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Wednesday
Jul202016

FTC Finalizes Crackdown on Four Companies Making False All-Natural Claims

In April, the FTC came to settlement agreements with four companies making allegedly false "All-Natural" claims. On July 13th, Following a public comment period, the Federal Trade Commission has approved four final consent orders against companies that allegedly misrepresented their personal care products as “All-Natural” or “100% Natural,” despite the fact that they contain man-made ingredients.

According to the FTC’s complaints, announced in April 2016, the companies, Trans-India Products, Inc., doing business as ShiKaiErickson Marketing Group, doing business as Rocky Mountain SunscreenABS Consumer Products, LLC, doing business as EDEN BodyWorks, and Beyond Coastal made deceptive all-natural claims in online ads for a variety of products, ranging from sunscreen to shampoo.

Under the final settlements, each of the companies is barred from making similar misrepresentations in the future and must have competent and reliable evidence to substantiate any ingredient-related, environmental, or health claims it makes.

The Commission vote approving the final orders and responses to the public commenters was 3-0. (The staff contact is Robert Frisby, Bureau of Consumer Protection, 202-326-2098.)

The Federal Trade Commission works to promote competition, and protect and educate consumers. You can learn more about consumer topics and file a consumer complaint online or by calling 1-877-FTC-HELP (382-4357).  Like the FTC on Facebook(link is external), follow us on Twitter(link is external), read our blogs and subscribe to press releases for the latest FTC news and resources.

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Tuesday
May312016

Sunscreen Ingredient Alters Genes

A nanoparticle commonly used in food, cosmetics, sunscreen and other products can have subtle effects on the activity of genes expressing enzymes that address oxidative stress inside two types of cells. While the titanium dioxide (TiO2) nanoparticles are considered "non-toxic" because they don't kill cells at low concentrations, these cellular effects could add to concerns about long-term exposure to the nanomaterial.

Researchers at the Georgia Institute of Technology used high-throughput screening techniques to study the effects of titanium dioxide nanoparticles on the expression of 84 genes related to cellular oxidative stress. Their work found that six genes, four of them from a single gene family, were affected by a 24-hour exposure to the nanoparticles.

The effect was seen in two different kinds of cells exposed to the nanoparticles: human HeLa cancer cells commonly used in research, and a line of monkey kidney cells. Polystyrene nanoparticles similar in size and surface electrical charge to the titanium dioxide nanoparticles did not produce a similar effect on gene expression.

"This is important because every standard measure of cell health shows that cells are not affected by these titanium dioxide nanoparticles," said Christine Payne, an associate professor in Georgia Tech's School of Chemistry and Biochemistry. "Our results show that there is a more subtle change in oxidative stress that could be damaging to cells or lead to long-term changes. This suggests that other nanoparticles should be screened for similar low-level effects."

The research was reported online May 6 in the Journal of Physical Chemistry C. The work was supported by the National Institutes of Health (NIH) through the HERCULES Center at Emory University, and by a Vasser Woolley Fellowship.

Titanium dioxide nanoparticles help make powdered donuts white, protect skin from the sun's rays and reflect light in painted surfaces. In concentrations commonly used, they are considered non-toxic, though several other studies have raised concern about potential effects on gene expression that may not directly impact the short-term health of cells.

To determine whether the nanoparticles could affect genes involved in managing oxidative stress in cells, Payne and colleague Melissa Kemp - an associate professor in the Wallace H. Coulter Department of Biomedical Engineering at Georgia Tech and Emory University - designed a study to broadly evaluate the nanoparticle's impact on the two cell lines.

Working with graduate students Sabiha Runa and Dipesh Khanal, they separately incubated HeLa cells and monkey kidney cells with titanium oxide at levels 100 times less than the minimum concentration known to initiate effects on cell health. After incubating the cells for 24 hours with the TiO2, the cells were lysed and their contents analyzed using both PCR and Western Blot techniques to study the expression of 84 genes associated with the cells' ability to address oxidative processes.

Payne and Kemp were surprised to find changes in the expression of six genes, including four from the peroxiredoxin family of enzymes that helps cells degrade hydrogen peroxide, a byproduct of cellular oxidation processes. Too much hydrogen peroxide can create oxidative stress which can damage DNA and other molecules.

The effect measured was significant - changes of about 50 percent in enzyme expression compared to cells that had not been incubated with nanoparticles. The tests were conducted in triplicate and produced similar results each time.

"One thing that was really surprising was that this whole family of proteins was affected, though some were up-regulated and some were down-regulated," Kemp said. "These were all related proteins, so the question is why they would respond differently to the presence of the nanoparticles."

The researchers aren't sure how the nanoparticles bind with the cells, but they suspect it may involve the protein corona that surrounds the particles. The corona is made up of serum proteins that normally serve as food for the cells, but adsorb to the nanoparticles in the culture medium. The corona proteins have a protective effect on the cells, but may also serve as a way for the nanoparticles to bind to cell receptors.

