Adulterated Hi-Tech Stamina-Rx Recalled

Supplement company Hi-Tech Pharmaceuticals is recalling all lots of its Stamina-Rx product as a result of recent testing by the FDA that determined the presence of undeclared benzamidenafil, a prescription drug used for treating ED (erectile dysfunction).

Although Stamina-Rx was marketed as a dietary supplement, under DSHEA, the presence of a prescription drug makes them adulterated products.

In addition, the FDA sent a recent letter to Hi-Tech informing Hi-Tech that the marketing of the products online and in product labeling positioned the products as unapproved new drugs.

Seems the FDA has a number of supplement companies on their radar screens which in the long run could turn out to be a positive for the dietary supplement industry if improved quality controls and safety regulations become more commonplace.

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Source: FDA

FDA Raids LG Sciences and Seizes Supplements Valued at $1.3 Million

The U.S. Food and Drug Administration has come to an agreement with LG Sciences LLC which will forfeit $1.3 million in dietary supplements that contain an unapproved food additive.

Earlier, U.S. Marshals seized over 23,300 bottles of "body-building" supplements marketed as "Methyl

1-D," "Methyl 1-D XL," and "Formadrol Extreme XL." Each product contains substances that rhe FDA has no scientific information on, and cannot determine whether they represent a hazard to consumers.

"The court order is the result of efforts by the federal government to protect consumers from products for which there is inadequate information to assure that they do not present a significant or unreasonable risk of illness or injury," FDA acting Associate Commissioner for Regulatory Affairs Michael Chappell explained. "It shows that the agency is prepared to use the necessary legal means to keep such products out of the marketplace."

According to FDA laboratory tests, the condemned Methyl 1-D and Methyl 1-D XL contained 1,4,6-androstatriene-3,17-dione, also known as "ATD" or 1,4,6-etioallocholan-dione. The condemned Formadrol Extreme XL contained ATD and 3,6,17-androstenetrione (also known as "6-OXO").

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