FDA Cosmetics Alert!
Warning letter sent to many major cosmetics manufacturers
From the FDA: (verbatim)
Import Alert Name:
"Skin Care Products Labeled As Anti-Aging Creams"
Import Alert # 66-38
Published Date: 03/27/2012
Type: DWPE with Surveillance
Import Alert Name:
"Skin Care Products Labeled As Anti-Aging Creams"
There are numerous skin care products on the market with exaggerated "anti aging" claims which cause the products to be unapproved new drugs. Examples of such claims are that the products "counteract," "retard," or "control" the aging process. Claims that the product will "rejuvenate," "repair," or "restructure" the skin may also be drug claims. A claim such as "molecules absorb and expand, exerting upward pressure to 'lift' wrinkles upward" is a claim for an inner structural change that would usually cause a product to be a drug
By letter of March 24, 1988, the Associate Commissioner for Regulatory Affairs informed these manufacturers that "Beginning 30 days after the date of this letter, any products found to be in substantial violation of the new drug and misbranding provisions of the act may be subject to regulatory action without prior notice.
"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug without an effective new drug application (NDA) as required by Section 505(a)."
OASIS Charge Code - UNAPPROVED"
Are we being sold snake oil?
Almost every major manufacturer of cosmetics is on this FDA’s “ yellow alert” letter, which is the FDA’s way of letting them know “we’re watching you”. The reason? Claims that their products “rejuvenate” “repair” or “restructure” the skin which are normally reserved for drugs, not cosmetics. Some of these problems go back as far as 1988, yet the Commissioner for Regulatory Affairs has been wrestling with these manufacturers to stop making these claims or they may be “subject to regulatory action”.
Who’s on the list of for what products? Companies from all over the United States are, well known companies like Coty, Estee Lauder, Christian Dior, Helena Rubenstien, Avon, Almay and others that you see on virtually every cosmetics counter in Every Town, USA. But other brands are there too. Imports from all over the world; China, Italy, Spain, you name it, are on this very extensive yellow alert list, too.
If you’re a spa or resort owner, you may want to contact the brands you carry to find out which products are being targeted by the FDA for this action.
A list of the major brands follows. The full report is here:
Coty Co. and
Coty US LLC
Neyda E Avila
Noblesse Intl Ltd
Rachel Perry Inc
Revlon, Inc and
Revlon Intl Inc
Shiseido Cosmetics America
Skin Culture Institute Inc
Swiss Skin Care Inc
The Hain Celestial Group
Yves Rocher USA Inc
|BRAZIL: Claude Bergere Cosmeticos
CANADA: C. E. Jamieson & Co. LTD
Nutra Reaserch Intl’l
SRL/ Skin Research
FRANCE: Arnaud Laboratories
Clarins, NOTES: Facial CREAM
GERMANY: Helena Rubinstein, Inc.
Mother Nature is a mysterious being! She’s invented a wonderful and beautiful plant that may someday easily, and without much fuss, cure skin cancer. No kidding.
At a time when more and more people are being affected, and yes, dying of skin cancer, I can’t believe we aren’t all slathering are bodies with this wonderful plant and anything made out of it, in the hopes that it just might help stop or reverse the damage the sun is doing to our dermis. Here’s what we know so far:
Calendula is high in antioxidants, fights inflammation, had been used to fight skin tumor growth, and has been used effectively to assist breast cancer patients.
Calendula has high amounts of flavonoids, plant-based antioxidants that protect cells from being damaged by unstable molecules called free radicals. Free radicals damage DNA by interfering with the proper replication of cells. Bad replication leads to errors. Your “copied” DNA is reproduced with an error, much like a bad photocopy that just keeps getting worse as you copy it over and over.
Calendula appears to fight inflammation, viruses, and bacteria. Calendula has been shown to help wounds heal faster, possibly by increasing blood flow and oxygen to the affected area, which helps the body grow new tissue. Plant pharmacological studies have suggested that Calendula extracts have anti-viral, anti-genotoxic, and anti-inflammatory properties in vitro. Calendula in suspension or in tincture is used topically for acne, reducing inflammation, and soothing irritated tissue.
The dried petals of the calendula plant are used in tinctures, ointments, and washes to treat burns, bruises, and cuts, as well as the minor infections they cause.
Calendula also has been shown to help prevent dermatitis or skin inflammation in breast cancer patients during radiation therapy. Breast cancer patients are susceptible to a particular kind of dermatitis. A researcher has found calendula helpful in treating these patients. (If you like to review the research on these topics yourself, I’ve listed my sources at the end of this blog entry.)
