How Does Federal Preemption Impact Consumers?
As part of the regulatory process creating OTC hearing aids, the FDA must evaluate how existing state laws governing hearing aids might interfere with this new category of devices. Importantly, as required by FDARA, any state law that the FDA believes to “restrict or interfere with the servicing, marketing, sale, dispensing, use, customer support, or distribution of over-the-counter hearing aids” will be preempted by federal law.
Preemption is a legal doctrine that commonly arises when there is a conflict between federal and state law, particularly as part of the regulatory process. The doctrine arises out of the Supremacy Clause found in the U.S. Constitution, which provides that “the Laws of the United States . . . shall be the supreme Law of the Land.” To put it simply, preemption not only forbids states from propagating new laws that interfere with federal law at issue, but it also renders any existing conflicting state laws invalid.
In the context of OTC hearing aids, the FDA is faced with the difficult task of making these important determinations—all while patients and consumers hang in the balance under the protection of important state-based consumer protections that may soon be in jeopardy.
Preemption is a legal doctrine that commonly arises when there is a conflict between federal and state law, particularly as part of the regulatory process. The doctrine arises out of the Supremacy Clause found in the U.S. Constitution, which provides that “the Laws of the United States . . . shall be the supreme Law of the Land.” To put it simply, preemption not only forbids states from propagating new laws that interfere with federal law at issue, but it also renders any existing conflicting state laws invalid.
In the context of OTC hearing aids, the FDA is faced with the difficult task of making these important determinations—all while patients and consumers hang in the balance under the protection of important state-based consumer protections that may soon be in jeopardy.
But there is good news.
To assist the FDA in fully understanding the practical implications regarding the application of its preemption mandate, including any potential unintended consequences, the Hearing Industries Association (HIA) conducted a 50-state survey of existing laws and regulations that could be impacted. HIA identified five primary areas of consumer protection that it strongly encourages the FDA to preserve at the state level as it promulgates OTC hearing aid regulations: (1) licensure-related requirements for the fitting, dispensing, or sale of hearing aids; (2) receipt requirements; (3) strong return periods; (4) important promotion and advertising restrictions, and (5) assistive technology device warranties.
What does it all mean?
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As the FDA continues to evaluate how best to implement the broad preemption mandate of FDARA to accommodate the new OTC hearing aid category, the FDA should strive to maintain strong existing state-based consumer protections, including across the five areas identified by HIA. Doing so will be critically important to ensuring OTC hearing aids, as well as traditional hearing aids, are safe and effective.
Here at HAH, we are actively communicating with stakeholders and government officials to ensure this happens, and we hope you will join us in advocating for strong patient safety measures. |
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