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Ingredient Controls in HACCP Systems
May 09, 2006
Source of Article: http://www.meatami.com/
In a May 8, 2006 Federal Register notice, the Food Safety and Inspection
Service (FSIS) informed establishments that prepare meat and poultry products
they need to ensure and maintain proper control over the use of ingredients,
especially those that present a potential public health concern, and over
the ingredient labeling of their products. The notice states that establishments
should guarantee that their systems provide such control as part of the
next HACCP system reassessment.
FSIS is seeking comment on the notice. Comments must be received by July
7, 2006. To read the entire document, click
$3 million in listeria suit
PHILADELPHIA - A woman who gave birth prematurely to a child with disabilities
was awarded a combined $3 million from two poultry companies tied to a
deadly 2002 listeria outbreak, court records unsealed Thursday show. Defendant
J.L. Foods also settled a wrongful-death case this week involving a 98-year-old
doctor who became ill from the bacteria and died a few months later. Several
other cases remain pending in Pennsylvania and New Jersey over the outbreak,
which killed eight people, sickened more than 50, and led to one of the
largest meat recalls in U.S. history. The listeria strain discovered in
the victims was found by federal investigators in meat processed at a
now-closed J.L. Foods plant in Camden, N.J., and in a plant of Pilgrim's
Pride subsidiary Wampler Foods - but not in the meat itself - in Franconia,
J.L. Foods' settlement this week with the family of Frank Niemtzow - a
retired family physician from Freehold, N.J., who delivered rock star
Bruce Springsteen - was not disclosed. The family had said his related
medical bills were $350,000.
The settlement was reached after opening statements got under way in federal
court in Philadelphia on Wednesday. Shakandra Hampton of Chester, Pa.,
reached a $1.75 million settlement with J.L. Foods and a $1.25 million
settlement with Pilgrim's Pride, court documents show. Most of the money
will go toward the care of her son, who was born premature in August 2002,
at the height of the outbreak.
Hampton - who early on told the Centers for Disease Control that she craved
deli turkey during her pregnancy and ate it several times a week - became
ill and went into labor about a month early. Her son was born deaf in
one ear and also has developmental delays.
"He's a happy, healthy child who struggles cognitively, and we're
hoping he eventually catches up to the rest of the population," said
lawyer Brandon Swartz, who represented the family.
A federal judge approved a 25 percent award for his firm plus costs, for
a total of about $715,000.
Niemtzow's estate and two other families also reached confidential settlements
with Pilgrim's Pride.
Cases still pending in Union County, N.J., include the family of an 81-year-old
man who died and a woman who became ill, lost her unborn twins and can
no longer bear children, plaintiffs lawyer Fred Pritzker said.
Listeria hits hardest among the elderly, pregnant women and those with
compromised immune systems, lawyers involved in the suit said.
U.S. District Judge Timothy Savage ruled this month that the plaintiffs
did not have to prove which plant produced the meat they ate, because
of the linked listeria strains and because people do not always know what
brand of deli meat they are buying.
temp for poultry
The U.S. Department of Agriculture, which for decades had recommended
that poultry be cooked to an internal temperature of 180 degrees for safe
eating, has re-evaluated that assessment. This month, the USDA's Food
Safety and Inspection Service established 165 degrees as the single safe
minimum internal temperature to kill food-borne pathogens and viruses
in poultry. "This is terrific news," said grilling expert and
cookbook author Cheryl Jamison, when informed of the change. "We
can enjoy chicken again without ending up with dried-out white meat."
Jamison and her husband (and co-author) Bill have long advised temperatures
of 165 to 170 degrees. -- Washington Post
step up precautions
SECURITY, TESTING LEVELS BOOSTED TO `CODE YELLOW'
By Greg Bluestein
CUMMING, Ga. - Going to the Milford family chicken farm is like trying
to infiltrate a high-security medical lab. After the car's wheels are
sprayed down with disinfectant, visitors are outfitted with blue biohazard
suits, clear boot coveralls, tight latex gloves and lunch-lady hair nets.
