The Food and Drug Administration issued a final rule amending the food additive regulations to no longer provide for the use of polycarbonate (PC) resins in infant feeding bottles (baby bottles) and spill-proof cups, including their closures and lids, designed to help train babies and toddlers to drink from cups (sippy cups), effective Aug. 16. According to the underlying petition, baby bottles and sippy cups manufactured from PC resins are no longer being introduced into the U.S. market, and manufacturers of baby bottles and sippy cups have abandoned the use of PC resins in making these products. Objections and requests for hearings are due by Aug. 16.
On July 12 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On July 11 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 issued its weekly Enforcement Report for July 11 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 gave notice that it signed a memorandum of understanding with the Mexican Secretariat of Health entitled “The Safety and Sanitary Quality of Fresh and Frozen Molluscan Shellfish Exported from the United Mexican States to the United States of America.” The memorandum, which contains a few minor changes from the 2003 memorandum (extended by a 2008 exchange of letters) with the same subject and title, accepts Mexico as a participant in the U.S. National Shellfish Sanitation Program (NSSP) in exchange for compliance of the Mexican Shellfish Sanitation Program with the NSSP, among other things. The agreement went into effect June 28, and has a duration of 5 years.
On July 9-10 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 said Serbian drug manufacturer Hemofarm A.D. will remain on Import Alert, with its products subject to refusal of admission to the U.S., in a warning letter dated June 20 and posted to the FDA website July 10. The FDA’s warning letter was in response to Hemofarm’s December 2011 response to an FDA inspection, which found, among other things: (i) insufficient standards, plans and test procedures to ensure quality and purity (for example, agar plates for recovery of microbial contamination were dry); inadequate processing techniques during water runs; etc. Hemofarm’s response lacked sufficient corrective actions, FDA said. Furthermore, Hemofarm had already failed another inspection in 2007. Therefore, FDA said, Hemofarm’s products will continue to be under Import Alert and barred from entry into the U.S.
The Food and Drug Administration warned CigarWebService of the Netherlands that violations of the Food Drug & Cosmetic (FD&C Act) by its cigarette tobacco products could result in penalties, no-sale orders, criminal prosecution, seizure, and/or injunction, it said in a warning letter dated June 25 and posted to its website July 10. Among other things, the FDA said a product for sale on CigarWebService’s websites called “Brookfield (mild American blend)” violates the FD&C Act because its description as “mild” makes it a modified risk product, which cannot be sold in the U.S. without FDA approval. The FDA also singled out CigarWebService’s Pink Elephant Vanilla Flavor cigarettes, which contain flavoring in violation of the FD&C Act.
The Food and Drug Administration requested corrective action by a Spanish active pharmaceutical ingredient (API) manufacturing facility, in a warning letter dated June 20 and posted to the FDA website on July 10. In its letter to Encros S.A., FDA said a July 11-15, 2011, inspection of company’s facility in Aranjuez, Spain, identified significant deviations from Current Good Manufacturing Pratices (CGMP) for the manufacture of APIs, including, among other things, a water system incapable of consistently producing purified water and failure to maintain buildings and equipment used in manufacturing. FDA said the company’s August 2011 response lacked sufficient corrective actions, and threatened to bar Encros’ products from entry into the U.S. unless corrective action is taken.
During the week of July 2-8, 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: