Showing posts with label Dr Ron Paul - Health Freedom. Show all posts
Showing posts with label Dr Ron Paul - Health Freedom. Show all posts

Wednesday, February 8, 2012

Health Freedom Bills Pending in the 112th Congress

Dr. Ron Paul and several other members of Congress have introduced several health freedom bills into the 112th Congress. I summarize them here, quoting from Thomas.gov.

The relevant Action Item, where citizens can express their views about these bills, and help educate decision makers, is here:
http://tinyurl.com/SaveOurSupplements

All of Health Freedom USA's
Current Action items are here:
http://tinyurl.com/PushBackHere



Updates DSHEA "Grandfather" Clause
H. R. 3380

To amend the Federal Food, Drug, and Cosmetic Act
concerning safe dietary ingredients in dietary supplements.
    The Congress finds as follows:
      (1) Improving the health status of United States citizens ranks at the top of the national priorities of the Federal Government. The importance of nutrition and the benefits of dietary supplements to health promotion and disease prevention are well known and have been documented in scientific studies.
      (2) Since enactment of the Dietary Supplement Health and Education Act of 1994 (DSHEA), dietary supplements have had an exemplary public health safety record. Based on national surveys, in 1994, 50 percent of the 260,000,000 Americans regularly consumed dietary supplements. In 2006, 232,000,000 adults over the age of 18 alone consumed dietary supplements, 53 percent of the United States adult population.
      (3) There were 4,000 dietary supplements in the marketplace in 1994, and in 2006 an estimated 29,000 dietary supplements were being consumed daily by Americans. Since the enactment of DSHEA, there has been 17 years of additional historical use-safety experience conducted by millions of Americans. Over 17 years, approximately 25,000 new supplements with new dietary ingredients have been approved by the Food and Drug Administration (FDA) under DSHEA and have and are being safely consumed by Americans.
      (4) Since January 2007, FDA regulations governing dietary supplement manufacturer good manufacturing practices, dietary supplement adverse event reporting, and private sector voluntary testing and auditing for supplement quality and purity have improved postmarketing consumer safety. Before DSHEA, these mechanisms did not exist.
      (5) There are DSHEA `grandfathered' supplements, dietary ingredients, and classified products which were on the market before October 15, 1994, and `generally recognized as safe' for human consumption. FDA regulatory policy, industry practices, and consumer marketplace paradigms have drastically changed over 17 years, but this policy has not.
      (6) The definition of a new dietary ingredient in section 413 of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 350b) does not recognize the current safe market in supplements, nor how intensively supplements have been regulated over the 17 years since enactment of DSHEA to protect public health and safety, and should be updated to reflect this reality...
    Section 413(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350b(d)) is amended by striking `October 15, 1994' each place it appears and inserting `January 1, 2007'.


    Requires Court Approval of FDA
    Actions Against DSHEA Products
    H. R. 2044

    To amend the Federal Food, Drug, and Cosmetic Act concerning claims about the effects of foods and dietary supplements on health-related conditions and disease, and for other purposes.
    ... In General- The Federal Government may not take any action to prevent use of a claim describing any nutrient in a food or dietary supplement (as such terms are defined in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321)) as mitigating, treating, or preventing any disease, disease symptom, or health-related condition, unless a Federal court in a final order following a trial on the merits finds clear and convincing evidence based on qualified expert opinion and published peer-reviewed scientific research that--
        (1) the claim is false and misleading in a material respect; and
        (2) there is no less speech restrictive alternative to claim suppression, such as use of disclaimers or qualifications, that can render the claim non-misleading...




    Shifts FTC Burden of Proof
    H. R. 2045

    To amend the Federal Trade Commission Act concerning the burden of proof in false advertising cases involving dietary supplements and dietary ingredients.
    ...EXEMPTIONS FROM REGULATION AS ADVERTISING- No content of any publication shall be considered advertising regulated under this Act unless the content is intended by the seller of a product to promote the sale of that product and the content includes--
          `(A) the name of the product offered for sale;
          `(B) an express offer to sell the named product; and
          `(C) a purchase price for the product.
        No content excerpted in whole or part from a peer-reviewed scientific publication shall be considered advertising regulated under this Act.
        `(3) NO IMPLIED CLAIMS- In any investigation commenced by the Commission and in any adjudicative proceeding in which the Commission is a party, the Commission shall not attribute to an advertiser accused of false advertisement any advertising statement not actually made by that advertiser.
        `(4) NOTICE, OPPORTUNITY TO CURE, AND BURDEN OF PROOF FOR INVESTIGATION- Before the Commission authorizes an investigation of false advertisement by an advertiser of a dietary supplement or a dietary ingredient, the Commission shall send the advertiser a written `Notice of Suspected Violation and Opportunity to Cure' informing the advertiser ...
    ... (5) BURDEN OF PROOF FOR FALSE ADVERTISEMENT CASES- In every proceeding before a court or the Commission in which an advertiser of a dietary supplement or a dietary ingredient is charged with false advertising, the burden of proof shall be on the Commission to establish by clear and convincing evidence that the advertisement is false, that the advertisement actually caused consumers to be misled into believing to be true that which is false, and that but for the false advertising content the consumer would not have made the purchase at the price paid. If a claimed health benefit of a dietary supplement or dietary ingredient is alleged to be false advertising, the Commission must additionally establish based on expert scientific opinion and published peer-reviewed scientific evidence that the claim is false. No order adverse to the advertiser shall be entered except upon the Commission satisfying this burden of proof.'...

    Reasonable Belief About Foods Protected
    H. R. 2908
    To protect the First Amendment rights of individuals to share their experiences and perceptions of the effects of foods and dietary supplements.
    ...Dissemination of Testimonials- Notwithstanding the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), the Federal Trade Commission Act (15 U.S.C. 41 et seq.), and any other provision of law--
        (1) no Federal official or employee may restrict dissemination of a testimonial containing a consumer's actual perception of the mitigative, preventive, or curative properties of any food or dietary supplement based on the consumer's experience with that food or dietary supplement; and
        (2) if a person disseminating a testimonial reasonably believes that the dissemination is covered by paragraph (1), such dissemination shall not constitute a violation of any Federal law...
    It is time to tell Congress that it must pay attention to our Health Freedom Rights! The FDA ignores Senators Harkin and Hatch, indicating that it is not interested in their views about dietary supplements and will continue its anti-nutrient policies.* We suggest it is time for the entire Congress to ACT! Please tell your congress-critters that is what you demand! http://tinyurl.com/SaveOurSupplements

    -----------------
    * as reported: http://www.nutraingredients-usa.com/Regulation/FDA-silent-on-calls-from-Sen-Hatch-and-Harkin-to-withdraw-NDI-draft-guidance

