The Food and Drug Administration and the Federal Trade Commission have jointly launched the "Fraudulent STD Products Initiative," which targets over-the-counter products bought online or in retail stores that make unproven claims to prevent, cure, and/or treat sexually transmitted diseases (STDs). FDA has also issued warning letters to specific companies regarding such fraudulent products. A Q&A document regarding this initiative is available here.
The Food and Drug Administration has issued an interim final rule, effective July 3, 2011, that will amend its regulations to lower the threshold for ordering administrative detention of food for human or animal consumption, as required by the Food Safety Modernization Act1. FDA states that with the new criteria, the number of administrative detentions2 for food is likely to increase.
The Food and Drug Administration announces that the Electronic Submissions Gateway (ESG) PRE-PRODUCTION will be unavailable from 9:00 PM to 11:00 PM on May 6, 2011 due to scheduled maintenance.
The Food and Drug Administration has made its quarterly update to FDA-TRACK, an agency-wide performance management system that monitors over 100 FDA program offices, including the Office of International Programs (OIP), the Office of Regulatory Affairs (ORA), Center for Devices and Radiological Health (CDRH) Center for Drugs Evaluation and Research (CDER), and Office of the Commissioner (OC). Among other things, the update shows that 57 verifications of foreign firm registrations were completed for China, India, and Latin America from Jan - Feb 2011.
On May 3, 2011, the Food and Drug Administration posted revised versions of the following Import Alerts on the detention without physical examination of:
The Food and Drug Administration has posted the transcript and additional webcasts from its March 29, 2011 public meeting on the import safety provisions of the Food Safety Modernization Act (FSMA). The additional webcasts include the breakout sessions on Import Certification of Food and the Voluntary Qualified Importer Program which were previously unavailable. (See ITT's Online Archives or 03/31/11 news, 11033124, for BP summary of the meeting which covered these two issues, though less extensively than the other topics which were webcast.)
On May 2, 2011, the Food and Drug Administration posted revised versions of the following Import Alerts on the detention without physical examination of:
The Food and Drug Administration has issued a warning letter to Refine USA, LLC regarding its marketing of the VeinGogh Ohmic Thermolysis System without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act. FDA states that failure to promptly correct the violations may result in regulatory action being initiated, including, but not limited to, seizure, injunction, and/or civil penalties.
The Food and Drug Administration has issued a warning letter to BNB Medical Co., Ltd. of Seoul, Korea regarding its manufacturing and marketing of BND Laser Hair Removal devices, Models W-808, CW-808 also known as Epila and Venus Laser Hair Removal devices without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act, and are subject to refusal of admission under the FFDCA. FDA may take steps to refuse these products, known as "detention without physical examination," until these violations are corrected.
The Office of Management and Budget has approved a Food and Drug Administration interim final rule entitled: "Prior Notice of Imported Food." The need for this rule is due to a statutory deadline.