Posts Tagged ‘FDA’

FDA’s weekly press synopsis

Thursday, January 28th, 2010 by Amy Porter

By Amy Cook Porter

Okay, I can never resist writing about the obvious, especially if the information comes from a legitimate source and who better to comment on than the the FDA’s weekly press synopsis.

Fresh on their website:

Effects of Switching from Whole to Low-Fat/Fat-Free Milk in Public Schools – New York City, 2004-2009www.cdc.gov/media/mmwrnews/2010/n100128.htm#2
Press Contact: Jessica L. Scaperotti
Press Secretary New York City Department of Health & Mental Hygiene
(212) 788-5290
These results suggest that substitution of low-fat and fat-free milk for whole milk in schools can substantively reduce student consumption of calories and fat. Changes to the New York City Department of Education’s milk policy greatly reduced the amount of calories and fat available to public school students. Due to the system-wide switch from whole to low-fat/fat-free milk in 2005, a milk-drinking student is exposed to 33 fewer calories and 3.4 fewer grams of fat per school day, or almost 6,000 fewer calories and over 600 fewer grams of fat annually. Annual savings are larger for students who drink white milk (7,000 fewer calories and over 900 fewer grams of fat) and school purchases of milk per student actually increased 1.3 percent after the switch. Given the prevalence of childhood obesity, school milk policy changes are a viable way to reduce calorie/fat exposure without decreasing consumption of important vitamins and minerals.
Anyone who follows a holistic approach notices two problems with the press release.

1. Children over the age don’t need milk, especially at the middle of the day.
2. Why don’t we give our kids milk in the middle of the day, it’s the sugar in milk that elevates their blood sugar and is associated with the calories, not the fat.

Anyone following me over the years has heard my rant as to why water is the best drink for kids at lunch time.  Fruit drinks, flavored waters and teas, and milk all have sugars.  Sugar gives our kids short term energy boosts.  Two hours later, they are tired and dragging.  So what do they want to do?  Eat a high calorie snack to recreate the sugar buzz.  Only this time, it takes more sugar or calories to create the sugar high.

As to the fat issue, reducing fats is dangerous.  Our kids’ bodies are growing as they approach puberty.  Thei bodies needs fats to make hormones.  These need to be good quality fats: fats from range fed cows; organic yogurts and butter, and my favorites – nuts, avocados and coconuts.  Here’s an easy to remember rule for choosing oils: use only oils made from nuts and plants with seeds.  Don’t use vegetable oils.

And my message to the Department of Education, take a refresher biology class.  The solution to the obesity problem is not found in milk.  It’s found in a well rounded diet that includes more fresh fruits and vegetables, less grains, less dairy and more exercise.  It does not come from watering down dairy products.

USDA Issues Supplemental Proposed Rule for Nutrition Labeling of Single Ingredient Products

Wednesday, December 23rd, 2009 by debbie

 (This is a very informative article from the USDA. Hope it will keep us all better informed Editor’s Note)

Rule Would Help Families Make Healthier Food Choices  

WASHINGTON, December 18, 2009 – The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) today announced that it will solicit further public comments on the proposed rule, “Nutrition Labeling of Single-Ingredient Products and Ground or Chopped Meat and Poultry Products.” The rule is designed to help families make more informed decisions when purchasing and consuming meat and poultry products by requiring nutrition labeling of major cuts of single-ingredient, raw meat and poultry products.

This supplement to the proposed rule responds to all comments received on the January 18, 2001, proposed rule and requests additional comments on policies for which there were significant differences of opinion.

On January 18, 2001, FSIS published a proposed rule in the Federal Register entitled, “Nutrition Labeling of Ground or Chopped Meat and Poultry Products and Single-Ingredient Products” (66 FR 4969). Because of the length of time since the publication of the proposed rule, FSIS is providing the public an opportunity to comment on this supplemental proposed rule. FSIS also welcomes comments on relevant issues for which there is new evidence since the proposed rule was issued.

Comments on the proposed rule must be received by February 16, 2010. Comments can be sent to Docket Clerk, U.S. Department of Agriculture, Food Safety and Inspection Service, 5601 Sunnyside Ave, Room 2-2127, Beltsville, Md. 20705; or through the Federal eRulemaking Portal at www.regulations.gov . Go to http://www.regulations.gov and in the “Search for Open Regulations” box, select “Food Safety and Inspection Service” from the agency drop-down menu and then click on “Submit.” In the Docket ID column, select Docket Number FSIS-2005-0018 to submit or view public comments and to view supporting and related materials available electronically.