Then, before entering the chicken coop, guests must immerse their feet
in a soupy but powerful iodine cleanser. Like other poultry farmers across
the country, the Milfords are taking extreme precautions to prevent their
livelihood from getting infected with the deadly avian flu virus, which
has devastated chicken markets in Europe, Asia and Africa but has yet
to be detected in the Western Hemisphere. As chicken producers for Tyson
Foods, they are required by the company to ban non-essential visitors
from the farm and test selected chickens before they're sent to the slaughter
-- one of 15,000 tests the company conducts each week for bird flu, which
is five times the number of tests it did last year. The tightened visitor
restrictions and increased testing are the company's ``code yellow'' precautions,
which have been in place for about three months as the virus spreads throughout
the world. In California, where poultry farmers were hit hard in 2003
by exotic Newcastle disease, another highly contagious illness that resulted
in more than 3 million birds being euthanized, vigilance is also high.
That outbreak is regarded as the single largest U.S. health emergency
involving commercial poultry in the past 30 years, and the response --
which involved 7,000 people from 10 state and federal agencies -- is being
studied for lessons that can be applied if avian flu arrives in the United
States. Last year, 100,000 birds from California's poultry farms were
tested for the disease, and the rate this year is expected to far outpace
Health officials worry that
the virus could potentially spark a pandemic if it mutates into a new
strain that could be easily transmitted among people. If the avian flu
strain ever reaches the United States, chicken growers are confident it
probably won't reach their isolated chickens, let alone humans. They,
however, probably will have to handle widespread fear from consumers.
And the staggering U.S. industry, which produces more than 35 billion
pounds of poultry a year, is why farmers in Georgia, the nation's leading
poultry producing state, and elsewhere are taking extreme precautions.
If news from abroad is any indicator, their fears are well placed. France's
poultry industry, Europe's largest, reported losing $48 million in monthly
sales as countries scale back their chicken imports. In Italy, consumer
fears of the virus have forced the industry to lay off some 30,000 workers.
Fear of a bird flu backlash has major producers such as Tyson Foods and
Gold Kist, and family farmers alike ramping up their efforts to keep consumers
Poultry growers are quick to
point out that none of the 205 cases of avian flu confirmed by the World
Health Organization resulted from eating poultry -- although one case
in Vietnam was contracted after a victim drank raw duck's blood. Of those
cases, 113 people have died. They add that cooking poultry at normal temperatures
would kill H5N1, the deadly strain of avian flu that's spread across Asia
to Europe and Africa. Just for good measure, KFC plans on tacking red,
white and blue stickers that say ``rigorously inspected, thoroughly cooked,
quality assured'' on the lid of every bucket of fried chicken it sells
in the United States. Neither Atlanta-based Chick-fil-A nor Oak Brook,
Ill.-based McDonald's has plans to add food-safety messages to the packaging
of their chicken products. Most chicken producers, including Little Rock,
Ark.-based Tyson and Atlanta-based Gold Kist, favor an ``all in, all out''
process that rids coops of all chickens before each new group is brought
in to ensure any disease can't be carried over. ``We're lucky. The way
our industry is set up is with enclosed housing,'' said Wayne Lord, a
Gold Kist vice president. ``Our commercial poultry are all housed inside
chicken houses so the chance for encounter with wild birds is extremely
remote. It's very insulated and very strictly monitored.'' To the Milfords,
who have been in the chicken business for generations, the precautions
are a sign of the times.
``Years ago, I don't remember
Papa having signs on the door saying: `Restricted -- No Admittance,' ''
said Troy Milford, who runs the farm with the help of his father, Dempsey.
