Health Supreme by Sepp Hasslberger

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January 29, 2004

FDA eyes natural slimming aids

The recently announced FDA ban on products containing ephedra, a herb that has been used to give energy and help lose weight, is only a first step, says FDA commissioner Mark McClellan. Three more substances are in the regulators' sights: bitter orange, aristolochic acid and usnic acid.

One would think that it was time to go after some more worthwhile targets, such as Aspartame, or to look into why the very medical system using drugs closely controlled by the FDA has become one of the major causes of death in not only the US, but the entire developed world. Other than green orange! People are dying by the hundreds of thousands.

You might have noticed that obesity is fast coming to be one of the greatest health concerns, not only in the US. Ephedra was used for slimming, and the three other "unsafe substances" the FDA says it's coming after are also used to help lose weight. Coincidence? - or is the FDA being sent out to handle the competition, before the pharma boys get to cash in on the obesity bonanza?

Jenny Thompson of HSI Baltimore comments on this new crusade the FDA seems to be engaged in - all to the advantage of the chemical and pharmaceutical industry.

Update June 2004:

An interesting article explains how the Federal Trade Commission is now "focussing on dietary supplements for children". Especially relevant the end of the article, which suggests that the FDA and FTC are co-operating on the question of slimming products:

"The staff of the two agencies have formed a joint enforcement task force that has led to improved information sharing and more effective joint actions that make the best use of the unique enforcement tools available to each agency," he said.

Speaking specifically of the growing number of dietary supplements to promote weight loss, Beales said this area has been one of particular concern for the FTC.

"The commission's efforts to stop the deceptive marketing of weight loss products to children is part of a larger ongoing effort to stop weight loss scams," he said. "Going back more than a decade, the agency has maintained an aggressive law enforcement program against weight loss scams, bringing more than 100 cases against false and misleading weight loss claims."

Seeing Double Standards

Health Sciences Institute e-Alert

January 29, 2004


Dear Reader,

Emboldened by their recent move to ban ephedra, FDA officials are chomping at the bit. Now they have three more supplement ingredients in their sights - all marked for official extinction.

Speaking last week at the University Mississippi School of Pharmacy, FDA commissioner Mark McClellan said that the agency, "will be doing more work in the coming months to more closely evaluate the potential safety risk of these products, and we could take further action to remove unsafe dietary supplements from the market."

Mr. McClellan said he was "concerned" about several dietary supplements, specifically mentioning three that are used in some weight-loss formulas: bitter orange, aristolochic acid and usnic acid.

From what I've read, those who use any of these supplements should be careful with them and certainly only take them as directed. But outlawing their sale with an FDA ban is like killing mosquitoes with a bazooka. Is the fuss really worth it?

Don't bet on it. Something else is going on here.

No contest

Should bitter orange, aristolochic acid and usnic acid be banned?

Problems have been reported with all three of these botanicals - mostly due to their misuse. But unlike ephedrine (the synthetic form of ephedra that has caused most of the problems for which ephedra has been blamed), these three have not been associated with the deaths of any high-profile athletes or teenage boys, prompting emotional scare headlines.

In fact, bitter orange, aristolochic acid and usnic acid may not have contributed to any deaths at all. (In Belgium, several kidney failures were associated with aristolochic acid, but they were erroneously reported as deaths.) But of course, a supplement that has the potential to cause kidney failure or, in the case of usnic acid, severe liver problems should be used with the greatest care.

Which brings us once again to acetaminophen. Just last week, in the e-Alert "Flick of the Wrist" (1/19/04) I told you how easy it is to overdose on acetaminophen, prompting liver failure that results in more than 100 deaths each year. From what I've read (there's not much out there on this topic) usnic acid has been cited as "playing a role" with one death due to liver failure, and nine cases of liver problems from which patients recovered.

So let's check our scorecard here:

* Acetaminophen: Multiple deaths yearly.
* Usnic acid: One death, maybe.

And yet, the day the FDA calls for a ban on acetaminophen will be the same day that pigs fly south for the winter. But somehow the FDA has decided that usnic acid is so dangerous that it needs to be classified as a forbidden poison.

Planting the seeds

What's really going on here?

For ten years, FDA officials have been frustrated by the Dietary Supplement Health and Education Act (DSHEA), which limits the agency's power to regulate food supplements in the same way drugs are regulated. In the e-Alert "Under the Gun" (11/10/03) I told you about congressional efforts to give the FDA greater latitude over supplements, but for the moment those efforts seem to have stalled.

So the ephedra ban was a sweet victory for the FDA (provided the ban survives a court challenge, which it probably will). Finally, FDA officials got to have things their way. But more than that, they helped their efforts to pass legislation for more regulatory control by sending a message to congressmen and the public: The safety of dietary supplements is unreliable.

The fact that this message is untrue is beside the point. The point is to get the message out there and repeat it until people believe that legislation to increase FDA powers is absolutely necessary. Is the public really in grave danger when products that contain bitter orange, aristolochic acid and usnic acid are on the shelves? That's very unlikely. But with the announcement that there are three more reckless culprits out there, the idea is planted again. And it appears that as the year goes along the idea will be repeated and planted again and again and again.

And more to come

In his Mississippi speech, Mr. McClellan stated that new dietary supplement regulations for manufacturing and labeling will be announced sometime in 2004. He said, "When these regulations are finalized later this year, the public will not be faced with 'buyer beware' any longer."