For further information contact Sally Jones, Senior Technical Advisor, Labeling and Program Delivery Division, Office of Policy and Program Development, USDA, FSIS, 5601 Sunnyside Avenue, Block A, 2nd Wing, 2nd Floor Room 2-2124, Beltsville, MD 20705, or by phone at (301) 504-0878.

FDA Alert on Contaminated Pet Treats

Monday, November 23rd, 2009 by debbie

To some of us our pets are like our children.When there are recalls or alerts about pet food or pet treats we want to know. This is an alert from the FDA on Pig Ears and Beef Hooves. If you have any made by these companies please don’t feed them to your pet, dispose of them as soon as you can.
The U.S. Food and Drug Administration is issuing this health alert to warn consumers not to use Pig Ears and Beef Hooves pet treats manufactured by Pet Carousel because the products may be contaminated with Salmonella. The products were distributed nationwide in both bulk and retail packaging for sale in pet food and retail chain stores. Pet Carousel is based in Sanger, Calif.

The products were manufactured under conditions that facilitate cross-contamination within batches or lots. Although no illnesses associated with these products have been reported, the FDA is advising consumers in possession of these products to not handle or feed them to their pets.

The affected pig ear products were packaged under the brand names Doggie Delight and Pet Carousel. The affected beef hooves were packaged under the brand names Choo Hooves, Dentley’s, Doggie Delight, and Pet Carousel. All sizes and all lots of these products made by Pet Carousel are included in this alert.

During September 2009, the FDA conducted routine testing of pig ears made by Pet Carousel. The test results detected a positive reading for Salmonella. This prompted an FDA inspection of Pet Carousel’s manufacturing facilities. During the inspection, the agency collected additional pet treat samples. Further analysis found Salmonella present in beef hooves, pig ears and in the manufacturing environment.

Salmonella can affect both humans and animals. People handling dry pet food and/or pet treats can become infected with Salmonella, especially if they have not thoroughly washed their hands after having contact with the treats or any surfaces exposed to these products. Consumers should dispose of these products in a safe manner by securing them in a covered trash receptacle.

Healthy people infected with Salmonella may experience some or all of the following symptoms: nausea, vomiting, diarrhea or bloody diarrhea, abdominal cramping and fever. Although rare, Salmonella can result in more serious ailments including arterial infections, endocarditis (inflammation of the lining of the heart), arthritis, muscle pain, eye irritation, and urinary tract symptoms. Consumers exhibiting these signs after having contact with this product should contact their health care provider immediately.

Pets with Salmonella infections may become lethargic and have diarrhea or bloody diarrhea, fever and vomiting. Some pets may only experience a decreased appetite, fever and abdominal pain. Infected, but otherwise healthy pets can be carriers and infect other animals or humans. If your pet has consumed any of the affected products or is experiencing any of these symptoms, contact your veterinarian immediately.

The FDA will continue to investigate this matter to determine the source of the Salmonella contamination and offer updates as appropriate.

FDA Improves Egg Safety

Thursday, October 1st, 2009 by debbie

Chick with eggsThe Food and Drug Administration (FDA) has announced a regulation to help make eggs safer to eat.
The regulation will reduce the number of illnesses caused by eggs contaminated with the bacterium Salmonella enteritidis (SE).
The regulation, released to the public on July 7, 2009, requires the egg industry to take specific preventive measures to keep eggs safe during their production, storage, and transport.  Egg producers will also be required to register with FDA and to maintain a prevention plan and records to show they are following the regulation.
FDA took this action because SE is a major cause of food-borne illness in the United States. Eating raw or undercooked eggs is an important source of SE infections in people. FDA estimates that 142,000 illnesses each year are caused by consuming eggs contaminated with SE.

