FDA WARNING_LETTER - Lesa Sverid

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).