FDA WARNING_LETTER - Immuneglory.com

The FDA and FTC issued a Warning Letter to Arenvy Laboratories, Inc. following a review of their website, www.immuneglory.com, concerning the marketing of ImmuneGlory products. The FDA determined that ImmuneGlory products are unapproved new drugs, violating sections 301(d) and 505(a) of the Federal Food, Drug, and Cosmetic Act, as they are not generally recognized as safe and effective for their labeled uses, which include treating and preventing herpes and cold sores. The products are also misbranded under section 502(j) because they are dangerous to health when used as labeled, potentially causing consumers to delay appropriate medical treatment. Furthermore, the labeling fails to provide adequate directions for use for conditions requiring professional supervision, leading to misbranding under section 502(f)(1). The introduction of these unapproved and misbranded drugs into interstate commerce violates sections 301(a) and (d). Specifically, orally administered products promoted for cold sores are considered new drugs and misbranded per 21 CFR § 310.537(b) and section 502. The firm must promptly correct these violations, notify the FDA within fifteen working days of corrective actions, and address distributed products. The FTC also requires substantiation of claims with competent scientific evidence, warning of potential legal action including injunctions and consumer repayment.