truthful non-misleading traditional
For the sake of consumer safety, the manufacturers
of existing products must not be prohibited from informing the consumer
of both the size of the old dose and the new dose. If FDA prohibits
the publication of this information on the labels and in the labeling of
existing products, they will not only be violating the First Amendment
ban on content based prior restraint in an unconstitutional attempt to
manipulate the public's behavior by denying them information, FDA will
be dramatically increasing the risks to the public of accidental overdose.
Moreover, the FDA's credibility will drop further as its actions are scrutinized
in public fora such as health newsletters and the Internet.
The alternate serving size provides 20 mg.
of ephedra alkaloids, a little more than the 17 mg. median dose and substantially
less than the 30 mg. mean dose of products that FDA identified in its market
survey, and with which millions of consumers may be familiar. By
providing the customer with an alternate serving size near the low end
of the traditional dose range, there is a reduced risk of large accidental
overdoses taken by consumers who reject FDA's recommended dose but who
otherwise don't know how much to take. If the FDA continues to arrogantly
delude itself by believing that it can control people's behavior by enforcing
ignorance through their proposed rule, they will succeed only in violating
the constitution, discrediting themselves, and causing greater risk and
harm through uninformed and unintentional gross overdoses.
.fo version of 15 August, 1997 1:00PM PDT;
ONE SIZE DOES NOT FIT ALL:
HERB IS NOT EPHEDRA HERB EXTRACT
EPHEDRA HERB EXTRACT
IS NOT SYNTHETIC EPHEDRINE
FDA'S PROPOSED RULE ANALYTICAL METHOD WILL NOT PROVIDE ACCURATE MEASUREMENTS
OF THE BIOAVAILABLE EPHEDRA HERB ALKALOIDS IN PRODUCTS MADE WITH ACTUAL
EPHEDRA HERB RATHER THAN WITH EXTRACTS
Food Advisory Committee meeting
August 27-28, 1996
When actual ephedra herb is ingested rather
than an instantly soluble ephedra alkaloid extract, blood levels of the
alkaloids increase much more slowly as the ground herb slowly releases
its alkaloids, thereby providing a time-release effect and reducing the
risk of adverse effects in sensitive individuals.
Products containing actual ephedra herb when
ingested are pharmacokinetically substantially different from products
containing ephedra alkaloid extracts; regulating them in an identical manner
is arbitrary, capricious, and contrary to fact.
Vol. I, pg. 146 Dr. Jasinski
"...we already know if you put medications in a certain sort of matrix
that's natural may alter this from -- the pharmacology from the pure medication
in terms of absorption and rate of limitation [elimination?]."
Vol. I, pg. 146 Dr. Yetley
"We are not aware of data on the botanicals that would answer the questions
you have." "But those are the scientific issues that we're asking
this group of experts to discuss and to make some recommendations on."
Vol. I, pg. 147 Dr. Inchiosa
"The herbs themselves might contribute to affecting the alkalinity
of the urine, which is going to affect the half-life of the drug, which
is going to influence the steady state plasma concentrations."
Vol. I, pg. 157 Dr. Hsieh
"Do you want us to look at the compounds, or do you want us to look
at the herb? And the two should not be equated." (emphasis added)
Vol. I, pg. 158 Dr. Yetley
"I understand that the two are not equated, but both could be ingredients
in the products that we're seeing. So you need--the botanical is certainly
very common, or at least extracts of the botanical, concentrated extracts
of the botanical are very common in these products. But it is also possible
that some of these products may have synthetic form, so it's really both."
Didn't the FDA do any analyses of the products
in their market review to determine whether there was synthetic ephedrine
added, whether there were any ephedra alkaloids other than ephedrine in
them (as would be the case with a genuine ephedra herb extract), and what
percentage contained the actual herb rather than an ephedra alkaloid extract?
Even though the FDA's Dr. Yetley correctly
states, "I understand that the two are not equated,..." FDA's proposed
Rule does precisely that; it treats ephedra herb products exactly the same
as ephedra herb alkaloid extract products.
Because of this, FDA must withdraw the Rule,
re-convene the Committee, reach new conclusions that correct these errors,
and re-propose a new Rule.
Vol. I, pg. 180 Dr. Jasinski
"Just a question of Dr. Obermeyer. What is the extraction efficiency?
