The Alliance for Natural Health USA (ANH-USA), formerly known as the American Association for Health Freedom, is a 501(c)(4) nonprofit organization dedicated to promoting alternative medicine and is associated with the libertarian health freedom movement. Located in Charlottesville, Virginia, the organization was founded in 1992 as the American Preventive Medical Association (APMA) and became a part of the international Alliance for Natural Health organization, headquartered in the United Kingdom, in 2009. [1]
ANH-USA lobbies government, files lawsuits, and files comments on proposed rulings on behalf of consumers, medical practitioners, and companies in the natural health industry. They promote an integrative approach to health that includes dietary supplements, functional food, and other lifestyle changes which they assert will reduce healthcare costs to a sustainable level. [2] ANH-USA runs a number of campaigns that focus on national and state policy issues affecting food safety, access to dietary supplements, organic foods, health claims, consumer choice in healthcare, and state medical boards. [3]
In April 2011, a U.S. federal judge ruled against a legal challenge by the ANH to the U.S. Food and Drug Administration's adoption of new manufacturing regulations. U.S. District Judge Beryl Howell found that the regulations "did not exceed the FDA's statutory authority, are not impermissibly vague under the due process clause, and are not arbitrary and capricious under the Administrative Procedure Act." The complaint was filed in 2009 by the ANH, along with Durk Pearson, Sandy Shaw and the Coalition to End FDA and FTC Censorship. [4]
ANH-USA has been a plaintiff in several significant lawsuits against the Food and Drug Administration related to suppression of health claims for dietary supplements.
ANH-USA's predecessor organization, APMA, was a co-plaintiff in Pearson v. Shalala in 1998. Congress had previously authorized the FDA to pre-approve health claims on foods (including dietary supplements) but the FDA created an undefined and difficult standard for approving such health claims, and after 10 years had approved only 10 such claims. Supplement manufacturers Dirk Pearson and Sandy Shaw sued the FDA in federal court for refusing to allow four health claims on their products that were supported by science, based on the First Amendment and the FDA's failure to define their standard for accepting a health claim. [5] The D.C. Appeals Court rejected the First Amendment argument, but ruled in favor of the appellants on the second argument, opining,
We agree with appellants that the [Administrative Procedures Act] requires the agency to explain why it rejects their proposed health claims—to do so adequately necessarily implies giving some definitional content to the phrase "significant scientific agreement." We think this proposition is squarely rooted in the prohibition under the APA that an agency not engage in arbitrary and capricious action. See 5 U.S.C. § 706(2)(A) (1994). It simply will not do for a government agency to declare—without explanation—that a proposed course of private action is not approved. See Motor Vehicle Mfrs. Ass'n v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29, 43 (1983) ("[T]he agency must ... articulate a satisfactory explanation for its action ..."). To refuse to define the criteria it is applying is equivalent to simply saying no without explanation.
— Circuit Judge Silberman, Pearson v. Shalala [6]
The APMA again joined Pearson and Shalala in suing the FDA in late 2000 for suppressing health claims that adequate intake of folic acid by pregnant women could prevent neural tube defects. The court opinion found that "It is clear that the FDA simply failed to comply with the constitutional guidelines outlined in Pearson [I]. Indeed, the agency appears to have at best, misunderstood, and at worst, deliberately ignored, highly relevant portions of the Court of Appeals Opinion." Additionally, "the FDA's conclusion that the 'weight' of the evidence was against Plaintiffs' Folic Acid Claim was arbitrary, capricious and otherwise in violation of law." [7]
ANH-USA was the lead plaintiff in a 2010 lawsuit against the FDA for denying further health claims and constructively suppressing other health claims by attaching disclaimers that effectively negated the preceding claim. The court found that "the FDA's decision to ban plaintiffs' colon and digestive tract claim because there is no credible evidence in support of it 'is unreasonable because it is not supported by a review of the available evidence or the FDA's own Guidance Report.' See Whitaker, 248 F. Supp. 2d at 13. Indeed, it appears that credible evidence (e.g., the Peters, Ghadrian, Criqui, and Willet studies) does support this claim. As such, complete suppression of the claim is unwarranted." Additionally, "the FDA has completely eviscerated plaintiffs' claim, with no explanation as to why a less restrictive approach would not be effective ... the FDA's replacement of plaintiffs' claim with different and contradictory language is inconsistent with the spirit, if not the letter, of Pearson I." [8]
The United States Food and Drug Administration is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products.
Folate, also known as vitamin B9 and folacin, is one of the B vitamins. Manufactured folic acid, which is converted into folate by the body, is used as a dietary supplement and in food fortification as it is more stable during processing and storage. Folate is required for the body to make DNA and RNA and metabolise amino acids necessary for cell division. As the human body cannot make folate, it is required in the diet, making it an essential nutrient. It occurs naturally in many foods. The recommended adult daily intake of folate in the U.S. is 400 micrograms from foods or dietary supplements.
