Pulchritude: Sun

Copyright NASA

149 million 6 hundred thousand kilometers away, the Sun appears as the brightest star in our sky.  It powers photosynthesis of our plants and heavily influences our weather and climate.   Radiation from the sun reaches Earth in the form of ultraviolet radiation (UV) and though the sun makes for great fun outdoors, its rays can be damaging to the skin with continuous exposure.  The Sun has long be the center of folklore and mythology.

How to Read Cosmetic Ingredient Labels XXIX

Considering it is Sunscreen Week, it only makes sense to cover a sunscreen! Sunscreen is a must for many, not only during the summer, but year round. If you are applying sunscreen daily, one must stop and think: “What exactly is in my sunscreen?” There has been a fiar amount of controversy surrounding sunscreens and their believed toxicity over the past few years, which have mainly centered about Zinc Oxide nanoparticles.

For today’s feature of Label Poise, we’re going to do things a bit differently.  Usually for Label Poise each ingredient along with its safety rating and information about its origin and purpose are listed, however, the sunscreen featured is very different from any of the other products that have been featured. This product has 52 ingredients (yes you read that correctly!)–2 active and 50 inactive. Many of the inactive ingredients have been covered here before, so only the active ingredients and the first 6 inactive ingredients will be covered.

The Label

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The Ingredients

Active
Titanium Dioxide: Safe!  Also known as CI 77891, this is a white pigment used for various applications. In pure form Titanium Dioxide is a potential human carcinogen when inhaled. Its health impacts are dependent on size (i.e. nanoparticles), based on the International Agency for Research on Cancer (IARC). It should be fine to use in this topical product. (MSDS)

Zinc Oxide:   Safe!/Beware!!Zinc Oxide is an inorganic compound that is commonly produced as a white powder. It is used in sunscreens to absorb UVA radiation. It can be a skin and eye irritant in pure form, as well as a mutagen to mammalian somatic cells, though it is not known to be carcinogenic, or teratogenic. Zinc oxide has been the source of significant controversy when it is produced as a nanoparticle, which allows it to provide the same UV protection without leaving a white residue on the skin. (MSDS)

Inactive
Water: Safe! Water is the ultimate moisturizer and is a key ingredient in any moisturizing product.

Butyloctyl Salicylate: Beware!/Avoid! This ingredient is an ester of Salicylic acid and is typically used as a skin conditioning agent and solvent. It is considered safe by the Cosmetic Ingredient Review when formulated to not increase the skin sun sensitivity or be a skin sensitizer. It is not believed to be a skin or eye irritant. It is not known to be a mutagen or aquatic toxin. (MSDS)

Cetyl Dimethicone: Avoid! Also known as Cetyl Dimethicone Copoyol and Cetyl PEG/PPG-10/1 Dimethicone, this ingredient is a synthetic silicone-based polymer that is typically used as an emollient, skin conditioning agent (occlusive), and anti foaming agent. This ingredient prolongs the release of active molecules and does not have a tacky texture applied to the skin. No toxicological information available. (MSDS)

DimethiconeBeware! Dimethicone is a synthetic chemical polymer siloxanes derived from silica. They are used as a skin conditioning agent and it forms a protective barrier on the skin the prevents moisture from leaving or entering, which can be harmful to skin. (MSDS)

Styrene/Acrylates Copolymer:  Beware! This ingredient is a polymer of styrene and a monomer of acrylic acid, methacrylic acid or a simple ester of one of the two. It is primarily used as a film former and is used fir its opaque properties. It has a large molecular weigh and does not penetrate the skin, though there are contamination concerns with acrylic acid, which is a respiratory toxicant and potential carcinogen, as well as 2-ethylhexyl acrylate which is a known immune system, skin, and lung toxicant. This ingredient has been reviewed by the Cosmetic Ingredient Review and is believed to be safe in low quantities, when formulated to be non irritating. No MSDS.

Trimethylsiloxysilicate:  Beware!/Avoid!  This ingredient is a silicone based polymer that is typically used as an emollient, skin conditioning agent (occlusive), and anti foaming agent. Due to its structure, it is not water soluble. This ingredient has been reviewed by the Cosmetic Ingredient Review and is not believed to be genotoxic, carcinogenic, skin irritants or sensitizers. No MSDS.

Not Covered

44 ingredients!!!

Sunscreen 101

Sunscreen is a topical application, commonly as a lotion, spray, or gel, that absorbs or reflects some of the sun’s ultraviolet radiation.  The use of sunscreen is of particular importance due to the effects that excess solar radiation has on the skin, which include mild effects such as sunburn and photodermatitis, or severe impacts such as melanoma and other forms of skin cancer. UVA (ultraviolet A) and UVB (ultraviolent B) rays are the major components of solar radiation that can damaging effects on the skin.

UVA & UVB
Penetration of UV Radiation

UVA is an abbreviation for long wavelength ultraviolet A radiation, while UVB is an abbreviation for medium wavelength ultraviolet B radiation.  UVA and UVB rays penetrate the various layers of skin.  Though UVA is more abundant and known to penetrate deeper layers of dermis (skin) than UVB, it is typically more benign than UVB.  UVA rays cause damage to the basal and squamous layers of the skin (see photo) and is a major contributor to wrinkling (photoaging) and skin aging, as well as carcinoma in the cells of the aforementioned skin layers.  Tanning beds can expose the skin to approximately 12 times the amount of UVA radiation than that of the sun.  UVB rays do not penetrate as deep as UVA rays but cause the same effects, such as photoaging (wrinkling) and skin aging, as well as cause the most malignant form of skin cancer, melanoma.

