The Food and Drug Administration is posting filer evaluation outcomes online, prospectively, starting from the beginning of fiscal year 2012, to help increase the accuracy of the information submitted to FDA and the accountability among the actors in the supply chain. This list will be updated monthly, and FDA will post the most recent outcome for each filer. The FDA states that, because this list is prospective, and updated monthly, interested parties should not make any inferences with regard to the status of filers that do not have filer evaluation outcomes posted on this site.
On March 15-16 2012, the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
In February 2012, the Food and Drug Administration submitted its annual report to Congress on the agency's foreign offices, pursuant to the Food Safety Modernization Act (FSMA). According to FDA's report, while strengthening the "product safety net" around the world is a core part of FDA's operating model and recent reports have found an increase in food borne illness caused by imported food, the agency currently doesn't have plans to open additional foreign offices.
The Environmental Protection Agency has issued a proposed rule, that would amend 40 CFR Parts 260 and 261 to revise certain provisions on cathode ray tubes (CRTs) that are exported for reuse and recycling. The proposed changes include, among other things: (1) a definition for CRT exporter; (2) more detailed notification instructions for both broken (for recycling) and intact (for reuse) used CRTs; and (3) an annual reporting requirement for exporters of broken used CRTs for recycling. Comments on the proposed rule are due by May 14, 2012.
On its "Lipstick and Lead: Questions and Answers" webpage, the Food and Drug Administration states that the agency is evaluating whether there may be a need to recommend an upper limit for lead in lipstick in order to further protect the health and welfare of consumers. The Campaign for Safe Cosmetics recently sent a letter to the FDA urging it to take this step as well as revise statements on its webpage on the safety of lead in lipsticks in light of an FDA study finding lead in 400 lipsticks in the U.S., as well as another recent study on the effects of lead exposure.
On March 13, 2012, the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
The Environmental Protection Agency and L’Oréal cosmetic company have announced a research collaboration designed to determine if EPA's chemical toxicity forecaster (ToxCast) can be used in systematical toxicity tests. L’Oréal is providing EPA $1.2 million in collaborative research funding plus robust safety data from a set of representative substances from the cosmetic sector, expanding the types of chemical use groups assessed by ToxCast. Because of the high costs and length of time it takes for animal testing, not all the chemicals in use have been thoroughly evaluated for potential toxicity.
On March 12, 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 has updated its Food Safety Modernization Act (FSMA) frequently asked questions (FAQ) document to add a Q&A on how the agency identifies a high-risk (HR) domestic facility. The answer to the question refers readers to another document, which states that the agency identifies a HR domestic facility based on the risk factors identified in section 421(a)(1) of the Food, Drug, and Cosmetic Act. HR domestic facilities must be inspected at least once in the first 5 years following enactment of the FSMA and then once every 3 years thereafter.
On March 9, 2012, the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of: