Chapter 4
Center for Food Safety and Applied
Nutrition
Last Update: October 07, 2002 |
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Allergens
In 2001, the FDA’s Center for Food Safety and Applied Nutrition
increased its activities on food allergen awareness. A major goal of
the initiative was to provide guidance to industry and regulators on
how to manage allergens through appropriate manufacturing and
labeling practices. Numerous food recalls were conducted in Fiscal
Year 2001, based on the presence of an undeclared food allergen in a
product.
In “Food Allergen Awareness: an FDA Priority, New Initiatives
Focus on Allergens in 2001,” authors Kenneth J. Falci, Ph.D., Kathy
L. Gombas and Elisa L. Elliot Ph.D., Series Editor: Catherine
“Kitty” Bailey, M. Ed., discuss food allergens.
“For sensitive individuals, the presence of allergens in food
is potentially life-threatening. Currently, there is no cure for
food allergy. The only successful method to manage food allergy is
avoidance of foods containing the allergen. Fortunately, most
consumers are aware of their specific sensitivities and can avoid
foods that might result in a life-threatening situation. For
example, a person with a peanut allergy may find it easy to avoid
whole peanuts. Formulated foods, however, present a separate
challenge. In such cases, the individual relies on accurate
ingredient labeling. The FDA, food manufacturers and special
interest groups are working to increase public awareness of the
seriousness of allergic reactions and to assure that allergens are
appropriately labeled in food products. For example, one of the
U.S. Department of Health and Human Services’ “Healthy People
2010" initiatives for the coming decade is to reduce the number of
deaths due to anaphylaxis caused by food allergens.
The number of allergic individuals in the U.S. is unknown.
Estimates suggest, however, that 1.5% of the adult population and
5% of children younger than three years old have some form of food
allergy. One estimate of the number of fatal food anaphylaxis
cases in the U.S. is 125 per year.
The Ingredient Label: Alert for the Allergy-Sensitive
Person
The FD&C Act requires, in virtually all cases, a complete
listing of all ingredients of a food on the food label. In certain
cases, such as with allergens, public health concerns have been
noted as FDA took steps to require particular wording in an
ingredient statement. For example, 21 Code of Federal Regulations
(CFR) 102.22 requires the food source identification for protein
hydrolysates, e.g., “hydrolyzed wheat gluten,” and “hydrolyzed soy
protein.” Failure to list an ingredient on the food label,
particularly an allergen, has resulted in product recalls. A
recent review of FDA food recall actions for undeclared allergens
such as peanuts, egg, or milk revealed an increase in recalls in
the last decade. Recall activity increased from an average of 35
per year at the beginning of the last decade to an average of 90
per year during the last four years of the same decade.”
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Bakery Products
Undeclared Eggs in Italian Rolls Result in Recall
In August 6, 2001, Bella Napoli, located in Troy, New York,
recalled a product labeled as Italian Rolls because it possibly
contained undeclared eggs. Dinner rolls, which contained eggs were
inadvertently packaged in bags and labeled as Italian Rolls, which
did not contain eggs. People who have an allergy or severe
sensitivity to eggs run the risk of serious or life-threatening
allergic reaction if they consume this product.
Rolls were distributed through Price Chopper stores in Troy,
Latham Cohoes and Watervliet. Product was packaged in a 16 ounce,
uncoded clear plastic bag, containing twelve rolls. The recall was
initiated when the New York State Department of Agriculture and
Markets laboratory analysis disclosed that the dinner rolls
contained eggs.
Chocolate Chip Cookies Recalled Due to Undeclared Pecans and
Almonds
FDA Assists Firm in Class I Recall of Cookies With
Undeclared Nuts |
On August 21, 2001, Publix Super Markets Inc., voluntarily
recalled Publix Bakery Chocolate Chip Cookies purchased between
August 13 and August 20, 2001, in Jacksonville, Florida division
stores. The product possibly contained undeclared pecans and
almonds. People who have an allergy or severe sensitivity to these
products run the risk of serious or life threatening allergic
reaction if they consume these products.
Publix Spokesman Lee Brunson said, "We are working very closely
with the Food and Drug Administration and our manufacturing facility
to resolve this situation with accuracy and expedience." The company
received no customer complaints regarding this product.
Recall of Animal Crackers with Undeclared Milk and Egg
FDA Analysis Reveals Low Levels of Calcium and Phosphorous
in Rice Beverage |
On June 11, 2001, the FDA’s Philadelphia District Office received
notice that Stuaffer Biscuit Co., York, Pennsylvania, was initiating
a voluntary recall of 8,163 cases of Jungle Jammers Animal Crackers
because of undeclared milk and egg products. The product was
packaged in a 13-ounce retail box for Save-A-Lot Food Stores and was
distributed in the following 12 states: Kentucky, Georgia, Michigan,
Tennessee, Missouri, Texas, California, Florida, New York, Ohio,
Maryland and Indiana, under the Save-A-Lot Food label only. The firm
issued a press release on June 11, 2001. The district followed up at
the firm to collect recall information.
