Sunday, October 28, 2007


I wanted to share this important educational message from Dr. Laibow -

The key point: "The US Constitution does not mention health freedom. Our right to natural health care and our own decisions in our health path rests in other Constitutional freedoms. "



Action Step: Go to

to tell Congress that secret tribunals, torture and the power to hold people forever without charges or legal representation are not the America you want to live in, and certainly not the America the Constitution gives us. Urge Congress to support the Restoration of Habeas Corpus Act of 2007, S. 185 and the American Freedom Agenda Act of 2007, HR 3835.

The US Constitution does not mention health freedom. Our right to natural health care and our own decisions in our health path rests in other Constitutional freedoms. Tragically, those freedoms have been eroded by the White House and by a Congress which has, all too frequently, forgotten its Oath of Office to protect and defend the Constitution of the United States. S. 185, if passed, will restore your right of Habeas Corpus and cancel the secret Military Commissions recently put in place which can try people in secret - secrecy so great, in fact, that the charges facing you - if any - and the evidence against you -if any - are secret from you. If S. 185 and/or HR 3835 are passed, people could no longer be held indefinitely with secret charges leveled against them (or no charges at all), secret evidence (or no evidence at all), no legal representation and no right to tell anyone where they are.

HR. 3835, the American Freedom Agenda Act of 2007, introduced by Ron Paul (R-TX) goes even further and restores Habeas Corpus, cancels these secret military tribunals, forbids torture, kidnapping, rendition of people to foreign countries for torture and detention, protects journalists who are doing their jobs from charges of espionage and, in general, restores many of the basic Constitutional rights which have been ripped away from us by legislation, Signing Statements, Executive Orders and Homeland Security Directives.

These freedoms must be in place or the very concept of health freedoms becomes meaningless. I urge you, if health freedom is important to you, to take action immediately AND make sure that you send this email Health Freedom Alert to every person on your list and urge them to do the same.

A Quick and Heart-Felt Thank You

Health Freedom information follows this section but I wanted to thank the folks who are helping us keep your freedoms alive.

If you are among the Natural Solutions Foundation supporters who responded to my request for financial support, especially recurring donations

and tax deductible donations to help fund the DVD
now in progress, "Murder by the Numbers: the Codex Agenda", you have my sincere and genuine thanks. We still have hundreds of thousands of people, however, who have not yet stepped up to the plate. Tax deductible donations to the Foundation can be as little as $10 per month (more is very welcome, of course) while donations to fund the DVD in amounts of $100 or more will be acknowledged in the film itself.

This IS your battle: your health (and other) freedoms are at risk. Please take a moment and set up your recurring donation right now. We are here to safeguard those freedoms, but we need your on-going support.

Health Freedom At Risk:
Compulsory Drugging of Children I

Action Step: Go to t o urge Congress to support the Child Medication Safety Act, S. 891 to protect kids and their parents from school-driven health fascism.


Under the guise of "Public Health" and "Mental Health", our children are being exposed to highly profitable, but dangerous, and potentially lethal, medication against parents wishes. In this series we will take a look at a number the ways in which forced drugging of children is either already taking place or is in the works. Using deceptive and incorrect "information", unvalidated and unscientific "screening" tools created by the drug companies and the increasingly invasive police power of the state to over ride parental rights, children are exposed to iatrogenic -doctor induced- mis treatment, removal from their homes to dangerous and abusive foster care and the emotional trauma of these abuses. These violations of our health freedoms and of the future of our country -since we are damaging huge numbers of our young people - must stop. And it is up to us to stop it.

Vaccinations, with all their well-documented dangers, psychoactive medication, with its fearsome brain and behavioral damage, forced chemotherapy come to mind.


In this email we will talk about the phony "screening" of children and adolescents like "Teen Screen" is a huge industry and a major health hazard since they frequently result in unwarranted, knee jerk diagnoses of children and, in the vast majority of cases, in a prescription for dangerous psychiatric drugs.