Have you done this? If you take the herb and make a tea, what is the extraction
efficacy?" (emphasis added)
Vol. I, pg. 180 Dr. Jasinski
"I'm not talking about your chemical analysis. If somebody makes a
tea, what is the extraction efficacy?" (emphasis added)
Vol. I, pg. 180 Dr. Obermeyer
"That depends on brew time. So if you would steep it for one minute
versus three minutes versus someone that forgot it in their tea cup for
ten minutes, that would be much different." (emphasis added)
Vol. I, pg. 181 Dr. Jasinski
"What's the maximum extraction efficacy you can do if you make a tea
and you put it in the pot and you boil it up?" (emphasis added)
Vol. I, pg. 181 Dr. Obermeyer
"We have not worked on that for the maximum. What we would extract
it for would be methanol to be the maximum out of an herb..." (emphasis
The FDA has no idea how much of the ephedra
alkaloids would actually be extracted and ingested from a cup of tea made
with actual ephedra herb (rather than ephedra extract or synthetic ephedrine
HCl). Furthermore, the FDA has no idea how much of the ephedra alkaloids
would be extracted in the human gut from ground ephedra herb consumed as
an iced tea which is consumed without brewing.
The numbers the FDA's Dr. Obermeyer is providing
are the results of chemical analysis that have very little if anything
to do with how a tea containing actual ephedra herb (rather than ephedra
alkaloid extract) is used. There is no hot methanol extraction, either
in the consumers' tea pots or in the human GI tract.
Vol. I, pg. 181 Dr. Jasinski
"I mean, the question before the group is, you know, in terms of dose
and what you're going to get and what the safe dose is going to be. If
you don't know what people get out of the herb when they brew it, there's
no way to answer this question." (emphasis added)
FDA's proposed Rule treats products containing
actual ephedra herb exactly the same as products containing ephedra herb
extract which is arbitrary, capricious, and contrary to fact. Because
of this, FDA must withdraw the Rule, do its laboratory homework, re-convene
the Committee, reach new conclusions that correct these errors, and re-propose
a new Rule.
Vol. I, pg. 181 Dr. Obermeyer
"Right. Most of the products really are encapsulated or tablets of
the ma huang extract. This is what we are seeing mostly. And very few products
are actually the herb root as a tea." (emphasis added)
FDA's Dr. Obermeyer here admits that Dr. Jasinski
is correct in his concerns that ephedra herb products are not the same
as ephedra alkaloid extract products. Dr. Obermeyer also admits that
"very few" of the products that the FDA is considering in this meeting
"are actually the herb ... as a tea.".
If the FDA wishes to proceed with their proposed
Rule without gathering the needed new data on actual ephedra herb products,
holding new Committee meetings, and making major modifications in the Rule
and analytical method, FDA should exempt all products from this Rule that
contain actual ephedra herb rather than ephedra herb alkaloid extracts
or synthetic ephedrine. To apply the proposed Rule to products that
contain actual ephedra herb (not ephedra herb alkaloid extracts or synthetic
ephedrine) would be arbitrary, capricious, and contrary to fact.
Technical note: Although we have an herbal
text which refers to the "twigs and roots" being used in ephedra herb teas,
we do not believe that use of the roots is a common commercial practice.
Ephedra Sinica (and related species) is a perennial; leaves (which look
rather like green twigs or pine needles) and the stems that bear them are
harvested, not the roots. By leaving the roots and some of the stems
and leaves, the plant's stems and leaves grow back next spring, and can
be harvested year after year. This is particularly important since
Ephedra Sinica is a slow growing plant. If grown from seeds or cuttings,
several years will pass before the plant can be harvested. We have
seen a lot of the ephedra herb that is imported into the U.S., but we have
seen only the needle-like leaves and the stems that bear them; we have
never seen any ephedra roots.
Vol. I, pg. 184 Dr. Fong
".... The data as I sit here running through my mind is when you talking
about extraction with methanol, and then people taking the capsule with
the total extracts or with the herb in there, and what is the bioavailability?
We really don't know what the patient is getting, at least in my mind."
Vol. I, pg. 184 Dr. Obermeyer
"I believe the literature would probably support your thoughts." (emphasis
This is a member of the FDA staff here
implying that the FDA has not done a search of the literature on the amount
of ephedra alkaloids which are bioavailable from the actual herb (as opposed
to a methanolic extract), let alone done the research themselves!
