Tag: Food And Drug Administration Fda

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Hyperbaric Oxygen Therapy

Over the last several year, probably more than 10 years now, professional athletes have been using Hyperbaric chambers to improve healing from bruising and injuries and it has worked fantstically for them. I am a big fan at leveraging the tech that professional athletes use for recovery from exercise but I was at the FDA consumer site today and saw that people have stretched the idea of Hyperbaric Oxygen Therapy into a new cure all for almost everything.

We see these kind of things often. A great idea is extended to be a cure all for lots of things that it was never designed for. Steroids for muscle weight gain, Acai berries for anything, and lately hyperbolic therapy for people with genetic diseases. Not sure how this can be extended to the following diseases but it looks like there is some research that may say it works.

Hyperbaric Oxygen Therapy

Hyperbaric Oxygen Therapy involves breathing oxygen in a pressurized chamber. The Food and Drug Administration (FDA) has cleared hyperbaric chambers for certain medical uses, such as treating decompression sickness suffered by divers.

Hyperbaric Oxygen Therapy has not, however, been proven to be the kind of universal treatment it has been touted to be on some Internet sites. FDA is concerned that some claims made by treatment centers using Hyperbaric Oxygen Therapy may give consumers a wrong impression that could ultimately endanger their health.

Hyperbaric oxygen therapy involves intermittent inhalation of 100% oxygen under a pressure greater than regular air pressure, so in a pressurized tank. Despite over a century of use in medical settings, hyperbaric oxygen remains a controversial therapy. The last 20 years have seen a clarification of the mechanism of action of hyperbaric therapy and a greater understanding of its potential benefit.

I have been able to find some reports of use for these things. Hyperbaric chamber treatment for Autism, and using it for treatment of  diabetic related foot ulcers, and even a treatment for Hypoxia?

As with other things that we see this looks like a technology that may be promising for some things but of course you need to be careful in what you read and be responsible to check the pros and cons of any therapy.


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Diet Supplement? Sexual Enhancer? or just garbage?



The U.S. Food and Drug Administration (FDA) is warning consumers not to purchase or consume Zimaxx, Libidus, Neophase, Nasutra, Vigor-25, Actra-Rx, or 4EVERON. These products are promoted and sold on web sites as “dietary supplements” for treating erectile dysfunction (ED) and enhancing sexual performance, but they are in fact illegal drugs that contain potentially harmful undeclared ingredients. These products have not been approved by FDA, and there is no guarantee of their safety and effectiveness, or of the purity of their ingredients.

What can the FDA do about crap products?

FDA advises consumers who have used any of these products to discontinue use and to consult their health care provider. FDA encourages anyone experiencing ED to seek guidance from a health care provider before purchasing a product to treat this medical condition.

“These products threaten the public health because they contain undeclared chemicals that are similar or identical to the active ingredients used in several FDA-approved prescription drug products. This risk is even more serious because consumers may not know that these ingredients can interact with medications and dangerously lower their blood pressure,” said Dr. Steven Galson, Director of FDA’s Center for Drug Evaluation and Research.

Chemical analysis by FDA revealed that Zimaxx contains sildenafil, which is the active pharmaceutical ingredient in Viagra, a prescription drug approved in the United States to treat ED. The other products contain chemical ingredients that are analogues of either sildenafil or a pharmaceutical ingredient called vardenafil. Vardenafil is the active ingredient in Levitra, a prescription drug that, like Viagra, is approved in the United States to treat ED. There is no mention of any of these ingredients in any of the illegal products’ labeling.

What does the FDA Warning Letter say?
Diet Supplement? Sexual Enhancer? or just garbage?This deception poses a threat to consumers because the undeclared ingredients may interact with nitrates found in some prescription drugs (such as nitroglycerin) and lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. ED is a common problem in men with these conditions, and they may seek products like the ones noted above because these products claim that they are “all natural” or that they do not contain the active ingredients used in FDA-approved ED drugs. In addition, because the manufacturing source of the active ingredients in these “dietary supplements” is unknown, there is no assurance that the ingredients are safe, effective, or pure.

FDA Warning Letters to the firms marketing these products state that the products are illegal drugs based on claims made for the products or their ingredients. The letters also state that the products’ labeling is false and misleading because it fails to disclose the presence of the chemical ingredients or the potential side-effects associated with the products’ consumption. FDA instructed agency staff to stop the importation of Libidus, and the agency recently stopped a shipment of 4 EVERON from entering the United States. Based on responses to these actions, FDA may take additional enforcement steps.