UVA = 400-320 nanometers UVB = 320-290 nanometers UVC= 290-100 nanometers
SPF

SPF is an acronym for Sun Protection Factor and is a label used to indicate how well the product will protect an individual’s skin from burning due to extended sun exposure.  SPF is determined by using the equivalent of noontime sun indoors and determining how long it takes an individual’s skin to burn using SPF or not using SPF.  SPF often refers to protection from UVB, though certain active ingredients in sunscreen also protect against UVA rays.

A simple way to determine how long you can be exposed to sun before you ‘burn’ with sunscreen is to multiply the SPF factor by the amount of time it takes your skin to burn without sunscreen.  Therefore, if it takes your skin 15 minutes to burn without sunscreen and you wear SPF 45 sunscreen you can be exposed to sun for 675 minutes (11 hours and 15 minutes) without burning when applying the recommended amount of sunscreen.  It should be noted that sweating and water exposure decrease the effectiveness of the sunscreen and therefore should be reapplied as recommended.  The amount of time it takes skin to burn will vary based on skin color.  Darker skin tones have the best natural protection from the sun and take significant time to ‘burn’, whereas pale skin has very minimal protection and burns easily.

Protection

The most commonly used active ingredients in sunscreen that absorb UVA and UVB radiation include titanium dioxide, zinc oxide, oxybenzone, avobenzone, dioxybenzone, and aminobenzoic acid (PABA).  Most these active ingredients provides protection from UVB though some also protect from UVA, or only from UVA radiation.  Clothing can offer sun protection, depending on thickness though it typically does not exceed and SPF of 6.  Various natural ingredients (oils, butter, etc.) offer low SPF protection as well.

 

Thank you for reading!  If you have any questions or comments, please feel free to share in the comments!

Surgeon General Warning on Skin Cancer

Surgeon General warning on skin cancer

Skin cancer is on the rise, according to the American Cancer Society, with more cases diagnosed annually than breast, prostate, lung and colon cancer cases combined.

The United States surgeon general issued a call to action Tuesday to prevent the disease, calling it a major public health problem that requires immediate action. Nearly 5 million people are treated for skin cancer each year.

“Until today, the surgeon general has never said, ‘UV radiation is bad for you; protect your skin,’ ” acting Surgeon General Dr. Boris Lushniak said.

The U.S. Department of Health and Human Services has set five goals for communities to decrease the risk of skin cancer, such as providing shade at parks, schools and other public spaces, and reducing indoor tanning.

A dermatologist himself, Lushniak said it’s important for parents to teach their children about sun safety, just as they would dental care and eating healthily.

“We have to change the social norms about tanning,” he said. “Tanned skin is damaged skin, and we need to shatter the myth that tanned skin is a sign of health.”

Melanoma, the deadliest form of skin cancer because of how fast it spreads to other parts of the body, accounts for 2 percent of skin cancer cases but is responsible for the majority of skin cancer deaths, according to the American Cancer Society.

Each year, more than 63,000 cases of melanoma are diagnosed in the United States, and 9,000 people die from it. From 1973 to 2011, melanoma rates increased more than 200 percent, according to the Department of Health and Human Services. The National Cancer Institute reported that melanoma is the most common form of cancer in adults ages 25 to 29 and second most common for young adults aged 15 to 29.

To reduce the risk of skin cancer, the Centers for Disease Control and Prevention recommends wearing a hat, sunglasses and protective clothing and using sunscreen with an SPF of at least 15.

On Monday, the House of Representatives passed the Sunscreen Innovation Act.

The bill includes a review process for all manufacturers submitting a new sunscreen to the Food and Drug Administration, with a deadline for the FDA to provide final decisions: one year for pending applications and 1½ years for new ones.

The last over-the-counter sunscreen ingredient approved by the FDA was in the 1990s, according to the Public Access to SunScreens Coalition. Eight new sunscreen applications have since been filed with the FDA. All are still waiting for review, the coalition says; some have been waiting for over a decade.

The current policy requires the FDA to undergo an extensive rule-making process before reviewing any new product application and adding it to the approved list, according to coalition policy director Michael Werner. This can take years, making the process inefficient.

“This law takes out the rule-making aspect and allows the FDA to simply issue a decision,” Werner said.

Many of the new sunscreens awaiting approval in the United States have been available in Europe, Central Asia and South America for years. Generally speaking, the ingredients waiting for approval are simply newer types of UVA filters than are currently being used, Werner said, but they differ slightly by manufacturer.

Indoor tanning is also a major contributor to skin cancer. It’s estimated that more than 400,000 cases of skin cancer each year are related to indoor tanning, 6,000 of which are melanomas, according to Assistant Secretary for Health Dr. Howard Koh.

There are laws requiring minors to have parental consent in 44 states, but only 10 prohibit minors from indoor tanning altogether. According to the CDC, about 30 percent of white women ages 18 to 25 report indoor tanning.

“The concern with indoor tanning is the concentrated burst of high-intensity UV rays on uncovered skin,” Lushniak said. “Although it’s only a short burst, it’s a higher intensity than what one would experience outdoors.”

Two-thirds of adults reported having a sunburn in 2010, according to the CDC. Because a single sunburn increases a person’s risk for skin cancer, Lushniak said that it’s important for people to realize that sun safety applies to everyone, even if you’re not fair-skinned.