Some Producers Exempt
The regulation does not apply to producers with fewer than 3,000 laying hens. These producers account for less than 1 percent of U.S. eggs. The regulation also does not apply to producers who sell all of their eggs directly to consumers.
Producers who treat their eggs to destroy SE, such as by in-shell pasteurization, or who process their eggs into egg products, need to comply only with the parts of the regulation addressing refrigeration and registration. FDA requires all producers who must comply with the regulation to do so between 12 and 36 months after issuance of the regulation, depending on the size of the operation.
This article appears on FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.
Date Posted: July 7, 2009

According to Connor Murphy, Livestock and Poultry Manager, Grant Family Farms, Wellington, CO that while this new ruling will pertain to their farm – they do have over 3,000 laying hens – this regulation seems similar to current rules on record keeping. 
He talked about the National Poultry Improvement Plan which is considered the gold standard for flock health in the Unites States.  Most organic farmers follow this Plan which is more stringent than the FDA requirements.  He said that organic farms, especially those that are members of the Community Supported Agriculture (CSA) have to be more careful, since they don’t pasteurize their eggs.  Pasteurizing irradiates the eggs.

Diabetics FDA warning Stolen Insulin

Thursday, September 3rd, 2009 by debbie

 The Food and Drug Administration (FDA) is reminding the public that stolen vials of the long-acting insulin Levemir made by Novo Nordisk Inc. still may be on the market. FDA first alerted the public to the theft in June 2009.

Evidence gathered to date suggests that the stolen insulin was not stored and handled properly and may be dangerous for people to use. The agency has received multiple reports of patients who suffered an adverse event due to poor control of glucose levels after using a vial from one of the stolen lots.

In June 2009, FDA reported that three lots of Levemir totaling 129,000 vials had been stolen in North Carolina. So far only about 2 percent of the total amount stolen has been recovered.

The agency continues to aggressively investigate this matter and is asking for the public’s help in reporting any information regarding these vials to FDA’s Office of Criminal Investigations (OCI) by calling 800-551-3989 or by visiting the OCI Web site.

Advice for Patients
Check your personal supply of insulin to determine if you have Levemir insulin from one of the following lots: XZF0036; XZF0037; XZF0038. You can locate the lot number on the side of the box of insulin and also on the side of the vial.
Do not use your Levemir insulin if it is from one of these lots. Replace it with a vial of Levemir insulin from another lot. If you must switch to another brand of insulin for any reason, first contact your health care provider because another insulin product may require adjustments in dosing.
Always look at your insulin carefully before using it. Levemir is a clear and colorless solution.

Current FDA Recalls – August 6

Saturday, August 8th, 2009 by debbie

When Dr Joshua Sharfstein took over the FDA as acting commissioner I had mixed feelings.  Would this be another do-nothing appointee?  Well, based on today’s update on all the product recalls and warnings in the past 60 days, I would say he has done quite a bit.

It is worth going through the list to see if you are currently using any of these products.  Some of these have not been posted on the website before.   The one that worries me the most is the Nuby teether.  Most parents don’t pay attention to the name on the pacifier they buy.  Their kids could be unknowingly using one of these. 

The other recall that caught my eye is the one for e-cigarettes (electronic cigarettes).  Until this recall, I hadn’t heard of an e-cigarette.  Yet, according to our teenagers, “these are all the rage.”

These are battery-operated devices designed to look like and to be used in the same manner as conventional cigarettes.

“Sold online and in many shopping malls, the devices generally contain cartridges filled with nicotine, flavor, and other chemicals. They turn nicotine, which is highly addictive, and other chemicals into a vapor that is inhaled by the user. “   
 ~ FDA Warns of Health Risks Posed by E-Cigarettes (http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm173401.htm)
 
Reporting Side Effects
After the Food and Drug Administration (FDA) approves a product and it is on the market, FDA continues to monitor unexpected and undesirable side effects (adverse events) of that product.
Health care professionals and consumers may report side effects, product quality problems, product use errors, or therapeutic failure with the use of medical products to FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, by fax, or by phone.
• Online
• Regular Mail: Use postage-paid FDA form 3500 and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787.
• Fax: 1-800-FDA-0178
• Phone: 1-800-332-1088
MedWatch reports can signal a safety problem and lead to an FDA action to protect the public from harm, serious illness, or even death.

