Educating Congressional Staffers

While the rest of us are enjoying the hazy days of late summer, my intrepid co-trustees at Natural Solutions Foundation, Gen. Bert Stubblebine and Dr. Rima Laibow are in Washington DC, educating congressional staffers who are already back in town about pressing health freedom and FDA reform issues -- as Congress gets ready to reconvene.

Here is the message they are delivering this week:

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Natural Solutions Foundation Media Releasewww.GlobalHealthFreedom.org
Protecting Health Freedom for Consumer and Entrepreneur

1. While manufacturers and retailers seek to meet consumer demand for high potency, high quality Dietary Supplements and advanced Natural Therapies, abusive FDA regulatory initiatives restrict continued access to them. FDA enforcement includes unwarranted raids against “mom-and-pop” shops, including a current invasion diabetes therapy providers. FDA enthusiastically endorses this “aggressive enforcement policy” (http://www.fda.gov/oc/whitepapers/enforce.html)

2. Access to wholesome nutrition is threatened by regulatory initiatives:

* FDA CAM (“Complimentary and Alternative Medicine) Guidance) – final – would criminalize natural health services not provided by licensed physicians, create new regulatory category of “Complementary and Alternative Products” which would be regulated as unlicensed drugs and devices if used with an intent to bring about a beneficial health result. Ex: FDA threatened to turn cherries into an untested (forbidden) drug when Michigan Cherry Growers Ass’n mounted 6 independent scientific papers on benefits of cherry juice for arthritis on its website.

* FDA Health Claims Guidance – draft – would prevent disclosure of food-related health benefits to consumers by requiring impossible significant scientific agreement instead of more reasonable common law standard – “more than a scintilla of evidence”. This policy is consistent with Codex prohibition on “advertising” which reveal health benefits that would change consumer’s food beliefs, behaviors or purchases.

* FDA Dietary Supplement GMPs (Good Manufacturing Practices) – final – would, by FDA’s own admission, close down significant numbers of small businesses.

FDA Economic Impact: “significant economic impact on a substantial number of small entities.... Establishments with above average costs, and even establishments with average costs, could be hard pressed to continue to operate. Some of these may decide it is too costly and either change product lines or go out of business.... very small [less than 20 employees] and … small dietary supplement manufacturers [less than500 employees] will be at risk of going out of business.... costs per establishment are proportionally higher for very small than for large establishments....The regulatory costs of this final rule will also discourage new small businesses from entering the industry…”

Supplements, because they are treated as food, are generally regarded as safe under the Dietary Supplements Health and Education Act (DSHEA, 1994).

* AER (Adverse Event Reporting) Regulations for dietary supplements, despite little to no history of dangers associated with supplements, are about to be issued. These could easily lead to questionable reporting and misuse of data, further threatening dietary supplements with additional draconian and unnecessary regulation

3. “Harmonization” with Codex Alimentarius is the basis for the regulatory initiatives. FDA has announced preference for International Standards (i.e., Codex) in preference to U.S. regulation and law. (Fed. Reg., October 11, 1995). Consistent with the definition of advertising adopted by the Codex Committee on Food Labeling (2007) with FDA leadership, these regulations will create a stranglehold on truth and choice. FDA head of Office of Dietary Supplements, who also acts as the US Codex Delegate, is pushing to eliminate health claims and information re: health benefits for foods both domestically and through Codex.

4. The FDA Revitalization Act, pending congressional conference committee, is a bad law which rewards FDA abuse of power with more power to abuse and more money to do it with. Sect 608 of the Senate version would protect DSHEA (the 1994 Dietary Supplement Health Education Act) products from additional regulation and should remain in the law.

5. Conflicts of interest in favor of drugs and against foods (a major economic competitor to drugs) currently leads FDA to preside over the active degradation of the food supply, including the subclass of food known as "Dietary Supplements”, at the same time the FDA fails to protect the public from dangerous drugs. Properly used drugs are a leading cause of death in the developing world. Supplements do not pose a significant morbidity/mortality threat.

Solution:

1. Reverse the decision Congress made in 1938 to put drug and food regulation under the auspices of the same organization. Experience since that time has shown this to be a serious administrative and regulatory error. To protect the integrity of the food supply and the health of Americans, it is essential to separate food regulatory authority from the same regulatory agency which regulates drugs.

2. Support HR 2117, The Health Freedom Protection Act, which protects Health Claims for Dietary Supplements from FDA restrictions unless the claim cannot be made truthful by revision.

