Re: Re: OT: Senate hearing on dietary supplements

October 27, 2003

Hi Karolyn,

As a question to you how do you feel about adverse event reporting to the

FDA by supplement manufacturers? To date there is nothing in the

legislation of DSHEA to compel supplement manufacturers to comply with this

request. Without new regulations it (adverse event reporting) will remain

voluntary. Given the number of adverse events reported (and recognition

that they are underreported) if these supplements were to have been drugs

they would have been withdrawn and recalled long ago. Baycol was recalled

based on 35 adverse events....many supplements exceed this number and are

still available...is that protecting the public? As DSHEA is written

reoporting of adverse events alone is not sufficient evidence that the

supplement is unsafe. The law as currently written requires the FDA to

perform independent testing to determine if a supplement is unsafe...it

(theFDA) cannot act on reports of adverse events alone....unlike drugs.

Then we have the problem of what does the FDA test? Are the supplements

standardized and identical across brands...NO...then what and how would you

reccomend the FDA overcome this obstacle...there is nothing in DSHEA to

address this issue whatsoever!! How would you like to see the withdrawl

of dangerous supplements proceed? How about the issue of doctored

supplements? Current law requires the manufacturer to do nothing as far as

proving the supplement contains what the label says it contains. The

current law requires that the FDA test each and every supplement it wishes

to regulate...an enormous and expensive proposition which could easily be

avoided by requiring the manufactuer to provide data on purity and label

compliance....the current law has nothing requiring this. Would not

modification of the law putting the burden of proof on the manufacturer be

a much better route...they are, after all, the ones to benefit from the

sales of the product much like a drug company.

Not requiring the supplement manufacturer to provide proof of quality and

purity opens the door for all of the fraudulent products which are ever so

prevelant on the internet and elsewhere. The law (DSHEA) has hamstrung the

FDA and its ability to effectively regulate and protect consumers. How

would you feel if your prescription meds were adulterated with unknown (to

you) substances and/or drugs? I wouldn't feel very good about that would

you? We haven't even touched on claims of efficacy just on quality

control. I see manny complaints, and rightly so, of pharmaceutical

companies making misleading claims about drug efficacy and safety yet the

same folks complaining have no problem with fraudulent claims and bogus

products being available to the public...of course the caveat is always it

is up to the consumer to educate themselves! Why not say the same about

presription drugs...anything goes and it is up to the consumer to be savvy

enough to decide what they need and why they need it...as well what is safe

and what is not. I am sorry but there are numerous and abundant problems

with the wording of DSHEA and until it is modified the fraud will continue

unabated.

I am interested in your thoughts on these matters!

regards,

BobK

October 29, 2003

Throwing money at this problem will not work. The legislation needs to be re-vamped to address the problems associated with DSHEA which allows these fraudulent products to persist in the marketplace.

FDA Draws Fire Over Dietary Aids

http://www.latimes.com/news/printedition/asection/la-na-supplements29oct29,1,5303105.story?coll=la-news-a_section

Times Headlines

Senators urge tougher enforcement against supplements known to be health risks.

