Posts belonging to Category FDA



Foods to Avoid During Pregnancy

Recently, FoodSafety.gov developed and published the following message about foods to avoid while pregnant.

foodsBecause pregnancy affects your immune system, you and your unborn baby are more susceptible to the bacteria, viruses, and parasites that are in some foods and can cause foodborne illness. Even if you don’t feel sick, some “bugs” like Listeria and Toxoplasma can infect your baby and cause serious health problems. Your baby is also sensitive to toxins from the foods that you eat, such as mercury in certain kinds of fish.

Keep this checklist handy to help ensure that you and your unborn baby stay healthy and safe. Be sure to invest in a food thermometer to check the temperatures of cooked foods.

Don’t Eat These Foods Why What to Do
Soft CHEESES made from unpasteurized milk, including Brie, feta, Camembert, Roquefort, queso blanco, and queso fresco May contain E. coli or Listeria. Eat hard cheeses, such as cheddar or Swiss. Or, check the label and make sure that the cheese is made from pasteurized milk.
Raw COOKIE DOUGH or CAKE BATTER May contain Salmonella. Bake the cookies and cake. Don’t lick the spoon!
Certain kinds of FISH, such as shark, swordfish, king mackerel, and tilefish (golden or white snapper) Contains high levels of mercury. Eat up to 12 ounces a week of fish and shellfish that are lower in mercury, such as shrimp, salmon, pollock, and catfish.Limit consumption of albacore tuna to 6 ounces per week.
Raw or undercooked FISH (sushi) May contain parasites or bacteria. Cook fish to 145° F.
Unpasteurized JUICE or cider (including fresh squeezed) May contain E. coli. Drink pasteurized juice. Bring unpasteurized juice or cider to a rolling boil and boil for at least 1 minute before drinking.
Unpasteurized MILK May contain bacteria such as Campylobacter, E. coli, Listeria, or Salmonella. Drink pasteurized milk.
SALADS made in a store, such as ham salad, chicken salad, and seafood salad. May contain Listeria. Make salads at home, following the food safety basics: clean, separate, cook, and chill.
Raw SHELLFISH, such as oysters and clams May contain Vibrio bacteria. Cook shellfish to 145° F.
Raw or undercooked SPROUTS, such as alfalfa, clover, mung bean, and radish May contain E. coli or Salmonella. Cook sprouts thoroughly.

Be Careful with These Foods Why What to Do
Hot dogs, luncheon meats, cold cuts, fermented or dry sausage, and other deli-style meat and poultry May contain Listeria. Even if the label says that the meat is precooked, reheat these meats to steaming hot or 165° F before eating.
Eggs and pasteurized egg products Undercooked eggs may contain Salmonella. Cook eggs until yolks are firm. Cook casseroles and other dishes containing eggs or egg products to 160° F.
Eggnog Homemade eggnog may contain uncooked eggs, which may contain Salmonella. Make eggnog with a pasteurized egg product or buy pasteurized eggnog. When you make eggnog or other egg-fortified beverages, cook to 160°F
Fish May contain parasites or bacteria. Cook fish to 145° F.
Ice cream Homemade ice cream may contain uncooked eggs, which may contain Salmonella. Make ice cream with a pasteurized egg product safer by adding the eggs to the amount of liquid called for in the recipe, then heating the mixture thoroughly..
Meat: Beef, veal, lamb, and pork (including ground meat) Undercooked meat may contain E. coli. Cook beef, veal, and lamb steaks and roasts to 145° F. Cook pork to 160° F. Cook all ground meats to 160° F.
Meat spread or pate Unpasteurized refrigerated pates or meat spreads may contain Listeria. Eat canned versions, which are safe.
Poultry and stuffing (including ground poultry) Undercooked meat may contain bacteria such as Campylobacter or Salmonella. Cook poultry to 165° F. If the poultry is stuffed, cook the stuffing to 165° F. Better yet, cook the stuffing separately.
Smoked seafood Refrigerated versions are not safe, unless they have been cooked to 165° F. Eat canned versions, which are safe, or cook to 165° F.

 

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Regulating Sugars in Soft Drinks

sugarsIn a press release issued yesterday, HealthDay News reported that a leading consumer advocacy group, along with nutrition experts and health agencies from a number of U.S. cities, are calling for lowering the amount of sugars added to soft drinks.