“We know that the risk level for skin cancer decreases with more skin pigmentation,” he said. “But no one is immune. All races are still diagnosed and still affected by UV rays.”

(via Pix11 — July 30, 2014)

Sunscreen Week!!

NPSunscreenWeek

It’s Sunscreen Week!  Everything you wanted to know about sunscreen, including natural and organic options, can be found here over the course of the following week.  Sunscreen has been the source of controversy over the past 5 years due to concerns of safety, toxicity, and efficacy.   If there is anything you want me to cover specifically please let me know in the comments!!

P.S. Don’t Forget to Follow Us Here:

Pulchritude: Aloe Vera

Aloe vera is globally revered for its multitude of health and beauty benefits.  Aloe vera is a succulent plant that grows 24-39 inches in height, with thick green leaves that flare from the base of the short stemmed plant. The leaves have serrated edges and has small white thorns.  Aloe vera (Aloe barbadensis) flowers in the summer and bears yellow tubular flowers that are typically 2-3 centimeters in length. Aloe vera leaves are rich in phytochemicals, which may contribute to its believed medicinal benefits. Aloe vera has a variety of synonyms, however, Aloe barbadensis is most commonly used in cosmetics. The origin and natural range of Aloe vera is uncertain due to its global cultivation, though it is suspected to be native to North and north East Africa, and the southern Arabian peninsula. Many of the believed health benefits, both ancient and contemporary, have not been confirmed by scientific studies, with the exception of the use of aloe vera on burns and to treat other skin ailments. Aloe vera use dates back at least 6000 years where it was highly valued in ancient northern Africa, and was used in Ayurvedic medicine in ancient India.

How to Read Cosmetic Ingredient Labels XXVIII

Baby, Baby, Baby.  They are often the most sensitive to the chemicals contained in cosmetics, therefore it is important to use the upmost caution when picking out bath and body products for an infant.  This product caught your eye because it is made by a brand you have used in the past, but they have introduced a ‘natural’ line that is free of all of the harmful chemicals their regular formula contains.  Whew, relief! Or is it?  Remember, I am teaching you Label Poise–how to walk the walk, talk the talk, and buy products that meet YOUR standards, whether natural, organic, or safe enough.  For instructions on Label Poise visit our Label Poise page.

The Label

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The Ingredients

Water:  Safe!  Water is the ultimate moisturizer and is a key base in many products.

Decyl Glucoside:  Safe!  This ingredient is derived from the reaction of glucose from corn (GMO?) starch with decanol (fatty alcohol) of coconuts. Decyl Glucoside is a non-ionic surfactant that can be used as a foaming agent, emulsifier, or conditioner. It is biodegradable and is not known to be toxic, carcinogenic, mutagenic, or teratogenic (MSDS).

Polyglyceryl-10 Laurate:  Avoid!  Also known as dodecanoic acid, this ingredient is an ester of lauric acid and polyglycerin-10. It is used as an emulsifier, surfactant, and skin condition agent. There is very limited additional information about this ingredient. It is not known to be a skin or eye irritant, nor is it a sensitizer. No information on carcinogenicity, mutagenicity, or teratogenicity. This ingredient has not been reviewed by an expert panel. (MSDS)

Cocoglycerides:  Safe!   This ingredient is a non-ionic surfactant that can be used as a foaming agent, emulsifier, or conditioner.  It is typically derived from coconut oil, corn (GMO?), or fruit sugars, though it is dependent on the supplier.  The label of this product just says it was derived from a ‘vegetable’ source, which is likely one of the aforementioned.  This ingredient is biodegradable and is not known to be carcinogenic, mutagenic, or teratogenic.  In pure form Coco-Glucoside can be a skin irritant or cause inhalation irritation.  (MSDS; Review)

Sodium Coco-Sulfate:  Beware!  This ingredient is derived from various isolated fatty acids in coconut oil. This product is similar to/contains sodium lauryl sulfate, but contains other fatty acids such as capric, caprylic, oleic, and stearyl. Each fatty acid is reacted with sulfuric acid, then sodium carbonate, which produced sodium [fatty acid] sulfate. The term ‘coco’ is used to avoid using the individual name of each fatty acid that is derived from coconut oil. Though sodium coco sulfate contains sodium lauryl sulfate it is not believed to be as harsh, though it has similar concerns to sodium lauryl sulfate. This ingredient is a surfactant and is typically used in concentrations of 1-15% of the formula.  It is believed to be skin irritant and severe eye irritant, though it is not believed to be a carcinogen, skin sensitizer, or a cause of chronic toxicity.  (MSDS; MSDS; MSDS)

Coco-Glucoside:  Safe!  This ingredient is a non-ionic surfactant that can be used as a foaming agent, emulsifier, or conditioner. It is typically derived from coconut oil, corn (GMO?), or fruit sugars, though it is dependent on supplier. This ingredient is biodegradable and is not known to be carcinogenic, mutagenic, or teratogenic. In pure form Coco-Glucoside can be a skin irritant or cause inhalation irritation. (MSDS)

Glyceryl Oleate:  Safe!  This ingredient consists of oleic acid and glycerin both from vegetable sources as indicated on the bottle.  It is used as an emollient, emulsifier, and fragrance ingredient.  (MSDS)

Sodium Benzoate:  Beware!  This ingredient is the potassium salt of sorbic acid, which is likely synthetically derived though it is naturally occurring in some berry species.  It is widely used as a preservative in food, wine, and personal care products.  It is known to be a skin, eye, and lung irritant in pure form, though it is not generally considered to be a carcinogen, mutagen, or teratogen in humans, however, additional research suggests that is is mutagenic and genotoxic in human blood cells (in vitro).  It is typically not used in concentrations above 0.2%, so it should be fine in this product.  (MSDS)

Cetyl Hydroxyethylcellulose:  Avoid!  This ingredient is an ether of Cetyl Alcohol and Hydroxyethylcellulose. It is a thickening agent, and emulsion stabilizer. The concentration in this product is less than 1%, which may be line with the Cosmetic Ingredient Reviews use allowance of 0.008% to 0.3%. No MSDS found.