Recent Safety Alerts

• Recall: Weight-Loss Products
• Recall: Male-Enhancement Products Marketed as Dietary Supplements
• Recall: Infusion Sets Used With Insulin Pumps
• Recall: Stealth Chocolate and Stealth Vanilla Powdered Dietary Supplement
• Recall: Nuby Gel Filled, Cottontails, and Playschool Teethers
• Early Communication on Safety of Xolair
• Warning About Electronic Cigarettes
• Warning About Steroid-Containing Body Building Products

 
Recall: Weight-Loss Products
Four weight-loss dietary supplements marketed by Young You Corporation have been recalled:

• Slimbionic, 30 capsules/box
• One Weight Loss Pill, 30 capsules/bottle
• SlimDemand Capsules, 30 capsules/box
• Botanical Weight Loss, 30 capsules/box
• 
The products were sold and distributed nationwide via the Internet and at the company’s Weight Loss and Rejuvenation Center in Tarzana, Calif.

The risk: FDA laboratories have found that these products contain sibutramine, which is not declared on the label. Sibutramine is an FDA-approved drug used to curb the appetite for weight loss. FDA has not approved the Young You products as drugs; therefore, the safety and effectiveness of these products are unknown.
Sibutramine is known to substantially increase blood pressure or pulse rate in some people and may be especially dangerous for people with a history of coronary artery disease, congestive heart failure, arrhythmias (disorders of heart rate or rhythm), or stroke.

Recommendations
• Destroy these products or return them to Young You at 19590 Ventura Blvd., Tarzana, CA 91356.
• Contact Young You Corporation at 818-344-3344 for more information.
 
Recall: Male-Enhancement Products Marketed as Dietary Supplements
The following dietary supplements marketed by Nature & Health Co. have been recalled:

• LibieXtreme
• Y-4ever
• Libimax X Liquid
• Powermania Liquid and Capsule
• Herbal Disiac
• 
The products were sold in stores in California, Georgia, Illinois, Texas and Ohio.

The risk: FDA laboratories have found that these products contain a drug ingredient of FDA-approved drugs for erectile dysfunction. The ingredient is not declared on the label, making these products unapproved drugs.
The undeclared ingredients in these products may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels.

Recommendations
• Stop using these products immediately.
• Contact your health care professional if you have experienced any problems that may be related to taking these products.
• Contact Nature & Health at (714) 671-0016 or at sales@naturenhealth.com for information on returning the products for a refund.

 
Recall: Infusion Sets Used With Insulin Pumps
Quick-set infusion sets made by Medtronic Inc. that are used with MiniMed Paradigm insulin pumps have been recalled because the infusion sets may not allow the insulin pump to vent air pressure properly. An infusion set is a thin plastic tube used to deliver insulin from an insulin pump to a person with diabetes.

Affected infusion sets have lot numbers starting with the number “8” and have one of these reference numbers:

• MMT-396
• MMT-397
• MMT-398
• MMT-399
• 
The lot number (for example, 8XXXXXX) is clearly marked on both the product box label and on each individual infusion set package.

The risk: The infusion set may deliver too much or too little insulin and may lead to serious injury or death.

Recommendations
• Stop using “Lot 8” Quick-set infusion sets.
• Return any affected infusion sets to the company, which will replace them at no additional charge. For more information, see Medtronic’s Web page or call Medtronic at 800-345-8139.

 
Recall: Stealth Chocolate and Stealth Vanilla Powdered Dietary Supplement
The powdered dietary supplement, Stealth Chocolate and Stealth Vanilla, has been recalled because it may be contaminated with the bacteria Salmonella. The product, made by Vital Pharmaceuticals Inc., was distributed nationwide, including GNC Distribution Centers and the VPX Sports Distribution Center, as well as internationally.

The powdered product is packaged in 5-pound blue plastic jars with a red band around the top and bottom of the jar. The label bears the brand name of VPX and STEALTH, Muscle Amplification Lean Mass Gainer, and the flavor Vanilla Blast or Chocolate Rush.

The risk: Salmonella can cause serious infections and even death in young children, frail or elderly people, and others with weakened immune systems.

Recommendations
• Return the product to the store where you bought it for a refund.
• Call Vital Pharmaceutical Inc. at 800-954-7904 or 954-641-0570 for more information.
 