The press release reads as follows:

Led by the nonprofit Center for Science in the Public Interest (CSPI), the group  sent a petition to the U.S. Food and Drug Administration asking the agency to determine safe levels of high-fructose corn syrup and other sugars in sodas and assorted soft drinks.

Currently, the average 20-ounce bottle of soda contains about 16 teaspoons of sugars made from high-fructose corn syrup, the CSPI said. The American Heart Association currently recommends that men consume no more than 9 teaspoons of added sugars daily, and women no more than 6 teaspoons’ worth.

Some 14 million Americans of all ages now get more than one-third of their calories from added sugars, the petition stated.

“The consumption of such high amounts of sugar and high-fructose corn syrup [in sodas] are causing serious health problems, obesity, diabetes, heart disease, among others,” said CSPI Executive Director Michael Jacobson.

There’s been a great deal of scientific evidence gathered over the past decade to support that link to health problems, he said, and “we’re contending that much of the evidence centers around beverages.” The CSPI believes most sugary sodas could be safely replaced by those made with low-calorie sweeteners.

The group said its petition has the support of public health departments in Baltimore; Boston; Los Angeles; Philadelphia; Seattle; Portland, Ore.; and other cities, as well as leading academics at Harvard and Yale universities and other institutions around the country.

According to Jacobson, the FDA is legally bound to examine the health effects of the amount of sugars being consumed and take corrective action.

The center is first asking the FDA to determine the safe level of sugar in drinks. Also, it wants the FDA to issue targets for the sugar content of other sugary foods and urge industry to voluntarily reduce sugar levels in those foods, Jacobson said.

“The third thing is to educate consumers to choose healthier foods and beverages,” he said.

The FDA classifies high-fructose corn syrup, sucrose and other sugars as “generally recognized as safe,” Jacobson said.

“What we’re asking the FDA to do is to modify those regulations and set some limits in beverages,” he said.

In the 1980s, the FDA twice committed to looking at limiting the level of sugars in foods if new scientific evidence found sugar levels were harmful to the public, or if sugar consumption rose, Jacobson said.

“We are reminding the FDA of that and saying you have an obligation to revisit this and protect the public’s health,” he said.

It will take years before any action is taken, but that gives industry time to adjust to using less sugar in drinks, Jacobson said.

Jacobson said economic issues shouldn’t be part of the FDA’s consideration. “There are winners and losers for any kind of a regulation. The sugar industry and the corn industry [which supplies ingredients for high-fructose corn syrup] would be losers, but the soft drink industry might be winners,” he said.

The makers of no-calorie sweeteners “would probably make out like bandits,” Jacobson said.

The CSPI hopes new sweeteners — such as rebiana, made from the stevia plant — will replace high-calorie sugar, making drinks healthier.

Although some people are concerned that these sweeteners may be harmful, Jacobson said they are still a better option than sugar.

“The FDA considers all these sweeteners perfectly safe,” Jacobson said. “We think the certain harm that’s coming from the 16 teaspoons of sugar in a 20-ounce bottle of soda greatly outweighs the speculative risk from artificial sweeteners,” he added.

“We have an obesity epidemic on our hands, with two-thirds of Americans obese or overweight, and that should take precedence over smaller concerns,” Jacobson said.

One industry representative took issue with the new petition.

“As we continue to debate the root causes of our nation’s obesity issue, we need to rely on science and facts, not look for quick fixes that draw focus away from developing real solutions to a complex problem,” said J. Patrick Mohan, the interim president of the Corn Refiners Association, which represents high-fructose corn syrup manufacturers.

And the American Beverage Association, which represents soft drink makers, said its industry is already making changes.

“Today about 45 percent of all non-alcoholic beverages purchased have zero calories and the overall average number of calories per beverage serving is down 23 percent since 1998,” the ABA said in a statement issued Wednesday. And according to the U.S. Centers for Disease Control and Prevention, “Americans are consuming 37 percent fewer calories from sugars in soft drinks and other sweetened beverages than in 2000,” the group added.

“Everyone has a role to play in reducing obesity levels — a fact completely ignored in this petition,” the ABA said. “This is why the beverage industry has worked to increase options and information for consumers.”

Dr. David Katz, director of Yale University’s Prevention Research Center, said he joined the CSPI effort and is “proud to have signed the petition.”

“The evidence that an excess of added dietary sugars, in any of its many guises, is a major contributor to the prevailing public health ills of our time is now essentially incontrovertible,” he said. “It stands to reason that lowering those levels will help in efforts to reduce the levels of obesity, diabetes and other chronic disease.”

