FDA WARNING_LETTER - Phoenix Biotechnology, Inc. - December 16, 2020

The FDA issued a Warning Letter to Phoenix Biotechnology, Inc. and Avila Herbals, LLC, following a December 2020 review of their websites and social media. The FDA observed that Avila Herbals, LLC's website, https://myoleander.com/, offers "Oleander 4X," a product labeled to contain oleander, for sale in the United States. This product is intended to mitigate, prevent, treat, diagnose, or cure COVID-19 and other conditions in people. Avila Herbals, LLC states it partnered with Phoenix Biotechnology to make "Oleander 4X," and the product label indicates it is manufactured by Avila Herbals, LLC for Phoenix Biotechnology, Inc.

The FDA determined that "Oleander 4X" is an unapproved new drug sold in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). The introduction or delivery for introduction of this product into interstate commerce is prohibited under section 301(d) of the FD&C Act, 21 U.S.C. 331(d). The FDA considers this product especially concerning due to its claims to treat serious and/or life-threatening conditions like COVID-19 during a public health emergency.

Examples of violative claims include statements on Phoenix Biotechnology's website about ole