Xanthan Gum:  Safe!  This ingredient is a polysaccharide (carbohydrate consisting of sugar molecules) secreted by Xanthomonas campestris (a bacterium). It is not known to be carcinogenic, mutagenic, teratogenic, or cause developmental toxicity, though it can be an eye, skin, and lung irritant in pure form. There is a risk of long term biodegraded products being more toxic than pure Xanthan Gum. (MSDS)

Fragrance:  Beware!  Fragrances are often synthetic. Though they are low in concentration in the product, there is still a small chance of having an allergic reaction.

Citric Acid:  Safe!  This ingredient is naturally occurring in citrus fruits, but is typically produced by feeding sucrose or glucose to mold and additional chemical treatment.  It is used in cosmetics as a pH adjuster.  It is generally considered safe, though it is a skin and eye irritant in pure form. (MSDS)

Sodium Hydroxide:  Beware!  Also known as caustic soda or lye, this ingredient is likely used to aid surfactants or increase pH. In pure form it can be dangerous, toxic to eyes, lungs, and skin, though it is typically used in low concentrations in personal care products. (MSDS)

 

Nature’s Pulchritude’s Verdict:  This product is a vast improvement from the regular formula of this product.  However, this product is not necessarily ‘safe’ for babies, though a majority of the ingredients are supposedly naturally derived, and are rated as Safe!.  The two biggest concerns in the product are in the first 5 ingredients, which is not ideal.  Though it claims to be safe enough for newborns, the third ingredient in this product has little information available on it.  Polyglyceryl-10 Laurate  has not been reviewed by a cosmetic expert panel, which is quite troublesome.  Though an MSDS, the only one available,  did not indicate it was an irritant or sensitizer, there was no information on carcinogenicity, reproductive toxicity, endocrine disruption or mutagenicity.  Sodium Coco Sulfate is believed to be a severe eye irritant therefore it is quite questionable if this product is like “pure water” to eyes.  This product is definitely better than common baby washes, however, it is not without concerns.  It is on par with many of the other ‘natural’ baby products on the market.  It is best to err on the side of caution, however, this baby wash may be worth a try for toddler, use your best judgement for a newborn or infant.

Triclosan Linked to Hormones, Cancer Spotlights FDA Process

AUGUST 11–The chemical triclosan has been linked to cancer-cell growth and disrupted development in animals. Regulators are reviewing whether it’s safe to put in soap, cutting boards and toys. Consumer companies are phasing it out. Minnesota voted in May to ban it in many products.

At the same time, millions of Americans are putting it in their mouths every day, by way of a top-selling toothpaste that uses the antibacterial chemical to head off gum disease — Colgate-Palmolive Co.’s Total.

Total is safe, Colgate says, citing the rigorous Food and Drug Administration process that led to the toothpaste’s 1997 approval as an over-the-counter drug. A closer look at that application process, however, reveals that some of the scientific findings Colgate put forward to establish triclosan’s safety in toothpaste weren’t black and white — and weren’t, until this year, available to the public.

Colgate’s Total application included 35 pages summarizing toxicology studies on triclosan, which the FDA withheld from view. The agency released the pages earlier this year in response to a lawsuit over a Freedom of Information Act request. Later, following inquiries from Bloomberg News, the FDA put the pages on its website.

The pages show how even with one of the U.S.’s most stringent regulatory processes — FDA approval of a new drug — the government relies on company-backed science to show products are safe and effective. The recently released pages, taken alongside new research on triclosan, raise questions about whether the agency did appropriate due diligence in approving Total 17 years ago, and whether its approval should stand in light of new research, said three scientists who reviewed the pages at Bloomberg News’s request.

Rodent Bones

Among the pages were studies showing fetal bone malformations in mice and rats. Colgate said the findings weren’t relevant. Viewed through the prism of today’s science, such malformations look more like a signal that triclosan is disrupting the endocrine system and throwing off hormonal functioning, according to the three scientists.

Colgate’s application materials also show that the FDA asked questions about the thoroughness of cancer studies, which are partly addressed in recently released documents.

Some questions about triclosan’s potential impact on people are, by nature, unanswerable. Humans are exposed to dozens of chemicals that may interact in the body, making it almost impossible to link one substance to one disease, said Thomas Zoeller, a biology professor at the University of Massachusetts Amherst, who specializes in how chemicals affect the endocrine system.

‘Huge Risk’

“We have created a system where we are testing these chemicals out on the human population. I love the idea they are all safe,” Zoeller said. “But when we have studies on animals that suggest otherwise, I think we’re taking a huge risk.”

New York-based Colgate isn’t accused of wrongdoing, and the 35 pages don’t prove triclosan is harmful. It was the FDA’s decision to keep the documents off of its website, Colgate said.

The FDA followed standard procedure by redacting information that had come from a third party, said spokeswoman Andrea Fischer. Some studies were done in the labs of Ciba-Geigy, the first triclosan maker and a predecessor to its current primary maker, BASF SE, according to the documents. The pages didn’t denote which studies were done by an outside party, or who the party was. Fischer declined to identify them.

