The Food and Drug Administration on May 2 released a Food Safety Modernization Act (FSMA) Operational Strategy document intended to guide the agency’s efforts as it looks to bring industry into compliance with new regulations and oversee its new programs. “The agency has to design methods to promote widespread voluntary industry compliance with the new rules, as well as establish preventive public health-focused inspection and sampling programs to oversee compliance,” it said in an emailed announcement. “In addition, the FDA is developing effective enforcement strategies to be deployed when producers, processors, distributors and importers fail to comply on a voluntary basis.”
The Food and Drug Administration issued its weekly Enforcement Report for April 30 that lists the status of recalls and field corrections for food, drugs, biologics, and devices. The report covers both domestic and foreign firms.
The Food and Drug Administration warned an Italian canned food exporter that it may refuse entry to its products after finding violations of U.S. Low Acid Canned Food (LACF) and Emergency Permit Control regulations. The agency’s April 18 warning letter says that, unless Pancrazio fixes violations uncovered during an FDA inspection of its Cava dei Terreni facility in Italy, FDA may put the company’s products on import alert subject to detention without physical examination. FDA also said it will have to perform a reinspection to verify compliance once the problems are fixed, and will bill Pancrazio’s U.S. agent for expenses incurred.
On April 30 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On April 29 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
During the week of April 21-27, the Food and Drug Administration modified the following existing Import Alerts (not otherwise listed on the FDA's new and revised import alerts page) on the detention without physical examination and/or surveillance of:
The Food and Drug Administration is proposing to reclassify surgical mesh used for transvaginal pelvic organ prolapse repair as high-risk Class III devices, and is also proposing to require premarket approval (here), after finding new health risks associated with the device. The reclassification would only cover surgical mesh for transvaginal prolapse repair, and would not cover surgical mesh used to treat stress urinary incontinence or for abdominal prolapse repair, hernia repair, and other non-urogynecologic indications, said FDA (here). FDA's proposed order would also reclassify urogynecologic surgical mesh instrumentation from Class I into Class II with additional "special controls." Comments are due July 29.
On April 28 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
The Food and Drug Administration on April 28 banned some nutrient content claims in food labeling for certain omega-3 fatty acids. FDA’s final rule prohibits statements on labels that a food is “high in,” “rich in” or an “excellent source of” the omega-3 fatty acids docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA). It also restricts similar claims for alpha-linolenic acid (ALA), but doesn’t go as far as to ban all ALA content claims. The final rule takes effect Jan. 1, 2016.
On April 25 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of: