Since its inception, the Alliance for Natural Health USA has waged many successful battles to protect alternative health options . 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 (DSHEA), widely considered to be the single most important piece of legislation for the industry. This law guarantees access to safe, effective, and affordable dietary supplements.
We led the effort to establish the National Center for Complementary and Alternative Medicine in in 1998. It’s part of the National Institutes of Health, undertakes research, does training, and disseminates data to the public and professionals. NCCAM still isn’t where we want it to be, but we hope to get it there.
To date, we have filed nine precedent-setting lawsuits against the FDA, which have established qualified health claims for saw palmetto, omega-3 fatty acids, fiber, vitamin E, vitamin B, and selenium.
Our first suit was the landmark case of Pearson v. Shalala—and because we won, there is now widespread public knowledge about the importance of consuming enough folate during pregnancy to prevent neural tube defects. Prior to this legal victory, supplement manufacturers were not permitted to let consumers know about this important nutrient relationship, and many consumers were in the dark. “Qualified health claims” characterize the relationship between a substance and its ability to reduce the risk of a disease or health-related condition. They are permitted in relation to foods and supplements—a precedent established by the landmark decision of Pearson v. Shalala.
We sued the FDA (and won!) 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not allowing the dissemination of truthful, scientific information on dietary supplement labels as part of their 2011 Draft Guidance on New Dietary Ingredients.
In addition, we have achieved some remarkable victories, both in Congress and in court:
Compounding
Congress has been wrestling with legislation about compounded medications, which many consumers rely upon—compounding can provide just the right dose, delivery system, and combination of medicines, which benefit the patient far more than premade medications. The FDA created some provisions that sparked a dramatic outcry from ANH-USA’s grassroots activists. We have won significant victories to protect compounded medications and continue to fight to maintain the integrity of this important medical treatment option.
Ensured that a USP (The United States Pharmacopeia and The National Formulary (USP–NF) is a book of public pharmacopeial standards. It contains standards for (chemical and biological drug substances, dosage forms, and compounded preparations), excipients, medical devices, and dietary supplements) 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. Since people come in all shapes, sizes, with unique biochemistries, it is important to allow doctors to customize dosages for individual needs.
Removed a Senate bill provision that compounders needed to perform random controlled trials (RCTs) in order to meet a “safety and efficacy” standard. 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 Senate bill that doctors must substantiate the need for a compounded prescription. This requirement would create an untenable burden on physicians and would impede the use of compounded medicines.
Removed the impossible-to-measure standard that physician office use of compounded drugs can only represent 10% of compounding pharmacy sales, as well as a provision requiring physician reporting within a few days.
Pressured the FDA to reverse their initial stance and allow compounding pharmacies to continue providing 17P (a progesterone medicine that can help prevent preterm birth) to pregnant women, despite the efforts of KV Pharmaceutical to ban it as a competitor to their drug Makena.
The US Food and Drug Administration is revising the list of drug products that are to be withdrawn or removed from the market for reasons of safety or effectiveness. ANH-USA submitted formal comment to the agency, protesting its proposed elimination of public participation from the process—compounded medications are of great value to consumers, and many are being unfairly branded as unsafe or ineffective. We may pursue legal action if FDA doesn’t take our concerns into consideration.
The FDA is taking nominations its list of bulk drug substances that may be compounded. We submitted two nominations as well as formal comments.
In our comments regarding the FDA’s proposed list for outsourcing compounding facilities, we are arguing against the new standards FDA established for a facility to be included on the list. This opens the door for us to take legal action following further action by FDA.
We created savecompounding.org as resource for individuals concerned about the growing regulatory hysteria and pressure surrounding compounded medications. This site contains myth busting information, stories, and links to action alerts that allow you to get involved in this important issue.
