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.
http://www.fda.gov/Food/NewsEvents/ConstituentUpdates/ucm390447.htm
Saturday, March 29, 2014
Bella Vi, Super Fat Burner contain dangerous drugs: Tainted dietary supplements
Thursday, March 27, 2014
Terra-Medica Recall Specified Lots of Pleo Homeopathic Drug Products
Terra-Medica, Inc. is voluntarily recalling 56 lots of Pleo-FORT, Pleo-QUENT, Pleo-NOT, Pleo-STOLO, Pleo-NOTA-QUENT, and Pleo-EX homeopathic drug products in liquid, tablet, capsule, ointment, and suppository forms to the consumer level. FDA has determined that these products have the potential to contain penicillin or derivatives of penicillin, which may be produced during the fermentation process.
In patients who are allergic to beta-lactam antibiotics, even at low levels, exposure to penicillin can result in a range of allergic reactions from mild rashes to severe and life-threatening anaphylactic reactions. To date, Terra-Medica has not received any reports of adverse events related to this recall, nor any reports of product tests indicating penicillin content in the products.
The products are used as homeopathic drugs and have a label stating “Distributed by SANUM USA Corp.” The affected products are identified by package size, batch (lot) number and expiry date (ranging from March 2014 – May 2018) in the table accompanying this release. The batch number can be located at the side panel on the label. The affected products were distributed nationwide through health care practitioners, who may have sold the products through websites.
Terra-Medica is notifying its customers by letter and email and is arranging for return of all recalled products. Consumers and distributors that have product which is subject to the recall should stop using the products and return them to the point of purchase.
http://www.fda.gov/Safety/Recalls/ucm389832.htm
New Life Nutritional Center Issues Recalls Super Fat Burner, Maxi Gold and Esmeralda
New Life Nutritional Center is recalling all lots of “Super Fat Burner capsules, Maxi Gold capsules and Esmeralda softgels” to the user level after FDA analysis revealed the products contain undeclared active pharmaceutical ingredients: sibutramine, phenolphthalein or a combination of both sibutramine and phenolphthalein.
Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010 (due to increased risk of seizures, heart attacks, arrhythmia and strokes). Phenolphthalein is an ingredient previously used in over-the-counter laxatives, but because of concerns of carcinogenicity, it is not currently approved for marketing in the United States. These undeclared ingredients make these products unapproved new drugs for which safety and efficacy have not been established. At this time no illnesses or injuries have been reported to New Life Nutritional Center in connection with these products.
These products are used as weight loss aids and are packaged in 30 capsule bottles. All lots of these products are being recalled. New Life Nutritional Center distributed these products to customers residing in NY, NJ, LA, TX, VA, and MA via retail stores and internet sales through their website at www.newlifenutritional.com.
http://www.fda.gov/Safety/Recalls/ucm390608.htm
Pure Edge Nutrition, LLC Recalls Bella Vi Brand Products Due to Undeclared Sibutramine and Phenolphthalein
Toms River, NJ, Pure Edge Nutrition, LLC is voluntarily recalling one lot of each: Bella Vi Insane Bee Pollen Capsules, Bella Vi BTrim Ultimate Boost, Bella Vi BTrim Max, Bella Vi Extreme Accelerator, Bella Vi Insane Amp’d, and two lots of Bella Vi Amp’d Up to the consumer level. The products have been found to contain undeclared Sibutramine or a combination of both Sibutramine and Phenolphthalein through FDA laboratory analyses. Sibutramine a previously approved controlled substance, was removed from the US market in October 2010 for safety reasons, Phenophthalein is used medicinally as a laxative and not approved for marketing in the US. Therefore, these products are unapproved new drugs.
Products containing sibutramine and phenophthalein pose a threat to consumers because Sibutramine can increase blood pressure and/or pulse rate in some patients and may present a risk for those with a history of coronary artery disease, congestive heart failure, arrhymias or stroke. These products may also interact in life threatening ways with other medications a consumer may be taking. To date, the company has not received any reports of adverse events related to this recall. The recall was initiated after discovering the Sibutramine and Phenophthalein were included as ingredients by the manufacturer.
