Alexandria, VA—The Alliance for Natural Health (ANH) USA has filed a lawsuit in the United States District Court for the District of Columbia. The suit aims to overturn the Food and Drug Administration's (FDA) effective ban on homeopathic drugs, following FDA’s 2022 guidance, which says all homeopathic drugs to go through the same new drug pre-market licensing system used for pharmaceutical medications. FDA said its risk-based approach will be used to prioritize enforcement and regulatory actions involving categories of products that FDA says may pose a higher risk to public health.
ANH-USA, along with homeopathic drug maker Meditrend Inc., claims the guidance is unlawful and contradicts decisions previously established by Congress. Critics of FDA's guidance argue that it is impractical and financially unattainable for most homeopathic drug manufacturers, and that it threatens the viability of a $4+ billion industry. AHN-USA pointed out that millions of Americans use homeopathics.
Regulatory Overreach?
“The FDA’s guidance is a stunning example of agency overreach,” said Jonathan Emord, Esq., General Counsel for ANH-USA. “Not only has the FDA ignored the careful consideration given to this unique category of drugs by Congress, it has violated the law, notably the Administrative Procedure Act and the Coronavirus Aid, Relief, and Economic Security Act of 2020.”
Emord highlighted the Supreme Court decision to overturn the Chevron doctrine, which had granted broad deference to regulatory agencies. According to Emord, this decision creates a critical opportunity to challenge what he describes as government overreach that limits individual rights and consumer choice.
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Homeopathy Industry at Risk
If enforced, FDA's guidance could eliminate consumer access to homeopathic drugs, ANH-USA contends. Rob Verkerk, Ph.D., Executive and Scientific Director of ANH-USA, argued that the FDA’s actions are based on exaggerated safety concerns.“Copious evidence shows that these are among the very safest healthcare products in use,” said Dr. Verkerk. “What the FDA should have done is follow the remit given by Congress and develop a new regulatory framework suitable for homeopathics.”
Dr. Verkerk expressed optimism about a solution, noting that Americans for Homeopathy Choice has drafted a bill that could establish a suitable regulatory framework for homeopathic drugs.
The full complaint can be accessed here.