    Monday, August 3, 2009

    Three For Liberty - Three Weeks to Save Health Freedom - Three Action Items

    Natural Solutions Foundation
    The Voice of Global Health Freedom

    www.HealthFreedomUSA.org

    Three for Liberty Campaign
    Three Action Items; Three Weeks to Save Health Freedom

    Action Items at: http://www.healthfreedomusa.org/?p=3209

    Action eAlert at: http://www.healthfreedomusa.org/?p=3230

    Direct Links to the Action Items:

    1. The House of "Representatives" passes draconian (sic) food safety bill... now its the Senate's turn to hear from us!

    Take Action Here: http://salsa.democracyinaction.org/o/568/t/1128/campaign.jsp?campaign_KEY=26714

    2. And mass forced vaccination comes closer... Demand your Right to Self-Shield!

    Take Action here: http://salsa.democracyinaction.org/o/568/campaign.jsp?campaign_KEY=27275

    3. BUT... Dr. Ron Paul offers a prescription to Congress: two new bills, HR 3394 and 3395 - regulate the regulators and promote Free Health Speech!

    Take Action here: http://salsa.democracyinaction.org/o/568/campaign.jsp?campaign_KEY=27732

    Note: the first two Action Items have been revised. If you submitted them before, along with one for each member of your family or household, we urge you to do so again since, once revised, they count as new items. These actions could save your life, assuming we all act together to speak the power of our collective truth to legislative power.

    Are you the one? Are you the one person who makes the difference? Are you the one person who alerts your neighbors like Paul Revere and defeats the forces threatening our lives, our liberty and our sacred honor?

    If you are, then you are mounted up and ready to ride - only this time, it's a freedom mouse that will carry your message to your neighbors and to the heavens because we need both your neighbors and the support of the Universe to make sure that our cause, our just cause, survives.

    We are talking about literal survival here: if our food is poisoned we will not survive. If our bodies are poisoned, we will not survive. Health Freedom is Our First Freedom!

    In three weeks, if we don't act NOW, the evil (sic) Food Safety bill will pass the Senate; vaccines will be mandated and Dr. Paul's important bills will not move forward. On the other hand, if we act NOW, our Push Back will make all the difference!

    "Liberty is to the collective body what health is to every individual body. Without health no pleasure can be tasted by man; without liberty, no happiness can be enjoyed by society." - Thomas Jefferson

    Thank you!

    Natural Solutions Trustees:
    Maj. Gen. Bert Stubblebine (USA ret.) - President
    Dr. Rima E. Laibow, MD - Medical Director
    Ralph Fucetola JD - Counsel

    Sunday, March 16, 2008

    The "Soft Fascism" of Fake Health Freedom

    Dr. Ron Paul's comment that our Constitutional Republic was being replaced by a type of "Soft Fascism" came home to me this weekend. Kathy and I are attending the annual Sound Health Conference, being held in SE Ohio. See: www.vocalprofiling.com. Dr. Laibow (speaking over the Internet) and I had an opportunity to discuss health freedom with several people from Ohio as well as other attendees.

    What I heard from the Ohioans shocked me. I had been following some of the details of the struggle for health freedom here, but had not had an update in months.

    To start with, Ohio law is not favorable to freedom of choice in health care. This state, since 1983, has had a very restrictive dietitian's law that prevents non-registered individuals from speaking freely to other individuals about nutrition. While this old law is contrary to Constitution principals, such as that announced in Thompson v Western States - 535 U.S. 357, 2002 (I've written about this important US Supreme Court health freedom decision in earlier blogs) it has set the tone for CAM health care enactments in Ohio.

    What has happened? When nutritionists and other CAM practitioners sought protection from the dietitians' monopoly, a health freedom bill was introduced... and then, some months later, it was discovered that the bill was apparently amended to include a "registration" provision that required anyone who wanted to exercise their health freedom professionally to first register with the state. Failure to register carries a $10,000 fine, but nothing in the law specifies who is required to register before speaking. Of course this would be an unconstitutional enactment. The state cannot condition freedom of speech on government registration, and, as the Supreme Court reminded us in Thompson,

    "We have previously rejected the notion that the Government has an interest in preventing the dissemination of truthful commercial information in order to prevent members of the public from making bad decisions with the information."

    So, you ask, who would be sly enough to turn a health freedom bill into a law designed to restrict health freedom? How did the health freedom movement react? True health freedom advocates reacted strongly and were accused of "refusing" to "compromise and cooperate." Certain people who pretend to support health freedom, but appear to be funded from dubious sources, made the accusation to state legislators.

    PLEASE PAY ATTENTION TO THIS: refusing to surrender one's freedom is NOT a failure to "compromise and cooperate;" only someone who is a crypto-fascist a heart could think so. Despite the self-serving beliefs of politicians, the state does not have unlimited authority to interfere with our private and personal decisions, such as what health care to accept or reject.

    That is the essence of freedom. When any so-called health freedom group suggests programs that decrease freedom and increase the power of politicians and their appointees, those people are fake health freedom fronts for the monopolists and control freaks. What they want is a decrease in health and freedom.

    In the case of State v Biggs (46 SE Reporter 401, 1903) the North Carolina Supreme Court dealt with a person who was advising people as to diet, and administering massage, baths and physical culture. In the Biggs case, the defendant "advertised himself as a 'nonmedical physician'...[and] held himself out to the public to cure disease by 'a system of drugless healing'..." p.401. That Court held that there could be no "state system of healing" p.402 and while "Those who wish to be treated by practitioners of medicine and surgery had the guaranty that such practitioners had been duly examined...those who had faith in treatment by methods not included in the 'practice of medicine and surgery' as usually understood, had reserved to them the right to practice their faith and be treated, if they chose, by those who openly and avowedly did not use either surgery or drugs in the treatment of diseases..." p.402. Biggs was acquitted.

    While a CAM practitioner registration law might protect registered persons from competition, that is not a legitimate function of law. And while it may "protect" people from making what some bureaucrats may think are "bad" decisions with truthful information, that is not a legitimate function of law either.

    The North Carolina Supreme Court concluded, a century ago in Biggs, supra., at p.405: "Medicine is an experimental, not an exact science. All the law can do is to regulate and safeguard the use of powerful and dangerous remedies, like the knife and drugs, but it cannot forbid dispensing with them. When the Master, who was himself called the Good Physician, was told that other than his followers were casting out devils and curing diseases, he said, 'Forbid them not.'"

    ----------------------------

    Update: 2008 Sound Health Conference Report:
    http://www.lifespirit.org/SHRI-2008-Conference.htm

    Monday, March 10, 2008

    Ron Paul, Health Freedom Advocate

    Despite the MDM (Mass Deception Media) distortions, Dr. Paul has not "quit" the presidential campaign. The campaign to Restore the Republic and Return to the Constitution is not over. It has just begun.

