Tag Archives: parenting

Major Brand Must Pay $72 Million for Cancer Death Linked to Talcum Powder

This sad case is an example of a chronic exposure (exposed to something over a long span of time) and how it can be detrimental to health.  Many ingredients are not harmful in small doses (acute exposure) but if they accumulate in the body they can cause harm.  The claims against Johnson & Johnson are worrisome and bring to the forefront (again) deceptive practices companies use to benefit their sales–something that has been seen in other consumer product industries. 

Copyright Reuters

Johnson & Johnson was ordered by a Missouri state jury to pay $72 million of damages to the family of a woman whose death from ovarian cancer was linked to her use of the company’s talc-based Baby Powder and Shower to Shower for several decades.

In a verdict announced late Monday night, jurors in the circuit court of St. Louis awarded the family of Jacqueline Fox $10 million of actual damages and $62 million of punitive damages, according to the family’s lawyers and court records.

The verdict is the first by a U.S. jury to award damages over the claims, the lawyers said.

Johnson & Johnson faces claims that it, in an effort to boost sales, failed for decades to warn consumers that its talc-based products could cause cancer. About 1,000 cases have been filed in Missouri state court, and another 200 in New Jersey.

Fox, who lived in Birmingham, Alabama, claimed she used Baby Powder and Shower to Shower for feminine hygiene for more than 35 years before being diagnosed three years ago with ovarian cancer. She died in October at age 62.

Jurors found Johnson & Johnson liable for fraud, negligence and conspiracy, the family’s lawyers said. Deliberations lasted four hours, following a three-week trial.

Jere Beasley, a lawyer for Fox’s family, said Johnson & Johnson “knew as far back as the 1980s of the risk,” and yet resorted to “lying to the public, lying to the regulatory agencies.” He spoke on a conference call with journalists.

Carol Goodrich, a Johnson & Johnson spokeswoman, said: “We have no higher responsibility than the health and safety of consumers, and we are disappointed with the outcome of the trial. We sympathize with the plaintiff’s family but firmly believe the safety of cosmetic talc is supported by decades of scientific evidence.

Trials in several other talc lawsuits have been set for later this year, according to Danielle Mason, who also represented Fox’s family at trial.

In October 2013, a federal jury in Sioux Falls, South Dakota found that plaintiff Deane Berg’s use of Johnson & Johnson’s body powder products was a factor in her developing ovarian cancer. Nevertheless, it awarded no damages, court records show.

Valeant Pharmaceuticals International Inc now owns the Shower to Shower brand but was not a defendant in the Fox case.

The case is Hogans et al v. Johnson & Johnson et al, Circuit Court of the City of St. Louis, Missouri, No. 1422-CC09012.

(Reporting by Jonathan Stempel in New York. Additional reporting by Jessica Dye in New York; editing by Steve Orlofsky and Alan Crosby)

via Reuters http://news.yahoo.com/j-j-must-pay-72-million-cancer-death-154301727–finance.html;_ylt=AwrC0CZlGdZWpgkAzmzQtDMD;_ylu=X3oDMTByaWg0YW05BGNvbG8DYmYxBHBvcwM4BHZ0aWQDBHNlYwNzcg–

 

 

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Sundial Brands Announce Strategic Partnership to Drive Its Purpose-Driven Entrepreneurship

A well known beauty brand that produces quality products with fair trade and certified organics products via SheaMoisture and Nubian Heritage recently announced an investment partnership that has been met with controversy. Check back tomorrow for my take on this partnership and why you should or should not be concerned!

Copyright Sundial Brands LLC (No Copyright Infringement Intended)

New York – (September 2, 2015) – Sundial Brands, the natural skin care and hair care manufacturer widely recognized for introducing the New General Market concept to beauty and retail, today announced that it has signed an agreement to enter into a strategic partnership with Bain Capital Private Equity, a leading global investment firm, to accelerate the company’s growth. Sundial founder and CEO Richelieu Dennis will continue to provide vision and leadership for the company, which will remain majority family-owned and operated including board, management and day-to-day operationsThe partnership will drive Sundial’s social entrepreneurship model, accelerate its multi-brand portfolio strategy – including investments in community-minded entrepreneurs and brands – and advance its transformative approach to serving New General Market consumers. It also ensures that Sundial’s community of consumers will remain at the forefront of the beauty landscape. Financial terms of the minority investment were not disclosed.

Copyright Sundial Brands LLC (No Copyright Infringement Intended)

“Our love of people has always been our motivation and our competitive advantage,” said Dennis. “While we have been presented several opportunities to be acquired by multinational corporations, we are most excited that our collaboration with Bain Capital fulfills our commitment to remain an independent family-owned and operated company with a purpose-driven business model that puts community at our core. Our consumers have always been partners with us, and now they can continue to walk with us on this journey. We recognize that African-American women have long been at the forefront of the natural hair and body movement that has created the dynamic cultural shift that we see today. It is exciting for us to see how Naturalistas have now empowered women from all backgrounds to embrace their natural beauty. In addition, they have compelled multinational beauty brands and retailers to acknowledge and be more respectful of their needs. Our family has understood this since 1912 – the value of listening to underserved consumers and delivering on their unmet needs. We are moving forward to build Sundial into a global family-owned-and-operated consumer brand of which they can be even more proud.”

“We are also excited to welcome Bain Capital as a valuable partner who shares our commitment to our communities globally and understands how our brand of social entrepreneurism can be enhanced to achieve our vision for growth and impact,” Dennis added.  “Sundial is now in the strongest position to continue to lead this beauty revolution, alongside all of our consumers, so that no one gets left behind.” Deval Patrick, a Managing Director at Bain Capital and the former Governor of Massachusetts, played an active role in the partnership discussions and will join the Board of Directors of Sundial.