The Natural Solutions Foundation is a 501 ( c )3 nonprofit with 230,000 members, founded in 2004, with the goal of protecting the majority of humans in their preference for healthy, natural therapies, goods and services, from threatening overregulation by national and international Government Entities. Its Medical Directed is Rima Laibow, MD. For more information or to sign up for our e Newsletter, please check out our website, http://www.globalhealthfreedom.org/.
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The reports I am receiving indicate that Congress may be ready to listen to the call for real reform of the FDA and for the adoption of Dr. Ron Paul's health freedom bill.

My thanks, as always, to Charlie Frohman, our equally intrepid DC consultant, for sheparding Rima and Bert through the House and Senate office buildings maze! http://www.cfrohman.com/ As always, the messanger and the message...

Dissent in the Health Freedom Movement

As a trustee of the Natural Solutions Foundation - http://www.globalhealthfreedom.org/ - I am concerned about some recent criticism.

Some health freedom groups have expressed the view that the FDA Revitalization Act (now pending a conference between the two Houses of Congress) has nothing to do with Dietary Supplements and our concerns about this law are unfounded.

While there are a number of bad clauses in what we call the FDA "enabling act" because it rewards a failing agency with more power to abuse, the House version of the bill does not mention foods or dietary supplements. The Senate version has an additional section 6 (sponsored by Senator Durbin) which was originally inspired by recent bad food (including pet food) imports.

That section is about food safety and establishes an “adulterated food registry.” Even after assurances from Senator Kennedy, on the Senate record, that the law would not be used against food supplements, Senator Harkin and others demanded that language protecting dietary supplements be added to the law. They were supported in this by thousands of constituent messages to Congress through the NSF web site.

It is our view that the proposed statutory language was so vague as to allow FDA more room to attack supplements. Thus, while not supporting the bill, we do applaud section 608, protecting supplements from what bill supporters claim would be an unlikely attack on supplements. If the food safety section 6 remains in the final law, we are assured by our friends "on the Hill" the DSHEA product exemption will remain in place.

Those who criticize us apparently trust the FDA rather more than we do. We, on the other hand, agree with Dr. Ron Paul, who earlier this year called an FDA move against alternatives "an abuse of FDA power..."

We remain concerned that giving the agency more power will allow it to continue its stated policy of 'harmonizing' our health freedoms to international restrictions.

We reject that approach and will continue to be a strong voice for freedom of choice in healthcare. That is the Foundation's purpose: to educate Congress and decision makers about Natural Solutions that will enable people to control their own healthcare decisions. One way the Foundation does that is to make wholesome, organic, nonGM, non-irradiated foods and supplements available on its supporters' buyers club web site, www.Organics4U.org .

Here is an outline of Title VI (Food Safety) of the Senate version of the new law (S 1082):

601 - Congressional findings relating to food safety

601 - ensuring the safety of pet food (18 months for FDA to make saftey regulations)

603 - ensuring efficient and effective communications during a recall (human and pet food)

604 - State and federal cooperation

605 - [After specifically citing DSHEA] an adulterated food registry is created

606 - Sense of the Senate that US should make food safety agreements with trading partners

607 - Annual report to Congress required

608 - Rule of construction: nothing in this title "shall be construed toaffect..." regulation under DSHEA or AER law

609 - authorization of appropriations "as may be necessary"

So, clearly, if the Senate version is adopted, we need section 608. This is not just a pet food issue; anyone who read Title VI that way misread it.

FDA Comment Page Open Again for Health Claims Guidance

This message just received from Natural Solutions Foundation's Health Freedom Alliance eAlert System ( you can join at www.globalhealthfreedom.org ):

"Your Voice Can Be Heard Again!!!

"Good news! This is Kathy Greene, Dr. Rima's assistant.

"Our Natural Solutions Foundation media director, Tom Cowles, told you last week about the roadblocks that had been set up to prevent you from telling the FDA to leave our supplements alone. I've been handling many emails from people who couldn't get through to the FDA but want their voices heard. The great news is we just got a new link to the draft FDA Health Claims Guidance for your comments. The comment period ends in just a few weeks, so we have to act fast! Tell your friends! Tell your neighbors!

"PLEASE FORWARD THIS EMAIL FAR AND WIDE!!!

"The new FDA guidance will make it much harder for vitamin companies to tell you about the health benefits of nutrients.

