Recall:Salmonella Alert! Products Containing Hydrolyzed Vegetable Protein or HVP
Filed under: Dangerous Foods, Is it Safe?, Recall, Recalled Foods, Salmonella
Could become the largest food recall ever: read more details here.
Recall: Products Containing Hydrolyzed Vegetable Protein
Federal health authorities announced Thursday the recall of a commonly used flavor enhancer after samples of the product were found to contain salmonella.
“I would say it’s likely to be in thousands of food products,” said Dr. Jenny Scott, senior adviser to the director at the Office of Food Safety at the Food and Drug Administration’s Center for Food Safety and Applied Nutrition, about the product, called hydrolyzed vegetable protein, also called HVP.
The bacterium, identified as Salmonella Tennessee, was found in HVP manufactured by Basic Food Flavors Inc. of Las Vegas, Nevada, the officials said.
HVP is used in processed foods, including soups, sauces, chilis, stews, hot dogs, gravy, seasoned snack foods and dressings.
“We are working hard to respond to this particular outbreak; we also are working hard to put in place the kinds of preventive control measures to prevent this kind of contamination from happening in the first place,” said FDA Commissioner Dr. Margaret A. Hamburg.
Officials noted in a telephone conference call with reporters that no illnesses have been reported and any risk to consumers would be considered low.
“Many of the foods that incorporated this product at very low levels have kill steps in place that would eliminate salmonella,” said Dr. Joshua Sharfstein, FDA’s principal deputy commissioner. He was referring to steps in preparation that would heat the product enough to kill any bacteria. “For those that don’t, we’re providing specific guidance around the need to recall,” he said.
But officials acknowledged they did not yet know just how many products might wind up being recalled.
“The manufacturer had many first-level consignees who obviously had individuals and firms that they sold to,” said Dr. Jeff Farrar, associate commissioner for food safety, FDA’s Office of Foods. “We expect this to get larger over the next several days to, actually, maybe several weeks.”
A call to the manufacturer was not returned immediately.
Sharfstein said the agency learned of the problem in early February, when a Basic Foods customer tested the product and reported to FDA that it was contaminated.
Farrar said he did not know when the plant was last inspected.
The recall affects all bulk HVP produced at the facility since September 17. The FDA posted several dozen products containing the ingredient at www.foodsafety.gov, but officials said the list was not complete. The recalled products include dips, salad dressings and soup mixes.
Farrar said the agency was recommending recalls of those products containing HVP that might be eaten without processing or cooking that would kill the bacteria. But more needs to be done, he said. “This situation clearly underscores the need for new food safety legislation to equip FDA with the tools we need to prevent contamination,” said Farrar.
Salmonella bacteria sometimes cause fatal infections in young children, elderly people and anyone with a weakened immune system.
Symptoms in healthy people might include fever, diarrhea, nausea, vomiting and abdominal pain.
The Center for Science in the Public Interest said the recall is “yet more proof that the Food and Drug Administration needs more authority, more inspectors and more resources to ensure that our food supply is safe.”
It added, “Most Americans would be stunned to learn that FDA doesn’t even have the authority to make recalls like these mandatory.”
A bill passed in July by the House with overwhelming bipartisan support would go a long way toward beefing up the agency’s ability to intervene in such cases, said Erik Olson, director of food and consumer product safety at The Pew Charitable Trusts.
“The existing law is basically a reactive law,” he said. “If you find contamination problems, the FDA reacts and goes out and tries to find the problem and asks for a voluntary recall.”
The FDA Food Safety Modernization Act, the law pending in the Senate, “would change the whole system, modernize it to say we’re going to try to prevent the contamination before it occurs.”
But support for the bill is not universal.
The National Sustainable Agriculture Coalition is seeking changes in the bill before passage, according to Senior Policy Associate Kate Fitzgerald.
“The last thing we want to do as a government is to inhibit these regional food systems by poorly crafted regulation,” she said. Under the proposed legislation, a farmer selling broccoli heads would be classified as a farmer, but a farmer selling broccoli florets would be classified as a facility and subject to more rigorous controls, she said.
“No one benefits if we pass a food-safety bill but it doesn’t make the food system better,” she said.
Steve Etka, legislative director at the National Organic Coalition, offered a similar view. “We want to make sure the bill is clear that it’s targeted toward the riskiest behaviors,” he said. “Right now, we think it’s kind of missing the mark in that regard.”