Fights Gingivitis

Colgate said Total’s effectiveness and safety are supported by more than 80 clinical studies involving 19,000 people, and that it gave the FDA 98 volumes, numbering hundreds of pages each, in support of Total. Colgate submits annual reports to the FDA reviewing new science and safety findings, said Colgate spokesman Thomas DiPiazza.

“In the nearly 18 years that Colgate Total has been on the market in the U.S., there has been no signal of a safety issue from adverse-event reports,” DiPiazza said. Colgate also pointed to an independent 2013 review by the Cochrane Oral Health Group, a network of doctors, researchers and health advocates, which found no evidence of harmful effects associated with using Colgate Total.

Total has an important health benefit because it fights plaque and gingivitis, DiPiazza said. Gingivitis can progress to periodontal disease, which affects almost half of Americans 30 and over, according to a 2012 study by the Centers for Disease Control and Prevention.

Soap Review

The FDA reviews all new safety information on ingredients to determine whether a reassessment is necessary, said Jeff Ventura, a spokesman. The agency is revisiting triclosan in hand soaps though not in Total, said Sandra Kweder, deputy director of the agency’s Office of New Drugs. That’s because while triclosan hasn’t been proven superior to soap and water at washing hands, she said, its benefit as an active ingredient in toothpaste was made clear through its FDA approval process.

Colgate removed triclosan from its Softsoap liquid handsoaps and Palmolive antibacterial dish liquid in 2011, citing changing consumer preferences and superior formulations. It said it has no plans to reformulate Total, which is the only triclosan toothpaste approved for U.S. sale.

This article is based on interviews with Colgate, former and current FDA staff and oral biology experts, transcripts of FDA meetings, as well as on the 35 pages, which the FDA shared in January with the Natural Resources Defense Council, a public-health advocate that sued for them. The scientists who examined the pages included Zoeller, a second university-affiliated endocrine specialist, and an environmental toxicologist affiliated with the Environmental Working Group, a public health advocacy.

Pet-Food Dispensers

Of the more than 84,000 chemicals sold in the U.S., few are attracting more scrutiny than triclosan. Used for decades in handsoaps, it is now part of almost 200 products including rugs and pet-food dispensers. Companies including Johnson & Johnson and Procter & Gamble Co. have vowed to remove it from their lineups. In May, Avon Products Inc. announced its plans to go triclosan-free.

Those moves are coming in part as consumers, armed with toxicity ranking systems such as the Environmental Working Group’s Skin Deep Database, have turned away from chemicals including Bisphenol A and phthalates, even in the absence of firm scientific or regulatory conclusions.

Wariness is mounting as factors from environment to diet are blamed for a global rise in endocrine-related diseases. Breast, ovarian, prostate and testicular cancer rates have increased over the past 40 to 50 years, according to a 2012 report from the World Health Organization and the United Nations Environment Programme. A rise in preterm and low birthweight babies, early breast development in girls and undescended testicles in boys may be linked to endocrine-disrupting chemicals, the report says.

Regular Exposure

Zoeller, the endocrine specialist, said that while an estimated 800 to 1,000 chemicals are believed to disrupt the endocrine system, triclosan is one of about 10 to which people are regularly exposed. “We may not have to change very much to have a big impact,” he said.

Total, the No. 3 selling brand in the U.S., lost 2 percent of its market share last year, with $189.8 million in sales for the year that ended on Jan. 26, according to market research firm Mintel Group Ltd. Colgate’s Tom’s of Maine line grew 14 percent, to $38.9 million, suggesting shoppers are gravitating toward more natural options, the report said.

Procter & Gamble, which makes Crest 3D White and Crest Pro-Health — the top two U.S. toothpastes according to Mintel — has sought to capitalize. A Google search for “triclosan” and “toothpaste” brings up an advertisement linked to a Procter & Gamble site touting Crest products as “100% triclosan free.”

Triclosan-Free

P&G’s oral-care products have been triclosan-free in the U.S. and several other markets “for a number of years,” said Kristopher Parlett, a spokesman for the Cincinnati-based company. P&G doesn’t produce or market triclosan-containing oral care products anywhere, he added.

GlaxoSmithKline Plc, which once had triclosan in some Aquafresh and Sensodyne toothpastes, has reformulated all of its oral care products that previously contained it, said spokeswoman Joanmarie Goddard. She couldn’t say what year they had been reformulated or whether triclosan versions had been sold in the U.S. The decision was a response to consumer concern that triclosan across a range of products “may have a negative environmental impact in the future,” she said.

Hand Scrubs

From its beginnings as an ingredient in surgical hand scrubs, triclosan — also identified as 5-Chloro-2-(2,4-dichlorophenoxy)phenol — has grown to a $100 million a year chemical globally, according to statistics from the Kline Group. BASF, based in Ludwigshafen, Germany, sells it under the trade names Irgasan and Irgacare. India-based Kumar Organic Products Ltd. and Vivimed Labs Ltd. also make it.

BASF says that 40 years of global studies and publications prove triclosan’s efficacy in oral care and cosmetic products, as well as in hand disinfectants and other health-care applications, according to Thomas Nonnast, a spokesman. Klaus Nussbaum, a spokesman for Kumar, said studies have established triclosan’s safety. Vivimed didn’t respond to requests for comment.

