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U.S. Department of Health and Human Services

Safety

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True Man

Audience: Consumers, healthcare professionals

[UPDATE 11/21/2007] American True Man Health Inc., expanded its recall of dietary supplement products to include Energy Max, Energy Supplement Men's Formula with the expiration date up to and including December 2010.

[UPDATE 11/05/2007] FDA has requested a recall of True Man Sexual Energy Nutrient Capsules and Energy Max Energy Supplement Men's Formula Capsules, both illegal drug products that contain potentially harmful, undeclared ingredients. This recall request comes as a result of the company previously failing to notify all of their consignees, and involves True Man Sexual Energy packaged in blister pack cartons of 10 capsules and Energy Max packaged in blister pack cartons of 20 capsules.

[Posted 05/10/2007] FDA informed consumers and healthcare professionals regarding the dangers associated with the purchase or use of True Man or Energy Max products promoted and sold as dietary supplements throughout the United States. Both products, promoted as sexual enhancement products and as treatment for erectile dysfunction (ED), are illegal drug products that contain potentially harmful, undeclared ingredients. The undeclared ingredients may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Both products contain either a thione analog of sildenafil, the active ingredient in Viagra, or a piperadino analog of vardenafil, the active ingredient in Levitra. Both Viagra and Levitra are FDA approved products for the treatment of ED. FDA has not approved True Man and Energy Max, therefore, the safety and effectiveness of these products are unknown. Consumers should discontinue use of these products and consult their healthcare professional about approved treatments for ED.

[November 16, 2007 - Firm Press Release - FDA]
[November 02, 2007 - News Release - FDA]
[May 10, 2007 - News Release - FDA]