Information current as of noon March 04, 2010
56 entries in list
Hydrolyzed Vegetable Protein Containing Products Recall List: Main Page
Note: This list includes products subject to recall in the United States since February 2010 related to hydrolyzed vegetable protein (HVP) paste and powder distributed by Basic Food Flavors, Inc. This list will be updated with publicly available information as received. The information is current as of the date indicated. Once included, recalls will remain listed. If we learn that any information is not accurate, we will revise the list as soon as possible. When available, this database also includes photos of recalled products that have been voluntarily submitted by recalling firms to the FDA to assist the public in identifying those products that are subject to recall.
Deceptive Labeling Practices gets called out by FDA-Can you trust labels?
Filed under: Is it Safe?, Labeling and Labels, Tips on Food Safety, What it is?
In a move called “unprecedented” by watchdog agency Center for Science in the Public Interest (CSPI), the Food and Drug Administration (FDA) issued warning letters to 17 food companies about their deceptive labeling practices.
Basically, the companies receiving these letters did one of two things wrong. Let me present these two issues and give a few examples for each and then tell you what I think about all of this.
Issue #1: The product label bears a nutrient content claim but does not meet the requirements to make the claim. Specifically if the product package includes the claim “0 grams trans fat” and the product contains more than 13 grams of total fat, 4 grams of saturated fat or 480 mg of sodium per labeled serving, it must include a disclosure statement on the label, adjacent to the claim, referring the consumer to nutrition information for those nutrients.
Here are a few examples:
* Gorton’s Beer Batter Crispy Battered Fish Fillet: They make the “0 grams trans fat” claim without a disclosure statement when a serving of the product contains 19 g total fat, 4.5 g saturated fat and 680 mg sodium per serving.
* Dreyer’s Nestle Drumstick Classic Vanilla Fudge and Dreyer’s Dibs Bite Size Ice Cream Snacks Vanilla Ice Cream with Nestle Crunch Coating: The package label states “O grams trans Fat” but the products contain 19 grams total fat; 10 grams saturated fat (Drumstick) and 28 grams total fat, 20 grams saturated fat (Dibs).
* Spectrum Organic All Vegetable Shortening: This product doesn’t meet the requirement for the use of the term “cholesterol free” on its label because the product contains 6 grams of saturated fat per tablespoon (it exceeds the limit of 2 grams or less saturated fat per Reference Amount Customarily Consumed)… and it doesn’t comply with the requirements for making the claim “less saturated fat than butter.”
Issue #2: The therapeutic claims on their website established that the product is a drug because it is intended for use in the cure, mitigation, treatment or prevention of disease.
* *Salada Naturally Decaf Green Tea (Redco Foods): Their website promotes their tea products for conditions that cause them to be drugs under the Federal Food, Drug and Cosmetic Act. For example, they make the statement that green tea can inhibit the cancer process and regulate cholesterol levels.
* Diamond of California Shelled Walnuts: Again, the FDA determined, based on claims made on their website, that their walnuts products are promoted for conditions that cause them to be drugs. Here are some of the statements made on their website that FDA mentioned specifically:
o “Studies indicate that the omega-3 fatty acids found in walnuts may help lower cholesterol; protect against heart disease, stroke and some cancers; ease arthritis and other inflammatory diseases; and even fight depression and other mental illnesses.”
o “In treating major depression, for example, omega-3s seem to work by making it easier for brain cell receptors to process mood-related signals from neighboring
neurons.”
o “There’s good evidence that omega-3s can increase HDL (good cholesterol), further reducing the risk of stroke and heart disease.”
So what do I think about all of this? I totally understand FDA going after processed food products like frozen desserts or breaded fish fillets boasting “0 grams trans fat” when they are still high in total fat and saturated fat. Job well done here, although they are really only asking for the companies to add a disclosure statement to correct this. CSPI and other nutrition experts like myself would ideally want them to ban the statement entirely in a product exceeding the total fat and saturated fat guidelines.
And I would understand them going after companies stating “made with whole wheat,” when the product only contains a small portion of whole wheat – but then they didn’t go after these companies in this go-around.
But I’m not so thrilled about them going after companies selling whole foods like olive oil, walnuts and green tea. I am trying to move people toward eating more whole foods – foods that offer phytochemicals and other potentially helpful food components such as fiber and monounsaturated fat – instead of processed foods. These companies mostly got in trouble for the information they include on their websites. Maybe it’s just me, but I am much more concerned about what is being stated on product labels than on company websites.
As far as information on websites, I understand that health information and study results presented should clearly state whether the evidence is “suggestive” or “preliminary.” But in some cases I think consumers actually benefit from seeing some of this new information as it is emerging, especially if the bottom line is leading them to consume more whole foods. If we all waited for the government to review study evidence and make their all important “health claims” for various nutrient and disease associations, some of this potentially powerful information might not get out to those interested for another decade.
