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# Court Approves Regeneca Worldwide Consent Decree
- URL: https://www.fdaweb.com/court-approves-regeneca-worldwide-consent-decree/
- Published: 2017-02-09T12:00:00.000Z
- Updated: 2026-09-14T22:05:47.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137940

A California federal court has approved a consent decree sought by FDA with dietary supplement distributor Regeneca Worldwide, requiring it to stop selling its products, which were found to contain unsafe ingredients, including 1,3-dimethylamylamine (DMAA). An FDA [news release](http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm540858.htm?ref=fdaweb.com) says that DMAA is an amphetamine derivative that has been widely used in sports supplements sold in the U.S. Although it was at one time approved as a drug for nasal congestion, the release says, no medical use of DMAA is recognized today.

FDA issued an 8/2012 Warning Letter to Regeneca for marketing a dietary supplement containing DMAA. The agency says that despite assurances that Regeneca was correcting violations noted in the Warning Letter, it continued to distribute a dietary supplement that was found to contain DMAA.

The consent decree prohibits the company from marketing unapproved new drugs and adulterated and misbranded dietary supplements. Before Regeneca can resume operations, it must, among other things, hire good manufacturing practice and labeling experts, implement procedures to comply with good manufacturing practice and labeling requirements, and receive written permission from FDA to resume operations. The decree also requires the company to destroy all remaining products.