Now, here is where calendula research gets really juicy! Studies have shown calendula to be effective in retarding the growth of skin cancer skills treated topically, although no studies have shown a reversal in skin cancer cells. Read that again – calendula has been shown to slow or stop the growth of skin cancer cells when treated topically. That means, simply applied to the skin. Do you know how incredible that is? This study found that calendula had a cytotoxic effect on skin cancer. A cytotoxic agent is toxic to tumors in laboratory cultures.
A comfortable position is that calendula, which is generally a nontoxic substance to humans and can be ingested, should be considered by all organic body product technicians, and by all body product consumers, as a seriously positive ingredient additive to topical products – soaps, creams, lotions, shampoos and the like.
My recommendation is to target your product matching areas of your body that are exposed to the sun the most – head, face, shoulders and hands. You’ll notice that this is the area that most often experiences sun damage, sometimes visible, sometimes not.
Organic Soap and Spa will be introducing some new products at the International Esthetics Cosmetics Show and Conference in Las Vegas in June that add calendula to it’s formulas – Lavender Calendula Shampoo - available only in salons and retail stores; and Ayurvedic mud soap with ground calendula.
Here’s to your skin health!
Sources: "Phase III randomized trial of Calendula officinalis compared with trolamine for the prevention of acute dermatitis during irradiation for breast cancer". J Clin Oncol.;():1447-53 22 (8): 1447–53. 2004-04-15
Bolderston A, LLoyd NS, Wong RK et al. (2006). The prevention and management of acute skin reactions related to radiation therapy: a systematic review and practice guideline. Support Care Cancer. 14:802-817
Jimenez-Medina E, Garcia-Lora A, Paco L et al. (2006). A new extract of the plant Calendula officinalis produces a dual in vitro effect: cytotoxic anti-tumor activity and lymphocyte activation. BMC Cancer. 6:6.
Ukiya M, Akihisa T, Yasukawa K et al. Anti-inflammatory, anti-tumor-promoting, and cytotoxic activities of constituents of pot marigold (Calendula officinalis) flowers. (2006). J Nat Prod. 69:1692-1696.
I DO A LOT OF RESEARCH
reading blogs, technical documents and yes, medical research. I love the blogs the most. I reach out to bloggers, sometimes I tweet, although we have someone who's job it is to do that. I like the one-on-one it provides. I have in my mind a pyramid of knowledge and assumptions:
pure research - KNOWLEDGE
technical documents - KNOWLEDGE+ assumptions
articles - KNOWLEDGE+ASSUMPTIONS
blog posts - knowledge +ASSUMPTIONS
hmmm.... do you see the problem?
Here are some disturbing things I've read from bloggers that I really like!
- "Rosemary must a be a "BAD" ingredient because most major shampoos don't have it"
- Alpha Hydroxy Acids are to be avoided (huh?)
- If you don't like how a product works it's because you're using it wrong
- WEN is a completely organic shampoo
Rosemary is expensive, so it should not surprise you that mass produced shampoos don't have it. Interestingly, rosemary has been used as a hair restorative, or "hair tonic" since the Roman times, and there are a few small studies that look very promising using Rosemary and Lavender that have stimulated hair regrowth, but further studies need to be done to prove it's efficacy. Bad? Far from it. It's antifungal, antibacterial, and mops up free radicals on your skin and scalp. You do need to use a product 3 days in a row to see clinical benefits according to most studies. Products that we sell that have it can be found HERE!
Alpha Hydoxy Acids are great naturally occuring acids that can be useful in loosening dried, dead, and damaged skin cells, revealing beautiful new skin cells hiding below. Who wouldn't want that? There is so much research about Alpha Hydroxy Acids - you can search for yourself if you like. They are found in fruits ranging from apples to lemons and are found in products like facial soaps, scrubs and peels. Some products that we sell that have the most of these great natural acids can be found HERE!
Several bloggers have written about a product that requires, shall I say, an UNUSUAL routine of counting, dividing, and pumping, and waiting, etc, that sometimes disapoints. The blogger may love the product, but I can never side with a product that blames the consumer for failing them. If you have to blame your consumer, then your product is unusally complex and you didn't explain it well. Shame on your company. I even SUSPECT that these are company PLANTS, not actual bloggers...
Now I don't like pinpointing any particular brand, but WEN is a marketing gorilla! Cudos to them! However, WEN is not a certified organic product, folks. A lot of people still think Aveda is a completely organic product, Aveda shampoo contains a harmful engine degreaser SLS, and they both use chemical preservatives not allowed by the USDA for organic products. Like our products, WEN does not contain SLS, and that is a big step in the right direction. However - Gather around, this is still a secret - we've got a BRAND NEW PRODUCT LINE that is 100% PURE! Not mostly PURE - but PURELY ORGANIC!
We are currently working with a USDA certification team to make sure our ingredients are SOOO luscious they are nearly FOOD! I know you'll love them.
