Antibacterial hand and body wash no more effective than soap and water

Back in December of 2013 we mentioned on this blog that the FDA was going to require manufacturers of antibacterial soap to prove that their product actually was more effective than plain soap and water (read the post here). Manufacturer had three years to provide that proof. That time is now up and that FDA has issued it’s final ruling.

Turns out manufacturers of antibacterial soap didn’t have the necessary proof and couldn’t actually substantiate their claims so the FDA was left with no other choice than to rule that…

“over-the-counter (OTC) consumer antiseptic wash products containing certain active ingredients can no longer be marketed. Companies will no longer be able to market antibacterial washes with these ingredients because manufacturers did not demonstrate that the ingredients are both safe for long-term daily use and more effective than plain soap and water in preventing illness and the spread of certain infections. Some manufacturers have already started removing these ingredients from their products.”

Even worse, there seems to be some proof that OTC antibacterial products are harmful, leading to bacterial resistance or hormonal effects.

You can read the complete press release here.


FDA Wants Proof that Sanitizers Actually Work

We’ve talked about this on this blog before… there really isn’t any proof that sanitizers actually work. I’m guessing that the FDA has read my blog 🙂 because they are now asking for proof that these so called disinfectants actually do work.

The FDA isn’t saying that they don’t work, they are just asking manufacturers to provide proof that they actually do; proof that they are going to have a hard time providing because studies have shown that 1. the alcohol in the disinfectants has to be on the surface for much longer than it is in almost all instances and 2. germs and bacteria that aren’t killed produce super germs that are now immune.

Check out the full article at http://www.today.com/health/fda-wants-proof-hand-sanitizers-work-t100392

 


FDA advises testing for Zika in all donated blood

Press release from the FDA…

“As a further safety measure against the emerging Zika virus outbreak, today the U.S. Food and Drug Administration issued a revised guidance recommending universal testing of donated Whole Blood and blood components for Zika virus in the U.S. and its territories.

“There is still much uncertainty regarding the nature and extent of Zika virus transmission,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “At this time, the recommendation for testing the entire blood supply will help ensure that safe blood is available for all individuals who might need transfusion.”

The FDA first issued guidance on Feb. 16 recommending that only areas with active Zika virus transmission screen donated Whole Blood and blood components for Zika virus, use pathogen-reduction devices, or halt blood collection and obtain Whole Blood and blood components from areas of the U.S. without active virus transmission. All areas with active transmission in the U.S. are currently in compliance with this guidance. The revised guidance announced today recommends that all states and U.S. territories screen individual units of donated Whole Blood and blood components with a blood screening test authorized for use by the FDA under an investigational new drug (IND) application, or a licensed test when available. Alternatively, an FDA-approved pathogen-reduction device may be used for plasma and certain platelet products.

The FDA is updating its guidance after careful consideration of all available scientific evidence, consultation with other public health agencies, and taking into consideration the potential serious health consequences of Zika virus infection to pregnant women and children born to women exposed to Zika virus during pregnancy. Testing of donated blood is already underway in Florida and Puerto Rico, as well as in other areas, and it has shown to be beneficial in identifying donations infected with Zika virus. Expanded testing will continue to reduce the risk for transmission of Zika virus through the U.S. blood supply and will be in effect until the risk of transfusion transmission of Zika virus is reduced.

Zika virus is transmitted primarily by the Aedes mosquito. Zika virus can also be spread by sexual contact. Although 4 out of 5 people infected with Zika virus never develop symptoms, when symptoms do occur they may include fever, arthralgia (joint pain), maculopapular rash (red area with small bumps), and conjunctivitis (red, irritated eyes). In addition, Zika virus infection during pregnancy can cause serious birth defects and is associated with other adverse pregnancy outcomes.

“As new scientific and epidemiological information regarding Zika virus has become available, it’s clear that additional precautionary measures are necessary,” said Luciana Borio, M.D., the FDA’s acting chief scientist. “We are issuing revised guidance for immediate implementation in order to help maintain the safety of the U.S. blood supply.”

The first local or non-travel related transmission of Zika virus in the U.S. by mosquitoes was reported from Puerto Rico in December 2015; and soon thereafter, local transmission was reported in American Samoa and the U.S. Virgin Islands. In July 2016, the first cases of local or non-travel related transmission of Zika virus in the continental U.S. were reported in Miami-Dade County, Florida.

