
 
 
HICNet Medical News Digest      Mon, 01 May 1995        Volume 08 : 
Issue 16
 
Today's Topics:
 
  1995 FDA Consumer Articles
 
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1995 FDA CONSUMER ARTICLES
 
OTC Options:  Pain, Pain Go Away
by Ruth Papazian
       Used to be, aspirin and other salicylates were the only
medications available for nonprescription relief of minor ailments-
-from headaches and fever to muscle strain and minor arthritis.
Today, consumers looking for temporary relief from such garden-
variety ills have their pick of what can be a bewildering array of
"regular," "extra-strength," and "maximum pain relief" tablets,
caplets and gel caps on the drugstore shelf.
       Though this cornucopia can seem confusing, the products' pain-
relieving ingredients fall into just four categories: aspirin (and
other salicylates), acetaminophen, ibuprofen, and naproxen sodium.
For the most part, these over-the-counter (OTC) analgesic
ingredients are equally effective. However, some may be more
effective for certain types of ailments, and some people may prefer
one type to another because of their varying side effects. "Knowing
the pros and cons of each type of pain reliever will allow you to
choose among them," says William T. Beaver, M.D., professor of
pharmacology and anesthesia at Georgetown University School of
Medicine in Washington, D.C.
 
Old Faithful
       Americans have been reaching for aspirin for almost 100 years
as an all-purpose pain reliever (see "Aspirin: A New Look at an Old
Drug" in the January-February 1994 FDA Consumer). Aspirin (or
acetylsalicylic acid) works in part by suppressing the production
of prostaglandins, hormone-like substances that have wide-ranging
roles throughout the body, such as stimulating uterine
contractions, regulating body temperature and blood vessel
constriction, and helping blood clotting. "Regular" strength
aspirin contains 325 milligrams (mg) per tablet; "extra" or
"maximum" strength, 500 mg per tablet. The usual adult (defined as
12 years and older) dosage is one to two 325-mg aspirin tablets
every four hours.
       Some manufacturers add caffeine to aspirin. "There is no
evidence that caffeine relieves pain, but it can enhance the
effects of aspirin, possibly by lifting a person's mood," says
Michael Weintraub, M.D., director of FDA's Office of OTC Drug
Evaluation. Since a two-tablet dose provides roughly the same
amount of caffeine as a cup of coffee, you can get the same effect
by taking two plain aspirin with coffee.
       To minimize the stomach irritation aspirin can cause, some
brands are "buffered" with calcium carbonate, magnesium oxide, and
other antacids or coated so the pills don't dissolve until they
reach the small intestine. Buffered formulas may offset aspirin's
directly irritating effects on the stomach lining. They may be
useful for people who get heartburn or stomach pain when they take
aspirin, as well as for those with arthritis, who need to take as
much as 4,000 mg every day.
       Aspirin also causes gastrointestinal (GI) upset indirectly (by
inhibiting production of a prostaglandin that protects the stomach
lining by stimulating mucus production); buffering does nothing to
offset this effect.
       The downside of coated aspirin products is that they may  take
up to twice as long to provide pain relief as plain aspirin,
according to Weintraub. Last September, an FDA advisory panel
recommended that labels on products containing aspirin warn that
heavy drinkers are especially vulnerable to developing GI bleeding.
       Aspirin should not be taken by people who have:
~      ulcers, because it can worsen symptoms
~      asthma, because it can trigger an attack in some asthmatics
~      uncontrolled high blood pressure, because of an increased risk
of one type of stroke
~      liver or kidney disease, because it may worsen these
conditions
~      bleeding disorders or who are taking anticoagulant medication,
because it may cause bleeding.
       Continual high dosages of aspirin can cause hearing loss or
tinnitis--a persistent ringing in the ears.
       FDA requires products containing aspirin and other salicylates
to carry a label warning that children and teenagers should not use
the medicine for chickenpox or flu symptoms because of its
association with Reye syndrome, a rare disorder that may cause
seizures, brain damage, and death.
       The label also alerts pregnant women that use of aspirin in
the last trimester may increase the risk of stillbirth and of
maternal and fetal bleeding during delivery.
 
One Aspirin Alternative
       Twenty years ago, FDA approved acetaminophen (Tylenol, and
other brands and generics) in dosages of 325 mg and 500 mg for OTC
use. "Nobody knows exactly how acetaminophen works, but one theory
is that it acts on nerve endings to suppress pain," says Weintraub.
Acetaminophen is as effective as aspirin in relieving mild-to-
moderate pain and in reducing fever, but less so when it comes to
soft tissue injuries, such as muscle strains and sprains, he adds.
The usual adult dosage is two 325-mg tablets every four hours.
       Acetaminophen-based products to ease menstrual cramps often
contain other ingredients, such as pamabrom (a diuretic) or
pyrilamine maleate (an antihistamine used for its sedative
effects). "While these ingredients are safe, they have not been
proven effective against uterine cramps, although they may relieve
other symptoms associated with menstrual pain," says Weintraub.
       Though acetaminophen is no better or faster at pain relief
than aspirin, the drug is gentler on the stomach and reduces fever
without the risk of Reye syndrome. However, even at moderate doses,
acetaminophen can cause liver damage in heavy drinkers. At press
time, FDA was planning to require a warning about this on the
labels of OTC products containing the drug.
 