Today’s actions follow a first-of-its-kind FDA survey, in which the agency analyzed 17 dietary supplements marketed on the internet to treat ED and to enhance sexual performance in men. “Our survey found that many of the so-called ‘dietary supplements’ marketed as treatments for erectile dysfunction actually contain non-dietary chemicals, including chemicals used as active ingredients in FDA-approved drugs. The claims made for these products were in fact claims made for the undeclared non-dietary chemicals they contain, which rendered them illegal drugs. FDA is committed to protecting the public health by removing such illegal and dangerous products from the market,” said Margaret O’K. Glavin, FDA’s Associate Commissioner for Regulatory Affairs.

If you are looking for a sexual enhancer there are two products that seem to be popular and work well and those are Zalestra and Fematril.

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Sunscreen and Babys




Sunscreen and babys has been and issue since my daughter was born 12 years ago. No one really cares about sunscreen and babys until they have their own.  You’re at the beach, slathered in sunscreen. Your 5-month-old baby is there, too. Should you put sunscreen on her? Not usually, according to Hari Cheryl Sachs, M.D., a pediatrician at the Food and Drug Administration (FDA).

“The best approach is to keep infants under 6 months out of the sun,” Sachs says, “and to avoid exposure to the sun in the hours between 10 a.m. and 2 p.m., when ultraviolet (UV) rays are most intense.”

Sunscreen and Babys

Sunscreens are recommended for children and adults. What makes babies so different?

For one thing, babies’ skin is much thinner than that of adults, and it absorbs the active, chemical ingredients in sunscreen more easily, explains Sachs. For another, infants have a high surface-area to body-weight ratio compared to older children and adults. Both these factors mean that an infant’s exposure to the chemicals in sunscreens is much greater, increasing the risk of allergic reaction or inflammation.

The best protection is to keep your baby in the shade, if possible, Sachs says. If there’s no natural shade, create your own with an umbrella or the canopy of the stroller.

If there’s no way to keep an infant out of the sun, you can apply a small amount of sunscreen—with a sun protection factor (SPF) of at least 15—to small areas such as the cheeks and back of the hands. Sachs suggests testing your baby’s sensitivity to sunscreen by first trying a small amount on the inner wrist.

Cover Up your baby

Sunscreen and Babys

sunscreen and babies

The American Academy of Pediatrics (AAP) suggests dressing babyes in lightweight long pants, long-sleeved shirts, and brimmed hats that shade the neck to prevent sunburn. Tight weaves are better than loose. Keep in mind that while baseball caps are cute, they don’t shade the neck and ears, sensitive areas for a baby.

Summer’s heat presents other challenges for babies.

Younger babys also don’t sweat like we do, Sachs says. Sweat naturally cools the rest of us down when we’re hot, but babies haven’t yet fully developed that built-in heating-and-cooling system. So you want to make sure your baby doesn’t get overheated.

In the heat, babies are also at greater risk of becoming dehydrated. To make sure they’re adequately hydrated, offer them their usual feeding of breast milk or formula, says Sachs. The water content in both will help keep them well hydrated. A small of amount water in between these feedings is also okay.

Sun Safety Tips for Babys

Here are some things to keep in mind this summer when outside with babies:

  • Keep your baby in the shade as much as possible. If you do use a small amount of sunscreen on your baby, don’t assume the child is well protected.
  • Make sure your child wears clothing that covers and protects sensitive skin. Use common sense; if you hold the fabric against your hand and it’s so sheer that you can see through it, it probably doesn’t offer enough protection.
  • Make sure your baby wears a hat that provides sufficient shade at all times.
  • Watch your baby carefully to make sure he or she doesn’t show warning signs of sunburn or dehydration. These include fussiness, redness and excessive crying.
  • Hydrate! Give your baby formula, breast milk, or a small amount of water between feedings if you’re out in the sun for more than a few minutes. Don’t forget to use a cooler to store the liquids.
  • Take note of how much your baby is urinating. If it’s less than usual, it may be a sign of dehydration, and that more fluids are needed until the flow is back to normal.
  • Avoid sunscreens containing the insect repellant DEET on infants, particularly on their hands. Young children may lick their hands or put them in their mouths. According to AAP, DEET should not be used on infants less than 2 months old.
  • If you do notice your baby is becoming sunburned, get out of the sun right away and apply cold compresses to the affected areas.

The FDA has a lot of other info that is great for health in the Summer and in the sun, not just about sunscreen and babys. Check it out at http://www.fda.gov

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