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Schoon Scientific and Regulatory Consulting for Beauty, Cosmetic and Personal Care product companies

 

 

News Briefs and information on Beauty, Cosmetic and Personal Care product industry related topics.

News BriefsUpdated: June 12, 2010

 
Top News Stories for 2009-2010 — In addition to the latest news briefs presented on this page, Doug Schoon has also compiled the most important cosmetic and personal care news stories of 2009-2010.  
Click here to view the top news stories for 2009-2010top news stories
 

MAY 2010

FDA Cracks Down on False Medicinal Claims
Regarding Bee Byproducts

The US Food and Drug Administration (FDA) conducted a raid on Wisconsin-based Beehive Botanicals, Inc., confiscating creams, capsules, tablets, gums, throat sprays and shampoos. The FDA stated that Beehive Botanicals is misrepresenting their bee byproducts (e.g. propolis) by using unapproved and unfounded medical claims on their website and in marketing materials. The company wrongly claimed that bee byproducts can cure or prevent diseases such as asthma, dermatitis, ulcers, cancer, kidney disease, bone fractures and insomnia.

Source: www.startribune.com
 

Consumer Product Safety Information Database

The Consumer Product Safety Commission (CPSC) proposes to establish a publicly available database where consumers can find product safety information. The proposed database would allow product users to submit reports of harm or injury and that information will be provided to product manufacturers. Although well intended, much needs to be considered, such as confidentiality issues, how to deal in accurate reports/information, etc. The CPSC is accepting written comments until July 23, 2010. You can see a summary of the work by clicking on the link below and looking under "Federal Register Notices".

Source: www.cpsc.gov
 

APRIL 2010

FDA Comments on Triclosan Concerns

Responding to an inquiry by Rep. Edward Markey of Massachusetts, The US Food and Drug Administration (FDA) has commented on the concerns related to the use of "triclosan" in antibacterial soaps, toothpastes, body washes and other personal care products. The FDA stated that based on existing scientific evidence, there is no need to change consumer use of products containing triclosan. The FDA found that triclosan provides a clear benefit, but believe it's still an open question as to whether this ingredient provides any significant benefits over washing with regular soap and water. To see the entire FDA statement, click on the link below. The second link leads to another FDA document "Triclosan: What Consumers Should Know."

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/
 
http://www.fda.gov/ForConsumers/ConsumerUpdates/
 

MARCH 2010

USDA and FDA both Confirm that Cosmetics Made with
“Organic” Ingredients are no Safer

Since the beginning of the United States "National Organic Program" the agency heading up this program, the United States Department Of Agriculture (USDA), has stated that "organic" is a lifestyle preference, not an indication of safety. Neither organic foods nor organic cosmetics/personal care products are any safer than those not making this claim. This month, the FDA chimed in with their thoughts on whether or not organic ingredients are any safer, "No. An ingredient source does not determine its safety; for example, many plants, whether or not they are organically grown, contain substances that may be toxic or allergenic... All cosmetic products and ingredients are subject to the same safety requirement: They must be safe for consumers under label or customary conditions of use. Companies and individuals who market cosmetics have a legal responsibility to ensure that their products and ingredients are safe for the intended use."

For the FDA's Complete Statement on "Organic Cosmetics" see the link below.
www.fda.gov
 

FEBRUARY 2010

Colorado Says “No Way” to Silly Cosmetic Regulation

In February, following the urging of irresponsible fear-based advocacy groups such as the EWG, two naive and uninformed democratic legislators from Colorado were duped into proposing an amazingly silly regulation that would have completely shut down sales of all cosmetics and personal care products in the state. Under the proposed law, any product containing even one molecule of a "toxic substance" would not be allowed on Colorado store shelves. But wait, don't "natural ingredients" also contain traces of toxic substances? Yes, they do!

Nature is a dangerous place filled with many types of naturally occurring poisons and toxins, so NO cosmetic product on the planet is 100% free of potentially toxic substances. Of course, our bodies detoxify these natural toxins quite easily, as long as their concentrations remain low and within safe levels. Fortunately, others in Colorado have more sense than Rep. Diane Primavera and Sen. Betty Boyd and the bill was flat-out rejected. With luck, the voters of Colorado will remember this waste of time and tax payer dollars on election day.

