On May 24, 2012, 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 announced the availability of a guidance for industry entitled “Meeting with Industry and Investigators on the Research and Development of Tobacco Products,” which describes FDA’s current policies and recommendations on FDA meetings with tobacco manufacturers, imports, researchers, and/or investigators relating to their plans to conduct research to inform the regulation of tobacco products, or support the development or marketing of tobacco products. FDA said this guidance does not pertain to other types of meetings or meeting requests with Center for Tobacco Products (CTP) staff. FDA is requesting comments on the guidance, which may be submitted at any time. FDA is also asking for comments, due by July 24, 2012, on two proposed information collections on (i) recommended materials to be included in such a meeting request, and (ii) recommended materials to be included in a meeting information package.

The Food and Drug Administration announced a meeting on “Requirements for Importing Food and Drug Administration Regulated Products Into the United States” in Des Plaines, IL on July 18, 2012. The topics to be discussed are FDA regulations with respect to importing pharmaceutical products, medical devices, food products, as well as technology which applies to brokers and forwarders. Attendees must submit registration information (including name, title, firm name, address, telephone, and fax number) to Lisa Misevicz at lisa.misevicz@fda.hhs.gov by July 2, 2012.

The Food and Drug Administration issued its weekly Enforcement Report for May 23, 2012, that lists the status of recalls and field corrections for food, drugs, biologics, and devices. The report covers both domestic and foreign firms.

On May 23, 2012, the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

On May 22, 2012, 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 May 14 through May 20, 2012, 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 of:

The Food and Drug Administration issued a warning letter to Italian company BTS S.p.A., which said the FreeEMG and PocketEMG medical devices manufactured by that firm are adulterated because the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation. FDA said that, although it previously received a response from the company concerning its investigation, the response was not adequate. According to FDA, U.S. federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information into account when considering the award of contracts. Additionally, premarket approval applications for Class III devices to which the Quality System regulation deviations are reasonably related will not be approved, and Requests for Certificates to Foreign Governments will not be granted, until the violations have been corrected.

Indonesianfoodmart.com of Rockville, MD, is recalling all packages of "Tempeh Starter Yeast" because they have the potential to be contaminated with Salmonella, the Food and Drug Administration said. The recalled "Tempeh Starter Yeast "and “Super Starter Yeast” were distributed nationwide and internationally through direct mail orders. The product was also distributed to the following areas: Australia, Canada, Slovenia, New Zealand, Brunei, Poland and Croatia. The product comes in sealed, clear plastic packages marked with a small computer printed label. The following sizes were sold: 30gm, 50gm, 250 gm, and 1000 gm. Several illnesses have been reported to date that may be in connection with this problem. Upon being notified of the risk by the FDA, the Indonesianfoodmart.com immediately discontinued their operations. Indonesianfoodmart.com did not manufacture the product which was imported from Indonesia.

The Food and Drug Administration found serious deviations from the acidified food regulations during an inspection of the Zory, Poland facility of Polish Company Smak Sp. z o.o., FDA said in a warning letter issued May 15. According to the warning letter, Smak intentionally made changes to the thermal processing method of its acidified food products and failed to submit revised scheduled process filings to FDA before manufacturing and shipping such acidified food products as red beets grated, pickled mushrooms, sauerkraut, sauerkraut with carrots, and pickled cucumbers. FDA acknowledged receipt of revised process filings in February 2012, but said that these filings were returned as inadequate as they were missing critical processing information.