CONTENTS:
- Medical Devices
- Drugs & Biologics
- Food & Dietary Supplements
- Tobacco
Medical Devices
IOM report: FDA's 510(k) process needs
to be revised
A report by the Institute of Medicine suggested that the
510(k) process used for clearing medical devices should be
overhauled because dependence on "substantial equivalence
cannot assure that devices reaching the market are safe and
effective." The Advanced Medical Technology Association called
the report a "disservice to patients." Jeffrey Shuren,
director of the FDA's device center, said the agency
"believes that the 510(k) process should not be eliminated but
we are open to additional proposals and approaches for continued
improvement."
Analyst: IOM's 510(k) report may lead
to increase in PMA applications
The number of applications seeking premarket approval for
medical devices will increase and companies will be required to
conduct more clinical trials as a result of an Institute of
Medicine report that calls for the 510(k) process to be overhauled,
said David Lewis, a Morgan Stanley analyst. Lewis said companies
should reconsider their investments in research and development as
the process of securing product approvals is likely to become more
costly.
MITA praises Senate committee for hearing
on device user fee
Medical Imaging and Technology Alliance has lauded the move by the
Senate Committee on Health, Education, Labor, and Pensions to hold
a hearing on Thursday regarding the Medical Device User Fee and
Modernization Act. MITA agrees with committee members'
assessment that the agency's device review procedures have led
to longer review periods and reduced access to medical
technologies, said David Fisher, MITA executive director.
FDA warns Electro-Cap over documentation
problems
The FDA issued a warning letter to Electro-Cap International,
citing problems with its documentation processes and design changes
related to its products. William Hardin, the firm's president,
said the issues raised in the letter originated from errors the
company made in its documentation. Hardin said the company needs to
address the agency's concerns through its new 510(k)
applications it plans to submit for its products.
Boston Scientific to reduce global
workforce
Boston Scientific has announced plans to cut about 1,200 to 1,400
positions, starting this quarter until the end of 2013. The
workforce reductions are part of the company's restructuring
effort to save $225 million to $275 million in annual costs by
2013.
Varian Medical tapped to supply
radiotherapy systems in Scotland
Palo Alto, Calif.-based Varian Medical Systems will distribute its
radiotherapy devices to five hospitals in Scotland, under a single
procurement agreement worth $36 million. The Scottish government
described Varian's device as "technically more advanced
[for] its imaging, motion management and treatment
delivery."
Study: Mammography has little effect on
breast cancer mortality
Scientists compared breast cancer deaths in three pairs of European
countries and found that the countries showed little difference in
mortality rates, even in areas where mammography screening was
introduced about 10 to 15 years earlier. The finding "suggests
that screening has not played a direct part in the reductions of
breast cancer mortality," the researchers noted. However,
researchers who published results in June on the longest breast
cancer screening study ever conducted found that not only do
mammographies and other forms of screening save lives, but more and
more lives are saved by screening as time goes by.
Senator aims to change FDA calculation of
device review time
Sen. Richard Burr, R-N.C., said he will hold up an FDA
reauthorization bill unless the agency agrees to count the time it
spends waiting for more information from manufacturers in its
performance reports. The agency agreed to speed up its review of
medical devices in exchange for user fees but currently stops the
clock until manufacturers provide requested information.
FDA seeks comments on reprocessing of
reusable devices
The FDA has reopened the period for accepting feedback on
reprocessing of reusable devices as part of its efforts to protect
patient safety. The agency has set a Sept. 26 deadline for public
comments.
Palm scanner gives N.Y. hospital the upper
hand in speed, safety
New York University's Langone Medical Center has started using
a palm vein scanner to identify patients for faster check-ins and
improved safety. The device uses near-infrared waves and matches
the images of patients' palm veins with their health
records.
