FDA halts operations at peanut butter plant

WASHINGTON (AP) — The Food and Drug Administration halted operations of the country’s largest organic peanut butter processor Monday, cracking down on salmonella poisoning for the first time with new enforcement authority the agency gained in a 2011 food safety law.

FDA officials found salmonella all over Sunland Inc.’s New Mexico processing plant after 41 people in 20 states, most of them children, were sickened by peanut butter manufactured at the plant in Portales and sold by Trader Joe’s grocery chain. The FDA suspended Sunland’s registration Monday, preventing the company from producing or distributing any food.

The food safety law gave the FDA authority to suspend a company’s registration when food manufactured or held there has a “reasonable probability” of causing serious health problems or death. Before the food safety law was enacted early last year, the FDA would have had to go to court to suspend a company’s registration.

Michael Taylor, the FDA’s deputy commissioner for foods, said the agency’s ability to suspend a registration like this one is a major step forward for the agency.

“Consumers can be assured that products will not leave this facility until we determine they have implemented preventive measures that are effective to produce safe products,” Taylor said.

Sunland had voluntarily closed its plant after a September outbreak and planned to reopen its peanut processing facility on Tuesday, with hopes of selling peanut butter again by the end of the year. Sunland’s Katalin Coburn said FDA’s decision to suspend the registration was a surprise to the company and Sunland officials had assumed they were allowed to resume operations.

The company now has the right to a hearing and must prove to the agency that its facilities are clean enough to reopen. Coburn said Sunland is cooperating with FDA and company officials hope they can be up and running again soon.

Sunland is the nation’s largest organic peanut butter processor, though it also produces many non-organic products. The company recalled hundreds of organic and non-organic nut butters and nuts manufactured since 2010 after Trader Joe’s Valencia Creamy Peanut Butter was linked to the salmonella illnesses in September.

In addition to Trader Joe’s, Sunland sold hundreds of different peanut products to Whole Foods, Safeway, Target and other large grocery chains.

During a month-long investigation, after the outbreak linked to processor Sunland and to Trader Joe’s, FDA inspectors found samples of salmonella in 28 different locations in the plant, in 13 nut butter samples and in one sample of raw peanuts.

The agency also found improper handling of the products, unclean equipment and uncovered trailers of peanuts outside the facility that were exposed to rain and birds.

The FDA said that over the past three years, the company shipped products even though portions of their lots, or daily production runs, tested positive for salmonella in internal tests. The agency also found that the internal tests failed to find salmonella when it was present.

FDA inspectors found many of the same problems — including employees putting their bare fingers in empty jars before they were filled, open bags of ingredients, unclean equipment, and many other violations — in a 2007 inspection. Similar problems were recorded by inspectors in 2009, 2010 and 2011, though government officials didn’t take any action or release the results of those inspections until after the illnesses were discovered this year.

In a statement issued earlier this month, Sunland’s president and chief executive officer, Jimmie Shearer, denied the company knowingly shipped tainted products.

“At no time in its 24-year history has Sunland, Inc. released for distribution any products that it knew to be potentially contaminated with harmful microorganisms,” Shearer said in a statement posted on the company’s website. “In every instance where test results indicated the presence of a contaminant, the implicated product was destroyed and not released for distribution.”

A separate peanut butter outbreak in 2009 not related to Sunland was linked to hundreds of illnesses and nine deaths.


Source: Yahoo!

FDA Investigating 5 Deaths Linked to Monster Energy Drink

FDA Investigating 5 Deaths Linked to Monster Energy Drink

The FDA has received reports of five people who died after consuming Monster Energy — Monster Energy Deathsa high-caffeine energy drink — in the past 3 years, the New York Times reports.

Other adverse events reported to the agency include one nonfatal MI, abdominal pain, vomiting, tremors, and abnormal heart rate. It is unclear whether patients who experienced adverse events also took alcohol or drugs.