While company-sponsored safety tests on triclosan that would become part of Colgate’s FDA application for Total began as early as 1968, U.S. agencies have yet to comprehensively review it for other uses.

Safety Tests

In 1974, the FDA proposed issuing a so-called monograph that would determine whether antibacterial ingredients such as triclosan were considered safe and effective for hand soaps. Two years later, the U.S. Toxic Substances Control Act of 1976, which aimed to comprehensively regulate chemicals, grandfathered in existing substances with no safety testing.

The law gave the EPA — which oversees triclosan’s use in durable goods including fabrics and sealants — the power to restrict or test substances. It excluded food, drugs and cosmetics, which fall under the FDA’s mandate. The FDA, four decades after its first promise, has yet to issue a ruling on whether triclosan is safe or effective in soaps.

In the meantime, triclosan made its way into toothpaste.

Colgate spent 10 years and $38 million developing Colgate Total, according to Mintel. Introduced in 1992, it was marketed in almost 100 countries before gaining U.S. approval, according to transcripts of FDA meetings.

Four Applications

Colgate applied to the U.S. four times starting in 1992, according to FDA records, before gaining the FDA’s blessing on July 11, 1997. In a statement at the time, Colgate called Total “the most significant advancement in home dental care since the introduction of fluoride.”

In the early 2000’s, Caren Helbing, a professor at the University of Victoria in Canada, noticed the SARS outbreak in China had led to a germ-killing frenzy. Seeing triclosan listed as an active ingredient in many antibacterial products, she looked up its chemical structure. It was similar to both thyroid hormones and to polychlorinated biphenyls, or PCBs, she said. Such a structure, she and other scientists have said, allow the chemicals to become active on hormone receptors.

Helbing, who has a Ph.D. in biochemistry and microbiology, found that tadpoles exposed to triclosan developed into smaller froglets and had malformed legs — results that she and other scientists published in the peer-reviewed Aquatic Toxicology journal in 2006.

Thyroid Function

Other studies found no such links between the chemical and hormone function. A 2011 paper published in Science of the Total Environment found that over four years, the use of triclosan toothpaste had no detectable effect on thyroid function in humans. Three of that study’s five authors received a grant from Colgate. One, Greg Seymour, a professor at the School of Medicine at the University of Queensland, said Colgate requested the analysis of thyroid hormones after it granted them money for a separate study on gingivitis. Colgate had no input on data collection or analysis, he said.

The Cochrane paper, which Colgate cited in its favor, comes to a more complex conclusion. The review of more than 30 studies published from 1990 to 2012 found “moderate quality evidence” that Total is more effective than other toothpastes at fighting gum bleeding and inflammation. On the topic of safety, authors Philip Riley and Thomas Lamont, speaking about the review in a podcast, said the studies didn’t cover enough years to allow them to investigate any long-term ill effects.

Long-Term Exposure

“What I would be concerned about is the amount people are exposed to over time,” said William Bowen, a professor emeritus at the University of Rochester Medical Center, who specializes in oral biology and also served on a subcommittee at the FDA that evaluated dental products in the 1990s.

Meanwhile, triclosan is showing up in humans and the environment. It was found in the urine of 75 percent of 2,517 Americans tested, including children, according to a 2003 study by the Centers for Disease Control and Prevention. It and a related chemical, triclocarban, were detected in 90 percent of surface water samples from the Great Lakes and in many fish species, according to a July 2014 study by the Canadian Environmental Law Association.

Scientific studies that have raised health concerns include one 2012 study linking triclosan to reduced fertility in mice, and another that year suggesting it could impair muscle function. A study last year linked it to lowered sperm production and changed sperm shape in rats. Triclosan’s core credentials have also come under scrutiny: While some studies have supported its benefit in killing bacteria, others have found it no more effective than soap and water — and in some cases suggested it could support growth of bacteria including the type that causes staph infections.

EU Ban

In 2010, the European Union banned triclosan in materials that come into contact with food. Three years later, the EPA, which reviewed the chemical in 2008, began another review, 10 years earlier than planned. It cited the “rapidly developing scientific database” on the chemical, which includes studies on thyroid effects, according to its website.

Amid these debates, the Natural Resources Defense Council turned its attention to one of triclosan’s main regulators. In 2013, it sued the FDA for the toxicology data the agency had relied on in approving Colgate Total. In January, the FDA handed the NRDC the 35 pages and later put them online along with a previously unreleased cancer study and other information.

The pages included a summary of a 1992 study showing that pregnant mice receiving higher doses of triclosan had lower-weight fetuses and increased incidence of irregular bone formation in their skulls and paw bones. Five of the 120 mice delivered prematurely. A study on pregnant rats the same year found that at higher doses, rat litters had increased incidence of delayed bone formation in areas including the skull, vertebrae and pelvis.

The application dismissed both results — saying the premature births weren’t dose related and were therefore “incidental.” The bone-formation issues were due to toxic effects on the mother, not the fetus, the summary said.

Not Enough Detail

The summaries didn’t provide enough detail to justify those dismissals, according to the scientists reviewing them.

“Wow. They kept that private?” said Zoeller of the University of Massachusetts. “The distinction between maternal and fetal toxicity is an excuse to do nothing. And it’s not scientifically justifiable.”

Such results could have served as clues for later scientists if they had been made public, said the third reviewer, Johanna Congleton, a scientist at the EWG who has a PhD in Environmental Toxicology from Cornell University.

