FDA IHCTOA Letter

What does IHCTOA mean?

What does IHCTOA mean?

FDA IHCTOA Letter is an acronym for It Has Come to Our Attention Letter, which is an early alert that something may be wrong. Typically, we talk about FDA Warning Letters, which are a precursor to formal enforcement actions by the Agency. An FDA IHCTOA Letter, however, is a private letter (i.e., not published on FDA’s website but remains subject to disclosure pursuant to FOIA request) that provides a critical opportunity to avoid an FDA Warning Letter.

30-Days

Most FDA IHCTOA Letters provide 30-days to respond. This is more than the 15-days provided to respond to a Warning Letter or Form 483 or the 7-days required to respond to a Notice of Action when importing. It’s important not to rush a response and use the time wisely by reviewing claims, confirming registrations or classifications, and verifying what the regulations permit.

CDRH

In certain situations, CDRH may become aware a company may be promoting a medical device product in a way that potentially violates the Federal Food, Drug, and Cosmetic Act. CDRH issues an IHCTOA Letter to the company as an early communication to gather additional information and provide the company to respond with evidence of compliance or corrective actions.

CTP

In 2019 FDA CTP used the IHCTOA Letter to verify compliance with the Deeming Regulation. In particular, FDA sought evidence of when a tobacco product entered the market. The FDA took the extra step of publishing these letters, such as this example.

IHCTOA Response Tips

When responding to the FDA it’s important to read the letter carefully and respond in a timely and professional manner. Be sure to clearly understand what FDA is asking for and respond with the specific information needed. Don’t be afraid to take responsibility, such as acknowledging claims that were problematic and providing proof of revisions. And always, if in doubt consult with an expert.

How to Address Broader Compliance Risks After an IHCTOA Letter 

Receiving an IHCTOA Letter gives a company an important opportunity to evaluate FDA’s concerns before the matter potentially escalates. An inadequate response may increase the risk of more formal actions, including FDA Warning Letters. For manufacturers, we recommend reviewing whether the issue extends beyond the specific product or claim identified by the agency. This may include promotional statements involving medical devices or marketing practices for tobacco and e-cigarette products. 

For device companies, that review may also involve confirming whether current claims remain within the scope of an existing clearance or whether changes require navigating FDA 510(k) submission requirements. Addressing related concerns early can strengthen the overall response. 

We help companies review claims, registrations, supporting records, and corrective actions before responding to FDA. Our regulatory guidance and enforcement defense focuses on developing a response that directly addresses the agency’s concerns while documenting meaningful corrective measures. If significant compliance problems continue, FDA may pursue stronger enforcement remedies, including consent decrees and DOJ injunctions. A well-supported response can help demonstrate that identified issues are being taken seriously. 

Need Help Responding to an FDA IHCTOA Letter? 

Our attorneys assist regulated companies with evaluating FDA concerns, preparing responses, and implementing corrective strategies. We also help determine whether similar compliance issues may exist elsewhere in the business. Each response should reflect the company’s specific products, claims, and regulatory history. If you have a company facing a complex IHCTOA matter, reach out to us, and our FDA regulatory attorneys will provide you with the right guidance for your case.