CODEX Archives

CODEX is coming! Archive.

[ CODEX Archive ]
[ Main Archives Page ] [ Glossary/Index ]
[ FAQ ] [ Recommended Books ] [ Bulletin Board ]
   Search this site!

CODEX is coming! Archive.

Posted by Walt Stoll on September 09, 2003 at 16:10:24:

Misty L. Trepke

Regulating Vitamins

Regulating VitaminsBy Kelly Patricia O Meara

The age-old, surefire call to regulate is being trumpeted once more
in the interest of "public safety." This time it is to keep the
public safe from those infamous killers - vitamin pills. Sen.
Richard Durbin (D-Ill.) has introduced legislation that effectively
would give the Food and Drug Administration (FDA) the authority to
remove from the market any dietary supplement it chooses, including
vitamins E and C. Opponents of the bill say the senator may be
deficient in his understanding of natural supplements and has
overestimated the daily allowable dose of federal regulatory
intervention that Americans will swallow.

Durbin's Dietary Supplement Safety Act of 2003 (S 722), cosponsored
by Sens. Hillary Clinton (D-N.Y.), Charles Schumer (D-N.Y.) and
Dianne Feinstein (D-Calif.), is said to result from the growing
number of deaths allegedly associated with the use of dietary
products containing the natural supplement ephedra, including that
of Baltimore Orioles pitcher Steve Bechler on Feb. 17. While fatal
use by a few high-profile athletes has focused attention on dietary
supplements containing natural stimulants, Durbin says it was the
death of his 16-year-old constituent Sean Riggins, who died from an
ephedra-induced heart attack on Sept. 3, 2002, that pushed the
senator to fight for a federal prohibition of the supplement and to
get ephedra banned in Illinois, the only state in the nation to take
such a step.

What Durbin says he hopes to do, in the name of public safety, is to
require manufacturers of dietary supplements to prove the product is
safe before marketing it. The Durbin bill would expand the FDA's
authority to require exotic proof of safety from any dietary-
supplement maker if the agency has received so much as a single
report of an adverse reaction (AR). If the manufacturers fail during
hideously expensive tests to prove that the product is safe, the
commissioner of the FDA can remove it from the market.

The legislation would require manufacturers of dietary supplements
to report to the FDA, within 15 days, any and all serious adverse
health events by anyone using their products, something critics say
is almost impossible to do as a matter of simple practicality. Even
so, the Durbin claims about dangers seem nothing if not wildly
exaggerated. Although the Illinois senator claims "scientific
reports have linked ephedrine and similar dietary supplements to 117
deaths and more than 17,000 other health-related problems," in 2001
the Department of Health and Human Services (HHS) received just 10
adverse-event reports from manufacturers for all dietary-supplement
products combined. Durbin's take on the disconnect between HHS and
other alleged scientific reports is that "the voluntary-reporting
system under current law is clearly not working."

What is interesting about the legislation is that, even though the
senator spotlights ephedra and other "stimulant" products to excite
interest in his case for added federal regulation on natural
supplements, the word "ephedra" does not appear anywhere in the
eight-page bill. Critics say this is because the senator wants to
impose on manufacturers of natural dietary supplements the same
exorbitant costs as have been imposed on drug manufacturers to make
prescription medicines prohibitively expensive for so many
Americans. Apparently Durbin thinks that is the only way the public
can be protected.

Consider some of the drug products long regulated by the FDA - drugs
that already must be "proved safe" before being brought to market.
Take for example the chemical stimulant Ritalin, which is taken by
tens of millions of school-age children every day. According to the
FDA, between 1990 and 1997 there were 160 deaths associated with
methylphenidate (Ritalin) and 569 hospitalizations, 36 of which were
life-threatening. And it is widely accepted that the FDA formally
receives less than 1 percent of suspected serious ARs.

Furthermore, the adverse side effects of the natural ephedra and the
pharmaceutical Ritalin, both popular stimulants, are all but
identical. Yet neither Durbin nor any other federal lawmaker has
called for the removal of Ritalin from the market. Consider these
warnings of potential adverse reactions. Ephedra: nervousness,
dizziness, tremor, alterations in blood pressure or heart rate,
headache, gastrointestinal distress, chest pain, myocardial
infarction, stroke, seizures, psychosis and death. Ritalin:
nervousness, dizziness, irregular or fast heartbeat, chest pains,
high blood pressure, severe headache, palpitations, angina, cardiac
arrhythmia, abdominal pain, unusual bleeding, tics, blurred vision,
insomnia, toxic psychosis, death.