Copyright Sundial Brands LLC (No Copyright Infringement Intended)

In 1992, Dennis founded Sundial with his college roommate, Nyema Tubman, and his mother, Mary Dennis, shortly after graduating from Babson College and being unable to return to his home country of Liberia because of civil war.  With a passion for entrepreneurship and a vision to fill unmet consumer needs, Dennis decided to pursue a bold concept: address skin and hair care issues traditionally ignored by mass market companies.  Drawing from culturally-authentic traditions born out of his family’s roots in Africa and passed down to him from his grandmother, Dennis incorporated four generations of recipes, wisdom and global experiences into efficacious natural bath and body care products.  In two short decades, Sundial has grown from selling products on the streets of New York City to having distribution and co-creation of its flagship brands – SheaMoisture and Nubian Heritage – with major retailers across the United States. Via its purpose-driven Community Commerce business model, the company creates opportunities for sustainable social and economic empowerment throughout its supply chain and communities in the U.S. and Africa, focusing on entrepreneurship, women’s empowerment, education and wellness.

“We are strategically aligned with our new partner around the elevation of the New General Market as a key growth driver and the opportunity to identify and invest in new ways to better serve our consumer community,” said Dennis.  “We have defined the New General Market as ‘an amalgamation of cultures, ethnicities and demographics aligned against commonalities, need states and lifestyles.’  Most critical are the commonalities and employing multi-need strategies that acknowledge both the differences within populations and the similarities across populations.  We all share similar needs that are often unmet or under-served.  When we focus on those, we can provide solutions that serve everyone in much more meaningful, relevant ways.”

Bain Capital Private Equity has a long track record of investing in and partnering with management teams to help grow companies.  Some of its consumer and retail investments have included TOMS, Canada Goose and Bright Horizons Family Solutions.

“Richelieu and his family have built an amazing business and community centered on the idea of the New General Market, an idea that is very well aligned with where we as consumers and as a country are headed. We could not be more excited to partner with Sundial Brands to continue to enhance this differentiated approach to innovation, social entrepreneurship and community engagement,” said Ryan Cotton, a Managing Director at Bain Capital.

 

Celebrity Backed Direct Sales Company to Launch Beauty Line

Beauty is a multi-billion dollar business market that more and more brands are delving into.  The natural niche within this business market is steadily gaining market share.  It is no wonder this brand has decided to expand in this direction.  Cosmetics can be very tricky when it comes to delivering high quality ingredients and performance simultaneous, so we will see if this brand can deliver ‘honest’ non-toxic ingredients and products that rival top of the line brands (at whatever price point) in performance.  We will also see if they offer foundations in a wide variety of shades unlike many other cosmetic brands on the market. 

By Marcy Medina
 
Jessica Alba, the new standard bearer for celeb-entrepreneur, is expanding The Honest Company, the online retailer she cofounded in 2011, but she’s also feeling the heat of her fame.

Fresh off a controversy surrounding the brand’s SPF 30 sunscreen — which became the subject of an angry online grassroots campaign claiming the product didn’t work, complete with photos that showed badly sunburned users — Alba is gearing up for the Sept. 9 launch of a full color cosmetics and skin-care line called Honest Beauty.

Regarding the sunscreen controversy, The Honest Company has been relatively mum, declining to elaborate beyond a statement saying, “Our team is reaching out to everyone who has posted on social media to assure you that we’re committed to your safety and satisfaction. As always, we’ll do what it takes to make it right.” Brand experts say Alba can ultimately overcome the backlash, but they’re urging her to be more aggressive about publicly tackling the problem.

Sitting down with WWD exclusively — pre-sunscreen snafu — at The Honest Company headquarters in Santa Monica, Calif., Alba was more forthcoming about her strategic vision for her brand and how beauty fits into the picture. “The values we stand for — safe, effective products to lead a healthy life — translate into every vertical,” she said. “Beauty was always part of the plan. It was just a matter of when, how and being able to execute it properly. I didn’t want to do this half-ass.”

So Alba assembled a 50-person Honest Beauty team, including director of beauty Kristin Mason, who cofounded Delux Beauty with Jillian Dempsey. Its Web site and e-commerce will exist separately from The Honest Company, and will have its own logo and look. The target demographic is 15- to 35-year-olds, although Alba hopes to reach a wider customer base than The Honest Company, which is known for its diapers and bath and body products geared toward kids and mothers.

If successful, the beauty side could eventually dwarf its parent company in terms of scale and revenue. “The size of the beauty market is much larger than the other categories we are claiming today, so does it have the potential to be larger than The Honest Company? Absolutely,” said Brian Lee, cofounder and chief executive officer of The Honest Company. “We wouldn’t go into a category unless we thought we could make a large impact.” Lee declined to give beauty sales projections, but The Honest Company continues to grow, reportedly recently raising $100 million in a new round of funding, valuing it at about $1.7 billion.

The 83-piece collection includes 17 skin-care products and a 66-piece makeup range. There’s a Daily Beauty Fluid with SPF 30 (it contains 19.7 percent non-nano zinc oxide, a different formulation than The Honest Company SPF 30 sunscreen with 9.3 percent that caused the uproar), tinted SPF 20 moisturizer, gel cleanser, moisturizers for oily and dry skin, and an eye cream. In cosmetics, there’s a double-ended mascara and lash primer, crème concealers and blushes, chubby lip pencils and glosses, eyeliner, eye shadow and brow pencils and a cream foundation compact.

