What happened
Original notice title
Ayuryoga, Inc. MARCS-CMS 628168, May 19, 2022
From the archived source record
The claims on your website and social media websites establish that your Kottakkal ayurvedic products are unapproved new drugs sold in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a) and 331(d). Unapproved New Drugs Based on a review of your websites, your Kottakkal ayurvedic products are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or function of the body. Conclusion This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. As such, the cited violations in this letter should not be viewed to apply solely to the specific products mentioned in this letter. This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction. Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. Food and Drug Administration, CDER/OC/Office of Unapproved Drugs and Labeling Compliance, by email to FDAADVISORY@fda.hhs.gov. Becker Director Office of Unapproved Drugs and Labeling Compliance Office of Compliance Center for Drug Evaluation and Research Food and Drug Administration 1 This webpage is also linked from a post on your LinkedIn social media website, which states “#Highbloodpressure does not have to be permanent: #Ayurveda has solutions for managing high blood pressure.
What the official notice says to do
Check the original notice for the instructions that apply to the named product, company, and affected lots.
Read the official notice →Status and source details
- Status recorded in the archive
- No closeout listed in FDA table
- Source checked
- Jul 16, 2026
- Record revision
- a54ebeafa52d
This is a dated record. Its current status may have changed since the source was captured. A record applies to its stated scope; it is not a safety rating for every product from a company.
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