Tuesday, December 19, 2017

FDA Bans Triclosan, 23 Other Antiseptic Ingredients

Anyone who's been following this blog knows I have been blogging against Triclosan forever! Well, finally the FDA has caught up -- although Triclosan's been banned in Europe for a long time and yet it's in all sorts of stuff here. Be forewarned!

Read it via Medscape here

Troy Brown, RN
The US Food and Drug Administration (FDA) has finalized a rule that bans the marketing of over-the-counter (OTC) healthcare antiseptic products containing triclosan or any of 23 other active ingredients.
The FDA found that these ingredients are not generally recognized as safe and effective (GRASE), inasmuch as the companies that manufacture them have failed to provide additional safety and efficacy data. The FDA first proposedthe rule in 2015; affected products include hand washes and rubs, surgical hand scrubs and rubs, and patient antiseptic skin products.
Products containing these active ingredients must now undergo premarket review; the FDA will consider these products to be new drugs and will require manufacturers to gain approval through new drug applications.
The FDA is giving manufacturers 1 year to reformulate or remove these products from the market, although manufacturers have already stopped using many of these ingredients. This rule will not affect most healthcare antiseptics currently on the market. Triclosan is the only non-GRASE active ingredient being used in healthcare antiseptic products on the market today, according to a statement from the agency.
The FDA has deferred final rule-making for 1 year on the six most common active ingredients in OTC healthcare antiseptic products currently on the market. Those ingredients are alcohol (ethanol), isopropyl alcohol, povidone-iodine, benzalkonium chloride, benzethonium chloride, and chloroxylenol. The deferral, which is subject to renewal, will give manufacturers additional time to conduct safety and efficacy studies.
The final rule does not apply to healthcare antiseptics presently on the market under new drug applications and abbreviated new drug applications.
"This action only concerns OTC products that are commonly marketed to health care providers and used primarily in medical settings like hospitals, health care clinics, and doctors' offices. We've determined that 24 ingredients, including triclosan, most of which were infrequently used, cannot be used in OTC health care antiseptics without pre-market review because there was a lack of sufficient safety and efficacy data," FDA Commissioner Scott Gottlieb, MD, said in a news release.
"However, it's important to note that this action does not impact all health care antiseptic ingredients. Rather, given the public health importance of these products, the FDA is deferring final rulemaking on the six most commonly used ingredients while manufacturers collect the data needed to properly weigh their safety and efficacy. Manufacturers using these six active ingredients in OTC health care antiseptics have known since 2015 that the FDA sought additional information on these products. The FDA expects that this information may help better inform us on antiseptic resistance and antibiotic cross-resistance in the health care setting. Importantly, this doesn't mean that products containing these six ingredients are ineffective or unsafe. These antiseptic products remain an important resource in health care settings. Personnel should continue to use these products consistent with infection control guidelines while the additional data are gathered," Dr Gottlieb explained.
The FDA addressed consumer antiseptic washes in 2016, with a proposed rule in June 2016 and a final rule in September 2016.
"Ensuring the safety and effectiveness of over-the-counter health care antiseptics has been a priority for the FDA, not only because these products are an important component of infection control strategies in health care settings, but also because of the role these products may play in contributing to antimicrobial resistance if they're not manufactured or used appropriately," Dr Gottlieb said. "Health care providers are on the front lines of care. They need and deserve to have safe and effective means for preventing the spread of infection. That's why the FDA has been vigilant in seeking the data to support the continued use of 30 active ingredients used in over-the-counter (OTC) health care antiseptics."
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Friday, August 25, 2017

Poor semen quality in men possibly due to chemicals

No surprise common chemicals in everyday products (e.g., parabens) may contribute to infertility:

(Reuters Health) - Men who have been exposed to common chemicals known as parabens have lower testosterone levels and more sperm that are abnormally shaped and slow moving, according to a study that suggests these ingredients may contribute to infertility.
Researchers examined lab tests done on 315 male patients of a fertility clinic in Poland to pinpoint issues they were having with reproduction. All of the men provided samples of urine, saliva, blood and semen for analysis.
Compared to men who had low concentrations of parabens in their urine, men with high concentrations of the chemicals also had a larger proportion of sperm with the abnormal morphology that’s associated with infertility, the study found.
Higher levels of parabens in the urine were also associated with DNA damage in the sperm and with decreased sperm motility, which may contribute to infertility.


Wednesday, March 22, 2017

FDA Affirms Lymphoma Link to Breast Implants

Makes sense considering you are putting plastic in your body

via MedPage Today: 

In 2011 the FDA became aware of a possible association between breast implants and subsequent development of ALCL. At the time so few cases of BIA-ALCL existed that the agency could not draw definitive conclusions about the association. Since then, information and understanding about the association increased substantially, including evidence that BIA-ALCL occurs more often in women who have implants with textured, rather than smooth, surfaces.
New information about BIA-ALCL came from medical device reports (MDRs), current medical literature, data from a patient registry established by the American Society of Plastic Surgeons and the Plastic Surgery Foundation (PSF), and product and labeling information provided by implant manufacturers.
Last year the WHO officially recognized BIA-ALCL as a rare form of lymphoma. Also, the PSF and National Comprehensive Cancer Network published physician information about the disease, and several regulatory bodies outside the United States issued statements and shared new information about BIA-ALCL.

read more here

Tuesday, March 21, 2017

An Appliance that DOES do what it says

I have become an evangelist for the Instant Pot for so many reasons. It actually does SO many things that I'll have to do several posts. Especially great for small NYC kitchens. So hang on !

Sunday, December 18, 2016

Perfect go-to stocking stuffers for a radiant holiday....

What to do about filling this?

I have a few suggestions. I LOVE Mineral Fusions' new lipsticks, lead free and comes in wonderful colors like "Delicious." And ALSO does not dry your lips out BUT the color stays. Really!

And who remembers Indian Earth? The all-mineral "makeup" that works with any skin tone? It's back !!  And you can get it in a teeny tiny terra cotta pot with a tiny pouf. Nostalgia and natural makeup--what's not to like?

Last but not least, my holiday season TRAVEL HACK: Nutriblade's wheatgrass shot means I can get a few in my bag and through the airport (especially with Pre-chek) because they are less than 3 oz, gluten free, organic, and full of nutrients--even better than Emergen-C in my opinion. Have not had a cold even in this hectic travel season and this is why...

And if you *do* start getting a cold, this Primal Essence Ginger zing was surprisingly good as a tea--and squirted into a chicken soup:

What are your favorite stocking stuffers for a year of wealth and health???

Sunday, December 04, 2016

Bye large cell companies

We honestly love TING, a pay as you go service. Check it out: https://zlh56o4i6hd.ting.com/

Wednesday, November 16, 2016

Common emulsifiers can cause cancer in mice

It's interesting--I get headaches from stuff like gellan gum and carrageenan, and apparently emulsifiers in common processed foods cause cancer in mice, via altering the microbiome. It's also associated with ulcerative colitis and other inflammation--

The microbiota is also a key factor in driving Crohn's disease and ulcerative colitis, the two most common forms of inflammatory bowel disease (IBD). IBD is known to promote colon tumorigenesis and gave rise to the term "colitis-associated cancer." Low-grade inflammation, a condition more prevalent than IBD, was shown to be associated with altered gut microbiota composition and metabolic disease and is observed in many cases of colorectal cancer. These recent findings suggest dietary emulsifiers might be partially responsible for this association.

read more here