Titanium dioxide is well known for its photo-catalytic effects under ultraviolet light, but the researchers don't think that's in play here because their culturing was done in ambient light - or in the dark. The individual nanoparticles had diameters of about 21 nanometers, but in cell culture formed much larger aggregates.

In future work, Payne and Kemp hope to learn more about the interaction, including where the enzyme-producing proteins are located in the cells. For that, they may use HyPer-Tau, a reporter protein they developed to track the location of hydrogen peroxide within cells.

The research suggests a re-evaluation may be necessary for other nanoparticles that could create subtle effects even though they've been deemed safe.

"Earlier work had suggested that nanoparticles can lead to oxidative stress, but nobody had really looked at this level and at so many different proteins at the same time," Payne said. "Our research looked at such low concentrations that it does raise questions about what else might be affected. We looked specifically at oxidative stress, but there may be other genes that are affected, too."

Those subtle differences may matter when they're added to other factors.

"Oxidative stress is implicated in all kinds of inflammatory and immune responses," Kemp noted. "While the titanium dioxide alone may just be modulating the expression levels of this family of proteins, if that is happening at the same time you have other types of oxidative stress for different reasons, then you may have a cumulative effect."

Thursday
May192016

Study: Triclosan Alters Gut Bacteria

Scientists from Oregon State University say that triclosan, an antibacterial agent found in many products ranging from hand soaps to toys and even toothpaste, can rapidly disrupt bacteria found in the gut.

In the new study, researchers found that triclosan exposure caused rapid changes in both the diversity and composition of the microbiome in the laboratory animals. It's not clear what the implication may be for animal or human health, but scientists believe that compromising of the bacteria in the intestinal tract may contribute to the development or severity of disease.

"There has been a legacy of concern about exposure to microbial pathogens, which has led to increased use of these antimicrobial products," said Thomas Sharpton, an assistant professor of microbiology and statistics in the OSU Colleges of Science and Agricultural Sciences, and corresponding author on the new study.

"However, there's now a growing awareness of the importance of the bacteria in our gut microbiome for human health, and the overuse of antibiotics that can lead to the rise of 'superbugs.' There are consequences to constantly trying to kill the bacteria in the world around us, aspects we're just beginning to understand."

Some bacteria were more susceptible to the impact of triclosan than others, such as the family Enterobacteriaceae; and others were more resilient, such as the genus Pseudomonas.

Triclosan was first used as a hospital scrub in the 1970s and now is one of the most common antimicrobial agents in the world, found in shampoos, deodorants, toothpastes, mouth washes, kitchen utensils, cutting boards, toys, bedding, socks and trash bags. It continues to be used in medical settings, and can be easily absorbed through the skin.

"Clearly there may be situations where antibacterial agents are needed," said Christopher Gaulke, lead author on the study and a postdoctoral microbiology researcher in the OSU College of Science.

"However, scientists now have evidence that intestinal bacteria may have metabolic, cardiovascular, autoimmune and neurological impacts, and concerns about overuse of these agents are valid. Cumulative impacts are also possible. We need to do significantly more evaluation of their effects, some of which might be dramatic and long lasting."

The gut-associated microbiome performs vital functions for human health, prevents colonization with pathogens, stimulates the development of the immune system, and produces micronutrients needed by the host. Dysfunction of this microbiome has been associated with human disease, including diabetes, heart disease, arthritis and malnutrition, the scientists pointed out in their study.

Humans are routinely exposed to an array of chemicals, metals, preservatives, microbes and nutrients, some of which may be beneficial, some innocuous, and others harmful, the researchers said. Part of the strength of the present study is developing improved ways, through rapid screening of zebrafish, to more easily determine which compounds may be acceptable and which are toxic, scientists say.

Triclosan has been a concern in part because it is so widely used, and it's also readily absorbed through the skin and gastrointestinal tracts, showing up in urine, feces and breast milk. It also has been associated with endocrine disruption in fish and rats, may act as a liver tumor promoter, and can alter inflammatory responses.

This study showed it was quickly associated with shifts in the microbial community structure and can alter the abundance of specific taxa.

Collaborators on this research included scientists from the OSU Environmental Health Sciences Center and OSU College of Agricultural Sciences.

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Wednesday
May042016

New Study Finds Parabens Can Harm Fetus

A study led by SUNY Downstate Medical Center's School of Public Health says that using personal care products with parabens during pregnancy may lead to adverse effects in newborns.

"The study found a link between women with higher levels of butyl paraben, which is commonly used as a preservative in cosmetics, and the following birth outcomes: shorter gestational age at birth, decreased birth weight, and increased odds of preterm birth," says Laura Geer, PhD, MHS, associate professor in the Department of Environmental and Occupational Health Sciences in the School of Public Health at SUNY Downstate.

