FDA Enforcement Action Archives - Experienced Health Care and FDA Attorneys

04 Oct

Florida Health Care Clinic license application submission on behalf of health care providers.

Florida Health Care Clinic license application submission on behalf of health care providers should be handled by experienced health care attorneys.

15 Jan

Is it the ENDS for flavored cartridge-based products?

The U.S. Food and Drug Administration (FDA) on January 2, 2020, issued a policy prioritizing enforcement against flavored e-cigarette products that are manufactured and marketed in a manner that appeal to minors because the are flavored or marketed to taste or look like popular cereals, juices, or candies. Since implementation of the FDA’s premarket authorization

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

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

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

21 Jan

FDA issues warning letter to dietary supplement for illegal drug claims and unapproved dietary ingredients

On December 31, 2013 the U.S. Food and Drug Administration (FDA) issued a warning letter to Star Scientific, Inc. covering two dietary supplement products bearing illegal drug claims and unapproved new dietary ingredients — Antabloc and CigRx The U.S. Food and Drug Administration (FDA) has warned Star Scientific that the therapeutic claims made in association

23 Jul

FDA issues Warning Letters against dietary supplement products making diabetes claims

The U.S. Food and Drug Administration (FDA) announced today that it “is taking action to remove from the market illegal products, including some labeled as dietary supplements, that claim to mitigate, treat, cure or prevent diabetes and related complications.” The FDA’s announcement comes just days after the agency issued Warning Letters to 15 foreign and

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

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

Category Archives: FDA Enforcement Action