By Shweta Govindarajan, Times Staff Writer

WASHINGTON — Amid growing public concern over the safety of dietary supplements, legislators criticized the Food and Drug Administration on Tuesday for failing to take a harder regulatory stance against some products and urged the agency to step up enforcement efforts against those that are known to pose serious health risks."There is no excuse for a supplement manufacturer to market products that are unsafe or inaccurately labeled or that make outlandish claims," said Sen. Orrin G. Hatch (R-Utah) at a hearing held by the Senate Committee on Commerce, Science and Transportation. "Unfortunately, a small number of irresponsible supplement companies are taking advantage of consumers." Hatch, a longtime supporter of the supplements industry, noted that some products "do raise serious concerns" — particularly citing ephedra, an ingredient in weight-loss supplements that has been linked to seizures, heart attacks and death, according to the American Medical Assn.The FDA classifies dietary supplements as food and does not require them to meet the same approval standards as prescription drugs, which have to undergo rigorous premarket testing. Many supplements, such as vitamin tablets and calcium pills offer known health benefits. Under the 1994 Dietary Supplements Health and Education Act, which Hatch co-sponsored, supplements can enter the market without FDA approval, and manufacturers are not required to inform the watchdog agency of any adverse effects that are associated with the product. The FDA is in the process of determining whether dietary supplements should carry labels that clearly state their ingredients and their amounts, said M. , associate commissioner for regulatory affairs. He did not say how long it might take to make a decision. The agency also is working with the Federal Trade Commission, which has prosecuted supplement manufacturers that engage in false advertising. Although congressional leaders approved of the agencies' progress, action should have come sooner, they said. "We're always playing catch-up. We're playing catch-up rather than assessment. Why did it take nine years?" asked Sen. McCain (R-Ariz.), referring to the 1994 law that also gives the FDA authority to push dietary supplement companies to follow more stringent manufacturing practices. Hatch and Sen. Tom Harkin (D-Iowa) have co-sponsored legislation to give the FDA additional funding and resources to more aggressively pursue manufacturers of the products that cause concern. "The FDA simply does not have the staff to do its job. I say Congress should remedy that," Hatch said.Consumers often do not realize that dietary supplements do not come under the same scrutiny as prescription drugs, said Sen. Durbin (D-Ill.). He has introduced a bill that would require supplement manufacturers to report any adverse health effects to the FDA.A similar bill has been introduced in the House by Reps. A. (D-San Diego), Henry A. Waxman (D-Los Angeles) and D. Dingell (D-Mich.). "Did anyone imagine we would be selling these witches' brews of chemicals that no one has tested?" Durbin asked. "These products are being tested on unsuspecting Americans every day."

October 29, 2003

Karolyn,

I would agree with your reluctance to legislate based on knee-jerk reactions but in this case I don't think the reactions are knee jerk. Why are ephedra based products still on the market? If these were prescription drugs which had killed so many people they would have been recalled long ago...but they are still widely available and the reason for this is that the law protects these products from recall. Also consider the number of products available which contain aristocholic acid. These products have been used for centuries but they cause kidney cancer...something that seems to have been missed until recently. Now if a prescription drug or even a food additive were to have been found to be a reliable compound for inducing cancer it would be pulled from the market very quickly. Yet these products are available to all who want to buy them...why?...because the current law is inadequate to protect the public.

There are many compounds out there under the guise of supplements and these mixtures are often new and untested...so yes the American public is a guinea pig in a large money making experiment.