Fact: Teen Screen has no scientific validity and is a marketing ploy to sell dangerous drugs which may cause irreversible harm to children and teen agers to a new market: healthy children.

Fact: Teen Screen has never been shown to reduce suicidality in children while anti depressants and anti psychotic drugs are well documented to increase the risk of suicidal thoughts, attempts and successful suicides. In fact, these drugs often carry "Black Box" warnings to alert consumers to the increased risk of suicidal thoughts and actions in people taking them.

Here is what has to say about Teen Screen: TeenScreen is a very controversial so-called "diagnostic psychiatric service", aka suicide survey; done on children who are then referred to psychiatric treatment. The evidence suggests that the objective of the psychiatrists who designed TeenScreen is to place children so selected on psychotropic drugs.

"It's just a way to put more people on prescription drugs," said Marcia Angell, a medical ethics lecturer at Harvard Medical School and author of "The Truth About Drug Companies". She said such programs will boost the sale of antidepressants even after the FDA in September ordered a "black box" label warning that the pills might spur suicidal thoughts or actions in minors. (The New York Post, December 5, 2004)

TeenScreen is based on the thoroughly discredited "Diagnostic and Statistical Manual".

How Teen Screen Works

TeenScreen lures kids as young as 9 years old into taking the suicide survey by offering them free movie passes, food coupons, "I completed TeenScreen" stress balls, pizza parties and candy bars - if they consent to the procedure.

One tactic TeenScreen officials use is to sell the child on the suicide survey first and after they have the child's agreement, they later contact parents.

TeenScreen Project Coordinator, Kathleen Cigich, was quoted as saying: "We found early on, though, that sending out letters directly to parents is prohibitively time consuming and gets a low response rate. We thought, why not go to students themselves and offer a $5 video store coupon to anyone who brings back a parental consent form within a two-day turnaround period. It works. Our response rate is extremely high."

Passive Consent: No Parents Need Respond

TeenScreen also utilizes a "passive consent form" which requires no written parental approval. The passive consent form is sent home to parents and if they DON'T return it TeenScreen considers that the parents approve. TeenScreen officials favor passive consent because they say it boost their chances of screening kids to 95% as opposed to the written parental consent technique. What if the child forgets to bring the consent form home? What happens if the parent is too busy to refuse in writing? They've consented in the eyes of TeenScreen personnel.


Next, the child is given a paper and pencil test over about 10 minutes with highly suggestive and meaningless questions like :

Has there been a time when nothing was fun for you and you just weren't interested in anything?
Has there been a time when you felt you couldn't do anything well or that you weren't as good-looking or as smart as other people?
How often did your parents get annoyed or upset with you because of the way you were feeling or acting?
Have you often felt very nervous when you've had to do things in front of people?
Have you often worried a lot before you were going to play a sport or game or do some other activity?
Have you tried to kill yourself in the last year?
Are you still thinking of killing yourself?
Have you thought seriously about killing yourself?
Have you often thought about killing yourself??
Have you ever tried to kill yourself?
Normal children answering honestly will endorse at least one of the first 5 questions. That is enough to get them "diagnosed" with one supposed mental health disorder or another.

Check, Check, Check, Have We Got a Diagnosis for You!

The child then sees a mental health adviser and a check list is administered to confirm the "diagnosis" and earn the child a referral. Click ( to see the mental health check list used to assign a diagnosis. Next, it's off to a psychiatrist and then the real tragedy begins. Up until now, it was merely a matter of violating parental rights, persuading children they are ill when they may just be normal children, taking time away from legitimate school activities, inserting intrusive and potentially dangerous ideas into impressionable kids and damaging the self-image and ego of the child (perhaps permanently). Once a psychiatrist gets involved, however, things get very, very dangerous.