As Alba looks over the lineup of pink and gray bottles and silver compacts, she’s drawn to the primer, rice powder cleanser and makeup-remover wipes. “There’s no hero product; we tried to offer anything you could ever need,” she said. “If women like one product, they’re likely to try more. I will always try something that a girlfriend tells me she loves, way more than watching a commercial about it.”

To that end, social media will form the core of the brand’s public relations strategy at launch, ranging from quick-take tutorials on Instagram to inspirational quotes on Pinterest. To date, The Honest Company hasn’t employed traditional media such as print ads, television or billboards. “We’re not there yet,” said Alba, who has 5.8 million followers on Instagram. (The Honest Company has 363,000.) “We’re still wrapping our heads around that ROI [return on investment]. Online, you can track your investment in a very real way, so we’re doing what we know.”

That means mobile storytelling and shopping. “We want to reach our customer in an interesting, innovative and on-the-go way. Women are on their phones consuming fashion and beauty content, connecting with their families and friends. We wanted to integrate our launch and e-commerce capabilities into a seamless mobile experience,” she said.

Honest Beauty will have a brick-and-mortar presence with a six-month pop-up shop opening at The Grove in Los Angeles on Sept. 25. The 1,100-square-foot space will feature midcentury modern lines with warm, organic materials and eclectic touches. Local artists will contribute to video installations and store windows. Tech will also feature prominently: Customers can try on makeup virtually with real-time 3-D makeup application stations, take a selfie to share with friends and capture their look in a photo booth.

While no other pop-ups are in the works, Alba said she’s open to retail in the future. “Having the choice to come in or order online is a convenience we know customers want,” she said.

Like other famous faces in the beauty biz, Alba’s years of on-camera experience have given her a certain insight into the product base. “I’ve been working since I was 12, so I have over 20 years’ experience with makeup, and I am used to a really high standard of effectiveness and quality,” she said.

She observed that the current beauty market falls into two camps, the first being products that are natural and ineffective (an ironic assessment, perhaps, given the sunscreen dustup) or those that contain chemical ingredients an increasing number of consumers are looking to avoid.“The most important thing for us was effectiveness and safety, so we led with that,” Alba noted. “It’s about giving people peace of mind and telling them what we are honestly free of.” That refers to potentially harmful ingredients such as parabens, phthalates, petrolatum, sulfates and chemical sunscreens. Instead, the products contain naturally derived botanicals such as chamomile, calendula, aloe vera, rosehip and green tea.

Prices range from $8 to $40 for skin care and $15 to $30 for cosmetics. Sourcing such ingredients and products in small batches can be costly, but Alba and Lee said the company is willing to work on smaller margins in order to make the products accessible. “We are building a prestige brand, but we are offering it at a price point that is within reach. That has been challenging operationally as far as figuring out what that sweet spot is, where we’re willing to take a hit on margins, and will certain things ever scale,” said Alba. Lee added, “The company was founded to help create a healthier environment for everybody, not just rich folks. That’s why we take a hit on margins, because we’ll only make a difference if we get it in people’s hands.”

Toxic Substance Control Act To Be Updated After 39 Years

Finally! 

The US is finally about to update its toxic chemical protections, after 39 years

But convenience comes with a cost. Any baby born in America today is likely to carry hundreds of synthetic chemicals in his or her body at birth. According to a 2008-2009 report by the US Department of Health and Human Services, traces of nearly 300 pollutants, “such as chemicals used in fast-food packaging, flame retardants present in household dust, and pesticides,” have been found in the umbilical cord blood of newborns. And some chemicals in common use today are linked with certain cancers, Parkinson’s, developmental disorders and other illnesses. Any baby born in America today is likely to carry hundreds of synthetic chemicals in his or her body  

So it is a national scandal that the United States’ primary chemical safety law hasn’t been updated since the day it was enacted, back when America’s No. 1 song was “Disco Duck” and appointment TV meant “Charlie’s Angels.” Since the day it passed in 1976, the Toxic Substances Control Act (TSCA) hasn’t protected anyone. The chemicals in products you buy at the store—from clothes to couches to cleaning supplies—are essentially untested and unregulated.

For decades, Congress has been trying to fix TSCA, but the lawmakers have gotten nowhere.

There have been hearings since 1994, and several proposed bills, but industry opposition kept the reform effort from advancing. Meanwhile, thousands of chemicals have come on the market. They permeate every aspect of American life. And the Environmental Protection Agency (EPA) has been all but powerless to police them. 

In recent years, however, some companies have begun to realize the current system isn’t good for their bottom lines either. As one DuPont executive testified before Congress in 2010:

“In the absence of reforms to TSCA we are seeing a plethora of state actions that are serving to create tremendous uncertainty in our markets…we think a robust reformed TSCA would remove the motivation for state by state regulation of chemicals.”

She went on to describe the hundreds of millions of dollars her company had spent to reformulate products after the market moved away from a particular chemical in response to consumer pressure. Now, after years of denial, many in the industry are now willing to accept more federal regulation to secure a predictable system that will restore consumer confidence in the safety of their products. The Lautenberg Act would let EPA do the things most Americans assume it can already do.
 

Companies such as Walmart—which announced a robust chemicals policy in 2013—began to step up and do their own testing on household products. That helped nudge chemical companies to the negotiating table—and so did new state laws. Although states have only restricted about a dozen chemicals or chemical groups for health reasons in 40 years—providing little protection to most Americans—the threat of 50 different local regulators was enough to get industry to see the benefits of a  single strong federal regulator, empowered to offer a final “yay” or “nay.” 

