Legal Work

April 21, 2015
Category: Uncategorized

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 Protecting natural practitioners from monopolistic attacks

To ensure consumers are able to see the natural health practitioner of their choosing, ANH is actively working to both eliminate the Academy of Nutrition and Dietician 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.
 

leg-page-supps-slEnsure access to quality supplements

As staunch advocates of natural health, ANH-USA works 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 preventing 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.
 

leg-page-censor-slStop censorship of science

Access to scientific information regarding natural health modalities is critical to ANH-USA’s mission. Without information, consumers are unable to make informed choices about their health.
To this end, ANH-USA actively opposes the Federal Trade Commission’s (FTC) inappropriate attack on natural foods and supplements—specifically, the benefits they claim on their labels. To advertise any disease-related claims, the FTC wants to require two RCTs—randomized controlled trials—which are prohibitively expensive. Court rulings have struck down the requirement of two RCTs, but have suggested that one RCT could be appropriate.
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.
 

leg-page-organic-slProtect 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. This means weighing in on government efforts to develop nutrition guidelines based on outdated science, as well as protecting the integrity of the “organic” label.
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 is firmly against efforts at both the state and federal levels to mandate vaccinations. Vaccine policies should be based on informed consent, not forced compulsion, in light of numerous safety concerns. More can also be done to ensure the safety of vaccines, like removing dangerous ingredients and using adverse events to determine a particular vaccine’s safety.
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.
The FDA held 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.
Finally, in an effort to protect consumer access to important diagnostic tests, ANH-USA has engaged the FDA in regard to their proposal to regulate laboratory-developed tests as medical devices. These tests, and others like them, are crucial to individualized medicine and should not be subject to needless and burdensome regulation.

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