When Parental Judgement Becomes Medical Neglect

Many states in the US have given themselves the authority to compel parents to medicate their children even if they do not believe the child should be taking meds OR RISK LOSS OF PARENTAL CUSTODY. The child will be either medicated by the parents (often under Court order) or taken away from the family and placed in foster care. Children in foster care are, sadly, all too frequently abusively medicated, sexually and physically molested/abused and emotionally damaged, sometimes to horrifying degrees. I know. I was the Child Psychiatrist for the Westchester County Department dealing with children in foster care for about a decade and am well aware of the abysmal conditions children in other states experience as well.
I n some states, the drugging craze has gone so far that school personnel are permitted to refuse to allow children into school if they are not medicated with potent, and dangerous, psychiatric drugs.

Good Bills to Protect Kids from Bad Public Policy

Two bills now before Congress will prevent this kind of abuse and prevent the use of Federal funds for mental health screening such as Teen Screen. S. 891, the "Child Medication Safety Act" was introduced into the Senate by Senators Inhoff and Coburn on March 15, 2007. Here is the heart of the Act with the main phrases underlined:


(a) In General- As a condition of receiving funds under any program or activity administered by the Secretary of Education, not later than 1 year after the date of enactment of this Act, each State shall develop and implement policies and procedures prohibiting school personnel from requiring a child to obtain a prescription for substances covered by section 202(c) of the Controlled Substances Act (21 U.S.C. 812(c)) or a psychotropic drug as a condition of attending school or receiving services.

(b) Rule of Construction- Nothing in subsection (a) shall be construed to create a Federal prohibition against teachers and other school personnel consulting or sharing classroom-based observations with parents or guardians regarding a student's academic performance or behavior in the classroom or school, or regarding the need for evaluation for special education or related services under section 612(a)(3) of the Individuals with Disabilities Education Act (20 U.S.C. 1412(a)(3)).

(c) Prohibition of Payment of Funds- No Federal education funds may be paid to any local educational agency or other instrument of government that uses the refusal of a parent or legal guardian to provide a substance covered by section 202(c) of the Controlled Substances Act (21 U.S.C. 812(c)) or a psychotropic drug for such individual's child of a charge of child abuse, child neglect, education neglect, or medical neglect until the agency or instrument demonstrates that it is no longer using such refusal as a basis of a child abuse, child neglect, education neglect, or medical neglect charge.

Let Your Congressman/woman Know You Support This Sensible Law

Constitutional Rights, Parental Rights, Civil Rights, Normal Childhood Developmental Phases and Stages and good old fashioned Common Sense make it clear that this bill is badly needed. Government funds should not fund medical fascism and Senators Inhoff and Coburn are to be commended for their willingness to defy the market needs of Big Pharma and support the parental rights and developmental stages of parents and children. Click to send a letter to Congress telling them that health freedom, not health fascism, is important to you.

Thanks for your activism!

Yours in health and freedom,

Rima E. Laibow, MD
Medical Director
Natural Solutions Foundation

Tell Your Friends About

Join us in the fight to protect health freedom -

Ask the U.S. government to change its policy on Codex Alimentarius

Make a contribution and help raise funds for the health freedom fight

Register to vote in the US

EDUCATE CONGRESS - SUPPORT the Restoration of Habeas Corpus Act of 2007, S. 185 and the American Freedom Agenda Act of 2007, HR 3835 -

Monday, October 22, 2007

Health Freedom Message from Dr. Ron Paul

Just received this message -

" From: "Ron Paul 2008" <>
To: <>
Subject: Health freedom Allow Subject
October 22, 2007

Discover what Ron Paul has done as a congressman. Imagine what he will do as president.

When health freedom advocates need a congressman to fight against attempts to restrict access to dietary supplements, they turn to Dr. Ron Paul. Dr. Paul is the leader in Washington who is not afraid to fight the powerful special interests that want to limit access to dietary supplements.

When Dr. Paul learned the Food and Drug Administration (FDA) was trying to censor truthful health claims by supplement manufacturers, he introduced the Health Freedom Protection Act (H.R. 2117).