Soda and other sugary drinks are the single biggest source of calories in the U.S. diet, with Americans, on average, consuming between 18 and 23 teaspoons — about 300 to 400 calories — of added sugars each day, according to the petition.

Many teens and young adults consume even more sugar than the average. Some get at least 25 percent of their calories from added sugars, according to the 2007-2008 U.S. National Health and Nutrition Examination Survey.

The CSPI petition notes that cities around the country have taken note of the problem and have acted. In New York City, Mayor Michael Bloomberg is capping restaurant soda serving sizes at 16 ounces — a move that has met with considerable resistance from some who believe it tramples individuals’ rights.

Note: A judge blocked the enforcing of the NYC law, that was to go into effect earlier this week, just a day before it was to become law.

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FDA Warns Against using a Supplement Called WOW

The FDA says that taking an over the counter supplement can be a health risk.

FDAThe following warning comes from the Food and Drug Administration (FDA) about a product distributed and sold under the name ‘WOW’, which  is really just another product in disguise, one that can cause serious harm.

Earlier in 2012, FDA twice warned the public about taking Reumofan Plus—marketed as a “natural” dietary supplement for the treatment of many conditions. It contains undeclared active ingredients found in prescription drugs that should only be used under the supervision of a health care professional.

Brad Pace, regulatory counsel at FDA’s Health Fraud and Consumer Outreach Branch, says some distributors have deliberately put a new label and a new name, WOW, on bottles of Reumofan Plus to deceptively sell remaining supplies. Pace says WOW has been distributed to online retailers and other distributors, as well as directly to consumers.

FDA is concerned that other distributors will also put different labels on Reumofan Plus and sell it under other names.

The agency offers this advice to consumers:

  • Immediately consult a health care professional if you are now taking Reumofan Plus or WOW.
  • Do not use any products with “Riger Naturals S.A.” printed on the bottom of the bottle. Reumofan Plus is manufactured in Mexico by Riger Naturals.
  • Report any health problems related to these products to FDA’s MedWatch Safety Information and Adverse Event Reporting Program.

Serious Health Risks

Since June, FDA has received dozens of reports from consumers who used Reumofan Plus of serious, and sometimes fatal, outcomes. The reports include liver injury, severe bleeding, corticosteroid withdrawal syndrome, adrenal suppression and stroke.

FDA laboratory analysis confirmed that WOW contains the same undeclared prescription drug ingredients that are in Reumofan Plus:

  • dexamethasone—a corticosteroid used to treat inflammatory conditions such as asthma and rheumatoid arthritis, that can increase the risk of infection, and cause increased blood sugar levels, changes in blood pressure, damage to bones, psychiatric problems. When taken for a prolonged period at high doses, it can cause adrenal suppression.
  • diclofenac sodium—a non-steroidal anti-inflammatory drug (NSAID) that may cause increased risk of cardiovascular events, such as heart attack, as well as serious gastrointestinal problems.
  • methocarbamol—a muscle relaxant that can cause sedation, dizziness and low blood pressure, and impair mental or physical abilities to perform tasks such as driving a motor vehicle or operating machinery.

In addition to causing injury on their own, the hidden drugs found in these products could interact with other medications, resulting in serious health consequences.

Medical Advice Needed

Because one of the hidden ingredients—dexamethasone—is a corticosteroid, people taking these supplements must work with their health care professional to safely stop taking the drug. A person who abruptly stops taking corticosteroids after long-term use or after taking high doses runs the risk of suffering from a withdrawal syndrome and life-threatening adrenal suppression.

The withdrawal syndrome may include nausea, low blood pressure, low blood sugar levels, fever, muscle and joint pain, dizziness and fainting. Adrenal suppression of cortisol production can be life-threatening because, among its many important roles in the body, cortisol is needed to maintain normal blood pressure and supply glucose to vital tissues, such as the brain and red blood cells, in response to stressors such as trauma, surgery, and infection.

FDA notes that there may be other harmful hidden ingredients in these products. Ingredients may vary from lot to lot, and products found to have hidden drug ingredients are generally not manufactured in a way that would ensure their quality and safety.

Source: This article appears on FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.

 

 

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How Safe is Getting a Tattoo?

Before someone you love gets a tattoo, ask them to consider this report from the Federal Drug Administration (FDA) issued on August 22, 2012.

The Food and Drug Administration (FDA) is particularly concerned about a family of bacteria called nontuberculous Mycobacteria (NTM) that has been found in a recent outbreak of illnesses linked to contaminated tattoo inks.

