# FDA WARNING_LETTER - Galyna / Ivan Podornikova - Unknown Date

Source: https://www.keypedia.com/records/warning_letter/galyna-ivan-podornikova/e4e3a621-13e1-4748-8f1a-8ded4bef3a1f

> FDA WARNING_LETTER for Galyna / Ivan Podornikova on Unknown Date. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Galyna / Ivan Podornikova
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: The FDA issued a Warning Letter after reviewing the company's websites, which offer unapproved and misbranded new drugs for sale to U.S. consumers, violating the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The violations include:
1.  **Unapproved New Drugs**: Products like "Viagra Professional," "Cialis Super Active," and "Female Viagra" are considered drugs under section 201(g) of the FD&C Act due to their intended use for disease treatment or affecting body structure/function. They are also new drugs under section 201(p) as they are not generally recognized as safe and effective. No approved applications under section 505 of the FD&C Act are in effect for these products, violating sections 505(a) and 301(d).
2.  **Misbranded Drugs**:
    *   The websites offer prescription drugs, including controlled substances, without requiring a prescription from a licensed practitioner, thus misbranding them under section 503(b)(1).
    *   These drugs are intended for conditions not amenable to self-diagnosis, and their labeling lacks adequate directions for safe use by a layman, misbranding them under section 502(f)(1). They are not exempt from this requirement under 21 C.F.R. § 201.115.
    *

## Related Officers

- [Michael M. Levy](https://www.keypedia.com/people/michael-m-levy/3e0fdd21-e691-406d-81cf-4fe2460a6309)
- [Galyna Podornikova](https://www.keypedia.com/people/galyna-podornikova/abd4850f-604c-4e60-a199-2b67b9b31cff)
- [Ivan Podornikova](https://www.keypedia.com/people/ivan-podornikova/b2b258bc-1ab0-4f7a-a557-5a198982e26e)

Company: https://www.keypedia.com/companies/galyna-ivan-podornikova/da41aa15-a52b-48d1-8429-2b394b29d7e3

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