Amplified Effect

Since Total’s approval, researchers have gained new insights into chemicals that disrupt the endocrine system. The Total studies focused on whether triclosan had an amplified effect as exposure levels rose — a model consistent with a longstanding belief that the bigger the dose, the greater the poison.

Newer science has shown that even small doses of certain chemicals can significantly affect hormone functions, if they are delivered at the wrong moment — and that rising doses may cause new unpredictable effects, rather than a rising incidence of the same issue. Some of the data Colgate dismissed in the non-public pages are “almost a hallmark of endocrine disruption,” said Helbing, who conducted the study on frogs.

The effects Helbing had documented — smaller froglets and malformed legs — could be seen with doses equivalent to 1/10 of what a person would use in squeezing a pea-sized amount of Total onto a toothbrush twice a day, Helbing said.

The 35 pages of recently released documents also include a cancer study in which triclosan was fed to rats for as long as two years. FDA reviewers deemed the study inadequate, according to the recently released document, and called for another.

Industry Alliance

Shortly after, in February 1996, an FDA dental-products panel said the agency was working closely on a new cancer study with the Triclosan Industry Alliance — a trade group whose members, according to documents on the FDA’s website, included Colgate, Procter & Gamble and Ciba Specialty Chemicals. Colgate said it believes the alliance no longer exists.

According to the minutes of the meeting obtained through a Freedom of Information Act request, the study was expected in 18 months. Total was approved 17 months later.

An industry group’s study was submitted to the FDA in 1999, said Colgate’s DiPiazza. Both Colgate and the FDA declined to make that study available.

Carcinogenicity Concerns

The FDA, in response to a Bloomberg News inquiry, said the agency’s concerns about carcinogenicity had been resolved by a cancer study that was submitted in January 1997. The study, which the FDA put on its website following a Bloomberg News inquiry, “supports the FDA’s conclusion that triclosan does not pose a cancer risk for humans,” DiPiazza said.

David Kessler, a former commissioner of the FDA from 1990 to 1997, just prior to when Colgate Total was approved, said he couldn’t comment on the thoroughness of the agency’s review. Typically, he said, only confidential commercial information is redacted from public documents. It’s the manufacturer’s responsibility, he said, to assure its product is safe and that relevant information is made public.

“The real question is did Colgate do a good job,” Kessler said.

Colgate continues to reference its FDA bona fides. This spring, Minnesota became the first state to pass a triclosan ban. Effective 2017, the state will prohibit the sale of triclosan-based cleaning products for the hands and body — except those with FDA approval, such as Total.

Colgate Lobbied

“Colgate came in and lobbied, and said it’s a good product,” said John Marty, a state senator who sponsored the bill.

The FDA, meanwhile, has vowed to deliver the monograph covering triclosan in handsoaps — the one it promised for the first time four decades ago — by 2016.

As part of that review, the agency will look at recent safety data on triclosan, said Kweder, the deputy director of the new drugs office. Kweder said the FDA doesn’t plan to revisit its Total decision but that if it finds concern in its broader review, it could look back into Total’s 1997 approval.

“But we would have to have a good reason to do that,” Kweder said.

(via Tiffany Kary; Yahoo Finance)

How to Read Cosmetic Ingredient Labels XXVII

Conditioner is a key step in every hair routine.  You are looking to try another all natural conditioner, that meets all of your hair needs.  Is this product right for you?  Remember, I am teaching you Label Poise–how to walk the walk, talk the talk, and buy products that meet YOUR standards, whether natural, organic, or safe enough.  Forinstructions on Label Poise visit our Label Poise page.

The Label

LabelPoise27

The Ingredients

Water: Safe! Water is the ultimate moisturizer and is a key ingredient in any moisturizing product.

Cetearyl Alcohol: Safe! Typically naturally derived from Coconut and Palm Oils (though it can be derived synthetically), it is a mixture of Cetyl and Stearyl fatty alcohols.  This ingredient acts as a thickener and moisturizer in personal care products.  In pure form,  this ingredient can be a slight skin irritant and permeator, and is toxic to mucous membranes.  The is no data available on human toxicity, carcinogenicity, mutagenicity, developmental toxicity, and teratogenicity.  (MSDS)

Glycerin: Safe!  Glycerin is a humectant that attracts moisture in the skin. Glycerine can be derived from fats and oils, or synthetically–which is not indicated here.  (MSDS)

Cetyl Esters: Beware!  This ingredient is derived from vegetable sources, such as coconuts, and is typically used as a thickener in cosmetics.  It is comprised of various fatty alcohols and fatty acids.  It is typically 1 to 3% of the weight of the formula.  There is no data regarding toxicity, carcinogenicity, or mutagenicity.  (MSDS)

Behentrimonium Chloride: Beware! Also known as Docosyltrimethylammonium chloride, Behentrimonium Chloride Is a “quaternary ammonium compound” made from corn (likely GMO) or canola oil. It is used as an antistatic, detangling aid, conditioning agent, and disinfectant. This product is toxic to aquatic animals, however, the concentrations in the product are likely less than 3% and should not be harmful. This product can cause skin irritation upon prolonged or repeated exposure (via MSDS), though concentrations and exposure length is not likely enough to be harmful. In pure form Behentrimonium Chloride is also an eye irritant that can cause severe and permanent damage with prolonged exposure. In the U.S. it is used in concentrations of 0.2 – 7% by weight of the formula, depending on the product. It is banned by the European Union in concentrations over 0.1% in “ready to use” products. There is no data available regarding mutagenicity and carcinogenicity. (Author’s Note: Avoid if you are averse to GMOs, I don’t recall using this ingredient in a product so err on the side of caution.) (MSDS)