``But everyone is more aware now.'' Another sign of the times: As he walks
around his 13-acre plot, which houses four coops that grow 78,000 chicks
at a time, Milford can check his cell phone for messages and e-mail alerts
from the company with bird flu news. The tight controls needed to protect
chickens from disease come naturally to modern chicken coops, Milford
said. At his coops, shutters automatically clamp down after cooling fans
cut off and sensitive sensors connect to a computer to regulate the building's
temperature. Entering one of them is like entering a dark wind tunnel,
tinged with the stench of 20,000 clucking 5-week-old chicks. It's a far
cry from the days when the family first entered the chicken business in
the 1930s, when Dempsey's grandmother bought 80 acres in the north Georgia
foothills. Since then, plots have been handed down from generation to
generation as the region has emerged as one of the nation's leading poultry
centers. Nearby Gainesville, just across the county line, calls itself
the ``Poultry Capital of the World'' and Cumming boasts dozens of poultry
farms, including three run by Dempsey's siblings around the corner for
a road named after the family. While avian flu might lead to a host of
new restrictions, it's just the latest challenge the industry must mount,
said Dempsey, an ever-smiling 66-year-old in blue overalls. ``You wouldn't
have thought about it till 10 years ago,'' Dempsey said. ``It's a good
thing, though. When you go to all the grocery stores, you don't worry.''
CASH FOR FOOD SAFETY
CANADA: A new C$2.64 million food-safety initiative is launched in British
Canada¡¯s new government is
to provide British Columbia with $2.64 million for a Food Safety Initiative
(FSI) to enhance and promote food-safety systems in its food processing
industry. The FSI is part of the Agricultural Policy Framework, a federal-provincial-territorial
strategy for long-term sustainability and profitability in the agriculture
and agri-food sector.
¡°We are proud to be working
with the government of British Columbia on this initiative to make this
important contribution to the province's food processing industry,¡± said
Canada¡¯s Minister of Agriculture and Agri-Food and Minister for the Canadian
Wheat Board Chuck Strahl. ¡°Enhanced food-safety systems help protect the
health of Canadians.¡±
The focus of the Food Safety
Initiative is to work with the non-federally registered food processing
industry to raise awareness of food-safety issues and help producers meet
food safety standards.
Outreach activities will be
delivered by the Food Protection Services of the British Columbia Center
for Disease Control in partnership with the regional health authorities,
the food processing industry and the Ministry of Agriculture and Lands.
British Columbia¡¯s food and
beverage processing sector generated $6.15 billion in sales in 2004, of
which $1.9 billion was exported. The processing sector, dominated by a
large number of small and medium-sized firms, employs 31,000 people.
¡°This initiative will be particularly
helpful for small-scale producers who are working to meet new food safety
regulations,¡± said British Columbia Agriculture and Lands Minister Pat
Bell. ¡°Together with industry, we want to ensure the highest level of
food safety in our province on everything from meat to baked goods. Food-safety
standards provide even greater consumer confidence in British Columbia
Safe Handling of Raw Produce and Fresh-Squeezed Fruit and Vegetable Juices
seriousness of mad cow disease found in Alabama
Mad cow disease was recently confirmed in a cow in Alabama,
according to two tests conducted by the U.S. Department of Agriculture.
Even so, the USDA seems just as reluctant as usual to admit that U.S.
herds continue to be infected with mad cow disease. Even though the results
of this second test have been announced, there is a whole lot of spin
from the USDA on trying to suppress the severity of this news -- so let
me translate it into plain English for you.
First, this positive result is from the second test conducted on this
particular cow in Alabama. The first test also produced a positive result,
but it was a less precise test -- one that's faster and less expensive
to conduct. When the first test produced a positive result, the USDA declared
it to be "inconclusive" -- that's USDA doublespeak for the word
"positive." They call it inconclusive because they don't want
to use the word "positive" anywhere near mad cow disease. But
you'll notice that the USDA never proclaims a negative result on this
initial low-cost screening to be inconclusive -- it's simply called "negative"
and it doesn't bother with any other testing. In other words, this testing
system is frighteningly unscientific. If the first test is so inaccurate
as to be considered inconclusive by the USDA, then how does it know that
a negative result on the first test is sound?
Perhaps a negative result is also inconclusive and this test is completely
useless. On the other hand, if the test is useful -- that is, if it is
accurate enough to be able to declare a cow free of mad cow disease --
then why is it called inconclusive when a cow tests positive?
