Hyla Cass, M.D.
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 Labeling information is strictly limited by the Dietary Supplement Health and Education Act (DSHEA), which the FDA passed in 1994. dshea created new guidelines for supplement makers about how they could market, package, and label their products—and put strong limits on any claims made about the medicinal use of those products.
A supplement label can make "structure and function claims," which describe only the ways in which the nutrients affect the body's structure or function. But it can't state that the supplement prevents or treats any disease. |
Mike Adams, the Health Ranger
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 This has been a very helpful discussion, because Senator Hatch and I could never support legislation that would interfere with dshea and we are glad to receive the assurances of the chairman and the ranking Republican on the committee.
On May 1 we sent out another urgent call to action because Durbin was planning an end run around dshea that would further attack dietary supplements. Once again the people flooded the Senate and on May, 3, 2007, Senator Hatch responded to the concerns we raised. The Congressional Record states:
Mr. HATCH. Mr. |
Mike Adams, the Health Ranger
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 So it is regulated, and the thing with dshea is, the dshea laws that require enforcement from the FDA, in many cases, simply haven't been enforced. So when people are going outside the guidelines of dshea and making invalidated claims and things like that, it can tend to give the industry a bad name. And the FDA, which has the authority, I mean the total authority currently, to go out and to stop that, in some cases has chosen not to and just allowed that to happen so they can pretend, "Hey, we should have tougher standards and tougher guidelines." That's the crux of the debate right now. |
| So when dshea came into being, there were still people who said, "Dietary supplements just aren't regulated." Well, that's completely false. They are regulated. They fall within the guidelines of the FDA. There's page after page after page of recommendations. What is a dietary supplement, what isn't a dietary supplement, what you can say about it, what you can't say about it and how you promote it to the marketplace.
So it is regulated, and the thing with dshea is, the dshea laws that require enforcement from the FDA, in many cases, simply haven't been enforced. |
Hyla Cass
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| Labeling information is strictly limited by the Dietary Supplement Health and Education Act (DSHEA), which the FDA passed in 1994. dshea created new guidelines for supplement makers about how they could market package, and label their products—and put strong limits on any claims made about the medicinal use of those products.
A supplement label can make "structure and function claims," which describe only the ways in which the nutrients affect the body's structure or function. But it can't state that the supplement prevents or treats any disease. |
Craig Pepin-Donat
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 The dshea also dramatically reduced the FDA control over dietary supplements.
Under the dshea, the dietary supplement manufacturer is responsible for ensuring that a dietary supplement is safe before it is marketed. Just like drugs, the FDA is responsible for taking action against any unsafe dietary supplement product after it reaches the market. |
Mike Adams, the Health Ranger
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 So after the era of FDA raids ended with the passage of dshea in 1994, the agency went covert, so to speak, and they've waged their war against health freedom using laws, regulations and guidelines rather than guns and body armor. It's worked beautifully for them. Following the legalization of television drug ads in late 1997, the pharmaceutical business exploded and has only increased ever since.
So now the FDA primarily uses bureaucratic tactics instead of law enforcement tactics. Hence the new CAM Guidelines. |
Mike Adams, the Health Ranger
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| On May 1 we sent out another urgent call to action because Durbin was planning an end run around dshea that would further attack dietary supplements. Once again the people flooded the Senate and on May, 3, 2007, Senator Hatch responded to the concerns we raised. The Congressional Record states:
Mr. HATCH. Mr. President, a number of questions have been raised about how the Durbin amendment on food safety, adopted yesterday by a unanimous vote, would affect regulation of dietary supplements…. |
| Yes, we took great pains to make certain there would be no conflict with dshea. Regarding foods, and dietary supplements are generally regulated as foods, the general directive of the Foundation is to identify holes in the evaluation of food safety and identify ways to address those deficiencies through collaborative research with industry.
Mr. HARKIN. So to make this absolutely clear, what you are saying is that the bill we are debating would in no way interfere with consumers' access to dietary supplements?
Mr. HATCH. |
| DSHEA, a law we fought side-by-side to see enacted.
Mr. ENZI. It might be helpful if I explained the provision you are discussing, as my office has received many calls as well and I believe the callers are not informed about this matter. Subtitle B of title II of S. 1028 establishes the Reagan-Udall Foundation for the Food and Drug Administration. |
Mike Adams, the Health Ranger
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| HARKIN: This has been a very helpful discussion, because Senator Hatch and I could never support legislation that would interfere with dshea and we are glad to receive the assurances of the Chairman and the Ranking Republican on the Committee.