In addition to protecting the nation’s blood supply, the FDA works to protect the safety of our nation’s supply of human cells, tissues, and cellular and tissue-based products; supports the development and availability of diagnostic tests that may be useful for identifying the presence of or prior exposure to the Zika virus; works with commercial and government developers to advance the development of investigational vaccines and therapeutics; and monitors for fraudulent products and false product claims related the Zika virus.

The FDA, an agency within the U.S. Department of Health and Human Services, promotes and protects the public health by, among other things, assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.”


FDA Releases Updated Ruling on Food Transport

From the FDA website

“The U.S. Food and Drug Administration today finalized a new food safety rule under the landmark FDA Food Safety Modernization Act (FSMA) that will help to prevent food contamination during transportation. The rule will require those involved in transporting human and animal food by motor or rail vehicle to follow recognized best practices for sanitary transportation, such as properly refrigerating food, adequately cleaning vehicles between loads and properly protecting food during transportation.

The action is part of a larger effort to focus on prevention of food safety problems throughout the food chain, and the rule implements the Sanitary Food Transportation Act of 2005 (SFTA) as well as the requirement in section 111 of FSMA that instructed FDA to issue SFTA regulations. The regulation will apply to food transported within the United States by motor or rail vehicle, whether or not the food is offered for or enters interstate commerce. Shippers, loaders, carriers and receivers engaged in transportation operations of food imported by motor or rail vehicle and consumed or distributed in the United States are also subject to the final rule.

“Consumers deserve a safe food supply and this final rule will help to ensure that all those involved in the farm-to-fork continuum are doing their part to ensure that the food products that arrive in our grocery stores are safe to eat,” said Michael R. Taylor, the FDA’s deputy commissioner for foods and veterinary medicine.

The rule was proposed in February 2014 and takes into consideration more than 200 comments submitted by the transportation industry, food industry, government regulatory partners, international trading partners, consumer advocates, tribal organizations and others. It also builds on the transportation industry’s best practices for cleaning, inspecting, maintaining, loading and unloading and operating vehicles and transportation equipment.

Implementation of the sanitary transportation rule and all FSMA final rules will require partnership, education and training.

“We recognize the importance of education and training in achieving widespread compliance, and we are committed to working with both industry and our government partners to ensure effective implementation of all of the new food safety rules under the Food Safety Modernization Act,” said Taylor.

Businesses would be required to comply with the new regulation one year after publication of the final rule, with smaller businesses having two years to comply with the new requirements.”

Read the complete press release.

 


FDA Proposes Ban on Powdered Medical Gloves

Glove

On March 21st the Food and Drug Administration (FDA) announced that it intended to ban powdered medical gloves.

The powder used in powdered gloves is used to make the gloves easier to put on and take off. The powder, however, carry proteins that can cause respiratory allergic reactions in some people.

Medical personel (Doctors, nurses, etc…) are the ones most at risk but patients are also at risk and, as is often the case, trade one medical problem for another when they end up having respiratory issues because of the protein in the powdered gloves used by the medical staff.

The ban, at this time, extends only to medical powdered gloves and does not include powdered gloves in other areas.


Do Hand Cleaners Really Work?

We’ve talked about this before on this blog, the fact that hand sanitizers really don’t work and might, in fact, be doing more harm than good (See the post “That which is supposed to protect may be harming instead“).

Now the FDA is finally coming to the same conclusion and is stating that they want more data to ascertain the effectiveness and safety of hand sanitizers used in hospitals. The FDA is asking manufacturers of these products to provide more data to help them make more educated recommendations, data that most manufacturers probably don’t have yet, including data about the effects of long-term use.

The issue, according to the FDA is the fact that these sanitizers are being used more widely than ever before and that the antiseptics are being absorbed into the skin and therefore into the body. It is possible that this might results in an increase in cancer and hormone problems.

Also at issue is whether, as we’ve mentioned before, these antiseptics are, in fact, producing superbug bacteria that will no longer be so easy to kill.

You can read more about this story on the ABC News website.


FDA Warns that Powdered Caffeine can Kill

I recently watched an episode of the “Brew Dogs” (if you haven’t watch “Brew Dogs” catch it on youtube). They were in Seattle and they were trying to make the most caffeinated beer in the world. To do this, coffee wasn’t going to be enough so they went to a lab and we got to watch as they extracted caffeine and made it into a powder.

Turns out brews dogs aren’t the only ones doing this and powdered caffeine is now available on the internet. The problem is that this pure caffeine in even small doses can be fatal.