Advocates of natural medicines say the antidepressant Prozac, made
by pharmaceutical giant Eli Lilly, is another interesting case
Durbin may want to review before putting all his "public-safety"
eggs in the FDA basket. As of September 1993 there had been nearly
30,000 AR reports associated with Prozac filed with the drug agency,
including side effects such as delirium, hallucinations,
convulsions, violent hostility and psychosis, plus 1,885 suicide
attempts and 1,734 deaths - 1,089 by suicide. And according to
Thomas G. Whittle and Richard Wieland, critics who obtained
documents under the Freedom of Information Act, "both Eli Lilly and
officials of the FDA were aware that at least 27 deaths had been
linked to the use of Prozac prior to the drug being released on the

These figures are 10 years old, and yet the FDA has not pulled
Prozac from the market. Despite tens of thousands of AR reports
detailing adverse reactions, the federal agency tasked with
overseeing the public safety of drugs has not required Eli Lilly
to "prove" that Prozac is safe. In fact, according to Whittle and
Wieland, "a 1986 FDA safety review [of Prozac] ... discovered that
Eli Lilly had failed to report information about the onset of
psychotic episodes in people during Prozac's testing." And still the
FDA took no action against the drugmaker.

But, when it comes to natural dietary supplements, here is Durbin
doing his part to protect the public by setting a standard that
critics say is far above that for pharmaceuticals. "It is
impossible," Durbin says, "for anyone to calculate exactly how many
people have had their lives ended or their health ruined by ephedra
during the months since I first raised the issue, but whether it was
500 or five, it was too many. We can lead the country in protecting
our kids by imposing reasonable safety restrictions on these
dangerous drugs; this experience with ephedra should convince
everyone the law should be changed in order to protect the American

Given the enormous number of AR reports filed about Ritalin and
Prozac, to name just two pharmaceuticals, critics wonder aloud why,
given the senator's concern about public safety, he has submitted no
legislation to ban the use of those products, especially since
Ritalin and ephedra both are stimulants and there is virtually no
difference between the adverse reactions reported with their use.
Apparently the guiding Durbin principle that says, "whether it was
500 or five, it was too many," doesn't apply when it comes to highly
profitable drugs pushed by the pharmaceutical giants, according to
holistic practitioners who prefer natural remedies.

Julian Whitaker, a medical doctor who is founder and director of the
Whitaker Wellness Institute in Newport Beach, Calif., tells Insight
that "this legislation isn't about safety at all. It's about loss of
control that the FDA has experienced over the last seven or eight
years when it comes to regulation of the nutritional-supplement
industry with passage of the 1994 Dietary Supplement Health and
Education Act (DSHEA). It basically said the FDA no longer could
rule arbitrarily on the nutritional-supplement industry by denying
publication of truthful information on supplements. The 1994 law
gave the nutritional-supplement industry a safe harbor that kept its
products from being designated as drugs subject to prohibitively
expensive regulation, and the industry has a safety record that
reportedly is the best of any consumer-product company in the United
States. This is especially important when you realize there are
5,000 deaths attributed to aspirin every year, 30,000 deaths known to
be caused by over-the-counter drugs and 240,000 deaths from
prescription pharmaceutical drugs used correctly."

Whitaker, the author of nine books on nutrition, is just getting
warmed up. "We don't know the deaths that come from vitamins,
particularly ephedra, were the result of abuse," he says. "When over-
the-counter drugs are responsible for deaths no one cares even to
write about it, but if a baseball player dies from a heat stroke and
he's got ephedra in his system they blame the ephedra. Suppose,
though, that he had Sudafed, Tylenol or alcohol in his bloodstream.
Are they going to take those products off the market? Look at it
this way: We have millions of people suffering from alcohol-related
health problems because of alcohol abuse. Is Congress going to take
alcohol off the market?"

David Seckman, executive director of the National Nutritional Foods
Association, the oldest and largest trade association in the United
States representing natural products, including retailers,
manufacturers and wholesalers, tells Insight, "This legislation is a
bad idea and there are some provisions that we're very concerned
about. It mandates that manufacturers submit adverse-reaction
reports for supplements, and it defines products like stimulants
that won't be allowed to be used as supplements. Naturally the bill
explicitly excludes things like caffeine from the list. This is
because, if you look at the definition of what a stimulant is, you
learn that it is anything that increases the heart rate - which is
just about anything. The commissioner of the FDA, after just one
adverse-reaction report, would have the discretion to make the
manufacturer of the targeted product prove it is safe before it
again can be marketed."

