CONTENTS:
- Medical Devices
- Drugs & Biologics
- Dietary Supplements
- Tobacco
Medical Devices
GE to work with Singaporean agency to
improve medical imaging
Singapore's Agency of Science, Technology and Research has
collaborated with GE Global Research on development of imaging
technology for medical use, including PET, CT and MRI. The
partnership aims to work with local hospitals to speed up diagnosis
and improve treatment of cancer and other diseases.
Guidance maps clearance process for trials
of knee cartilage products
New guidance from the FDA outlines the process for obtaining
clearance for clinical studies of devices, combination products and
biologics designed to replace or repair knee cartilage. The guidance requires manufacturers seeking
investigational device exemption to submit documents describing
materials used, individual elements, anticipated product changes
and related data.
Disinfecting port protector from Ivera
Medical gets FDA OK
Ivera Medical has received 510(k) clearance from the FDA for its
Curos disinfecting port protector meant to minimize the risk of
catheter-based bloodstream infections. The device has been shown in
clinical trials to disinfect intravenous access ports in three
minutes.
FDA fails to meet deadline on device user
fee proposal
The FDA missed the Jan. 15 deadline to submit to Congress its
proposal on fees to accelerate medical device reviews as the agency
remains in negotiations with the industry. The FDA is asking for up
to $805 million over five years, while the latest meeting minutes
available show the industry has proposed $447 million. If agreement
isn't reached by Feb. 15, Congress may take over the
negotiations, although AdvaMed's Wanda Moebius reported that
progress is being made.
Agfa wins FDA clearance for digital
imaging device
The FDA has given Agfa HealthCare the green light to offer its DX-M
computed radiography digitizer on the U.S. market. The device,
which has needle-based detectors, features the company's
Musica2 advanced image processing system and is designed for use in
general radiography and digital mammography.
Experts say FDA's "chemical
action" definition is too broad
Industry experts have expressed concern that the FDA's
definition of a "chemical reaction" to rule out a product
as a device is subjective and too broad. According to the FDA, if a
product facilitates cellular or molecular responses or if it
changes an entity to influence its interaction with a human's
or animal's body, then it is not a device. This definition may
lead the Center for Devices and Radiological Health to not consider
a new product approval application as a device, which will make
device makers uneasy because they are used to being reviewed by the
CDRH, experts said during a panel discussion Wednesday at the
University of St. Thomas, Minnesota.
EU considers targeted sampling of
Brazilian juice
The European Commission notified the orange juice industry that it
might follow the FDA's lead in testing imports for the
fungicide carbendazim. The commission will consider Brazilian juice
sampling based on U.S. findings, but it would use a maximum residue
limit of 200 parts per billion, 20 times higher than the FDA's
limit.
Funding round brings in $2.5 million for
Cambridge Heart
Cambridge Heart said it has pulled in $2.5 million in its latest
round of private placement. The Tewksbury, Mass.-based company
develops noninvasive cardiac disease diagnostic tests that run on
its proprietary Microvolt T-Wave Alternans measurement systems.
SPR Therapeutics pulls in $2.2 million in
Series A funding
Cleveland-based SPR Therapeutics has secured $2.2 million in a
Series A financing round led by NDI Medical and has also enlisted
an investment firm to help it find strategic partners, CEO Maria
Bennett said. The company is awaiting CE mark approval for its
device used to treat shoulder pain in stroke patients and plans to
seek FDA clearance for the product in two years.
Radiology group develops imaging
application
Columbus Radiology has developed a website that can serve as a
smartphone mobile application and features guidelines to help
physicians in their decisions regarding imaging procedures. The
company said it is working with hospitals and other groups to
launch licensed versions of the application.
Glucose meter allows wireless connection
between patients, docs
Bethesda, Md.-based Telcare has launched a new cellular-enabled
blood glucose meter designed to allow wireless transmission of
glucose readings to patients' doctors, pharmacists or
caregivers. The Telcare BGM automatically uploads testing data to
the Telserve database, which doctors and caregivers can access
through a provider portal.
