Archive for the ‘Food Safety News’ category

Shirley’s Cookie Company In. Issues Allergy Alert on Undeclared Peanuts in "Chocolate Whoopie Pie"

October 24, 2018

Shirley’s Cookie Company Inc. of Claysburg, PA, is recalling its 16 ounce packages of “Chocolate Whoopie Pie” because they may contain undeclared peanuts. People who have allergies to peanuts run the risk of serious or life-threatening allergic reaction if they consume these products. Read The Complete Story!

FDA permits marketing of a diagnostic test to aid in the determination of menopausal status

October 24, 2018

FDA permits marketing of a diagnostic test to aid in the determination of menopausal status

Statement from FDA Commissioner Scott Gottlieb, M.D., on how new regulatory authorities will assist the agency in more forcefully addressing opioid crisis; included as part of the newly enacted Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act

October 24, 2018

The SUPPORT Act grants FDA additional authorities to meaningfully advance efforts to combat the crisis of opioid addiction plaguing our nation.

FDA approves new drug to treat influenza

October 24, 2018

FDA approved Xofluza (baloxavir marboxil) to treat acute uncomplicated flu in patients 12 years old and older who have been symptomatic for less than 48 hours.

Federal judge enters consent decree against Tennessee over-the-counter drug manufacturer

October 23, 2018

A federal court orders a Tennessee-based company to stop selling over-the-counter (OTC) drug products

FDA launches global operation to crack down on websites selling illegal, potentially dangerous drugs; including opioids

October 23, 2018

FDA warns website networks as part of global crack down for selling illegal pharmaceuticals

Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s efforts to advance new ways to increase the availability of naloxone as one means for reducing opioid overdose deaths

October 23, 2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s efforts to advance new ways to increase the availability of naloxone as one means for reducing opioid overdose deaths

Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s ongoing commitment to improving efficiency, transparency of tobacco product application review process as part of FDA’s comprehensive framework to reduce tobacco-related disease and death

October 22, 2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s ongoing commitment to improving efficiency, transparency of tobacco product application review process as part of FDA’s comprehensive framework to reduce tobacco-related disease and death.

Statement by FDA Commissioner Scott Gottlieb, M.D., on FDA’s new steps to help produce farmers, processors more effectively comply with food safety requirements

October 19, 2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s new steps to help produce farmers, fresh-cut produce processors more effectively comply with food safety requirements

Trump Administration Launches “Winning on Reducing Food Waste” Initiative

October 18, 2018

The U.S. Department of Agriculture (USDA), the U.S. Environmental Protection Agency (EPA), and the U.S. Food and Drug Administration (FDA) today announced the signing of a joint agency formal agreement under the “Winning on Reducing Food Waste” initiative.

FDA and DHS increase coordination of responses to medical device cybersecurity threats under new partnership; a part of the two agencies’ broader effort to protect patient safety

October 16, 2018

FDA and DHS announce partnership to address medical device cybersecurity threats

Statement by FDA Commissioner Scott Gottlieb, M.D., on FDA’s new steps to modernize drug development, improve efficiency and promote innovation of targeted therapies

October 15, 2018

FDA issues two guidance documents to provide drug developers greater clarity and direction as they pursue the next generation of therapies and treatments for patients.

FDA advances investigation into whether more than 40 e-cigarette products are being illegally marketed and outside agency’s compliance policy

October 12, 2018

FDA advances investigation into whether more than 40 e-cigarette products are being illegally marketed and outside agency’s compliance policy

FDA approves new DNA-based test to determine blood compatibility

October 11, 2018

FDA approves new DNA-based test to determine blood compatibility.Test is first of this type approved to report genotypes as final results

Voluntary Recall Issued for Sweet Me Creamery Brookie Dough Ice Cream that may Contain an Undeclared Peanut Allergen

October 10, 2018

Kemps of St. Paul, Minn., is voluntarily recalling Sweet Me Creamery Brookie Dough ice cream, individual pints and pint four-packs, because it may contain an undeclared peanut allergen. Individuals who have an allergy or severe sensitivity to peanuts run the risk of a serious or life-threatening allergic reaction if they consume these products. Read The […]

Bazzini LLC Recalls Certain Pistachio Products Because of Possible Health Risk

October 10, 2018

BazziniI LLC of Allentown, PA out of an abundance of caution, is recalling 4,000 pounds of Roasted and Salted Colossal Natural, Super Colossal Natural and Rams Head Natural in Shell Pistachios received from one of its suppliers because it has the potential to be contaminated with Salmonella. NO OTHER BAZZINI PISTACHIOS OR BAZZINI PRODUCTS ARE […]

Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to advance the development of generic copies of complex drugs to improve patient access to medicines

October 9, 2018

FDA issued a new series of guidance documents that will advance the development of generic transdermal and topical delivery systems

FDA approves expanded use of Gardasil 9 to include individuals 27 through 45 years old

October 5, 2018

FDA approves expanded use of Gardasil 9 to include individuals 27 through 45 years old

FDA allows marketing of first self-fitting hearing aid controlled by the user

October 5, 2018

FDA allows marketing of a new device, the Bose Hearing Aid, intended to amplify sounds for individuals 18 years or older with perceived mild to moderate hearing impairment (hearing loss). This is the first hearing aid authorized for marketing by the FDA that enables the user to fit, program and control the hearing aid on […]

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