On Jan. 19 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 is proposing to establish a limit on N-nitrosonornicotine (NNN) in finished smokeless tobacco products, it said (here). The agency said NNN is a “potent carcinogenic agent found in smokeless tobacco products and is a major contributor to the elevated cancer risks associated with smokeless tobacco use.” FDA proposes that the limit would apply to smokeless tobacco products manufactured, imported, distributed or sold beginning three years after the publication date of the final rule. Comments on the proposal are due April 10.
The Food and Drug Administration released a draft guidance document (here) to assist sprout operations in complying with the agency’s Food Safety Modernization Act product safety rule, it said (here). Sprout operations, including foreign operations if their products are imported into the U.S., are required to comply with the new regulations (or their equivalent) beginning on Jan. 26, 2017, earlier than operations involving other types of produce. Small businesses get a one- or two-year grace period, depending on size. Comments on the draft guidance are due July 24.
On Jan. 18 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Jan. 17 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
The Government Accountability Office reported some progress in the Food and Drug Administration's foreign offices and inspection operations in a new report (here). Since its previous report in 2010, "FDA has begun to take steps to enhance the agency’s strategic planning for the foreign offices and has developed two performance measures," it said. Still, the agency is lacking in its measures of "effectiveness of the offices’ contributions," it said. Position vacancies in the foreign offices also remain too high, it said. "Given that one of the reasons for opening the foreign offices was to conduct inspections, the large number of vacant investigators is concerning," the GAO said. The GAO recommended that the FDA "assess the effectiveness of the foreign offices’ contributions by systematically tracking information to measure whether the offices’ activities specifically contribute to drug safety-related outcomes, such as inspections, import alerts, and warning letters," and establish foreign office staffing goals. The Department of Health and Human Services, which the FDA is part of, concurred with the GAO's recommendations and is taking "immediate steps to address them," the GAO said.
On Jan. 13-14 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 recently revised a draft guidance document (here) on control of listeria monocytogenes in ready-to-eat foods, it said (here). The draft guidance is intended to help entities that manufacture, process, pack or hold food comply with FDA’s regulations on preventive controls for human food, the agency said. Comments on the draft guidance are due July 26.
The Food and Drug Administration announced the release (here) of a new draft guidance document (here) on warning statements for small-packaged cigars. The draft guidance is intended for manufacturers, packagers, sellers, distributors and importers of cigars in packaging that is too small or otherwise unable to accommodate a label with sufficient space to bear required warning statements. According to the draft guidance, “FDA does not intend to take enforcement action with respect to cigars that do not comply with the size and placement requirements in the regulation when the information and specifications required under the regulation appear on the carton or other outer container or wrapper that could accommodate the required warning statements, or on a tag otherwise firmly and permanently affixed to the cigar package.”
On Jan. 12, the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of: