Archive for the ‘Food Safety News’ category

Dollar General Announces Voluntary Recall of Clover Valley® Iced Oatmeal Cookies Over Undeclared Milk and Tree Nuts

January 9, 2018

Dollar General Corporation announced a voluntary recall of its 12-ounce packages of Clover Valley® Iced Oatmeal Cookies with lot # L46217 30 with a best-by date of August 18, 2018 over concerns of undeclared milk and tree nuts. Consumers with a milk and/or nut allergy or sensitivity to these items should not consume these products […]

Statement by FDA Commissioner Scott Gottlieb, M.D., update on recovery efforts in Puerto Rico, and continued efforts to mitigate IV saline and amino acid drug shortages

January 4, 2018

Statement by FDA Commissioner Scott Gottlieb, M.D., update on recovery efforts in Puerto Rico, and continued efforts to mitigate IV saline and amino acid drug shortages

Statement from FDA Commissioner Scott Gottlieb, M.D. on FDA Food Safety Modernization Act enforcement discretion guidance

January 4, 2018

FDA announced today guidance outlining four key areas that it does not intend to enforce in the FDA Food Safety Modernization Act rules. The provisions relate to the “farm” definition, requirements related to written assurances from a manufacturer’s customers, requirements for importers of food contact substances, and requirements related to certain human food by-products for […]

FDA warns American CryoStem Corporation of significant deviations related to its unapproved stem cell product, Atcell

January 4, 2018

FDA warns American CryoStem Corporation of significant deviations related to its unapproved stem cell product

California Popsicle, Inc. Issues Allergy Alert on Undeclared Milk in Ice Bars

January 3, 2018

California Popsicle, Inc. dba Polly Ann Ice Cream of South San Francisco, CA is recalling ice bars, because it may contain undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products. Read The Complete Story!

Statement from FDA Commissioner Scott Gottlieb, M.D. on new steps to facilitate efficient generic drug review to enhance competition, promote access and lower drug prices

January 3, 2018

FDA today announced additional steps to encourage generic competition as part of our continued implementation of the Drug Competition Action Plan. FDA is releasing two documents that together will improve aspects of the submission and review of generic drug applications (known as Abbreviated New Drug Applications, or ANDAs).

FDA permits marketing of device to treat diabetic foot ulcers

December 28, 2017

FDA permits marketing of device to treat diabetic foot ulcers

Statement from FDA Commissioner Scott Gottlieb, M.D. on efforts to support more efficient and effective food recalls

December 26, 2017

FDA discusses the steps taken to improve the recall process, the HHS OIG report on recalls, and new policies being considered.

Fresh Pak Inc. Recalls Lot Specific Sliced Apple Products Because of Possible Health Risk

December 22, 2017

Fresh Pak Inc. of Detroit, MI is announcing a voluntary Lot specific recall of red/green apple slices. Jack Brown Produce, Inc. (supplier) requested Fresh Pak Inc. to perform a recall for the reason that they could have potentially been contaminated with Listeria monocytogenes, an organism that can cause serious and sometimes fatal infections in young […]

FDA updates the label of Tasigna to reflect that certain patients with a type of leukemia may be eligible to stop treatment after sustained response

December 22, 2017

FDA updates the label of Tasigna to reflect that certain patients with a type of leukemia may be eligible to stop treatment after sustained response

FDA clears stereotactic radiotherapy system for use in treating breast cancer

December 22, 2017

FDA clears stereotactic radiotherapy system for use in treating breast cancer

FDA approves drug to treat dangerously low blood pressure

December 21, 2017

The FDA today approved the new drug Giapreza (angiotensin II) injection for intravenous infusion to increase blood pressure in adults with septic or other distributive shock.

FDA approves novel gene therapy to treat patients with a rare form of inherited vision loss

December 19, 2017

FDA approves novel gene therapy to treat patients with a rare form of inherited vision loss

FDA proposes new, risk-based enforcement priorities to protect consumers from potentially harmful, unproven homeopathic drugs

December 18, 2017

Today, the U.S. Food and Drug Administration proposed a new, risk-based enforcement approach to drug products labeled as homeopathic. To protect consumers who choose to use homeopathic products, this proposed new approach would update the FDA’s existing policy to better address situations where homeopathic treatments are being marketed for serious diseases and/or conditions but where […]

Statement from FDA Commissioner Scott Gottlieb, M.D., on new FDA efforts to support more efficient development of targeted therapies

December 15, 2017

FDA issues two draft guidances that will provide medical product developers with greater clarity on the FDA’s recommendations for researching and developing the next generation of individualized therapies.

FDA launches new tool for sharing information that allows doctors to better manage antibiotic use; improve patient care

December 13, 2017

Today the FDA is announcing a new approach to get critical updates regarding antibiotics and antifungal drugs to health care professionals as part of an overall effort to combat antimicrobial resistance. The agency created a website that will provide direct and timely access to information about when bacterial or fungal infections are likely to respond […]

FDA approves first drug for Eosinophilic Granulomatosis with Polyangiitis, a rare disease formerly known as the Churg-Strauss Syndrome

December 12, 2017

FDA approves first drug for a rare autoimmune disease that causes an inflammation in the wall of blood vessels of the body. This is a new indication for a previously-approved drug.

FDA warns companies for promoting alternatives to street drugs

December 12, 2017

The FDA today posted a warning letter to the marketers and distributors of Legal Lean Syrup, a drink, and Coco Loko, a “snortable” chocolate powder, for selling unapproved new drugs and misbranded drugs.

FDA approves Admelog, the first short-acting "follow-on" insulin product to treat diabetes

December 11, 2017

The FDA today approved Admelog (insulin lispro injection), a short-acting insulin indicated to improve control in blood sugar levels in adults and pediatric patients 3 years and older with type 1 diabetes mellitus and adults with type 2 diabetes mellitus. Admelog is the first short-acting insulin approved as a “follow-on” product.

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