Bioconnect aims to raise about $10 million
in funding round
Ambler, Pa.-based Bioconnect Systems hopes to obtain as much as $10
million in a Series B funding round. The company will use the
proceeds to support clinical studies, seek FDA approval and
commercialize its Optiflow Vascular Anastomotic System, an
implantable device designed to improve the way surgeons create
fistulas in hemodialysis patients.
CareFusion lands FIPS certification for
Alaris infusion pumps
CareFusion said its Alaris pumps for intravenous drug delivery have
been certified as meeting the National Institute of Standards &
Technology's Federal Information Processing Standard for such
devices. The company is the first to obtain such certification,
which is required for all infusion systems that wirelessly transmit
sensitive data via the Veterans Affairs Department networks.
St. Jude Medical debuts MRI-safe pacemaker
in India
St. Jude Medical is rolling out in India its Accent MRI system,
which is billed as the first MR-conditional pacemaker to enable
patients implanted with the device to safely receive full-body MRI
scans. Kaustav Bannerjee, St. Jude Medical?s India manager, said
the growing incidence of heart disease in that country is expected
to boost demand for the device.
Ventana Medical strikes deal with Bayer for cancer
assay
Ventana Medical Systems has signed a deal with Bayer Pharma to
develop, produce and market a molecular diagnostic assay that will
help pinpoint patients who may potentially benefit from the drug
firm's antibody-drug conjugate for cancer treatment. The deal
follows similar agreements that Ventana recently struck with Syndax
Pharmaceuticals and Pfizer.
Funding round brings in $10 million for
Carticept Medical
Carticept Medical said in a regulatory filing that it has secured
$10 million in a financing round. The Alpharetta, Ga.-based company
specializes in devices used to treat damaged cartilage, including
an automated, ultrasound-guided system for patients with joint pain
and arthritis.
Medtronic's Endurant II stent graft
arrives in EU market
Medtronic has announced the commercial release of its Endurant II
stent graft in Europe, which comes on the heels of a CE mark
approval for the device. The system, which is used to treat
abdominal aortic aneurysms, is on schedule to obtain premarket
approval in the U.S. this year.
2 biotech firms create Chinese diagnostics
business
Life Technologies and DaAn Gene agreed to form a joint venture
called Life Technologies DaAn Diagnostics. The China-based business
will use Life Technologies' 3500Dx Capillary Electrophoresis
device and Big Dye Cycle Sequencing technologies to develop
molecular diagnostic tests.
Boston Scientific reports positive trial
results for Epic stent
Patients with iliac artery disease had a reduced rate of major
adverse events, at 3.4%, nine months after receiving Boston
Scientific's Epic stent, according to a 125-patient study. The
company will use the data to back its FDA submission for the Epic
stent, which presently is classified as an investigational device
in the U.S.
Innovation challenge seeks "Star
Trek"-style medical tricorder
The X Prize Foundation and Qualcomm Foundation are offering a $10
million prize to innovators who can create a medical device similar
to the tricorder used in "Star Trek." The 42-month challenge, unveiled at the 2012
Consumer Electronics Show, is looking for a device that is
user-friendly, weighs five pounds or less, can detect 15 diseases
noninvasively and can record health metrics such as blood pressure
and heart rate.
Criticare, Opto enter supply deal for
patient monitors in Russia
India-based device maker Opto Circuits has entered a deal with
Criticare Systems to provide its nGenuity patient monitors to four
hospitals in the Tyumen Oblast province of Russia. The devices will
be distributed through Elmedica, Criticare's supply channel in
Russia.
Biotronik to set up shop in
Singapore
Berlin-based Biotronik has announced plans to establish an office
in Singapore to bolster its presence in the Asia Pacific region.
The device maker expects its product offering, which includes its
MRI-safe Lumax implantable defibrillator that already has CE mark
approval in Europe, to promote continued growth for the company
over the short term.
Terumo boosts surgical product line with
Onset acquisition
Onset Medical, which develops sheath technology for urology and
cardiology procedures, has been acquired by Terumo Medical for
undisclosed terms. The acquisition, which will allow Onset to
operate under the Terumo Interventional Systems division, is
expected to expand Terumo's minimally invasive surgical device
portfolio.
