Protect Access To Good Food
Reform the FDA
Protecting Medical Practitioners From Monopolistic Attack
Protect Individualized Medicine and Individual Choice
As staunch advocates of natural health, ANH-USA has long worked to insure that consumers have access to quality supplements. Our organization’s first lawsuit 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not allowing the dissemination of truthful, scientific information on dietary supplement labels as part of their 2011 Draft Guidance on New Dietary Ingredients.
We continue to work on a number of legal fronts to protect access to quality dietary supplements.
- We are closely monitoring the progress of the FDA’s New Dietary Ingredient (NDI) guidance, with the goal of ensuring that it does not develop into preapproval for some supplements.
- We are also working to eliminate the required investigational new drug (IND) requirements, which could have the effect of turning natural ingredients into drugs.
- The ANH-USA legal team is also working to prevent the inclusion of supplements in the FDA’s Redbook toxicological guidance, another instance of regulatory over-reach and disregard for current laws concerning supplements.
ANH-USA is also concerned about recent attacks on folate. Fully 44% of the US population is not able to convert synthetic folic acid into the usable form of B9, folate; 90% of sensitive populations, such as autistic children, require the natural form of folate. ANH is working to prevent a back-door FDA ban on folate in its Nutrition Fact Panel proposal, laying the groundwork for potential legal action.
We are also at work at the legislative and regulatory levels.
- We are closely monitoring the progress of the FDA’s New Dietary Ingredient (NDI) guidance, with the goal of insuring that it does not develop into a costly and damaging preapproval system for dietary supplements.
- We are also working to reform investigational new drug (IND) requirements, which could have the effect of turning natural ingredients into drugs.
- We are working with our champions in the House and Senate to prevent legislative attacks on supplements, and to enact proactive measures to enhance consumer access to supplements.
We submitted a comment to the Office of Dietary Supplements, a division of the National Institutes of Health (NIH), regarding the Office’s development of their strategic plan for 2015-2019. We suggested that, to achieve the Office’s purpose of exploring the role of dietary supplements as a significant way to improve health care, the strategic plan should include three topics to be studied. Specifically, we recommended:
- that the Office should study the economic impact of requiring dietary supplements to go through the drug approval process prior to making known any health benefits;
- that the strategic plan include an investigation of the necessity of folate as a crucial alternative to folic acid for individuals with certain gene mutations;
- and we suggested that proper attention should be paid to the benefits of colloidal silver as a means to address the growing problem of antibiotic resistance.
We will be submitting a comment to the FDA opposing the inclusion of dietary supplements in the Redbook, which is FDA’s guidance to the food industry related to food additives, food contact substances and generally recognized as safe (GRAS) ingredients.
There are two very strong reasons to oppose the expansion of the Redbook to include dietary supplements. First, this would conflict directly with the Dietary Supplement Health and Education Act of 1994 (DSHEA). DSHEA excludes dietary supplements from the definition of food additives in the FDCA and created a regulatory framework for dietary supplements specifically. Second, the name and history of the Redbook indicate very clearly that it was intended to be associated with the safety evaluation of food and color additives, not dietary supplements.
Access to scientific information regarding natural health is critical to ANH-USA’s mission. Without information, consumers are unable to make informed choices about their health.
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. This allows for the truthful dissemination of the benefits of nutrients. These cases were argued by Jonathan Emord, the nation’s foremost legal advocate of natural health.
We also 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.
ANH-USA will continue to pursue legal remedies not only to protect free speech rights for natural products, but also to protect consumer access to information about the therapeutic effects of natural products.
ANH-USA actively opposes the Federal Trade Commission’s (FTC) attacks on natural foods and supplements—specifically, preventing consumers from learning about the potential benefits of herbs, botanicals, vitamins, and other supplements.
ANH-USA is pursuing legislative remedies not only to protect free speech rights for natural products, but also to protect consumer access to information about the therapeutic effects of natural products.
To prevent a back-door FDA ban of another B vitamin, natural folate, 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.
ANH-USA is also monitoring so-called “Ag-Gag” bills—legislation that suppresses free speech when it comes to exposing abuses on factory farm operations. ANH-USA will continue to coordinate grassroots pressure when such bills arise.
A significant component of sustainable, natural health is a proper diet. ANH-USA works to insure consumer access to healthy foods and information based on the most up-to-date science available.
ANH 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.
Additionally, ANH-USA is monitoring legal challenges to mandatory GMO-labeling laws, with the aim of protecting states that require labels on products that contain genetically modified ingredients.
