The U.S. Food and Drug Administration today took major steps to prevent foodborne illness by finalizing rules implementing the bipartisan Food Safety Modernization Act that, for the first time, establish enforceable safety standards for produce farms, and make importers accountable for verifying that imported food meets U.S. safety standards. The Agency also issued a rule establishing a certification program for accredited entities conducting food safety audits of foreign food facilities. These final rules will help produce farmers and food importers take steps to prevent problems before they occur.

Following a rigorous, science-based review, the U.S. Food and Drug Administration announced today that for the first time it has authorized the marketing of new tobacco products through the premarket tobacco application (PMTA) pathway. This action permits the tobacco products to be sold in the U.S., but does not mean that they are safe or “FDA approved.” All tobacco products are potentially harmful and addictive and those who do not use tobacco products should continue to abstain from doing so.

The U.S. Food and Drug Administration today approved Cotellic (cobimetinib) to be used in combination with vemurafenib to treat advanced melanoma that has spread to other parts of the body or can’t be removed by surgery, and that has a certain type of abnormal gene (BRAF V600E or V600K mutation).

The U.S. Food and Drug Administration today approved Genvoya (a fixed-dose combination tablet containing elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide) as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older.

The U.S. Food and Drug Administration today approved Nucala (mepolizumab) for use with other asthma medicines for the maintenance treatment of asthma in patients age 12 years and older. Nucala is approved for patients who have a history of severe asthma attacks (exacerbations) despite receiving their current asthma medicines.

The U.S. Food and Drug Administration (FDA) has ordered Sun Valley Juice Company of Ketchum, Idaho, to stop receiving, processing, preparing, packing, holding, and distributing juice until the agency determines that the company is in compliance with laws and regulations applicable to producing food that is safe.

This week the U.S. Food and Drug Administration filed complaints initiating the first-ever No-Tobacco-Sale Order (NTSO) actions for a group of retailers who have repeatedly violated certain restrictions on the sale and distribution of tobacco products, including sales to minors. Under the law, the FDA may pursue an NTSO against retailers that have a total of five or more repeated violations of those restrictions during compliance inspections within 36 months.

Today the U.S. Food and Drug Administration expanded the approved use of Yervoy (ipilimumab) to include a new use as adjuvant therapy for patients with stage III melanoma, to lower the risk that the melanoma will return following surgery.

The U.S. Food and Drug Administration today approved Imlygic (talimogene laherparepvec), the first FDA-approved oncolytic virus therapy, for the treatment of melanoma lesions in the skin and lymph nodes.

The U.S. Food and Drug Administration today approved Imlygic (talimogene laherparepvec), the first FDA-approved oncolytic virus therapy, for the treatment of melanoma lesions in the skin and lymph nodes.