Roche strikes marketing deal with
Ind-Swift for heart assay
Roche Diagnostics has agreed to allow Indian generics company
Ind-Swift to distribute in India its TROP T rapid test, an assay
that can diagnose heart attacks in 15 minutes. Dr. Bhuwnesh
Agrawal, chairman and managing director at Roche Diagnostics India
and South Asia, said the partnership will allow the company to gain
a foothold in its target markets.
W.L. Gore gets expanded FDA approval for
endovascular graft
The FDA has granted approval to W.L. Gore and Associates to expand
the use of its Gore Tag Thoracic Endoprosthesis device, an
endovascular graft initially approved for aneurysm treatment. The
expanded label allows the use of the device for treating patients
with aortic tears.
Konica scores FDA clearance for digital
mammography upgrade
Konica Minolta Medical Imaging's enhanced Xpress CR digital
mammography system has been cleared by the FDA for use with the
company's CP1M 18 x 24 and 24 x 30 cassettes. The clearance
also applies to the use of the CS-3 control station with the
imaging firm's Regius 210 and 190 readers.
Aerocrine gets reimbursement win for
asthma device in U.S.
Aerocrine said the Medicaid program in Mississippi has approved the
reimbursement coverage for its FDA-cleared Niox Mino asthma
management device, so that now 29 U.S. states, as well as the
District of Columbia, have agreed to cover the system. The Swedish
firm also received clearance to market the device in Taiwan and
Korea.
Thoratec gets FDA warning over delayed
filings
Thoratec has received a warning letter from the FDA concerning the
late filing of two medical device reports following the
agency's inspections last year. The company said it believes
the issues raised in the FDA warning letter can be addressed
without affecting its financial results or operations.
Physcient eyes $4 million in funding for
chest surgery device
Durham, N.C.-based Physcient hopes to obtain $4 million in funding
to further develop and file a 510(k) application for its Assuage
device. The technology, which could be commercially available in
about 16 to 18 months, would allow less trauma to patients
undergoing open-chest procedures than traditional thoracic
retractors.
Cardica halts European trial of
MicroCutter XPress 30 device
Cardica said it has ended patient enrollment in a clinical study of
its MicroCutter XPress 30 in Europe. Although no adverse events
tied to the device were reported, the company said it will need to
make modifications to boost the device's performance in thicker
tissue. "We are disappointed that the XPress 30 did not
perform as well as we expected in the upper range of tissue
thickness but understand and are confident we can make the changes
needed to enhance performance," said President & CEO Dr.
Bernard Hausen.
Personalized knee replacement device using
robotics debuts in U.K.
Stanmore Implants announced that its Savile Row device, which the
company touts as the first fully customized knee replacement system
to use robotics during insertion, is commercially available in the
U.K. The device uses robotic technology to allow for more accurate
surgery, boost implant longevity and reduce the risk of early
revision procedures, according to the Elstree, U.K.-based
company.
Funding round brings in $1.86 million for
InCytu
A regulatory filing disclosed that InCytu has raised $1.86 million
in its latest round of financing from 11 unnamed investors. The
Lincoln, R.I.-based company will use the money to move its platform
technology for the Cellarium cancer vaccine from development to
clinical trials, said Anthony Vasconcellos, InCytu's president
and CEO.
Mecca pilgrims turn to Zoll's devices
to combat heat stroke
Zoll Medical said the Saudi Arabia Ministry of Health purchased six
of its temperature management devices to treat heat stroke patients
during last year's Hajj pilgrimage to Mecca. The device, which
uses an intravascular cooling process, has been shown in a clinical
trial to cut fever by 64% compared with surface cooling.
Zimmer beefs up product portfolio with
Synvasive buy
Zimmer has purchased Synvasive Technology for undisclosed terms.
The buyout will allow Zimmer to add to its product offering
Synvasive's eLIBRA Dynamic Knee Balancing device and its
STABLECUT surgical saw blades.