Recall: Nuby Gel Filled, Cottontails, and Playschool Teethers
Certain teethers made by Luv N’ Care LTD have been recalled because they may contain harmful bacteria in the gel contained in the teether. The teethers affected have the following UPC codes and brand names:

48526-00451 Nuby
48526-00452 Nuby
48526-00453 Nuby
48526-00454 Nuby
48526-00455 Nuby
48526-00459 Nuby
48526-00467 Nuby
48526-00472 Nuby
48526-00473 Nuby
48526-00482 Nuby
48526-00483 Nuby
48526-00487 Nuby
48526-00490 Nuby
48526-00519 Nuby
48526-00521 Nuby
41520-87115 Cottontails
50428-91511 Playschool
41520-91660 Cottontails

The teethers were sold through retail stores nationwide and also on the Internet. They are packaged in a plastic bubble on a printed card.

The risk: The bacteria (Bacillus subtilis and Bacillus circulans) that have been found on the teethers can cause stomach pain, vomiting, and diarrhea in children with weakened immune systems if the teether is punctured and the liquid from the teether is swallowed.

Recommendations
• Stop using the teethers immediately.
• Throw the teethers out or return them to the store where you bought them for a refund.
• Contact Luv N’ Care LTD at 1-800-256-2399 ext. 3106 for more information.

 
Early Communication on Safety of Xolair
FDA is evaluating safety findings known at this point from an ongoing study of Xolair (omalizumab). Xolair is approved for use by people 12 years of age and older with moderate to severe asthma who react to an airborne allergen year-round and whose symptoms are not controlled well with inhaled corticosteroids.

The risk: These interim findings suggest an increase in adverse events involving the blood vessels of the heart or brain (cardiovascular or cerebrovascular events) in people treated with Xolair compared to another group of people not given the drug.

This type of communication (early communication) is part of FDA’s effort to communicate early with the public when the agency is still evaluating data and has not reached a conclusion.

Recommendations:
• Do not stop taking Xolair without the advice of your health care professional.
• Talk with your health care professional about the risks and benefits described in the prescribing information for Xolair, as well as the new information from the ongoing study, called EXCELS.

 
Warning About Electronic Cigarettes
FDA’s laboratory analysis of electronic cigarette samples found diethylene glycol, a toxic chemical used in antifreeze, and cancer-causing substances (carcinogens). Also known as “e-cigarettes,” these battery-operated devices turn nicotine, flavor, and other chemicals into a vapor that is inhaled by the user.

For a full consumer update, see FDA Warns of Health Risks Posed by E-Cigarettes.
 
Warning About Steroid-Containing Body Building Products
FDA has warned the public about potentially serious health risks associated with body building products that claim to contain steroids or steroid-like substances. Although marketed as dietary supplements, they are unapproved new drugs that have not been reviewed by FDA for safety and effectiveness.

For a full consumer update, see Warning on Body Building Products Marketed as Containing Steroids or Steroid-Like Substances.
This article appears on FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.
Date Posted: August 7, 2009

Acetaminophen – When to Take It

Wednesday, July 1st, 2009 by debbie

Tylenol
By Debra Frick
This is a pretty inportant adivisory on taking Tylenol and any other product that contains Acetaminaphen. If you are taking Acetaminaphen on a regular basis you should check with your doctor about the effects this drug may be having on your health.

On June 29 and 30, 2009, FDA will hold an advisory committee meeting in Adelphi, Md., about how to address the problem of liver injury related to the use of acetaminophen in both over-the-counter (OTC) and prescription products.  For more information about the meeting, visit the Advisory Committee Web page.

For those who have not been following, there has been much controversy around the use of acetaminophen especially for those 55+.  Finally, the FDA is meeting to discuss when it is wise to take acetaminophen and when not.  In its own right, it is not a bad pain reliever.  It’s just been abused.  One caplet is good.  Two must be better.  And would it hurt to take a third a couple of hours later?  Some bodies just can’t take that many.  Or, they are allergic to red dyes.  Or, they have side effects.

Acetaminophen has been used to relieve mild to moderate pain and to reduce fever.  For those allergic to aspirin, have ulcers, or clotting (bleeding) disorders acetaminophen is a viable substitute.  Just not for everyone.

Here are some things to think about.  When deciding if acetaminophen is the right pain reliever for your family.