Source: www.cosmeticsandtoiletries.com
 

JANUARY 2010

Paraben Free Claims Could Backfire on the
Personal Care/Cosmetic Industry

Many companies have been quick to jump on the "free from" bandwagon, especially where arabens are concerned, fueling irrational fears that such ingredients should be avoided. Large companies such as Beirsdorf and the other major players are offering a number of "araben-free" products, even though these companies offer other product lines that are not paraben-free. How's that supposed to work? The article referenced below hypothesizes that a tipping point may be reached whereby industry would be forced to vigorously defend ingredients even though they are backed by a large body of scientific evidence supporting safe use at specific concentrations. The public is being trained by fear-based advocacy groups to believe that one or two weak or inconclusive studies claiming an ingredient is unsafe outweighs strong evidence for safety. Personally, I think that day may be just around the corner!

Source: www.cosmeticsdesign.com
 

Newest Data on Parabens Suggest No Adverse
Hormonal Effect on the Body

A new study performed at the request of the EU Scientific Committee on Consumer Safety (SCCS) show that parabens are only partially absorbed after dermal exposure and also strongly suggests they are fully metabolize before they can enter the bloodstream. The metabolite PHBA (para-hydroxybenzoic acid) was found in the bloodstream, but no concentrations of parabens were measured. Since PHBA is not known to have any estrogenic effects and is found widely in plants and human food, these trace exposures in humans pose no health risk.  click to read more of this article

“The study confirms the results of a number of other research studies, which concluded from their work that parabens are metabolized rapidly and to a large extent in living organisms and therefore cannot exhibit any adverse effects," states the industry trade group COLIPA.

For several years, some consumer advocacy groups have distorted information to aggressively attack paraben preservatives just to create fear in the minds of consumers. Scientists who have reviewed the latest data believe it will convince the SCCS of the safety for these important ingredients.

Source: www.CosmeticsDesign.com
 

DECEMBER 2009

Cancer Rates Continue to Fall in the US

Cancer diagnosis and deaths continued to decline in the US according to the latest available data States a recent report from the National Cancer Institute. New diagnosis for all types of cancers has fallen on average about 1% each year between 1999 and 2006.

This information flies in the face of scare mongering claims made by consumer advocacy groups who want us to believe that increased use of cosmetics and personal care products are causing more cancers. These fear based activist groups continue to use such erroneous claims to needlessly frighten the public and raise unfair and unwarranted concerns. Both the US FDA and Health Canada have publicly stated that cosmetics are among the safest product categories under their regulation and neither have expressed concerns that cosmetics or personal care products are contributing to an increase in cancer in humans.

Source: The Wall Street Journal (December 8, 2009)
 

USDA has No Plans to Crackdown on
Use of the Term “Organic”

In a recent press release, the Organic Consumers Association (OCA) erroneously claimed that the USDA is about to crackdown on the misuse of the word "organic" for personal-care and cosmetic products. According to industry experts, this is not likely to occur in the foreseeable future. When asked if a crackdown was imminent, National Organic Standards Board (NOSB) member Joe Smille admitted that he did not think a crackdown was imminent. The results of the most recent NOSB meeting can be found in the November 2009 new release (below), “National Organic Standards Board Powerless to Enforce Organic Standards on Cosmetics.”  click to read more of this article

This is not the first time the OCA has reported incorrect information in relation to the issue. It appears that the OCA may be intentionally providing misinformation to consumers in hopes of furthering their own agenda to force USDA organic agriculture/food regulations upon the cosmetic industry, even though these regulations are not appropriate for cosmetic or personal care products.  Schoon Scientific believes this association is an unreliable source of factual information.

Source: www.CosmeticDesigns.com
 

NOVEMBER 2009

National Organic Standards Board Powerless
to Enforce Organic Standards on Cosmetics

At the NOSB semi-annual meeting in November it was “recommended” that the Secretary of Agriculture enact a regulation extending the NOP to personal-care products. To date the law has not changed: for personal-care products NOP compliance remains “voluntary” and the NOSB does not have the authority to enact regulations.  click to read more of this article

Should the Secretary accept the NOSB recommendation, any draft regulation must go through a public comment period. At the NOSB meeting the Deputy Administrator from the Department of Agriculture National Organics Program expressed reservation about the Department's authority to adopt the NOSB recommendation and added that moving forward with regulation would not be a high government priority.