Class 1 Recall of Hamburger Buns
On September 12, 2001, Flowers Bakeries of Thomasville, Georgia,
initiated a recall of select codes of Cobblestone Mill seeded 8-pack
hamburger buns because the buns possibly contained undeclared egg as
an ingredient. People who have an allergy or severe sensitivity to
egg run the risk of serious or life-threatening allergic reaction if
they consume these products. The Cobblestone Mill seeded 8-pack
hamburger buns were distributed to supermarkets and other food
stores in West Virginia, Kentucky, North Carolina, South Carolina,
Tennessee, Ohio and Virginia.
The firm initiated the recall after it was discovered that
product containing egg was distributed in packaging that did not
reveal the presence of egg. Subsequent investigation indicated the
cause of the problem was a temporary breakdown in the company's
production and packaging processes. |
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Beverages
Warning Letter Issued for Low Levels of Nutrients
On July 25, 2001, the FDA’s New Jersey District Office issued a
Warning Letter to Parmalat/Farmland Dairies, Wallington, New Jersey,
for their Westbrae Natural Rice Beverage. FDA conducted an
inspection of Farmland Dairies from November 16 - 21, 2000. During
the inspection investigators collected a sample of the beverage. FDA
analysis revealed that the levels of calcium and phosphorus in the
product were found to be well below the declared amount of calcium
on the label. FDA laboratory results disclosed results of 16.1%,
9.64% and 21% of the declared amount of calcium. In addition,
laboratory analysis disclosed 31.6%, 23.5% and 39.2% of the declared
amount of phosphorus.
Infant Formula Class I Recall
In July 2001, the FDA’s Detroit District Office received notice
from Mead Johnson Nutritionals, Evansville, Indiana, of a new
formula recall. The firm distributed sample packs [originally
intended for distribution to physicians] at retail stores without an
ingredient statement or nutritional labeling. The FDA’s Center for
Food Safety and Applied Nutrition conducted a health hazard
evaluation and concluded that one of the three products, Enfamil
LactoFree infant formula, represented a Class I health hazard for
infants allergic to milk protein.
The single serve containers, which did not declare milk protein,
could become separated from the outer pack, which stated "the
goodness of milk protein without the lactose." The firm determined
that 19 sample packs had been sold in one or more Babies 'R Us
stores located in the following nine states: Colorado, Iowa, Kansas,
Minnesota, Missouri, Oklahoma, Tennessee, and Texas. A press release
was issued on July 28, 2001.
Damaged Evaporated Milk From Canada Detained
FDA Supervises Reconditioning and Destruction of Detained
Product |
On March 19, 2001, the FDA’s San Juan District Office detained a
shipment of canned evaporated milk, manufactured by Nestle, Canada.
The product consisted of 129,696 cases of 24 cans of 13 ounces each,
valued at 1 million dollars. The evaporated milk had been damaged
due to bad weather conditions while in transit to Nestle, Inc.,
Puerto Rico. The FDA’s San Juan District Office supervised a
reconditioning process conducted by Nestle Inc. The product was
found to be unfit for human consumption was destroyed under the FDA
and U.S. Customs supervision.
Firm Recalls Packaged Drinking Water
Sanitizer Found in Bottled Drinking Water
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On August 17, 2001, Bareman Dairy, Holland, Michigan, announced
that, in cooperation with the FDA, it was conducting a recall of
19,700 Gallons of Bareman Dairy Crystal Clear Drinking Water
Packaged in One Gallon Containers. The Gallon Containers were coded
with a “sell by” date of Dec 8 JD. Bareman Dairy determined that a
portion of this lot possibly contained an equipment sanitizer.
This sanitizer was made of a mix of peroxiacetic acid and
hydrogen peroxide. Consumption could cause irritation or burning of
the throat and stomach. The company advised consumers that “If you
experience irritation or burning, immediately dilute by drinking
several glasses of water and contact the proper medical authority,
do not induce vomiting.” The recall was instituted after company
testing revealed the problem pursuant to a customer complaint. The
product, run under the Bareman Dairy label, was distributed in
Michigan’s Lower Peninsula, Northwestern Indiana, and Illinois.
Consumers who purchased the Drinking Water dated December 8 were
urged to discontinue use of the product immediately and return to
the place of purchase for a full refund.