    Dr. Paul will continue on the ballot in the remaining states and Ron Paul Republicans will be at the Convention to contest the platform and educate the party. The goal is to bring Dr. Paul's positions, including his strong positions on health freedom and against all forced drugging, including vaccinations, to the convention.

    See Rand Paul's explanation at:

    http://www.dailypaul.com/node/42027

    Sunday, February 3, 2008

    Dr Ron Paul - the ONLY health freedom candidate.

    "The government should never have the power to require immunizations or vaccinations."

    Health Freedom Message from Dr. Ron Paul, Member of Congress from Texas. Why waste your vote on the media-nominated when you can vote your conscience, and maybe help restore the Constitution.

    Dr. Paul's statement:

    "Americans are justifiably concerned over the government’s escalating intervention into their freedom to choose what they eat and how they take care of their health.

    The Food and Drug Administration (FDA), in order to comply with standards dictated by supra-national organizations such as the UN‘s World Food Code (CODEX), NAFTA, and CAFTA, has been assuming greater control over nutrients, vitamins and natural health care providers to restrict your right to choose the manner in which you manage your health and nutritional needs.

    I have been the national leader in preserving Health Freedom.

    I have introduced the Health Freedom Protection Act, HR 2117, to ensure Americans can receive truthful health information about supplements and natural remedies.

    I support the Access to Medical Treatment Act, H.R. 2717, which expands the ability of Americans to use alternative medicine and new treatments.

    I oppose legislation that increases the FDA‘s legal powers. FDA has consistently failed to protect the public from dangerous drugs, genetically modified foods, dangerous pesticides and other chemicals in the food supply. Meanwhile they waste public funds attacking safe, healthy foods and dietary supplements.

    I also opposed the Homeland Security Bill, H.R. 5005, which, in section 304, authorizes the forced vaccination of American citizens against small pox. The government should never have the power to require immunizations or vaccinations. "

    http://www.ronpaul2008.com/issues/health-freedom/

    Thursday, January 24, 2008

    Ron Paul Speaks Out Against Forced Vaccination

    Wednesday, Jan 23, 2008
    InfoWars.net - by Steve Watson

    "Presidential candidate Ron Paul has spoken out against forced vaccination and the federal government's eagerness to dictate what Americans may and may not put into their bodies.

    The Congressman, a fully qualified obstetrics and gynecology doctor, made his position plain in an interview with the Huffington Post's election reporter James Freedman:

    "I don't think anything should be forced on us by the government, [and] immunization is one thing that we're pressured and forced into," he said.

    "A responsible parent is going to say, 'Yeah, I want my child to have that,' [but] when the government makes a mistake, they make it for everybody. You know, that's what worries me. They don't always come up with the perfect answer sometimes... and people have had some very, very serious reactions from these immunizations."

    Besides certain laws that apply only to government medical specialists - there is no law that enforces the mandatory use of any vaccine in the United States. Enforced medical treatment is an assault and a violation of the 14th amendment, the reason Ron Paul, a strict Constitutionalist, is so directly against it.

    However, some in Washington seem determined to ignore the Constitution and to make some vaccinations (usually the most profitable ones) mandatory.

    There has recently been a spate of cases where officials, with the assistance of directed media propaganda, have attempted to cajole parents into believing that laws require vaccination.

    Last February one such media hoax fooled parents in Texas and other areas of the country into believing that the HPV vaccine, which experts have slammed as untested and has continued to be linked to dangerous side-effects, is now required by law and that young girls must take it. Merck Pharmaceuticals hit the headlines after it was revealed that the company was set to capitalize on this fraud by making obscene profits from a crony deal with Governor Rick Perry, while children were put at risk.

    Last November we reported on a case in Prince George's County, Maryland, where parents of more than 1600 children were told they could be put in jail for failing to get their kids vaccinated. At the time a local Fox News affiliate reported, "A new law was passed last year requiring children from 5th through to 10th grade to have the vaccine," which was a total lie. A state prosecutor involved in the case then admitted that there is no law that mandates any vaccine."

    Read the rest at InfoWars.

    http://www.infowars.net/articles/january2008/230108Vaccines.htm

    Wednesday, January 2, 2008

    Vitamin Lawyer endorses Ron Paul

    I've joined many other freedom advocates to endorse Dr. Paul's efforts to restore the Constitution.

    See it at:
    http://people.ronpaul2008.com/endorsements/2007/12/29/ralph-fucetola/

    Monday, November 26, 2007

    Tiburon Statement:
    NO FORCED VACCINATIONS!

    08/19/09 Update: Citizens Petition to Stop the Shot, with Action Item:
    http://www.healthfreedomusa.org/?p=3312

    Your Right to Self-Shield instead of taking the jab; with preparedness links:
    http://www.healthfreedomusa.org/?p=2752

    Follow this issue on http://www.twitter.com/healthfreedomus
    Hashtags: #selfshield #pandemic #noforcedvax #vaccine #healthfreedom

    Join the No Forced Vaccination Forum:
    http://groups.yahoo.com/group/no-forced-vaccination/join

    ------------
    Original Posting:

    A group of Health and Freedom advocates met over Thanksgiving Weekend in emergency strategic session, at Tiburon, California and by electronic means; see my blog of November 24, 2007.

    It was clear to those present that the most pressing public issue at this moment is the use of the police power to restrict and control people's health choices. This was tragically demonstrated on November 17 at the Prince George's County Courthouse when 1600 parents were threatened with jail and fines if they failed to vaccinate, or in some cases, re-vaccinate, their children when either the school had lost their records or the parents did not (or chose not to) have them vaccinated. The sad spectacle of children inoculated at the point of a gun was observed by our legislative consultant who also reported on this miscarriage of the rule of law. The spectacle of police with weapons and dogs prepares us, perhaps, for further such outrages on an even greater scale, in the event of an alleged biological weapon or supposed pandemic incident.

    We reviewed the Declaration of Helsinki forbidding involuntary medical experimentation and treatment - http://www.wma.net/e/policy/b3.htm and considered the recently adopted laws mandating psychiatric testing and drugging of children and laws mandating mass vaccination, we issued the following statement:

    Tiburon Statement
    Convening for Health Freedom of Choice
    Protecting our Children from Forced Vaccination

    Health and Freedom leaders and advocates, meeting in an emergency strategic session at Tiburon, California and electronically, declare -

    We collectively call upon Congress and State Legislatures to take immediate steps to restore and guarantee freedom of choice in vaccination and health care and to protect our children and us against forced treatments.

    The moral imperative embodied in the World Medical Association Declaration of Helsinki forbids involuntary medical treatment or experimentation in the absence of fully informed, voluntary consent.

    We have a right to legal protection against mandatory inoculations of our children, such as those which occurred on November 17, 2007 in Prince George’s County Court House, enforced by police.

