Contact: Barbara Haumann (413-376-1220)
Organic Trade Association (OTA) hails panel for empowering consumers with ways to reduce their cancer risk

GREENFIELD, Mass. (May 6, 2010)—. The President’s Cancer Panel Report released on May 6 exhorts consumers to choose food grown without pesticides or chemical fertilizers , antibiotics, and growth hormones to help decrease their exposure to environmental chemicals that can increase their risk of contracting cancer. Organic products avoid the use of these chemicals.

“Exposure to pesticides can be decreased by choosing, to the extent possible, food grown without pesticides or chemical fertilizers…Similarly, exposure to antibiotics, growth hormones, and toxic run-off from livestock feed lots can be minimized by eating free-range meat raised without these medications,” according to the landmark report, “Reducing Environmental Cancer Risk: What We Can Do Now,” submitted to President Obama by Dr. LaSalle Leffall, Jr., an oncologist and professor of surgery at Howard University, and Dr. Margaret L. Kripke, an immunologist at the M.D. Anderson Cancer Center in Houston.

“Organic production and processing is the only system that uses certification and inspection to verify that these chemicals are not used on the farm all the way to our dinner tables,” said Christine Bushway, Executive Director of the Organic Trade Association (OTA).

Organic production is based on a system of farming without the use of toxic and persistent pesticides (herbicides, insecticides, and fungicides) and synthetic fertilizers. Organically produced foods also must be produced without the use of antibiotics, synthetic hormones, genetic engineering and other excluded practices, sewage sludge, or irradiation. Organic foods are minimally processed without artificial ingredients, preservatives, or irradiation to maintain the integrity of the food. In addition, animal confinement in feedlots is prohibited.

“Consumers should know that organic foods have the least chemicals applied in their production and the least residues in the final products. Thus, those seeking to minimize their exposure to these chemicals and follow the recommendations of the President’s Cancer Panel can look for the USDA Organic label wherever they shop,” said Bushway.

“The American people—even before they are born—are bombarded continually with myriad combinations of these dangerous exposures,” the panel wrote in a letter to President Obama. It added. “The Panel urges you most strongly to use the power of your office to remove the carcinogens and other toxins from our food, water, and air that needlessly increase health care costs, cripple our Nation’s productivity, and devastate American lives.”

It added, “Many known or suspected carcinogens first identified through studies of industrial and agricultural occupational exposures have since found their way into soil, air, water and numerous consumer products…Some of these chemicals have been found in maternal blood, placental tissue, and breast milk samples from pregnant women and mothers who recently gave birth. Thus, chemical contaminants are being passed on to the next generation, both prenatally and during breastfeeding.”

“OTA is gratified to see a prestigious scientific panel recognize what the organic farmers and the organic community have realized about environmental health and organic agriculture for decades, and we applaud them for taking on this critical issue,” Bushway added.

The full report is available online.

The Organic Trade Association (OTA) is the membership-based business association for organic agriculture and products in North America. Its members include growers, shippers, processors, certifiers, farmers’ associations, distributors, importers, exporters, consultants, retailers and others. OTA’s Board of Directors is democratically elected by its members. OTA’s mission is to promote and protect the growth of organic trade to benefit the environment, farmers, the public and the economy (www.ota.com).

Organic Trade Association (OTA) encourages consumers to choose organic fruits and vegetables

By Barbara Haumann, 413-376-1220

Following closely on the heels of the President’s Cancer Panel Report exhorting consumers to choose food grown without pesticides or chemical fertilizers , antibiotics, and growth hormones to help decrease their exposure to environmental chemicals that can increase their risk of contracting cancer, a study published in today’s issue of the journal Pediatrics concludes that exposure to organophosphate pesticides at levels common among U.S. children may contribute to the prevalence of attention deficit hyperactivity disorder (ADHD) in these children.

“Studies have increasingly shown the importance of minimizing young children’s exposure to even low levels of chemical pesticides. This study adds to that wealth of knowledge and arms parents with information that helps them reduce their children’s pesticide intake,” said Christine Bushway, OTA’s Executive Director, pointing out that the use of organophosphates is prohibited in organic production.