“Carnation Follow-Up Formula” Recalled Due to Possible Health
Risk
Excessive Levels of Magnesium Found in “Follow-Up” Formula
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On September 14, 2001, Nestlé, Glendale, California, initiated a
recall of 120 cans of Nestlé Carnation Follow-Up Formula,
32-fluid-ounce Liquid Ready to Feed, due to excessive magnesium in
these cans. Long term extended use of the product could have the
potential to cause severe adverse health effects, such as low blood
pressure and irregular heart beat.
Symptoms to look for in children would include poor feeding,
unusually pale color and weakness. There were no reports of
illnesses associated with this product. The product was distributed
only to Wal*Mart stores in the following Texas cities: Crockett,
Hempstead, Lewisville, Denton, Plano, Garland, Murphy, Corsicana,
Sulphur Springs, Humble, The Woodlands, Longview, Katy-Houston,
Center, Irving, Bedford, Grand Prairie, Lancaster and Arlington.
No other Nestlé Carnation formula products or forms (such as
powder or concentrate) were involved. The recall was limited to 120
cans of Nestlé Carnation Follow-Up Formula, 32- fluid-ounce Ready To
Feed with the following production code stamped on the top of cans:
1203EWFR3551. The code appeared under the "use by" date, 22 Jan
2003, and may or may not be followed by one additional letter. The
recall was the result of routine quality assurance sampling by the
company which revealed that one batch of the formula had a high
magnesium content.
FDA Supervises Destruction of Moldy Tomato Juice
On June 22, 2001, the FDA’s San Juan District Office witnessed
the destruction of 459 cases of 24/12 ounce cans of Tomato Juice
manufactured by Productos Del Tropico, C.X.A., Dominican Republic,
valued at $3,442.50. The product was sampled, and laboratory results
revealed the product contained excessive rot and mold. The product
was consigned to Empresas La Famosa, Toa Baja, Puerto Rico, who
voluntarily chose to destroy the product. |
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Candy and Sweeteners
FDA Warns Consumers About Candy That Poses Choking Hazard
"Konjac" Jelly Cups Imported from Asia Cause Choking in
Children |
On August 17, 2001, FDA issued a warning to consumers of a
potential choking hazard posed by “konjac” jelly cups imported from
Asia. After consultation with the Consumer Product Safety
Commission, the FDA issued a second warning on October 5, 2001. Some
of the candy had warning labels, suggesting that it not be eaten by
children or the elderly. Other labels warned of a choking hazard and
said to chew the candy thoroughly. Some of the candy was sold with
no warning label at all. Local authorities reported three
children’s’ deaths from choking in the United States associated with
conjac jelly candy. There were also reports of deaths in other
countries.
The candy was sold in several fruit flavors. It was found in
small sealed plastic cups that may or may not contain a chunk of
fruit. Each jelly cup is about the size of a single-serve coffee
creamer. The candy is sold in retail stores and on the Internet
under a variety of names.
FDA Sampling Results in Recall of Candy
FDA Lab Analysis Discloses Lead in Candy as High as 4.60
ppm |
On August 17, 2001, Villarreal Distributors of San Antonio,
Texas, recalled over 20,000 candy containing clay pots of JARRITOS
brand Tamarindo candy. The recall was initiated because the candy
had been found to contain excessive levels of lead. Lead is very
toxic and dangerous to humans, especially children, women of
childbearing age, pregnant women and their unborn children. Although
people with lead in their blood often do not exhibit the symptoms of
lead toxicity, such symptoms include the following: stomach aches,
colic, nausea, vomiting, abnormal irritability, and insomnia. Lead
can also permanently damage the central nervous system, resulting in
learning difficulties in school children as well as cause other
long-term health problems.
The JARRITOS brand Tamarindo candy was distributed in Illinois,
Ohio, Wisconsin, New Jersey, Mississippi, Iowa, Missouri, Montana,
Indiana, Tennessee, Kentucky, Nebraska, South Carolina, Alabama and
Maryland, through retail sites, especially ethnic markets, stores
and bakeries that cater to Latinos. The product was imported from
Mexico, manufactured by La Barca II Dulceriain Jalisco, Mexico. The
product was sold as 12 candy containing clay pots per labeled
package. The label stated JARRITOS and Tamarindo 100% Natural with a
picture of a boy. Each pot was also individually packaged in an
unlabeled clear plastic bag.
The recall was the result of a routine sampling program by the
FDA that revealed that the candy had levels as high as 4.60 ppm. It
is believed the lead had leached from the clay pots into the candy.