That realization provided an opening for longtime public health champion Sen. Frank Lautenberg (D-NJ) to negotiate with chemical industry ally Sen. David Vitter (R-LA) in 2013. After Lautenberg passed away, Sen. Tom Udall of New Mexico took over on the Democratic side, continuing the negotiations. 

The bill Udall and Vitter came up with, known as the Lautenberg Act,  would let EPA do the things most Americans assume it can already do. These include a mandate to review the safety of all chemicals in commerce, a required safety finding before a new chemical can enter the market, powerful new authority to require testing of chemicals, and explicit requirements to protect the most susceptible—infants and pregnant women— from harmful chemicals, along with concrete deadlines, a new source of funding, and more. Cutting a deal with big bad interest groups can lead to progressive change.

Rare political circumstances have forced the industry to make major concessions, so the result is a strong bill that has 11 Democratic and 11 Republican sponsors. It actually might pass—yes, something big might pass Congress and become law—and it would be the most important environmental law since the 1990 Clean Air Act Amendments. (The House also seems to be working on a bipartisan basis.) 

But laws are never perfect. The big trade-off here is that some decisions by EPA on chemicals will supersede some state actions and restrictions.  As David Vitter put it, “Republicans agree to give EPA a whole lot [of] new additional authority, which we’re not in the habit of being excited about, to state the obvious. In exchange, that leads to … a common rulebook.”

Even so, there are limits to the preemption of state authority in the bill. For example, all state actions taken before 2015 remain intact, and, after enactment, states can restrict a chemical until and unless EPA takes up that same chemical and addresses the same uses.

This week, three progressive Democrats announced their support for the bill after negotiations yielded changes that allow states to “co-enforce” federal requirements on chemicals and better ensure EPA can restrict chemicals in finished products (such as formaldehyde-laden floor boards). Still, there is no question the bill remains a compromise. In many ways, the dynamic here is like Obamacare, where the President had to cut deals with Big Pharma and the insurance industry to get legislation passed. That bill wasn’t perfect, but nine out of ten Americans have health insurance and the other benefits of the law.

In other words, cutting a deal with big bad interest groups can lead to progressive change. 

Of course, to some that’s heresy. They see the strange bedfellows as being more important than the substance. In my view, we’ve got a classic case of the perfect vs. the good—and in an era when precious little good has come out of Washington, I’ll take it. 

After decades of inaction and several “ideal” bills that couldn’t attract the bipartisan support necessary to pass, it’s time to move forward. We can let this moment pass and leave American families vulnerable to the dangerous chemicals that surround us, or we can forge ahead with a dramatic improvement over current law.

(via Quartz)

 

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

LabelPoise28

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 XX

Finding safe, effective products for your baby is of the upmost importance!  The growing number of concerned parents and yielded and increase in ‘natural’ baby products.  This product touts being all natural, 95% USDA biobased, and paraben free, all of which fit your Label Poise so you purchase it for your baby!  The product is also made by a company that is well known in the natural products world.  Just like with ‘natural’ or organic products for adults, product quality does not always live up to marketing.

The Label

LabelPoise20

The Ingredients

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

Polyglyceryl-3 Stearate:  Avoid!  This ingredient is an ester of stearic acid and polyglycerin-3. It is used as an emulsifier and is used in concentrations of 3-10% in this product. There is no additional information about this ingredient. It may very well be non-toxic, but there is no evidence to substantiate that. No MSDS.

Caprylic/Capric Triglyceride:  Safe!  This ingredient is used as an emollient and is typically derived from esters of caprylic acid (coconut oil), capric acid (coconut oil), and glycerin.  Caprylic/Capric Triglyceride is used primarily as an emollient and spreading agent.  It can penetrate the hair and skin to condition and leaves a lightweight non greasy barrier. It is very stable and is unlikely to oxidize.  It may be a slight eye irritant and it is not known to be a skin irritant unless their is prolonged exposure. It is not a carcinogen. (MSDS)

Cocoglyceride:  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)

Glyceryl Stearate:  Safe!  Also known as Glyceryl Monostearate, this ingredient is typically derived from vegetable sources such as palm kernel and soy oil, and is the glycerol ester of stearic acid.  It is used as an emulsifier, stabilizer, lubricant, and decreases the ‘greasiness’ of oils.  It is believed to form a barrier on the skin to decrease moisture loss.  In pure form is is a slight skin irritant.  The is no data available on human toxicity, carcinogenicity, mutagenicity, developmental toxicity, and teratogenicity. This ingredient is considered “generally regarded as safe” by the FDA.  (MSDSMSDS )

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)

Stearyl Alcohol:  Safe!  This is also a fatty alcohol that is often used as an emollient and emulsifier in conditioner. (MSDS)

Cetyl Alcohol:  Safe!  This is a fatty alcohol that is often used as an emollient and emulsifier in conditioners. It is typically derived naturally from coconut or palm oil.  (MSDS)

Zea Mays (Corn) Starch:  Safe!  Corn Starch is used as for its abrasive, absorbent, skin protecting, and viscosity increasing (aqueous) properties. It is derived from corn, therefore it may be from GMO corn, Beware! if this is a concern.  It is not known to be carcinogenic or mutagenic. (MSDS)

Olea Europaea (Extra Virgin Olive) Fruit Oil:  Safe!  Olive oil is used for its skin conditioning and anti-inflammatory properties.  It is rich in vitamins E and A, as well as antioxidants.

