Category Archives: FDA Enforcement Action

30 Apr

FDA Warning Letters demand “immediately cease distribution” of dietary supplements with BMPEA

On April 23, 2015 the U.S. Food and Drug Administration (FDA) issued warning letters to several dietary supplement companies distributing dietary supplements containing beta-methylphenethylamine (BMPEA), an ingredient widely used in weight loss,  energy, and exercise endurance supplements. Studies show that BMPEA can cause an accelerated and irregular heartbeat. These warning letters come over one year

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06 Apr

U.S. government sues food manufacturer after Listeria outbreak

On April 3, 2015, the U.S. government filed suit against Wholesome Soy Products of Chicago, to stop the company from distributing food products after an outbreak of Listeria was linked to the company’s mung bean and soybean sprouts, associated with several illnesses last summer. That same day, Wholesome Soy Products Inc. accepted a consent degree outlining conditions it

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16 Jan

Spa Owner Sentenced to Prison for Illegal Sylicone Injections

Elva Navarro, of Hidalgo,Texas,  has been sentenced to three years in federal prison to be immediately followed by one year of supervised release for violating the U.S. Food, Drug and Cosmetics Act by using an adulterated device. Court documents demonstrated that Navarro administered injections of liquid silicone into individuals who would frequent her facility – Bella

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08 Mar

FDA issues warning letter to makers of AeroShot “caffeine inhaler”

On March 5, 2012, The U.S. Food and Drug Administration (FDA) issued a warning letter to Breathable Foods Inc., makers of AeroShot1, for false or misleading statements in the labeling of their product, and told the company that the Agency has questions about the safety of the “caffeine inhaler.” The FDA also expressed concern about the

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31 Jan

FDA seeks permanent injunction against cheese manufacturer for failure to correct violations despite federal & state warnings

The U.S. Food and Drug Administration (FDA) has asked a federal court to prevent Mexicali Cheese, a New York cheese manufacturer, from continuing to operate because of a history of unsanitary conditions and producing cheese in a facility contaminated with Listeria monocytogenes bacteria. According to a complaint for permanent injunction filed by the U.S. Department

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