"ACTION ITEM! Use link below to voice your concern about regulating our supplements!
Click Here to Submit your Comment to the FDA (Full links at bottom of email)

"Many thanks goes to Health Freedom supporter, Marlina, for discovering where the comment page was moved to! Click here to see her Forum page for some great suggestions!
General Stubblebine and Dr. Laibow will be back in Washington DC in about a week, so we want to give them all the ammunition they need: HUNDREDS OF THOUSANDS OF MESSAGES TO FDA AND CONGRESS! So, as the General says, get your mouse ready! Aim! Fire!
Click Here to Submit your Comment to the FDA (Full links at bottom of email)

"Thank you so much for making the Health Freedom movement the powerful expression of citizen concern it has become. I can remember licking stamps and demonstrating at local FDA offices back in 1993 and 1994 to convince Congress to pass DSHEA, the law that lets us talk freely about nutrients. Now it's much easier: all you need do is click your mouse! And it would really be nice if you "double clicked:" once to send your message and then, a second time, right here to help us with your generous donation. We volunteer our time so your voice can be heard, but we must cover the Foundation's expenses, so your voice will have the power it deserves. Please give generously, and click, click!

"Yours in health and freedom,
Kathy Greene
Assistant to Dr. Rima

"FDA Comment Link:
http://www.accessdata.fda.gov/scripts/oc/dockets/comments/getDocketInfo.cfm?EC_DOCUMENT_ID=1640&SORT=&MAXROWS=15&START=106&CID=&AGENCY=FDA

EU Backs Off Banning Natural Vitamins

Congradulations to Dr. Robert Verkerk, leader of the UK's Alliance for Natural Health - www.alliance-natural-health.org !!

Natural sources of vitamins and minerals, which could have been subject to banning in the EU will escape the strictures of the EU Food Supplements Directive (FSD). These ingredients will now be regulated as foods. This news is contained in new letter from the EU that reverses the position of the EC's legal unit given to ANH in March 2006 and upholds ANH's interpretation of the European Court of Justice (ECJ) 2005 ruling that Dr. Verkerk viewed as protective for natural source supplements.

The letter, received in the past few days, from Mr. Demetris Vryonides of the Legal Affairs Unit and Mr. Basil Mathioudakis, of the Food, Law, Nutrition and Labeling Unit, states: "We consider that wheat germ oil can be used in food supplements without having to be authorised and included on Annex II of the Directive. For similar reasons the dossiers on mixed carotenoids, food derived folates, [and two proprietary palm blends containing carotenoids and tocotrienols respectively] will not be processed further." The ANH had submitted many natural source products to the EU for inclusion in the "positive list" of allowed supplement ingredients. The letter indicates, in effect, that these ingredients will not be subject to banning.

Dr Robert Verkerk, ANH executive and scientific director, said "We are delighted to finally have this clarification from the European Commission on a point of law the ANH has been aware of since the ECJ ruling. The wider implications of this for the industry are farreaching and it effectively opens the door to functional foods and supplements containing nutrients derived from natural sources."

The US and EU regulate supplements differently, with the US taking the Constitutionally mandated Common Law approach that whatever is not prohibited is allowed; the EU's legal approach is essentially whatever is not permitted is forbidden. This limited victory for Health Freedom shows that engaging the regulatory system, as ANH has, can sometimes have beneficial results.

Adverse Event Reporting...

See: http://www.aer-consultants.com/ for background on the AER Act of 2006.

Act as signed into law:
http://www.fda.gov/cder/regulatory/public_law_109462.pdf

AER Regulations Immanent

This late breaking news from NutraIngredients. Please note this indicates that FDA is about to issue the Adverse Event Reporting regulations mandated by the law President Bush signed last December. The law is supposed to go into effect 12/22/07. These guidelines would be the 4th major guideline about Dietary Supplements issued by FDA over the past half year or so.... an unprecedented level of regulation enhancement.

