Botanical Be Selling Unapproved Drugs: FDA

FDA says its review of a Web site maintained by Botanical Be in El Paso, TX, found that the company is taking orders for several products labeled as dietary supplements that legally are considered to be misbranded, unapproved new drugs. A 12/21/2023 Warning Letter says the products contain undeclared diclofenac, the active ingredient in Voltaren.

The letter says diclofenac is a non-steroidal anti-inflammatory drug (NSAID) that may cause an increased risk of cardiovascular events and serious gastrointestinal damage. “This hidden drug ingredient may also interact with other medications and significantly increase the risk of adverse events, particularly when consumers use multiple NSAID-containing products,” FDA says.

Botanical Be was told to respond with a list of specific steps it has taken to correct the violations and prevent their recurrence, with documentation of the steps and a schedule for completing the corrections.