In a statement, an FDA spokesperson said that it is the manufacturer’s responsibility to investigate adverse events associated with the beverage, according to the Times. She added that the FDA had not yet established a causal link between the energy drink and the deaths.

A 24-oz. can of Monster Energy contains 240 mg of caffeine, roughly equivalent to two cups of brewed coffee.


New York Times story (Free)

Background: Physician’s First Watch coverage of AAP statement on sports and energy drinks (Free)

Published in Physician’s First Watch October 24, 2012

McDonald’s adding calorie counts to U.S. menus


Public Health

Last Updated: 2012-09-12 18:55:01 -0400 (Reuters Health)

By Lisa Baertlein

(Reuters) – McDonald’s Corp will begin telling diners next week how many calories are in its Big Macs (550) and French fries (500 for a large size).

The world’s No. 1 hamburger chain said on Wednesday it is going to start listing calorie information on menus in some 14,000 U.S. restaurants ahead of a national rule that will require larger restaurant chains to make the disclosures.

The state of California and cities like New York already require that calories be clearly listed on menus.

Under the new U.S. healthcare law, restaurants must soon clearly post calories and other nutrition details on menus. The rules target restaurants with 20 or more locations, as well as other retail food outlets. Most major chains have resisted, without legislation and the threat of fines.

McDonald’s, under pressure from consumer groups and public health advocates, has also taken steps to make menu items healthier.

It tweaked its popular Happy Meals for children – reducing the French fries portion by more than half and adding apples automatically to every order.

McDonald’s was slow to adopt calorie labeling. When the labeling requirements were gaining interest several years ago, a McDonald’s nutritionist told a group of health reporters in Los Angeles that the company opposed the rules because they violated customer privacy.

More than two years ago, Panera Bread Co became the first national restaurant chain to voluntarily post calories at company-owned stores. Sandwich chain Subway has used calorie disclosures to position itself as a healthier alternative to rivals like McDonald’s and Burger King Worldwide Inc.

Copyright © 2012 Reuters Limited. All rights reserved. Republication or redistribution of Reuters content, including by framing or similar means, is expressly prohibited without the prior written consent of Reuters. Reuters shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon. Reuters and the Reuters sphere logo are registered trademarks and trademarks of the Reuters group of companies around the world.

Copyright 2012 Reuters.

FDA to crash medical app development party

FDA to crash medical app development party

More than 40,000 medical apps are now available for download to smartphones or tablets, and government regulators have taken notice.

FDA to crash medical app development party

In fact, the Food and Drug Administration (FDA) crafted a set of guidelines

Full Story Here

How Bevacizumab Monotherapy Can Help Patients with ROP

Did you miss the July 5th issues of the Ophthalmology Times eReport? In this e-newsletter we released information on Bevacizumab (Avastin, Genentech) monotherapy for zone I retinopathy of prematurity, gender difference in presbyopia assistance, a scholarship for the “most beautiful eyes” and more. Check out the articles in this issue below.

Bevacizumab monotherapy shows potential for some patients with ROP

Bevacizumab (Avastin, Genentech) monotherapy for zone I retinopathy of prematurity (ROP) might have potential for treating pre-term infants who are in phase II of the pathogenesis of ROP. Read more

Gender differences may factor into presbyopia assistance

Ophthalmologists should consider gender differences in arm length and reading distance preferences when prescribing reading glasses or bifocal lenses, according to a recent study published in Investigative Ophthalmology & Visual Science. Such factors mean that women tend to desire assistance with presbyopia symptoms earlier than men do. Read more

George Bartley to become Ophthalmology editor in January

George B. Bartley, MD, will succeed Andrew P. Schachat, MD, as editor-in-chief of Ophthalmology, the American Academy of Ophthalmology’s (AAO’s) flagship journal, in January. Dr. Schachat has served in this capacity since 2003. Read more

Scholarship to be awarded for ‘most beautiful eyes’

A $10,000 educational scholarship is up for grabs in Prevent Blindness America’s (PBA’s) 2012 Most Beautiful Eyes Contest. Read more