The answer, of course, has nothing to do with science but everything to
do with food politics and USDA efforts to protect the U.S. beef industry.
In fact, many of the top people who work at the USDA used to be key executives,
public relations people or marketing people working for various meat industry
groups in the United States. It's no surprise that they would want to
protect the industry they are supposed to be regulating.
for more information
to face lawsuit over ¡®all natural¡¯ 7UP
15/05/2006 - Just a month after the reformulation of its flagship Seven
Up drink, Cadbury Schweppes is set to face a lawsuit that accuses the
firm of deceptively advertising the product as ¡®natural¡¯. The suit is
to be filed by public pressure group Center for Science in the Public
Interest (CSPI), which claims the re-branding is misleading as the drink
contains high fructose corn syrup.
Last month, Cadbury Schweppes
reformulated Seven Up to contain only five ¡®100 percent natural' ingredients:
filtered carbonated water, high fructose corn syrup, natural citric acid,
natural flavors and natural potassium citrate. Television adverts for
the product claim it ¡°tastes better than ever because we stripped out
all the artificial stuff,¡± and show cans of the drink being picked from
fruit trees or harvested from the ground. But the continued presence of
high fructose corn syrup has brought the firm under attack. ¡°Pretending
that soda made with high fructose corn syrup is ¡®all natural,' is just
plain old deception,¡± said CSPI executive director Michael Jacobson. The
problem lies in the fact that the Food and Drug Administration (FDA) does
not provide a definition of the term ¡®natural'. The US Department of Agriculture
(USDA), which sets out regulations for meat and poultry products, states
that products can only carry a ¡®natural' claim if they contain no artificial
or synthetic ingredients, and if they are minimally processed. And although
the FDA has been petitioned to adopt the USDA's definition of the term,
current FDA policy simply states that a food can be considered ¡®natural'
if ¡°nothing artificial or synthetic¡± has been added to it that would not
normally be expected to be in that food. The US Natural Ingredient Resource
Center devised its own definition of natural ingredients last year, after
inviting comments from the food industry. It said natural ingredients
should be present in or produced by nature, produced using ¡°minimal processing¡±
(using methods possible in a household kitchen or on a farm), and ¡°directly
extracted¡± using simple methods. ¡°High fructose corn syrup isn't something
you could cook up from a bushel of corn in your kitchen, unless you happen
to be equipped with centrifuges, hydroclones, ion-exchange columns, and
buckets of enzymes,¡± said Jacobson. The suit to be filed by the CSPI will
seek to prevent Cadbury Schweppes from describing any product containing
high fructose corn syrup as ¡®natural'. The CSPI will also seek restitution,
corrective advertising and attorney's fees. In March this year the Sugar
Association filed a petition with the FDA requesting the establishment
of a clear definition for the use of the term ¡®natural' on food and beverage
product labels, claiming that the current lack of a formal definition
for the term has resulted in misleading claims and consumer confusion.
According to recent studies, "all-natural" is reported as being
the most frequent "positive" new product category. In 2004,
the National Marketing Institute reported that 63 percent of consumers
have a preference for natural foods and beverages. And food sales in natural
product stores reached a reported $11.4 billion in 2003.
Another research firm, IRI,
said in January this year that 94 per cent of American households had
bought a natural product, and predicted the sector would show high single-digit
growth over the next five years. And the natural soda market grew by almost
15 per cent between May 2004 and May 2005, according to market research
group SPINS. In 1993, the FDA said it had not included a definition of
the term in its Nutrition Labeling and Education Act (NLEA) ¡°because of
resource limitations and other agency priorities.¡± However, it did concede
that the use of the term on food labels is ¡°of considerable interest to
consumers and industry¡± adding that ¡°because of the widespread use of
this term, and the evidence that consumers regard many uses of this term
as noninformative, the agency would consider establishing a definition.¡±
need for Salmonella awareness
A study on human Salmonella brandenburg infection indicates rural communities
need to be more aware of infectious diseases spreading from animals to
humans. The bacteria causes gastrointestinal illness. It was initially
confined in New Zealand to sheep and rural workers associated with animal
husbandry. The study by Otago University's John Holmes said rates of Salmonella
brandenburg in people had decreased slightly in recent years. But there
were increasing rates of infection in people less directly involved in
agriculture, Holmes said.