Butyrospermum Parkii (Shea) Butter:  Safe!  This ingredient is derived from the nut of the Shea Tree and is used for its moisturizing properties.  (MSDS)

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)

Lactic Acid:  Beware!  Lactic Acid (C6H6O3) is a naturally occurring Alpha Hydroxy Acid (AHA). Lactic Acid be naturally extracted from milk fermentation, from bacteria converting glucose and sucrose, or produced synthetically. It can be used as a humectant, exfoliant, or skin conditioning agent. Absorption of lactic acid via the skin is pH dependent, and occurs more rapidly in low pH environments (acidic). It is not known to be carcinogenic or mutagenic though it can be a serious hazard to the eyes, skin, and lungs in pure form. The concentration in this product is less than 1%, therefore it is not a high concern.  (MSDS; 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.

Citrus Aurantium Dulcis (Orange) Peel Oil*:  Safe!  Orange Peel Oil is used as a skin conditioning agent and fragrant.

Citrus Grandis (Grapefruit) Peel Oil*:  Safe!/Beware!  Grapefruit Peel Oil is used as a skin conditioning agent and fragrant.  This ingredient has use restrictions in the EU, but should be fine for use in this product. (MSDS)

Citrus Nobilis (Mandarin Orange) Peel Oil*:  Beware!/Avoid!  Mandarin Orange Peel Oil is used as a skin conditioning agent and fragrant. This product should be avoided while pregnant, and likely is not safe for babies. Considering this product is formulated for babies, that is troubling, despite the low concentration. (MSDS)

Dehydroacetic Acid: Safe! This ingredient is a preservative used for its fungicide and bactericide properties. Dehydroacetic acid is a sodium salt of sodium dehydroacetate. It is suggested to be used in concentrations of no more than 0.6%. It can be a skin, eye, and lung irritant, and can be toxic to kidneys, liver, and central nervous system in pure form. It is not believed to be carcinogenic or mutagenic. (MSDS)

Potassium Sorbate:  Safe!/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)

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)

* indicates D-Limonene is a component of essential oils.

 

Nature’s Pulchritude’s Verdict:   This product is marketed as being natural and 95% plant based, however, 2 of the ingredients–one being the second ingredient–have no available information on toxicity.  That is not a likely risk most people would knowingly take on themselves, let alone their vulnerable child.  This product also touts being 95% USDA Biobased.  Never heard of it?  Me either.  Biobased means that a product is composed of, in whole or in significant part, of biological products, renewable domestic agricultural materials, forestry materials, or intermediate stock.  The boundaries of plant-based are not clearly defined.  It should also be pointed out that key biobased crops include soybeans and corn, which happen to be two of the most genetically modified crops produced in the US.  The MSDS for this product is available online and does not list and concerns of toxicity.  The composition of the formula is listed on the MSDS: Water (30-100%), Polygyceryl-3 Stearate (3-10%), Cocoglycerides – Cetyl Alcohol (1-3%), Rest (<1%).  I would not purchase this product.

How to Read Cosmetic Ingredient Labels XVI

Babies and young children are often most vulnerable to potentially dangerous chemicals in cosmetics. Are the products you use on your baby safe?   This baby shampoo is made by a company that is known for environmentally products, so you trust the product based on brand recognition.  Though many people base their shopping on brand recognition and reputation, this is not always a good idea.  Did you make the right choice by purchasing this product?  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.

The Label

LabelPoise16

The Ingredients

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

Decyl Glucoside:  Safe!  This ingredient is derived from the reaction of glucose from corn starch (GMO?)  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).

Sodium Coco Sulfate:  Avoid!/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. There is no toxicological information on this ingredient, though it has the same concerns about skin and eye irritation as sodium lauryl sulfate. Given that babies have more sensitive skin than adults and there is no toxicity information on this ingredient, it is best to Avoid! for babies, and Beware! for adults. (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)

Olive Leaf Extract:  Beware!  Olive Leaf extract is used for its skin conditioning, antioxidant, anti-inflamatory, and antimicrobial properties.  It is not known to be carcinogenic, mutagenic, teratogenic, or cause developmental toxicity.  This ingredient can be a skin, eye, lung, and digestive irritant in pure form (MSDS)

Aloe Vera Powder:  Safe!  This is the inner leaf of the aloe vera plant that has been processed into a powder form. Aloe gel from the inner leave is pasteurized and concentrated using low temperature evaporation. The product is then freeze dried to preserve freshness and alleviated the need for a preservative. Aloe vera powder is non-toxic, is not a carcinogen, and is not known to be a skin or eye irritant. Information on mutagenicity is not available. (MSDS; MSDS)

Magnesium Chloride: Safe!  Magnesium Chloride (MgCl2) is a natural inorganic salt that can be extracted from brine or sea water. It can be produced using various chemical reactions. It is used to increase viscosity of the water (aqueous) portion of a cosmetic formulation. Magnesium Chloride is generally considered safe by the FDA. In pure form it can be a skin irritant and targets the kidneys. It is typically used in low concentrations and should be of minimal concern. It is not known to be a carcinogen. (MSDS; MSDS)

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)

Essential Oils and Botanical Extracts:

      • Citrus Aurantium Dulcis (Orange) Peel Oil: Safe!  Orange Peel Oil is used as a skin conditioning agent and fragrant.
      • Citrus Grandis (Grapefruit) Peel Oil:  Safe!/ Beware!   Grapefruit Peel Oil is used as a skin conditioning agent and fragrant.  This ingredient has use restrictions in the EU, but should be fine for use in this product. (MSDS)
      • Citrus Nobilis (Mandarin Orange) Peel Oil:  Beware! Mandarin Orange Peel Oil is used as a skin conditioning agent and fragrant. This product should be avoided while pregnant, and likely is not safe for babies. Concentrations in this product are very low and are rinsed off, so exercise caution. (MSDS)