Seckman says, "Our concern is that we're talking about products that
have been used safely and effectively for thousands of years that
now can be pulled from the market because of just one report. People
will be able to call in with an adverse reaction to multivitamins
and the commissioner will have the authority to make the
manufacturer prove that multivitamins are safe. Under the 1994
DSHEA, supplements were classified as foods and under a totally
different category than drugs. Drugs require premarket approval and
are granted a patent. You're not going to be able to do that with
vitamin C and other such natural products. It's just going to put
the commissioner in a precarious situation to make determinations
about the safety of natural products."

As Seckman notes, "Under the current law the FDA already has the
ability to ban any product that it finds is not safe. Our contention
is that if the FDA commissioner finds a product that is unsafe, and
can prove it, then that product should be banned. We don't think the
congressional intent was or is that every time there is an issue
with a supplement we need Congress to decide whether vitamin C or
any other natural supplement should be banned. The language is
already there. Look at garlic, for instance. Should you have to
prove that garlic is safe before you put it on the market? This is a
possibility under the proposed legislation. And you always are going
to find people who have adverse reactions to something they take,
even things like vitamin C and garlic. We don't think this
legislation is wise."

Len Horowitz, an internationally known public-health authority and
author of more than a dozen books, including Emerging Viruses and
Death in the Air: Globalism, Terrorism and Toxic Warfare, isn't
buying the public-safety mantra. "This isn't a public-safety issue,"
Horowitz explains. "It may be disguised as one, but it has nothing
to do with public safety. Everything is tremendously regulated to
the detriment of society, and I believe that the pharmaceutical
industrialists have their hand in every aspect of the regulations
and legislation."

Horowitz continues, "You know, people are overdosing on coffee every
day, but you don't see Congress regulating Starbucks. This argument
has to be understood within the context of the fear mentality
generated by the media on behalf of the pharmaceuticals who don't
want to tell you that the third leading cause of death in the U.S.
is drug-induced, physician-prescribed, hospital-prescribed
medications. You don't see the intensity over that, but you do see
it over and over again when someone overdoses on ephedra."

He asks, "Are supplements dangerous? What isn't dangerous? Water is
dangerous. Try hyperventilating for five minutes and you'll pass
out. That's dangerous. This is about an induction of phobia - a fear
that is disproportionate to the actual size of the threat. Saying
that one case or even 100 cases of people overdosing from too many
vitamins, [that] amounts to trying to induce a phobia to push
legislation - dreaming up justification for insane regulations."

Opponents argue that the numbers don't come anywhere near showing a
need for what they regard as legislative overkill. Especially when
one considers that, according to the FDA, adverse reactions to
dietary supplements represent less than one-half of 1 percent of all
substance-adverse events. Of course, Sens. Durbin, Clinton, Schumer
and Feinstein disagree.

Kelly Patricia O'Meara is an investigative reporter for Insight.

Re: Get busy writing your reps

Posted by on September 09, 2003 at 17:36:00:

In Reply to: CODEX is coming! Archive. posted by Walt Stoll on September 09, 2003 at 16:10:24:

If you haven't already written asking your state senator to vote no...what are you waiting for?

Re: Get busy writing your reps

Posted by Mary on September 09, 2003 at 23:02:45:

In Reply to: Re: Get busy writing your reps posted by on September 09, 2003 at 17:36:00:

Calling might be better. Reach thier offices faster. The mail is slowed down by the security checks they have to perform.
Take no chances. Kill this bill!

Re: CODEX is coming! Archive.

Posted by Mary on September 09, 2003 at 23:20:30:

In Reply to: CODEX is coming! Archive. posted by Walt Stoll on September 09, 2003 at 16:10:24:

Thanks, Walt and

Follow Ups:

Re: Get busy writing your reps

Posted by dd on September 09, 2003 at 23:37:49:

In Reply to: Re: Get busy writing your reps posted by Mary on September 09, 2003 at 23:02:45:

So Mary, here is something interesting.

I wrote again to my senators, including Diane Feinstein.
I got pretty nasty this time, actually stating that it was a
slow form of murder to allow pesticides, chemicals,
cigarettes, alchohol, fast foods, be legal, and
then take away supplementation that could be the only
possible thing to turn the damage around from these
things they keep legal, for the sake of money. I also
said the public will not take this, and that they can bet
on upheaval..etc..

