Thursday, May 31, 2007

05/31/07 - Ron Paul's Bill is the Answer to FDA Failings

Ron Paul’s Health Freedom Protection Bill is the answer to the FDA’s failings…

Head of FDA wants to work more closely with Drug Companies...

Report from Gardner Harris - "May 30 - When Dr. Andrew C. von Eschenbach took over the Food and Drug Administration in 2005, the agency had a crisis over drug approvals that had missed or ignored dangerous side effects in Vioxx, antidepressants and other prominent medications. Dr. von Eschenbach promised improvements, and agency officials said they would no longer be caught flatfooted on drug safety. But this month, The New England Journal of Medicine published a study suggesting that a major diabetes pill, Avandia, might increase the risk of heart attacks.

Concerns over that drug and others have led Republicans and Democrats in the House and the Senate to call for investigations. A House hearing is planned for June 6. Dr. von Eschenbach said in a briefing on Wednesday that his agency needed to collaborate more closely with drug companies.

’The point is that we need to look at the role of the F.D.A. in being a bridge to the future, not a barrier to the future,’ he said at his office here."

My question: is working closely with Drug Companies the solution... or the problem?

I suggest that a better solution would be promoting natural remedies without dangerous side effects; not putting up bureaucratic barriers to them. This can best be done by allowing people access to truthful information about traditional, non-drug approaches; by letting natural product purveyors make
serious health claims... exactly what Ron Paul's Health Freedom Protection Act would do.

In the twelve hours since sent an email blast seeking support for the Paul bill over 10,000 people have written their congresspeople supporting the bill! We still need hundreds of thousands to move Congress.

Here's where to do it: or

Protect our herbs, vitamins, minerals and natural remedies from bureaucratic meddling!!

Wednesday, May 16, 2007

05/16/07 - Ephedra ban continued: Risk - Benefit Analysis Comes to Herbs


EPHEDRA BAN CONTINUED: Risk - Benefit Analysis Comes to Herbs

The United States Supreme Court decided not to hear the Ephedra case appeal on May 13, 2007. This decision leaves standing the appeal court reversal of the Utah district court's voiding of the FDA's ban on the Chinese herb Ephedra. Take a deep breath! That means, in effect, a drug industry risk/benefit standard has been imposed on at least part of the Dietary Supplement industry. Instead of the standard of “safe if used as directed,” which is the standard that applies to all foods, herbs can now be subjected to the type of analysis that applies to drugs.

But not equally, as the Ephedra case shows. Let's take Aspirin for example: tens of millions use it daily; 1500 die each year. Apply Risk/Benefit Analysis: drug allowed. Another example: Viagra(R) - hundreds of thousands use it; hundreds are harmed yearly. Drug allowed. Now take Ephedra: at its height, 25,000,000 used it daily. Over ten years, there were 5 deaths that may have been associated with Ephedra abuse; not using it according to directions. Result: the herb is banned. To this observer, this does not appear to be equal treatment. Or based on science and reason.

According to NutraIngredientsUSA, "The most recent court ruling on Ephedra blurs the distinction between supplements and drugs and could force the industry to conduct clinical tests, says the Natural Products Association..." The "once-popular herbal, was banned by the FDA's final rule in 2004 on the grounds that it does not present a significant health benefit to outweigh the reported increased risk of heart attack, stroke and death. ... A year later the ban was successfully challenged by Nutraceutical in a Utah court since the 1994 Dietary Supplements Health and Education Act (DSHEA) does not make mention of risk-benefit balance in establishing whether a supplement presents an unreasonable risk. Rather, the FDA drew on the medical devices provisions of the Food Drug and Cosmetics Act, which does state that this is a determining factor. ... Since then the pendulum has swung back and forth on appeal..."

Judge Campbell's reasoning, however has not been rejected by the Supreme Court, as it decided in its discretion, not to hear the case. Future cases asserting the same legal claim, that Congress intended Dietary Supplement law to be harmonized with food law, not drug law, could be further strengthened by steps the US Senate took last week to exempt Dietary Supplements when it approved enhanced powers for FDA.