    Taxpayers have paid nearly $2 billion to compensate families for the death or disability of their children due to vaccination.

    We, the undersigned, call upon the Congress of the United States and legislators of each State to adopt the strongest possible legal protections to ensure health care freedom of choice, including the universal right to vaccination exemptions.

    Issued Thanksgiving Weekend, November 25, 2007

    Signed (with affiliations for identification purposes only),

    Major General Albert N. Stubblebine III (US Army Ret. - www.globalhealthfreedom.org )

    James Turner, Esq. (Foundation for Health Choice – www.foundationforhealthchoice.com )

    Rima E. Laibow, MD (Natural Solutions Foundation – www.healthfreedomusa.org )

    Ralph Fucetola JD (Institute for Health Research – www.inhere.org)

    Mary Beth Brangan (Ecological Options Network – www.eon3.net)

    Stephanie Sutton (Phisciences – www.phisciences.com )

    Dr. Patrick Flanagan (Phisciences – www.phisciences.com )

    Sali Randel (Holistic News Network – www.holisticnewsnetwork.com )

    We invite other health and freedom conscious people to add their names to the Statement; please email your name, organization, link to dr.laibow@gmail.com with "TIBURON" in the subject line.

    Saturday, November 3, 2007

    Dr. Ron Paul Answers Questions about Health Freedom

    Natural Solutions Foundation's members have sent over 80,000 messages to all current candidates for President of the United States. Here is the first response.

    -------------

    November 3, 2004

    Here are the questions we asked of each Presidential candidate on our Health Freedom Scorecard. To date, only Dr. Ron Paul (R-TX) has provided his answers to those questions.

    We urge all candidates for the office of President of the United States take the time and effort necessary to consider, and answer,

    HFUSA: The FDA current Good Manufacturing Practices (cGMP) Final Rule Do you support the FDA cGMP Final Rule for dietary supplements, issued on June 22, 2007, requiring the batch testing of all food dietary supplements although- Supplements have an enviable safety record- The FDA’s own economic analysis of the impact of the cGMP shows that it will drive a significant number of small and medium size manufacturers out of business?

    Dr. Paul: I oppose all federal regulations that burden dietary supplement manufacturers. There is no need for the federal government to impose “Good Manufacturing Practices” on the dietary supplement industry. In addition, the federal government lacks constitutional authority to create standards for the supplement industry.

    HFUSA: The FDA draft Guidance on Health Claim substantiation A. Are your aware of the FDA draft guidance on Health Claim substantiation, issued this summer, which mandates an unreasonably high “Significant Scientific Agreement” standard instead of the FTC “competent and reliable scientific evidence”, as proposed in HR 2117, The Health Freedom Protection Act?

    Dr. Paul: I oppose the CAM Regulation draft guidelines and submitted comments to the FDA in opposition to the CAM regulations.


    HFUSA: Do you support HR2117 {Health Freedom Protection Act]?

    Dr. Paul: I introduced HR 2117, and oppose all FDA actions that in any way infringe on the First Amendment rights of consumers to learn about the health benefits of dietary supplements.


    HFUSA: Protection of Dietary Supplements Do you support continuing strong protection for Dietary Supplement Health and Education Act (DSHEA) products?

    Dr. Paul: I support DSHEA.


    HFUSA: Bio-Identical Hormones Do you support the right of men and women to use supplemental Bio-identical Hormones such as DHEA and progesterone to support normal function during change of life and premature aging in preference to less effective, dangerous and more expensive prescription drugs if they prefer bio-identical hormones?

    Dr. Paul: The federal government has no constitutional authority to stop Americans from using bio-identical hormones.

    HFUSA: Compounding Pharmacies Do you support the right of Compounding Pharmacists and licensed physicians to continue to provide compounded medications, on a doctor’s prescription, for special needs and choices of individuals, communicating their availability to the public, as permitted by the landmark Supreme Court case of Thompson vs. Western States Medical Centers?

    Dr. Paul: The federal government has no constitutional authority to restrict the operations of compounding pharmacies.

    HFUSA: A. Trilateral Cooperation Charter/North American Union/Security and Prosperity Partnership A. Do you support the “North American Union” and its companion “Security and Prosperity Partnership” which were created without Congressional debate and approval?

    Dr. Paul: A. I am the leading Congressional opponent of the North American Union and the Security and Prosperity Partnership.

    HFUSA: B. Do you support FDA’s policy of “harmonization” of regulations with those of Mexico and Canada through the North American Union and the already-operating Trilateral Cooperation Charter which fuses the national health departments of all three countries into a single entity without Congressional oversight or authorization of any entity?

    Dr. Paul: B. I oppose all efforts to harmonize American law with the law of other countries and I have taken the lead in working to mobilize congressional opposition to the Trilateral Cooperation Charter.

    HFUSA: C. Do you support such executive agreements without Congressional debate and approval?

    Dr. Paul: C. No; I do not support allowing the President to erode our freedom and threaten our sovereignty by executive agreement.

    HFUSA: D. If elected, do you pledge to use the power of the Executive Branch of Government to overturn or reverse the North American Union, Security and Prosperity Partnership and the Trilateral Cooperation Charter?

    Dr. Paul: D. As President, I will withdraw the United States from the North American Union, the Security and Prosperity Partnership, and the Trilateral Cooperation Charter.

    HFUSA: HARMonization of FDA regulations with international and foreign agencies and entities A. Do you support FDA?s policy of ?harmonization? of regulations with those of the European Union, under executive agreement?

    Dr. Paul: A. I oppose harmonization. Centralization of power and control breeds oppression.

    HFUSA:B. Do you support FDA?\'s policy of 'HARMonization'.? of regulations with the standards and guidelines of the Codex Alimentarius when those texts are created through the US efforts on behalf of industrialized food supply constituents and degrade and render toxic the US and global food supplies?

    Dr. Paul: B. I am the leading Congressional opponent of CODEX.

    HFUSA: C. If elected, what steps do you pledge to take to end these HARMonization activities of the FDA, USDA, FTC and EPA?

    Dr. Paul: C. I will seek to stop US participation in the Codex process and make it clear to the UN and the WTO that my administration will not change one comma in American law to make the bureaucrats at Codex happy.

    HFUSA: Anti-HARMonization Statute Do you support strict enforcement of the Anti-Harmonization Statute, 19 USC 3512, which prohibits such harmonization with respect to the US food supply and those foods known as Dietary Supplements?

    Dr. Paul: I was instrumental in drafting the anti-harmonization statute, so, yes; I supported strict enforcement of it.

    HFUSA: FDA HARMonization with international standards A. Are you aware and do you support the FDA’s announced policy of “harmonization” with International Standards, even where those standards are not finalized: “In a notice published in the Federal Register of October 11, 1995 (60 FR 53078), FDA articulated its policy regarding the development and use of standards with respect to the harmonization of various national and international regulatory requirements and guidelines? - http://www.cfsan.fda.gov/~lrd/fr970707.html ?