3-way deal seeks to develop companion test
for Pfizer's Xalkori
Pfizer, Roche Holding unit Ventana Medical Systems and Cell
Signaling Technology formed a three-way partnership for a
diagnostic test to be used with Xalkori, a recently FDA-approved
drug for nonsmall-cell lung cancer. Ventana will create the
immunohistochemistry-based device using CST technology to identify
patients with ALK gene rearrangement.
Intact Vascular pulls in $1.1 million in
debt offering
Wayne, Pa.-based Intact Vascular has obtained $1.1 million in a
round of debt financing targeted at $1.5 million, according to a
regulatory filing. The company develops medical systems used in
blood vessels.
Blood glucose monitor from Roche gets FDA
OK
Roche has received FDA clearance for its Accu-Chek Nano SmartView
system for monitoring blood glucose. The device, which is targeted
for U.S. market launch in the first half of this year, is designed
to allow diabetes patients to create personalized test alerts and
meal markers, as well as compute their average glucose levels.
BG Medicine appoints former bioMerieux
exec as CEO
Eric Bouvier, former president and CEO of bioMerieux, has been
selected to serve as president and CEO at diagnostics device firm
BG Medicine. Bouvier replaces Dr. Pieter Muntendam, who will remain
as BG Medicine's executive vice president and chief medical
officer.
Drugs & Biologics
PhRMA: Clearer FDA rules are needed on
primary-care drugs
A lack of explicit guidance on the FDA's risk-benefit
determination hinders the development of treatments for common
medical conditions in primary care, said Chris Viehbacher, chairman
of the Pharmaceutical Research and Manufacturers of America and CEO
of Sanofi. The FDA has drawn criticism from drugmakers for its
cautious approval process for weight-loss medicines and other
products intended for wide use.
FDA approves pediatric formulations of
Gilead's HIV drug Viread
Gilead Sciences received FDA approval to market three lower doses
of HIV drug Viread for patients ages 6 to 12. Viread, or tenofovir
disoproxil fumarate, is available at 300 milligrams for use with
other anti-retrovirals in patients age 12 and older. The FDA also
authorized an oral powder version for 2- to 5-year-olds.
J&J settles Risperdal marketing case
in Texas for $158M
Johnson & Johnson reached a $158 million settlement with Texas
in a lawsuit that accused the company of improperly promoting
Risperdal and overstating the antipsychotic's benefits. J&J
did not admit any fault or liability.
Merck agrees to end Canadian liability
claims involving Vioxx
Merck & Co. will pay as much as $36.5 million to resolve
litigation in Canada related to Vioxx, a withdrawn treatment linked
to stroke and heart attack. The drugmaker previously settled U.S.
criminal and civil allegations of off-label marketing for about
$950 million.
Medipost's stem cell drug gets OK in
South Korea
Medipost obtained approval from the Korea Food and Drug
Administration to sell Cartistem, an allogeneic stem cell drug that
aids in knee cartilage regeneration. Cartistem is the world's
first approved drug that uses stem cells from other people, the
South Korean agency said.
FDA declines to approve Bristol and
AstraZeneca's dapagliflozin
AstraZeneca and Bristol-Myers Squibb received a complete-response
letter from the FDA for type 2 diabetes medicine dapagliflozin. The
agency wants more clinical data and possibly further testing, the
companies said. FDA advisers had refused to endorse dapagliflozin,
citing risks of cancer and liver injury.
Former Sanofi researcher admits stealing
confidential information
Yuan Li, a former scientist at Sanofi, pleaded guilty in federal
court to secretly accessing data on important compounds and selling
them through the website of Abby Pharmatech, in which Li had a 50%
interest. She is scheduled to be sentenced April 23 and faces a
$250,000 penalty and as long as 10 years in prison.
EU OKs Mass. plant for Genzyme's Fabry
disease drug
The European Medicines Agency is permitting Sanofi division Genzyme
to produce Fabry disease medicine Fabrazyme at a Framingham, Mass.,
facility. The approval "represents an important milestone in
our manufacturing recovery and a path toward unconstrained supply
for all patients," said Genzyme CEO and President David
Meeker. The biotech firm still awaits FDA approval.