Hansen Medical gets CE Mark for robotic
technology
European regulators have given Hansen Medical the CE Mark for its
Magellan robotic technology, which aids in the manual implantation
of medical devices. The technology is used in combination with the
NorthStar robotic catheter and other ancillary tools, which have
not yet been cleared by European regulators.
Silicone chip offers faster, cheaper
genetic analysis, scientists say
Scientists at the University of British Columbia and the Centre for
Translational and Applied Genomics have created a silicone chip
about the size of a 9-volt battery that routes fluid through
microscopic tubes and valves, allowing the analysis of individual
cells. "Single-cell genetic analysis is vital in a host of
areas, including stem cell research and advanced cancer biology and
diagnostics, but until now, it has been too costly to become
widespread in research and for use in health care," research
team leader Carl Hansen said. The technology will allow
"clinicians to distinguish various cancers from one another
and tailor their treatments accordingly," he said.
FDA proposes subjecting more pacemakers to
premarket approval
The FDA has issued draft guidance that would require manufacturers
to seek premarket approval for class III implantable pacemaker
pulse generators to help guarantee effectiveness and safety. The
agency is seeking input on the guidance, and interested parties can
apply for reclassification of their products.
Boston Scientific plans $150 million
expansion in China
Boston Scientific said it will spend $150 million to expand its
operations and workforce in China over five years. The expansion,
which will include building a manufacturing plant and training
centers for doctors, could bump up the company's Chinese sales
to $500 million in 2017.
Report: Investments in Midwest medical
startups hit $315M in first half
A BioEnterprise report found that health care startups in the
Midwest secured $315 million in investments during the first half
of this year, down 24% from the same period last year. The report
noted that biopharmaceutical firms secured $153 million while
device firms raised $85 million. During the period, Minnesota
garnered the most funding with $88 million.
Phraxis hopes to raise $5 million for
hemodialysis device
Phraxis seeks to obtain $5 million to support the company's
510(k) application for its implantable hemodialysis device, which
is used in patients with kidney failure. The Minnesota-based
startup plans to conduct a clinical study of the device in the
months ahead.
ArthroCare's SpeedFix suture system
secures FDA clearance
The FDA has granted clearance to ArthroCare for its SpeedFix suture
device, which is designed to treat tears in shoulder joints.
Experts create material to rebuild
disfigured faces
Researchers at Johns Hopkins University have developed a
biomaterial designed to reconstruct soft facial structures that
become disfigured through disease or injury. The material can be
administered to the skin as a liquid, sculpted into shape and
exposed to light to firm up the implant.
Study finds Stryker's Matrix coils
effective in treating aneurysms
Stryker's Matrix detachable coil devices proved to be as
effective as GDC detachable coils in treating ruptured and
unruptured aneurysms, according to a clinical trial presented at
the Society of NeuroInterventional Surgery's annual meeting.
The study also found that Matrix coils had a lower rate of aneurysm
recurrence than GDC coils. Stryker purchased the device from Boston
Scientific earlier this year.
3 device makers offer promising
alternative to CPAP treatment
Three device firms have created an implantable neurostimulation
tool designed to treat patients with moderate to severe symptoms of
obstructive sleep apnea and offer an alternative to continuous
positive airway pressure masks. Inspire Medical Systems has already
obtained CE Mark approval for its device, while FDA has yet to
grant clearance to ImThera and Apnex Medical to start clinical
trials of their systems.
Ohio-based group works on male
incontinence device
Researchers at Continental Dry Works in Columbus, Ohio, are working
on a male urinary incontinence device. The tool, called The Pocket,
resembles an athletic cup and includes a layer of quick-drying mesh
over an absorbent material, which collects urine inside a
semi-rigid outer shell.
Proposed FDA regulation of mobile health
apps draws industry attention
Draft guidance outlining the FDA's plans to pursue regulation
of certain mobile health solutions sparked a range of reactions
from industry stakeholders and observers. The regulations could
stymie innovation but would help clarify the fragmented medical-app
segment, said Zachary Bujnoch of Frost & Sullivan. Similarly,
Chris Bergistrom of WellDoc said his group "applauds the FDA
for quickly and aggressively tackling this complex area as the
explosion of mobile applications has created confusion for both
manufacturers and consumers."