In the 2005 case, Judge Tena Campbell held, “...the legislative history of the DSHEA indicates that Congress generally intended to harmonize the treatment of dietary supplements with that of foods when it added the dietary supplement subsection to the food adulteration provision…”

It is therefore incumbent upon Congress to protect this salutary policy and further enhance it, by writing a much stronger exemption for all foods and natural products into S.1082, the FDA Revitalization Act of 2007 when it comes before the House. Keep your mouse-tail twitching and stay tuned to get ready to bombard Congress with one simple demand:

"Protect our herbs, vitamins, minerals and natural remedies from bureaucratic meddling!!"

Check for further details.

To contact Congress:

Friday, May 11, 2007

05/11/07 - OMB approves cGMPs- S.1082 amend confirmed

VLUeM - 05/11/07 - Vitamin Lawyer Update Memo

1. New GMP Standards Cleared by OMB
2. Vitamin Lawyer Health Freedom Blog: DSHEA Exemption?

1. New GMP Standards Cleared by OMB – as reported on the Internet


Completes Effort to Implement Key Aspect of DSHEA

>Washington – Sen. Orrin G. Hatch (R-Utah) today announced the Office of Management and Budget has given final clearance for good manufacturing practices (GMP) regulations for dietary supplements.
>“Finally!” Hatch said. “This is very good news. Senator Harkin and I have been pushing the FDA to publish these for more than a decade.”

>Hatch is one of the principal authors of the Dietary Supplement Health and Education Act of 1994, which gave the FDA the authority to write GMP guidelines specific to supplements. GMPs are the standards inspectors will use to assure purity, potency, and all the other requirements of clean, legal manufacturing.

The GMPs are expected to be published within the next five weeks.

>“GMPs are crucial because they assure the public that the products they are buying live up to their labels,” Hatch said. “Since it took an unusually long time to issue these final guidelines, I want to review the final version very carefully to make certain they are good regulations. Every indication leads me to believe the Administration was very sensitive to the impact the GMPs might have on the industry, especially on small businesses.”

We are likely to get a look at the GMPs within the next few weeks. I will keep this elist informed of these developments, that I have long predicted. When the GMPs are issued, I will update the standard Vitamin Lawyer Consultancy SOPs (Standard Operating Procedures) to conform. My current formats are outlined at: -- 


2. Vitamin Lawyer Health Freedom Blog

The political situation, as it impacts Dietary Supplements and Alternative Practices is moving so fast that a couple of Update eMemos a month cannot keep up, so I’ve started a blog on these issues: - you need to be aware of the latest developments… and two of those are: (1) Dr Ron Paul, congressman from Texas and presidential candidate, called the draft FDA CAM guidance “an abuse of FDA power…” and (2) despite some confusion on the issue, we have written confirmation from Sen. Kennedy’s office that the Senate did approve SAmend 1022 (94 to 0), exempting DSHEA products from the Kennedy FDA enhancement bill (but, the broader exemption for all food and natural products needs to be added when the House considers the bill). More at

Let Congress hear from you:

Thursday, May 3, 2007

05/03/07 - Responding to Net Attacks; Victory in Congress!

PRIVATE MESSAGE: The purpose of the ...VLUeM e-memo is to update the Vitamin Lawyer and

Vitamin Lawyer News web sites for my contacts and client list. Please take a look at – we have a new look and better indexing.
1. Strategies for Responding to Net Attacks – Fake Ratings Sites
2. Strategies for Responding to Net Attacks – DoS Preparation
3. Health Freedom Issues: VICTORY IN CONGRESS TODAY!

1. Strategies for Responding to Net Attacks – Fake Ratings Sites

Here is a copy of an email I just provided to one of my regular clients:

“There are several strategies that can be used to respond to fake "third party" sites that are actually competitor sites designed to denigrate competing products. These responses vary from mild to extreme; from inexpensive to very expensive.

But, before getting to those strategies, some preliminary issues may help understanding how far to go.

First, who actually owns the offending site? I searched the WhoIs database at and find a "private registration" through Network Solutions (NS is the original & "Cadillac" of the URL registrars). The problem is, the register does not have to cooperate without starting a lawsuit and serving a subpoena on it; one trick is to start a small claims action (which is relatively cheap) and issue the subpoena from that.