Ceptaris' lymphoma gel gains
orphan-drug designation in EU
Ceptaris' mechlorethamine, a drug candidate for cutaneous
T-cell lymphoma, was given orphan-drug status by the European
Medicines Agency. The FDA, which previously granted the same
designation, is reviewing the gel-based treatment.
Novartis receives Chinese approval of
Lucentis and Galvus
The Chinese State Food and Drug Administration approved
Novartis' Lucentis to treat wet age-related macular
degeneration and Galvus as an add-on to standard type 2 diabetes
drug metformin. Novartis is among drugmakers expanding in emerging
markets to boost top-line growth.
Japan authorizes RLS drug Regnite from
XenoPort and Astellas
XenoPort and Astellas Pharma' Regnite, or gabapentin enacarbil,
was approved in Japan as a treatment for moderate to severe cases
of primary restless legs syndrome. The milestone triggers a $10
million payment to XenoPort.
Bayer will seek FDA approval of bowel
cancer drug regorafenib
Bayer HealthCare plans to seek FDA approval of angiogenesis
inhibitor regorafenib for patients with advanced colorectal cancer
who have no other medical options. Study data show longer survival
for some patients taking the drug, which works by shutting down the
mechanism that tumors use to grow blood vessels.
Hemispherx gets 2 patents for Alferon to
prevent viral infection
Hemispherx Biopharma was awarded two U.S. patents for Alferon in
low-dose oral formulation, which is being studied as immunotherapy
for flu and other viral diseases. An injectable Alferon is approved
to treat genital warts.
Alnylam and Tekmira are in legal dispute
over siRNA patents
Tekmira Pharmaceuticals was sued by Alnylam Pharmaceuticals for
infringement of several patents covering small interfering RNA
molecules. The lawsuit says a development pact between Tekmira and
Bristol-Myers Squibb goes beyond three drug targets for which
Tekmira has a nonexclusive license under an amended partnership
with Alnylam.
Lawmaker criticizes FDA's handling of
mislabeled drugs
Novartis' voluntary recall of drugs, including painkillers,
from a Nebraska plant because of a mix-up could have been avoided
if the FDA acted more proactively during inspections, said Rep.
Mary Bono Mack, R-Calif. An FDA spokeswoman cited reasons the
agency did not order a recall, including preventing a shortage of
medically necessary drugs.
FDA authorizes BTG's Voraxaze to
prevent chemo-induced toxicity
BTG received FDA approval of Voraxaze, an injectable medicine that
breaks down chemotherapy agent methotrexate to prevent kidney
failure and other side effects of prolonged exposure. During a
study, 10 of 22 patients had a low concentration of methotrexate in
their blood within 15 minutes of taking Voraxaze, and the effect
was sustained for eight days, the FDA said.
FDA: Prochieve seems ineffective in
reducing preterm-birth risk
Clinical information does not support the efficacy of Columbia
Laboratories and Watson Pharmaceuticals' progesterone gel
Prochieve in lowering certain women's risk of giving birth
prematurely, according to a preliminary FDA review. On Friday, an
advisory panel will determine whether Prochieve should be
recommended for approval.
Researchers accuse Tamiflu maker of
withholding clinical data
Researchers from the Cochrane Collaboration who reviewed 20 studies
found that Tamiflu did not decrease flu-related complications in
the lower respiratory tract, plus the drug caused nausea. The
researchers fear other adverse reactions were under-reported. They
also said maker Roche Holding withheld information about the drug
for the review, which Roche denied.
Comparative effectiveness board to
announce national priorities
The Patient-Centered Outcomes Research Institute, an independent
board tasked with comparing the effectiveness of medical
treatments, will announce its priorities for spending $3 billion
over the next decade. Some patient advocacy groups worry that the
board's recommendations, which are not intended to be binding,
will cause insurers to drop coverage for certain treatments.
CMS to issue pharma transparency
rules
Companies that make products covered by Medicare or Medicaid will
have to disclose all payments to doctors, which will be posted on a
publicly available federal website. The rules will cover companies
with at least one product covered by Medicare or Medicaid.