What do you think? What are some of the most outrageous health claims you have seen on food packages?
10 Foods that can cause you to get sick
10 Foods Most Likely to Make You Sick
Leafy Greens, Eggs, and Tuna Are Among Foods Mostly Like to Cause Food-borne Illness
By Todd Zwillich
WebMD Health News
Reviewed by Louise Chang, MD
Oct. 6, 2009 — Here’s a surprise: Some of the healthiest foods may also be the most likely to cause food-borne illness.
That’s the conclusion in a report by the Center for Science in the Public Interest (CSPI). The report shows leafy greens, sprouts, and berries are among the most prone to carry infections or toxins.
“We don’t recommend that consumers change their eating habits,” says Caroline Smith DeWaal, the CSPI’s head of food safety programs. Instead, the group is trying to point out vulnerabilities in the nation’s food safety system as it lobbies Congress to beef up enforcement.
The group analyzed CDC data on food illness outbreaks dating back to 1990. They found that leafy greens were involved in 363 outbreaks and about 13,600 illnesses, mostly caused by norovirus, E. coli, and salmonella bacteria.
The rest of the top 10 list included:
* Eggs, involved in 352 outbreaks and 11,163 reported cases of illness.
* Tuna, involved in 268 outbreaks and 2,341 reported cases of illness.
* Oysters, involved in 132 outbreaks and 3,409 reported cases of illness.
* Potatoes, involved in 108 outbreaks and 3,659 reported cases of illness.
* Cheese, involved in 83 outbreaks and 2,761 reported cases of illness.
* Ice cream, involved in 74 outbreaks and 2,594 reported cases of illness.
* Tomatoes, involved in 31 outbreaks and 3,292 reported cases of illness.
* Sprouts, involved in 31 outbreaks and 2,022 reported cases of illness.
* Berries, involved in 25 outbreaks and 3,397 reported cases of illness.
It is unclear how many of the outbreaks can be blamed on the foods themselves. The CDC’s database can’t discriminate between outbreaks caused by tomatoes, for example, vs. those caused by other ingredients in a salad. Foods like potatoes are almost always consumed cooked, so it is unlikely that potatoes themselves caused 108 outbreaks.
Still, Smith DeWaal called the list “the tip of the iceberg” when it comes to food-borne illnesses in the U.S. Not all outbreaks are reported to public health authorities. In addition, the analysis focused only on foods regulated by the FDA; that leaves out beef, pork, poultry, and some egg products, which are policed by the U.S. Department of Agriculture.
“Consumers always want to know what they should do to avoid getting sick,” says Sarah Klein, lead author of the report. She recommends “defensive eating,” including keeping food cold and cooking it thoroughly, chilling oysters and avoiding them when raw, and avoiding raw eggs or using them in homemade ice cream.
Several bills that are circulating in Congress aim to crack down on food safety by requiring all food producers to keep written safety plans and giving the FDA more power to inspect plans and enforce rules.
“In a relative scale our food supply remains quite safe,” says Craig Hedberg, a professor of environmental and occupational health at the University of Minnesota School of Public Health. The CDC says 76 million Americans get sick from food-borne illnesses each year.
“Because most people don’t experience a bad outcome from a lapse in good behavior it’s difficult to enforce,” he says.
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Food Safety Reform, Is our food safe?
Food safety reform is on the table again
Pistachios Food and Drug Administration Kraft
Paul Sakuma / Associated Press
The Food and Drug Administration was tipped off by Kraft Foods Inc. on March 24, after the company found salmonella during routine testing.
The pistachio warning, coming not long after the peanut product recall, may lead to legislative changes.
By Mary MacVean
April 3, 2009
Consumers could be forgiven for feeling a little weary about this week’s recall of pistachios that might be contaminated with salmonella.
It comes just weeks after thousands of products containing peanuts were voluntarily recalled in a salmonella outbreak that sickened about 700 people, and follows highly publicized food-borne disease outbreaks connected to peppers and spinach.
www.Malt-O-Meal.com/VoluntaryRecall
“As consumers, we all have that reaction, ‘Here we go again,’ ” said Jeff Levi, executive director of the Trust for America’s Health, a Washington-based nonprofit organization that works to reform the food safety system.
But the string of alerts keeps food safety on the minds of Americans and could lead to legislative changes in California and the rest of the country.
The Food and Drug Administration told consumers Monday to stop eating anything containing pistachios — an effort to keep people from getting sick while investigators looked for the source and the extent of the problem.