Second, does anyone actually see the offending site? I checked the rating for the offending site. It has worse than a 3,000,000th rating. Your rating is in the Top One Million. So this offending site may not be much of a problem. By the way, being in the Top One Million is a good thing!

Here are some options:

0. Create & promote a competing site with similar name & image to dilute the offending site's search engine status.
1. Legal letter from attorney to offender, sort of saying: “Cease & Desist your defamatory posting and stop using our trademark!” with copies to URL register and ISP.
2. Written complaint for unfair competition, false claims, to appropriate Attorney General Consumer Protection Agency; copy to offender.
3. Same as #2, but to Federal Trade Commission, if more of a federal issue situation.
4. Lawsuit in state court for unfair competition, trademark violations, etc.
5. Lawsuit in federal court under cyber protection laws (such as the Cybersquatting Act).”


2. Strategies for Responding to Net Attacks – DoS Preparation

It takes a sophisticated opponent to engineer Denial of Service (DoS) attacks on a web site. Individual computers and even local networks have to be commandeered and turned to the nefarious task of massively requesting information from the attacked site, so it crashes under the assault. Since the attack is coming from many IP addresses, it is difficult to stop.

These are certain simple steps you can take, with your webmaster, to minimize the threat. The first step is to always have a mirror site on another server. Then, if attacked, the alternate site can take over until the attack stops. There is a certain way to code your site that can minimize the effect of a DoS attack. I acknowledge receiving this information from Mike Adams of – a great Internet source of information. For various reasons, I am not publicly releasing this information. If you would like to know more about this, please email me at and put “DoS” in the subject line.


3. Health Freedom Issues Continue to Reach 100,000’s

During the past 5 weeks we have seen an awesome outpouring of citizen protest against a growing list of FDA, congressional and international pressure on our health freedoms. Around 180,000 people sought to file comments with the FDA about the draft CAM guidance, before the comment period ended. At the same time, several troubling bills are wending their way through Congress and Codex, the UN food agency, continues to be a battleground. Commenting on this, Dr. Rima Laibow, MD, Medical Director of the Natural Solutions Foundation - – recently stated on her blog:

"Right now the American Public is being whipsawed: first the dangerous FDA CAM Guidance (Complimentary and Alternative Medicine/Modalities) which threatens to turn all health practices into medicine which only physicians could practice and the foods and supplements supporting natural health into
unlicensed drugs – and, yes, there is a real danger to your health freedom despite a good deal of internet chatter to the contrary!) - and now the sudden advancement of Senator Ted Kennedy disastrous bill, S 1082 (“the FDA Revitalization Act of 2007”, plus the identical House bill) from Committee to the floor of the Senate for a vote in the immediate future without public hearings. It would be easy to succumb to “health freedom vigilance fatigue”, which is, I believe, exactly what the intended effect is supposed to be. There is even speculation that Senator Kennedy moved this bill forward so rapidly BECAUSE the American public responded so vigorously to the CAM Guidance and are presumed to be preoccupied with it."

You can keep up with the latest developments at the Health Freedom Blog:

VICTORY IN CONGRESS! And some very good news: Congress has accepted the following amendment to S.1082 - Enhancing Drug Safety and Innovation Act of 2007 - from Sen. Durbin. It appears that Congress heard our concerns! Hundreds of thousands of messages to FDA no doubt reverberated through the halls of Congress. The amendment was adopted with 94 out of 100 votes.

Sec. X08. Rule of Construction

Nothing in this title (or an amendment made by this title) shall be construed to affect--

(1) The regulation of dietary supplements under the Dietary Supplement Health and Education Act; or

(2) The adverse event reporting system for dietary supplements created under the Dietary Supplement and Nonprescription Drug Consumer Protection Act.

Like many victories in Congress, you hardly ever get everything you want. A leading supplement industry lawyer, J. Emord originally proposed exempting all "foods" from the new law (Counsel stated: "It is a fundamental tenet of food and drug law that foods and food ingredients are presumed to be safe and have to be established to be adulterated only if they present a significant or unreasonable risk of illness or injury.") This approach would have offered even greater protection for natural products, but we are grateful that enough members of Congress heard the loud shout from the public and responded so quickly to at least protect DSHEA products -- the power of Internet politics at its best.