# FDA WARNING_LETTER - Lesa Sverid - Unknown Date

Source: https://www.keypedia.com/records/warning_letter/lesa-sverid/76a063fc-afd7-456a-a417-cf4132b95c55

> FDA WARNING_LETTER for Lesa Sverid on Unknown Date. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Lesa Sverid
- Product Type: Drugs
- Office Name: Department of Health and Human Services
- Summary: The FDA and FTC issued a Warning Letter to Ms. Lesa Sverid regarding the marketing of products (O2xygen Force, DMSO Cream, DMSO Roll-on, DMSO Cream w/Aloe, and AlkaLife) on www.neveranoutbreak.com. The FDA determined these products are unapproved new drugs and misbranded.

Violations include:
- **Unapproved New Drugs:** Products are marketed with claims to prevent, treat, or cure herpes (HSV 1 and 2), making them drugs under 21 U.S.C. §§ 321(g)(1)(B) and (C). They are "new drugs" (21 U.S.C. § 321(p)) lacking FDA-approved New Drug Applications (NDAs), violating 21 U.S.C. §§ 331(d) and 355(a).
- **Misbranding:**
    - **Lack of Adequate Directions for Use:** Genital herpes is not amenable to self-treatment, so adequate directions for laypersons cannot be provided, violating 21 U.S.C. § 352(f)(1).
    - **Dangerous to Health:** Claims for prevention/cure of genital herpes may lead consumers to delay appropriate medical treatment, making products dangerous to health and misbranded under 21 U.S.C. § 352(j).

## Related Officers

- [Associate Director](https://www.keypedia.com/people/mary-k-engle/9426dfba-028c-4d3a-bb62-7bdea653e6bc)
- [Former FDA Deputy Commissioner](https://www.keypedia.com/people/deborah-m-autor/b16e4745-566a-4102-ae98-d314ad1b61f5)
- [District Director](https://www.keypedia.com/people/mutahar-shamsi/f1ed0c75-3167-41cb-a918-130aa6d0fb07)

Company: https://www.keypedia.com/companies/lesa-sverid/ac906efd-2866-49b5-8916-a8577201b73d

Office: https://www.keypedia.com/offices/department-of-health-and-human-services/cecfcda4-4afa-4a1f-a7b7-a020b79f9861