More than 3,000 Americans are estimated to die each year from foodborne illnesses and many more are hospitalized and sickened. Yet most of these illnesses and deaths are preventable. While the U.S. has one of the safest food supplies in the world, Congress entrusted the FDA with new authorities and resources – as part of the FDA Food Safety Modernization Act (FSMA) – to update and strengthen the FDA’s risk-based approach to the oversight of food safety.
FDA approves Vosevi for Hepatitis C
The U.S. Food and Drug Administration today approved Vosevi to treat adults with chronic hepatitis C virus (HCV) genotypes 1-6 without cirrhosis (liver disease) or with mild cirrhosis.
Garden of Light Inc. Recalls Woodstock Organic Matcha Vanilla Oats Because of Possible Health Risk
Garden of Light, Inc. dba Gluten Free Solutions of East Hartford, CT, is voluntarily recalling the Woodstock Organic Matcha Vanilla Oats, 1.8 oz. which is manufactured by Garden of Light for Blue Marble Brands. The product has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women. The recalled item, Woodstock Organic Matcha Vanilla Oats, was distributed nationwide in retail stores.
FDA approves new treatment to reduce the risk of breast cancer returning
The U.S. Food and Drug Administration today approved Nerlynx (neratinib) for the extended adjuvant treatment of early-stage, HER2-positive breast cancer. For patients with this type of cancer, Nerlynx is the first extended adjuvant therapy, a form of therapy that is taken after an initial treatment to further lower the risk of the cancer coming back. Nerlynx is indicated for adult patients who have been previously treated with a regimen that includes the drug trastuzumab.
Bestherbs Coffee LLC Issues Voluntary Nationwide Recall of New Kopi Jantan Tradisional Natural Herbs Coffee due to the Presence of Undeclared Active Pharmaceutical Ingredients and Undeclared Milk
Grand Priarie, TX, Bestherbs Coffee LLC is voluntarily recalling all lots of New of Kopi Jantan Tradisional Natural Herbs Coffee, 13 grams to the consumer level. FDA laboratory analysis confirmed the presence of desmethyl carbodenafil. Desmethyl carbodenafil is structurally similar to sildenafil, the active ingredient in Viagra, an FDA-approved prescription drug for erectile dysfunction (ED). New of Kopi Jantan Tradisional Natural Herbs Coffee also contains undeclared milk.
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Texas Legend Foods Issues Allergy Alert on Undeclared Cheese, Milk & Egg in "Silver Star Chipotle Dip"
Texas Legend Foods of Austin, TX, is recalling its 16 ounce jars of Silver Star Chipotle Queso Dip because they contain undeclared cheese, milk and eggs. People who have allergies to cheese, milk and eggs run the risk of a serious or life-threatening allergic reaction if they consume this product.
Statement from FDA Commissioner Scott Gottlieb, M.D., on National Academies of Sciences, Engineering, and Medicine report on pain management and prescription opioid abuse
In March 2016, the FDA asked the National Academies of Sciences, Engineering, and Medicine (NASEM) to outline the state of the science regarding prescription opioid abuse and misuse, as well as the evolving role that opioids play in pain management. We greatly appreciate all the work done by NASEM over the past year to produce the comprehensive report released today, which includes recommendations for the FDA and others on this important issue.
Statement from Alberto Gutierrez, Ph.D., Director, Office of In Vitro Diagnostics and Radiological Health, FDA’s Center for Devices and Radiological Health on the status of FDA’s investigation into inaccurate results from certain lead tests
On May 17, the U.S. Food and Drug Administration warned Americans that Magellan Diagnostics’ LeadCare test systems performed on blood drawn from the vein (venous) may provide inaccurate results.
Sunneen Health Foods Issues Recall of Parfait Due to Undeclared Allergens
Sunneen Health Foods is voluntarily recalling mislabeled Whole Foods Market PB&J parfaits sold at five Whole Foods Market stores in New York and New Jersey because the products contained soy and tree nut (almond and coconut) allergens that were not listed on the product label. People who have an allergy or severe sensitivity to soy or tree nuts run the risk of serious or life-threatening allergic reaction if they consume these products.
Andropharm Issues Voluntary Nationwide Recall of Sten Z and M1 Alpha Due to Labeling that it Contains Derivatives of Anabolic Steroids
lorida- Andropharm is voluntarily recalling all lots of Sten Z and M1 Alpha capsules to the consumer level because these products contain derivatives of anabolic steroids rendering them unapproved drugs for which safety and efficacy have not been established and therefore subject to recall.