    Dr. Paul: A. As stated before, I am strongly opposed to harmonization.

    HFUSA:B If elected, what steps do you pledge to take to reign in such HARMonization and return the US to regulatory sovereignty?

    Dr. Paul: B. please see my previous answers.

    HFUSA: World Trade Organization and similar international bodies A. Do you support harmonizing America’s legal structure and freedoms to international restrictions through participation in bodies such as the World Trade Organization?

    Dr. Paul: A. No; I oppose harmonizing American laws with those of foreign countries to satisfy the WTO or any other international regime.

    HFUSA: B. Do you support withdrawing from the World Trade Organization?.

    Dr. Paul: B. Yes; as a Congressman, I took advantage of the clause in the WTO enabling legislation that allows any member of Congress to introduce legislation withdrawing the United States from the WTO. In fact, by twice introducing WTO withdrawal legislation, I twice forced Congress to vote on withdrawing the United States from the WTO.

    HFUSA: C. Do you support withdrawing from the United Nations?

    Dr. Paul: C. Yes; I have introduced legislation to withdraw from the UN (HR 1146).

    HFUSA: Divesting the FDA of food regulatory authority A. Since nutrient and natural health products are regulated as Food in accordance with US law, do you support a division of the FDA into two separate agencies, one focusing on Foods (including dietary supplements and all natural or non-pharmaceutical health products) and the other finally focusing on protecting the safety of the public with regard to dangerous drugs and invasive medical devices?

    Dr. Paul: A. No; I favor reducing the power of the FDA, not “rearranging deck chairs on the Titanic” by dividing the FDA bureaucracy.

    HFUSA: B. Do you support the FDA’s approval of genetically modified foods in the absence of any safety testing, requiring only a patent before the genetically modified food can be admixed with the food supply?

    Dr. Paul: B. Consumers should have the right to choose whether or not to use genetically modified food without having the FDA deny them that choice.

    HFUSA: C. Do you support the FDA’s position that since the FDA has declared genetically modified foods equivalent to natural ones in the absence of any testing to demonstrate that to be the case and its stated understanding that the public would reject genetically modified foods if they knew what they were buying and eating, that it would be false and misleading if genetically modified foods were identified as such so their labeling is prohibited?

    Dr. Paul: C. Consumers have every right to demand that genetically-modified food be labeled as such.

    HFUSA: Compulsory medical treatment A. Do you support the use of the State’s powers to compel compulsory mental health or other screening, forced drugging or other medical treatment under any circumstances?

    Dr. Paul: A. No; I oppose compulsory medical treatment.

    HFUSA: B. Do you support removing children from parental custody when parents refuse to use medication for alleged “mental health problems” in their children?

    Dr. Paul: B. The federal government has no authority to remove children from their parents’ custody because those parents have refused to medicate their children according to federal edicts.

    HFUSA: C. Do you support removing children from parental custody when parents refuse to use medication for the allopathic (pharmaceutical) treatment of life threatening diseases such as cancer?

    Dr. Paul: C. The federal government has no constitutional authority to remove a child from a parent’s custody because of that parent’s refusal to seek state-ordered medical treatments for their child.

    HFUSA: D. Do you support the forced use of pharmaceutical or other medical treatment in adults under any circumstances?

    Dr. Paul: D. I have a difficult time imaging a scenario where I would support forcing medical treatment on someone against their will, especially in my capacity as a federal elected official.

    HFUSA: E. Do you support the right of parents or adult persons to chose natural medical treatments over pharmaceutical ones if they desire?

    Dr. Paul: E. Of course; I support the right of adults to choose natural medical treatments. I have consistently cosponsored legislation in Congress to protect this right.

    HFUSA: Mandatory screening A. Do you support mandatory mental health or other health screening?

    Dr. Paul: A. I am the leading Congressional opponent of Mandatory Mental Health Screening.

    HFUSA: B. Do you support the use of Federal funds for such screening?

    Dr. Paul: B. I have introduced the Parental Consent Act (HR 2387), which forbids federal funds for mandatory mental health screening of children without parental consent. I oppose any use of funds for mandatory mental health screening.

    HFUSA: C. Do you support the use of Federal funds to pay for forced drugging of children or adults?

    Dr. Paul: C. Yes, I oppose the use of federal funds to pay for forced medicating of children (or adults).

    HFUSA: Natural Health Options Do you support the use of Federal funds for natural medical and health therapy services and treatments on a par with pharmaceutical and other allopathic treatments, at the discretion of the patient?

    Dr. Paul: As long as the federal government is financing health care, it should allow the beneficiaries to choose to use their federal funds for alternative treatments.

    HFUSA: Vaccination A. Do you oppose mandatory vaccination under all circumstances?

    Dr. Paul: A. It is difficult for me to imagine a scenario where I could support forced vaccinations, especially in my capacity as a federal elected official.

    HFUSA: B. Do you support continuing the pharmaceutical industry’s exemption from legal responsibility for injuries caused by vaccinations?

    Dr. Paul: B. No, I do not believe the pharmaceutical industry should be protected from paying compensation to those harmed by their vaccines.

    HFUSA: C. Do you support continuing the pharmaceutical industry’s exemption from legal responsibility for injuries caused by drugs approved for any indication?

    Dr. Paul: C. No, the pharmaceutical industry should not be protected from being held accountable to those injured by their products.

    HFUSA: . Reproductive Autonomy A. Do you support a woman’s right to control her reproductive life without interference from the Federal government?

    Dr. Paul: A. As a physician, I oppose abortion. I believe this should be dealt with by state and local governments; it is not a federal issue.

    HFUSA: B. If elected, what will you pledge to do to protect the reproductive autonomy of women?

    Dr. Paul: [No Answer provided]

    HFUSA: Freedom Plank How soon can the American public expect a formal Health Freedom Plank in your campaign platform?

    Dr. Paul: There is further information on my position on health freedom on my website at http://www.ronpaul2008.com/issues/health-freedom/ .

    Monday, October 22, 2007

    Health Freedom Message from Dr. Ron Paul

    Just received this message -

    " From: "Ron Paul 2008" <mail@ronpaul2008.com>
    To: <ralph.fucetola@usa.net>
    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: https://www.ronpaul2008.com/donate/ "

    Sunday, September 23, 2007

    Amending HR2117 to further protect health freedom

    The following is text from a memo I helped to provide to Natural Solutions Foundations about suggesting language to Congress to further protect Health Freedom.