regards,

BobK

[ ] Re: OT: Senate hearing on dietary supplements

Bob - I just have a problem with knee-jerk responses and witch hunts. I do not disagree with your position on frauds. Who would?"Did anyone imagine we would be selling these witches' brews of chemicals that no one has tested?" Durbin asked. "These products are being tested on unsuspecting Americans every day." We are guinea pigs for everything. Don't you agree?Karolyn> Throwing money at this problem will not work. The legislation needs to be re-vamped to address the problems associated with DSHEA which allows these fraudulent products to persist in the marketplace.> > > > FDA Draws Fire Over Dietary Aids > > http://www.latimes.com/news/printedition/asection/la-na-supplements29oct29,1,5303105.story?coll=la-news-a_section> > Times Headlines > > > > Senators urge tougher enforcement against supplements known to be health risks.> > > > By Shweta Govindarajan, Times Staff Writer> > WASHINGTON - Amid growing public concern over the safety of dietary supplements, legislators criticized the Food and Drug Administration on Tuesday for failing to take a harder regulatory stance against some products and urged the agency to step up enforcement efforts against those that are known to pose serious health risks.> > "There is no excuse for a supplement manufacturer to market products that are unsafe or inaccurately labeled or that make outlandish claims," said Sen. Orrin G. Hatch (R-Utah) at a hearing held by the Senate Committee on Commerce, Science and Transportation. "Unfortunately, a small number of irresponsible supplement companies are taking advantage of consumers." > > Hatch, a longtime supporter of the supplements industry, noted that some products "do raise serious concerns" - particularly citing ephedra, an ingredient in weight-loss supplements that has been linked to seizures, heart attacks and death, according to the American Medical Assn.> > The FDA classifies dietary supplements as food and does not require them to meet the same approval standards as prescription drugs, which have to undergo rigorous premarket testing. Many supplements, such as vitamin tablets and calcium pills offer known health benefits. > > Under the 1994 Dietary Supplements Health and Education Act, which Hatch co-sponsored, supplements can enter the market without FDA approval, and manufacturers are not required to inform the watchdog agency of any adverse effects that are associated with the product. > > The FDA is in the process of determining whether dietary supplements should carry labels that clearly state their ingredients and their amounts, said M. , associate commissioner for regulatory affairs. He did not say how long it might take to make a decision. > > The agency also is working with the Federal Trade Commission, which has prosecuted supplement manufacturers that engage in false advertising. > > Although congressional leaders approved of the agencies' progress, action should have come sooner, they said. > > "We're always playing catch-up. We're playing catch-up rather than assessment. Why did it take nine years?" asked Sen. McCain (R-Ariz.), referring to the 1994 law that also gives the FDA authority to push dietary supplement companies to follow more stringent manufacturing practices. > > Hatch and Sen. Tom Harkin (D-Iowa) have co-sponsored legislation to give the FDA additional funding and resources to more aggressively pursue manufacturers of the products that cause concern. "The FDA simply does not have the staff to do its job. I say Congress should remedy that," Hatch said.> > Consumers often do not realize that dietary supplements do not come under the same scrutiny as prescription drugs, said Sen. Durbin (D-Ill.). He has introduced a bill that would require supplement manufacturers to report any adverse health effects to the FDA.> > A similar bill has been introduced in the House by Reps. A. (D-San Diego), Henry A. Waxman (D-Los Angeles) and D. Dingell (D-Mich.). > > "Did anyone imagine we would be selling these witches' brews of chemicals that no one has tested?" Durbin asked. "These products are being tested on unsuspecting Americans every day."

November 4, 2003

Bob, you are quite informed for a lay

person outside of the (health food) industry. I would like to invite you a

little bit into it so you can see some of the things that are being done like

adverse event recording. I can give you a password into a members only trade

group where we are drawing up adverse event recording and compliance guidelines.

You might find that what you think is not there, is in fact in the process.

You will also find information that might

give you the facts showing that the FDA has all the authority it needs to

enforce safety in the industry, but, by its own words, does not have the

funding.

Your statement that “if supplements

were to have been drugs…Baycol was recalled based on 35 adverse events”

does not compare equally. Bob, read this:

“FDA has received reports of 31 U.S. deaths due to

severe rhabdomyolysis

associated with use of Baycol”.

I ask you, what herb (other than Ephedra which is in the process of

recall) has ever produced 31 deaths?

Your statement of “Then we have the problem of

what does the FDA test?” is a very unsubstantive statement. It tests what

it tests. For instance with Ephedra it tests for too high of ephedrine levels

(along with general mircrobial and heavy metal levels) and for others it would

test for whatever experience has shown to be risky factors. For instance, Oriental

ginseng has been known to have pesticides. We test all ginsengs for pesticides.

Period.

This leads to my next point about supplements being tested. I and all

companies I do business with will not buy a nutraceuticals ingredient unless it

is accompanied by a FDA certified laboratory certificate of analysis showing

that it has the markers specified for the strength of that botanical, microbial

analysis, heavy metal testing, and, usually, pesticide testing results.

You have renegade companies operating outside the community of the

industry who sell certain herbs in extremely high concentrations as stimulants

against all convention of herbalistic dosage. The FDA does not have to police

the entire industry (companies like www.consumerlabs.org

with their independent lab testing does that) but rather they should enforce

the criminal behavior of renegade companies.

The criminal behavior of some Californians does not mean that Bob K is

a criminal. Nor does the action of a few renegade companies indict the entire

health food industry. There are companies out there that the consumer value of consistent

www.consumerlabs.org favorable

analysis of the purity and safety of their product is all the guideline needed.