LOOD FOR THEM at LAS VEGAS, IESCS, JUNE 9 - 12th!
So many folks post things based on fear or assumptions, not facts, so be careful out there!
If you would like to join us in LAS VEGAS, and get some incredible, personalized SWAG, Click HERE Mention IECSC in the NOTES Field!
Previous NOTES Entry:
Our customers are awesome. You
come in to the store, call our 800 number (888.327.4137)
or order online and you give us great feedback on Twitter and on Facebook.
When you walk into an Organic Soap and Spa store, we
greet you like this:
“Welcome! Have you ever been in our
store before? Just so you know, all of our
products are 85 – 100% organic. We don’t use dyes,
perfumes, sulfates, SLS, parabens, waxes, harmful
chemicals or preservatives. Let us know how we can
help you today!” And then we pretty much leave our
customers to browse and enjoy the experience.
(More on that in another entry!)
Many people have questions, comments or
express their concerns at this point. Because we
have an extensive training program, we love to share our
experiences and research sources. While browsing
the Organic Consumers Association website (http://www.organicconsumers.org/),
I came across a repost of Ronnie Cummins’ Huffington
Post article: Top 10 Reasons to Use Organic
Cosmetics, from August 12, 2010. I think this
article is great, but to me, it doesn’t explain the why behind these facts. Maybe
Ronnie didn’t have the luxury of space that I do, so I’d
like to share with you some of my thoughts and research
notes with regards to the article.
10. Fuel Oil
There's an oil spill leaking from U.S.
bathrooms that's roughly the same size as
the BP disaster in the Gulf of Mexico. It's coming from
the petrochemical-based cosmetics we're rubbing into our
hair and skin and rinsing down the drain. Wow, that’s pretty self-explanatory. Let’s
The widespread use of
products containing the antibacterial agent triclosan is
promoting the growth of dangerous superbugs. The
use of nanosilver will also
lead to the development of antibiotic resistance among
Triclosan is the active ingredient in many of those
antibacterial washes, sprays and gels. It was
developed for use in hospitals, but ended up in many of
those hand sanitizers we buy and put in our purses
without another thought. It’s time to toss those
products and replace with an organic alternative.
I suggest our nice, thick 100%
organic cleansing gels.
6. Make Us
Exposure to phthalates, endocrine
disrupting chemicals found in perfumes, nail polish and
other cosmetics, is linked to childhood
me know if you would like our extensive article on
this subject. At a high level, this is extremely
worrisome since phthalates aren’t something you can find
on a label. They hide in perfumes, especially,
since those formulas aren’t revealed on labels.
Why I find this extremely disturbing is this:
When you purchase so-called “organic” soaps or products
at fairs and food markets, most of these companies are
very small, cottage industries. Essential oils are
extremely expensive, especially when purchased in small
quantities. So, to save money and be competitive,
most of these “farmers’ markets” soaps are crafted with
perfumes, not essential oils. How ironic that you
could end up with harmful phthalates using a product
that seems to be of organic origin. Ask the
question: How is this soap scented?
Organic Soap and Spa does not use perfumes in our
5. Speed Up
As girls are showing signs
of puberty at younger and younger
ages, researchers are beginning to examine
the link between cosmetics ingredients that mimic the
effect of estrogen and premature
Girls younger than 10 with early
onset puberty show a high rate of exposure to endocrine
disruptors found in nail polishes and other
Phthalates, triclosan, musks and
parabens are all known to alter the hormone
This is so disturbing. As a mother, aunt and
sister, I have heard so many tales of early onset of
puberty amongst my friends and family. When we’re
talking about this reality, even without the research,
you come to realize something is going on
here. And then the research confirms what we
already are seeing in our elementary schools and in our
homes. Children are being exposed to body product
chemicals at an alarming rate. (see
my previous post for in depth discussion on
this). What you can do: Limit exposure
to body products. Choose
chemical free body products instead for your babies
According to a report
on the health risks of secret ingredients
in fragrance, hormone-disrupting chemicals
commonly found in perfumes may be a factor in
infertility, which increased by 20 percent in American
couples between 1995 and 2002.
I believe we are still discussing phthalates
here. I recommend discontinuing use of perfumes,
period. Our employees may not wear perfume in any
of our locations. The odor interferes with our
customers experience and we don’t want to expose our
customers to any known health risks. Read
3. Cause Birth
Nail salon workers exposed to solvents without proper ventilation, face an
increased risk for miscarriages and birth defects
similar to fetal alcohol syndrome.