EU is reviewing Vanda's antipsychotic
Fanapt for approval
Vanda Pharmaceuticals said its schizophrenia drug candidate Fanapt
is undergoing regulatory evaluation in the EU. Novartis holds U.S.
and Canadian marketing rights to Fanapt.
Valeritas gets CE Mark for insulin
delivery device
European regulators have approved Valeritas' V-Go insulin
delivery system, which can administer basal-bolus therapy to adult
patients. The disposable device already is cleared in the U.S.
FDA issues guidelines covering changes in
510(k) devices
The FDA has released
draft guidelines that outline the types of changes to
previously cleared 510(k) devices that will require device makers
to submit new premarket applications. Such changes could include
new labeling, technology or performance parameters. Dr. Jeffrey
Shuren, director of the agency's Center for Devices and
Radiological Health, said the guidance is intended to help device
makers save on time and reduce costs as they alter their
products.
Kansas Bioscience Authority to award $6
million in grants
The Kansas Bioscience Authority's board has voted to award $6
million in grants to research projects and life sciences startups
in the state. Among the recipients is Novita Therapeutics, which
will use an equity investment worth $600,000 to develop an
implantable heart device.
NxStage taps Theradial to supply its
hemodialysis device in France
NxStage Medical has signed an agreement that calls for Theradial to
distribute its System One hemodialysis treatment device in France
over five years. The deal also covers the marketing of
NxStage's Medisystems ButtonHole needles among dialysis
providers in the country.
Becton names president as chief
executive
Becton Dickinson has selected President and Chief Operating Officer
Vincent Forlenza to serve as its new CEO, effective Oct. 1.
Forlenza will replace Edward Ludwig, who will serve as the
company's executive board chairman through June 2012.
Smith & Nephew restructures to focus
on higher growth markets
U.K.-based Smith & Nephew will combine its orthopedic
reconstruction unit in Tennessee and its endoscopy division in
Massachusetts into a single entity called Advanced Surgical Devices
Division, a spokesman for SNN said. The move would allow the
orthopedic giant to focus on key growth markets in India, Russia,
China and Brazil.
Study: Glucose sensor holds promise for
spotting chemicals in blood
Scientists at the University of Illinois at Urbana-Champaign have
demonstrated that an off-the-shelf glucose monitoring device has
the potential to detect uranium, cocaine and other substances in
blood samples without the need for costly laboratory tests. The
hope is to make chemical test kits commercially available, one
researcher said.
Michigan hospital uses robotic arm for
spine surgery
Dr. John Keller of Michigan's Metro Health Hospital has begun
using a computer-aided robotic arm to assist in spinal implant
surgery. The tool, called Renaissance, was developed by Israeli
firm Mazor Robotics and enables providers to pinpoint the spot to
place a screw in the patient's spine and lessens tissue
retraction during surgeries.
FDA requests feedback on SOP for
communicating regulatory matters
The FDA has introduced a standard operating procedure mandating the
Center for Devices and Radiological Health to use "Notice to
Industry" letters to more quickly inform device makers of any
revisions to its regulatory prospects, which could have an effect
on information submitted to the agency as part of an
investigational device exemption or premarket application. The
guidance document outlining the new SOP will be up for comment
through Sept. 19.
Alphatec responds to FDA's warning
letter over PureGen
Alphatec Spine has provided the FDA with additional information
supporting the existing classification of its PureGen bone
regeneration product, which it developed with Parcell Laboratories.
The move was in response to an FDA warning letter saying that
Parcell must obtain a biologics license to further develop the stem
cell-based product, which the agency says was miscategorized.
"Both Alphatec Spine and Parcell Laboratories are fully
committed to work closely and collaboratively with the FDA to
address the questions related to the PureGen product," said
Dirk Kuyper, Alphatec Spine's president and CEO.