"The Health Freedom Protection Act will force the FDA to at last comply with the commands of Congress, the First Amendment, and the American people by codifying the First Amendment standards adopted by the federal courts. Specifically, the Health Freedom Protection Act stops the FDA from censoring truthful claims about the curative, mitigate, or preventative effects of dietary supplements, and adopts the federal court's suggested use of disclaimers as an alternative to censorship. The Health Freedom Protection Act also stops the FDA from prohibiting the distribution of scientific articles and publications regarding the role of nutrients in protecting against disease," Dr. Paul explained.

Our health freedom is also threatened by attempts to "harmonize" American laws with those of other countries, thus forcing Americans to live under European-style restrictions of dietary supplements. Dr. Paul worked to add language to the 1997 FDA Modernization Act forbidding the FDA from harmonizing our rules with those of any other nation.

The primary instrument of "harmonization" is the Codex Alimentarius Commission, a group of international bureaucrats who are developing "health care standards" for the United Nations and the World Trade Organization. The FDA is an enthusiastic participant in the Codex process.

When Dr. Paul learned the Central American Free Trade Agreement (CAFTA) contained language that might facilitate the imposition of Codex's restrictive standards on American consumers, he informed his congressional colleagues of this danger with a series of letters. In addition, Dr. Paul sponsored several briefings on the issue.

More recently, Dr. Paul has shown how the FDA is working with its counterparts in Canada and Mexico on a Trilateral Cooperation charter that could "harmonize" regulation of dietary supplements among the three countries. Dr. Paul led a congressional inquiry into the Trilateral Cooperation, forcing the FDA to go on record about its involvement in the Trilateral charter.

As a congressman for 10 terms, Dr. Ron Paul has fought to protect your health freedom. Imagine what he will do as president.

Donate today: "

Sunday, October 21, 2007

Health Freedom Rally in Dallas TX

A Skype Chat exchange from earlier this evening; you can find out more about the Health Freedom Rallies at -

[6:53:57 PM] Rima E. Laibow, MD says: We are in the Dallas Health Freedom Rally
[6:58:38 PM] Ralph Fucetola says: Awesome! Send me a report from the rally as it is happening and I'll blog it!
[6:58:58 PM] Rima E. Laibow, MD says: You got it
[7:00:02 PM] Rima E. Laibow, MD says: Gerneral Stubblebine is addressing the group who have come to the Dallas Health Freedom Rally. I have just introduced the complex issues of Health Freedom and the way that Codex is impacting our health freedom.
[7:00:06 PM] Rima E. Laibow, MD says: Audience is spell bound.
[7:00:34 PM] Rima E. Laibow, MD says: Just finisdhed a Radio Interview with Marylee Smith for
[7:00:58 PM] Rima E. Laibow, MD says: Rally being filmed by EONS3 for full length documentary.
[7:02:00 PM] Ralph Fucetola says: Great!

Saturday, October 20, 2007

Dr. Ron Paul on Healthcare

Here is a report I found on the Internet about a recent speech given by Dr. Paul -

Ron Paul, M.D. Speaks on Health Care
The Dartmouth Review
Sunday, October 14, 2007
By A. S. Erickson

On September 29th Texas Congressman and Republican Presidential Candidate Dr. Ron Paul, the only candidate who is a doctor, spoke to students of Dartmouth Medical School about his health care platform.

A palpable air of anticipation filled the room prior to Paul taking the lectern. The students in the room, predominately liberal, were actually excited to hear what this Republican had to say about health care. I’ve seen talking heads assign Paul's popularity on college campuses to his stance on the Iraq War (decidedly non-interventionist), but in the auditorium students weren't talking about foreign policy. Instead, praise for Paul abounded based on his honesty and integrity. Students knew that he said what he actually believed, and, if elected, he would act on what he has promised.

Paul began his remarks by telling students that, "the medical system is going well except for a few groups: the patients, the doctors, the hospitals, the labs, and the politicians. Everybody else is happy."