The government was tipped off by Kraft Foods Inc. on March 24, after it found salmonella in routine testing and recalled some trail mix.
Ebola-Reston found in the Philippines, killing pigs to stop spread.
Filed under: Banned Foods, Dangerous Foods, Is it Safe?, What it is?
MANILA, Feb 23 (Reuters) – The Philippines will slaughter 6,000 pigs at a hog farm north of the capital Manila to prevent the spread of the Ebola-Reston virus, health and farm officials said on Monday.
But the government has lifted a quarantine on a second hog farm after tests by experts from the World Health Organisation (WHO), World Organisation for Animal Health (OIE) and Food and the Agriculture Organisation (FAO) showed no more signs of the disease.
The country has more than 13 million heads of swine and the discovery of Ebola-Reston on two hog farms north of Manila was isolated, the government said.
"There is ongoing viral transmission in Bulacan ... as a precautionary measure, depopulation will be carried out in the Bulacan farm," Health Secretary Francisco Duque told reporters, referring to the farm just north of Manila.
The government said 6,000 pigs would be killed, burned and buried as experts sought to determine the source of Ebola-Reston in pigs as well as pig-to-pig and from pig-to-human transmission. Duque said 147 human samples have been tested for Ebola, but only six have tested positive. But all six remain healthy, he added.
"Ebola-Reston poses a low risk to human health at this time," Duque said.
It is the first time the virus has been found outside monkeys and the first time it has been found in pigs. The virus had previously jumped from monkeys to humans but this was the first case of a jump from hogs.
The Ebola-Reston virus was found in the Philippines as early as the late 1980s and 25 people were found infected after contact with sick monkeys. But only one developed flu-like symptoms and later recovered. (Reporting by Manny Mogato; Editing by Sugita Katyal)
China clears Danone, milk products of melamine
Filed under: Banned Foods, China Product Safety, Dangerous Foods, Is it Safe?, Melamine, china
China clears Danone, milk products of melamine
By AUDRA ANG – 12 hours ago
BEIJING (AP) — Chinese quality investigators have found that milk products from a unit of France’s Groupe Danone SA are melamine-free, and also said an unapproved additive used by one of China’s largest dairies is safe but was used illegally.
The separate investigations into the products of Danone’s Dumex Baby Food Co. Ltd. and Mengniu Dairy Group Co. underscore the government’s chronic problems with policing product quality. Melamine-contaminated milk was linked to the deaths of at least six Chinese babies and illnesses of nearly 300,000 others last year.
In a statement released over the weekend, the Shanghai Municipal Bureau of Quality and Technical Supervision said it had tested 932 batches dairy products produced by the Dumex subsidiary since mid-September “and all are melamine-free.”
It also said no melamine, an industrial chemical used in the manufacture of plastics and fertilizer, was found in more than 1,700 batches produced before mid-September, when the dairy scandal broke.
“Our valued consumers can continue to use our product with confidence,” Dumex said in a statement. “Now more than ever, we remain committed to providing products of the highest quality to our loyal consumers.”
Meanwhile, the Health Ministry said a panel of experts had reviewed OMP, a milk protein added by Mengniu to its premium Telunsu line and declared that "consumption ... is not hazardous to health."
However, the ministry said that OMP is not a government-approved additive and Mengniu "promoted its function in an exaggerated manner."
"Law enforcement and inspection departments will further deal with the illegal actions of Mengniu," the ministry said, without giving any details.
It said the company had stopped using OMP and was in the process of getting official approval.
Telephones were not answered at Mengniu's media department on Monday.
Last year's milk scandal, over nitrogen-rich melamine that was added to milk to fool protein tests, was China's worst food contamination crisis. It also exposed loose controls over large companies like Mengniu and Yili Industrial Group Co., whose products were recalled.
Both companies had been exempt from government inspections under waivers given to companies deemed to have proper quality controls, which have since been scrapped.
17 Harmful additives banned
Filed under: Banned Foods, Is it Safe?, Melamine, Red Dye 1, china
Chinese health ministry bans 17 harmful substances in food
BEIJING – China has published a list of 17 acids, chemicals and other substances that have been banned as food additives, amid a four-month safety campaign following a scandal over tainted milk.
A Chinese customer browses through various instant noodles at a supermarket in Zhengzhou, Dec. 16. China has banned 17 substances as food additives as part of a four-month safety campaign launched following a scandal over tainted milk. – AFP
Illegal items posted on the Chinese health ministry’s list include boric acid, a chemical used as an insecticide or flame retardant that is known to be added to noodles or the skin of dumplings to increase their elasticity.