Australian regulator approves GI
Dynamics' EndoBarrier
The Australian Therapeutic Goods Administration has granted GI
Dynamics approval to market its EndoBarrier Gastrointestinal Liner,
an implant that forms a barrier between food and the intestine, for
the treatment of obesity and type 2 diabetes. EndoBarrier, which is
classified as an investigational device in the U.S., is being
marketed in South America and Europe.
Report: Value of global imaging market
could reach $26.6B by 2016
The global diagnostic imaging market could be valued at $26.6
billion by 2016, spurred by the aging population, medical
innovations and the increasing knowledge about preventive care,
according to a report from research firm MarketsandMarkets. Hybrid
nuclear imaging modalities, including PET/CT, SPECT/CT and MRI/PET,
are leading the imaging services that are gaining market attention,
according to the report.
Study: Medtronic's Resolute beats out
Boston Scientific's Taxus stent
An eight-month study found that patients who received
Medtronic's Resolute drug-eluting stent had lower rates of
in-stent late lumen loss and target lesion failure compared with
those who got Boston Scientific's Taxus stent. The Japanese
trial could aid Medtronic in its bid to secure regulatory approval
for the device in Japan.
Sunshine Heart secures $5M for
counterpulsation device
Sunshine Heart said it generated $5 million from the sale of 115
million shares of the firm's stock. The Eden Prairie,
Minn.-based company will use the proceeds to further develop its
C-Pulse(R) Heart Assist System, which is used in patients with
moderate to severe heart failure.
Cardiovascular Systems' deal with
hospital GPO takes effect
Cardiovascular Systems is moving ahead with distributing its
artery-declogging device to hospital group purchasing organization
HealthTrust, under a deal that went into effect July 15. The
catheter-based device is designed to clear plaque from blocked
arteries.
OraSure expands in molecular diagnostics
with DNA Genotek purchase
OraSure Technologies has agreed to pay $53 million to purchase DNA
Genotek, a Canada-based developer of oral-fluid collection systems
used in molecular diagnostics. The acquisition is expected to be
completed during the third quarter.
ResMed taps CareFusion to market its
ventilators in the U.S.
CareFusion has signed a five-year exclusive deal to distribute
ResMed's ventilators to health facilities in the U.S. The
devices, which secured U.S. market approval this year, aid patients
struggling to breathe on their own.
Study: Blood test may also predict heart
disease in diabetes
Using the hemoglobin A1c test may also predict cardiovascular risk
in patients with type 2 diabetes, a study in the Archives of
Internal Medicine found. According to the findings, about 71.9% of
female and 24.5% of male participants with the disease both have
less than 20% risk of developing cardiovascular conditions over the
next decade.
PercuVision plans upgrade of urological
catheter
PercuVision is working on a second-generation version of its
DirectVision System, designed to treat urinary catheter issues. The
Columbus, Ohio-based company will use $1 million in state funds to
help with upgrading the device, which could be available as soon as
next year.
Drugs & Biologics
Judge throws out lawsuit challenging
embryonic stem cell funding
U.S. District Judge Royce Lamberth dismissed a lawsuit challenging
federal funding for studies involving embryonic stem cells,
upholding an appeals court ruling in April. Last year, Lamberth
ordered an injunction on government funding for such research.
"We're evaluating all of our options for appeal,"
said Steven Aden, one of the lawyers representing the scientists
who filed the lawsuit.
FDA approves generic diabetes treatment
from Strides
The FDA authorized multiple doses of Strides Arcolab's
acarbose, a generic treatment for diabetes. Strides said Perrigo
will launch the product under a profit-sharing arrangement.
AstraZeneca sets aside $647M to settle
Seroquel lawsuits
AstraZeneca resolved 28,461 product-liability lawsuits claiming the
company was aware of diabetes risk in antipsychotic Seroquel. The
company allotted $647 million to settle the cases. The drugmaker
might use some of the money for 250 outstanding lawsuits.