If the NOP were about to adopt a standard for personal care products, it likely would not follow the food standard, since that would make no sense. Schoon Scientific believes that trying to force the food standard on cosmetics is the reason for all the confusion. It makes no sense to do this and those that are pushing for this are mostly marketers who want to dupe the public into thinking their products are safer than their competitors.

The USDA has clearly and repeatedly stated that “Organic” doesn’t mean safer, better or higher quality... it is simply a preference.

Source: www.ams.usda.gov
 

OCTOBER 2009

FDA Claims Popular Eyelash Growth Product is a Drug,
Not a Cosmetic

The FDA sent a letter to Allergan expressing concerns that the eyelash growth drug Latisse is being incorrectly promoted as a cosmetic product. The active ingredient, bimatoprost, clearly affects the structure and function of the body and is therefore not a cosmetic, according to the FDA definition of a cosmetic product. Interestingly, Allergan had been involved in a lawsuit against Jan Marini Skin Research to force them to discontinue selling a cosmetic product that utilizes this ingredient. Allergan has also received the more severe FDA warning for inappropriate promotion of their acne medication “Aczone”. The FDA claims that the study cited by Allergan is a "complete misrepresentation” of the results. Allergan, which has a track record of innovative promotional ploys, has drawn the attention of the FDA and is apparently under heightened scrutiny due to repeated problems in this area. Allergan claims they are working closely with the FDA to address all of their concerns.

Source: MSNBC.com
 

SEPTEMBER 2009

FDA Study Confirms Traces of Lead in Lipstick
Is Not a Safety Concern

A report released by the Campaign for Safe Cosmetics (CSC) consumer advocacy group has needlessly alarmed consumers by raising irrational fears that many popular lipstick products contain dangerous levels of lead. FDA scientists tested the same selection of lipsticks evaluated by the CSC and have determined that the lead levels present are safe and well below limits recommended by other public health authorities. The FDA found that lipsticks tested had average levels of 1.07 ppm or 0.001%.
click to read more of this article

Since lead is a naturally occurring substance found throughout nature, it would be practically impossible to completely eliminate all traces of lead and it's not at all surprising to find trace levels that are far lower than what occur in normal drinking water. California’s has set the most stringent levels for lead in the US and it allows up to 5 ppm in cosmetics. The FDA concluded that the lead levels are within The range that would be expected from lipsticks formulated with permitted and approved color additives.

This is not the first time the Campaign for Safe Cosmetics has issued dire and unfounded warnings concerning cosmetic products. Even now, they continue to demand that the FDA require lipstick to be 100% lead free. In the opinion of Schoon Scientific, this consumer advocacy group has repeatedly distorted information to needlessly frighten and alarm consumers, and they should not be considered as a credible source of information.

Source: www.fda.gov

For credible information about lead in lipstick or lipstick ingredients see: www.cosmeticsinfo.org
 

AUGUST 2009

New FDA Regulations Require Companies to Respond to
Inspection Violations Within 15 Days

Manufacturers now have 15 days to respond to inspection reports to avoid an FDA warning letter. The change is intended to help the agency be more effective in protecting the public and may help to weed out bad actors from legitimate industry. According to the FDA, warning letters will also be sent out in a more efficient fashion, since they no longer require clearance by the Office of Chief Council, unless there are “significant legal issues.” The FDA will no longer issue multiple warning letters to noncompliant firms before taking more significant actions according to FDA Commissioner Margaret Hamburg, and the FDA may move immediately without issuing formal warning letters. If there are "significant health concerns or egregious violations" that pose "an immediate threat to health."

Source: www.theRoseSheet.com (Aug. 24, 2009)
 

Canada Reclassifies Antiperspirants as Cosmetics

Health Canada no longer considers aluminum or zirconium base antiperspirants as drugs under new regulations. Canada has determined that these products mode of action is "mechanical in nature" and does not correct, change or modify natural body functions. However, antiperspirants designed to reduce hyperhidrosis (overproduction of sweat) or claim to protect for more than 24 hours will continue to be classified as drugs. Marketing claims have also been modified and certain phrases such as "stops or prevents perspiration” or even "helps keep you dry”, will no longer be allowed. Companies have a grace period of six months to create and implement new cosmetic labels and a one-year grace period to deplete existing stocks. For more information, click on the link below.