>From Rx to OTC
       Like aspirin, ibuprofen and naproxen sodium inhibit
prostaglandin production. However, they are more potent pain
relievers, especially for menstrual cramps, toothaches, minor
arthritis, and injuries accompanied by inflammation, such as
tendinitis. FDA approved ibuprofen for OTC marketing in 1984 at a
dosage level of 200 mg  every 4 to 6 hours, and naproxen sodium in
1994 at a dosage level of 200 mg every 8 to 12 hours.
       "Ibuprofen and naproxen sodium were converted to OTC status
after their manufacturers did the necessary studies to show that
these pain relievers were effective at OTC dosages, which are lower
than prescription dosages," explains Weintraub. The lowest dosage
strength for prescription-strength ibuprofen (Motrin and others) is
300 mg per tablet, and 275 mg per tablet for the prescription
version of naproxen sodium (Anaprox, for example). "In addition,
the pharmaceutical companies had to show that these drugs were safe
for use by a larger, more varied group of people [than would have
received them by prescription only] and that the drugs were safe to
use without medical supervision, as is the case with all
nonprescription drugs."
       Taken at the recommended adult dosage, OTC ibuprofen (Advil
and others) and naproxen sodium (Aleve) are somewhat gentler on the
stomach than aspirin. However, people who have ulcers or who get GI
upset when taking aspirin should avoid both. In addition,
asthmatics and people who are allergic to aspirin should avoid
ibuprofen and naproxen sodium. An FDA advisory panel has
recommended labeling on ibuprofen products like that recommended
for aspirin, warning heavy drinkers about increased risk of gastric
bleeding and impaired liver function (products with naproxen sodium
labels already include this information).
       Although ibuprofen and naproxen sodium interfere with blood
clotting much less than aspirin does, they should not be used by
people who have bleeding disorders or who are taking
anticoagulants. Children under 12 should not be given either drug,
except under a doctor's supervision, and people over 65 are advised
to take no more than one naproxen sodium tablet every 12 hours.
       Choosing an OTC pain reliever involves balancing effectiveness
for a particular ailment with side effects. Often this is a very
individual choice, based in part on your health history and how the
drug affects you. Regardless of which type of OTC pain reliever you
choose, remember that it is intended to be used on a short-term
basis, unless directed by a doctor, cautions Weintraub. The warning
labels on these products include limitations on duration of use to
ensure that chronic or serious illnesses are not masked. Typically,
labels advise against taking the product for more than 10 days to
relieve pain (for children, the upper limit is five days), or more
than three days to reduce fever. If symptoms worsen, pain persists,
or there is redness or swelling, medical attention should be
sought.
 
Ruth Papazian is a writer in New York City.
******************************************************************
 
HACCP: Patrolling for Food-Borne Illness
by Paula Kurtzweil
       Like a cop on the beat, James Reed patrols his assigned food
processing area daily for any wrongdoing. But instead of seeking
out thugs on street corners, he's prowling for broken glass and
other food hazards lurking inside automated food processing lines.
       Reed is a lead person in Heinz USA's Pittsburgh factory, where
he oversees the filling and capping of 900 baby food jars a minute.
Several times a day he fills in for other employees and stops the
processing line, checks the machine for glass, documents findings
via computer, and, if necessary, withdraws the affected food
products for disposal.
       Reed's actions are part of a new food safety system that
focuses on preventing food-borne hazards that can cause illness.
The system is known as Hazard Analysis Critical Control Point, or
HACCP (pronounced hassip), and Heinz is one of a number of U.S.
food manufacturers that have adopted it within the last five years.
The National Food Processors Association estimates that about half
of its 300 member processors use some form of HACCP in their
operations.
       More may soon join them. In August 1994, FDA announced in an
advance notice of proposed rule-making that it was considering
whether to make HACCP mandatory for much of the U.S. food supply.
FDA already requires HACCP for the low-acid canned food industry
and has proposed it for the seafood industry.
       Also, FDA incorporated HACCP into its 1994 Food Code. The Food
Code is FDA's guidance and recommendations to state and territorial
agencies that license and inspect retail food establishments in the
United States and can serve as a model for them. Many restaurants
and retail food establishments already follow HACCP principles,
some because their local regulators mandate it. (See "New Food
Code: A Menu of Modern Safety Standards" in the April 1994 FDA
Consumer.)
       And, the U.S. Department of Agriculture has announced it will
propose HACCP for the meat and poultry industry. (USDA regulates
meat and poultry; FDA all other foods.)
       "This system--though it is simple and based on common sense--
signals one of the broadest food safety policy shifts in the last
50 years," said FDA Commissioner David A. Kessler, M.D.
 