First be aware of which drugs have acetaminophen in it.  Read the label.  It should say what ingredients are contained within.  Here are the most common products.  It is also found in drops, syrups, capsules, and pills.

•    Tylenol – Over the counter
•    Vicodin – Prescription Drug
•    Percocet – Prescription Drug
•    APAP – Medical abbreviation
•    Paracetamol – name in the United Kingdom

There are many drugs that interact with acetaminophen.
•    alcohol
•    antacids
•    cimetidine
•    medicines for mental problems and psychotic disturbances
•    phenobarbital
•    warfarin
If you have any of these problems or diseases, consider using another pain reliever.
•    anemia
•    an alcohol problem
•    infection
•    kidney disease
•    liver disease
•    phenylketonuria
•    an unusual or allergic reaction to acetaminophen, aspirin, other medicines, foods, dyes or preservatives
•    and one not on the list, it dries out sinuses and eyes.  So contact wearers eyes dry out more quickly.
The signs and symptoms of liver damage take time to appear.  Early symptoms of liver damage (for example, loss of appetite, nausea, and vomiting) can be mistaken for something else, like the flu. Liver damage can develop into liver failure or death over several days.

Here are some of the side effects that warrant contacting your health care provider:
•    bloody or black, tarry stools
•    decrease in amount of urine passed
•    difficulty breathing, wheezing
•    fever or sore throat
•    nausea, vomiting
•    skin rash
•    stomach cramps
•    unusual bleeding or bruising, pinpoint red spots on the skin
•    unusual tiredness or weakness
•    yellowing of the skin or eyes

Again it is advisable to check with your doctor about all medications you are taking and thier possiable side effects.