Canada to expedite review of
ViroPharma's angioedema drug
Cinryze, ViroPharma's treatment for hereditary angioedema,
obtained priority-review status from Health Canada. The regulator
is expected to complete its evaluation within the second half of
the year.
Survey to gather providers' feedback
on prescription drug ads
The FDA will conduct a national survey of 2,000 health care
providers about direct-to-consumer advertising for prescription
medicines, according a notice to be published in the Federal Register.
A previous survey found differences in opinions on how ads
influence clinical practice.
FDA: User error caused problems with
CardioGen-82
The FDA has released a statement saying initial results of an
investigation show problems with Bracco Diagnostics' cardiac
PET imaging agent CardioGen-82 appear to be the result of user
error rather than a manufacturing issue. The agency in July warned
against the use of the product after it was linked to two possible
cases of radiation exposure that was excessive. The FDA said it is
collaborating with Bracco to improve the product's
labeling.
FDA fines Red Cross $9.59M over
violations
The FDA has fined the American Red Cross $9.59 million over
violations of blood-safety rules after an investigation stemming
from a 2010 inspection. "We are disappointed that the FDA
believed it necessary to issue a fine for an inspection conducted
so long ago and it is important to know we have already taken
corrective steps to address those matters and that improvements in
operations have been made," the Red Cross said.
Glenmark gets favorable ruling in
arbitration with Napo
A U.S. arbitration panel issued an interim order that bars Napo
Pharmaceuticals from ending a licensing deal with Glenmark
Pharmaceuticals or from considering the partnership terminated. At
issue is experimental diarrhea medicine crofelemer. Glenmark said
the next arbitration hearing is scheduled at the end of March.
Reuters (1/13)
Lawsuit alleges Walgreen and Par
overcharged for generics
Walgreen filled prescriptions between April 1999 and December 2006
with higher-priced capsules from Par Pharmaceutical instead of
lower-priced tablets prescribed by doctors, according to a lawsuit
filed by the United Food and Commercial Workers Unions and
Employers Midwest Health and Pension Funds. Drugs included generic
versions of Boehringer Ingelheim's heartburn medicine Zantac
and Eli Lilly and Co.'s antidepressant Prozac.
User-fee agreement heads to
Congress
A final agreement between the FDA and the pharmaceutical industry
on user fees for prescription, generic and biosimilar drugs was
submitted for approval by Congress. "At a time of greater
budgetary constraint, user fees provide a critical way for
leveraging appropriated dollars, ensuring that the FDA has the
resources needed to conduct reviews in a timely fashion," FDA
Commissioner Margaret Hamburg said.
FDA strengthens warning label of blood
cancer drug Adcetris
The FDA confirmed three cases of progressive multifocal
leukoencephalopathy in lymphoma patients treated with Seattle
Genetics and Takeda Pharmaceutical's Adcetris, or brentuximab,
and ordered a boxed warning about the brain infection risk. The
agency also warned against mixing Adcetris with bleomycin, another
cancer medicine, because the combination might cause pulmonary
toxicity.
FDA updates guidance on recalls of 2
injectable drugs
The FDA released a new guidance involving Bedford Laboratories'
voluntary recall of certain lots of antibiotic polymyxin B and
muscle relaxant vecuronium bromide due to particulate
contamination. The agency said no adverse reactions have been
reported and advised health care providers to quarantine the
affected products until they are returned to maker Bedford.
Genentech to face trial over Raptiva's
adverse effects
The first of many lawsuits alleging that Genentech played down
risks of Raptiva, a psoriaris drug, is scheduled to go to trial in
California on Jan. 30. Raptiva was taken off the market in 2009
because of its link to a fatal brain infections.
282 child-specific drugs are in the
pipeline, group says
The biopharmaceutical industry has 282 drugs undergoing clinical
development or FDA evaluation for conditions affecting the
pediatric population, the Pharmaceutical Research and Manufacturers
of America reported. The lineup includes therapeutic candidates for
cancer, infectious diseases, genetic diseases and neurological
illnesses. Researchers are also evaluating many existing drugs for
use in children.