A dietary supplement is a manufactured product intended to supplement a person's diet by taking a pill, capsule, tablet, powder, or liquid. A supplement can provide nutrients either extracted from food sources, or that are synthetic. The classes of nutrient compounds in supplements include vitamins, minerals, fiber, fatty acids, and amino acids. Dietary supplements can also contain substances that have not been confirmed as being essential to life, and so are not nutrients per se, but are marketed as having a beneficial biological effect, such as plant pigments or polyphenols. Animals can also be a source of supplement ingredients, such as collagen from chickens or fish for example. These are also sold individually and in combination, and may be combined with nutrient ingredients. The European Commission has also established harmonized rules to help insure that food supplements are safe and appropriately labeled.
A health claim on a food label and in food marketing is a claim by a manufacturer of food products that their food will reduce the risk of developing a disease or condition. For example, it is claimed by the manufacturers of oat cereals that oat bran can reduce cholesterol, which will lower the chances of developing serious heart conditions. Vague health claims include that the food inside is "healthy," "organic," "low fat," "non-GMO," "no sugar added," or "natural".
Glucosamine (C6H13NO5) is an amino sugar and a prominent precursor in the biochemical synthesis of glycosylated proteins and lipids. Glucosamine is part of the structure of two polysaccharides, chitosan and chitin. Glucosamine is one of the most abundant monosaccharides. Produced commercially by the hydrolysis of shellfish exoskeletons or, less commonly, by fermentation of a grain such as corn or wheat, glucosamine has many names depending on country.
A nutraceutical is a pharmaceutical alternative which claims physiological benefits. In the US, nutraceuticals are largely unregulated, as they exist in the same category as dietary supplements and food additives by the FDA, under the authority of the Federal Food, Drug, and Cosmetic Act. The word "nutraceutical" is a portmanteau term, blending the words "nutrition" and "pharmaceutical".
The Washington Legal Foundation (WLF) is a non-profit legal organization located at 2007-2009 Massachusetts Avenue NW, on Embassy Row in Washington, D.C. Founded in 1977, the Foundation's stated goal is "to defend and promote the principles of freedom and justice." The organization promotes pro-business and free-market positions and is widely perceived as conservative.
Durk Pearson is a research scientist best known for coauthoring a series of books on longevity, beginning with Life Extension: A Practical Scientific Approach.
The health freedom movement is a libertarian coalition that opposes regulation of health practices and advocates for increased access to "non-traditional" health care.
The Alliance for Natural Health (ANH) is an advocacy group founded in 2002 by Robert Verkerk and based in the United Kingdom. ANH was founded to raise funds to finance a legal challenge of the EU Food Supplement Directive. ANH lobbies against regulation of dietary supplements, in favour of pseudo-scientific alternative medicine, and advocates dietary and other lifestyle approaches to health. It also criticizes established science showing that Megavitamin therapy lack any health benefit.
MonaVie is a defunct, American multi-level marketing company that manufactured and distributed products made from blended fruit juice concentrates, powders, and purées. The company was the subject of several controversies. Health claims for its products had not been scientifically confirmed or approved by regulatory authorities, and its chairman had been previously involved in false health claims concerning another beverage company. According to Forbes, MonaVie's business plan resembled a pyramid scheme. In 2015, the company defaulted on a US$182 million loan and went into foreclosure. Florida-based Jeunesse Global took over MonaVie’s assets when it purchased the note for $15 million.
The Nutrition Labeling and Education Act (NLEA) is a 1990 United States Federal law. It was signed into law on November 8, 1990 by President George H. W. Bush.
The Nutritional Health Alliance is an industry lobby group which lobbies United States lawmakers to pass industry friendly health legislation.
Wyeth v. Levine, 555 U.S. 555 (2009), is a United States Supreme Court case holding that Federal regulatory approval of a medication does not shield the manufacturer from liability under state law.
The regulation of food and dietary supplements by the U.S. Food and Drug Administration is a process governed by various statutes enacted by the United States Congress and interpreted by the U.S. Food and Drug Administration ("FDA"). Pursuant to the Federal Food, Drug, and Cosmetic Act and accompanying legislation, the FDA has authority to oversee the quality of substances sold as food in the United States, and to monitor claims made in the labeling about both the composition and the health benefits of foods.
The United States is the largest grower of commercial crops that have been genetically engineered in the world, but not without domestic and international opposition.
Oxilofrine is a substituted phenethylamine stimulant drug chemically related to ephedrine and to synephrine.
Gregory James Caton was an American businessman, inventor, manufacturer, convicted felon, and promoter of various herbal products, the main one being Cansema, which Caton claimed cures skin cancer, although the U.S. Food and Drug Administration (FDA) banned it in 2003 as worthless. Caton was the founder of Alpha Omega Labs, a manufacturer of natural health care products, that currently distributes internationally from Guayaquil, Ecuador.
Sulfoaildenafil (thioaildenafil) is a synthetic drug that is a structural analog of sildenafil (Viagra). It was first reported in 2005, and it is not approved by any health regulation agency. Like sildenafil, sulfoaildenafil is a phosphodiesterase type 5 inhibitor.
The Dietary Supplement Health and Education Act of 1994 ("DSHEA"), is a 1994 statute of United States Federal legislation which defines and regulates dietary supplements. Under the act, supplements are regulated by the FDA for Good Manufacturing Practices under 21 CFR Part 111. The act was intended to exempt the dietary and herbal supplement industry from most FDA drug regulations, allowing them to be sold and marketed without scientific backing of their health and medical claims.