M. chelonae, one of several disease-causing NTM species, can cause lung disease, joint infection, eye problems and other organ infections. These infections can be difficult to diagnose and can require treatment lasting six months or more.

Some of these contaminated tattoo inks have caused serious infections in at least four states in late 2011 and early 2012. FDA is reaching out to tattoo artists, ink and pigment manufacturers, public health officials, health care professionals, and consumers to warn them of the potential for infection.

FDA also warns that tattoo inks, and the pigments used to color them, can become contaminated by other bacteria, mold and fungi.

To raise awareness and make diagnoses more accurate, FDA strongly encourages reporting of tattoo-associated complications to its MedWatch program, says Linda Katz, M.D., M.P.H., director of FDA’s Office of Cosmetics and Colors.

“Getting the word out to tattoo artists is particularly critical. Even when they diligently follow hygienic practices, they may not know that an ink itself may be contaminated. Contamination is not always visible in the inks,” Katz says.

FDA’s goal is to encourage these artists to take certain precautions in their practice and to urge potentially infected clients to seek medical care. “Reporting an infection to FDA and the artist is important. Once the problem is reported, FDA can investigate, and the artist can take steps to prevent others from being infected,” says epidemiologist Katherine Hollinger, D.V.M., M.P.H., from the Office of Cosmetics and Colors.

A Challenging Investigation

Tattoo inks are subject to FDA regulation. FDA investigates and intervenes when a serious safety issue arises.  And that’s what happened here.

FDA’s CORE (Coordinated Outbreak Response and Evaluation) Network initiated and coordinated the investigation with state and local health departments and laboratories, the Centers for Disease Control and Prevention (CDC), and FDA investigators working in numerous district offices.

The investigation began in January 2012 when FDA, through its MedWatch reporting program, learned about seven people in Monroe County, New York who had NTM infections. They’d all gotten tattoos from the same artist, who used the same brand of ink on all of them. The infections occurred on the newly acquired tattoos, with red bumps appearing soon after the tattoo had healed.

FDA later became aware of 12 more people with an NTM infection who were also clients of this same tattoo artist. The same brand of ink was also used on them. Of these 19 people, 14 were confirmed to have the same type of NTM infection. An NTM sample from a sealed container of the same type of ink used to tattoo the affected individuals was a perfect match to the NTM linked to these infections.

Meanwhile, FDA learned of outbreaks of NTM infections in other states, including but not limited to Washington, Iowa, and Colorado. The cases in these states involved different NTM species or different ink manufacturers than those in New York. While the infections in Washington, Iowa, and Colorado were not linked to the New York infections, there was a link identified between the M. chelonae infections in Washington and Iowa.

For the New York outbreak alone, FDA investigators visited the tattoo ink supplier and manufacturer. These were located as far away as California. These investigations resulted in a recall of the implicated ink.

Strategies for Controlling Risks of Infection

Tattoo artists can minimize the risk of infection by using inks that have been formulated or processed to ensure they are free from disease-causing bacteria, and avoiding the use of non-sterile water to dilute the inks or wash the skin.  Non-sterile water includes tap, bottled, filtered or distilled water.

Consumers should know that the ointments often provided by tattoo parlors are not effective against these infections. NTM infections may look similar to allergic reactions, which means they might be easily misdiagnosed and treated ineffectively.

Once an infection is diagnosed, health care providers will prescribe appropriate antibiotic treatment according to Katz. Such treatment might have uncomfortable side effects, such as nausea or gastrointestinal problems. However, without prompt and proper treatment an infection could spread beyond the tattoo or become complicated by a secondary infection.

If you suspect you may have a tattoo-related infection, FDA recommends the following:

  • Contact your health care professional if you see a red rash with swelling, possibly accompanied by itching or pain in the tattooed area, usually appearing 2-3 weeks after tattooing.
  • Report the problem to the tattoo artist.
  • Report the problem to MedWatch, on the Web or at 1-800-332-1088; or contact FDA’s consumer complaint coordinator in your area.

Inks and pigments can be contaminated through:

  • use of contaminated ingredients to make inks,
  • use of manufacturing processes that introduce contaminants or allow contaminants to survive,
  • use of unhygienic practices that contaminate ink bottles or mixing with contaminated colors,
  • use of non-sterile water to dilute the inks,
  • Using tattoo inks past their expiration date.

This article appears on FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.

 

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