Formaldehyde, applied to dried seafood to improve its appearance, but also commonly used as a disinfectant, was another dangerous substance on the banned list, published on the ministry’s Web site late on Monday.
Some of the substances, such as the carcinogenic dye Sudan Red 1, had already been banned by the government, but this was the first official compilation of illegal food additives in China.
In a related story, Chinese police are investigating 27 cases of melamine-laced animal feed, state media said Monday, three months after the industrial chemical was detected in milk, triggering a worldwide food scandal.
The Ministry of Agriculture examined 22,700 batches of feed throughout the country, and found 545, or 2.4%, were found to contain excessive melamine, the official China Daily reported.
Twenty-seven cases had been transferred to police for further investigation, the report said, citing Wang Xiaohong, a top official at the ministry’s National Feed Office.
The government said this month at least six children may have died in China after drinking milk laced with melamine, a chemical normally used to make plastic, and a further 294,000 suffered kidney-related problems.
The scandal, which came to light in September, caused international concern and led to recalls and bans of Chinese-made dairy products around the world.
The melamine was mixed into watered-down milk so dairy products would have the appearance of higher protein content.
The scandal widened when eggs sent from the mainland to Hong Kong were also discovered to contain melamine in October, with the chemical similarly added to chicken feed to give it the appearance of more protein.
China is the largest feed and feed additive exporter after the US, with output estimated to be 131 million tonnes this year, according to the China Daily.
This prompted authorities to launch a four-month food safety drive at the beginning of December to try to restore confidence in the “Made-in-China” brand.
The government said when it announced the campaign that it would start out softly, with companies urged to correct their own shortcomings. But officials would soon begin raiding food producers deemed high-risk and carry out random checks, it warned.
Banned food additives
The list of banned food additives on Monday also included sodium thiocyanate, used in the manufacture of textiles, and added to milk and dairy products to keep them fresh.
Anthony Hazzard, a regional adviser for food safety in the World Health Organization’s (WHO) Western Pacific office, said the list could prove useful in reducing the illegal use of such chemicals, by raising awareness.
But he told AFP it was more efficient to have a list of additives that could be used in food rather than an unending list of ones that could not.
As part of the crackdown, the health ministry also published on Monday the names of additives that could easily be abused when added to food products.
It mentioned leavening agents as one such substance, used to make cakes and dough sticks, which could leave excessive aluminium residues if added in excessive quantities.
But the ministry warned the lists were not exhaustive.
"These lists... cannot cover all problems linked to illegally adding substances in food and abusing additives in the industry," it said in its online statement. - AFP
How much melamine is safe? World Heath Org says traces seem safe
By FRANK JORDANS
GENEVA (AP) — The World Health Organization said Friday that tiny traces of the chemical melamine are not harmful in most foods, but it joined the U.S. and EU in setting a strict limit that regulators should impose before pulling products off the shelf.
Melamine was recently found to have contaminated milk products around the world and has been implicated in the sickening of nearly 300,000 babies in China and killing at least six infants there.
A meeting of food safety experts held by WHO in Ottawa, Canada, decided on Friday that while there is no good reason to have any melamine in food products at all, a maximum of 0.2 milligrams of melamine per kilogram of body weight can be tolerated per day.
Jorgen Schlundt, WHO's director for food safety, said that threshold is lower than the European Union's limitation of 0.5 milligrams. The U.S. Food and Drug Administration, which originally set its limit at 0.63 milligrams, later reduced its tolerable daily intake to 0.063 milligrams.
WHO's guidance is used by governments to set their minimum food safety standards.
Melamine, a nitrogen-rich chemical used in the production of plastics, was first discovered to be a major problem when it appeared in Chinese infant formula in September. Since then traces have been found in milk products around the world.
Last month the FDA said tests found traces of melamine in the infant formula of one major U.S. manufacturer and cyanuric acid, a related chemical, in the formula of a second major maker.
Schlundt stressed that the threshold the WHO has set — which stipulates that a 50 kilogram (110-pound) person could tolerate 10 milligrams of melamine per day — is not a “safe” level for melamine, but merely the amount a human being can consume without higher health risk.
Melamine is used in some food packaging and can rub off into packaged food products. It also is part of a cleaning solution used on some food processing equipment.
Red Dye No 3 and other dyes, are they safe?
Red Dyes in Food, are they safe? Should they be banned?
Red Dye # 40 has been linked unofficially to some behavioral problems with young children.
Red dye No. 40 is found in hundreds of foods, including Twizzlers, Doritos, Twinkies, chocolate cake mix, vanilla frosting and crosissants.
