> FDA News Digest > March 3, 2003 > ________________________________________________________________ > > HHS Acts to Reduce Potential Risks of Supplements with Ephedra > > The Department of Health and Human Services has announced a series of > actions designed to protect Americans from potentially serious risks of > dietary supplement products containing ephedra, a substance derived from > the Chinese herb ma huang. The Department is seeking rapid public comment > on the new evidence on health risks associated with ephedra to establish > an up-to-date record as quickly as possible to support new restrictions on > ephedra-containing products. Also public comments on issues such as a > proposed warning label for ephedra products still being marketed and > taking enforcement measures against ephedra products that make unsupported > claims about sports performance enhancement are being solicited. > Press release: http://www.fda.gov/bbs/topics/NEWS/2003/NEW00875.html > Federal Register notice: > http://www.fda.gov/OHRMS/DOCKETS/98fr/95n-0304-npr0003.pdf > Fact sheet: http://www.fda.gov/bbs/topics/NEWS/ephedra/factsheet.html > White paper: http://www.fda.gov/bbs/topics/NEWS/ephedra/whitepaper.html > _________________________________________________________________ > > Blood Particle Investigation Finds No Current Threat to Blood Supply > > Unusual particles found recently in some blood components, though not > fully explained, appear to be no threat to blood safety at this time, FDA > reports. All analyses to date of possible infectious agents, chemical > contaminants, or blood bag defects have found no abnormalities that > indicate a public health risk. The agency is investigating the theory that > the particles can result from certain physical conditions of blood > handling. > http://www.fda.gov/bbs/topics/NEWS/2003/NEW00874.html > ___________________________________________________ > > FDA Committee Discusses Resuming Suspended Gene Therapy Trials > > An FDA advisory committee has discussed measures that could allow certain > gene therapy trials to proceed with appropriate safeguards. The trials, > which involve inserting new genes in blood stem cells for treatment of > life-threatening diseases, were placed on hold earlier this year following > reports of two children in the trials developing leukemia. > http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01202.html > __________________________________________________________________ > > Letters Explain FDA Enforcement Policy for Unapproved Drugs > > FDA has sent follow-up letters to 66 manufacturers and distributors of an > unapproved expectorant drug product, providing them with further details > on the agency's enforcement policy regarding unapproved drugs. FDA > initially notified the companies in October 2002 that their marketing of > guaifenesin extended-release drug products require FDA approval. The > latest letter grants a grace period but states that the unapproved drugs > must be off the market by November 2003. > http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01201.html > __________________________________________________________________ > > Distribution of Dioxin-Containing Animal Feed Mineral Mixes Stopped > > FDA's dioxin-monitoring program has found elevated levels of dioxin in > some mineral components used in feeds for livestock, poultry and > aquaculture. Based on the information, the agency has requested a recall > of certain animal feed and feed products that covers 11 states and Canada. > Dioxin, with cumulative exposure, is potentially cancer-causing and may > cause reproductive or developmental health problems. > http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01203.html > __________________________________________________________________ > > New Website Highlights 2002 Medical Device User Fee Act > > The Medical Device User Fee and Modernization Act (MDUFMA), signed into > law last October, gave FDA important new responsibilities and resources. > Among its provisions: collecting fees for medical device reviews; allowing > certain inspections by accredited third parties; and implementing new > rules for reprocessed single-use devices. A new FDA website provides links > to detailed information about the law. > MDUFMA website: http://www.fda.gov/oc/mdufma/ > Federal Register notice explaining fee payment: > http://www.fda.gov/OHRMS/DOCKETS/98fr/03-4490.html > ___________________________________________________ > > RECALLS > > The following products have been recalled for the reasons shown. Go to the > linked page for more information: > > Quaker Oatmeal Brown Sugar Bliss Cold Cereal (may contain almonds) -- > http://www.fda.gov/oc/po/firmrecalls/quaker02_03.html > > Mozhayiskoe Sterilized Milk and Milaya Mila Sterilized Milk (contains > prohibited drug sulfonamide) -- > http://www.fda.gov/oc/po/firmrecalls/russianmilk02_03.html > > Asian Boy Sweet Winter Melon Candy (undeclared sulfites) -- > http://www.fda.gov/oc/po/firmrecalls/bcntrading02_03.html > > Kushishang Dried Potatoes and Hong Fu Dried Potato Slices (undeclared > sulfites) -- http://www.fda.gov/oc/po/firmrecalls/kushishang02_03.html > __________________________________________________________________ > > PUBLIC MEETINGS > > For a list of upcoming FDA meetings, seminars, and other public events, go > to http://www.fda.gov/opacom/hpmeetings.html. > __________________________________________________________________ > > Thanks for subscribing to the FDA News Digest. Our next posting will be > March 10. > > To leave this list at any time, send an e-mail to > LISTSERV@LIST.NIH.GOV > In the body of the message, write > SIGNOFF FDA-NEWSDIGEST-L >
