The week has brought great relief from both the heat and the humidity this week which was most welcomed. The garden got a break as did the gardener. Soon the Congress will all go home and the town and the traffic will subside somewhat for the last month of summer vacation. That is good.
While we anticipate that, here are a few points of interest to observe from the past week:
- FDA Seeks Public Input on Menthol Cigarettes – The agency announced that it was issuing an Advanced Notice of Proposed Rulemaking (ANPR) to seek additional information to help the agency make informed decisions about the presence and effects of menthol in cigarettes. The agency has issued a preliminary evaluation of the possible health effects of menthol in cigarettes and is inviting comment on that as well. FDA is finding three menthol-related studies; 1) looks at whether genetic differences in taste perceptions explain why certain racial and ethnic populations are more likely to use menthol cigarettes; 2) to compare exposure to smoke-related toxins and carcinogens from menthol and nonmenthol cigarettes; 3) to examine the effects of menthol and nonmenthol compounds in various tobacco products on both addiction and toxicants. Written or electronic comments (link above) may be submitted until September 23.
- Warning Letters Sent to 15 Companies Marketing Diabetes Treatments – the products, FDA said, contained undeclared active drugs.
- FDA Allows Marketing of New TB Test – A first for the U.S., FDA announced that it will permit the marketing of a test that is being labeled for the simultaneous detection of TB bacteria as well as for resistance to the antibiotic rifampin. The release stated that the test – called Xpert MTB/RIF Assay – is less copmlex to perform than other previous tests for detecting TB bacteria and results are available in approximately two hours.
- FDA MedWatch Alert Regarding Ketoconazole – While I don’t usually carry much news about MedWatch alerts, this one struck me only because of the length of time that ketoconazole has been in use. Back in my days of work in HIV/AIDS in the early 1980s, I recall its widespread use for people with AIDS in the treatment of oral candidiasis (a/k/a thrush). Today FDA issued a MedWatch alert announcing several actions related to ketoconazole warning that there is a possibility of severe liver injuries and adrenal gland problems and that there is a potential for harmful drug interactions. The actions include a label change and revised MedGuide.
- Two New Proposed Rules from FDA Regarding Imported Food – A public comment period was opened regarding two new proposed rules under the Food Safety Modernization Act (FSMA). Importers would b e held accountable for verifying that their foreign suppliers are implementing prevention-oriented food safety practices, achieving the same level of safety as domestic growers and processors. In addition, the rules aim to strengthen the quality of foreign food safety audits. Comments can be made until September 16, 2013 though the agency states in the release that it intents to grant a 60-day final extension.
That’s it for me this week. I hope everyone has a wonderful weekend.