Interesting news from the FDA. FDA is publishing an advance notice of proposed rulemaking (ANPRM) which seeks input to assist the Agency in implementing section 211 of the FDA Food Safety Modernization Act (FSMA), which added new provisions to the Reportable Food Registry (RFR) requirements of the Federal Food, Drug, and Cosmetic Act. Such amendments are intended to help keep consumers notified and safe from foodborne illness. In general, section 211 of FSMA provides that FDA may require a responsible party to submit to the Agency “consumer-oriented” information regarding a “reportable food” (with the exception of fruits and vegetables that are raw agricultural commodities), including information necessary to enable a consumer to accurately identify whether the consumer is in possession of a reportable food. A reportable food is defined as a food (other than dietary supplements or infant formula) for which there is a reasonable probability that use of, or exposure to, such food will cause serious adverse health consequences or death to humans or animals.
In addition, section 211 of FSMA directs FDA to use such “consumer-oriented” information to create one-page summaries that would be posted on FDA’s website for the purposes of consumer notification. Further, grocery stores with 15 or more physical locations, that sold the reportable food, would be required to prominently display the one-page FDA summary, or information from the summary, within 24 hours of FDA’s web posting. Grocery stores would also be required to display the information for 14 days.
Through the ANPRM, FDA is seeking input to help determine, among other things:
what information should be required in consumer notifications so that consumers can determine whether a food in their possession is a reportable food;
the format in which the information should be presented;
what types of retail establishments FDA should consider to be “grocery stores” subject to the consumer notification requirements;
how grocery stores should be made aware that the information has been published on FDA’s website;
what constitutes prominent display or sharing of the information by a grocery store with its customers;
the impact on grocery stores from posting the information;
if consumers should be notified that this type of information will not be generated for dietary supplements, infant formula, and fruits and vegetables that are raw agricultural commodities; and
if FDA should require industry to submit consumer-oriented information to FDA, even if the food will not be available for sale to consumers at the retail level.
FDA will consider input received in implementing section 211 of FSMA.
FDA believes that the information it obtains through the ANPRM will assist the Agency in implementing and efficiently enforcing the amendments under section 211 of FSMA.
All interested parties are invited to comment on the ANPRM.
Saturday, March 29, 2014
Thursday, March 27, 2014
Purely Pomegranate, Inc. is recalling GOKNUR Organic Frozen/IQF Pomegranate Arils (seeds) because they may be contaminated with the Hepatitis A virus. The lot code is 21-15-13-2-1-O, with production date 17.10.2012, crop year 2012 and carton number 8721.
Sunday, March 16, 2014
|2 bottles of kratom (Mitragyna speciosa) extract (Thai Kratom Red Veine), each bottle 20ml. (Photo credit: Wikipedia)|
|Fda (Photo credit: Wikipedia)|
Glucosamine is an amino sugar and a prominent precursor in the biochemical synthesis of glycosylated proteins and lipids. Glucosamine is part of the structure of the polysaccharides chitosan and chitin, which compose the exoskeletons of crustaceans and other arthropods, as well as the cell walls of fungi and many higher organisms
The study found no evidence that drinking glucosamine supplement reduced knee cartilage damage, relieved pain or improved function in people who complained of chronic knee pain, acording to Dr. C. Kent Kwoh, professor of medicine and medical imaging at the University of Arizona College of Medicine.
|Diabetes Awareness (Photo credit: charliebarker)|
Diabetes is the only harmful side effect linked to statins, a study found, with 3 percent of people on statins being newly diagnosed with diabetes, compared with 2.4 percent of people taking placebos. That means that for every five new cases of diabetes in people taking statins, one is caused by the drug.
Read more here: http://www.npr.org/blogs/health/2014/03/13/289768822/statins-might-not-cause-aching-muscles-but-diabetes-risk-is-real
Saturday, March 08, 2014
Pfizer said it was recalling two lots of its Effexor XR antidepressant and another lot of its generic version of the drug after a pharmacist reported finding one capsule of a different medicine in a bottle of Effexor.
The other drug found by the pharmacist was Tikosyn, which is used to treat a common and potentially dangerous irregular heartbeat known as atrial fibrillation.