ANH-USA is also working to reform California’s Proposition 65 (“Prop 65”) law, which was originally intended to warn consumers of the presence of toxic chemicals in their food and environment. Several provisions of the law have led to conditions which make it ineffectual to consumers (ubiquitous presence of warning labels make informed choice impossible). Prop 65 has also given birth to an entire industry of trial lawyers in search of quick settlements, increasing the price consumers pay for products and reducing their access to many products from companies that refuse to do business in California.
To insure that all Americans have access to safe and healthy food, ANH-USA supports legislation at the federal and state level that would require the labeling of genetically modified foods, with the additional aim staving off legislative efforts to preempt states that pass mandatory labeling laws.
ANH-USA also supports efforts in Congress to ban dangerous pesticides and protect pollinators (such as honeybees and Monarch butterflies), a key link in the human agricultural chain. As GMO-crops become more widespread, pesticide use increases and threatens to decimate pollinator populations.
We will be commenting on the Dietary Guidelines Advisory Committee’s scientific report that will affect the new 2015 Dietary Guidelines for Americans. ANH-USA is pointing out that the recommended level for vitamin D is remarkably low and is based on evidence that is out of date. We also take issue with the failure to recognize dietary supplements as a good way for people to achieve the levels of vitamins and minerals that are recommended.
The report recommends that advises consumers to reduce their consumption of saturated fat and red meat. However, we suggest that more recent studies have not shown a link between saturated fat and heart disease. Additionally, not all red meat is the same, with grass-fed, organically raised beef being significantly healthier than grain-fed, CAFO-raised meat. Consequently, the recommendation should be revised to reflect this difference.
Reform the FDA
Time and time again, clear evidence has shown the extent to which the Food and Drug Administration is captured by special interests with an agenda, particularly the pharmaceutical industry. Big Pharma continually exerts its influence over the FDA in order to hurt competitors such as dietary supplements, homeopathy, and compounding. This is the real catalyst behind FDA actions that attempt to treat supplements like drugs and limit consumer access to individualized medicine and choice in healthcare.
To eliminate the crony-capitalist element, ANH-USA is engaged in efforts to move supplements into the jurisdiction of a different agency. We also act as a watchdog over all FDA’s actions and weigh in to shape regulations in order to protect consumers.
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. FDA responded to our petition in December 2014, saying that because it is such a complex issue, they have not been able to reach a decision yet. We are waiting for FDA’s decision.
In an effort to protect consumer access to important diagnostic tests, ANH-USA has engaged in FDA’s comment process regarding FDA’s proposal to regulate laboratory-developed tests as medical devices. Along with many other groups, we argued that FDA lacks the authority to do this and that FDA should not be using the informal guidance process to impose substantive rules.
The FDA is in the process of holding public hearings to evaluate its enforcement policies for homeopathic drug products. In order to protect consumer access to homeopathic medicines, ANH-USA will take an active role in official proceedings through written comments or other legal actions.
To ensure consumers are able to see the health practitioner of their choosing, including naturopathic physicians, nutritionists, and doctors who specialize in integrative medicine, ANH is actively working to both eliminate the Academy of Nutrition and Dietician’s monopoly on nutrition services in the states and create better due process protections for integrative physicians who are targeted by state medical boards for practicing a natural, higher standard of care.
To date, we have scored victories in 19 states to protect the rights of medical practitioners to provide nutritional advice to clients and patients.
Protect individualized medicine and individual choice
Advocating for sustainable, natural healthcare means moving away from a one-size-fits all model and towards an approach that takes into account an individual’s biology and genetics. The legal team at ANH-USA work on a number of fronts to ensure consumer access to important elements of individualized medicine.
ANH-USA filed an amicus brief in support of famed attorney Jonathan Emord’s Ohio lawsuit to overturn the Affordable Care Act (Obamacare), arguing that the individual mandate provision is unconstitutional.
We joined a suit against the government, filed with the Association of American Physicians & Surgeons, to seek declaratory relief from the Affordable Care Act, stating that it contains a number of unconstitutional measures.
As new FDA guidances threaten to limit consumer access to compounded, individualized medicines, ANH-USA has taken an active role in the new rule formation. ANH-USA has submitted a series of administrative comments to protect doctors’ ability to use these important preparations in their offices, ensure transparency and public participation, and protect access to the full spectrum of important compounded medications such as bioidentical hormone preparations. Our series of administrative comments pave the way for us to sue the FDA if it doesn’t take our concerns into consideration as the guidance documents and rules are finalized.