Vitrectomy system gains 510(k) clearance

Synergetics USA Inc. has received 510(k) marketing clearance from the FDA for its proprietary vitrectomy system (VersaVIT). Read more

Acucela receives ‘Emerging Leader’ award

Acucela Inc. has been named as a recipient of the 2012 Emerging Leaders award from the Japan-U.S. Innovation Awards. Read more

NicOx, RPS sign worldwide licensing agreement

NicOx S.A. and Rapid Pathogen Screening Inc (RPS) have entered into a licensing agreement that gives NicOx access to RPS’s point-of-care ocular diagnostic tests. Read more

US FDA staff questions dosing of Lucentis eye drug

US FDA staff questions dosing of Lucentis eye drug

U.S. drug reviewers on Tuesday said Roche Holding AG’s eye drug Lucentis (ranibizumab injection) appeared to help patients with diabetic macular edema (DME), but questioned whether two different doses of the drug were equally safe and effective.

Staff from the U.S. Food and Drug Administration reviewed Lucentis ahead of an advisory panel of outside experts, which meets on Thursday to vote on whether to recommend approval of expanded use of the drug, which is administered monthly by injection.

Lucentis is already approved to treat wet age-related macular edema. It is also approved for macular edema following retinal vein occlusion (RVO).

Roche is hoping to expand its use to people with diabetic DME, the most common cause of moderate vision loss in patients with diabetes. There are currently no FDA-approved drugs for DME, a leading cause of vision loss among people of working age.

DME is currently treated by laser, which stops blood vessel leakage and can slow vision loss but rarely leads to vision improvement, Roche said.

In clinical trials Lucentis, made by Roche unit Genentech, helped patients see at least 15 extra letters on an eye chart, the primary goal of the study, FDA reviewers said.

People were also generally able to sustain the improvement in vision for at least 24 months — although those who took the 0.5 mg dose lost a bit of vision after the 18th month.

Both doses (0.5 and 0.3 mg) were generally safe, although there were slightly more deaths at the higher dose — 11 people who received the 0.5 mg dose died during the clinical trial, compared to seven taking the 0.3 mg dose and three receiving a sham injection. Each group contained 250 patients.

The FDA will ask advisers to recommend whether both doses of the drug should be approved for use against DME.

Copyright © 2012 Reuters Limited. All rights reserved.
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Top 5 Updates on Cataracts in 2012

From femtosecond platforms to how cataracts effects driving, eye-care news in regards to cataracts has been quite eventful this year. The following links are to our hand-picked cataracts news pieces from Ophthalmology Times that we think you’ll be interested in.

Cataracts, blurred vision ‘severely’ effected driving

Results of motor vehicles agency-administered vision tests do not necessarily reflect fitness to drive, according to a study published in Investigative Ophthalmology & Visual Science. Read more

New CE mark adds utility for laser platform

OptiMedica Corp. has announced that its proprietary platform that combines a femtosecond laser, integrated three-dimensional optical coherence tomography (OCT) imaging, and a proprietary pattern-scanning technology (Catalys Precision Laser System) has been granted CE mark approval for creating single-plane and multi-plane arc cuts/incisions in the cornea during cataract surgery. Read more

Biometry, IOL power formulae improve outcomes

Accuracy of IOL power calculation can be significantly increased through the use of a low-coherence laser interferometry device (Lenstar LS900, Haag-Streit) for optical biometry combined with a last-generation, four-variable, “paraxial” ray-tracing formula (Olsen formula; PhacoOptics software, IOL Innovations). The benefit is due to improved prediction of postoperative IOL position, said Thomas Olsen, MD. Read more

Surgeon Dr. Robert Welsh dies

Robert C. Welsh, MD, believed to be the first U.S. surgeon to limit his practice to cataract surgery, died Jan. 8. He was 89. Read more

FDA clears femtosecond laser program

The FDA has cleared a new femtosecond laser platform (Femto LDV Z Models, Ziemer Ophthalmic Systems AG). The platform has been released globally. Read more