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FDA Approval
 
 
    FDA Requests Recall of Xiadafil VIP Tabs
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    (HealthNewsDigest.com) - The U.S. Food and Drug Administration today requested that SEI Pharmaceuticals, of Miami, Fla., recall all Xiadafil VIP Tabs sold in 8 tablet bottles (Lot # 6K029) or blister cards of 2 tablets (Lot # 6K029-SEI) because these products contain a potentially harmful, undeclared ingredient that may dangerously affect a persons blood pressure and can cause other life-threatening side effects.

     

    FDA Warns Consumers Against Using Mommys Bliss Nipple Cream
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    (HealthNewsDigest.com) - The U.S. Food and Drug Administration is warning consumers not to use or purchase Mommys Bliss Nipple Cream, marketed by MOM Enterprises Inc. The product, promoted to nursing mothers to help soothe and heal dry or cracked nipples, contains potentially harmful ingredients that may cause respiratory distress or vomiting and diarrhea in infants.

     

    FDA Shuts Down Seafood Processing Company, Requires Products Be Recalled
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    (HealthNewsDigest.com) - The company, under a different name, had manufactured dried smoked catfish steaks and other smoked seafood products and had been subject to a consent decree of permanent injunction requiring it to develop and implement an adequate Hazard Analysis and Critical Control Point (HACCP) plan for its fish and fishery products. The firm had not developed this plan. The company cannot restart manufacturing until they have implemented an FDA-approved HACCP plan.

     

    FDA Takes Action against Cream Cheese Companies, Executives
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    (HealthNewsDigest.com) - The U.S. Food and Drug Administration today announced the shut down of cream cheese and seafood operations at Lifeway Foods, Inc. and its subsidiary, LFI Enterprises, Inc., both Illinois companies, until they are found compliant with food-safety laws.

     

    FDA Embarks on Major Hiring Initiative for its Public Health Mission
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    (HealthNewsDigest.com) - Biologists, chemists, medical officers, mathematical statisticians and investigators are among the experts in demand as the U.S. Food and Drug Administration begins a multi-year hiring initiative.

     

    FDA Orders Pet Food Maker to Obtain Emergency Operating Permit
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    (HealthNewsDigest.com) - The U.S. Food and Drug Administration issued an order requiring that Evangers Dog & Cat Food Co., Inc., in Wheeling, Ill., obtain an emergency permit from the FDA before its canned pet food products enter interstate commerce.

     

    FDA Proposes Recommendations for Two Animal Drug Funding Programs
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    (HealthNewsDigest.com) - The U.S. Food and Drug Administration today delivered recommendations to Congress for two programs that provide funding for the review of pioneer and generic animal drugs.

     

    FDA Strengthens Safeguards for Consumers of Beef Issues Regulation on Animal Feeds with Added Safeguards Against BSE
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    (HealthNewsDigest.com) - The U.S. Food and Drug Administration today issued a final regulation barring certain cattle materials from all animal feed, including pet food. The final rule further protects animals and consumers against bovine spongiform encephalopathy (BSE, also known as "mad cow disease")

     

    FDA Approves VYVANSE (lisdexamfetamine dimesylate), the First and Only Once-Daily Prodrug Stimulant to Treat ADHD in Adults
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    (HealthNewsDigest.com) - Basingstoke, U.K. and Philadelphia, PA April 23, 2008 Shire plc (LSE: SHP, NASDAQ: SHPGY,), the global specialty biopharmaceutical company, today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for VYVANSE (lisdexamfetamine dimesylate), for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults.

     

    Salmonella Illnesses in Multiple States May be Linked to Recently Recalled Cereal
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    (HealthNewsDigest.com) - The Food and Drug Administration (FDA) today announced that at least 23 people in 14 states have been diagnosed with salmonellosis that was caused by the same strain of Salmonella that was found in the recently recalled unsweetened Puffed Rice and unsweetened Puffed Wheat Cereals produced by Malt-O-Meal.

     

    FDA Finds Hazardous Levels of Selenium in Samples of "Total Body Formula" and "Total Body Mega Formula"
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    (HealthNewsDigest.com) - 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.

     

    Federal Authorities Seize More Than $100,000 of Unapproved Drugs Marketed as natural supplements
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    (HealthNewsDigest.com) - 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, Natural 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.

     

    Federal Agents Seize Nearly $1.3 Million of Illegal Dietary Supplements
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    (HealthNewsDigest.com) - 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.

     

    Civil Penalties Sought Against Maker of Hearing Aid
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    (HealthNewsDigest.com) - The Food and Drug Administration (FDA) is seeking a $2.2 million penalty against a hearing aid manufacturer for violations of federal law. The violations may have exposed recipients of the devices to unnecessary health risks.

     

    FDA Warns Consumers about "Total Body Formula" and "Total Body Mega Formula"
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    (HealthNewsDigest.com) - The U.S. Food and Drug Administration is advising consumers not to purchase or consume Total Body Formula in the flavors of Tropical Orange and Peach Nectar, or Total Body Mega Formula in the Orange/Tangerine flavor. The liquid dietary supplement products may cause severe adverse reactions, including significant hair loss, muscle cramps, diarrhea, joint pain and fatigue.

     

 
 

 

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