Furthermore this is a tacit admission that these are substantive relevant
Vol. I, pg. 186 Dr. Dentali
"My understanding is that these products that are the industrial supply
for what companies are buying and then placing in the capsule mixed with
other ingredients are extracts of water and alcohol, not pH manipulated.
So you may have high temperature water, alcohol, and that's why the concentrations
typically are not higher than 6 percent..."
This refers to the process currently used
to produce the commercially available ephedra herb extracts. These
ephedra herb extracts are clearly made in a different way - with a hot
methanol/water mixture - than how a consumer would brew tea (no methanol),
which in turn is different than direct ingestion of the actual ground herb,
which would not involve the high temperatures used in brewing. Products
made with ephedra herb extract are different from products where the actual
herb is brewed in hot water, which in turn are different from products
where actual ground ephedra herb is ingested without high temperature brewing.
Vol. I, pg. 186 Dr. Jasinski
"So you just put it into a pot and add alcohol and water and you boil
Vol. I, pg. 186 Dr. Dentali
Vol. I, pg. 186 Dr. Dentali
"Evaporate it off, put it on a carrier."
There is much faster gut absorption of the
alkaloids when on a carrier (from an ephedra herb extract) as compared
to the rate of gut absorption when a person swallows actual ground herb.
Vol. I, pg. 152 Dr. Dentali
"I did happen to come across two studies, and I can get the reference
to you and possibly a copy of it. One was conducted in Japan. They
had been seeing--they reported seeing a high incidence of adverse effects
recently with products containing ephedrine alkaloids. They realized that
their data was based on ephedrine and not the extract, and they conducted
an animal trial with equivalent amounts of ephedrine alkaloids and comparing
the two--in mice, I believe. ... Generally, they found that absorption
levels were about half time-wise and the concentrations in the plasma were
about half." (emphasis added)
Ephedra herb extract is not ephedrine, and
its pharmacological effects are not the same as ephedrine. Most of
the products producing serious adverse reactions were abused ephedrine
containing products, some misbranded as ephedra herb extract products.
It is very common to analyze a so-called ephedra product and find nothing
but ephedrine; these products do NOT contain either ephedra herb extract
or ephedra herb.
Vol. I, pg. 276 Jones
"The available data indicates that though ephedra herb shares some
of the properties of ephedrine itself, it also possesses beneficial properties
in its own right and is furthermore much better tolerated on an alkaloid
equivalence basis." (emphasis added)
Vol. II, pg. 80 Mr. Appler
Continues to analyze the Texas reports. He states "...of the
94 reports in the Poison Control Center for North Texas, there were exactly
two that were related to herbal and two others related to ma huang. In
every one of those cases, as Dr. Patrick points out, there was no permanent
injury of any sort and all the results seen there were mild." (emphasis
Vol. II, pg. 257 Dr. Dentali
"The other area that I feel that didn't receive adequate scientific
attention was the differences between the herb, the herb extract, and ephedrine."
Ephedra herb extract is not ephedrine.
Ephedra herb is not ephedra herb extract; the FDA proposed Rule analytical
method LIB No. 4053 may be suited to products containing ephedra alkaloids
from ephedra herb extract; we will leave comments on this to those who
use ephedra herb extract in their products. We use only ephedra herb
(no alkaloid extract, no synthetic alkaloids). FDA's proposed analytical
method is incapable of accurately measuring the amount of bioavailable
ephedra alkaloids contained in the actual herb.
When a consumer drinks a serving of ephedra
herb tea - made with the actual herb, not an alkaloid extract - the extraction
of the ephedra alkaloids from the herb in the hot water filled teacup is
less than when the herb is extracted in a boiling methanol-water solution
in an extract factory or in the FDA's proposed Rule analytical method.
No consumer uses a boiling hot methanol-water mixture to make his or her
When a consumer ingests ground ephedra herb
in an iced tea that has never been boiled, the extraction of the ephedra
alkaloids occurs slowly in the consumer's gut at 37oC, not in a boiling
mixture of methanol and water. The FDA's proposed Rule analytical
method will greatly exaggerate the real deliverable ephedra alkaloid content
of actual ephedra herb products. Remember,
the FDA's method was designed to measure the alkaloid content of products
made with the alkaloid extract; it has not been validated for products