The article reported findings from a study examining the association between urinary concentrations of metabolites of organophosphates and ADHD in children ages 8 to 15. Using data from the National Health and Nutrition Examination Survey, researchers led by Maryse Bouchard, a researcher in the Department of Environmental and Occupational Health at the University of Montreal, analyzed the levels of pesticide metabolites in the urine of 1,139 children and found children with above-average levels had roughly twice the odds of being diagnosed with ADHD.

As the largest study of this kind so far, it reminds consumers that organophosphates were originally developed for use in chemical warfare because they are known to be toxic to the nervous system. Organophosphate compounds are used in agriculture to kill pests.

“Organic food production and processing is the only system that uses certification and inspection to verify that these chemicals are not used,” Bushway added. “Those seeking to minimize their exposure to these chemicals can look for the USDA Organic label wherever they shop.”

The abstract of the paper published in the journal Pediatrics is accessible online.

For more information on organic, go to OTA’s consumer web site, www.organicitsworthit.org.

This is a voluntary recall of OneTouch SureStep Test Strips.  If you use the these strips, please contact your provider.  This notice says that you can use the strips; and, it’s best to err on the side of caution.

OneTouch SureStep Test Strips (LifeScan): Recall

Audience: Diabetes healthcare professionals, consumers

LifeScan and FDA notified healthcare professionals of a voluntary recall of eight lots of OneTouch SureStep Test Strips, used by people with diabetes to measure their blood glucose levels at home. The test strips are being recalled because they may provide falsely low glucose results when the glucose level is higher than 400 mg/dL.

If patients use the falsely low test results to determine their insulin dose, they may give themselves too little insulin, which could result in poor blood glucose control. High blood glucose must be recognized and treated promptly to avoid serious complications, such as coma and death.

The eight lots of consumer OneTouch SureStep Test Strips being recalled are identified in the firm’s press release. Lot numbers  are located on the outer carton and test strip vial. LifeScan estimates approximately fourteen thousand packages (50- and 100-count) of consumer OneTouch SureStep Test Strips were distributed nationwide between August 1, 2009 and January 28, 2010.

It is important that patients with recalled test strips continue to test their blood glucose. Patients with access to a meter that does not use OneTouch SureStep Test Strips should use this other meter to test their blood glucose until replacement product from LifeScan arrives. If an alternate meter is not available, patients may continue to test using the recalled OneTouch SureStep Test Strips. However, if patients obtain results above 400 mg/dL, they should contact their healthcare professional for further instructions because their glucose may be significantly higher.

Read the complete MedWatch 2010 Safety summary, including a link to the firm’s press release, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm202254.htm

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.

The 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.

 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.

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

By Amy Cook-Porter

In today’s economy who can afford to be sick?  And prescription medication – those overpriced drugs – are ranging anywhere from $1 – $10 a pill.  So is it a wonder that patients do what they can to make them last?

Now the FDA has issued a warning about splitting tablets.  They say it could be dangerous.  With that I agree.

The pharmacies selling Viagra and other male meds, made buying a larger dose and “cutting it down to size” popular.  Buy a handy pill cutting kit at the local pharmacy for $5.00 and voila, a 1 month supply (from what I hear is 9 pills) turns into 36 pills.

Now here’s the first dilemma.  Not all pills are cut alike.  Some are bigger; some smaller.  So that means the dose varies.  For the sensual male, this isn’t a big deal.  The smaller ones are good for an Afternoon Delight; the larger, for going at it all night.

But, what if we are talking about other medications that need equal doses?  Uneven cutting could be a problem.

Here are other concerns:

Forgetting to cut the pills.  This happens.  Get busy, run out of cut pills, and then need one.  Would taking a whole pill hurt.  If the original prescription dosage called for 15 mg; and this dose was 30 mg, the dosage is way too much.  Will it hurt?  Why risk it?

Being lazy or forgetful is not a good thing.  Nor is being creative.  Don’t try breaking a tablet with your teeth, hoping lessen the dosage.  Once the pill is wet with saliva, chemistry interactions begin.  Not a good thing for the half not being swallowed.

This is especially a concern if the pill or capsule has a time-release coating.  Once you break the outer seal, you’ve compromised the time release and the content inside.

So my advice, find a good health care provider who works with plants, not chemicals.  That way you won’t have to worry about time-released coatings, splitting pills and chemical interactions.  Herbs work as effectively, cost much less, and most don’t require a long term commitment.

To read the full FDA article that was posted on July 21, 2009 go to http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm171492.htm

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.

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
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