Alistrol FDA Warning Letter 2012: Historical Background and Corrective Actions

Alistrol FDA Warning Letter 2012: Historical Background and Corrective Actions

Company statement from CLE Holistic Health. This is not an FDA closeout letter or an FDA endorsement.

We understand that customers researching Alistrol may encounter an FDA warning letter issued in 2012. We believe it is important to address that history openly and explain the actions our company took.

What happened in 2012?

The FDA raised concerns relating to Alistrol and associated product labeling and online marketing claims. Following the warning letter, CLE Holistic Health reviewed the cited concerns and states that it corrected the relevant labeling and website marketing materials in 2012.

What is the status today?

According to CLE Holistic Health, the corrective actions described above were completed in 2012. This statement reflects the company's account of its actions; it does not mean that the FDA has issued a formal closeout letter or verified the current regulatory status of Alistrol.

Our ongoing commitment

We remain committed to accurate product information, responsible marketing and product quality. Customers and healthcare practitioners are encouraged to review current product labeling, ingredient information and any available product quality documentation when considering Alistrol.

Alistrol is marketed as a natural health product in Canada under Health Canada Natural Product Number (NPN) 80047013. A Canadian NPN is not FDA approval.

Questions?

For current product information or questions about this historical matter, please contact CLE Holistic Health through our website.

Steven Kalia
CLE Holistic Health
Company statement, October 2026