# FDA WARNING_LETTER - Center for Wellness and Integrative Medicine - June 25, 2020

Source: https://www.keypedia.com/records/warning_letter/center-for-wellness-and-integrative-medicine/46763ae7-4461-41ff-909c-eb674aa61e8b

> FDA WARNING_LETTER for Center for Wellness and Integrative Medicine on June 25, 2020. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Center for Wellness and Integrative Medicine
- Inspection Date: 2020-06-25
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: On June 30, 2020, the FDA and FTC issued a Warning Letter to Dr. Tomy Arema regarding the sale of unapproved and misbranded products related to COVID-19 on their website, drtomyarema.com. The FDA reviewed the website on June 17 and June 25, 2020, identifying products like "COVID Supplement Protection Pack," Thymosin-Alpha, and Methylene Blue Capsules marketed with claims to mitigate, prevent, treat, diagnose, or cure COVID-19.

These products are deemed unapproved new drugs, violating section 505(a) of the FD&C Act (21 U.S.C. § 355(a)), and misbranded drugs under section 502 (21 U.S.C. § 352). Their introduction into interstate commerce is prohibited by sections 301(a) and (d) (21 U.S.C. § 331(a) and (d)). The letter emphasizes the ongoing public health emergency declared for COVID-19.

The FDA requires immediate action to cease the sale of these products and demands an email within 48 hours to COVID-19-Task-Force-CDER@fda.hhs.gov detailing corrective steps, recurrence prevention, and supporting documentation. Failure to comply may result in legal action, including

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Company: https://www.keypedia.com/companies/center-for-wellness-and-integrative-medicine/f75b561d-6c2c-4089-b53f-14ad15f69b04

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c