Genetically Modified Organisms (GMOs)
Genetic engineering is a pervasive presence in our food chain that threatens our environmental, financial, and personal health. In over 90 countries, GMOs have been totally or partially banned due to these threats. In the U.S. there is not even a requirement that people be told that foods contain genetically engineered materials. ANH believes that individuals have the right to know if their food contains GMOs and we are engaged in local, state, and national legislative battles related to this issue.
Working 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.
ANH helped draft the GMO labeling bills that became law in Connecticut and Maine. Our activists submitted thousands of messages in support of these bills as well.
We created GMOFactCheck.com as a resource for individuals seeking accurate information about GMOs. This site contains an interactive map which tracks pending legislation and links our members to action alerts which allow them to get involved in this important issue.
ANH was a key supporter of the first unrestricted GMO labeling law in the nation. In 2014, Vermont became the first state to pass a mandatory GMO labeling law.
ANH worked to support GMO state labeling initiatives in Oregon, Colorado, Hawaii, California, Maryland, Arizona, New Mexico, Oklahoma, Florida, Georgia, Tennessee, Kentucky, West Virginia, Illinois, Iowa, Minnesota, Wisconsin, Louisiana, Indiana, and Washington.
Dietetics Monopoly
The Academy of Nutrition and Dietetics (formerly the American Dietetic Association) works to create a monopoly for its 72,00o members, primarily Registered Dietitians (RDs). The organization has been working with state legislatures to exclude well-credentialed nutritionists, even those with more experience and education, from working in competition with the RDs.
We have been working state by state to revise existing monopolistic legislation and block new laws that seek to exclude nutritionists. For example, we:
Worked to proactively replace a ten-year old monopolistic dietitian law in Illinois with a new law that recognizes licensure for credentialed nutritionists, many of whom have advanced degrees, instead of allowing only Registered Dietitians to be licensed. The law will also provide greater protections for acupuncturists, health food stores, small businesses, and individuals who provide nutrition advice.
Helped defeat anti-competitive legislation pushed by the California Dietetic Association that would have restricted the practice of nutrition to Registered Dietitians alone.
Modified regulations in Delaware and Michigan that would have limited the practice of nutrition to Registered Dieticians to include Certified Nutrition Specialists.
ANH was able to add language protecting nutritionists to Sen. Jeff Merkley’s (D-OR) “Older Americans CARE Act,” a bill that helps fund programs that support the elderly and which had previously excluded nutritionists.
Defeated 19 attempts by the AND to create exclusionary state nutrition licensing laws and won a ruling from the Centers of Medicare and Medicaid insuring equal treatment for nutrition professionals regarding therapeutic diets in hospitals.
Helped gain inclusion for Non-RD nutritionist credentialing in the US Department of Labor’s definition of the profession of dietitians and nutritionists.
We created the website ReallyEatRight.org to counteract the propaganda of the AND via their website, EatRight.org.
Anti-Supplement Legislation
Thanks to DSHEA, America has enjoyed access to safe and affordable dietary supplements since 1994. And although this important legislation clearly established a framework to regulate the supplement industry and categorized supplements as food, not drugs, numerous efforts have been made to undermine this framework. The attacks on DSHEA and supplement access have increased through the years led by the FDA, pharmaceutical companies, and a media reliant on drug company advertising. ANH works diligently to defend your access to nutritional supplements:
ANH activists 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.
Activated our grassroots to send over 100,000 messages to Congress in less than 24 hours and soundly defeated Sen. Durbin’s amendment to the Prescription Drug User Fee Act 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’s regulatory system).
Organized an emergency response to a major threat to dietary supplements in Congress: Sen. McCain’s Dietary Supplement Safety Act. ANH-USA activists sent more than 200,000 messages to Congress opposing the bill, and we took out a full-page ad in Roll Call, the Capitol Hill newspaper, which highlighted misleading remarks from Sen. McCain on the Senate floor. In just three weeks, Sen. McCain took the almost unheard-of step of withdrawing support for his own bill, which subsequently died without a vote.
