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FDA Press Releases

FDA cautions consumers about Estrella Family Creamery cheeses

The U.S. Food and Drug Administration is warning consumers to discard cheeses from Estrella Family Creamery of Montesano, Wash., because they may be contaminated with Listeria monocytogenes. Environmental samples and one product sample collected by the FDA during an August 2010 inspection at the facility have tested positive for L. mono.

FDA seeks court order against Michigan dairy

The U.S. Department of Justice, on behalf of the U.S. Food and Drug Administration, has filed a complaint for permanent injunction against Scenic View Dairy of Hamilton, Mich., its president, and three of its managers alleging that they sold dairy cows for human consumption that contained illegal drug residues in edible tissues.

FDA launches new organizational performance management system

The U.S. Food and Drug Administration today launched an innovative performance management system designed to advance the President’s commitment to transparency, public participation, and collaboration in the work of government.

FDA Warns Consumers to Avoid TimeOut Capsules

The U.S. Food and Drug Administration is warning consumers not to take TimeOut Capsules because it contains an active drug ingredient that can dangerously lower blood pressure. The product is marketed as a dietary supplement for sexual enhancement.

FDA releases guidance on federal menu labeling requirements

The U.S. Food and Drug Administration today released two documents that outline steps to help chain restaurants comply with new federal nutrition labeling requirements.

FDA Warns of Possible Dangers from Portable Foot-Tanning Device

The U.S. Food and Drug Administration is warning consumers about the risk of ultraviolet radiation overdose with the Tootsie Tanner portable foot tanning device.

Study: Presence of murine leukemia virus found in CFS Patients, others

Researchers have found murine leukemia viruses (MLV) in blood samples collected from patients diagnosed with chronic fatigue syndrome (CFS) and some healthy blood donors, according to a study published online today by the scientific journal Proceedings of the National Academy of Sciences (PNAS).

Urgent Nationwide Egg Recall

The current recall of eggs in their shells, or “shell eggs,” is part of an ongoing and intensive investigation by local, state, and federal officials into the cause of recent cases of Salmonella Enteritidis.

Urgent Nationwide Frozen Mamey Fruit Products Recall

An investigation by the CDC and state partners showed an epidemiologic link between an ongoing outbreak of Salmonella Typhi and frozen mamey fruit products sold under the La Nuestra brand by Montalvan Sales Inc. Ontario, Calif, and under the Goya brand by Goya Foods Inc. Secaucus, New Jersey.

U.S. Marshals seize food from rodent-infested Ga. warehouse

U.S. Marshals, acting under a court order sought by the U.S. Food and Drug Administration, today seized packaged food products from a rodent-infested warehouse in Athens, Ga. A variety of products, including crackers, cookies and potato chips, were intended for sale to jails and prisons throughout the southeastern United States.

FDA Proposes Withdrawal of Low Blood Pressure Drug

The U.S. Food and Drug Administration today proposed to withdraw approval of the drug midodrine hydrochloride, used to treat the low blood pressure condition orthostatic hypotension, because required post-approval studies that verify the clinical benefit of the drug have not been done.

FDA approves ella™ tablets for prescription emergency contraception

The U.S. Food and Drug Administration today approved ella™ (ulipristal acetate) tablets for emergency contraception. The prescription-only product prevents pregnancy when taken orally within 120 hours (five days) after a contraceptive failure or unprotected intercourse. It is not intended for routine use as a contraceptive.

FDA: Aseptic Meningitis Risk with Use of Seizure Drug Lamictal

The U.S. Food and Drug Administration today warned that the drug Lamictal (lamotrigine), approved to treat seizures and bipolar disorder, can cause aseptic meningitis, an inflammation of the protective membranes (meninges) that cover the brain and spinal cord not caused by bacterial infection.

FDA: Salmonella risk from frozen rodents fed to reptiles

The U.S. Food and Drug Administration is warning U.S. and international customers who may have purchased frozen mice, rats and chicks from Biggers and Callaham LLC, dba/MiceDirect.com, that these products, which are used as food for reptiles, have the potential to be contaminated with Salmonella.

FDA Seeks Injunction Against Colorado Manufacturer of Cultured Cell Product

The U.S. Food and Drug Administration is seeking an injunction in federal court against Regenerative Sciences LLC, of Broomfield, Colo., citing violations of current good manufacturing practice (cGMP) that cause its cultured cell product to be adulterated. The product is also misbranded due to the lack of adequate directions for use and the failure to bear the “Rx only” symbol.

FDA Issues Assessments of the 510(k) Program and Use of Science in Decision-Making

The U.S. Food and Drug Administration today issued two comprehensive evaluations containing recommendations that address three key objectives of the agency’s public health mission as it relates to medical devices – foster device innovation, create a more predictable regulatory environment, and enhance device safety.

Statement by Margaret A. Hamburg, Commissioner of Food and Drugs on the Reopening of Florida State Waters to Commercial Fishing

We are pleased to be able to support the state of Florida as it reopens state waters off Pensacola to commercial fishing. Through close coordination with our state and federal partners, we are confident all appropriate steps have been taken to ensure that seafood harvested from the waters being opened today is safe and that Gulf seafood lovers everywhere can be confident eating and enjoying the fish that will be coming out of this area.

Statement by Margaret A. Hamburg, Commissioner of Food and Drugs, on the Reopening of Some Mississippi State Waters to Commercial Fishing

We are pleased to be able to support the state of Mississippi as it reopens state waters in the Mississippi Sound, from the mainland to the barrier islands, to commercial fishing. Through close coordination with our state and federal partners, we are confident all appropriate steps have been taken to ensure that seafood harvested from the waters being opened today is safe and that Gulf seafood lovers everywhere can be confident eating and enjoying the fish and shrimp that will be coming out of this area.”

United States Seeks Permanent Injunction Against New York Food Processor

The U.S. Department of Justice, in an action initiated by the U.S. Food and Drug Administration, is seeking a permanent injunction against NY Gourmet Salads, Inc., a processor of ready-to-eat deli salads, seafood salads, and cream cheeses in Brooklyn, N.Y., and Leonard F. Spada, the company's president. (HR)

FDA Warns Consumers of Serious Harm from Drinking Miracle Mineral Solution (MMS)

The U.S. Food and Drug Administration is warning consumers not to take Miracle Mineral Solution, an oral liquid also known as “Miracle Mineral Supplement” or “MMS.” The product, when used as directed, produces an industrial bleach that can cause serious harm to health.

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