Paul weaved commentary on the current health care situation into a short autobiographical speech. He spoke of getting drafted for the Vietnam War in 1962, fresh out of Duke Medical School. He commented that working for the Army wasn't so bad as his pay went from $195 per month in residency to $700. While in the military he moonlighted three nights a month at the local hospital.“The amazing thing was it was the city hospital and there was no government; there [was] very little insurance and nobody was turned away whether they were illegal or legal, and nobody, nobody was quizzed. If you didn't have the money, you didn't pay, and people came in, and it wasn't that bad. People didn't lay on the side walks. You're more likely to hear stories today of people being neglected in emergency rooms and dying on stretchers because we have managed care.” Paul often came back to this point in referencing the health problems of today.

He is certain that the problems with today's health care stem from too much government involvement, not too little. “"This whole idea that we need centralized economic planning in anything is a fallacy, and it's a temptation to say, 'Yes, we can't have central economic planning for electronics, televisions, and cell phones because we want efficiency of delivery service, but medicine is different.'"

A major problem with today's society, according to Paul, is the confusion of 'needs' and 'rights': "We have rights to our lives and liberty and we have a right to pursue our happiness and we should have the right to keep the fruits of our labor. We have a moral obligation to help our fellow man." That doesn't mean, however, that we have a right to affordable health care.

Paul noted that because of all these governmental programs, "charity work doesn't seem to exist anymore; yet there was a time when there was substantial charity work. We've gotten this way because the government put us this way."

Accordingly Paul warned strongly against socialized medicine, which he feels is just around the corner, i.e. the current push for universal health care. One aspect of medicine that disappears with increased government tinkering is "the doctor patient relationship. That's about dead in this country, and that to me is the most important thing in medicine."
The more the government gets involved, Paul explained, the farther we get away from that ideal. Paul was also highly critical of current insurance schemes, claiming that the only things that should be insured are surgeries and other high cost possibilities. Instead of insurance for things like a check-up, Paul favored a medical savings account. "We should allow every individual to take a $3,000 tax credit, and they can put that away and use it to go and pay for their doctor visits. We as a people have really lost confidence in freedom."

He noted that this misplaced confidence made no sense, sighting cell phones as an area where, because of freedom, costs have gone down, and availability has gone up. On the other side of the spectrum is the Katrina/Rita disaster, which was spearheaded by the government.

Perhaps surprisingly for a doctor, Paul encourages more competition in the field of medicine.

Noting that many alternative methods of care have sprouted up in recent years, Paul said the competition would be in the best interest of the patients. The only thing he cautioned against was fraud, i.e. registered nurses putting M.D. behind their names. Once more coming back to his core principle Paul stated, "Politically, I believe in freedom of choice."

When Paul's time at Dartmouth Medical School came to a close, the students responded by giving him a standing ovation. His message was simple: "Under the Constitution, government shouldn't be in medicine.

Thursday, October 18, 2007

"Health Freedom" groups don't always support free speech...

We weren't invited to the "Health Freedom Assembly" in Minnesota last weekend (more about that later) so I can't comment directly about it, though I do trust the reporting of News With Views and so reproduce this summary - -

"The United States Health Freedom Assembly met October 12 - 14, 2007 at the William Mitchell College of Law in Saint Paul, MN, a gathering of many of the top state, federal, and international health freedom advocates, organizations, and industry. The meeting took on a tone of extreme importance as the FDA has issued policy and obtained broad new regulatory authority over health freedom in the past 12 months.