This is a major breakthrough -- Kennedy and Enzi are now on record stating this will in no way affect our dietary supplements. And Hatch and Harkin are on record as being concerned. There are still two problems. 1) Kennedy and Enzi are hard to trust, based on all the Big Pharma loopholes built into their bill. |
Mike Adams, the Health Ranger
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| To reassure those who are interested in the Dietary Supplement Health and Education Act, dshea, I wanted to take a moment to outline those changes. |
David Winston, RH(AHG), and Steven Maimes
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 When the dshea was passed, the U.S. Food and Drug Administration (FDA) estimated that there were about four thousand dietary supplements on the market. After this law was passed, the number has increased dramatically to more than thirty thousand, with more than one thousand being added each year.
It is difficult to estimate the market for herbal products, but the best estimates place the annual sales for 2005 in the United States around $5 billion. The global market for botanical medicines stands at more than $60 billion annually (World Health Organization, 2003) and is growing steadily. |
Mike Adams, the Health Ranger
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| ENZI: Yes, we took great pains to make certain there would be no conflict with dshea. Regarding foods, and dietary supplements are generally regulated as foods, the general directive of the Foundation is to identify holes in the evaluation of food safety and identify ways to address those deficiencies through collaborative research with industry.
SEN. HARKIN: So, to make this absolutely clear, what you are saying is that the bill we are debating would in no way interfere with consumers' access to dietary supplements?
SEN. |
Mike Adams, the Health Ranger
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 This move by the FDA is designed to once and for all destroy the 1994 dshea law that has made supplements "legal" while eliminating nutritional supplements and natural medicine from the United States, ensuring monopoly profits and control by drug companies and the FDA. It is the latest action item by the FDA / Big Pharma conspiracy that will not stop until health freedom has been abolished, drug companies rule the nation, and every citizen is diagnosied with a fictitious disease and drugged up on monopoly-priced pharmaceuticals. |
Mike Adams, the Health Ranger
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 In addition, to clarify for the readers, it was dshea in 1994 that essentially forced the FDA to keep their hands off certain dietary supplements, which were under intense attack at that time. I think it was Sen. Oren Hatch who co-sponsored that bill.
John: Yes, he was the primary sponsor of dshea and unfortunately nowadays, from my perspective at least, he has switched his allegiance. |
Mike Adams, the Health Ranger
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| So when people are going outside the guidelines of dshea and making invalidated claims and things like that, it can tend to give the industry a bad name. And the FDA, which has the authority, I mean the total authority currently, to go out and to stop that, in some cases has chosen not to and just allowed that to happen so they can pretend, "Hey, we should have tougher standards and tougher guidelines." That's the crux of the debate right now. The FDA has the complete authority under the existing guidelines and existing standards of dshea to regulate the industry as it should be. |
| Post-1994 with dshea there are very specific guidelines as a dietary supplement company that we operate within. So when dshea came into being, there were still people who said, "Dietary supplements just aren't regulated." Well, that's completely false. They are regulated. They fall within the guidelines of the FDA. There's page after page after page of recommendations. What is a dietary supplement, what isn't a dietary supplement, what you can say about it, what you can't say about it and how you promote it to the marketplace. |
Benjamin H. Natelson, M.D.
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 While dshea did legislate FDA oversight of these products, the rules governing their use are extremely liberal. Since evidence of effectiveness is not required, the only rule is that nutraceutical manufacturers can't make health claims about their products. So marketers have to be careful not to say that their product can relieve symptoms such as fatigue or pain. Doing so without evidence and FDA approval is illegal, although a glance at just about any health magazine shows ads that do make substantial health claims. |
Mike Adams, the Health Ranger
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| DSHEA, a law we fought side-by-side to see enacted.