    "This memorandum is provided for the Natural Solutions Foundation – www.healthfreedomusa.org – to support our efforts to educate Congress and decision makers on the public’s concern for real reform of FDA’s food safety and claims authority. Several bills are pending in Congress that address some of these concerns. Dr. Ron Paul of Texas has offered HR 2117, the Health Freedom Protection Act. Your legal advisory group recommends this bill as consistent with the Natural Solutions program.

    The bill, introduced earlier this year, mandates FDA “shall allow with reasonable and concise disclaimers not to exceed three sentences claims…” including “…the cure, mitigation, treatment, or prevention of any disease or any health-related condition.” It also addresses several other technical issues.

    In our opinion, this bill would greatly enhance public access to truthful and not misleading health information, in keeping with the US Supreme Court's dictum in Thompson v. Western States Medical Centers, "If the First Amendment means anything, it means that regulating speech must be a last - not first - resort. *** We have previously rejected the notion that the Government has an interest in preventing the dissemination of truthful commercial information in order to prevent members of the public from making bad decisions with the information. *** Even if the Government did argue that it had an interest in preventing misleading advertisements, this interest could be satisfied by the far less restrictive alternative of requiring ... a warning ..."

    This bill, cosponsored by Congressmen Burton of Indiana, Shays, Bartlett of Maryland, and Duncan, presents a clear opportunity to enhance legal protections for Dietary Supplements and natural remedies. Its adoption would shift FDA resources from over-regulation of safe food substances to what could be considered their main task, protecting people from dangerous drugs and medical devices.

    Since the bill was introduced, however, the FDA has continued its blitz of confusing food regulatory initiatives. After years of “benign neglect” several initiatives, such as the CAM Guidance, Health Claims Guidance, Good Manufacturing Practices and AER Regulations – all hitting the dietary supplement and natural products markets this year – threaten to stop and reverse progress toward meeting public demand for access to nutritional supplements, natural remedies and clean, unadulterated food.

    We therefore recommend that pro-health Senators take up the issue of these recent threats to the intent of DSHEA when considering legislation similar to Dr. Paul’s House bill, by including the following items in addition to the important points addressed by HR 2117. Attached to this memorandum is a listing of the recommended amendments to HR 2117. A marked-up copy of the bill is also available."

    The recommended amendments attached to the memo include the following "findings" by Congress:

    "1. Congress determined United States policy regarding Dietary Supplements with the unanimous adoption of the Dietary Supplement Health and Education Act of 1994 (DSHEA);

    2. That policy is: Dietary Supplements, including those offered to benefit health, are foods and foods are generally considered safe; United States law and regulations regarding Dietary Supplements shall be harmonized with food law in recognition of the remarkable safety record of Dietary Supplements, and

    3. United States and international agencies have failed to implement or significantly acknowledge this policy,

    The Congress of the United States determines that further protections are needed to restore the People’s right to freedom of choice in health care and dietary supplementation use. Further, food safety and claims regulation is too important a matter to remain a secondary mission for the Food and Drug Administration and, it is the sense of Congress, that this vital mission be divested from FDA and administered separately."

    The amendments protect our First Amendment Rights by mandating that FDA "...shall not issue any regulation to limit the publication or dissemination of information published by a third party source characterizing the relationship of any nutrient to the prevention, mitigation, treatment or cure of any disease or health condition. "

    There are also two new sections suggested for the bill:

    SEC. 6. HARMONIZATION WITH FOOD REGULATIONS. - which begins the process of protecting foods (including supplements) from being treated as "drugs."

    SEC. 7. COMMISSION TO STUDY DIVESTITURE OF THE FOOD AND DRUG ADMINISTRATION FOOD SAFETY AND CLAIMS AUTHORITY. - which begins the process of focusing FDA on its core mission of protecting the public from dangerous drugs and medical devices, by shifting foods safety and claim authority from the agency. Studying these issues might be a good first step. There are a number of different views being expressed. Some suggest a new Food Safety Agency is needed; others think the USDA can deal with food safety, as that is already part of its mission, while FTC can handle consumer complaints about claims, as this is already its mission. I prefer free market approaches to all safety and claims issues, with strict liability for marketers who harm their customers.

    # # #

    Wednesday, August 29, 2007

    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:

    ------------------------------------
    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/.
    -----------------------------------------

    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...

    Thursday, August 2, 2007

    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?

    Saturday, July 28, 2007

    Ron Paul's Health Freedom Plank

    Over the past few days the Ron Paul 2008 Campaign has been consulting with us; within the past hour the Campaign posted a powerful statement regarding Health Freedom on their Issues web page:

    http://www.ronpaul2008.com/issues (bottom issue on the right)

    The text reads:

    -----------------------
    "Health Freedom

    Americans are justifiably concerned over the government’s escalating intervention into their freedom to choose what they eat and how they take care of their health.

    The Food and Drug Administration (FDA), in order to comply with standards dictated by supra-national organizations such as the UN‘s World Food Code (CODEX), NAFTA, and CAFTA, has been assuming greater control over nutrients, vitamins and natural health care providers to restrict your right to choose the manner in which you manage your health and nutritional needs.
    I have been the national leader in preserving Health Freedom.

    I have introduced the Health Freedom Protection Act, HR 2117, to ensure Americans can receive truthful health information about supplements and natural remedies.

    I support the Access to Medical Treatment Act, H.R. 746, which expands the ability of Americans to use alternative medicine and new treatments.

    I oppose legislation that increases the FDA‘s legal powers. FDA has consistently failed to protect the public from dangerous drugs, genetically modified foods, dangerous pesticides and other chemicals in the food supply. Meanwhile they waste public funds attacking safe, healthy foods and dietary supplements

    I also opposed the Homeland Security Bill, H.R. 5005, which, in section 304, authorizes the forced vaccination of American citizens against small pox. The government should never have the power to require immunizations or vaccinations."
    -----------------------

    With this strong pro-Health Freedom statement, Dr. Paul once more shows himself to be a true friend of every American. He clearly challenges the statist assumptions of the federal political establishment and further sets himself apart from their failed policies. As someone recently remarked, "This country is sick and needs a good doctor... not another d----d lawyer..."

    Thank you Dr. Paul!