Makers of diabetes drug Bydureon respond
to FDA concerns
Alkermes, Eli Lilly and Co. and Amylin Pharmaceuticals sent the FDA
additional data on their diabetes treatment Bydureon, or exenatide.
The response includes a finding that Bydureon does not affect heart
rhythm of healthy people. "We are confident that the study
results and our detailed submission have addressed the requirements
outlined by the FDA, and we remain committed to making Bydureon
available to patients in the U.S. as soon as possible," said
Amylin official Christian Weyer.
Yaupon submits topical lymphoma drug for
FDA approval
Yaupon Therapeutics is seeking FDA approval to market a gel-based
topical version of mechlorethamine hydrochloride for treating
early-stage mycosis fungoides. The agent is approved as IV
chemotherapy for the disorder, a common form of cutaneous T-cell
lymphoma.
Genzyme and Isis seek EU approval of
cholesterol drug
Isis Pharmaceuticals and Genzyme filed a marketing application in
the EU for mipomersen to treat familial hypercholesterolemia, a
rare genetic disorder characterized by high cholesterol. The
injectable drug is designed for self-administration weekly. The
drugmakers expect to submit mipomersen for FDA approval this
year.
FDA is urged to strengthen warning on
steroid-based drugs
Consumer group Public Citizen and University of Michigan professor
Jonathan Trobe filed a petition urging the FDA to include a warning
about chorioretinopathy risk in prednisone and other steroid-based
medicines. "It's useful to know that a lot of visual
complications are associated with steroids, and if people develop a
problem, they should see an eye care specialist," said
Trobe.
ISTA gets FDA warning for misleading
promotion of Bromday
The FDA said a flier for ISTA Pharmaceuticals' eye drop Bromday
omitted information about safety risks. The drug was approved as a
replacement for Xibrom, which received a similar FDA warning last
year.
FDA agrees to review Takeda and
Affymax's anemia drug
Affymax and Takeda Pharmaceutical's drug candidate peginesitide
was accepted for FDA review. Formerly named Hematide, the
once-monthly drug is intended for anemia in kidney patients on
dialysis.
Hexal pulls EU application for a generic
of bone drug Bondronat
Novartis subsidiary Hexal decided to stop seeking EU approval to
market a generic version of Bondronat, Roche Holding's drug for
preventing bone problems in breast cancer patients. Hexal
"stated that its decision to withdraw the application was
based on the fact that the [European Commission] considers that the
co-marketing reasons weren't acceptable in this case,"
said the European Medicines Agency.
FDA uncovers falsified research data from
contractor Cetero
Drugmakers might need to re-evaluate bioanalytical data provided by
Cetero Research to support new-drug applications between April 2005
and June 2010, the FDA said. The agency said it uncovered falsified
clinical data during May and December inspections of the contract
research organization's Houston facility.
FDA proposes tougher criteria for
bioequivalency
The FDA plans to tighten bioequivalence requirements for drugs with
a narrow therapeutic index or critical dose. An advisory panel
discussed the appropriateness of the agency's definition and
scale of bioequivalency for such products.
FTC sets conditions for Perrigo-Paddock
merger
The Federal Trade Commission is requiring Perrigo and Paddock
Laboratories to divest six products as part of their $540 million
merger. The deal is expected to conclude during fiscal 2012, which
started July 1.
FDA warns of mixing Zyvox with
serotonergic antidepressants
The FDA warned that Pfizer's antibiotic Zyvox might interact
with serotonergic antidepressants and cause serotonin syndrome.
Zyvox's packaging insert "already includes prominent
information regarding the potential for serotonergic interactions,
the risk of serotonin syndrome and the need for careful observation
of patients prescribed Zyvox who are on such agents," said
Pfizer spokeswoman Kristen Neese.
