Responding to FTC Allegations of False Health Claims

Responding to FTC Allegations of False Health Claims

Getting an allegation letter from the FTC about false or deceptive health claims can be scary. But it doesn’t have to be the end of the world. Here’s some advice on how to respond in a constructive way.

Take a Deep Breath

It’s understandable to feel anxious or defensive when you get that letter. But try not to panic! An FTC allegation letter doesn’t necessarily mean you’ve done something wrong or illegal. It just means the FTC has some concerns they want you to address.

Review the Specific Claims at Issue

Carefully read through the FTC’s letter and make sure you understand exactly which claims they are challenging. They should cite specific examples from your marketing materials, website, etc. Focus your response on those particular claims – don’t make assumptions about other claims not mentioned.

Gather Your Substantiation

The FTC requires health claims to be supported by “competent and reliable scientific evidence” [2]. So gather all the documentation you have to back up the claims in question – clinical studies, expert opinions, scientific literature, etc. Make sure it’s credible research from impartial sources.

Be Honest About Any Weaknesses

If you find any gaps in the substantiation for a claim, don’t try to fudge it. It’s better to be upfront and acknowledge where your support could be stronger. Consider revising or dropping claims that lack solid backing.

Explain Your Reasoning

Don’t just data dump studies on the FTC. Put together a memo explaining why you believe the evidence you’ve gathered substantiates each challenged claim. Make your case in clear, simple language.

Consider Getting a Second Opinion

You may want to have a neutral third party like a contract research organization review your substantiation. Their objective assessment could strengthen your response.

Be Responsive and Cooperative

Reply to the FTC by their specified deadline and let them know you take their concerns seriously. Offer to provide additional information and work with them to resolve any issues.

Suggest Revised Claims

If you agree some claims need changing, propose alternative language you believe can be properly substantiated. The FTC may be receptive to reasonable revisions.

Keep Your Response Focused

Only address the specific claims and issues raised in the FTC letter. Don’t expand your response to make broad assertions about your practices or other products.

Consider Your Overall Compliance

While addressing the immediate allegations, also take the opportunity to review your broader compliance with FTC health advertising guidelines. Identify any other vulnerabilities that need shoring up.

Don’t Make Excuses

Stick to factual explanations and avoid trying to justify the claims. Defensive arguments won’t help persuade the FTC.

Be Willing to Make Changes

If the FTC identifies claims you can’t adequately substantiate, stop making those claims. Show you’re willing to modify your practices when warranted.

Ask for Guidance

If you’re unsure how to respond, seek input from the FTC case manager. They can often provide helpful direction on potential resolutions.

Consider Your Next Steps

Your response may satisfy the FTC’s concerns, but be prepared for the possibility of follow-up inquiries or a formal investigation. Know your options if things escalate.

Dealing with an FTC allegation letter isn’t fun, but approaching it constructively can lead to positive changes. Focus on finding reasonable solutions, and you may even end up with healthier marketing practices.

References

[1] FTC Health Claims Guidance

[2] FTC Health Products Compliance Guidance

[3] FTC Warning Letters

[4] How to File an FTC Complaint

[5] FTC Health Data Privacy

[6] FTC Health Products Compliance Guidance PDF