FDA Sends 100 Cease-and-Desist Letters: A Warning to Industry

September 11, 2025

On September 9, 2025, the U.S. Food and Drug Administration (FDA) and Department of Health and Human Services (HHS) dropped a regulatory bombshell: the FDA issued approximately 100 cease-and-desist letters and thousands of letters to industry targeting direct-to-consumer (DTC) drug ads.

This sweeping action is being interpreted as the start of a broader shift in FDA’s oversight of promotional content—particularly in digital and broadcast media.

“There’s a sense that FDA is trying to reset expectations,” said Nathan Downing, Managing Attorney at Gardner Law. “But it’s unclear how much of this will lead to substantive, lasting change. It may be largely symbolic, or it could mark the start of more sustained enforcement. We simply don’t know yet.”

FDA Didn’t Mince Words

In the FDA’s press release, they acknowledge their own history of limited enforcement:

"Despite widespread violations, the FDA has been increasingly lax and reactive in its enforcement approach over the last few decades. The FDA used to send more than a hundred warning letters each year, and misleading ads were rare. But over time, enforcement waned and the number of warning letters sent to pharmaceutical companies dropped to one in 2023 and zero in 2024."

FDA has made clear it intends to reverse course and reestablish a more aggressive approach to enforcement:

"The FDA will no longer tolerate such deceptive practices. Going forward, the agency will aggressively deploy its available enforcement tools. The FDA is already implementing AI and other tech-enabled tools to proactively surveil and review drug ads."

The Big Story: Rewriting Broadcast Advertising Rules

FDA Warns Pharma Companies over DTC Advertising

A key focal point is the FDA’s intent to revise or eliminate the “adequate provision” pathway, a regulatory approach in place since 1997 that allows broadcast ads to meet fair balance standards by combining a major statement of key risks with directions for accessing full prescribing information (e.g., a website, toll-free number, or print insert).

In its press release, FDA referred to this as a "loophole." That characterization reflects the Agency's policy perspective, not the law. The framework for fair balance and risk disclosure remains enforceable today:

Broadcast ads must include a major statement of the drug’s most important risks.
Ads may rely on “adequate provision” to direct consumers to full prescribing information.
Fair balance requires that risks be presented comparably to benefits.

FDA’s new rulemaking could remove the option to rely on adequate provision. That process will include public comment, an important opportunity for industry to engage. But even without a final rule, FDA may still assert that ads are misbranded and issue Untitled or Warning Letters under existing authorities.

What Is This Really About?

Some in the industry are questioning whether this represents a genuine policy shift at FDA or a largely symbolic effort to address longstanding concerns about the influence of drug ads.

Public officials, including President Trump and HHS Secretary Robert F. Kennedy, Jr., have increasingly called for stronger regulation of DTC drug ads, citing concerns about consumer misinformation, over-medicalization, and rising healthcare costs. One frequently mentioned but legally controversial idea has been an outright ban on DTC ads—an approach that would almost certainly face First Amendment challenges.

On the other hand, is there a valid point to be made here? The U.S. does spend more on prescription drugs than any other country, both in total (about $633 billion in 2023) and on a per-capita basis ($1,200–$1,400 per person annually, compared with $500–$800 in other high-income nations). Drugs account for 14–15% of U.S. health care expenditures, with brand-name prices often two to three times higher than those abroad. Against that backdrop, it is fair to ask whether the scale of U.S. drug consumption, and the marketing that drives it, warrants closer scrutiny. At minimum, industry should anticipate that these arguments will continue to resonate with policymakers and the public.

Rather than attempt a direct prohibition, FDA seems to be choosing a different path: tightening advertising standards to the point where certain formats, especially short broadcast spots, may become impractical given the volume of risk information that would need to be disclosed.

What Happens Next?

More enforcement may be coming, and companies should proactively reassess their DTC materials. While the initial wave of letters went out to drug companies, medical device companies should not assume they are exempt. FDA applies the standards of fair balance and truthful and non-misleading promotion across product categories, and DTC promotion of devices, particularly wearables, diagnostics, and digital health tools, is growing.

We’re already hearing from clients (both drug and device) with questions about how these developments may affect their advertising and promotional strategies. Many are reevaluating how to present risk information clearly, manage social media and influencer content, and determine whether current practices remain viable under FDA’s evolving expectations.

There’s also a growing recognition of a practical paradox: requiring all risks to be recited in a 60-second broadcast spot may impair rather than enhance patient understanding, especially when the disclosures become overly dense or technical.

“As one of only two countries in the world that permit direct-to-consumer drug advertising, it’s critical that ads are portrayed in a way that informs patients as opposed to overwhelming or confusing them,” said Rebecca Zadaka, Associate Attorney at Gardner Law. “By adding in too much risk information, it’s possible that patients actually understand less of the risks of a medication than if they received just the main risks and then spoke with their healthcare provider.”

Gardner Law’s Take

The full impact of these changes remains to be seen. Some companies may scale back DTC advertising, while others may adapt with longer, risk-heavy formats. This is a moment for thoughtful reassessment. Reviewing existing campaigns, tightening review protocols, and preparing teams for a more active enforcement environment can help reduce risk while strengthening trust with patients and regulators alike.

FDA is signaling a return to aggressive enforcement, but the legal durability of this new stance remains untested. By reframing “adequate provision” as a loophole, FDA risks opening itself to challenges that it is rewriting settled law without Congressional authority. Early litigation could emerge not only as a defensive strategy, but as a test of the limits of FDA’s power in this space.

Gardner Law helps drug and medical device companies navigate advertising compliance, promotional review, and FDA engagement. We advise on risk disclosures, claim substantiation, and digital strategy. If you're wondering whether these changes might affect your current approach, we’re happy to help you assess and adjust.