Sodium Benzoate and Potassium Sorbate:

      • Sodium Benzoate:  Safe!  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)
      • Potassium Sorbate:  Safe!/Beware!  This ingredient is the sodium salt of benzoic acid, and is commonly used as a preservative in food and cosmetics.  This ingredient is typically synthetically derived.  The FDA mandates that this ingredient is not to exceed 0.1% of the formula by weight.  When combined with ascorbic acid (Vitamin C), sodium benzoate can react to form benzene, a known carcinogen–this product contains a form of Vitamin C.  These claims have been substantiated by the FDA, though the benzene levels are considered less than World Health Organization limits to be considered dangerous.  Sodium benzoate is not known to be carcinogenic, mutagenic, or neurotoxic, though it can be teratogenic in embryos and fetuses.  This ingredient may cause skin and eye irritation in pure form.  (MSDS)

Tetrasodium Iminodisccinate:  Avoid!  This ingredient is a chealator that binds to mineral deposits and soap scum to prevent them from depositing on skin and allows them to be rinsed away. No MSDS found.

 

 

Nature’s Pulchritude’s Verdict: This product looked promising at first glance.  The only ingredients that were questionable were Magnesium Chloride and Tetrasodium Iminodisuccinate.  In actuality, Sodium Coco Sulfate was an unsuspecting concern.  This product is far better than the commonly found baby products, though it still has questionable ingredients. Sodium Coco Sulfate is a key example of deceptive marketing.  The word ‘coco’ leads many consumers to believe that the ingredient is naturally (coconut) derived and therefore safe.  Sodium Coco Sulfate and Tetrasodium Iminodisuccinate are both rated Avoid! because of lack of information, though they may not be hazardous.  Essential Oils can also be of minor concern, though they should be okay for use in this product given it is to be rinsed off, and is likely in low concentrations.  Err on the side of caution and skip this product unless your only other options are ‘conventional’ baby products.

 

Would you purchase this product?  Tell us in the comments!

Thank you for reading!

Tiny particles may pose big risk

This article is yet another example of technology taking precedence over toxicology studies.  Nanoparticles have been a source of controversy over the last few years for the reasons outlined in this article.  Despite the fact that nanoparticles are used in various consumer products, toxicology studies are in  just beginning to be published.

Christine Daniloff/MIT

Some nanoparticles commonly added to consumer products can significantly damage DNA.

By Anne Trafton–Thousands of consumer products — including cosmetics, sunscreens, and clothing — contain nanoparticles added by manufacturers to improve texture, kill microbes, or enhance shelf life, among other purposes.  However, several studies have shown that some of these engineered nanoparticles can be toxic to cells.

A new study from MIT and the Harvard School of Public Health (HSPH) suggests that certain nanoparticles can also harm DNA. This research was led by Bevin Engelward, a professor of biological engineering at MIT, and associate professor Philip Demokritou, director of HSPH’s Center for Nanotechnology and Nanotoxicology.

The researchers found that zinc oxide nanoparticles, often used in sunscreen to block ultraviolet rays, significantly damage DNA. Nanoscale silver, which has been added to toys, toothpaste, clothing, and other products for its antimicrobial properties, also produces substantial DNA damage, they found.

The findings, published in a recent issue of the journal ACS Nano, relied on a high-speed screening technology to analyze DNA damage. This approach makes it possible to study nanoparticles’ potential hazards at a much faster rate and larger scale than previously possible.

The Food and Drug Administration does not require manufacturers to test nanoscale additives for a given material if the bulk material has already been shown to be safe.  However, there is evidence that the nanoparticle form of some of these materials may be unsafe: Due to their immensely small size, these materials may exhibit different physical, chemical, and biological properties, and penetrate cells more easily.

“The problem is that if a nanoparticle is made out of something that’s deemed a safe material, it’s typically considered safe. There are people out there who are concerned, but it’s a tough battle because once these things go into production, it’s very hard to undo,” Engelward says.

The researchers focused on five types of engineered nanoparticles — silver, zinc oxide, iron oxide, cerium oxide, and silicon dioxide (also known as amorphous silica) — that are used industrially.  Some of these nanomaterials can produce free radicals called reactive oxygen species, which can alter DNA.  Once these particles get into the body, they may accumulate in tissues, causing more damage.

“It’s essential to monitor and evaluate the toxicity or the hazards that these materials may possess. There are so many variations of these materials, in different sizes and shapes, and they’re being incorporated into so many products,” says Christa Watson, a postdoc at HSPH and the paper’s lead author.  “This toxicological screening platform gives us a standardized method to assess the engineered nanomaterials that are being developed and used at present.”

The researchers hope that this screening technology could also be used to help design safer forms of nanoparticles; they are already working with partners in industry to engineer safer UV-blocking nanoparticles.  Demokritou’s lab recently showed that coating zinc oxide particles with a nanothin layer of amorphous silica can reduce the particles’ ability to damage DNA.

Rapid analysis

Until now, most studies of nanoparticle toxicity have focused on cell survival after exposure. Very few have examined genotoxicity, or the ability to damage DNA — a phenomenon that may not necessarily kill a cell, but one that can lead to cancerous mutations if the damage is not repaired.

A common way to study DNA damage in cells is the so-called “comet assay,” named for the comet-shaped smear that damaged DNA forms during the test. The procedure is based on gel electrophoresis, a test in which an electric field is applied to DNA placed in a matrix, forcing the DNA to move across the gel.  During electrophoresis, damaged DNA travels farther than undamaged DNA, producing a comet-tail shape.