The antimicrobial compound, triclocarban, mainly added to soaps, was associated with shorter gestational age at birth. Another common chemical added to lotions and creams, propyl paraben, was associated with decreased body length at birth. The long-term consequences of this are not clear, and, Geer adds, "Findings must be reproduced in larger studies."

The study was a collaboration with SUNY Downstate's Department of Obstetrics and Gynecology, and the Center for Environmental Security at Arizona State University's Biodesign Institute, directed by professor Rolf Halden, PhD, a noted expert in the study of antimicrobial chemicals. The findings are available online and will be published in a Special Issue "Emerging Contaminants" in the Journal of Hazardous Materials.

Dr. Geer says, "Our latest study adds to the growing body of evidence showing that endocrine-disrupting compounds can lead to developmental and reproductive problems in animals and in humans. Effects observed in previous studies mainly came from animal models only."

This study presents evidence of potentially adverse impacts in humans. Larger follow-up studies to confirm these findings are warranted. Geer suggests, "Based on this new evidence, the safety of use of these chemicals in our consumer products should be reassessed."

Regulations requiring removal of triclosan from various consumer care products have been in place since 2015 in the European Union, but broader regulatory action by the U.S. Food and Drug Administration and the U.S. Environmental Protection Agency has not ensued. Various U.S. manufacturers have pledged to voluntarily remove triclosan from various hygiene-related products, while the state of Minnesota has passed a ban on use of triclosan in sanitizing or hand and body cleaning products beginning in 2017.

Dr. Geer concludes, "Our study provides further evidence of the importance of assessing the risks of having these additional chemicals in our consumer products. While small-scale changes in birth size may not be of clinical relevance or cause for concern in individual cases, subtle shifts in birth size or timing at the population-level would have major impacts on the risk for adverse birth outcomes."

Monday
Apr252016

New Study Finds Laundry Detergent Packets are Most Toxic

A new study conducted by the Center for Injury Research and Policy of the Research Institute at Nationwide Children's Hospital and the Central Ohio Poison Center found that exposure to laundry detergent packets is more dangerous to young children than exposure to other types of laundry and dishwasher detergent.

The study, published online today in Pediatrics, found that from January 2013 through December 2014 Poison Control Centers in the U.S. received 62,254 calls related to laundry and dishwasher detergent exposures among children younger than 6 years old. The study included calls about both traditional detergent and detergent packets and found that detergent packets accounted for 60 percent of all calls. Almost half (45 percent) of the calls for exposure to laundry detergent packets were referred to a health care facility for evaluation and treatment, significantly more than calls related to exposures to traditional laundry detergent (17 percent), traditional dishwasher detergent (four percent), or dishwasher detergent packets (five percent).

Incidents related to laundry detergent packets saw the biggest rise - increasing 17 percent over the two year study period. Poison control centers received more than 30 calls a day about children who had been exposed to a laundry detergent packet, which is about one call every 45 minutes.

In addition, the most serious clinical effects such as coma, trouble breathing, heart problems, and death, were only seen in children exposed to the chemicals in laundry detergent packets. The risks of having a clinical effect, a serious medical outcome, hospitalization, or intubation were significantly higher for children who had been exposed to the chemicals in a laundry detergent packet than for those exposed to any other type of laundry or dishwasher detergent. At least one child a day in the U.S. was admitted to the hospital due to a laundry detergent packet exposure. The two child deaths in this study were both associated with exposure to laundry detergent packets.

In an effort to reduce unintentional exposures to the contents of laundry detergent packets, ASTM published a voluntary Standard Safety Specification for Liquid Laundry Packets in 2015, but some experts feel it did not go far enough.

"This voluntary standard is a good first step, but it needs to be strengthened," said Gary Smith, MD, DrPH, the senior author of the study and director of the Center for Injury Research and Policy at Nationwide Children's Hospital. "Unless this unacceptably high number of exposures declines dramatically, manufacturers need to continue to find ways to make this product and its packaging safer for children."

Experts recommend that families with children younger than 6 years old use traditional detergent instead of packets. "Many families don't realize how toxic these highly concentrated laundry detergent packets are," says Marcel J. Casavant, MD a co-author of the study, chief of toxicology at Nationwide Children's Hospital and medical director of the Central Ohio Poison Center. "Use traditional laundry detergent when you have young kids in your home. It isn't worth the risk when there is a safer and effective alternative available."

Parents and child caregivers can help children stay safer by following these tips: 

  • People who have young children that live in or visit their home should use traditional laundry detergent, which is much less toxic than laundry detergent packets.
  • Store all laundry detergent including packets up, away, and out of sight - in a locked cabinet is best for laundry packets.
  • Close laundry detergent packet packages or containers and put them away immediately after use.
  • Save the national Poison Help Line number (1-800-222-1222) in your cell phone and post it near your home phones.