This is a great site about red dyes and the history of what is going on with dyes in general.
Click here to read more.
Note: This is an older article and oddly enough when I researched red dye 3, I could not find any new info as far as it being banned. The FDA apparently tried to ban it at one point and failed.
Red No. 3 and Other Colorful Controversies
by Dale Blumenthal
The lure of red cherries in canned fruit cocktail is legendary in many
American families. Siblings fight over them, parents use them to bribe or
treat their children, and even adults count the cherries spooned into their
dessert. But, the days of the fruit cocktail cherry colored by FD&C Red No. 3
may be numbered. Because large amounts of the color have been shown to cause
cancer in rats, FDA recently ended certain uses of FD&C Red No. 3 and plans to
end the remaining uses. The cherries in 21st century fruit cocktail could
well be light brown.
Color has long been recognized as important in consumer acceptance of nearly
every food, medication and cosmetic product. Even the hue of the containers
can make the difference between a best seller and a “no-sale-er.”
A research project in the 1970s, reported in the October 1973 issue of
Marketing, illustrated just how big the impact of color can be on the
acceptance of food items in particular. Research volunteers were served a
meal of steak, peas and French fries. They ate part of the meal under special
lighting that concealed the fact that the colors of the food had been
altered. When, under normal lighting, the test group discovered that their
steaks were blue, peas red, and french fries green, some participants became
ill at the sight of the unnaturally colored food they had been eating.
Color Safety
Food once was colored only with natural dyes. Beets, peppers, grape skins,
saffron, and even brilliantly scarlet extracts prepared from dried bodies of
cochineal insects lent their distinctive colors to the cook’s creativity.
By the 19th century, colors derived from other chemicals came into use–with
sometimes serious health consequences (see “Additives for Eye Appeal” in the
July-August 1973 issue of FDA Consumer). Lead chromate and copper sulfate
began to be used to tint candy and pickles. Arsenic and other poisonous
impurities were added when mixing up new color additives. Dyes made from
coal-tar and petroleum derivatives also appeared in foods, drugs and cosmetics.
How, then, can a consumer be sure that the bright primary colors and the
subtle shadings that color many consumer products today are safe to eat, use
in drugs, put on skin or hair, or–as with colored contact lenses–stick in
the eyes? A monitoring process–directed by FDA and refined over several
decades–ensures that this is so.
FDA began a comprehensive assessment of the safety of color additives with the
passage of the Pure Food and Drugs Act of 1906. The country had changed from
an agricultural to an industrial nation. No longer did most Americans live on
farms and produce their own food. Instead, much of the food a nation of city
dwellers ate was processed, chemically preserved, and marketed by large firms
competing for consumers’ attention.
It was a time of triumph for synthetic dyes, followed by concern on the part
of public health officials about the safety of these dyes. Harvey Wiley,
chief of USDA’s Bureau of Chemistry, challenged the ease with which
manufacturers added chemicals to food. Food safety became Wiley’s special
cause, and he was instrumental in bringing about passage of the first federal
Food and Drugs Act in 1906.
This landmark food law prohibited the use of any color additive in foods if
the color would deceive the consumer, conceal inferiority or damage, or
otherwise result in misbranding and adulteration. However, Wiley believed
that the use of color additives in food required further investigation. He
hired an outside consultant, dye expert Bernard Hesse, Ph.D., to study the
problem.
After reviewing 80 of the most commonly used colors, many of which had never
been tested before, Hesse recommended only seven color additives as safe for
use in food. His recommendation was announced in a 1907 regulation, Food
Inspection Decision 76, which also introduced a system for voluntary
certification of synthetic food colors.
Pre-Market Approval
The Federal Food, Drug, and Cosmetic Act of 1938 elaborated on the earlier
regulations by providing for the listing and mandatory certification of
synthetic color additives used in foods, drugs and cosmetics. During the
1950s, a safety concern associated with the improper use of FDC’s Orange No. 1
prompted additional safety studies on color additives used in food, including
FDC’s Red No. 3.
Then, in 1960, Congress amended the Food, Drug, and Cosmetic Act of 1938 to
set up a pre-market approval system for new color additives and to require
demonstration of the safety of color additives already in use.
Approved color additives were divided into two groups: those requiring FDA’s
certification (synthetic dyes made mostly from coal tar and petroleum
derivatives) and those exempt from FDA’s certification (substances derived
from vegetable, animal or mineral products). Each batch of a synthetic color
is tested by the manufacturer and a sample submitted to FDA for certification
according to specifications in the Code of Federal Regulations. Colors exempt
from batch certification must also meet specifications in the CFR.