U.S. inquires about AstraZeneca-Medco ties
involving 4 drugs
The Justice Department subpoenaed AstraZeneca and pharmacy-benefit
manager Medco Health Solutions for documents about their
relationship pertaining to four medicines. The products are
antacids Prilosec and Nexium as well as hypertension drugs Plendil
and Toprol XL.
FDA approves Strides unit's generic
cancer drug gemcitabine
A Strides Arcolab unit obtained FDA approval to launch gemcitabine,
an injectable treatment for cancer. "Gemcitabine is part of
the oncology portfolio licensed to Pfizer in January 2010 for the
U.S. market and will be launched immediately," said Strides
Arcolab.
Price controls for Medicare Part D could
thwart competition, innovation
The Obama administration's proposal to implement in Medicare
Part D price controls adopted in other parts of Medicare in an
attempt to reduce the deficit could eliminate competition among
drugmakers and private insurers, stifle medical innovation and
undermine a program that has been successful in saving money for
the government and seniors, Tomas J. Philipson, a professor of
public policy at the University of Chicago, writes in this Wall
Street Journal opinion piece. "It turns out that in addition
to its competitive structure, Part D also has the strength of being
relatively more means-tested than other parts of Medicare. The
bottom line is that Part D's model works and it should be
extended into other parts of Medicare -- not vice versa,"
Philipson writes.
Patent expiration will drive down prices
of best-selling drugs
Seven of the industry's 20 blockbuster medicines will go off
patent within the next two years, clearing the way for generic
versions, which usually are 20% to 80% cheaper. Pfizer's statin
Lipitor as well as Sanofi and Bristol-Myers Squibb's
anticoagulant Plavix will lose market exclusivity by September
2012.
FDA's CDER outlines need for
postmarket data on drug safety
A report from the FDA's Center for Drug Evaluation and Research
published in the Federal Register outlines several areas that it
says need to be improved to address the country's regulatory
science needs. Ensuring the accuracy of postmarket data is an
important tool in evaluating drug therapy results, according to the
report. The report also touched on other areas that need to be
improved, including the development of predictive models,
monitoring of trials and personalization of treatments.
Takeda tries again for FDA approval of 2
diabetes medicines
Takeda Pharmaceutical reapplied for FDA approval of diabetes drug
candidate alogliptin as well as a fixed-dose combination of
alogliptin and pioglitazone. The agency set a six-month review
period for both drugs.
FDA expands use of Daiichi's liquid
diabetes drug Welchol
The FDA granted Daiichi Sankyo approval for another formulation of
liquid diabetes drug Welchol, which lowers blood glucose and
cholesterol. The latest formulation can be mixed with fruit juice
or diet soda.
Lupin submits generic of Watson's
contraceptive for FDA OK
Warner Chilcott received notice that Lupin is seeking FDA approval
of generic Lo Loestrin Fe, a birth control pill. Warner is
reviewing the notice and will pursue a patent-infringement lawsuit
within 45 days, the company said.
FDA OKs another delivery method for
Baxter's immunotherapy
The FDA is allowing subcutaneous, or under-the-skin, administration
of Gammagard Liquid, Baxter International's treatment for
primary immunodeficiency. The prescription drug is also delivered
by IV infusion.
Biogen's MS drug Fampyra gets
conditional EU approval
The European Commission granted Biogen Idec conditional approval
for Fampyra to improve walking ability of adults with multiple
sclerosis. The oral treatment is sold by Acorda Therapeutics in the
U.S. as Ampyra.
Canada approves Valeant's insomnia
treatment Sublinox
Valeant Pharmaceuticals International received approval in Canada
to market Sublinox as short-term therapy for insomnia. The drug is
expected to be launched in the fourth quarter.
Food & Dietary Supplements
Report: Tips about food safety issues will
earn rewards in China
The Chinese Food Safety Commission asked all local agencies to give
rewards to people who tip them off about the illegal use of
additives and other food safety problems, according to a directive
cited by Xinhua news agency. The agencies are expected to offer
protection against "revenge attacks," to those who report
food safety irregularities, according to state media.
