Food and Drug Administration

Federal Register: Guidance for Industry and Food and Drug Administration Staff; In Vitro Diagnostic 2009 H1N1 Tests for Use in the 2009 H1N1 Emergency; Availability

Food and Drug Adminstration (FDA): CDRHNew (Free subscription) | 06/11/2009

FDA is issuing this guidance to inform industry and agency staff of its recommendations for the type of information and data FDA believes needs to be included in an Emergency Use Authorization Request (EUA) for in vitro diagnostic (IVD) devices intended..

What you need to know about H1N1

The Known Causes of Seizures (Free subscription) | 6 hours ago

Getting infected with the H1N1 virus that causes swine flu is a real possibility since the virus is continuing to spread and there's still not enough vaccine to go around. Being informed, though, can help you reduce your risk. Here's what you need to know to protect yourself and your family. 1. Pregnant women need one shot; young kids, two. Initial results from clinical trials show that pregnant women...

GlaxoSmithKline and XenoPort Announce Extension of GSK1838262 (XP13512) FDA Review Date to February 9, 2010

The Earth Times Online Newspaper (Free subscription) | yesterday

LONDON & RESEARCH TRIANGLE PARK, N.C. & SANTA CLARA, Calif. - GlaxoSmithKline (NYSE: GSK) and XenoPort, Inc. (Nasdaq: XNPT) today announced that the U.S. Food and Drug Administration (FDA) has extended the original Prescription Drug User Fee Act (PDUFA) goal date for its review of th

FDA warns against erectile dysfunction supplement

Booster Shots (Free subscription) | 06/11/2009

The Food and Drug Administration is warning consumers that Stiff Nights, a "dietary supplement" used to promote erections, contains an illegal drug and is potentially dangerous. Following a complaint, the FDA investigated the product and found that it contains sulfoaildenafil,...

• FDA: Dangerous sexual enhancement booster - Joseph Kim, MD, MPH

Scientific fraud: ruminations on duplicity and its consequences

RenewAmerica columns (Free subscription) | 06/11/2009

(Judie Brown) - Over the past nearly 16 years, I have learned an awful lot about certain subjects that were never high on my hit parade before getting involved in the pro-life movement. But since wonders never cease, this process of being educated and immediately horrified continues. To put this in the proper perspective, let's just say that when I first learned that the U.S. Food and Drug Administration...

FDA warns Web companies not to sell flavored cigs

Daily Advance - Business (Free subscription) | 06/11/2009

RICHMOND, Va. — The Food and Drug Administration said Friday that it has warned several compan...

Jelly bean recall: Jelly Belly says its labels left off an ingredient people are allergic to

WalletPop Blog (Free subscription) | 06/11/2009

Filed under: Food , Recalls , Consumer Ally For people with peanut allergies, beware these innocent-looking jelly beans. Jelly Belly is recalling 7.5-ounce cylinders of 49 Flavors Jelly Belly jelly beans, the U.S. Food and Drug Administration said . The label does not mention that the ingredients include peanut butter and peanut flour. "People who have an allergy to peanuts or a severe sensitivity...

Food Recalls There’s Peanut Butter in Jelly Bellys?

DadTalk (Free subscription) | 06/11/2009

While I don’t go after every Food and Drug Administration recall, this one caught my attention: The Jelly Belly Candy Company is warning that they left off peanut butter from one of their package labels. Who would have though there was real peanut butter in any of the Jelly Belly products? I thought they were 100 percent artificial! The recall, by the way, is for the 49 Flavors of Jelly Belly...

FDA warns Web companies not to sell flavored cigs

Rocky Mount Telegram - Business (Free subscription) | 06/11/2009

RICHMOND, Va. — The Food and Drug Administration said Friday that it has warned several compan...

Dogs snacks recalled by PetSmart due to salmonella fears

WalletPop Blog (Free subscription) | 06/11/2009

Filed under: Recalls , Consumer Ally PetSmart stores are warning dog owners to protect their pooches from getting salmonella from some treats sold at its stores, the U.S. Food and Drug Administration said . Two types of Dentley beef hooves sold between Oct. 2 and Nov. 3 are being recalled over fears they could be contaminated with the bacteria. They are: Dentley's Bulk Cattle Hoof UPC# 73725703323...

FDA and FSIS to improve food safety

Joseph Kim, MD, MPH (Free subscription) | 06/11/2009

FDA NEWS RELEASE: For Immediate Release: Nov. 5, 2009 Media Inquiries: Michael Herndon, 301-796-4673 , michael.herndon@fda.hhs.gov Neil Gaffney, 202-720-9113 , neil.gaffney@fsis.usda.gov Consumer Inquiries: 888-INFO-FDA FDA and FSIS Collaborate To Improve Tracing of Unsafe Food Products The Goal is to Prevent or Mitigate Foodborne Illness A joint public meeting focused on improving the system for tracing...

FDA Warns Companies against Marketing Illegal Flavored Cigarettes

Food and Drug Administration (Free subscription) | 06/11/2009

The U.S. Food and Drug Administration is enforcing the flavored cigarette ban provision of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) by issuing several warning letters to companies continuing to sell illegal flavored cigarettes to consumers in the United States through their Web sites.

FDA Issues Salmonella Warning About Pet Treats

North Country Gazette (Free subscription) | 06/11/2009

The U.S. Food and Drug Administration is issuing a health alert to warn consumers not to use Pig Ears and Beef Hooves pet treats manufactured by Pet Carousel because the products may be contaminated with Salmonella. The products were distributed nationwide in both bulk and retail packaging for sale in pet food and retail chain stores. [...]

• Dog Treat Warning For Pig Ears and Beef Hooves, Nov 2009 - Whole Food And More
• FDA Health Alert for Certain Pet Treats Made by Pet Carousel - Food and Drug Administration
• See the 6 articles on the same subject

Stiff Nights No More

Terra Sigillata (Free subscription) | 06/11/2009

I should probably create a new blogpost category just for erectile dysfunction dietary supplements adulterated with authentic or synthetic analogs of prescription phosphodiesterase-5 (PDE5) inhibitors (e.g., Viagra, Cialis). However, FDA has already created a page for this earlier this year after dozens of companies have been identified as putting real drugs into their erectile dysfunction products....

F.D.A. Fighting False Online Claims About Swine Flu Treatments

Tuscaloosanews.com (Free subscription) | 06/11/2009

LESLIE WAYNE The Food and Drug Administration has identified 140 different dubious products sold online and has sent letters to 75 manufacturers.

• F.D.A. Fighting False Online Claims About Swine Flu Treatments - New York Times

Tobacco Marketing Helps Recruit New Smokers

money | 12/08/2009

The Food and Drug Administration documented an intent and effect of advertising for cigarettes in its proposed assertion of jurisdiction over these products and its proposed rule. In a summary statement, the agency commented: Have you ever ordered custom written essays ? [T]he preponderance of quantitative and qualitative studies of cigarette advertising suggests: (1) A causal relationship between...

Salmonella recall on brands expanded

kellya | 17/04/2009

The federal Food and Drug Administration has announced an expanded recall of Uncle Chen and Lian How brand products that may be contaminated with salmonella. The voluntary recall now includes sauces, oils and oil blends, in addition to dry spices sold under the Uncle Chen and Lian How brands.