www.nutraingredients-usa.com/news/ng.asp?n=78773&m=1NIU803&c=jegwylrviswtnqa

CRN urges FDA interpret adverse events bill with caution - By Clarisse Douaud

"08/03/2007 - The Council for Responsible Nutrition (CRN) has expressed its concern to the US Food & Drug Administration (FDA) over alleged labeling requirements the agency may include in its upcoming adverse events reporting guidance ... The points in question pertain to a requirement for labels to include a full street address as well as introductory language informing customers how … [report adverse events] … ‘To issue guidance that would require de facto label changes would cause a great deal of confusion…’ wrote [CRN] in the July 31 letter addressed to … FDA's Center for Food Safety and Applied Nutrition… Known as the AER bill, the amendment to the Food, Drug and Cosmetic Act was passed in December 2007 and will oblige supplement manufacturers, packers and distributors to notify FDA of any serious adverse events reports (AERs). The bill is applauded by industry associations for its potential as an extra post-market precautionary measure to secure more credibility for supplement makers… now anticipating the imminent release of FDA's guidance on "the minimum data elements that should be included in a serious adverse event report". The document will essentially outline how the bill is to be interpreted … The so-called introductory language would instruct consumers how to use the contact information. For … example…: "To report an adverse event, contact..." and "If you experience problems with this product, contact…""

Like many people involved in the Vitamin Industry, I am a bit conflicted regarding the AER Act. I believe mandatory reporting of serious adverse events will prove Dietary Supplements to be very safe indeed; on the other hand, I can see how the system could be used to falsely paint all nutrients with the problems of a few examples of abuse or misuse. Since foods are generally recognized as safe, I doubt there will be many AE Reports... time will tell.

One thing we want to make sure, as Maury Silverman suggested in an email earlier today, "PLEASE TELL FDA NOT TO SCAPEGOAT DIETARY SUPPLEMENTS WHEN IT IS A CONCURRENT DRUG-DRUG INTERACTION. DRUGS DEPLETE NUTRITION."

This is true; drugs act by changing normal structure and function and must deplete nutrients to carry-on that effect. Thus, Mike Adams, NewsTarget.com, in expressing the 26 myths that rule the minds of what we might call the pharmaphiliacs (lovers of pharmaceuticals) satirically suggests:

"4. Most diseases are caused by pharmaceutical deficiencies and can only be treated with pharmaceutical supplementation.

5. Botanicals interfere with pharmaceuticals, not the other way around. There is no such thing as a pharmaceutical that interferes with an herb."

http://www.newstarget.com/021952.html

The truth is quite the contrary: dis-ease is predicated on nutritional deficiencies and the body needs good nutrition to return to normal structure and function.

We need to assure that the AER system takes into account dangerous drug-drug interactions and the harmful impact drugs have on nutrients before blaming the nutrients. When the AER Regulations are issued, these will matters will have to be taken up with the FDA.

FDA enabling act delayed... hope for Health Freedom Protection Act?

This report in late yesterday:

http://blogs.wsj.com/washwire/2007/07/31/no-action-likely-on-fda-bill-until-the-fall/

"No Action Likely on FDA Bill Until the Fall
Anna Wilde Mathews reports on the FDA.

"The House and Senate don't appear likely to reconcile their divergentversions of a major Food and Drug Administration bill before their August recess, according to congressional staffers and lobbyists.

"The bill is unusually time-sensitive because it renews the FDA'sability to collect fees from drug makers and device manufacturers that are needed to keep important agency operations running. The fee authority runs out at the end of the government's fiscal year, Sept.30.

"Lawmakers didn't want to play it too close and force the agency tosend out warnings to employees about possible layoffs. Staffers from the House and Senate have been negotiating for the last few weeks, trying to work out the outlines of a deal lawmakers could quickly complete and pass before heading out for their break. But the full meeting adjourned last night and now might not pick up again for the rest of the week. Staffers generally believe that a bill can't pass before the recess begins this weekend. The movement toward a fast agreement seems to have stalled over a variety of issues..."

From the perpective of supporters of Dr. Ron Pauls' Health Freedom Protection Act - HR 2117 - this is a good development and indicates that our efforts to educate Congress may be having an effect. How can the FDA be "revitalized" if Health Freedom protection is not in the picture? We specifically told the major players in Washington this past Monday,

"...the "FDA Revitalization Act" is not going to satisfy the American public. Congress must use the opportunity presented by HR 2117 to protect the health of the American people and that is our message to Congress today. The final adoption of the FDA Revitalization Act should be delayed; hearings should be held and careful consideration should be given to HR 2117, The Health Freedom Protection Act and other measures to protect the health freedom of Americans."

(From Gen. Stubblebine's 07/30/07 Congressional Briefing Document: "Congressional Choice: Health Freedom or Health Tyranny" - see previous posting for text.)

During the past three months over a half million citizen messages have been generated through the Natural Solutions Foundation - http://www.healthfreedomusa.org/ - to Congress, FDA, USDA educating DC decision makers that Health Freedom is an issue of great concern to the public. Will Congress listen?