    Friday, July 20, 2007

    Current Health Freedom issues

    Since the last days of 2006 there have been a series of challenges to Health Freedom

    * Adverse Event Reporting Act [signed late December 2006]

    * FDA CAM Draft Guidance [Fed Reg. Notice on 02/26/07]

    * USDA & Codex: Organic Standards Diminished

    * Codex: Raising Toxic Levels, Mandating Irradiation

    * Codex: GM (Genetically Modified) Labeling Failures

    * FDA GMPs (Good Manufacturing Practices for Dietary Supplements) [Late June 2007]

    * Senate & House adoption of FDA enabling bills [S.1082 & HR.2900] [Only S.1082 contains DSHEA protection language]

    * Failure of US House to consider Health Freedom Protection Act – HR.2117 [Although over 100,000 messages to Congress demanded such protection]

    Now the FDA has directly challenged HR.2117 with a new draft guidance, “Evidence-Based Review System for the Scientific Evaluation of Health Claims” [07/02/07]

    Citation: http://www.cfsan.fda.gov/~dms/hclmgui5.html

    This draft guidance document represents the agency's current thinking on

    1) the process for evaluating the scientific evidence for a health claim,
    2) the meaning of the significant scientific agreement (SSA) standard
    3) credible scientific evidence to support a qualified health claim. …

    Ron Paul’s Health Freedom Protection Act (HR.2117) -

    Citation: http://www.govtrack.us/congress/billtext.xpd?bill=h110-2117

    Health Claims must be allowed unless the FDA determines that –
    (i) there is no scientific evidence that supports the claim;
    (ii) the claim is inherently misleading and incapable of being rendered non-misleading through the addition of a disclaimer

    The distinction between the Constitutional system of Freedom of Speech -proposed by its champion, Dr. Paul, and the FDA's bureaucratic illegal desire to impose "prior restraint" could not be clearer.

    The opportunity should be clear: support HR.2117 - the Health Freedom Protection Act. While we need further protectio with language addressing each of the pending challenges noted above, this is a good start.

    “It is all within our grasp, the restoration of the republic and our sovereignty … federalism, free enterprise, peace, prosperity, and the kind of future we all want for our families, ourselves, and our fellow Americans. The dream can be a reality … Instead of wars and inflation and spying and poverty, we can have peace and freedom and the blessings for our children and grandchildren of doing better than we have, of secure retirements and childhoods. No more theft -- of our savings or our liberty.” - Ron Paul at Google on 07/13/07

    Tuesday, July 17, 2007

    New FDA Draft Guidance: “Evidence-Based Review System for the ScientificEvaluation of Health Claims”

    New FDA Draft Guidance: “Evidence-Based Review System for the Scientific Evaluation of Health Claims” - http://www.cfsan.fda.gov/~dms/hclmgui5.html

    Following closely after the FDA draft anti-CAM guidance, this new draft guidance, just published, continues the FDA’s policy of more closely regulating the natural products industry. There is a 60 day comment period that should run until the end of August. Says the introduction:

    “This draft guidance document represents the agency's current thinking on 1) the process for evaluating the scientific evidence for a health claim, 2) the meaning of the significant scientific agreement (SSA) standard in section 403(r)(3) of the Federal Food, Drug, and Cosmetic Act …and 3) credible scientific evidence to support a qualified health claim. …

    "This guidance document describes the evidence-based review system that FDA intends to use to evaluate the publicly available scientific evidence for SSA health claims or qualified health claims on the relationship between a substance and a disease or health-related condition… This guidance document explains the agency's current thinking on the scientific review approach FDA should use and is intended to provide guidance to health claim petitioners …

    "The specific topics addressed in this guidance document are: (1) identify ingstudies that evaluate the substance/disease relationship, (2) identifying surrogate endpoints for disease risk, (3) evaluating the human studies to determine whether scientific conclusions can be drawn from them about the substance/disease relationship, (4) assessing the methodological quality of each human study from which scientific conclusions about the substance/disease relationship can be drawn, and (5) evaluating the totality of scientific evidence.”

    This guidance attempts to impose a high standard on Health Claims.

    Dr. Ron Paul’s pending bill, the Health Freedom Protection Act - HR.2117 - addresses this further FDA power grab by imposing the standard commercial substantiation requirement instead.

    Essentially Dr. Paul's bill shifts the burden of proof onto the FDA whenever the agency wants to deny the public the benefit of health claims information about Dietary Supplements. It provides that reasonable health claims, with proper disclosure language, shall be allowed "unless the Secretary determines that -- `(i) there is no scientific evidence that supports the claim; and `(ii) the claim is inherently misleading and incapable of being rendered nonmisleading through the addition of a disclaimer."

    Thus, even "a scintilla" of scientific evidence would allow the making of nonfraudulant claims that Dietary Supplements may be of benefit to individuals. The requirements of the bill are consistent with the law that already governs the agency's position, announced in 2004, "FDA intends to apply a standard for substantiating claims for dietary supplements that is consistent with the Federal Trade Commission's (FTC's) standard for dietary supplements and other health related products of 'competent and reliable scientific evidence'.''

    The text of the bill, reintroduced on May 7, 2007, can be found at: http://www.govtrack.us/congress/billtext.xpd?bill=h110-2117

    This latest FDA Guidance needs further analysis and comments will need be addressed to the FDA recommending that Dr. Paul’s approach be substituted for the overly bureaucratic approach favored by the Agency. If not, Congress needs to act fast to protect our alternatives!

    Saturday, July 14, 2007

    Road Trip

    This blog is about a quick road trip to DC, but first... 

    Earlier this week the House passed its version of the FDA enabling act, HR.2900, without the Dietary Supplement protective language (the "Durban Amendment") that the Senate had added to its version, S.1082, passed last month. 

    The bill was brought before the House under a "special rule" which means the House leadership allowed only limited debate and NO amendments. Since the versions of the bills passed were not the same, the two houses of Congress have to either convene a conference committee or one house or the other has to pass the other house's version. 

    Or, of course, Congress could do nothing, which, in this case would be the best thing to do. The original Senate bill was flawed in many ways, not the least, in the bizarre notion that what Dr. Ron Paul has characterized "...abuse of FDA power..." can be cured by giving the FDA more power to abuse! If the bills do not just die without further congressional action, it is time to pressure Congress to make sure that protective language even stronger than the Durban Amendment is in the final bill. 

    That Amendment merely protected Dietary Supplements from enhanced FDA power; what is needed is language protecting all health claims for dietary supplements, natural remedies and alternative modalities. Knowing all that, on Thursday I met Dr. Rima Laibow and Gen. Bert Stubblebine, the leaders of the Natural Solution Foundation (I'm a member of the NSF Board). 

    They were just returning from attending the Codex Commission meeting held in Rome this year. The World Food Code (Codex) Commission continued with its globalist agenda of degrading organic standards, allowing higher levels of toxins in the food supple, attacking supplements and natural remedies... all the usual politics of the "Bigs" -- Big Pharma, Big Chema, Big Agra, Big Government, etc. But you can read about that in detail at Dr. Rima's blog on www. globalhealthfreedom.org -- where you can also sign up for the NSF eAlert system, allowing you to join hundreds of thousands using the Internet to bring pressure on Congress to leave our alternatives alone.