cull 1mln birds after avian flu outbreak
Special report: Global fight against bird flu
BUCHAREST, May 14 (Xinhua) -- Romania is planning to cull some 1 million
domestic fowl after the deadly H5N1 bird flu virus was found in three
central locations of the country, Agriculture Minister Gheorghe Flutur
said on Sunday.
"Almost 1 million birds will be culled in total in central Romanian
regions that have been hit or could be hit by bird flu," Flutur told
a press conference.
"The discovery of bird flu on a farm (in the Codlea region) is a
first in Romania, since the first case of the disease was detected on
Oct. 7, 2005. We will quickly cull the farm's approximately 350,000 chickens,
as well as other poultry in contaminated centers," he said.
Earlier in the day, the National Veterinary Health Agency said it had
found the H5N1 virus in the central region of Fagaras, as well as on a
poultry farm in Codlea.
Romanian authorities already found new cases of the virus, which can be
deadly to humans, in the central town of Hurezu on Friday. Meanwhile,
Health Minister Eugen Nicolaescu said the drug Tamiflu had been given
out to residents in the affected regions to prevent a possible human case
of bird flu. Romania closed down its last bird flu quarantine zone in
the east of the country on April 20. But the newly detected cases show
that the country still has a long way to go in its efforts to ward off
the epidemic. The first bird flu case in Romania was detected in the Danube
delta last October. Since then, the epidemic had spread to more regions
of the country, bringing to 53 the number of restricted quarantine zones.
No cases of human infections have been reported in the country. Enditem
eliminated bird flu?
By Kathy Jones
May 14, (foodconsumer.org) - Even as the deadly H5N1 strain of the bird
flu virus is devastating flocks in Europe and Africa, the Asian countries
such as Vietnam and Thailand, where the disease originated, have remained
relatively calm. The deadly march of the avian flu virus had triggered
fears of flu p andemic, but these fears have not materialized till now.
Dr. David Nabarro, chief pandemic flu coordinator for the United Nations
was full of praise for the way Asia has handled a difficult crisis. He
singled out Thailand and Vietnam for the way the governments have responded
to the crisis. "These are two countries where there has been very
strong political leadership, excellent work by government officials, and
an intensive engagement of people at community level," he said. "They
show that with the right level of engagement, we can reduce the threats
posed by bird flu, and I'd like to see the same energy carried through
to fruition in other countries as well."
Vietnam where almost 50 percent of the initial cases were reported has
not reported a single human case or an outbreak of flu in poultry this
year. Thailand, the second-hardest-hit nation has also not seen a human
case for over a year and a poultry outbreak for over six months.
These signs are being interpreted very positively in health circles and
are a welcome relief to one and all. Another break has been the fact that
belying expectations, birds making the spring migration north from Africa
have not brought the bird flu virus into Europe. more
achieve allergen-free soy breakthrough
Researchers have isolated two Chinese soybean lines that can
grow without the primary protein linked to soy allergies in children and
adults. The scientists say that the two lines will be given away to breeders
seeking to produce new varieties of allergy-free soybeans without genetic
engineering. The breakthrough could help food makers tap the growing free-from
food market, which is set to double on the back of growing consumer concern
over health and well-being.
Market analyst Mintel says that the UK sector, which is being driven by
increased public awareness of food allergies and intolerance, has already
enjoyed sales growth of over 300 per cent since 2000. In addition, because
the newly identified lines occur naturally, they can be successfully crossed
into other soybean lines "without any biotechnology-derived component,"
the researchers noted.
Crop scientists at the University of Illinois at Urbana-Champaign and
the USDA-Agricultural Research Service's Donald Danforth Plant Science
Centre in St. Louis screened more than 16,000 soybean lines kept in the
USDA's National Soybean Germplasm Collection.