The FDA is seeking to undermine the law known as DSHEA (Dietary Supplement Health and Education Act of 1994), the cornerstone of health freedom in America. Emboldened by its new powers the FDA is now poised to trample the first amendment rights of companies and Americans who seek to explain or understand how nutrition can support health. The FDA campaign has begun.Just as the Health Freedom Assembly got under way the FDA announced its latest assault on a dietary supplement company that sought to explain how an herbal product, backed by considerable science and many years of traditional medical use, could be of help to diabetics. At the request of the FDA, U.S. Marshals seized approximately $71,000 of goods from FulLife Natural Options, Inc., of Boca Raton, Fla., which marketed and distributed Charantea Ampalaya Capsules and Charantea Ampalaya Tea. The case highlights interference of the FDA in the dissemination of scientific information that supports natural health options, a clear violation of the first amendment – as well as the absurd use of federal police power against a well-meaning U.S. company.

The double standard is obvious. On September 27, 2007 President Bush signed the FDA Reauthorization Bill into law, ushering in sweeping changes at the FDA that now allow massive conflicts of interest, permitting the FDA to act as a pseudo drug company. During debate on this bill Congressional leaders had seriously considered a ban or severe restriction on direct to consumer drug ads, as most often the adverse side effects of drugs are seldom understood when a drug is first approved (like Vioxx). However, the media came to the defense of Big Pharma fearing they would lose billions in ad revenue. Media lawyers and lobbyists successfully lobbied Congress to block any significant restrictions on direct to consumer ads, arguing that such restrictions would violate the first amendment rights of Big Pharma!"

This interesting article is certainly correct -- there has been a double standard in the law, where "licensed" drug claims are permitted without truly adequate warnings to the public about dangerous side effects while truthful and not misleading nutrient benefit statements are blocked.

While I applaud any gathering of people who are interested in health freedom, and have great respect for several of the organizations represented, I am somewhat taken aback that this "Assembly" would exclude Natural Solutions Foundation from its past meetings.

Further, without any of the NSF trustees present and without an opportunity for response, I am surprised the responsible group would entertain calls, from at least one delegate present, to "censure" NSF... no reason given. Why, with the evident impact of NSF, would any responsible actor in the Health Freedom movement single out and attack this one NGO? Is "turf" that important?

We were heartened, however, to hear that other participants, with whom we have a cordial and cooperative relationship, stood up in our defense and this ridiculous attack was thwarted.

It is good to know we have friends... ;)

Wednesday, October 17, 2007

Mme. Defarge returns

My inspiration and wife of 34 years, Kathy Greene, has started her own blog, Madame Defarge Returns. The spirit of that knitting revolutionary from A Tail of Two Cities is back again.

If I were a supporter of the neocon "Old Regime" I'd worry. As a supporter of the Republic, I am delighted!

Read it at:

Tuesday, October 16, 2007

Is PR Web Censoring Alt Healthcare News?

Not all threats to health freedom come from overzealous government and nefarious commercial interests.

In the past few months I've noted a disturbing trend at many supposed neutral information sites, such as Wikipedia and now PRWeb (a Vocus, Inc. Company) where so-called "sceptic" and "quackwatch" attitudes are making it increasingly difficult to provide uncensored information about advanced "alternative" healthcare to the public.

Wikipedia has been widely criticized recently regarding how its system can be abused by people with an agenda, to prevent controversial information from being posted.

Now it appears leading Internet media release facility PRWeb may be censoring certain alt healthcare information, although it has never announced that it would prejudge healthcare information that does not follow the Big Pharma PC line.

A blatant example of this has come to light in the past few hours. Here is a copy of an email from Dr. Rima Laibow, Medical Director of the Natural Solutions Foundation - - to PRWeb complaining about potential censorship.

------ Original Message ------
Received: Tue, 16 Oct 2007 08:33:36 AM EDT
From: "Dr. Rima Laibow" <>
CC: "Ralph Fucetola JD" <>
Subject: Re: regarding future communications

I am appalled. Your censorship is totally unwarrented. I asked PRWeb to provide distribution services, not control of the press. "Drugging" is a term of art, not an opinion.