The 1960 amendments placed the color additives already in use on a provisional
list to permit their continued use while the manufacturers developed the
necessary data for a petition to support the listing of the color additive.
Many of the color additives requiring certification come in two forms:
straight colors and lakes. Straight colors in many cases are water-soluble
dyes. Certain straight colors are used to make “lakes” or water-insoluble
forms of the color additive. Lakes are used in products in which leaching or
“bleeding” of color would pose problems, such as in cookie fillings, coated
tablets, candies, chewing gum, and lipsticks. The agency is currently
planning a proposal regarding the regulation of lakes.
Manufacturers seeking approval for new color additives or for those on the
provisional list were required to submit a petition to FDA with scientific
data demonstrating that a specific color was safe for its intended uses. If
the agency approved the petition, the color was placed on a “permanent”
listing. Colors can be approved for use in food, drugs, and cosmetics (FDC),
in drugs and cosmetics only , or specifically for external drug and
cosmetic use .
To date, of the original 200 provisionally listed color additives, 90 have
been listed as safe and the rest have either been withdrawn by industry or
delisted by FDA.
FD&C Red No. 3
FDA terminated the provisional listings for FD&C Red No. 3 on Jan. 29, 1990,
at the conclusion of its review of the 200 straight colors on the 1960
provisional list. Commonly called erythrosine, FD&C Red No. 3 is a tint that
imparts a watermelon-red color and was one of the original seven colors on
Hesse’s list.
The provisionally listed uses that were recently terminated include use of the
straight color in cosmetics and externally applied drugs and all uses of the
lakes of FD&C Red No. 3.
The case of FDC Red No. 3, however, presents what one individual familiar
with color regulation calls a “regulatory inconsistency.” Although the
provisional uses (about one-third of its uses) are now banned, FDC Red No. 3
is still permanently listed for use in ingested drugs and food, such as baked
goods, cherries, dairy products, desserts, dietary supplements, food
seasonings, jellies, jams, and vegetable products.
This paradox came about because of improvements in scientific methods and the
timing of the petitioner’s submission for permanently listing the food and
ingested drug uses. After the 1960 provisional listings, studies were
performed on FDC Red No. 3. Results did not show any safety concerns, and in
response to a petition by the Certified Color Manufacturers Association
(CCMA), FDC Red No. 3 was permanently listed for use in ingested drugs and
foods in June 1969.
Cosmetic and externally applied drug uses of the color remained provisionally
listed while studies on skin exposure were conducted. Meanwhile, FDA expanded
its safety requirements in 1977 to include more extensive studies on
provisionally listed color additives. Based upon the results of new studies
on FDC Red No. 3, conducted by the International Research Development
Corporation and completed in 1982, the agency concluded that FDC Red No. 3
causes thyroid cancer in male rats.
The Cosmetic, Toiletry and Fragrance Association and CCMA argued that no
direct cancer-causing effect was seen in animals given the color in the low
levels used in consumer goods. FDA, however, decided that the evidence of
thyroid tumors in rats was clear, and that the additional research cited by
industry did not establish that an indirect mechanism--such as a hormonal
effect triggered by the dye--caused the tumors, rather than the dye itself.
Thus, FDA denied the manufacturers' petition for further permanent listings of
the color. Based on data from the studies, the agency estimated that the
lifetime risk of thyroid tumors in humans was at most 1 in 100,000.
Like FDC Red No. 3, FDC Blue No. 1 and FDC Yellow No. 5 were also
permanently listed for food and ingested drug uses in 1969. When FDA reviewed
new, more extensive studies on FDC Blue No. 1 and FDC Yellow No. 5, the
agency found that these two color additives did not cause cancer in animal
studies. (But, since FDC Yellow No. 5 causes allergic reactions in some
people, FDA requires its listing on food labels.)
As experts note, while the provisional listings for straight colors have
ended, advances in science will require continual monitoring of the safety of
color additives.
Delaney Dilemma
The decision to ban the provisional uses of FDC Red No. 3 is based on the
Delaney Clause of the 1960 Color Additive Amendments. Under that clause, FDA
cannot approve color additives shown to induce cancer in humans or animals in
any amount.
Many government officials, however, believe that the inflexibility of the
Delaney Clause should be replaced by a standard that allows for what may be an
insignificant cancer risk. Advances in technology and the ability to detect
minute quantities of cancer-causing chemicals in foods may make the risk
standard of the Delaney Clause unnecessarily stringent in some cases. In
announcing the decision to terminate the provisional uses of FD&C Red No. 3,
Health and Human Services Secretary Louis W. Sullivan, M.D., said that the
decision to ban the uses of Red No. 3 was not based on risk but on the legal
mandate of the Delaney Clause.
