And the multi-million dollar Sinkie Health MinStars did not know that? Which party are they from? 
Colgate Total Ingredient Linked to Hormones, Cancer Spotlights FDA Process
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.
...................
...................
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.
.......................
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.
.............................
Full article here:
http://www.bloomberg.com/news/2014-08-11/in-35-pages-buried-at-fda-worries-over-colgate-s-total.html
Colgate Total Ingredient Linked to Hormones, Cancer Spotlights FDA Process
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.
...................
...................
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.
.......................
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.
.............................
Full article here:
http://www.bloomberg.com/news/2014-08-11/in-35-pages-buried-at-fda-worries-over-colgate-s-total.html
