Archive for August, 2007

Congressional One Pager

Friday, August 31st, 2007

Natural Solutions Foundation Media Release
www.GlobalHealthFreedom.org

GeneralStubblebine@GlobalHealthFreedom.org

 

Protecting Health Freedom for Consumers and Entrepreneurs

1. While health care reformers want a more educated health care consumer, FDA seeks to further stifle health information. FDA has issued a Guidance prohibiting the making of any Health Claims that lack “Significant Scientific Agreement,” an impossible standard since “significant” and “agreement” cannot be defined. Under a policy of “Harmonization,” as well as a published preference for international over domestic rulemaking (Federal Register, October 11, 1995), FDA’s own Head of Dietary Supplements Office convinced an international body, the UN-sponsored Codex Alimentarius, to prohibit as “advertising” any food related health benefit information that can change consumer behavior. Congress should pass HR 2117, the “Health Freedom Protection Act,” to allow “common law”claims and follow Supreme Court decisions, empowering consumers with helpful information on food and supplements.2. While these same health reformers want to expand access, FDA is threatening supply with another FDA Guidance, on “Complementary and Alternative Medicine” (CAM), which creates new categories of “medicine”, services and products not authorized by Congress. By using the word “Medicine” instead of “Modalities,” FDA is setting up natural therapies for a takeover by the world of licensed physicians. FDA’s intent here was made clear in March, 2007, when, after the Michigan Cherry Growers Association published scientific evidence of the healing benefits of cherries for arthritis, FDA forced the removal of that information under threat forbidding cherries as an “untested drug.” Since state medical boards often forbid natural therapies as outside the scope of medical practice, licensees who engage in such modalities could lose their licenses; lack of insurance coverage for natural modalities further will further restrict their availability. Congress should hold hearings on FDA’s attack on the natural therapies industry.

3. With a pending recession threatening jobs, FDA is poised to put manufacturers of natural therapies out of business. FDA’s own Economic Impact analysis of its dietary supplement “Good Manufacturing Practices” (GMPs) showed “establishments with not only high costs, but also average costs, could be hard pressed to continue to operate…Very small businesses with less than 20 employees will be at risk of going out of business.” Supplement manufactures already are facing cruel surprise invasions by FDA inspectors dedicated to a “strong enforcement policy” (www.fda.gov/oc/whitepapers/enforce.html). Congress should divest the FDA of “food regulation”, adding an independent Inspector General and a consumer ombudsman to protect the US food supply.4. In an FDA Revitalization bill pending Conference, the Senate version seeks to reform food regulation in response to complaints about Chinese import dangers. Section 608 would exempt from this food proposal supplements which as “food” are generally considered safe under the 1994 Dietary Supplement Health Education Act (DSHEA). Any final FDA Reform bill should retain Section 608.

Introducing the Health Freedom Protection Act

Friday, August 31st, 2007

HON. RON PAUL OF TEXAS
Before the U.S. House of Representatives

May 2, 2007

Introducing the Health Freedom Protection Act

Madam Speaker, I rise to introduce the Health Freedom Protection Act. This bill restores the First Amendment rights of consumers to receive truthful information regarding the benefits of foods and dietary supplements by codifying the First Amendment standards used by federal courts to strike down the Food and Drug Administration (FDA) efforts to censor truthful health claims. The Health Freedom Protection Act also stops the Federal Trade Commissions (FTC) from censoring truthful health care claims.

The American people have made it clear they do not want the federal government to interfere with their access to dietary supplements, yet the FDA and the FTC continue to engage in heavy-handed attempts to restrict such access. The FDA continues to frustrate consumers’ efforts to learn how they can improve their health even after Congress, responding to a record number of constituents’ comments, passed the Dietary Supplement and Health and Education Act of 1994 (DSHEA). FDA bureaucrats are so determined to frustrate consumers’ access to truthful information that they are even evading their duty to comply with four federal court decisions vindicating consumers’ First Amendment rights to discover the health benefits of foods and dietary supplements.

FDA bureaucrats have even refused to abide by the DSHEA section allowing the public to have access to scientific articles and publications regarding the role of nutrients in protecting against diseases by claiming that every article concerning this topic is evidence of intent to sell a drug.

Because of the FDA’s censorship of truthful health claims, millions of Americans may suffer with diseases and other health care problems they may have avoided by using dietary supplements. For example, the FDA prohibited consumers from learning how folic acid reduces the risk of neural tube defects for four years after the Centers for Disease Control and Prevention recommended every woman of childbearing age take folic acid supplements to reduce neural tube defects. This FDA action contributed to an estimated 10,000 cases of preventable neutral tube defects!

The FDA also continues to prohibit consumers from learning about the scientific evidence that glucosamine and chondroitin sulfate are effective in the treatment of osteoarthritis; that omega-3 fatty acids may reduce the risk of sudden death heart attack; and that calcium may reduce the risk of bone fractures.

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, mitigative, 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.

This legislation also addresses the FTC’s violations of the First Amendment. Under traditional First Amendment jurisprudence, the federal government bears the burden of proving an advertising statement false before censoring that statement. However, the FTC has reversed the standard in the case of dietary supplements by requiring supplement manufactures to satisfy an unobtainable standard of proof that their statement is true. The FTC’s standards are blocking innovation in the marketplace.

The Health Freedom Protection Act requires the government bear the burden of proving that speech could be censored. This is how it should be in a free, dynamic society. The bill also requires that the FTC warn parties that their advertising is false and give them a chance to correct their mistakes.

Madam Speaker, if we are serious about putting people in charge of their health care, then shouldn’t we stop federal bureaucrats from preventing Americans from learning about simple ways to improve their health. I therefore call on my colleagues to stand up for good health care and the First Amendment by cosponsoring the Health Freedom Protection Act.