Medolife Illegally Selling Unapproved New Drugs: FDA

FDA says its April review of Web sites maintained by Medolife Rx in Burbank, CA, determined that it markets several unapproved new drugs. A 4/19 Warning Letter says the products are concerning from a public health perspective because they claim to cure, mitigate, treat, or prevent serious and/or life-threatening conditions including cancer, HIV, and Covid-19.

The Warning Letter cites examples of claims made on the firm’s Web sites and says its drug products are not generally recognized as safe and effective for their uses and thus are legally considered to be new drugs.

Although the Medolife products are labeled as homeopathic, FDA says, homeopathic drug products are subject to the same statutory requirements as other drugs.

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