It was a VERY aggressive letter. Then a few weeks
later, I kid you not, they sent someone to my home. On
Friday afternoon, I noticed a secret service car parked in
front of my home. (it was marked secret service). I
couldn't see inside. All windows were darker than dark,
car was black. My neighbor as well was eyeing the car.
I had to go to work around 3:00 p.m. I got in my car,
drove off, adrenaline going for sure, and unsure if I
should leave my home. But, I just went ahead to work.
I came home very late that night, no sign of anything
strange. Nothing. My neighbor told me that as soon
as I left, they pulled away. I couldn't believe it.

Today I got a ridiculous response, AGAIN, from
Feintstein, saying she gets umpteen thousand letters
a day. "Thank you for expressing you opinions and
views," or something to that affect. Unbelievable.

I am not going to write anymore. It just goes in the
trash I am sure, unless you alarm them, as I guess I
did. But, still, it doesn't do any good. I think you are
right. Phone calls. Even then, my brother does this a
lot, and basically gets nowhere. Yet, you still have to
fight the good fight. It gives some sort of hope.



Re: Get busy writing your reps (Archive in CODEX.)

Posted by Walt Stoll on September 10, 2003 at 07:52:36:

In Reply to: Re: Get busy writing your reps posted by on September 09, 2003 at 17:36:00:

Thanks, June One, Mary and DD.


Follow Ups:

Re: Get busy writing your reps

Posted by Mary on September 11, 2003 at 01:22:14:

In Reply to: Re: Get busy writing your reps posted by dd on September 09, 2003 at 23:37:49:

Hi dd,

You have to be careful about what you put in writing. There are lots of nut cases in the world and it doesn't surprise me that a government car was parked outside. Keep an eye out for them again. I don't want to scare you but they may be watching you. It's prudent not to put angry, threatening words on paper and then mail it to your senator :)

John Ashcroft has the Patriot Act now and it's potentially very dangerous for American citizens who could be caught up in it's web. VERY SERIOUS threat to our liberty and freedom.
If you have time, you might want to do a little reading up on it.

As angry as I am, I would never do that. It's only asking for trouble. I could easily jump down their throats for what they are doing to the American people whom they are supposed to be representing. (I personally do not like Feinstein and will not vote for her ever again.) I've been a lifelong Democrat but no more. I'm voting either Republican or Independent. Depends on the person. You can bet I will be voting for "yes on the recall" and sure as hell will NOT vote for Cruz Bustamonte who wants CALIF. to be given back to Mexico.
have C-Span late at night covers many hearings at the Capitol. Sometimes I'm up and listened. It's unbelievable the things you learn and pick up on when you watch. Good reps and bad reps. Very interesting. I may video tape some for viewing later at a more reasonable hour.

Anyway, No more letters, huh? I don't want my good friend, pan pal or whatever to have anything happen to her. We need you in this fight to save our access to supplements.


P.S. I think a quick telephone call to Sen Boxer and Sen Feinstien's offices at the Capitol in DC would be a much better idea. I called them about 3 weeks ago and asked them to vote NO on S722 (Durbin's bill) -- first time ever I might add. They guy who answered wanted to know my name and zip code. BTW, we all need to do that again, soon. They've rewritten the bill and are going to have it up for vote again, as I understand it. Don'n know when for sure. But I ain't a gonna wait.

Re: Get busy writing your reps

Posted by dd on September 11, 2003 at 22:50:43:

In Reply to: Re: Get busy writing your reps posted by Mary on September 11, 2003 at 01:22:14:

Hi Sis,

Yep, no more letters, only calls. I won't give up the fight,
you don't have to worry about that. And, I hear you loud
and clear on the angry letter thing. Not a smart choice
on my part. I would not t be me if I didn't stand up for
the most important things in this life. I am glad to know
there are many others out there fighting, like you. I wish
more people would take heart. I have been reading
your posts, and I know that you are frustrated with the
lack of response. I am as well. I guess some, like
Barb, have taken action, but I am not sure that many
will. Sad, because a board like this would seem to be
a very good place to get "it" going.
It is bizarre to me that the posts that get the most
responses seems to be subjects that would be in
People Magazine. Strange to see that kind of response
on a wellness board. Oh well. I wonder if it bumms out

Ok, you sister of mine, I am off the computer. I have
been trying to get my life in order in my home, and have
limited my time on the old box here. Luv ya back.