Measuring how far the DNA can travel reveals how much DNA damage has occurred. This procedure is very sensitive, but also very tedious.

In 2010, Engelward and MIT professor Sangeeta Bhatia developed a much more rapid version of the comet assay, known as the CometChip. Using microfabrication technology, single cells can be trapped in tiny microwells within the matrix. This approach makes it possible to process as many as 1,000 samples in the time that it used to take to process just 30 samples — allowing researchers to test dozens of experimental conditions at a time, which can be analyzed using imaging software.

Wolfgang Kreyling, an epidemiologist at the German Research Center for Environmental Health who was not involved in the study, says this technology should help toxicologists catch up to the rapid rate of deployment of engineered nanoparticles (ENPs).

“High-throughput screening platforms are desperately needed,” Kreyling says. “The proposed approach will be not only an important tool for nanotoxicologists developing high-throughput screening strategies for the assessment of possible adverse health effects associated with ENPs, but also of great importance for material scientists working on the development of novel ENPs and safer-by-design approaches.”

Using the CometChip, the MIT and HSPH researchers tested the nanoparticles’ effects on two types of cells that are commonly used for toxicity studies: a type of human blood cells called lymphoblastoids, and an immortalized line of Chinese hamster ovary cells.

Zinc oxide and silver produced the greatest DNA damage in both cell lines.  At a concentration of 10 micrograms per milliliter — a dose not high enough to kill all of the cells — these generated a large number of single-stranded DNA breaks.

Silicon dioxide, which is commonly added during food and drug production, generated very low levels of DNA damage. Iron oxide and cerium oxide also showed low genotoxicity.

How much is too much?

More studies are needed to determine how much exposure to metal oxide nanoparticles could be unsafe for humans, the researchers say.

“The biggest challenge we have as people concerned with exposure biology is deciding when is something dangerous and when is it not, based on the dose level. At low levels, probably these things are fine,” Engelward says. “The question is: At what level does it become problematic, and how long will it take for us to notice?”

One of the areas of greatest concern is occupational exposure to nanoparticles, the researchers say.  Children and fetuses are also potentially at greater risk because their cells divide more often, making them more vulnerable to DNA damage.

The most common routes that engineered nanoparticles follow into the body are through the skin, lungs, and stomach, so the researchers are now investigating nanoparticle genotoxicity on those cell types. They are also studying the effects of other engineered nanoparticles, including metal oxides used in printer and photocopier toner, which can become airborne and enter the lungs.

The research was funded by MIT’s Center for Environmental Health Sciences, the National Institute of Environmental Health Sciences, the National Science Foundation, and the National Institutes of Health. Other authors of the study are MIT graduate student Jing Ge, Harvard graduate student Joel Cohen, and Harvard postdoc Georgios Pyrgiotakis.

via MIT News Office

 

How to Read Cosmetic Ingredient Labels V

Today we’re in the store to buy another baby shampoo that you just finished.  You pick up a product by the go-to brand for baby products–they must know what they are doing, right?   There are several different options and you pick up the product with Cocoa and Shea Butters.  You start using your Label Poise and notice the product has a lot of chemicals you should ‘Beware!‘ and ‘Avoid!‘.  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.

Here are the tips I gave you in my first three posts on how to read ingredient labels:

  1. Ingredients are listed by quantity in the formula, from greatest to least, based on standards by the Federal Trade Commission (FTC).
  2. Ingredients are listed using the International Nomenclature of Cosmetics Ingredients (INCI), therefore they are listed using scientific nomenclature, or    binomial nomenclature (latin; taxonomy) for ingredients derived from plants.
  3. How ingredients are derived is seldom listed on the label (the same chemical can be derived synthetically or naturally).
  4. Fragrances are generically listed because they are considered trade secrets; typically naturally derived fragrances do not use “Fragrance (Parfum)” but a specific naming system.
  5. If it looks like a “chemical” it probably is, if you don’t want chemicals don’t buy it!  **Everything is a chemical, I’m referring to ‘bad’ chemicals here

The Label:

LabelPoise5

The Ingredients:

Water:  Safe!

Cocamidopropyl Betaine:  Beware!  This ingredient is a synthetic surfactant derived from coconut oil and dimethylamonipropylamine.  This ingredient can be a skin allergen and irritant and was voted Allergen of the Year in 2004 by the American Contact Dermatitis Society.  It is also an eye and lung irritant, though it is not known to be carcinogenic or mutagenic. (MSDS)

PEG-80 Sorbitan Laurate:  Beware!  PEG-80 Sorbitan Laurate is used as an emulsifier, mild solvent, and mild surfactant, which helps water combine with oil and dirt to be cleansed.  This ingredient is considered safe to use in cosmetics, however it is derived from polyethylene glycol, which may be contaminated with carcinogens 1,4-dioxane (1 ppt), formaldehyde (2.5 ppm), ethylene oxide (1 ppm), and acetaldehyde (3 ppt).  (MSDS)

Sodium Trideceth Sulfate:  Beware!/Avoid!  This ingredient is a surfactant.  Very limited information available.

Acrylates Copolymer:  Beware!  This ingredient is used as a binding, film forming, and antistatic agent.  It can be found in a variety of products including nail polish, hair sprays, sunscreen and mascara.  It is not known to be carcinogenic or mutagenic, thought it may be a skin or eye irritant. (MSDS)

Phenoxyethanol:  Avoid!  This is a preservative.  You will notice it is very high on the list of ingredients.  The FDA released a warning about how it can impact the central nervous system and induce vomiting in infants.  Interesting isn’t it?  it is commonly used because it is safer than formaldehyde-releasing preservatives.  It is also suspected to be a xenoestrogen (mimics estrogen), a cause of contact dermatitis and skin irritant.  I am not sure what concentration is in this product, but 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 all the Shea & Coco Butters that are used to market 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.

