Food and Drug Administration
Press releases from FDA
- Last build:
- Sat, 12 Apr 2008 18:40:00 GMT
- Language:
- en-us
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- http://www.fda.gov/bbs/topics/news/rssPress.xml
RSS FEED IDEMS: Food and Drug Administration
- Salmonella Illnesses in Multiple States may be Linked to Recently Recalled Cereal
The recalled products were distributed nationally under the Malt-O-Meal brand name as well as under private label brands including Acme, America's Choice, Food Club, Giant, Hannaford, Jewel, Laura Lynn, Pathmark, Shaw's, ShopRite, Tops and Weis Quality. The cereals have "Best If Used By" dates from April 8, 2008 (coded as "APR0808") through March 18, 2009 (coded as "MAR1809").
Sat, 12 Apr 2008 18:40:00 GMT - FDA Finds Hazardous Levels of Selenium in Samples of "Total Body Formula" and"Total Body Mega Formula"
The U.S. Food and Drug Administration announced today that it has found hazardous levels of selenium in samples of certain flavors of the dietary supplement products "Total Body Formula" and "Total Body Mega Formula." The FDA has received 43 reports of persons from nine states who experienced serious adverse reactions using these products.
Wed, 09 Apr 2008 20:20:00 GMT - Federal Authorities Seize More Than $100,000 of Unapproved Drugs Marketed as "Natural Supplements"
At the request of the U.S. Food and Drug Administration, today U.S. Marshals seized more than 14,000 dosage units of Shangai Regular, Shangai Ultra, Super Shangai, Naturalë Super Plus, and Lady Shangai. Although labeled as natural supplements, the seized products were all marketed to treat erectile dysfunction (ED), impotency, and/or to provide sexual enhancement, which caused them to be drugs under the Federal Food, Drug, and Cosmetic Act.
Wed, 09 Apr 2008 17:14:00 GMT - FDA Appoints Dr. Frank M. Torti to Senior Leadership Position
Commissioner of Food and Drugs Andrew C. von Eschenbach, M.D. today announced the appointment of Frank M. Torti, M.D., M.P.H. as the FDA's Principal Deputy Commissioner and first Chief Scientist.
Wed, 09 Apr 2008 14:45:00 GMT - Federal Agents Seize Nearly $1.3 Million of Illegal Dietary Supplements
At the request of the U.S. Food and Drug Administration, on Wednesday U.S. Marshals seized more than $1,301,712 of dietary supplements from LG Sciences, LLC, of Brighton, Mich., because the products contain unapproved food additives and/or new dietary ingredients that cause the products to violate the law. Labeled as dietary supplements, the products are marketed for use by body builders.
Fri, 04 Apr 2008 20:14:00 GMT - FDA Approves New Vaccine to Prevent Gastroenteritis Caused by Rotavirus
The U.S. Food and Drug Administration today announced the approval of Rotarix, the second oral U.S. licensed vaccine for the prevention of rotavirus, an infection that causes gastroenteritis (vomiting and diarrhea) in infants and children. Rotarix is a liquid and given in a two-dose series to infants from 6 to 24 weeks of age.
Thu, 03 Apr 2008 23:00:00 GMT - FDA Seeks Civil Penalties from Calif. Device Maker
The U.S. Food and Drug Administration (FDA) today announced it is seeking a 2.2 million dollar penalty against a California hearing aid manufacturer for violations of federal law, including manufacturing standards violations and the failure to notify the FDA of a change in an outside supplier or vendor, which may have exposed recipients of the devices to unnecessary health risks.
Fri, 28 Mar 2008 19:19:00 GMT - FDA Warns Consumers about Total Body Formula and Total Body Mega Formula
The liquid dietary supplement products may cause severe adverse reactions, including significant hair loss, muscle cramps, diarrhea, joint pain and fatigue.
Thu, 27 Mar 2008 23:55:00 GMT - FDA Identifies First Steps in Requirements for Safety Plans for Certain Drugs and Biologics
The U.S. Food and Drug Administration has identified 25 drugs and biologic products that will be required to submit safety plans called Risk Evaluation and Mitigation Strategy (REMS), the FDA said in a Federal Register notice published today.
Thu, 27 Mar 2008 20:07:00 GMT - FDA Makes Recommendations on Medical Devices That Treat Blocked Heart Arteries
U.S. Food and Drug Administration Commissioner Andrew C. von Eschenbach today announced that the agency has issued draft guidelines to aid the development, testing and manufacture of coronary drug-eluting stents, devices used to treat blocked heart arteries.
Wed, 26 Mar 2008 16:55:00 GMT - FDA Warns Consumers Not to Use Blue Steel and Hero Products
These products are promoted and sold over the Internet for the treatment of erectile dysfunction (ED) and for sexual enhancement.
Tue, 25 Mar 2008 23:55:00 GMT - FDA Warns of Salmonella Risk with Cantaloupes from Agropecuaria Montelibano
The U.S. Food and Drug Administration has issued an import alert regarding entry of cantaloupe from Agropecuaria Montelibano, a Honduran grower and packer, because, based on current information, fruit from this company appears to be associated with a Salmonella Litchfield outbreak in the United States and Canada. The import alert advises FDA field offices that all cantaloupes shipped to the United States by this company are to be detained.
Sat, 22 Mar 2008 13:42:00 GMT - FDA Approves New Medical Adhesive to Treat Burn Patients
The U.S. Food and Drug Administration today approved a new medical adhesive (a fibrin sealant) called Artiss for use in attaching skin grafts onto burn patients.
Wed, 19 Mar 2008 21:01:00 GMT - FDA Takes Next Step in Establishing Overseas Presence
In an important development, the U.S. Food and Drug Administration has received approval from the U.S. State Department to establish eight full time permanent FDA positions at U.S. diplomatic posts in the People's Republic of China, pending authorization from the Chinese government.
Fri, 14 Mar 2008 23:00:00 GMT - FDA Issues Alert on Tussionex, a Long-Acting Prescription Cough Medicine
Containing Hydrocodone
The U.S. Food and Drug Administration issued an alert today on the safe and correct use of Tussionex Pennkinetic Extended-Release Suspension in response to numerous reports of adverse events--including death--associated with the misuse and inappropriate use of this potent cough medication.
Tue, 11 Mar 2008 18:05:00 GMT