Old vs. New
       Traditionally, industry and regulators have depended on spot-
checks of manufacturing conditions and random sampling of final
products to ensure safe food. This system is seen as more reactive
than preventive because it finds problems after they have occurred
rather than as the food is being prepared.
       HACCP, on the other hand, focuses on problem prevention.
Companies analyze their food production processes and determine the
"critical control points." These are points in a food's production-
-from its raw state through processing and shipping to consumption
by the consumer--at which hazards can be prevented, controlled or
eliminated.
       At Heinz USA in Pittsburgh, for example, there are several
critical control points on the "capper," the machine that places
caps on baby food jars. One potential hazard is broken glass. Even
though the machine can automatically detect the presence of broken
glass, employees stop the line and inspect the machine every half
hour for broken glass. This checking is a preventive measure. It
helps ensure that glass does not get into the baby food.
       Cooking, chilling, sanitizing, preventing cross contamination,
and employee hygiene are other examples of critical control points.
       What HACCP doesn't do is replace basic sanitation and good
manufacturing practices that are a part of today's food safety
system, noted Jeffery Rhodehamel, a microbiologist in FDA's
division of HACCP programs. "HACCP works in concert with them," he
said.
 
HACCP Close Up
       As it does at Heinz, a HACCP program typically involves seven
steps:
~      Analyze hazards. Potential hazards associated with food are
identified. The hazard could be biological (such as a microbe),
chemical (such as mercury), or physical (such as broken glass or
metal). Also, establish preventive measures to control identified
hazards.
~      Identify critical control points.
~      Establish critical limits for each preventive measure
associated with a critical control point. An example for cooked
food might include setting the minimum cooking temperature and time
required to ensure a safe product. The temperature and time are the
critical limits.
~      Establish procedures to monitor the control points. Such
procedures might include determining how and by whom cooking time
and temperature should be monitored.
~      Establish corrective actions to be taken when monitoring shows
that a critical limit has not been met. Examples are reprocessing
or disposing of food if the minimum cooking temperature is not met.
~      Establish effective record keeping to document the HACCP
system. At Heinz USA in Pittsburgh, record keeping is computerized.
~      Establish procedures to verify the system is working
consistently--for example, auditing records to confirm that all
critical limits have been met during a production run.
       Each of these steps has to be based on sound scientific and
technical knowledge, such as published microbiological studies.
 
Why HACCP?
       A number of national and international organizations have
endorsed HACCP, including the National Advisory Committee on
Microbiological Criteria for Foods, which includes government and
non-government food safety experts, and the Codex Alimentarius
Commission, an international food standard-setting organization.
       HACCP is viewed favorably because of its potential to help the
United States and other countries cope with new food safety
challenges. Among the challenges most often cited is an increase in
the number of human disease outbreaks due to food-borne microbial
pathogens. For example, between 1973 and 1988, bacteria not
previously recognized as important causes of food-borne illness in
the United States--such as Escherichia coli O157:H7, Listeria
monocytogenes, and Salmonella enteritidis--became more widespread.
       "Fifty years ago, we were dealing with only a limited number
of food-borne pathogens," said FDA's Rhodehamel, referring to
Clostridium botulinum, Staphylococcus aureus, Salmonella, and the
parasite Trichinella spiralis. "Today, the list of known food-borne
pathogens is much more extensive."
       There also is increasing concern about chemical contamination,
such as the effects of lead on the nervous system.
       Another problem is that processing and packaging systems
designed to prolong shelf life may introduce new food safety risks.
       Also of interest is the increasing size of the U.S. food
industry--both in the amount of domestic food manufactured and the
number and kinds of foods imported. FDA now lists over 30,000 food
manufacturers and processors and more than 20,000 food warehouses
in its inventory, and in 1992 alone dealt with more than 1 million
imported food items. At the same time, FDA and state and local
agencies face severe resource constraints that make it increasingly
difficult to ensure food safety.
 
Advantages
       Advocates of HACCP believe that it offers a number of
advantages to help deal with these challenges. Most importantly,
HACCP:
~      focuses on preventing hazards from contaminating food
~      is based on sound science
 



~      places responsibility for ensuring food safety on the food
manufacturer or distributor. Under a HACCP-based inspection system,
the food company develops the HACCP plan, and government's role is
to verify that the company is carrying out its plan. Government
monitoring would ensure that preventive controls are in place and
working properly.
~      permits more efficient and effective government oversight,
primarily because the record keeping allows government
investigators to see how well a firm is complying with food safety
laws over time rather than how well it is doing on any given day.
Under the proposal FDA envisions, the agency would have access to
critical control point records.
~      helps food companies compete more effectively in the world
market. Members of the European Union and other countries, such as
Canada, will soon require imported foods and foods made within
their borders to be processed under HACCP requirements.
       At the Heinz plant in Pittsburgh, company officials have
discovered another advantage: a potential savings to the company.
According to Ed Sonnet, technical operations consultant for Heinz
USA, the HACCP system seems to have led to a drop in the number of
stock cases held at the company's Pittsburgh plant. These are cases
of food that are withheld from the market because of poor quality
or safety concerns.
       "We have a very strong feeling in our minds that HACCP is
doing a good job for us," he said. "We think we'll be able to
quantify it a lot better when we go into our other plants."
       Sonnett said HACCP will be implemented in the company's four
other U.S. manufacturing facilities by April 1995.
 
What's Ahead
       FDA has begun reviewing comments it received in response to
its August 1994 advance notice of proposed rule-making. At press
time, in late 1994, the agency was planning to begin a pilot HACCP
program with about six food manufacturing companies. FDA will use
information from this program to help decide whether to propose a
HACCP system for industry, and, if so, to what extent.
       If FDA decides to implement HACCP for the seafood industry, it
expects to issue final regulations this year. This program, along
with HACCP programs already in use, will likely lay the groundwork
for future food safety in the United States and the world.
 