Yesterday I attended a Congressional Briefing on "The Dangers of Child Psychiatric Screening and Drugging" hosted by the Intrernational Center for the Study of Psychology and Psychiatry and co-hosted by EdWatch Action, MFI, PsychRights, The EagleForum, CWA and AAPS, all recognized national Mental Health watchdog organizations. In fact, HR 2387, the Child Medication Safety Act (and S891, its Senate companion legislation of the same name) talks about preventing "coerced drugging". If it is good enough for Congress, I would think that it might suffice for PRWeb's editorial censors.

Please make the necessary date adjustments, and change the number of responses [by NSF supporters to Congress] to 74,444.

Your censorship policies, unannounced in any of your material, are inappropriate and have cost this campaign time, money and momentum. Please run this press release immediately amended as above.

Dr. Laibow


PRWeb needs to allay concerns of the alt healthcare community in order to maintain its credibility.

Friday, October 12, 2007

NGO Strives to Help Companies Meet Standard for FDA AER Regulation

Copy of Press Release of 10/13/07 on PR Web:

Nongovernmental Institute Sponsored Framework for Supplement Adverse Event Reporting
More information:

The Institute for Health Research announces publication of an Internet Guide for companies in the natural products industry using neutral third parties to screen and report possible adverse events resulting from taking dietary supplements or non-prescription medicines, the AER Guide.

Summit, NJ (PRWEB) October 13, 2007 -- The Institute for Health Research announces publication of an Internet Guide for companies in the natural products industry using neutral third parties to screen and report possible adverse events resulting from taking dietary supplements or non-prescription medicines, the IHR AER Guide. The draft guide for vitamin industry companies can be found at the Guide website, It is intended to meet the standards suggested by the draft AER guidance announced by the FDA yesterday.

The Dietary Supplement and Non-Prescription Drug Consumer Protection Act, known as the Adverse Event Reporting (or AER) Law, goes into effect on December 22, 2007, having been signed into law one year before. To date the FDA has not issued any regulation or guidance enabling the industry to comply with the law. After indications that the agency was going to issue the new regulation in September, to allow the industry sufficient time to react, the lack of action until yesterday has been criticized. 1

Supporting natural products' compliance with the new law, while gathering important research information, the Institute has created a community outreach, Adverse Event Reporting Consultants (AERC) with the web address: It has developed a collaborative structure, under its general sponsorship, in cooperation with credentialed healthcare professionals and advocacy groups, acting as a neutral third party, to evaluate adverse reaction claims, on behalf of consumers and purveyors.

The History of the FDA Bill:

Congress adopted the Dietary Supplement and Non-Prescription Drug Consumer Protection Act. The new AER law requires manufacturers and distributors to report all "serious" adverse events to the FDA. The bill was introduced June 21, 2006 by a group of Senators that included both critics and supporters of the industry. It was supported by major supplement industry groups. Others, including supplement consumer groups and health freedom advocates, vigorously opposed the bill. The bill was adopted on December 9, 2006 and signed into law on December 22, 2006. It becomes effective December 22, 2007 and the FDA had been expected to issue draft Regulations under the statute during September 2007. Issuing them on October 12, 2007 leaves the industry little time to prepare for the new reporting requirement.

With the FDA just specifying how these events are to be recorded and reported, most organizations are concerned how to address these events responsibly. AER Consultants has, as its Counsel Ralph Fucetola JD states, "…stepped up to the plate and developed a framework that in addition to complying with the FDA mandate will allow the collection of data that will be invaluable in the future to determine drug and non-pharmaceutical interactions..." The Institute invites public comment on the implementation of this consumer and industry initiative.


Also, see the FDA comment site for its draft AER

The Institute for Health Research is a non profit, nongovernmental, exempt organization. P.O. Box 642 Summit, NJ 07901 - . Its trustees are Karen Horbatt, MBA, President of The Green Turtle Bay Vitamin Company,, Ralph Fucetola JD, and Dr. Richard Podell, MD,


The release has been picked up by Medical News -

Today, 10/16/07, the release has a top Google position on "AER FDA guide" and the fourth position on "AER FDA."

