Naturista Store Markets Unapproved Drug: FDA

FDA says its review of a Web site maintained by the Naturista Store in Downey, CA, determined that the company is illegally marketing the Advance King product for sale in the U.S. A just-released 3/26 Warning Letter says Advance King is an unapproved new drug that is misbranded.

The agency says its laboratory analysis determined that the drug contains the undeclared active ingredients dexamethasone, diclofenac, and methocarbamol. It says Advance King is a drug that is intended to treat arthritis among other things and cannot be marketed legally as a dietary supplement.

FDA says it documented that the firm markets other products and reminds the Naturista Store that it is responsible for ensuring that its products do not contain undeclared or potentially harmful ingredients.

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