Paula Kurtzweil is a member of FDA's public affairs staff.
********************************************************************
 
Plasma Center Owner Sentenced
 
       The owner of a Cincinnati plasma center has been sentenced for
illegally shipping source plasma used in manufacturing in vitro
reagents for testing blood groups.
       Victor Torbeck, owner of Cincinnati-based Worldwide
Biologicals, Inc., was sentenced Sept. 23, 1994, in the U.S.
District Court for the Southern District of Ohio, Western Division,
to six months home confinement and three years supervised
probation. He was also fined $5,500 and assessed a $200 court fee.
       Torbeck pleaded guilty April 29 to two counts of introducing
into interstate commerce a misbranded medical device with the
intent to defraud and mislead, one count of misbranding a medical
device after receipt from interstate commerce and while held for
sale, and one count of making a false representation to FDA.
       As part of his plea agreement, Torbeck surrendered the United
States license for his plasma center and is barred for life from
working in the blood or plasma business.
       In vitro reagents are considered medical devices under the
Food, Drug, and Cosmetic Act. Source plasma centers that ship their
products in interstate commerce are required to be licensed by FDA.
       A routine inspection of Torbeck's Cincinnati laboratory July
18, 1991, by FDA's Cincinnati district revealed violations of the
agency's good manufacturing practice (GMP) regulations.
Investigators found that the laboratory was not adequately testing
blood products it received from all four of Torbeck's collection
centers--two in Cincinnati, including the firm's corporate
headquarters, one in Fayetteville, N.C., and one in Nashville,
Tenn. As a result of the GMP violations, FDA suspended the license
of the Cincinnati laboratory on Oct. 1.
       "We asked that [Torbeck] select another lab, which FDA had to
approve, to test the materials that he collected," said compliance
officer Eric Batchelor.
       Concurrently, FDA investigators in Raleigh, N.C., found that
the Fayetteville Center also had GMP violations and its license was
also suspended Oct. 1.
       The following month, FDA allowed the Fayetteville Center to
resume collecting plasma for purposes of a reinspection. In March
1992, the center was permitted to ship the products collected in
Fayetteville to Torbeck's corporate headquarters solely for
storage. However, he was not permitted to sell any plasma that had
been collected at the Fayetteville Center.
       On July 15, 1992, FDA learned from a confidential informant
that Torbeck had illegally sold and shipped from the center in
Cincinnati plasma that had been collected in Fayetteville.
       On Sept. 20, 1992, FDA investigators, along with U.S.
marshals, seized the records from Torbeck's Cincinnati corporate
headquarters facility.
       From records, investigators learned that Torbeck had received
from his Fayetteville center 12 bottles of plasma containing the
valuable antibody to the red blood cell Rh antigen E, which is the
primary component of Anti-E blood grouping  reagent.
       They found that on May 11, 1992, Torbeck illegally shipped to
Frankfurt, Germany, three bottles of plasma containing Anti-E and
on May 22, he shipped one bottle of misbranded plasma containing
Anti-E to Conroe, Texas. Torbeck had no license to make either of
these shipments.
       Agency investigators also learned that Torbeck falsely labeled
bottles of plasma as containing Anti-E to hide the fact that he had
illegally shipped the four bottles of plasma drawn from the
Fayetteville center.
       During an FDA inspection on June 26, Torbeck told agency
investigators that 12 bottles of plasma contained Anti-E, as the
labels stated, and were drawn from his Fayetteville center. The
investigators knew these statements were false.
       In November 1992, FDA asked the district court to issue
subpoenas to major U.S. manufacturers of medical devices using
blood products, requesting shipping and receiving information
concerning blood products received from Worldwide Biologicals.
During the next 16 months, agency investigator Marianne Allen
evaluated the manufacturers' records to try to determine when and
to whom Torbeck had shipped plasma.
       Based on FDA's evidence, Torbeck pleaded guilty to all counts
on April 29, 1994, rather than proceed with a grand jury
indictment. As a result, Torbeck transferred ownership of his
Cincinnati corporate headquarters to his son. The three remaining
collection centers, in Cincinnati, Nashville and Fayetteville, have
all since closed.
--Kevin L. Ropp
 