At least one teen has died from an overdose already and rumors are going around that teenagers are starting to snort it. If that’s the case, more deaths will follow.

The FDA is warning people to stay away from it as standard measuring equipment like measuring spoons are accurate enough; even a teaspoons can kill.

Because caffeine is in a lot of food and drinks as a natural by-product of tea, coffee and other substances, it isn’t regulated by the FDA, something that the FDA plans on changing in the near future.

Right now, caffeine is sold as a dietary supplement and widely available.

The FDA is warning people to just stay away from it and make sure that your children and teenagers know that it isn’t something to mess with.

 


FDA approves drug for allergies

According to a news release dated April 17th, the FDA has approves Ragwitek for treatment of pollen allergies to ragweed. According to the press release:

“The U.S. Food and Drug Administration today approved Ragwitek, the first allergen extract administered under the tongue (sublingually) to treat short ragweed pollen induced allergic rhinitis (hay fever), with or without conjunctivitis (eye inflammation), in adults 18 years through 65 years of age.

 
Ragwitek contains an extract from short ragweed (Ambrosia artemisiifolia) pollen. It is a tablet that is taken once daily by placing it sublingually, where it rapidly dissolves. Treatment with Ragwitek is started 12 weeks before the start of ragweed pollen season and continued throughout the season. The first dose is taken in a health care professional’s office where the patient is to be observed for at least 30 minutes for potential adverse reactions. After the first dose, patients can take Ragwitek at home.
 
“The approval of Ragwitek offers millions of adults living with ragweed pollen allergies in the United States an alternative to allergy shots to help manage their disease,” said Karen Midthun, M.D., director of the FDA’s Center for Biologics Evaluation and Research. 
 
Individuals with allergic rhinitis with or without conjunctivitis may experience a runny nose, repetitive sneezing, nasal itching, nasal congestion, and itchy and watery eyes. Short ragweed pollen is one of the most common seasonal allergens and is prevalent during the late summer and early fall months in most of the United States. Short ragweed pollen induced allergies are generally managed by avoiding the allergen, medications to relieve symptoms, or with allergy shots. 
 
The safety and effectiveness of Ragwitek was evaluated in studies conducted in the United States and internationally. Safety was assessed in approximately 1,700 adults. The most commonly reported adverse reactions by patients treated with Ragwitek were itching in the mouth and ears and throat irritation. Of the 1,700 adults, about 760 were evaluated to determine effectiveness. Some patients received Ragwitek; others received an inactive substitute (placebo). The patients reported their symptoms and additional medications needed to get through the allergy season. During treatment for one ragweed pollen season, patients who received Ragwitek experienced approximately a 26 percent reduction in symptoms and the need for medications compared to those who received a placebo. 
 
The Prescribing Information includes a boxed warning to inform that severe allergic reactions, some of which can be life-threatening, can occur. Ragwitek also has a Medication Guide for distribution to the patient.
 

Ragwitek is manufactured for Merck, Sharp & Dohme Corp., (a subsidiary of Merck and Co., Inc., Whitehouse Station, N.J.) by Catalent Pharma Solutions Limited, United Kingdom.”


Sodium Phosphate FDA Warning

It’s used primarily to treat constipation and available over-the-counter but if the dosage isn’t probably adhered to it can be extremely dangerous, even fatal. Sodium Phosphate is the drug that we are talking about and the usual dosage is to be taken no more than once in 24 hours. The problem is that in our “instant relief” world people take it more often than that.

The results can damage organs like the liver, the kidneys and the heart. The problem is seen most often in those who are really young or older as well as anyone who combines the Sodium Phosphate with other medications that may increase the dehydration. Even simple anti-inflammatory drugs such as aspirin and ibuprofen can be a problem.

You can read more about the FDA warning on their website.


FDA Warning on Spices

You follow all the health and safety tips to make sure that your food is safe. You disinfect, wipe and clean to make any contamination at bay. Then, just as dinner is almost finished cooking you add a few spices for flavor. Oops, you’ve just introduced a contaminant without being aware of it.

A new study by the FDA has found that “the average prevalence of filth adulteration of shipments of imported spice was 12%“.

Ironically, this applied only to imported spices as domestic spices were not tested.

The most common types of filth adulterants were insect fragments, whole/equivalent insects, and animal hair.

In case you want to read all 213 pages of the report you can download it by clicking on the image below.

FDA_Draft