Tuesday, October 9, 2007

FDA faulted for failure to issue AER regulations

Industry criticizes FDA for failure to act - where are the FDA regulations?
Private groups stepping in to prepare industry for AER reporting.

10/09/07 - FDA must commit to AER guidance
Functional Ingredients Staff

"The detailed data required under new adverse event reports (AERs) laws, need to be made transparent sooner rather than later, a major trade group has told the United States Food and Drug Administration. The Maryland-based American Herbal Products Association (AHPA) has requested what it considers an overdue guidance document to give the supplements industry a clearer idea of what is expected of them when the law kicks in on December 22. FDA guidance was expected on September 19 but has yet to see the light of day.

"AHPA is charging the FDA with failing to provide necessary guidance and made its thoughts known in a formal letter to the FDA and its parent agency, the US Department of Health and Human Services (HHS). The Dietary Supplement and Nonprescription Drug Consumer Protection Act will require serious AERs to be submitted to the FDA. The Act requires the Secretary of Health and Human Services to "issue guidance on the minimum data elements that should be included in a serious adverse event report as described under the amendments made by this Act."

"Congress clearly intended that businesses would have at least 90 days to digest the FDA's guidance and make any necessary changes to their staff or procedures in order be ready to comply with the law when it goes into effect," said AHPA president Michael McGuffin. "The clock is ticking."

Without implimenting regulations, the industry is truning to private experts for guidance. More at: - preparing for the new law.

Friday, October 5, 2007

Threat to DHEA Update

Natural Solutions Foundation's DC education agent inquired about the threat to DHEA reported by NaturesBotanicals, about which I blogged earlier. Here is one of the responses we got.

------ Original Message ------
Received: Wed, 03 Oct 2007 03:54:59 PM EDT
From: "Charles D. Frohman"
Subject: RE: DHEA outlawed?

Thanks very much; it's helpful to know which office is behind this.
Charlie Frohman

Senator Grassley's staff has been at work on this bill for several years; I don't believe it is any closer to passage now than it has been in the past. That being said, they are strong advocates of the legislation.

The other responders agreed with the above and one noted there were only two cosponsors for the bill. Bottom line: there is a threat, but there is time to educate Congress and decision makers on this important Health Freedom issue.

And here is the link to my report on the 1995 DHEA cases:

Monday, October 1, 2007

Health Freedom Threat Alert: DHEA may be outlawed!

DHEA threatened again -- instead of promoting freedom of choice in healthcare; instead of defending our right as adults to use whatever natural food products we choose to manage our own health, instead of reforming the out-of-control FDA, Congress is at it again... treating us like subjects to be controlled instead of free citizens of a free society.

Truly "When Congress is in session no person's life and liberty are safe..."

------ Original Message ------

Subject: Action Alert--Stop Congress from Restricting Access to DHEA Action Alert--Stop Congress from Restricting Access to DHEA

Your access to DHEA is in jeopardy! The Senate is considering a bill, S.762, to classify DHEA as an anabolic steroid, adding it to the list ofcontrolled substances and removing it from the market. H.R. 1249 is thecompanion bill in the U.S. House of Representatives. Your immediate help is needed to keep this safe and effective dietary supplement legal and accessible. DHEA is not an anabolic steroid. It is a naturally occurring hormone that hasa wide range of benefits, including maintaining muscle strength and strongbones, boosting immunity, and improving mood and sleep patterns. Furtherstudies suggest that DHEA may be helpful for such conditions as obesity,cancer and Alzheimers disease.

DHEA dietary supplements, which have been on the market for over 20 years, are derived from a plant in the wild yam family; for more information. -

We need your help to keep DHEA legal. Send a message to Congress asking yourSenators and Representative to oppose S. 762 and H.R. 1249 and any amendmentto restrict access to DHEA to minors. Congress should not restrict access toa dietary supplement that has given health to millions of Americans. Take action now! "

If you want some background see my article on how I kept DHEA legal in 1995.