 
Sorry, Wrong Label
 
       As a result of reporting to FDA a tomato can labeled "rejected
due to rust," a consumer in Lindhurst, N.Y., received an apology
and gift certificate from the California manufacturer who
mistakenly left the test label under a regular label after
reconditioning the can.
       The consumer discovered the test label while preparing cans
for recycling last spring and was concerned that food was possibly
being marketed in rusty cans. Fortunately, this was not the case,
and the manufacturer promised FDA it would try to keep its
employees "on their toes."
       Consumer safety officer Rochelle Globus, of FDA's Long Island
resident post, in the New York district, investigated the complaint
on June 21, 1994. Globus collected copies of the label and reported
the incident to FDA's San Francisco district office, which has
jurisdiction over the manufacturer, Tri-Valley Growers plant no. 7,
in Modesto, Calif.
       On July 20, Robert Howell, of the San Francisco district's
Stockton resident post, visited the plant and showed George Bishop,
the plant's distribution quality control manager, photocopies of
both labels. Bishop identified the can as having been manufactured
at his plant in 1991.
       Howell learned that Tri-Valley destroyed badly rusted cans,
but that it was not uncommon for the firm to recondition cans with
only minor rust. As interpreted by Bishop, the coding on the test
label indicated the can had undergone such reconditioning,
completing the process May 4, 1992.
       "Bishop insisted that before redistributing the products, can
integrity and appearance is always checked," Howell says. "He said
he would use my visit and the example to reinforce standing policy
and insure test labels would be removed. He said that while these
types of slip-ups are uncommon, they do happen, and that he would
try to keep his people on their toes."
 
--Dixie Farley
******************************************************************
 
Huge Cache of
Frozen Foods Destroyed
 
       Eleven vendors storing 58 tons of frozen vegetables and
seafood in a Washington state warehouse voluntarily destroyed the
food after a ruptured refrigerant line severely contaminated the
goods with ammonia gas.
       Seattle-based Olympic Cold Storage Service Inc., which has
since gone out of business, had housed the foods in its 90-year-old
facility. The disposed goods were worth "several hundred thousand
dollars," according to FDA documents.
       On Feb. 24, 1994, a forklift operator ran the lift into an
ammonia line on the third floor of the four-story facility. Ammonia
gas seeped from the damaged line into the third-floor storage area
and penetrated the packaging of frozen foods stored there, says Tom
Piekarski, compliance officer in FDA's Seattle district.
       "The company repaired the leak and tried to vent the gas with
fans," Piekarski says. "But from what we could determine, the
damage had already been done." Only food stored on the third floor
was contaminated.
       In mid-March, during a routine inspection of the facility, a
U.S. Department of Agriculture official noticed a strong ammonia
smell and notified FDA, which sent an investigator and an analyst
to inspect the warehouse March 22.
       On site, the FDA investigator was nearly overcome by the
strong ammonia odor. He choked and his eyes burned, yet he was able
to collect several food samples for testing. The analyst stayed
outside the facility.
       That same day, a Washington state inspector placed a 30-day
embargo on food stored on the facility's third floor. An FDA
laboratory analysis of the samples confirmed that ammonia
contamination had rendered the goods unfit for human consumption.
       When the state's embargo expired, the 11 owners of the damaged
food agreed voluntarily not to distribute the goods. Meanwhile, FDA
began the process of filing for seizure of the food.
       But by mid-May, Olympic Cold Storage had decided to go out of
business. With no storage space and with the possibility of
seizure, the food owners agreed to destroy all the contaminated
goods.
       From May 25 to 31, the food was taken to a local transfer
station for final transport to a waste management facility in
Arlington, Ore., where it was buried in a landfill.
       By not having to seize, store and dispose of the goods, the
federal government saved "thousands of dollars," Piekarski says.
 
--John Henkel
*******************************************************************
 