Illuminating the Hazards of Powerful Laser Products

Wednesday, July 1st, 2009 by debbie

Lasers
By Debra Frick and the FDA

Any one who has one of these accidentally pointed at thier eyes know that they can hurt and leave you with blurred vision and a powerful headache. Read on for more on the dangers of Laser Products.
Lecturers use laser pointers to draw attention to information on charts and slides. Construction workers use lasers to level and align pipes. Entertainers use laser projectors to create dazzling light shows. These are legitimate uses of lasers.
When used responsibly, lasers are safe. However, a powerful laser, used irresponsibly, is unsafe, particularly when misused as a toy or directed at people, vehicles, or aircraft.
What makes lasers potentially dangerous?
•    The light energy from a laser aimed into the eye can be hazardous, perhaps even more so than staring directly into the sun.
•    The startling effect of a bright beam of light can cause serious accidents when aimed at a driver in a car, a pilot in a plane, or even a person holding a cup of hot coffee.
Powerful and Unsafe
The Food and Drug Administration (FDA) is concerned about the increased availability in stores and on the Internet of certain types of laser products—some of which are being sold illegally because they are powered above 5 milliwatts (mW), which is a standard for certain types of lasers and laser projectors.
Manufacturers of some types of laser products that are powered above 5 mW must obtain permission from FDA before they are sold to the public. This power limit applies to lasers sold to the public for purposes of alignment, surveying, or leveling, and includes lasers used for pointing. Laser projectors powered above 5 mW and the laser light shows that they produce must also be manufactured with permission from FDA.
Green lasers are particularly troubling to FDA, says CDR Dan Hewett, U.S. Public Health Service, a health promotion officer in the Electronic Products Branch of FDA’s Center for Devices and Radiological Health.
“A green laser beam could cause a larger startling or flash-blinding effect compared to a similarly powered red laser because the human eye is especially sensitive to green light,” says Hewett. Flash blindness is a temporary loss of vision that occurs when the eye is suddenly exposed to intense light. The effect can last from several seconds to several minutes.
“As technology has evolved, lasers have increased rapidly in power and decreased in size and power consumption,” says Hewett. “Laser use in consumer products is increasing rapidly, and that demand has pushed the price of powerful lasers lower. As the price goes down, more people may acquire powerful, unsafe lasers, creating more opportunity for misuse and injury.”
Hewett emphasizes the reason for the 5 mW limit. “A 5 mW laser aimed directly into the eye won’t cause damage instantaneously. A person’s reflexes to look away, blink, or make other involuntary movements are protective. But if you keep your eyes open and stare into a 5 mW beam, it will cause damage. A higher-powered laser gives you less time to look away before injury can occur, and as power increases, eye damage may happen in a microsecond, even when looking at a beam reflection.”
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Lasers Pointed at Aircraft on the Rise
Laser lights beamed at aircraft also have FDA concerned. Incidents associated with laser lights beamed at aircraft have tripled in a 4-year period since December 2004, when the Federal Aviation Administration began tracking reports. In 2008, pilots reported a total of 950 cases of laser light striking an aircraft or illuminating a cockpit.
Eye injuries and flash blindness from laser beams hitting aircraft are also on the rise, with more pilots self-reporting injuries in 2008 than in the previous 3 years combined. The distraction from flash blindness could cause a serious accident.
Law enforcement agencies have the authority to arrest individuals who threaten the safety of others from laser misuse, and several of these individuals have been prosecuted under federal law.
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FDA’s Authority
FDA regulates radiation-emitting electronic products, including all types of lasers. The agency sets radiation safety product performance standards that must be met by manufacturers before laser products can be legally sold in the U.S. market.
FDA’s authority extends to testing laser products and inspecting displays of laser light shows to ensure the public is protected. FDA may also inspect manufacturers of laser products ranging from high-powered telescopes for professionals to low-powered toys for consumers. FDA can require repair, replacement, or refund for products that don’t comply with FDA standards or that have radiation safety defects. In addition to inspecting domestic manufacturers, FDA inspectors travel abroad to inspect foreign manufacturers of products that contain lasers.
“We have often found laser toys that have lasers for pointing that are powered above 5 mW,” says Hewett. “Sometimes toys or other laser products are powered above 5 mW after the batteries that come with them are replaced with fresh batteries.”
“Some of the companies we inspect have very sophisticated testing to make sure the products for public sale are not powered above the 5 mW Class IIIa limit,” says Emir Galevi, an FDA electronics engineer who does many of the foreign inspections. “But others are garage-based packing and distribution operations with inadequate testing procedures.”
FDA may send a warning letter to manufacturers, put a company or product on an import alert (which notifies inspectors to stop product shipments at the border), or take other action if a firm lacks proper quality control for its laser products.
Illegal laser products that are imported are also subject to detention and seizure by U.S. Customs and Border Protection. “The problem is that many of these illegal lasers come into the country through circuitous routes involving multiple distributors and multiple countries,” says Galevi. “Or they’re ordered one at a time through the Internet, which makes it difficult to track and stop them.”
FDA is working to discourage online sales of illegal lasers and online video demonstrations that describe how to modify a laser pointer to make it more powerful.
FDA requires that labeling on most laser products contain a warning about radiation and other hazards and a statement certifying that the laser complies with FDA safety regulations. The label must also state the product’s output power and hazard class. (See accompanying table.)
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Tips for Consumers
•    Never aim or shine a laser at anyone, including animals.
•    Look for the following information on the label to make certain that a laser (or a toy that includes a laser) is safe:
o    a statement that it complies with Chapter 21 CFR (the Code of Federal Regulations)
o    the manufacturer’s or distributor’s name and the date of manufacture
o    a warning to avoid exposure to laser radiation
o    a class designation up to Class IIIa
•    Be aware that the manufacturer of a Class IIIb or IV laser product must obtain permission (also called a “variance”) from FDA before the laser is sold to the public if the laser product:
o    is designed, intended, or promoted for surveying, leveling, or alignment (which includes pointing)
o    is a demonstration laser product (which includes laser projectors) that is designed, intended, or promoted for purposes of demonstration, entertainment, advertising display, or artistic composition
Surveying, leveling, or alignment laser products and demonstration laser products mentioned directly above that are powered above 5 mW with no label that indicates they were manufactured under a variance present a serious safety hazard and are not legal for sale!

Laser Hazard Classes
The Food and Drug Administration (FDA) recognizes four major hazard classes (I to IV) of lasers, including three subclasses (IIa, IIIa, and IIIb). The higher the class, the more powerful the laser and the potential to pose serious danger if used improperly. The labeling for Classes II–IV must include a warning symbol that states the class and the output power of the product. Approximate IEC equivalent classes are included for products labeled under the classification system of the International Electrotechnical Commission.

