Legal Work

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Insure access to quality supplements

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not allowing the dissemination of truthful, scientific information on dietary supplement labels as part of their 2011 Draft Guidance on New Dietary Ingredients.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.
 

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Stop censorship of science

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.
 

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Protect access to good food

A significant component of sustainable, natural healthcare is a proper diet. As such, ANH-USA works to ensure 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.
 
 
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 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.