    We need your email contact to alert you when and how to contact Congress to have the best effect; and, of course, our online system makes it easy to do. We did a "new media" online radio interview (Dr. Annette's show on http://www.bbsradio.com/ from Las Vegas and then drove together from the NY metro area to Washington for several important meetings. The nest day, Friday the 13th, we met several Washington "insiders" and visited friendly congressional offices on the Hill. I was really impressed by the commitment to Health Freedom expressed at Congressman Ron Paul's. There is a growing congressional caucus with upwards of thirty members who are seriously concerned with alternative modality, health freedom issues. 

    There will be serious efforts over the next couple months to bring forward more comprehensive protective legislation. We finished the trip with the taping of an expanded NSF video on The Codex Two Step and an appearance on consumer advocate Jim Turner's PRN program, Consuming Interests - http://turner.progressiveradionetwork.org/ All-in-all an excellent road trip! 

     PS - many thanks to Will, Drew and Millie for the driving, photos and entertainment!

    Monday, June 18, 2007

    Ron Paul and Health Freedom

    Here are the postings from my orginal blog about congressperson Ron Paul and the Health Freedom issue. 06/07/07 - Support for Dr. Paul's Health Freedom Protection Bill Grows As of 9:15 PM EDT Thursday, June 7th - total messages sent to the House in support of Dr. Paul's HR.2117 through Natural Solutions Foundation were 29,351 - the total had been 17,522 Tuesday. It's been less than a week that this Take Action alert has been active. 

     ------------------------------------------------ 

      05/28/07 - Congressman Paul Reintroduces Health Freedom Protection Act H.R. 2117 Dr. Paul has reintroduced the Health Freedom Protection Act. Essentially this bill shifts the burden of proof onto the FDA whenever the agency wants to deny the public the benefit of health claims information about Dietary Supplements. It provides that reasonable health claims, with proper disclosure language, shall be allowed "unless the Secretary determines that -- `(i) there is no scientific evidence that supports the claim; and `(ii) the claim is inherently misleading and incapable of being rendered nonmisleading through the addition of a disclaimer." Thus, even "a scintilla" of scientific evidence would allow the making of claims that Dietary Supplements may be of benefit to individuals. The requirements of the bill are consistent with the law that already governs the agency's position, announced in 2004, "FDA intends to apply a standard for substantiating claims for dietary supplements that is consistent with the Federal Trade Commission's (FTC's) standard for dietary supplements and other health related products of 'competent and reliable scientific evidence'.'' The text of the bill, reintroduced on May 7, 2007, can be found at: http://www.govtrack.us/congress/billtext.xpd?bill=h110-2117 In my opinion, this bill would greatly enhance public access to truthful and not misleading health information, in keeping with the US Supreme Court's dictum in Thompson v. Western States Medical Centers, "If the First Amendment means anything, it means that regulating speech must be a last - not first - resort. *** We have previously rejected the notion that the Government has an interest in preventing the dissemination of truthful commercial information in order to prevent members of the public from making bad decisions with the information. *** Even if the Government did argue that it had an interest in preventing misleading advertisements, this interest could be satisfied by the far less restrictive alternative of requiring ... a warning ..." This bill, cosponsored by Congressmen Burton of Indiana, Shays, Bartlett of Maryland, and Duncan, presents a clear opportunity to enhance legal protections for Dietary Supplements and natural remedies. Its adoption would shift FDA resources from over-regulation of safe food substances to what could be considered their main task, protecting people from dangerous drugs and medical devices. Currently, we need to encourage other congresspeople to join as cosponsors and get behind the Health Freedom Protection Act. The FDA "revitalization" bill was recently passed by the Senate; just before it was passed, when Congress noticed hundreds of thousands of people complaining to the FDA to leave our supplements alone, a protective clause was added, exempting Dietary Supplements. The House can now enhance that protection by extending it to all food substances and by adopting the Health Freedom Protection Act. Therefore, we should ask our congresspeople to attach the HFPA to the "revitalization" bill, HR 1561 (House equivalent of S. 1082). While we do not support the bill to increase FDA power, if it is passed, it should include protective language such as the HFPA language. Support Dr. Paul's bill: http://www.democracyinaction.org/dia/organizationsORG/healthfreedomusa/campaign.jsp?campaign_KEY=11754

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      05/06/07 - Good News this week! On 05/04 Congressman Ron Paul, physician and presidential candidate, termed the FDA anti-CAM draft guidance "an abuse of FDA power..." On the same day, S.1082, a bill many viewed as a threat to health freedom was amended to exclude Dietary Supplements, so they would continue to be governed by existing law. As to why S.1082 was amended to protect Dietary Supplement Health and Education Act (DSHEA) products, I have it from people "on the Hill" that Congress knew a constituent storm was brewing.I am personally aware that key congresspeople knew about the huge public response to the FDA draft guidance ploys. When people started contacting congresspeople on the S.1082 issue, supporting Counsel J Emord's suggestion that S.1082 be amended, the Senate acted quickly and decisively. They knew what would happen if they did not act, since they had just seen the storm over the FDA guidance, where over 180,000 people told the FDA to leave our alternative health care practices alone. I think it is really naive to assume these events were not connected in Beltway mentality, as some commentators have suggested.Our view that the antiCAM guidance is dangerous is not some bizarre fringe view. For example, Congressman Ron Paul MD, America's only true Constitutionalist candidate for President (and the Robert Taft or Barry Goldwater of this generation) filed his objections to the antiCAMguidance. He called it "an abuse of FDA power." He concluded his detailed analysis of the failures of the guidance, and its dangers, with these stirring words: 

    "The CAM Guidance is imprudent and will stifle innovation in medicine. The CAM Guidance proceeds from a failure to appreciate the interrorem effect of government action. . . . There is no reason to believe that the states are ineffective in prosecuting those comparatively few practitioners, CAM or non-CAM, who do cause harm. Thus, without any true need for the guidance, it conveys to CAM practitioners that FDA regards certain therapeutic uses of products to be unlawful. As the agency should know that will, in turn, dissuade those uses, despite the dubious legal basis for FDA's assumption of power. By dissuading those uses, FDA deprives patients of health care options without any proof that its action will improve public health. That is an abuse of FDA power...In sum, I request the FDA to withdraw the CAM Guidance. If the rule is not withdrawn, I urge FDA to amend the rule to state unambiguously in the document that FDA is barred by the FDCA from regulating health care practice and that off-label use of any regulated product by a health carepractitioner is lawful under federal law."

     When Natural Solutions Foundation said "We had a great victory!" we are referring to a victory by the broad Freedom Movement in this country, of which health freedom is just one aspect. No one organization has any monopoly over that movement and all deserve due credit for mobilizing the troops. We each have the right to our own opinions as to what correlation of forces led to such quick, and for us happy, congressional action. Our direct contacts on the Hill led us to our appraisal that the storm of protest over the FDA draft guidance last week emboldened our friends in Congress this week, and over-awed their opponents. Vigilance must continue, but this does show that an aroused public can expect to be noticed by people in power in Washington.