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ANH-USA: Making A Real Difference

ANH-USA effects change and protects the integrative medical community. We are dedicated to promoting integrative medicine and sustainable health and work to ensure that practitioners have the right to practice and consumers have the right to choose. The impact of our commitment is very real. Throughout our history we have played an important role in filing precedent-setting lawsuits and passing significant legislation that directly benefit the natural health community. We were instrumental in passing the Dietary Supplement Health Education Act of 1994, widely considered to be the single most important piece of legislation for the industry. We have filed seven lawsuits establishing qualified health claims for saw palmetto, folic acid, Omega 3 fatty acids, fiber, Vitamin E, Vitamin B and Selenium, and we successfully sued the US Food and Drug Administration (FDA) for violating the First Amendment as well as the Administrative Procedure Act by not allowing the dissemination of truthful, scientific information on dietary supplement labels.

Some of our most notable accomplishments include:

  • The public outcry to Congress from ANH activists against certain provisions in the Compounding bill, resulted in the following significant revisions:
    • Ensured that a USP monograph will protect compounded ingredients from FDA intrusion. Since important ingredients like bioidentical estriol have a USP monograph, this change will ensure that estriol is protected from the FDA and remains available for the millions of women who rely on it.
    • Protected the right of compounders to make non-standardized dosages of drugs.
    • The new version of the bill maintains the standard we inserted (from current law) for the definition of “difficult to compound.”
    • The provision that compounders needed to perform random controlled trials (RCTs) in order to meet a “safety and efficacy” standard was removed. This was a backdoor approach to banning compounded medicines, because no one could afford to pay for those trials of non-patentable or off-patent drugs, and RCTs in any case are inappropriate for medicine that is—by definition—individualized as compounding is.
    • Removed the requirement from the previous version of the Senate bill that doctors must substantiate the need for a compounded prescription.
    • The bill no longer sets up the impossible-to-measure standard that physician office use of compounded drugs can only represent 10% of compounding pharmacy sales, as well as the provision requiring physician reporting within a few days.

  • Together with a coalition of organizations, we successfully repealed the Monsanto Protection Act from a must-pass funding bill, which would have stripped federal courts of the authority to halt the sale and planting of potentially dangerous genetically engineered crops. Our activists sent thousands of messages to Congress protesting this provision.

  • Helped draft the GMO labeling bills that became law in Connecticut and Maine. Our activists submitted thousands of messages in support of the bill.

  • Proactively replaced Illinois’ ten-year old monopolistic dietitian law with a new law that recognizes licensure for advance degree and credentialed nutritionists instead of just Registered Dietitians. The law will also provide greater protections for acupuncturists, health food stores, small business and individuals to provide nutrition advice.

  • Activated our grassroots to send over 100,000 messages to Congress in less than 24 hours to defeat Senator Durbin’s amendment to the Prescription Drug User Fee Act (PDUFA) requiring that supplement companies register all their products – and the ingredients they contain—with the FDA. Our concern with the legislations was that it would have created a slippery slope toward a supplement pre-approval system (similar to the European Union regulatory system).

  • Submitted an amicus brief opposing the USDA’s “pasteurization” rule that applies even to raw, organic almonds. The allowed “pasteurization” methods would cause a marked reduction in nutrient content, and includes the use of a possible carcinogen.

  • Filed an amicus brief in support of POM Wonderful’s suit against the Federal Trade Commission to protect free speech rights for natural products and to protect consumer access to information about the therapeutic effects of natural products.

  • Mobilized activists to send more than 300,000 messages and make more than 20,000 phone calls to Congress and the FDA opposing the FDA’s draft guidance affecting New Dietary Ingredients. Worked closely with the Appropriations Committee, which controls FDA funding, to secure report language censuring the FDA for prematurely enforcing the NDI draft guidance and insisting that FDA withdraw the guidance, evaluate the significant concerns that had been expressed, and reissue a revised draft.