When a company’s entire reputation and good will is on the line, they toe

the line.

In Health!

Jay Wentworth

Emmons

jay@...

Re: [ ] Re:

OT: Senate hearing on dietary supplements

Hi Karolyn,

As a question to you how do you feel about adverse

event reporting to the

FDA by supplement manufacturers? To date

there is nothing in the

legislation of DSHEA to compel supplement

manufacturers to comply with this

request. Without new regulations it (adverse

event reporting) will remain

voluntary. Given the number of adverse

events reported (and recognition

that they are underreported) if these supplements

were to have been drugs

they would have been withdrawn and recalled long

ago. Baycol was recalled

based on 35 adverse events....many supplements

exceed this number and are

still available...is that protecting the

public? As DSHEA is written

reoporting of adverse events alone is not

sufficient evidence that the

supplement is unsafe. The law as currently

written requires the FDA to

perform independent testing to determine if a

supplement is unsafe...it

(theFDA) cannot act on reports of adverse events

alone....unlike drugs.

Then we have the problem of what does the FDA

test? Are the supplements

standardized and identical across

brands...NO...then what and how would you

reccomend the FDA overcome this obstacle...there

is nothing in DSHEA to

address this issue whatsoever!! How

would you like to see the withdrawl

of dangerous supplements proceed? How about

the issue of doctored

supplements? Current law requires the

manufacturer to do nothing as far as

proving the supplement contains what the label

says it contains. The

current law requires that the FDA test each and

every supplement it wishes

to regulate...an enormous and expensive

proposition which could easily be

avoided by requiring the manufactuer to provide

data on purity and label

compliance....the current law has nothing

requiring this. Would not

modification of the law putting the burden of

proof on the manufacturer be

a much better route...they are, after all, the

ones to benefit from the

sales of the product much like a drug

company.

Not requiring the supplement manufacturer to

provide proof of quality and

purity opens the door for all of the fraudulent

products which are ever so

prevelant on the internet and elsewhere. The

law (DSHEA) has hamstrung the

FDA and its ability to effectively regulate and

protect consumers. How

would you feel if your prescription meds were

adulterated with unknown (to

you) substances and/or drugs? I wouldn't

feel very good about that would

you? We haven't even touched on claims of

efficacy just on quality

control. I see manny complaints, and rightly

so, of pharmaceutical

companies making misleading claims about drug

efficacy and safety yet the

same folks complaining have no problem with

fraudulent claims and bogus

products being available to the public...of course

the caveat is always it

is up to the consumer to educate themselves!

Why not say the same about

presription drugs...anything goes and it is up to

the consumer to be savvy

enough to decide what they need and why they need

it...as well what is safe

and what is not. I am sorry but there are

numerous and abundant problems

with the wording of DSHEA and until it is modified

the fraud will continue

unabated.

I am interested in your thoughts on these matters!

regards,

BobK

November 4, 2003

I thank you, Jay--for the facts.

RE: [ ] Re: OT: Senate hearing on dietary supplements

Bob, you are quite informed for a lay person outside of the (health food) industry. I would like to invite you a little bit into it so you can see some of the things that are being done like adverse event recording. I can give you a password into a members only trade group where we are drawing up adverse event recording and compliance guidelines. You might find that what you think is not there, is in fact in the process.

You will also find information that might give you the facts showing that the FDA has all the authority it needs to enforce safety in the industry, but, by its own words, does not have the funding.

Your statement that “if supplements were to have been drugs…Baycol was recalled based on 35 adverse events” does not compare equally. Bob, read this:

“FDA has received reports of 31 U.S. deaths due to severe rhabdomyolysis associated with use of Baycol”.

I ask you, what herb (other than Ephedra which is in the process of recall) has ever produced 31 deaths?