It was discovered that two soybean lines (PI 567476 and PI 603570A) contained
virtually identical genetic mutations that do not contain the leading
allergy-causing P34 protein, which consists of 379 amino acids. more
UK Farm Is Given
All-clear After Anthrax Outbreak
LONDON (Dow Jones)--A
Welsh farm which was under restrictions after two cows died of anthrax
has been given the all-clear, the BBC reports on its Web site Friday.
Twenty days after its last anthrax death, restrictions ended at Ynys Gau
farm, at Gwaelod-y-Garth, near Cardiff. The public had been banned from
going on or near the farm and the movement of animals was halted. Experts
have ruled out an external source and believe it is due to a ground source.
The farm also tested positive for anthrax 35 years ago.
The herd has been closely monitored and there have been no further cases.
The anthrax was discovered following the sudden deaths of six cows at
Ynys Gau farm.
Farmers are required to report the sudden and unexpected death of livestock,
and routine testing revealed two of the cows had died of anthrax.
The carcasses of the two animals with anthrax were incinerated on the
farm. The other four animals were incinerated elsewhere, with the workers
there advised of health and safety procedures. The risk to users of the
local river had been described as "negligible," while the danger
to walkers and their paths after restrictions were lifted would be "minimal."
BBC News Web site: http://news.bbc.co.uk
156,235 pounds beef recalled for E. coli
May 8, 2006 ? WASHINGTON (Reuters) - The U.S. Department of Agriculture
on Friday said that an Oklahoma-based company has voluntarily recalled
156,235 pounds of ground beef products that may be contaminated with E.
coli bacteria. The company, Fadler, Southwest Food Distributors, LLC of
Tulsa, has voluntarily recalled beef products produced on various dates
between February 6 and May 3.
The problem was discovered through routine product testing on beef patty
products that were distributed to retail establishments, restaurants and
institutions in Arkansas, Kansas, Oklahoma and Missouri, the USDA said.
E. coli is a potentially deadly bacterium that causes bloody diarrhea
and dehydration, leaving the very young, seniors and those with compromised
immune systems at the highest risk.
study nature's toolbox to identify Salmonella
When you hear the word ¡°virus¡± you might think of something
that makes you sick.
But scientists have found some good viruses - tiny needle-like structures
that can actually make bacteria, such as Salmonella, explode.
Finding these good viruses, called bacteriophages, is important for agriculture.
There are many, many implications and applications as scientists find
new ways to understand and use phages.
USDA's Agricultural Research Service (ARS) and university scientists have
collected and identified some beneficial viruses that could help control
Salmonella bacteria in swine waste lagoons.
Salmonella can attack the stomach and intestines causing diarrhea or constipation,
headaches, cramping, nausea and vomiting, fever or blood in the feces.
The young and the elderly can become very sick from eating food that contains
Salmonella. Generally when we think of Salmonella, we think of eggs. We
shouldn't eat raw eggs because Salmonella could be present. But Salmonella
also live in the intestinal tract of animals. Salmonella can cause nasty
diseases like typhoid fever as well as food borne illness. Salmonella
also produces hydrogen sulfide - one of the stinky and dangerous parts
of pig manure. Hydrogen sulfide is produced by the breakdown of many compounds
in manure, but the use of the bacteriophages to control Salmonella might
someday have significance in odor control. Mike McLaughlin, a virologist
at the ARS Waste Management and Forage Research Unit at Mississippi State,
is directing a team that has devised methods to collect and identify bacteriophages
that attack Salmonella strains. Studying phages is relatively new for
McLaughlin. He has traditionally studied viruses of forages. more
tea doesn't lower heart disease risk
May 11, 2006, 00:13
Dear Dr. Tarka:
This letter responds to the health claim petition dated June 9, 2005,
submitted to the Food and Drug Administration (FDA or the agency) by Ito
En, Ltd and Ito En (North America), Inc. pursuant to Sections 403(r)(4)
and 403(r)(5)(D) of the Federal Food, Drug, and Cosmetic Act (the Act)
(21 U.S.C. 343(r)(4) and 343(r)(5)(D)). You are listed in the petition
as the person to whom correspondence should be addressed. The petition
requested that the agency authorize a qualified health claim characterizing
the relationship between the consumption of green tea and a reduction
of a number of risk factors associated with cardiovascular disease (CVD)
for use in the labeling of conventional foods and dietary supplements.
