FDA WARNING_LETTER - Butterfly Expressions LLC - July 01, 2020

On July 6, 2020, the FDA and FTC issued a Warning Letter to Butterfly Express regarding unapproved and misbranded products related to COVID-19. The agencies reviewed the company's websites (www.butterflyexpress.shop, www.butterflyexpressions.net) on June 22 and July 1, 2020, and its YouTube page (www.youtube.com/c/ButterflyExpressEssentialOils).

The FDA observed that Butterfly Express offers blessed waters, essential oils, hand sanitizers, homeopathic products, and tinctures for sale, with claims indicating they are intended to mitigate, prevent, treat, diagnose, or cure COVID-19. These products are deemed unapproved new drugs under 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). The introduction of these products into interstate commerce is prohibited by sections 301(a) and (d) (21 U.S.C. § 331(a) and (d)).

The letter emphasizes the public health emergency declared for COVID-19 and the urgent need to protect consumers from unapproved products. Butterfly Express is required to immediately cease selling these unapproved and unauthorized products for COVID-19-related uses