Defeated Rep. Waxman’s attempts to slip a sneak amendment into the Wall Street Finance Reform bill that would have greatly expanded the Federal Trade Commission’s power to target supplement companies.
Blocked dangerous language in the FDA Food Safety Modernization Act that would have created a slippery slope toward US harmonization with Codex Alimentarius, and created an exemption for dietary supplements.
Mobilized activists to send more than 30,000 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.
In response, Sens. Kyl, Kirk, and Lugar and Reps. Visclosky and Wolf wrote their own letters to the FDA expressing their constituents’ opposition to the guidance. In addition, Sens. 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.
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.
In response, Sens. Kyl, Kirk, and Lugar and Reps. Visclosky and Wolf wrote their own letters to the FDA expressing their constituents’ opposition to the guidance. In addition, Sens. 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.
We created supplementfactcheck.com as a means of combatting biased reporting in the media, an action center for individuals interested in protecting access to supplements, and an information center to provide factual reporting on the safety and efficacy of nutritional supplements.
Protections for Practitioners, Patients, And Businesses
One of the most important ways that ANH works to insure consumer access to alternative and complimentary health treatments is by protecting the ability of care providers to do business. Doctors, researchers, clinics and product manufacturers face an increasingly hostile environment and ever growing threats by the FDA and others to their businesses. We have enjoyed significant success in standing up to these threats to natural health.
Modified the Senate healthcare bill to ensure that the Comparative Effectiveness Research program (now called the Patient-Centered Outcomes Research Institute) includes integrative medicine practitioners on the board and advisory panel.
At the request of Sens. Tom Daschle and Tom Harkin, co-drafted the National Plan to Advance Integrated Health Care.
Worked with Reps. 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.
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.
Passed legislation in North Carolina that provides due process protection for practitioners targeted by the state Medical Board.
Worked with Reps. 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.
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.
Passed legislation in North Carolina that provides due process protection for practitioners targeted by the state Medical Board.
Filed an amicus brief in support of POM Wonderful’s suit against the Federal Trade Commission to protect free speech rights for natural products—to protect consumer access to information about the therapeutic effects of natural products.
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.
Other Challenges:
ANH-USA has submitted lengthy comments regarding FDA’s Nutrition Fact Panel proposal, laying the groundwork for potential legal action. Included in these comments were concerns related to a ban on the use of the word ‘folate’ on nutritional supplement labels, the exclusion of fluoride content warnings, and the ridiculously low suggested daily values for a number of important nutrients.
We petitioned the FDA to ban the use of phthalates from both prescription and nonprescription drugs. Phthalates are synthetic chemicals used in plastics, lubricants, insect repellants, nail polish, perfumes, and prescription drugs. Phthalates are acknowledged by the FDA to be known endocrine disruptors which cause sterility, birth defects, and developmental delays.
We’ve filed petitions to ban the use of the toxic chemical BPA in cash register receipts and children’s dental devices. BPA has been linked with serious health problems, including cancer, birth defects, and heart disease.
ANH filed a petition with the FTC over charges the agency made against DSM Nutritional Products. The FTC overstepped their legal authority by applying the standard for disease claims despite the fact that the company made no disease claims in their product marketing.
ANH submitted comments regarding the burden of filing an IND (investigative new drug) application, the first step toward drug approval. Food nutrition research has no part in the drug approval regime and our comments demonstrate that the guidance has not been finalized and therefore legally cannot be enforced.
We are engaged in the ongoing struggle to protect organic standards. The USDA has made moves to undermine those standards and render organic a meaningless word. We are currently fighting against the inclusion of 100 synthetics up for sunset consideration.
The freedoms we enjoy today are the direct result of the actions of activists like you. We will continue to work tirelessly to protect and promote natural health and freedom of choice in healthcare. As the crisis in conventional healthcare becomes increasingly evident to everyone, we have a unique opportunity to bring the word about sustainable and effective natural health options to millions of people around the world as well as our leaders at the local, state, and federal levels.