Class FDA    Class IEC    Laser Product Hazard    Product Examples
I    1, 1M    Considered non-hazardous. Hazard increases if viewed with optical aids, including magnifiers, binoculars, or telescopes.    •    laser printers
•    CD players
•    DVD players
IIa, II    2, 2M    Hazard increases when viewed directly for long periods of time. Hazard increases if viewed with optical aids.    •    bar code scanners
IIIa    3R    Depending on power and beam area, can be momentarily hazardous when directly viewed or when staring directly at the beam with an unaided eye. Risk of injury increases when viewed with optical aids.    •    laser pointers
IIIb    3B    Immediate skin hazard from direct beam and immediate eye hazard when viewed directly.    •    laser light show projectors
•    industrial lasers
•    research lasers
IV    4    Immediate skin hazard and eye hazard from exposure to either the direct or reflected beam; may also present a fire hazard.    •    laser light show projectors
•    industrial lasers
•    research lasers
•    lasers used to perform LASIK eye surgery
I hope this has given you good information. We hope to keep you informed and make all information readily avaliable to all so keep coming back for the lastest information.

FDA Warning:Pistachio Recall Update

Thursday, June 25th, 2009 by debbie

PistashiosThis is from the FDA (Food and Drug Administration).  There are two brands of pistachios that may be contaminated with Salmonella, both were repacked by Orca Distribution West Inc of Anaheim, CA.  Orca received and repacked pistachios recalled by Setton Pistachio of Terra Bella Inc., Terra Bella, Calif. 1

•    California Prime Produce

•    Orange County Orchards

These brands were distributed to airports for their kiosksand to hotels.  The pistachios are in clear six ounce plastic Ziploc bags, UPC Number: 8 10826 01116 2, with Sell By Dates of 7/30/09 and 8/30/09.

Because Salmonella is an organism that can easily affect people, its good to know the symptoms.

•    fever
•    diarrhea -may be bloody
•    nausea
•    vomiting
•    abdominal pain

If you have symptoms after eating these pistachios, consult your health practitioner.

For the most updated list of all the recalled products and pistachio products not subject to the recall, please visit:  http://www.fda.gov/Safety/Recalls/MajorProductRecalls/Pistachio/default.htm.

1  http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm168574.htm

FDA Warning: Nestle Tollhouse Cookies

Thursday, June 25th, 2009 by debbie

Tollhouse Cookies

This is an article that came from the FDA. It is very important that you do as the article says and pass this information to anyone you know that bakes such as girl scout leaders and church youth camp directors.

On June 19, 2009, the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) warned consumers not to eat any varieties of prepackaged Nestle Toll House refrigerated cookie dough due to the risk of contamination with E. coli O157:H7 (a bacterium that causes foodborne illness).
What to Do

* Throw away any prepackaged, refrigerated Nestle Toll House cookie dough products you may have in your home.
* Do not cook the dough because you might get the bacteria on your hands and on other cooking surfaces.
* Contact your health care professional immediately if you or your family have recently eaten the dough and have had stomach cramps, vomiting or diarrhea, with or without bloody stools.
* If you have additional questions about the recalled products, contact Nestle consumer services at 800-559-5025 or visit the company’s Web site.

What Action Has Been Taken?

* Nestle has voluntarily recalled all varieties of prepackaged, refrigerated Toll House cookie dough and is fully cooperating with the ongoing investigation by FDA and CDC.
* CDC is conducting an ongoing study with the help of several state and local health departments.

Since March 2009, there have been 66 reports of illness across 28 states. Of 25 people who were hospitalized, 7 have a severe complication called Hemolytic Uremic Syndrome. No one has died.
About E. coli O157:H7

* The bacteria cause stomach cramping, vomiting, and diarrhea, often with bloody stools.
* Most healthy adults can recover completely within a week.
* Young children and the elderly are at highest risk for developing Hemolytic Uremic Syndrome, which can lead to serious kidney damage and even death.

Safe Food Handling

FDA reminds consumers they should not eat raw food products that are intended for cooking or baking before eating. Use safe food-handling practices when preparing these products, including

* following package directions for cooking at proper temperatures
* washing hands, surfaces, and utensils after contact with these types of products
* avoiding cross-contamination
* refrigerating products properly

Since many people like to eat uncooked cookie dough this can be an extremely bad outbreak for E-Coli. Please keep yourself and your kids safe.