Orange Juice Scheme Gone Sour
by Paula Kurtzweil
       A scheme to produce and sell bogus orange juice concentrate
via secret rooms, hidden pipes, and deceptive record keeping has
left two Kentuckians with prison terms of more than six years each.
These are the longest sentences ever imposed for adulteration of
orange juice.
       Four other people also were sentenced, and two still await
sentencing.
       On Oct. 12, 1994, Judge John G. Heyburn of the U.S. District
Court in Louisville, Ky., sentenced Patsy J. Mays, former owner,
director, and secretary-treasurer of Sun Up Foods Inc. of Benton,
Ky., to six years and eight months in prison and imposed a $100,000
fine.
       Her brother-in-law, Samuel W. Mays, former Sun Up vice
president and operations manager, received the same prison
sentence. He was not fined.
       At press time, James V. Mays--Patsy Mays' husband and the
acknowledged ringleader of the hoax--awaited sentencing scheduled
for Dec. 6, 1994. He is a former owner, director and president of
Sun Up.
       The previous May 6, James Mays, Patsy Mays and Samuel Mays
were convicted on one count of conspiracy and 20 counts of
violating the Federal Food, Drug, and Cosmetic Act. James Mays and
Patsy Mays also were found guilty of seven and five counts of mail
fraud respectively.
       The company had been substituting an inexpensive liquid beet
sugar for some of the more expensive orange juice concentrate,
labeling the product unsweetened orange juice concentrate, and
selling it to manufacturers and dairies for making juice for retail
sales. According to documents obtained by FDA, the scheme allowed
Sun Up to increase its sales from almost nothing in 1984--its
second year of operation--to more than $57 million in 1989.
       The extent of the conspiracy was discovered in an FDA
investigation that included more than 250 interviews with at least
150 former employees, suppliers, builders, customers, and others
who did business with Sun Up. Investigators also reviewed an
estimated 1 million paper and computer documents seized by U.S.
marshals with help from FDA. The marshals also seized several
objects, including an electric control panel that had disguised an
entryway, as evidence of Sun Up's efforts to carry out the fraud in
secrecy.
       Also sentenced Oct. 12 were:
~      James Timothy Mays--son of James and Patsy Mays--Sun Up's vice
president of sales and marketing. He pleaded guilty to one count of
conspiracy and was sentenced to 20 months in prison.
~      Elizabeth Mays Murphy--the Mays' daughter--who, with her
husband, Stephen Murphy, owned Candy Base Co., a Sun Up sugar
supplier. They pleaded guilty to nine counts of Food, Drug, and
Cosmetic Act violations and were placed on probation for two years.
~      John Donald Langness, Sun Up's production and plant manager.
He pleaded guilty to one count of conspiracy and was placed on
probation for four years.
       Frank Farmer, another Sun Up sugar supplier, pleaded guilty to
one count of adulteration of orange juice with intent to mislead
and defraud. He was fined $50 and sentenced to three years
probation.
       As part of the plea agreements, these five testified against
James, Samuel and Patsy Mays during a three-week trial.
       Sun Up filed for bankruptcy in September 1990, under Chapter
11 of the Federal Bankruptcy Act. It shut down in May 1992. The
plant is now under new ownership.
       FDA first learned of possible illegal activities at Sun Up in
the late 1980s, when employees of Sun Up and other companies
anonymously reported to FDA that Sun Up was substituting sugar for
orange juice concentrate and marketing the product as an
unsweetened orange juice product.
       At that time, Sun Up operated a plant in Louisville, Ky. FDA
inspections of the plant found no evidence to support the
complaints.
       In late 1989, Sun Up moved its operations to a new facility in
Benton, Ky. In spring 1990, an East Coast customer of Sun Up
recalled an entire shipment of the product it had bought after
laboratory analysis showed contamination with beet sugar. FDA later
learned that because of the resulting publicity, Sun Up lost about
90 percent of its business in the first 60 days following the
recall. As a result, the company had to lay off employees and
reduce salaries by almost half.
       In December 1990, Leonard Farr, a compliance officer in FDA's
Cincinnati district office, attended a Florida Citrus Commission
interview of a former Sun Up employee.
       In an affidavit, the employee indicated that at both its
facilities, the company had bought large amounts of sugar and had
set up secret rooms to hold tanks of liquid beet sugar. The
employee also provided copies of purchase records and names of
people who would talk about Sun Up's activities.
       FDA immediately got a search warrant for the Benton facility.
During the search on Dec. 21, 1991, records were seized; however,
FDA investigators could not locate the secret room described by the
informant.
       During the next four months, FDA investigators conducted
interviews and, at one of them, learned the location of the secret
room. After obtaining a second search warrant on May 8, 1991, and
accompanied by U.S. marshals, FDA investigators again searched the
facility. This time, they found the hidden room. At FDA's request,
U.S. marshals seized a 4-by-2 1/2-foot steel electric control
panel, which disguised the only entry to the room. Investigators
also located stainless steel pipes hidden in the walls. The
pipeline was linked to the main processing area.
       During searches in May and July 1991, FDA investigators
identified a similar setup in the abandoned plant. They had to
rebuild the pipe system to see if some discarded pipes found on the
plant's property fit into the secret setup. They did.
       "I never saw anything as sophisticated as this," Farr said.
"These pipes were really well-hidden."
       Farr said the pipes were set up to look like part of the
sewage system, and during a government inspection, the line
carrying the sugar could be shut off and the outside pipe closed to
conceal the sugar line inside.
       Additional evidence showed that Sun Up:
 ~     ran its illegal activities from at least 1985 to late 1990
~      secretly received under cover of night up to 20 million pounds
of beet sugar
~      used Candy Base Co., of Louisville, Ky., and Murray, Ky., and
Frank Farmer, in Jackson, Tenn., as fronts for buying sugar. Both
billed Sun Up to make it look like they bought "orange concentrate"
instead of sugar.
~      cheated consumers out of $10 million to $20 million in fake
orange juice.
       FDA received no reports of deaths or illness from the "sugar-
sweetened" juice concentrate.
 
Paula Kurtzweil is a member of FDAs public affairs staff.
******************************************************************
 
The New Food Label
Better Information for Special Diets
by Paula Kurtzweil
(This is the fifth and last in a series of articles telling how to
use the new food label to meet specific dietary needs.)
       The right diet is important for everyone, but for Tony
Robinson of Orlando, Fla., it truly is his lifeblood.
       Robinson has end-stage renal disease. Three times a week, he
goes to a local medical center, where a dialysis machine does what
his kidneys no longer can: purify his blood.
       Between treatments, he's careful about what he eats because
some nutrients can cause harmful--sometimes deadly--levels of
substances to build up in his blood. He eats a diet low in protein,
sodium and potassium to keep those dangerous substances minimal,
and high in calories to maintain his weight.
       Until recently, he and his wife, who does most of the cooking,
kept mainly to foods listed in a brochure of "foods to eat" and
"foods to avoid" for people with end-stage renal disease. But now
they're using the new food label as another source of information.
       "The new label adds to what we already know," Robinson said.
"And mandatory nutrition labeling gives us the information we need
to choose from a wider range of food products."
 