This petition proposed as a model qualified health claim:
"Daily consumption of at least 5 fluid ounces (150 mL) of green tea
as a source of catechins may reduce a number of risk factors associated
with cardiovascular disease. FDA has determined that the evidence is supportive,
but not conclusive, for this claim. (Green tea provides 125 mg catechins
per serving when brewed from tea and 125 mg catechins as a pre-prepared
FDA filed the petition on July 28, 2005 as a qualified health claim petition
and posted the petition on the FDA website for a 60-day comment period,
consistent with the agency's guidance on procedures for qualified health
claims. The agency did not receive any comments on this petition.
This letter sets out the basis for FDA's determination that there is no
credible scientific evidence to support qualified health claims about
consumption of green tea or green tea extract and a reduction of a number
of risk factors associated with CVD.
I. Overview of Data and Eligibility for a Qualified Health Claim
A health claim characterizes the relationship between a substance and
a disease or health-related condition (21 CFR 101.14(a)(1)). The substance
must be associated with a disease or health-related condition for which
the general U.S. population, or an identified U.S. population subgroup
is at risk (21 CFR 101.14(b)(1)). Health claims characterize the relationship
between the substance and a reduction in risk of contracting a particular
disease. In a review of a qualified health claim, the agency first
identifies the substance and disease or health-related condition that
is the subject of the proposed claim and the population to which the claim
is targeted. FDA considers the data and information provided in the
petition, in addition to other written data and information available
to the agency, to determine whether the data and information could support
a relationship between the substance and the disease or health-related
condition. The agency then separates individual reports of human studies
from other types of data and information. FDA focuses its review on reports
of human intervention and observational studies.
In addition to individual reports of human studies, the agency also considers
other types of data and information in its review, such as meta-analyses,
review articles, and animal and in vitro studies. These other types
of data and information may be useful to assist the agency in understanding
the scientific issues about the substance, the disease or health-related
condition, or both, but cannot by themselves support a health claim relationship.
Reports that discuss a number of different studies, such as meta-analyses
and review articles, do not provide sufficient information on the individual
studies reviewed for FDA to determine critical elements such as the study
population characteristics and the composition of the products used. Similarly,
the lack of detailed information on studies summarized in review articles
and meta-analyses prevents FDA from determining whether the studies are
flawed in critical elements such as design, conduct of studies, and data
analysis. FDA must be able to review the critical elements of a study
to determine whether any scientific conclusions can be drawn from it.
Therefore, FDA uses meta-analyses, review articles, and similar publications
to identify reports of additional studies that may be useful to the health
claim review and as background about the substance-disease relationship.
If additional studies are identified, the agency evaluates them individually.
05/15. Food Safety Specialist (Portland OR)
05/15. Poultry Manufacturing
05/15. Quality Assurance Manager, Food and Nutritional Mfg (KY)
05/15. Food Safety Specialist - Japanese Cuisine (NY)
05/15. Quality Assurance Director - Food Industry (MI)
05/15. Quality Assurance Manager (IN)
05/15. QA USDA ASSOCIATE (LA, CA)
05/15. Materials Supervisor, GMP, HAACP, Shipping (PA)
05/15. Quality Assurance Supervisor (IL)
05/15. Food Safety Sanitarian - Seattle (WA)
05/15. Production Supervisor (Food Industry) (KS)
05/15. FOOD SERVICE DIRECTOR (VA)
05/15. Water Quality Supervisor (MO)
05/15. QC Manager - Food Ingredient Mfg - Milwaukee, WI