But I disagree. The public will be faced with a much more serious "buyer beware." Buyer, beware: Your health care choices are being stripped away.

To start receiving your own copy of the HSI e-Alert, visit HSI Baltimore's site and sign up.

See also:

The Role of the FDA
The Claim There is "No Scientific Evidence" for Alternative Treatments...

San Diego Union Tribune: Utah judge strikes down FDA ban on ephedra


posted by Sepp Hasslberger on Thursday January 29 2004
updated on Tuesday December 21 2010

URL of this article:


Related Articles

Ephedra discussed in US House Committee
23 July 2003 - the US House Energy and Commerce oversight subcommittee is hearing evidence on ephedra-containing supplements. The hearings will last two days and might result in a ban or restriction on ephedra sales by Congress, according to the committee chairman Billy Tauzin. ''These supplements ... can be bought at any 7-Eleven convenience store or gas station by anyone, including those under 18,'' Tauzin said, questioning ''whether continuation of... [read more]
July 24, 2003 - Sepp Hasslberger

FDA bans Ephedra: deaths may be Aspartame related
The FDA has announced a ban on Ephedra, a herb that has been used in different remedies for millennia and that more recently has been sold as an energy booster and slimming aid. While it is quite correct that a dangerous product should be banned if the risk posed by it is - let's use the FDA's own term - "unreasonably high", I am afraid that the evaluation of the... [read more]
December 30, 2003 - Sepp Hasslberger

Aspartame, not Ephedra causing cardiac arrests
18 December 2003 - Betty Martini releases more bad news about Aspartame, the toxic sweetener approved by the FDA, the European Scientific Committee and analogous health watchdog services around the world. One point that strikes a chord is the present anti-herbs campaign world wide, which is based on the supposed side effects, especially cardiac arrests blamed on Ephedra containing supplements. These "ephedra side effects" are being used to drive restrictive... [read more]
December 21, 2003 - Sepp Hasslberger

Ephedra - Ephedrine: what difference?
The FDA has announced it will issue a ban on ephedra - a herb. Ephedrine, the isolated active substance, seems to be the culprit in many of the adverse reactions that are associated with "ephedra"-containing slimming or energizing products, specially if it is combined with caffeine. The FDA knew of the dangers of this combination and had issued rules to prohibit such products. Nevertheless, they were quite freely available at... [read more]
February 03, 2004 - Sepp Hasslberger

Ephedra Battle Moves To The Courts
...NVE's suit, filed in the U.S. District Court for the District of New Jersey, asks for the court to set aside the ban because it violates the 1994 law. It also appears to set the legal groundwork for damage claims against the government. NVE claims in the suit that between 2000 and 2003 its revenues grew from $29 million to $80 million, nearly all from ephedra dietary supplements. But since... [read more]
March 11, 2004 - Chris Gupta

Feds Attack On Ephedra - Cover For Aspartame Poisoning?
..."The Atlanta Journal Constitution recently published an article about sudden death referring to Science magazine. It reported that 450,000 people drop dead each year and discussed consumers with an irregular heart rhythm. Aspartame notoriously triggers an irregular heart rhythm. Frankly, this is probably an understatement as to deaths. On Dec 16, 2001, the Sunday Telegraph in the UK wrote an article on sudden death and epilepsy. Aspartame is also a... [read more]
March 03, 2005 - Chris Gupta




Readers' Comments

Please stay in contact with Rick Collins,JD at

They are fighting in the USA against the ban on Pro Hormones, DHEA, and many supplements which are also under attack.

They need your help and they need to be informed about the ANH fight in England.

These two organizations need to work together.

Your information is very much appreciated.

Thank you,
Kip Holley
Madrid Spain

Posted by: Kip Holley on January 30, 2004 02:35 PM


The Supplement Safety Act S.722in the US Senate will give FDA the authority to remove any supplement after receiving only"1 or more reports of serious adverse events" where adverse events is later defined to include instances where there in NO PROOF of CAUSATION from the supplement.Just an association in a user who happened to be taking a supplement. This can easily happen by chance if millions of people take supplements which is the case.
Senator Richard Durbin of Illinois is the sponsor of the bill. Co sponsors are Senator Hillary Clinton,NY;Sen.Charles Schumer,NY, Sen.Diane Feinstein,CA and Sen.John McCain,AZ. I am organizing people to meet with the New York Senators. How aboy somebody in Illinois,California and Arizona?

Posted by: Arnold Gore on January 30, 2004 10:29 PM


As mentioned in the article, obesity is indeed being medicalized and the pharmaceutical companies are set to cash in...

Medicare redefines obesity as medical
By Elizabeth Weise, USA TODAY
In a major decision that turns obesity from a personal failure to a medical problem, Medicare announced Thursday that it would remove barriers to covering anti-obesity treatments after 40 years of saying fat was not an illness and not covered.

Posted by: Sepp on July 16, 2004 08:36 PM


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The Individual Is Supreme And Finds Its Way Through Intuition


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These articles are brought to you strictly for educational and informational purposes. Be sure to consult your health practitioner of choice before utilizing any of the information to cure or mitigate disease. Any copyrighted material cited is used strictly in a non commercial way and in accordance with the "fair use" doctrine.



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