All affected products are marketed as dietary supplements for weight loss and were packaged and distributed as follows:
Bella Vi Insane Bee Pollen Capsules is packaged in bottles of 60 capsules with lot # 201303 EXP: 14/03/07. Bella Vi Insane was distributed to consumers and distributors nationwide from March 1, 2013 – August 31, 2013.
Bella Vi BTrim Max is packaged in bottles of 60 capsules with lot # BTX13 EXP: 2015/08/15. Bella Vi Btrim Max was distributed to consumers and distributors nationwide from August 31, 2013 – September 31, 2013.
Bella Vi BTrim Ultimate Boost is packaged in bottles of 30 capsules with lot # BTRM3452 EXP: 2015/07/03. Bella Vi Btrim was distributed to consumers and distributors nationwide from July 1, 2013 – September 31, 2013.
Bella Vi Extreme Accelerator is packaged in bottles of 30 capsules with lot # BTRX7654 EXP: 2015/07/08. Bella Vi Extreme was distributed to consumers and distributors nationwide from July 1, 2013 – September 31, 2013.
Bella Vi Insane Amp’d is packaged in bottles of 60 capsules with lot # VINA2013 EXP: 2015/06/12. Bella Vi Insane Amp’d was distributed to consumers and distributors nationwide from June 1, 2013 – September 31, 2013.
Bella Vi Amp’d Up is packaged in bottles of 60 capsules with lot # AU2013AB EXP: 2015/05/20 and lot #BVAU813 EXP: 2015/08/12. Bella Vi Amp’d Up was distributed to consumers and distributors nationwide from May 1, 2013 – September 31, 2013.
Pure Edge Nutrition, LLC is notifying its distributors and customers by email and is arranging for return of all recalled products. Consumers and distributors that have product which is being recalled should stop using and return products to Pure Edge Nutrition, LLC.
Consumers with questions regarding this recall can contact Pure Edge Nutrition, LLC at (888) 417-3613 Monday – Friday 10:00 a.m. – 2:00 p.m. EST or email info@pureedgenutrition.com. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
http://www.fda.gov/Safety/Recalls/ucm390693.htm
Purely Pomegranate, Inc. Recalls GOKNUR Organic Frozen/IQF Pomegranate Arils
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.
http://www.fda.gov/Safety/Recalls/default.htm
http://www.fda.gov/Safety/Recalls/default.htm
Sunday, March 16, 2014
SNI National Recalls Kratom XL, Maeng Da Kratom, Max Kratom
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| 2 bottles of kratom (Mitragyna speciosa) extract (Thai Kratom Red Veine), each bottle 20ml. (Photo credit: Wikipedia) |
NI National is recalling all Kratom products,including Kratom XL 4 Pack, Maeng Da Kratom 10 Pack, Max Kratom 20 Pack, and Bali Kratom 40 Pack, from distributors and retail locations. These products contain Kratom (Mitragyna Speciosa).
Kratom is a botanical that qualifies as a dietary ingredient under section 201(ff)(1) of the Federal Food, Drug, and Cosmetic Act . When marketed as a dietary ingredient, FDA considers kratom to be a new dietary ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury. Furthermore, scientific literature discloses serious concerns regarding the toxicity of Kratom in multiple organ systems. Consumption of Kratom can lead to a number of health impacts, including respiratory depression, nervousness, agitation, aggression, sleeplessness, hallucinations, delusions, tremors, loss of libido, constipation, skin hyperpigmentation, nausea, vomiting, and severe withdrawal signs and symptoms.
http://www.fda.gov/Safety/Recalls/ucm389350.htm
Pain Free By Nature recalls Reumofan Plus Arthritis Supplement
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| Fda (Photo credit: Wikipedia) |
Woodland Park, CO. Pain Free By Nature is recalling "Reumofan Plus" Tablets purchased through their website at www.painfreebynature.com, because they contain undeclared active pharmaceutical ingredients: methocarbamol and diclofenac. Use of this product could result in serious and life-threatening injuries.