Novartis to cut jobs ahead of patent
expiration
Novartis will lay off nearly 2,000 U.S. employees as its
blockbuster blood pressure therapy Diovan loses patent protection
and the company reorganizes its U.S. general medicines unit. Sanofi
and AstraZeneca also announced job cuts recently.
FDA seeks to develop mobile health app on
adverse drug reactions
Inspired by problems that arose amid the 2009 H1N1 outbreak, the
FDA is looking for a vendor to develop a prototype of its Real-Time
Application for Portable Interactive Devices, or RAPID, to help the
agency gather data and send public health reminders on adverse
reactions to experimental drugs prescribed during emergencies.
Communication delays that arose when use of an experimental therapy
was authorized in 2009 highlighted the need for such an app. The
FDA will accept vendor applications through Wednesday, according to
a notice.
Food & Dietary Supplements
Leasa sprouts recalled by
Winn-Dixie
Winn-Dixie said it is voluntarily recalling Leasa brand broccoli
sprouts, gourmet sprouts, onion sprouts and spicy sprouts on
salmonella concerns. The recall is at all Winn-Dixie stores, and
applies to sprouts sold between Jan. 7 and Jan. 18, with expiration
dates between Feb. 1 and March 15.
IBM provides food-tracking
technology
IBM's InfoSphere system uses bar codes to track food through
the supply chain. Users can access the information through a mobile
phone by snapping a picture of a quick-response code.
N.J. lawmakers try again with raw-milk
bill
Lawmakers in New Jersey have introduced a bill allowing raw-milk
sales in the state, identical to a bill that was narrowly defeated
last year. If the bill becomes law, New Jersey will become the 31st
state to allow commercial sales of raw milk.
Guidance on foreign supplier verification
coming soon from FDA
The FDA hopes to release proposed regulations soon for importers on
verifying a food product's compliance with risk-prevention
standards under the Food Safety Modernization Act, an agency
spokesman said. Issuance of the guidance had been scheduled for
Jan. 4.
Rexall withdraws one lot of calcium
supplements
Florida's Rexall recalled one batch of its Calcium 1200 mg plus
1000IU Vitamin D3 softgel products because their bottles were
mistakenly filled with the supplement glucosamine. "People who
have an allergy or severe sensitivity to shellfish run the risk of
serious or life-threatening allergic reaction if they consume this
product," Rexall said.
FDA reassures public about safety of Gulf
seafood
A great deal of work was carried out to ensure that Gulf seafood is
safe to consume after the Deepwater Horizon oil spill, Deputy
Commissioner Michael Taylor wrote on the FDA's blog. "Just
to be sure that we did not miss anything, federal and state
officials continue to collect and test seafood from the Gulf,"
the FDA said on its website. "The seafood we have collected
continues to be free from harmful oil and dispersant
residues."
White paper provides meat-labeling
guidance
Hobart released a white paper that details what grocers must do to
comply with federal meat-labeling law, which requires nutrition
information for popular cuts of raw meat and poultry. The paper,
"New Mandatory Meat-Case Nutrition Labeling Rule," is
available for free download on Hobart's website.
Move could consolidate FSIS and FDA, OMB
official says
The Obama administration wants to consolidate regulatory food
safety roles of the FDA and the Agriculture Department's Food
Safety and Inspection Service, a consumer advocate told The
Hagstrom Report. A consolidation might occur if Congress grants
President Barack Obama power to implement government
reorganization, said Jeff Zients, director for management at the
Office of Management and Budget.
FDA finds no trace of fungicide in juice
from Canada
The FDA said three samples of orange juice from Canada tested
negative for carbendazim, paving the way for re-entry of the
imported product into the U.S. market. Results for other import
samples are expected this week, the agency said.
Tobacco
FDA advisers meet on dissolvable
tobacco
An FDA advisory committee is continuing a discussion on dissolvable
tobacco products during a three-day meeting that begins today.
Public health advocates expressed concern that such products pose a
risk of addiction and nicotine poisoning in young people.
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