In 1986, FDA took a different approach in approving four cosmetic dyes for
which cancer risk was trivial. The agency based its approval of Orange
No. 17, FDC Red No. 19, and Red Nos. 8 and 9 on the legal maxim "de
minimis non curat lex," meaning that the law does not concern itself with
trifles. A government review panel had assessed the worst-case risks for
externally applied drug and cosmetic uses for D&C Orange No. 17 as 1 in 19
billion (that is, exposure to external cosmetics containing FDC Orange No. 17
may cause at most one additional case of cancer in 19 billion people over a
70-year lifetime of exposure) and for FDC Red No. 19 as 1 in 9 million. The
maximum possible cancer risk for D&C Red Nos. 8 and 9 was evaluated as 1 in 60
million.
The next year, however, the U.S. Court of Appeals for the District of Columbia
held that the Delaney Clause does not contain an exemption for cancer-causing
color additives with only trivial risks. Thus, the court ordered FDA to ban
the colors listed under the de minimis principle.
In the past two Congresses, Senator Edward Kennedy of Massachusetts and
Congressman Henry Waxman of California have introduced legislation concerning
pesticides that others in government would extend to other
additives--including colors--as well. The proposed legislation would
substitute a "negligible risk" standard for the "zero-risk" standard (such as
described in the Delaney Clause) to the regulation of pesticides. The bills
define "negligible risk" as causing at most one additional case of cancer in 1
million people over a 70-year lifetime of exposure to the compound.
President Bush endorsed the negligible risk standard for pesticides in his
October 1989 Food Safety Plan. A joint press statement issued that same day
by HHS Secretary Sullivan, USDA Secretary Yeutter, and EPA Administrator
Reilly noted that while the president's plan specifically addresses pesticide
residues, the principle of negligible risk is one that naturally applies to
other additives to the food supply.
Small Risks
The ban of the provisionally listed uses of FDC Red No. 3 applies to new
manufacture and production of affected products. Because any health risks
posed by Red No. 3 are extremely small, FDA concluded that consumers may
continue to use existing supplies of products that already contain that color.
Following the mandate of the Delaney Clause, FDA will now reconsider the
permanently listed uses of the straight form of FDC Red No. 3. The procedure
for banning a permanently listed dye, however, is more complex than that for
terminating the provisional uses and requires time for public comment.
Though in the future, new definitions of acceptable risk spawned by new
technologies may replace the Delaney definition, for now FDA must operate
under this meaning and say to consumers that because of the risks, certain
uses of FD&C Red No. 3 can no longer be allowed.
Dale Blumenthal is a staff writer for FDA Consumer.
Lists Available
For complete lists of color additives approved for use in food, drugs and
cosmetics--including the year approved, uses and restrictions--write to:
Division of Colors and Cosmetics
FDA (HFF-442)
200 C Street, S.W.
Washington, D.C. 20204
Cocaine laced with levamisole, causes fatal illness
Just say no to drugs. Here is another example of why drugs are scary. You don't know the guy who is cutting your drugs, you think he cares about your health? No. Check it out the coke is being cut with levamisole, which is used to treat treat intestinal worms in humans and animals. The problem is it is suppressing peoples immune system to the point where a common cold could kill you! If you did some coke and found yourself sick and with a fever after, I suggest going to doctor ASAP. So far they only found this in Canada, the thing is after following banned foods and items that make people sick, one thing I know is these things escalate and grow, like the melamine crisis.
Maybe just one dealer cut the coke with that crap. Lets hope so.
This is the official story from the Canadian Press.
Seven people in Alberta have developed a form of immune system suppression after consuming cocaine laced with a chemical compound, public health officials said Friday.
The individuals developed agranulocytosis, a condition that makes the immune system incapable of fighting off infections.
It makes common infections become serious, even fatal, quite quickly.
"We are advising anyone who develops a fever or other signs of infection and has used cocaine to seek medical attention quickly," Dr. Gerry Predy, Alberta's Acting Chief Medical Officer of Health, said in a news release.
"Any skin abscess or lung infection that develops rapidly should also be treated immediately."
Officials have linked the cases to cocaine laced with levamisole, a chemical compound developed to treat intestinal worms in humans and animals.
The cases were reported in Edmonton, Red Deer, and in undisclosed locations in southern and northern Alberta.
Doctors in Alberta have been advised they should test and treat patients for this condition if they complain of a fever or other signs of infection after using cocaine.
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