Your statement of “Then we have the problem of what does the FDA test?” is a very unsubstantive statement. It tests what it tests. For instance with Ephedra it tests for too high of ephedrine levels (along with general mircrobial and heavy metal levels) and for others it would test for whatever experience has shown to be risky factors. For instance, Oriental ginseng has been known to have pesticides. We test all ginsengs for pesticides. Period.

This leads to my next point about supplements being tested. I and all companies I do business with will not buy a nutraceuticals ingredient unless it is accompanied by a FDA certified laboratory certificate of analysis showing that it has the markers specified for the strength of that botanical, microbial analysis, heavy metal testing, and, usually, pesticide testing results.

You have renegade companies operating outside the community of the industry who sell certain herbs in extremely high concentrations as stimulants against all convention of herbalistic dosage. The FDA does not have to police the entire industry (companies like www.consumerlabs.org with their independent lab testing does that) but rather they should enforce the criminal behavior of renegade companies.

The criminal behavior of some Californians does not mean that Bob K is a criminal. Nor does the action of a few renegade companies indict the entire health food industry. There are companies out there that the consumer value of consistent www.consumerlabs.org favorable analysis of the purity and safety of their product is all the guideline needed. When a company’s entire reputation and good will is on the line, they toe the line.

In Health!

Jay Wentworth Emmons

jay@...

-----Original Message-----From: Bob Kaufman [mailto:rckaufman@...] Sent: Monday, October 27, 2003 9:13 AM ; Subject: Re: [ ] Re: OT: Senate hearing on dietary supplements

Hi Karolyn,As a question to you how do you feel about adverse event reporting to theFDA by supplement manufacturers? To date there is nothing in thelegislation of DSHEA to compel supplement manufacturers to comply with thisrequest. Without new regulations it (adverse event reporting) will remainvoluntary. Given the number of adverse events reported (and recognitionthat they are underreported) if these supplements were to have been drugsthey would have been withdrawn and recalled long ago. Baycol was recalledbased on 35 adverse events....many supplements exceed this number and arestill available...is that protecting the public? As DSHEA is writtenreoporting of adverse events alone is not sufficient evidence that thesupplement is unsafe. The law as currently written requires the FDA toperform independent testing to determine if a supplement is unsafe...it(theFDA) cannot act on reports of adverse events alone....unlike drugs.Then we have the problem of what does the FDA test? Are the supplementsstandardized and identical across brands...NO...then what and how would youreccomend the FDA overcome this obstacle...there is nothing in DSHEA toaddress this issue whatsoever!! How would you like to see the withdrawlof dangerous supplements proceed? How about the issue of doctoredsupplements? Current law requires the manufacturer to do nothing as far asproving the supplement contains what the label says it contains. Thecurrent law requires that the FDA test each and every supplement it wishesto regulate...an enormous and expensive proposition which could easily beavoided by requiring the manufactuer to provide data on purity and labelcompliance....the current law has nothing requiring this. Would notmodification of the law putting the burden of proof on the manufacturer bea much better route...they are, after all, the ones to benefit from thesales of the product much like a drug company. Not requiring the supplement manufacturer to provide proof of quality andpurity opens the door for all of the fraudulent products which are ever soprevelant on the internet and elsewhere. The law (DSHEA) has hamstrung theFDA and its ability to effectively regulate and protect consumers. Howwould you feel if your prescription meds were adulterated with unknown (toyou) substances and/or drugs? I wouldn't feel very good about that wouldyou? We haven't even touched on claims of efficacy just on qualitycontrol. I see manny complaints, and rightly so, of pharmaceuticalcompanies making misleading claims about drug efficacy and safety yet thesame folks complaining have no problem with fraudulent claims and bogusproducts being available to the public...of course the caveat is always itis up to the consumer to educate themselves! Why not say the same aboutpresription drugs...anything goes and it is up to the consumer to be savvyenough to decide what they need and why they need it...as well what is safeand what is not. I am sorry but there are numerous and abundant problemswith the wording of DSHEA and until it is modified the fraud will continueunabated.I am interested in your thoughts on these matters!regards,BobK

November 5, 2003

Yes, Jay, you ARE the MAN! Applause!! Blessings, Satya