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# FDA: Economax’ Super Power Khan is Unapproved Drug
- URL: https://www.fdaweb.com/fda-economax-super-power-khan-is-unapproved-drug/
- Published: 2016-05-17T12:00:00.000Z
- Updated: 2026-09-14T21:03:31.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5135689

FDA’s New York District Office says that Super Power Khan, distributed as a dietary supplement by Economax, Flushing, NY, through a Web site, is an unapproved new drug that also is misbranded. A 5/6 [Warning Letter](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm499839.htm?ref=fdaweb.com) says that the agency confirmed through laboratory analysis that a sample of Super Power Khan contained the undeclared active ingredients sildenafil and hydroxyhomosildenafil, which are both phosphodiesertase type-5 inhibitors. Sildenafil is the active ingredient in Viagra and hydroxyhomosildenafil is a substance structurally similar to sildenafil, it says.

“Given that sildenafil was not marketed as a dietary supplement or as a food before Viagra was approved,” the letter says, “Super Power Khan, which contains sildenafil, is excluded from the definition of a dietary supplement.”

FDA says that Super Power Khan is an unapproved new drug because it is intended to prevent, treat, or cure disease conditions and/or affect the structure or function of the body. Labeling statement say its intended uses include to help men “suffering from erectile dysfunction, prostate problems, and premature ejaculation.” The product is legally a new drug because it is not generally recognized as safe and effective under the conditions prescribed, recommended, or suggested in its labeling. And it is misbranded because the labeling fails to bear adequate directions for use and because it contains undeclared active ingredients without adequate label warnings to protect users.

The company was told to notify FDA about the current status of its corrective actions and the specific steps taken to correct the noted violations, along with documentation of each action and a timetable for completion.