The FDA’s Latest Warning Letters: What They Reveal About Cosmetic and Supplement Claims

In recent months, the U.S. Food and Drug Administration (FDA) has issued a series of warning letters that highlight recurring problems in how cosmetic and supplement companies market their products. These letters are more than just administrative notices—they provide a window into the agency’s enforcement priorities and offer critical lessons for businesses operating in highly regulated industries.

For companies selling cosmetics or dietary supplements, understanding the nuances of FDA oversight isn’t optional. Missteps in product claims, labeling, or marketing can result in costly delays, brand damage, or even product removal from the market. So, what do these latest warning letters reveal, and how can businesses reduce their risk?

Understanding FDA Warning Letters: Key Takeaways for Businesses

An FDA warning letter is one of the agency’s most direct enforcement tools. While it is not the same as a product recall or seizure, it signals that the FDA has identified violations of federal law. The letter typically outlines the specific issue, such as unapproved drug claims or misbranded labeling, and gives the company a short window to correct it.

Understanding this framework is the first step in minimizing risk. Some key points to keep in mind:

• Public record: Warning letters are published on the FDA’s website, meaning reputational impact is immediate.
• First step toward escalation: If ignored, the agency may pursue more severe enforcement actions, including injunctions or seizures.
• Corrective action is required: Companies must show not just intent but concrete steps to resolve the violations.

How to Respond Effectively to an FDA Warning Letter

For businesses that receive one, knowing how to respond to FDA warning letter guidance is essential. The agency generally expects a written response within 15 business days, outlining corrective actions taken or planned.

A strong response should:

• Acknowledge the violations rather than dispute them without legal grounds.
• Detail corrective measures, such as revising product labels, updating marketing content, or retraining staff.
• Provide timelines to demonstrate urgency and commitment to compliance.

Importantly, businesses should avoid generic statements. The FDA expects specifics—who is responsible for corrective actions, what changes have been made, and how the company will prevent recurrence. Working with a regulatory attorney can help ensure that the response is both comprehensive and strategically sound.

Common Violations in Cosmetic and Supplement Claims

The latest FDA warning letters show familiar patterns, especially in the cosmetic and supplement industries.

1. Unapproved Drug Claims

Companies often describe products as treating or curing diseases (e.g., “reduces anxiety” or “treats eczema”). However, doing so classifies the item as a drug in the FDA’s eyes—triggering a different and stricter regulatory framework.

2. Misbranding Through Misleading Language

Vague or exaggerated claims about “scientific backing” or “clinically proven” benefits without proper evidence are frequent violations. The FDA views these as misbranding because they can mislead consumers.

3. Improper Structure/Function Claims

Even permissible supplement claims must be carefully worded. Companies are expected to have substantiation, and failing to phrase these claims correctly can turn a lawful statement into a compliance issue.

4. Labeling Noncompliance

Missing disclaimers, incomplete or inaccurate ingredient lists, and failure to follow required formatting are also common reasons for FDA warning letters. These issues may seem minor, but they can quickly escalate into enforcement actions.

These examples underscore that the problem isn’t always malicious intent—sometimes it’s a lack of clarity around what the FDA allows.

Preventing Future FDA Actions: Best Practices for Compliance

The best strategy is proactive compliance. Businesses can avoid regulatory pitfalls by:

• Auditing all product claims: Regularly review labels, websites, and social media content to ensure claims align with FDA guidelines.
• Documenting substantiation: Keep detailed records of studies or evidence supporting structure/function claims.
• Training marketing and sales teams: Ensure staff understand the legal limits of promotional language.
• Consulting regulatory experts: A legal review before launch can be far less costly than responding to an FDA enforcement action.

Ultimately, compliance is about building credibility and trust with consumers in a crowded market.

Staying Compliant in a Shifting FDA Landscape

FDA warning letters are roadmaps for what not to do in cosmetics and supplements marketing. By studying these enforcement actions, companies can better understand where the agency is drawing its lines—and how to stay on the right side of them.

For businesses that do receive one, knowing how to respond to FDA warning letter requirements can make the difference between a manageable correction and an escalated enforcement action. With the right compliance strategy and expert guidance, companies can protect both their products and their reputation in a highly scrutinized market. Contact us today to learn more about how FDA Atty can help with warning letter responses and other FDA-related issues.