Re: Get busy writing your reps

Posted by Mary on September 12, 2003 at 14:14:10:

In Reply to: Re: Get busy writing your reps posted by dd on September 11, 2003 at 22:50:43:

Hi Sis,

Yes, Walt gets very frustrated. Who wouldn't?? I don't know Walt personally and have never heard his voice except for reading his posts on this board. It's very evident that he gets frustrated. If you look at his earlier posts (a few years ago), you can see a big change in how he responds to people. He used to really take time and work with people and now he will often just say, "Look in the archives and let you know what you learned." I don't blame him one damn bit. I certainly don't have the patience this dear man has.

It's too bad, this board could be used as a wonderful vehicle to bring about positive changes restoring our Health Freedom but too many people who post here just seem to want to be taken care of and for Walt and the others who are very knowledgeable, like Labrat, SHAPE, R., Helping You, etc. to listen to their complaints.

They certainly don't seem to be interested in helping themselves much less doing anything for their fellow Americans. It's a very sad state of affairs.

Well, Sis, like I stated in an earlier post, they will pay dearly for this and the time is quite near when all hell may very well break lose. The writing is on the wall!
All one has to do is open their eyes...and they just sit on their butts, watching their TV sitcoms or sports programs and deluding themselves. What a bunch of Crap!!

John Hammel was nice enough to write to me this morning is regards to an email I had sent him regarding the possibility of my doing this work full time. Bottom line is, if I win the lottery I could afford to do it, otherwise I cannot. I'm not happy about this but it's reality, and that's that. I'm off to school and sad to say as angry as I am about our rights being taken away that I cannot spend large amounts of time on this. Believe me, if I could, I would in a heartbeat. I ain't no whimp. And Sis, I know you're not either.

Who knows, maybe we will meet someday. After all, we both live in the same state.

Luvya, too,


Re: Get busy writing your reps

Posted by dd on September 13, 2003 at 00:44:08:

In Reply to: Re: Get busy writing your reps posted by Mary on September 12, 2003 at 14:14:10:


I hear your every word. And yes, I did notice the
difference in Walt's posts. The more I read, the more I
understood how difficult this board must be, and the
dedication to keep it going must be taxing.

As far as meeting goes, perhaps one day we will. I
have met one person already that I befriended online
years ago. I was going on tour to his home town, and
we set up meeting face to face. It was odd at first in
some ways, but we became amazing friends. We
spent about three days just hanging out, and it was
just the same connection we had felt online and on the
phone. Pretty amazing. We have been friends ever
since. :)

I've got to go. Have fun at school.


Re: Get busy writing your reps (WHY THE ARCHIVES?) Archive

Posted by Walt Stoll on September 13, 2003 at 07:06:26:

In Reply to: Re: Get busy writing your reps posted by Mary on September 12, 2003 at 14:14:10:

Thanks, Mary.

The 'site is a bigger committment than either Bill or I ever thought it could be. One of the dangers of success, I guess :o).

However, in my defence I might suggest that early on the information was not available in the archives. As a matter of fact, the archives were created because I found myself answering the same basic questions over and over.

Now that most of the basic information IS available in the archives--with an investment of time by the person needing it--I can continue to try to spend my time where the information needed is NOT included in the archives.

Even Jesus made his healees "walk into the desert" to participate in their own healing. This was not because the desert was healing but because without personal investment no healing lasts very long. If the person is not willing to take the time to "walk into the archives" they CERTAINLY will not actually DO what they learn--which takes a LOT more effort.

I appreciate the opportunity to try to clarify this frustration many people have with this 'site. It is calculated to get the most information, AND CHOICES, to the most people with the energy and time I have to offer.




Re: Get busy writing your reps (WHY THE ARCHIVES?) Archive

Posted by dd on September 13, 2003 at 21:53:03:

In Reply to: Re: Get busy writing your reps (WHY THE ARCHIVES?) Archive posted by Walt Stoll on September 13, 2003 at 07:06:26:

I know your post is to Mary, but AMEN to all you said


Follow Ups:

Re: Get busy writing your reps

Posted by Mary on September 14, 2003 at 00:21:37:

In Reply to: Re: Get busy writing your reps posted by dd on September 13, 2003 at 00:44:08:

Wow! That's pretty cool, dd. We must make it a goal complete with a time frame to meet. You can reach me at:

I'm taking off and going kayakfishing in the ocean tomorrow. I'm getting very squirely. Was in school last night and all day today. Fun class. I love it. I'm really looking forward to going for it full bore.


Follow Ups:

[ CODEX Archive ]
[ Main Archives Page ] [ Glossary/Index ]
[ FAQ ] [ Recommended Books ] [ Bulletin Board ]
   Search this site!