  • Two days later, FDA acknowledged in a meeting with Senators Hatch and Harkin that the NDI draft guidance required substantial revision and agreed to rewrite the guidance, which will then be open for public comment once again.
  • Mobilized activists to send more than 300,000 messages and make more than 20,000 phone calls to Congress and the FDA opposing the FDA’s draft guidance affecting New Dietary Ingredients.
    • In response, Senators Kyl, Kirk, and Lugar and Representatives Visclosky and Wolf wrote their own letters to the FDA expressing their constituents’ opposition to the guidance. In addition, Senators Hatch and Harkin (two of the original authors of DSHEA) wrote a letter to FDA Commissioner Margaret Hamburg asking her to withdraw the guidance on the grounds that it goes against the Congressional intent of DSHEA.
  • Defeated anti-competitive legislation pushed by the ADA in California that would have restricted the practice of nutrition to Registered Dieticians alone.
  • Pressured the FDA to reverse their initial stance and allow compounding pharmacies to continue providing 17P to pregnant women, despite the efforts of KV Pharmaceutical to ban it as a competitor to their drug Makena.
  • Ensured that the ten-year jail sentences for food and supplement manufacturers who violate complicated FDA rules contained in Senator Leahy’s original Food Safety Accountability Act would not be part of the Senate Food Safety bill.
  • Sent more than 60,000 messages opposing Senator Leahy’s Food Safety Accountability Act which would have established ten-year prison terms for violating FDA regulations (including paperwork errors).
    • In response, Senator Leahy’s office reached out to ANH-USA to develop compromise language requiring proof of actual harm for prosecution, and the bill became so politically unpopular that it died without receiving a vote.
  • Filed three lawsuits against the U.S. Food and Drug Administration in support of the natural products industry’s right to speak freely to consumers about the science behind their products, and have so far won our suits on selenium and antioxidant health claims in federal court.
  • Defeated Congressman Waxman’s attempts to slip a sneak amendment into the Wall Street Finance Reform bill that would have greatly expanded the FTC’s power to target supplement companies.
  • Took out a full-page ad in Roll Call, a popular Capitol Hill newspaper, opposing Senator McCain’s 2010 anti-supplement bill (Dietary Supplement Safety Act), and mobilized our grassroots activists to send more than 200,000 messages opposing the bill.
    • As a result, Senator McCain withdrew support for his own bill and it died without receiving a vote.
  • Included an exemption for dietary supplements from dangerous Codex language in the FDA Food Safety Modernization Act that would have created a slippery slope toward US harmonization with Codex Alimentarius.
  • Modified regulations in Delaware and Michigan that would have limited the practice of nutrition to Registered Dieticians to include Certified Nutrition Specialists.
  • Passed legislation in North Carolina that provides due process protection for practitioners targeted by the State Medical Board.
  • Modified the senate healthcare bill to ensure that the Comparative Effectiveness Research (CER) program (now called the Patient Centered Outcomes Research Institute) includes integrative medicine practitioners on the board and advisory panel.
  • Worked with Congressmen Chaffetz and Polis to introduce the Free Speech about Science Act in the House of Representatives, which will permit supplement companies to cite peer-reviewed scientific research in support of product health benefits.
  • At the request of U.S. Senators Tom Daschle and Tom Harkin, co-drafted the National Plan to Advance Integrated Health Care.
  • Led the effort to pass the National Center for Complementary and Alternative Medicine (NCCAM), which became law in October 1998.
  • Obtained language in the Congressional Conference Committee report in 1996 on the Health Insurance Accountability and Portability Act (HIPAA) stating expressly that the practice of alternative medicine is not fraud.
  • Successfully sued the U.S. Food and Drug Administration (Pearson vs. Shalala) for violating the First Amendment by not allowing the dissemination of truthful, scientific information on dietary supplement labels.
  • Instrumental in passing the Dietary Supplement and Health Education Act of 1994, guaranteeing access in the United States to safe, effective and affordable dietary supplements.

We are successful because of the support of our members and activists. Learn more about becoming a friend of ANH-USA, or visit our online action center to make your voice heard.

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