Troutman Pepper Hamilton Sanders LLP

01/24/2022 | News release | Distributed by Public on 01/24/2022 23:08

State AGs Urge FDA to Listen Up and Preserve The States’ Consumer Protection Authority

On January 18, the National Association of Attorneys General (NAAG) sent a letter to the U.S. Food and Drug Administration (FDA), urging the agency to expressly ensure that state attorneys general (State AGs) continue to have the authority to enforce state consumer protection laws on the sale of hearing aids. This action aligns with the State AGs' goal of preserving their authority to enforce state laws and sensitivity toward any potential federal encroachment that would preempt their authority.

While the State AGs embraced the FDA's proposal to allow for the first time hearing aids to be sold over the counter directly to consumers, the bipartisan coalition of 42 states, led by the Connecticut and Ohio attorneys general, took the opportunity to remind the FDA of its role:

As primary enforcers of our respective states' consumer protection laws, state attorneys general [] have regulated the hearing aid market in concert with the FDA's labeling and dispensing requirements. Traditionally, the FDA has treated state requirements for hearing aids as complementary to its regulatory framework. Since the 1980s, the FDA has granted many state petitions for exemption from federal preemption for the following requirements aimed at protecting consumers in our respective states.

Explaining that each state has its own professional licensing requirements and applicable statutes intended to prohibit inappropriate advertisements and disclosures, the State AGs explained that the agency's proposal could be read liberally to "repeal virtually all the state-requested exemptions from preemption issued by the FDA since 1980 - even those related exclusively to non-[over-the-counter] hearing aids. Such language could create unneeded confusion and the potential for unnecessary litigation."

Ensuring that the FDA does not usurp the State AGs' authority has become a consistent theme and one we expect will continue both in future comment letters and related enforcement actions when AGs perceive the FDA as not taking sufficient action.

In another example, the State AGs recently expressed this same sensitivity to maintaining a role in regulating cannabis. In a July 2019 letter related to cannabis-derived compounds, the states asked the FDA to "continue to recognize the important role that states play in this emerging market." A bipartisan coalition of six (6) State AGs sent a second letter in November 2021, seeking to ensure a "cooperative federal-state partnership" in the regulation of cannabis.

As Troutman Pepper has recently reported, State AGs are keenly focused on protecting their wide range of statutory authority, and they are more organized than ever in acting collectively to protect these interests.