Panel to require provincial clearance for
biotech crop trials in India
The Genetic Engineering Approval Committee in India earlier this
month said it will require researchers to secure no-objection
certificates from provincial governments before starting field
trials of biotech crops. "Very few trials will take place
because of this order," said Ram Kaundinya, chairman of the
Association of Biotech Led Enterprises - Agriculture Group.
Kaundinya said association officials have begun talks with the
committee and agriculture ministry and will discuss the requirement
with state governments.
Congress steps forward to challenge
food-ad rules for children
The food, beverage, ad and media industries are winning some ears
on Capitol Hill, with members of Congress stepping up to challenge
the Federal Trade Commission's proposed voluntary guidelines to
curb food marketing to children. Both Democratic and Republican
lawmakers are stepping in, demanding cost-benefit analyses and
moving to forbid the use of funds to implement the guidelines,
which are considered by some to be voluntary in name only.
Safety law's controls aren't
needed at warehouses, groups tell FDA
Several groups, including the International Warehouse Logistics
Association and Grocery Manufacturers Association, told the FDA
that subjecting warehouses solely involved in storing packaged
foods to the Food Safety Modernization Act's full hazard
analysis and preventive controls provisions would be redundant.
Applying such extensive rules to such facilities "would create
significant costs and administrative burdens without a
corresponding benefit to public health," the associations
wrote in a petition to the FDA.
Senators seek FDA's explanation on
delay in gluten-free-labeling laws
Sens. Ron Wyden, D-Ore., and Patrick Leahy, D-Vt., asked the FDA
for updates on when it will implement gluten-free-labeling
regulations and demanded an explanation for the delay in enforcing
such rules. "The regulatory uncertainty surrounding FDA's
inaction has led to a proliferation of 'gluten free'
standards and labels provided by 3rd party groups. This creates
confusion for consumers, and hesitancy amongst producers on what
their requirements will be," they wrote in a letter to FDA
Commissioner Dr. Margaret Hamburg.
FDA looks at possible link between
salmonella and papaya
The FDA has warned people to avoid eating Agromod Produce's
papayas as it investigates a possible association with a salmonella
outbreak in 23 states, including Texas and Illinois. The agency
said the outbreak has sickened 97 people and hospitalized 10.
Agromod initiated a voluntary recall of several brands of papayas
that came from Mexico.
Georgia task force looks for solutions to
"food deserts"
The Georgia Supermarket Access Task Force will meet this week to
come up with ways to bring more fresh fruits and vegetables and
other healthier foods to urban "food deserts" in an
effort to reduce obesity rates. One study found that almost 2
million people in the state, including many children, live in
low-income neighborhoods that do not have enough supermarkets. The
elderly in such neighborhoods have problems finding transportation
to larger stores that offer better selections of food.
Tobacco
Appeals court hears arguments on tobacco
law
A three-judge panel of the 6th U.S. Circuit Court of Appeals heard
arguments in a case challenging the provisions of the Family
Smoking Prevention and Tobacco Control Act, which gives the FDA the
authority to regulate tobacco advertising. Noel Francisco, a lawyer
for R.J. Reynolds, argued that the law restricts tobacco
companies' free-speech rights. Mark Stern of the Justice
Department said the government has a duty to oversee the marketing
of "lethal and addictive" tobacco products.
American Spirit cigarettes tout green
production methods
Cigarette-maker Reynolds American is trying to get in on the
"greening" trend with magazine ads that call its Natural
American Spirit brand "eco-friendly." The company says
the green pitch refers only to its manufacturing process, which it
says has become more energy efficient, and is not a commentary on
the safety of the cigarettes. The ads attempt to "greenwash a
deadly and addictive product," said Vince Willmore of the
Campaign for Tobacco-Free Kids.
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