Source: www.hc-sc.gc.ca
 

JULY 2009

Bogus Study Tricks Media and Frightens Consumers

In recent decades periodic, unverified reports of a worldwide decline in sperm count/quality and increases in testicular cancer have been blamed on ingredients found in plastics, cosmetics and children's toys. A 2005 study performed by Dr. Shanna Swan loudly proclaimed that hormone disrupting ingredients in plastics, cosmetics and children's toys known as “phthalates” were causing baby boys to develop abnormally smaller penises (hypospadias). Dr. Swan’s so-called “study” utilized previously unknown test methods which have never been validated by the medical community or other scientists. Consumer advocacy groups pounced upon this single study, and offered it as proof that “phthalates are poisoning us”. The news media gave widespread attention to the Swan study treating it as if it were a valid and substantiated scientific report, when in fact it was neither.
click to read more of this article

Now a major new study of children in New York State by researchers at the New York Presbyterian Hospital, Columbia University Medical Center looked into this issue to determine if hypospadias rates have actually increased. What were the results?

“Hypospadias rates have not changed in New York State from 1992 to 2005. Combined with previous studies that demonstrate sperm counts are not declining, these data suggest that testicular dysgenesis syndrome… may not be evident in humans”

In other words, Dr. Swan and the consumer advocacy groups were totally wrong and neither penis size or sperm counts are declining, nor is there evidence that plastic or cosmetic ingredients are responsible for such effects. Despite the hundreds of the news stories generated by Dr. Swan's original and incorrect report that genital deformities may be caused by phthalates in cosmetics and plastic toys, to date not a single mainstream media publication has reported this new information. Schoon Scientific wonders why, and so should you.

Source: www.eurekalert.org
 

JUNE 2009

Are Chemicals Killing Us?
Toxicologists Believe Media Overstates Risks

Can you believe the news media when they tell us that every day we are being poisoned by chemicals we routinely used to improve our lives? No we can't, according to a survey of 937 members of the Society of Toxicology (SOT). This survey of toxicology professionals found that the public doesn't get a full and balanced picture of chemical risks. For instance, these knowledgeable experts overwhelmingly reject the notion that exposure to even the smallest amounts of harmful chemicals is dangerous or that the detection of any level of a chemical in your body indicates a significant health risk. And they are nearly unanimous in rejecting the notion that “organic” or “natural” products are inherently safer than others. Here are some other interesting facts that came out of this survey.  click to read more of this article

  • 74% believe that cosmetics do not pose a significant health risk.
  • 90% believe “organic or natural” products are NOT inherently safer.
  • Only 77% believe the US regulatory system is NOT inferior to Europe's.
  • 89% do NOT believe that “phthalates” are a high risk.
  • 97% think “Teflon” should NOT be rated as a high risk.
  • 91% believe “biphenol A” (BPA) should NOT be rated as a high risk.
  • 97% feel “parabens” should NOT be rated as a high risk.
  • 96% believe “triclosan” should NOT be rated as a high risk.
  • Only 14% rate “formaldehyde gas” as a high risk.
  • Only 6% believe that any exposure to harmful chemical is unacceptable.
  • 96% say that Greenpeace overstates the health risk of chemicals.
  • 80% said the Environmental Defense Fund overstates chemical risk.
  • 79% say the Environmental Working Group (EWG) overstates risks.
  • 80% say PETA overstates risks.
  • 90% say media coverage of risks lacks balance and diversity.
  • 74% believe the news media pays too much attention to individual studies rather than examining the overall evidence.
  • 73% believe the media pays too much attention to individual scientists rather than what the scientific community believes as a whole.
  • 68% believe the news media pays too much attention to studies put out by environmental groups.
  • 80% believe that leading national newspapers, magazines and television networks overstate chemical risk.
  • 97% say the media doesn't distinguish between good studies and bad studies.
  • WebMD is the only news source rated as accurate by the majority of toxicologist.

What’s the take-home message? “Lousy studies make the news” according to one of the authors. Don’t rely on activists or the media to tell the truth about chemical risks. Schoon Scientific believes that consumer advocacy groups and news media are doing a very poor job and NOT providing the public with truthful information, but instead are exaggerating and distorting supposed chemical dangers and causing irrational fear, confusion and unfounded concerns. Click on the link below and download the pdf file to see more eye-opening statistics.

Source: stats.org

Report PDF file: http://stats.org/stories/2009/Survey_7.09.pdf
 

 

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