Label Benefits
       Under the Nutrition Labeling and Education Act of 1990 and
regulations from the Food and Drug Administration and the U.S.
Department of Agriculture, virtually all food labels must now give
information about a food's nutritional content.
       That wasn't always the case. Until 1994, nutrition information
 



was voluntary. Manufacturers had to provide it only when a food
contained added nutrients or when nutrition claims appeared on the
label. Nearly 40 percent of products didn't carry nutrition
information.
       "Just to have the information on the label is a big plus for
consumers on therapeutic diets," said Camille Brewer, a registered
dietitian and nutritionist in FDA's Office of Food Labeling.
       Another group the regulations help is people with food
sensitivities. Every product with two or more ingredients must now
list the ingredients on the label. That includes standardized
foods, such as peanut butter, and some baked goods. These foods
previously were exempt from ingredient labeling because at one
time, most Americans were familiar with the recipes since they were
foods routinely prepared at home.
       Also, the source of some ingredients (for example, hydrolyzed
soy protein) must now be identified.
 
Get the Nutrition Facts
       Consumers looking for nutrition information about a food
should first look at "Nutrition Facts," usually on the side or back
of the package.
       For many people on special diets, the amount of the nutrient
in grams or milligrams is most important because their diets are
based on a set amount of one or more nutrients a day specific to
their needs--for example, 60 grams (g) of protein, 2,000 milligrams
(mg) of sodium a day. Special dieters can find the amount by weight
of nutrients listed in the top part of the Nutrition Facts panel.
       Some important points about the Nutrition Facts panel: The
values listed for total carbohydrate include all carbohydrates,
including dietary fiber and sugars listed below it.
       The sugars include naturally present sugars, such as lactose
in milk and fructose in fruits, as well as those added to the food,
such as table sugar, corn syrup, and dextrose. The label can claim
"no sugar added" but still have naturally occurring sugar. An
example is fruit juice.
       Also, potassium may be listed voluntarily with the nutrients
listed on the top part of the panel, just below sodium. Its % Daily
Value is based on a recommended intake of 3,500 mg a day.
       Other vitamins and minerals may be listed on the Nutrition
Facts panel, along with vitamins A and C, iron, and calcium.
       Amounts of vitamins and minerals are only presented as
percentages of the Daily Value.
       Calorie information appears at the top of the Nutrition Facts
panel, following serving size information. This information is
important for those needing to increase or decrease their calories.
 
Serving Size
       The serving size information gives the amount of food to which
all the other numbers on the Nutrition Facts panel apply.
       Now serving sizes are more uniform among similar products and
are designed to reflect the amounts people actually eat. Also,
serving sizes must be about the same for the same types of
products--for example, different brands of frozen yogurt--and for
similar products within a food category--for example, ice cream,
ice milk, and sherbet within the category frozen dairy-type
desserts.
       Having more uniform serving sizes makes it easier to compare
the nutritional values of related foods.
       People who follow special diets should be aware that the
serving size on the label may not be the same as that recommended
for their specific needs. For example, the label serving size for
cooked fish is 3 ounces (84 g). A person following a 60-gram
protein diet may be allowed only 1 ounce (28 g) of fish at a meal.
So, in this case, the nutrient values would have to be divided by
3 to determine the nutritional content of the 1-ounce portion
eaten.
 
Ingredients
       The ingredient list is a source of information especially
useful for people with food sensitivities. (See Ingredient
Labeling: What's in a Food?" in the April 1993 FDA Consumer.) Some
new requirements that provide more information in the list are:
~      Listing protein hydrolysates by source--instead of "hydrolyzed
vegetable protein," the list must state the type of vegetable (for
example, "hydrolyzed corn protein").
~      Stating FDA food-certified color additives by name--for
example, "FD&C Blue No. 1 and FD&C Yellow No. 6.  Before, they
could be listed simply as "colorings."
~      Declaring caseinate as a milk derivative in foods that claim
to be non-dairy, such as coffee whiteners.
 
On some labels, the ingredient list may state the source of
sweeteners, too, although this is voluntary. For example, instead
of "dextrose" or "dextrose monohydrate," the ingredient may be
listed as "corn sugar monohydrate."
 
Nutrient Claims
       Elsewhere on the label, consumers may find claims about the
food's nutrient content. Often, these claims appear on the front of
the package, where shoppers can readily see them. These claims
signal that the food contains desirable levels of certain
nutrients.
       Some claims, such as "low-sodium" "high in calcium," or "good
source of fiber," describe nutrient levels. (See "A Little 'Lite'
Reading," in the June 1993 FDA Consumer.) Some, but not all,
highlight foods containing beneficial amounts of nutrients for some
people with special dietary needs. The same claim may warn other
consumers, for whom the nutrient is detrimental, to avoid the
product. For example, a product claiming to be an "excellent source
of potassium" is not a wise buy for a person following a low-
potassium diet. (See "Nutrient Claims Guide for Individual Foods.")
 