Glycol Distearate:  Avoid!  This ingredient is used as an emollient.  It is the diester of ethylene glycol and stearic acid.  It is typically used in concentrations of 0.5 – 4%.  There is no data available about hazards, carcinogenicity, or mutagenicity. (MSDS)

Glycerin:  Safe!  Glycerin is a humectant that attracts moisture in the hair, if you are ‘glycerin sensitive’ avoid this product.  Glycerine can be derived from fats and oils or synthetically.

Fragrance:  Beware!  Fragrances are often synthetic. They are in moderate concentration in this product, so there may be a greater chance of having an allergic reaction.

Lauryl Methyl Gluceth-10 Hydroxypropyldimonium Chloride:  Avoid!  This ingredient is an ammonium salt used for its humectant and antistatic qualities.  There is no available information available on this ingredient.

Laureth-4:  Beware!  This is a synthetic polymer of lauryl alcohol and polyethylene glycol (PEG).  It is used as surfactant, antistatic agent, emulsifier, and masker.  This ingredient is typically used in concentrations of 1-5%.  It has low toxicity, is not mutagenic is lab animals. (PubChem)

Methylparaben:  Beware!  This ingredient is synthetic and acts as a preservative with anti-fungal properties.  It is naturally occurring in fruits such as blueberries as p-hydroxybenzoic acid.  This ingredient is readily absorbed into skin and it along with other parabens have been at the center of controversy about its role in causing cancerous cells in breast tissue being that parabens are xenoestrogens (mimic estrogen).  There is not conclusive proof that states that use of personal care products containing parabens causes cancer.  Methylparaben is suspected to cause DNA damage and increased skin aging when it reacts to UVB rays.

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)

Propylparaben:  Beware!  Propylparaben is used as an anti-fungal preservative, typically in concentrations less than 1%.  It is commonly synthetically produced though it is produced naturally in fruits as p-hydroxybenzoic acid.  It is readily absorbed into the skin and metabolized, and has been found in urine in limited tests.  This ingredient is readily absorbed into skin and it along with other parabens have been at the center of controversy about its role in causing cancerous cells in breast tissue being that parabens are xenoestrogens (mimic estrogen).  There is not conclusive proof that demonstrates that use of personal care products containing parabens causes cancer.

Tetrasodium EDTA:  Beware!/Avoid!  EDTA is an abbreviation for Ethylenediaminetetraacetic acid.  This ingredient is used as a chelating agent to sequester metal ions and causes them to lose the ability of reacting with other ingredients.  It is also used as a preservative.  It can improve lather and decrease incidence of soap scum.  Tetrasodium EDTA is a penetration enhancer and suspected to be toxic to the upper respiratory tract, skin, and eyes. Target organs are the kidneys and bladder.  This ingredient is toxic to the environment and is a suspected persistent organic pollutant (POP) by the EU.  (MSDS; MSDS)

Mineral Oil:  Beware!  This is a petrochemical typically derived from crude oil.  It can be found in high concentrations (One of the first 5 ingredients, more on this later) in a variety of products.  Mineral Oil prevents moisture from entering or leaving the skin.

Theobroma Cacao (Cocoa) Seed Butter:  Safe!  Derived from the seeds of the Cacao pod, it is used for its emollient and moisturizing properties.

Butyrospermum Parkii (Shea) Butter:  Safe!  This ingredient is derived from the nut of the Shea Tree and is used for its moisturizing properties.

Tocopheryl Acetate:  Safe!/Beware!  Tocopheryl Acetate, a form of Vitamin E, 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.

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

Yellow 10:  Beware!  This ingredient is typically derived from petroleum or coal tar.  It may be contaminated with carcinogens associated with petroleum. Its use is approved by the FDA, there is not information available on teratogenicity, carcinogenicity, mutagenicity, or developmental toxicity, though it is a skin, eye, and inhalation hazard and irritant. (MSDS)

Red 40:  Beware!  Also known as Allura Red AC, CI16035, FD&C Red 40, this ingredient is a synthetic dye used in food and cosmetics.  It is not recommended for use for consumption of children due to a study linking it and other synthetic dyes to hyperactivity and attention deficit hyperactivity disorder.  It is considered safe by the FDA and EU (individual countries have banned its use).  It is not known to be (no data) carcinogenic, teratogenic, or mutagenic, though it is a slight skin, eye, and lung irritant in pure form. (MSDS).

Nature’s Pulchritude Verdict:  Four of the first five ingredients are potentially hazardous.  This is a baby product that has an ingredient fairly high on the ingredient list that can impact the central nervous system and induce vomiting in infants, a warning that was issued by the FDA.  Need I say more?  This product looks worse than some shampoos used on adults.  Additionally, this product is marketed using the moisturizing factors of Cocoa and Shea Butters, being that babies lose moisture in their skin quickly.  Remember what I mentioned about ingredient list and quantity (Tip #1)?  The Cocoa and Shea Butters are 4th and 5th from the bottom, it is unlikely they are providing much “moisture.”  It is also questionable that several of the ingredients in this product had no available information, they could be harmless but they may also be harmful and that is not a change you would want to take with a baby.  On another note, the makers of this product have released a “naturals” version of their baby products, check back in a few weeks to see if it is really a better product.