Reumofan Plus is used as a treatment for muscle pain, arthritis, osteoporosis, bone cancer and other conditions. This product comes in thirty (30) tablet containers and is packaged in a green and gold box. Reumofan Plus was distributed nationwide through internet sales.
The recall was initiated after the US Food and Drug Administration discovered that the product was distributed in packaging that did not reveal the presence of the active pharmaceutical ingredients, making it an unapproved drug.
Pain Free By Nature did not manufacture the product but did distribute to customers nationwide. Distribution has been completely terminated by the company.
http://www.fda.gov/Safety/Recalls/ucm389049.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery
Study on Glucosamine: No Cure for Knee Pain
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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.
http://onlinelibrary.wiley.com/doi/10.1002/art.38314/abstract
Statins: Risk of Diabetes is Real
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| 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
Fake Supplement May Endanger Kids
Food and Drug Administration officials said this week that lots of the supplement L-citrulline sold by the compounding firm Medisca were found not to contain the drug at all. The company voluntarily recalled eight lots of the supplement, which is supplied to hospital and retail pharmacies nationwide.
“Health care professionals should discontinue dispensing from these lots, contact patients and return all unused product to Medisca Inc.,” FDA officials said in a notice.
L-citrulline is an amino acid used to treat certain urea cycle disorders, a genetic problem in which the body lacks one of six enzymes that help clear ammonia from the blood. Without enough L-citrulline, the ammonia builds up, potentially causing life-threatening brain damage and death.
http://www.nbcnews.com/health/health-news/fake-supplement-may-endanger-kids-fda-warns-n31266
Beef Recall Expanded
A Petaluma CA company’s recall of nearly 9 million pounds of beef is now affecting more than 1,000 establishments in 29 states and Canada, according to The Press Democrat. Nestle is voluntarily recalling some of its Hot Pockets because they might contain affected meat from Rancho Feeding Corp.
The U.S. Department of Agriculture has deemed products made from meat processed at Rancho Feeding Corp. in 2013 unfit for consumption because it processed diseased animals without a full federal inspection. So far, no illnesses have been reported.
Here is a partial list of specific products that are tied to the recall of meat processed at the Rancho Feeding Corporation in Petaluma. The most recent items are listed at the top:
Certain El Monterey taquitos and tornados, Ruiz Food Products, Dinuba, Calif.
Affected products:
El Monterey Beef & Cheese Taquitos – Flour Tortillas, 20 count; product codes 05/19/2014, 10/14/2014 and 10/17/2014; UPC 0 71007 40650 8
El Monterey Ranchero Steak Tornados, 4.5 lb (24 count); product codes 13 135, 13 281 and 13 287; UPC 1 00 71007 86390 2
Certain beef jerky products, Tillamook Country Smoker, Bay City, Ore.
Affected products:
— Teriyaki Beef Jerky, 75 count; product codes 12053, 22053; UPC 0 51943 25080 9
— Loonies Beef Jerky, 80 count; product codes 11443, 21443, 11573, 21573; UPC 051943 47941 5.
Certain Hot Pockets, Nestlé Prepared Foods, Chatsworth, Calif., facility.
Affected products:
Hot Pocket Philly Steak & Cheese, 9 oz., UPC4369507107, Batch numbers:
- 3021544512 with a best before date of March 2014
- 3029544512 with a best before date of March 2014
- 3197544512 with a best before date of September 2014
- 3240544512 with a best before date of October 2014
Hot Pocket Croissant Crust Philly Steak & Cheese, 9 oz., UPC 4369505634, Batch numbers:
- 3211544512 with a best before date of September 2014
- 3248544512 with a best before date of November 2014
- 3283544512 with a best before date of December 2014
Hot Pocket Philly Steak & Cheese, 54 oz., UPC 4369507520, Batch numbers:
- 3022544513 with a best before date of March 2014
- 3191544512 with a best before date of September 2014
- 3224544512 with a best before date of October 2014
- 3254544512 with a best before date of November 2014
- 3268544512 with a best before date of November 2014
Pfizer recalls antidepressant after report of wrong drug in bottle
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.
http://finance.yahoo.com/news/pfizer-recalls-antidepressant-report-wrong-230838090.html
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