Health Claims
       Health claims describe a relationship between a nutrient or
food and a disease or health-related condition. FDA has authorized
eight such claims; they are the only ones that can be used in a
label. The claims may show a link between:
~      calcium and a lower risk of osteoporosis
~      fat and a greater risk of cancer
~      saturated fat and cholesterol and a greater risk of coronary
heart disease
~      fiber-containing grain products, fruits and vegetables and a
reduced risk of cancer
~      fruits, vegetables and grain products that contain fiber and
a reduced risk of coronary heart disease
~      sodium and a greater risk of high blood pressure
~      fruits and vegetables and a reduced risk of cancer
~      folic acid and a decreased risk of neural tube defect-affected
pregnancy.
       Nutrient and health claims can be used only under certain
circumstances, such as when the food contains appropriate levels of
the stated nutrients.
       The intent of the new food label is not just to ensure that
label information is truthful but to provide more complete and
useful nutrition and ingredient information for consumers' use.
People with special dietary needs will likely find the labeling
changes a welcome bonus. n
 
Paula Kurtzweil is a member of FDA's public affairs staff.
 
Special Diets
       Label information can help individuals select foods
appropriate for their special dietary needs, determined by a
physician, registered dietitian, or nutritionist. Some medical
conditions that require special attention to diet are:
~      Kidney disease
       For many people whose kidneys have failed or are failing,
protein, potassium and sodium are restricted. The nutrient
phosphorus also may be restricted.
       People undergoing dialysis may be encouraged to eat 20 to 25
grams (g) of fiber daily because fluid restrictions, lack of
exercise, and some kidney medications can cause constipation. The
Daily Value for fiber, which is based on a 2,000-calorie diet, is
25 g.
       Daily Values are reference numbers based on recommended
dietary intakes to help consumers use label information to plan a
healthy diet. (See "'Daily Values' Encourage Healthy Diet" in the
May 1993 FDA Consumer.)
~      Liver disorders
       People with hepatitis, cirrhosis, and other liver diseases
often need a high-calorie, low-protein diet to help rejuvenate the
damaged liver and maintain adequate nutrition. They also may need
to increase their intake of vitamins--particularly folic acid,
vitamin B12, and thiamin--and minerals.
~      Food sensitivities
       According to the Food Allergy Network (a national nonprofit
organization)
common food allergens are milk, eggs, wheat, peanuts and other nuts, and
soy. The treatment: avoiding the food or foods containing them.
~      Celiac disease
       This is a genetic disorder in which the body cannot tolerate
gliadin, the protein component of the gluten in wheat, barley, rye,
and oats. So, people with celiac disease must avoid all products
containing these grains--even foods that may contain only small
amounts of the protein, such as vinegar, bouillon, and alcohol-
containing flavorings. The intolerance leads to malabsorption--not
only of the offending food but virtually all nutrients.
~      Cancer
       Because weight loss is common during cancer treatment, many
cancer patients need to increase their calories and protein intake.
       In the case of bowel obstruction--either from surgery,
radiation or the tumor--cancer patients may need to eat less fiber.
But, they may need more if they become constipated.
       To help reduce their risk of developing cancer again,
following treatment, patients may want to choose foods and
nutrients whose role in reducing cancer risk has been borne out by
significant scientific evidence. (See "Look for 'Legit' Health
Claims on Foods" in the May 1993 FDA Consumer.)
~      Bowel Disease
       Increased fiber is often recommended for people with chronic
constipation, irritable bowel syndrome, and diverticulosis. Low-
fiber diets may be called for during flare-ups of these and other
bowel diseases, such as Crohn's disease and ulcerative colitis.
 ~     Osteoporosis
       In osteoporosis, bone mass decreases, causing bones to become
brittle and easily broken, especially in later life. A low-calcium
intake throughout life is thought to be a major risk factor. The
Daily Value for calcium, based on calcium needs for all ages, is
1,000 milligrams. Vitamin D also is important because it aids
calcium absorption. The Daily Value for vitamin D is 400
International Units. n
 
--P.K.
 
Nutrient Claims Guide For Individual Foods
 
Fiber
High-fiber: 5 grams (g) or more per serving
Good source of fiber: at least 2.5 g per serving
More or added fiber: at least 2.5 g more per serving than the
reference food. (Label will say 10 percent more of the Daily Value
for fiber.)
 
Protein
High-protein: 10 g or more of high-quality protein per serving
Good source of protein: at least 5 g of high-quality protein per
serving
More protein: at least 5 g more of high-quality protein per serving
than reference food. (Label will say 10 percent more of the Daily
Value for protein.)
 
Calcium
High-calcium: 200 milligrams (mg) or more per serving
Good source of calcium: at least 100 mg per serving
More calcium: at least 100 mg more than reference food. (Label will
say 10 percent more of the Daily Value for calcium.)
 
Vitamin D
High in vitamin D: 80 International Units (IU) or more per serving
Good source of vitamin D: at least 40 IU per serving
More or fortified with vitamin D: at least 40 IU more than
reference food. (Label will say 10 percent more of the Daily Value
for vitamin D.)
 
Special Report
       Articles cited in this story are among those included in the
in-depth and easy-to-understand FDA Consumer special report, Focus
on Food Labeling. Copies cost $5 each. To order, write to:
Superintendent of Documents, P.O. Box 371954, Pittsburgh, PA 15250-
7954. Ask for stock number S/N 017-012-00360-5.
 
 
------------------------------
 
End of HICNet Medical News Digest V08 Issue #16
*********************************************
 
 
---
Editor, HICNet Medical Newsletter
Internet: david@stat.com                 FAX: +1 (602) 451-6135
 