FDA Alerts Public to Possible Health Risk Associated with Candy
Lollipops from Mexico
Excessive Lead in Lollipops From Mexico Leads to Recall
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On April 25, 2001, FDA issued an alert to consumers of a possible
Health Risk associated with Tamarind Candy from Mexico. FDA warned
consumers to avoid purchasing or consuming tamarind candy lollipops
labeled Dulmex brand “Bolirindo” because of high levels of lead that
may be associated with the product - especially its wrapper. People,
especially children, who consume high levels of lead can suffer
serious damage to their central nervous systems - sometimes leading
to permanent neurological damage.
Routine lead level testing of children conducted by the
California Department of Health Services revealed at least three
cases where 2 year old children may have suffered elevated lead
levels as a result of contact with this candy. These findings led
the California Department of Health Services and FDA to analyze this
product for lead contamination. Although sampling and analyses of
this product continues, preliminary findings indicate that at least
the lollipop wrapper’s exterior may have exceedingly high
concentrations of lead (21,000 parts per million).
In light of these preliminary findings and reported injuries, FDA
urged consumers not to consume these lollipops and to keep them out
of children’s’ hands. Eating the lollipops may expose them to
dangerously high levels of lead, especially if the candy becomes
damp or if the wrapper is chewed or eaten. Anyone who suspects they
or their child may have consumed these lollipops may want to consult
their doctor about having their lead level checked. The
product is a soft, dark brown, tamarind fruit candy lollipop on a
white or orange stick. It is wrapped in an orange-red wrapper with
“BOLIRINDO” in white lettering and picture of a brown tamarind
fruit. The product is known to be distributed in California, but may
also be present in other parts of the country, particularly in
Southwestern states.
Allergy Alert Issued for Undeclared Dairy in Candy Bar
On August 7, 2001, Golden Temple, Inc, Vashon, Washington, the
manufacturer of BumbleBar products, determined that milk had been
unintentionally added to 1.6 ounce BumbleBar's Chocolate Crisp bar.
Therefore, BumbleBar, Inc., voluntarily recalled its 1.6 ounce
Chocolate Crisp BumbleBars (UPC 7-60590-10072-5). People who have
allergies or severe sensitivities to dairy were urged not to consume
the affected product. The problem was isolated to 86 cases,
manufactured between March 31, 2001, and July 25, 2001. The lot
codes were printed on the case exterior near the label, on the
carton, or inside flap of the carton. The lot codes affected were:
21802, 22302, 31402, 31702, 32202, 32402, 32902, 40602, 41202,
41902, 42302, 42602, 51602, 52302. These lots were distributed in
the states of Washington, California, Colorado, Florida, Indiana,
and Arizona. The problem was discovered in the ingredient purchasing
specification for the organic chocolate used in the bars.
Specifications had been changed and production had resumed with a
non-dairy chocolate. The recall notice was issued to the
distributors who returned product and put dairy free product back
into distribution.
Consumer Complaint Results in Recall
FDA Inspection Finds Candies with 10,000 ppm of Undeclared
Milk Protein |
In March 2001, the FDA’s Minnesota District Office initiated an
inspection of Eileen's Candies, a candy repacker located in Green
Bay, Wisconsin. The inspection was conducted as a follow-up to a
consumer complaint. Analyses of a sample of Mills Fleet Farm
Butterscotch Chips detected 10,000 PPM of undeclared milk protein.
The inspection found that the bulk Butterscotch Chips and Ivory
Chips (white chocolate chips) were both improperly labeled by
Eileen's Candies when they were repacked into retail size packages.
Both bulk products were manufactured by Clasen Coatings, Middleton,
Wisconsin, and were properly labeled, but the "model" retail label
supplied to Eileen's Candies by Clasen Coatings lacked declaration
of Non-Fat Dry Milk and Whey Powder. Eileen's Candies recalled the
affected products.
FDA Assists U.S. Customs in Seizure of Candy
FDA Investigation Discloses Substitution of Candy With
Candy Contaminated with Filth |
On March 13, 2001, the Southwest Import Division [SWID] Consumer
Safety Officer accompanied U.S. Custom's officials in Laredo during
a seizure of 176 cases of Chorreada hot candy. This seizure was the
result of an investigation conducted by SWID's Laredo resident post
that indicated the cases of candy had been largely substituted for
an entry of candy refused admission by FDA because of contamination
with filth.
In addition to the seizure, SWID recommended that liquidated
damages be assessed for the importer's failure to redeliver the
merchandise actually refused admission by FDA. This seizure
represents the culmination of a cooperative effort between SWID's
Investigation and Compliance Branch and U.S. Custom's Office of
Investigation and Office of Fines Penalty and Forfeitures.
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