SEN. ENZI: It might be helpful if I explained the provision you are discussing, as my office has received many calls as well and I believe the callers are not informed about this matter. Subtitle B of Title II of S. 1028, establishes the Reagan-Udall Foundation for the Food and Drug Administration. |
J. Douglas Bremner
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 DHEA
Dehydroepiandrosterone (DHEA) is marketed as an antiaging pill, which, thanks to some fancy footwork in Congress (the dshea, or the Dietary
Supplement Health and Education Act, as explained earlier), is available over the counter. DHEA declines with normal aging. Since DHEA blocks the effects of stress hormones like Cortisol and has a protective effect on neurons in animal models, it has been described as an antistress and antiag-ing hormone. DHEA, since it is a precursor of testosterone, is being used by athletes to build muscle mass, but it is not very effective for this purpose. |
Mike Adams, the Health Ranger
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| Be sure to mention you support a free market on prescription drugs so that Americans can buy them from anywhere they want, and you support protecting nutritional supplements and dshea.
You can find your Senators' phone numbers by clicking here.
It is worth noting that we all owe many thanks to Byron Richards for spearheading this effort. Without the many hours of time and effort he's spent watching this bill and analyzing the details of proposed amendments, we would never have been able to coordinate such an effective grassroots response that's making a real difference! |
David Steinman
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 First parties who profit from the product's sales must adhere to strictly narrow structure-and-function claims allowed within the dshea framework. However, third parties like The Doctors' Prescription for Healthy Living, that is, publishing companies and other sources of information that do not profit from the sale of the product, are protected under the First Amendment and may make stronger claims. But these claims and reports should still be balanced and objective. |
Craig Pepin-Donat
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| Under the dshea, the dietary supplement manufacturer is responsible for ensuring that a dietary supplement is safe before it is marketed. Just like drugs, the FDA is responsible for taking action against any unsafe dietary supplement product after it reaches the market. Manufacturers neither need to register their products with the FDA, nor are they required to get FDA approval before producing or selling a dietary supplement unless it contains a new dietary ingredient not marketed or present in the food supply before October 15, 1994. |
Mike Adams, the Health Ranger
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| This turns dshea upside down if it goes through.
Mike: That is the whole point of it, of course, is to put all the blame on the vitamins. Look at the way conventional medicine treats herbs today; they always say the herb interferes with the medication.
John: Well, this is Senator Hatch doing a 180, becoming a traitor looking to stab us in the back. Unless consumers raise bloody hell, and unless we can stir up the grass roots in Utah to get him to back off, we are going to have problems here. |
Mike Adams, the Health Ranger
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 Here in the United States, we can also hopefully move in the same positive direction by keeping nutrition freely available, and by making sure that dshea remains in place so that nutritional supplements remain legal and prescriptions are not required. Hopefully, we can get some criminal convictions for the real criminals out there: the people running these pharmaceutical companies, the decision makers at the FDA, and the people at the top of the hierarchy in American organized medicine, who are directly responsible for the deaths of hundreds of thousands of Americans each and every year. |
Mike Adams, the Health Ranger
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| I supported dshea in 1994 when it came into law -- as did a huge majority of the population of America. It came in despite the focus groups of whoever was behind it, whether it was the FDA or pharmaceutical drug companies or whoever to discredit the choices that people are allowed to make when it comes to their own health and vibrancy. The American people spoke out in a gigantic way, and said, "Yeah, this is something we want. We want to have choices about these things. |
Mike Adams, the Health Ranger
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| Then, through that type of process, a law like dshea -- which has already come under attack anyway through things like the adverse event reporting legislation -- could be blown out of the water. That, by the way is S-3546, the Dietary Supplement and Non-Prescription Drug Consumer Act.
The Dietary Supplement Health and Education Act is under a state of seize. This would be yet another means. No one is learning about that in health food stores for the simple reason that the U.S. |
| John: Yes, he was the primary sponsor of dshea and unfortunately nowadays, from my perspective at least, he has switched his allegiance. Now he is working alongside Senator Durbin to try to ram this adverse event reporting legislation down our throats despite the fact that there would be no way to determine causality in the event of an adverse report.
Mike: That legislation would require supplement manufacturers to report any adverse events, when all adverse event reporting is optional for pharmaceuticals, correct?
John: Exactly. |
Mike Adams, the Health Ranger
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| The FDA has the complete authority under the existing guidelines and existing standards of dshea to regulate the industry as it should be. And they have chosen in some cases not to, and then they suggest that Ephedra has caused a couple of hundred people to die, when in fact they know there's over 100,000 deaths a year due to pharmaceutical drugs that are totally classified as safe and effective.
Mike Adams: And mahuang has been used for 5,000 years in China as part of traditional medicine.
Amazon John: Five thousand years in China. |
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