On April 22, 2011, the Food and Drug Administration updated Import Alert #99-33 on detention without physical examination of certain milk, milk products, fruit, vegetables, and baby formula from Japan due to radionuclide contamination. The update affects milk, kakina, and spinach from the Ibaraki prefecture and sand lance (a type of fish also known as sand eels) from the Fukushima prefecture. It also updates the product codes subject to the import alert.
The Food and Drug Administration is announcing the availability of a draft guidance entitled “Establishing That a Tobacco Product Was Commercially Marketed in the United States as of February 15, 2007.” In this draft guidance, FDA provides recommendations on the evidence that a manufacturer may use to demonstrate that a tobacco product was commercially marketed in the U.S. as of February 15, 2007. To be considered for the final version of the guidance, comments are due by June 24, 2011.
The Environmental Protection Agency announces that more than 2,500 products are now authorized under its Design for the Environment (DfE) Safer Product Labeling Program to carry the DfE label, and is implementing a requirement, effective immediately, that new DfE-labeled products list all ingredients (other than trade secrets) on the product label or in another easily accessible location. (DfE-labeled products do not contain known chemicals of potential concern, like carcinogens, reproductive or developmental toxicants. Products that carry the DfE label include all-purpose cleaners, laundry and dishwasher detergents, drain line maintainers, car and boat care and other products.)
The Food and Drug Administration is announcing the availability of a final guidance, “Civil Money Penalties and No-Tobacco-Sale Orders for Tobacco Retailers." With the release of this final guidance document, several provisions in the Family Smoking Prevention and Tobacco Control Act (the Tobacco Control Act) that relate to civil money penalties and no-tobacco-sale orders become effective.
On April 22, 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 released the final version of a strategic priorities document outlining the goals that will guide the agency and its 12,000 employees through 2015, entitled "Strategic Priorities 2011 -- 2015: Responding to the Public Health Challenges of the 21st Century.” The document includes a modernized field of regulatory science to help ensure the safety and effectiveness of medical products; an integrated global food safety system focused on prevention and improved nutrition; and expanded efforts to meet the needs of special populations. The full document is available here.
The Environmental Protection Agency is launching a “Be an Energy Star” video challenge for individuals to document the energy-efficient actions they are taking in their home, school, workplace and community. The videos will be featured on the Energy Star website and social networking websites where the public will view and vote for their favorite videos in the fall.
The Food and Drug Administration issued four warning letters to companies that manufacture and market over-the-counter (OTC) drug products, including hand sanitizers, that claim to prevent infection from methicillin-resistant Staphylococcus aureus bacteria (MRSA). Labeling and marketing materials for the affected products also claim that they can prevent infection from other disease-causing agents and some hand sanitizing drug products make claims related to preventing infection from E.coli and/or H1N1 flu virus. FDA does not have sufficient evidence demonstrating that these products are safe and effective for these purposes.
On April 20, 2011, the Food and Drug Administration updated Import Alert #99-33 on detention without physical examination of certain milk, milk products, fruit, vegetables, and baby formula from Japan due to Radionuclide Contamination in order to add mushrooms from the Fukushima prefecture to the list of products restricted by Japan.
On April 20, 2011, the Food and Drug Administration posted revised versions of the following Import Alerts on the detention without physical examination of: