January 28, 2022
Honorable Tom Miller
President
National Association of Attorneys General
1850 M Street NW, 12th Floor
Washington, DC 20036
Dear President Miller
As a non-profit, non-partisan organization representing tens of millions of U.S. consumers, Consumer Action for a Strong Economy (CASE) applauds the commitment of over 40 attorneys general in urging the Food and Drug Administration (FDA) to ensure that states maintain their critical role as key authorities of enforcement in the regulation of Over-the-Counter (OTC) hearing aids.
We further appreciate the bi-partisan, January 18, 2022 comments submitted by the National Association of Attorneys General (NAAG) to the FDA’s proposed rule on Establishing Over-the-Counter Hearing Aids. These comments offered an extremely reasonable and common-sense framework for the proposed rule to allow state authorities to maintain their role as the primary enforcers of consumer protection laws. The comments also stressed the importance of allowing state enforcement mechanisms to continue to work in concert with FDA regulations for enhanced consumer protections.
We remain concerned, however, that seven states have yet to lend their voice to this effort, and encourage them to join the fold. The authority vested in these state officials is specifically intended for enforcement of consumer protection issues such as OTC regulation. As we have seen, technology in the OTC market has developed rapidly, and with this development we have further seen an explosion of advertising in this sector, targeting millions of consumers with a wide-range of marketing claims. It is at this critical juncture that every state attorney general should be asserting the power vested in their office to protect the consumers within their borders.
Consumer interests and public health in general are best served not through a monolithic federal bureaucracy in Washington, but through the concerted efforts and collective wisdom of federal, state, and local authorities acting in the best interests, and with the best information and data, on behalf of their constituents.
The comments submitted by NAAG to the FDA rule raise vital issues concerning overly broad language in the proposed rule, which, as you state, “[c]ould be interpreted to repeal virtually all the state-requested exemptions from preemption issues by the FDA since 1980…” We share your concern that unclear, inconsistent language will lead to unclear and inconsistent enforcement and regulation of OTC products, as well as potentially costly and unnecessary litigation. This is why the office of no state attorney general should remain silent as this issue moves forward and final rules are considered.
We are strongly encouraged that several states that have domestic OTC manufacturers are not shying away from demanding that the FDA promulgate clear and forceful OTC rules that preserve and enhance state regulatory authority. Such actions demonstrate that these states are prioritizing consumer safety above all else, even when conflicts with local economic interests may arise. It is our hope that the remaining nine state attorney generals who have yet to join this effort will do so in short order, for this critical, bi-partisan effort on protecting consumer health and safety in an age of ever-emerging technologies. Thank you for your time and consideration.
Sincerely,
Matthew Kandrach
President
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Consumer Action for a Strong Economy (CASE)
211 North Union Street, Suite 100
Alexandria, VA 22314
Office: 703-718-5011
www.CASEforConsumers.org
@CASE_forAmerica