Citrus Grandis (Grapefruit) Extract: Beware! Grapefruit Extract is derived from the seed, pulp, and white membranes of the grapefruit. It is commonly used in cosmetics as a preservative as it is touted as having antimicrobial properties. Grapefruit extract is controversial because chemical tests revealed that the ingredient had synthetic components. It is a skin, lung, and eye irritant in pure form. (MSDS ; MSDS)

Daucus Carota Sativa (Carrot) Seed Oil*: Safe!  Carrot seed oil is used as an emollient and skin conditioning agent. It is high in omega 3 fatty acids, antioxidants, and nutrients such as Beta Carotene, vitamin A and Stigmasterol. It is not known to be toxic, an irritant, or sensitizer. (MSDS ; MSDS)

Aloe Barbadensis Leaf Juice: Safe!  This ingredient is used for its nutrient content and moisturizing properties.  (MSDS)

Punica Granatum (Pomegranate) Extract: Safe!  Pomegranate is believed to have antibacterial properties and contain antioxidants, vitamin C, as well as offer benefits against various diseases. It is not known to be toxic, though it can be an eye and skin irritant (allergic dermatitis) in pure form. (MSDS; MSDS)

Sea Water: Safe! This is water presumably from the ocean or sea, however, synthetic sea water is commercially available. It is typically saltly (high salinity) and contains various minerals.

Sea Silt Extract: Safe! Also known as Maris Limus extract, is is the extract of sea minerals. It is said to contain sulfur, purifying clay, oxygen, and trace elements. No MSDS found.

Guar Hydroxypropyltrimonium Chloride: Safe!  Also known as cationic guar gum, this ingredient is a quarternary ammonium (positively charged polyatomic ions) derivative of guar gum (a natural substance). It is added to shampoos for its conditioning and anti-static properties. In pure form, the dusts of this ingredient may be an irritant, however, it is not toxic to the skin and is not known to be carcinogenic. Information on mutagenicity is not available. (MSDS; MSDS)

Tocopheryl Acetate:  Safe!/Beware!  Tocpheryl Acetate is has antioxidant properties and can penetrate skin cells. It is generally regarded as safe however I saw some information (not on a MSDS) linking it to cancer so use your best discretion. (MSDS)

Phenoxyethanol:  Beware!/Avoid!  This is a preservative.  You will notice it is very high on the list of ingredients.    It is used because it is safer than formaldehyde-releasing preservatives, though the FDA released a warning about how it can impact the central nervous system and induce vomiting in infants.  It is also suspected to be a xenoestrogen (mimics estrogen), a cause of contact dermatitis and skin irritant.  In pure form phenoxyethanol is toxic to kidneys, the nervous system, and liver; it is an extremely hazardous eye irritant and a very hazardous eye irritant, though information on carcinogenicity, mutagenicity, teratogenicity, and developmental toxicity are not available.  It is banned in the EU and Japan in concentrations over 1%.  Therefore, one would assume it is either greater than the EU concentration restraint or it is in accordance, and the remaining ingredients in this product are at very low concentrations.  This ingredient is made from 2 carcinogens (benzene and ethylene oxide), though it itself is not known to be carcinogenic.  People around small children should ‘Avoid!‘ this ingredient, others should ‘Beware!‘. (MSDS)

Sodium Hydroxide: Beware!  Also known as caustic soda or lye, this ingredient is likely used to aid surfactants or increase pH. In pure form it can be dangerous, toxic to eyes, lungs, and skin, though it is typically used in low concentrations in personal care products. (MSDS)

Fragrance: Beware!  Fragrances are often synthetic. Though they are low in concentration in the product, there is still a small chance of having an allergic reaction.

Geraniol: Beware! Geraniol is a phytochemical, a monoterpenoid and alcohol, that is a component of many natural fragrance oils, such as rose oil, citronella oil, and palmarosa oil. It is used as a fragrant. It can be a skin and eye irritant in pure form. (MSDS)

Nature’s Pulchritude’s Verdict: This product has a short ingredient list and contains a majority of safe ingredients. The biggest concerns in the product are the preservatives grapefruit extract and phenoxyethanol, which are not high on the concern list. This conditioner just may be worth a try!

Pulchritude: Neem Tree

This tree is best known for its multitude of cosmetic and medicinal uses in Ayurveda. Neem trees are native to the Indian subcontinent, being found in India, Pakistan, Bangladesh, Nepal, and Sri Lanka. Neem trees (Azadirachta indica) typically grow between 49-66 feet in height, though it rarely grows to between 115 – 131 feet. Leaves of the Neem tree grow between 20 – 40 centimeters in length. The Neem tree produces fragrant white flowers which grow 0.24 inches in length, and 0.43 inches in width. The fruit of the tree is a drupe, can be round or elongated oval in shape and is typically 0.55-1 inch in length and 0.39 – 0.59 inches in width when ripe. Hindu traditional medicine, Ayurveda, utilizes the leaves and fruit of the Neem tree (Azadirachta indica) and is purported to treat a variety of ailments due to its believed antifungal, antiviral, antidiabetic, antibacterial, and sedative properties. Neem oil is made from pressing the leaves and fruit of the Neem tree and is believed to be great for the skin and can be used to treat eczema and psoriasis, and can be used for healthy hair. Many of the health benefits have not been fully scientifically tested, though available research shows it is safe in short term use in adults. Neem has been used an Ayurvedic practices for over 2,000 years in India.