Endocrine disruptors have been implicated in birth defects of the male
reproductive system, such as undescended testicles and a
penile deformity called hypospadias. Incidence of both
conditions appears to have risen in recent
Pregnant women with higher levels of
phthalates commonly found in fragrances,
shampoos, cosmetics and nail polishes are more likely to
have children who display disruptive behavior years
Cancer? Read this warning below
2. Give Us
The President's Cancer
Panel warns that nitrosamines found in
cosmetics are implicated in brain & kidney cancer,
phthalates found in cosmetics, hair conditioners, and
fragrances, increase the risks of breast and testicular
cancer, and nanomaterials found in cosmetics, personal
care products and suncreens "can be extremely
22% of all personal
care products are contaminated with the cancer-causing
including many children's products.
Extremely toxic. That’s very alarming.
1,4-dioxane is the off-label chemical that Johnson and
Johnson put in baby shampoo and baby cleansing products
sold in the US. (But not Canada, Japan or the
UK.) Phthalates have shown up in breast cancer
tissue. Johnson and Johnson has been the subject
of aggressive organic consumers efforts to change this,
and in the fall of 2011, they acquiesced, agreeing to
remove this harmful chemicals in the US formula.
But phthalates have no such effort underway. You
have to be diligent in avoiding shampoos, cosmetics and
sunscreens with perfumes, and therefore,
phthalates. This includes virtually every shampoo
on the market today. Even some labeled
If you want my next newsletter on Organic
here. These are companies that use terms and
advertising to lead you to believe they sell organic
products that are good for you and safe to use.
But guess what? Not so!
Lastly, products are not currently
regulated, as you can see below:
1. Aren't Regulated or Safety
The Food and Drug
Administration has no authority to make
cosmetics companies test products for safety or recall
products that are found to be harmful.
The President's Cancer
Panel recommends research on toxins and
endocrine disrupting chemicals in personal care products
and cosmetics, noting that only 11 percent of the
ingredients in these products have been tested for
You, dear consumer, have to be your own best advocate
to avoid these harmful products! Till next
Our Best Asset, the Next Generation, deserves
protection from these harmful chemicals
Previous NOTES entry:
LIVE CHEMICAL FREE in 2012
A new year, a new type of resolution. This is the kind you actually can and should keep.
Each month I'm going to blog about chemicals we use on our bodies every day and what it does to us - for better or worse. Our skin is our barrier to the great outdoors, and that is the reason I've chosen this picture on my blog. Well, at least for now! We need our skin to protect us from the basic elements, sure. Like wind, rain and sun. But who knew we'd be besieged with sooo much more.
When I was a kid, there were so many of us that "luxuries" like fancy shampoo, conditioners and special body products were few and far between. My grandmother knew how to make soap from lye and ash and she made it for her family, but I never was fortunate enough to see it or to use it. My mother was born during the depression, in 1931, and she was obliged to use this homespun soap. She took her first job outside the home at 14, and one of the first things she wanted to buy was "store bought" soap.
My how times have changed!
Recent research has shown that toddlers are exposed to as many as 61 body care product ingredients a day - most of which require absolutely no safety testing by the FDA whatsoever (You can read this for yourself here.) According to this study, children's skin is 30% thinner than adults, and it's no secret that children absorb chemicals at a greater rate than adults do, and that their immune system is generally more vulnerable to any type of of attack then a mature immune system, making these little sponges very vulnerable to chemical attacks.
This is just one survey of 3,000+ parents, but it is so alarming, showing that over 80% of children are exposed to ingredients commonly labled as "safe" or "natural" but that are in fact, linked to allergens, nervous system disorders and other negative health issues. Here's a disturbing quote:
Every week 82% of children are exposed to one or more ingredients with the potential to harm the brain and nervous system, according to our in-depth analysis of survey responses and product ingredient listings. Our analysis revealed [79 neurotoxic chemicals] in children’s products altogether, including some considered to be known human neurotoxins. Exposures to neurotoxins are of particular concern during infancy: the blood-brain barrier that helps block chemicals from reaching the brain is not fully formed until a child reaches about 6 months of age, leaving the infant brain highly vulnerable
to chemicals that can damage brain tissue and nerves (Grandjean 2006).
A Toxic Baby Bath Tub?
I'm not one for scare tactics, but sometimes things are incredibly scary because they are incredible. There is afoot a huge boycot of Johnson and Johnson due to it's No More Tears shampoo. Now, I don't like the shampoo because it uses an anesthetic to numb your child's eyes. This is perfectly legal. At least in the United States. I thinks it's awful.
And I don't like the amount of Sodium Laurel Sulfate, or it's derivatives, in any shampoo, not to mention, baby shampoo. But again, this is perfectly legal.
However, the boycott is due to something that has always been in the shampoo that is not on the label - two ingredients, in fact. Both ingredients are either known carcinogens, or create a compound that causes cancer. And neither is listed on the label. But wait, there's more! J&J makes this shampoo without these two troubling ingredients in the UK, Japan, and other countries. Now, J&J has given the USA a "cleaner" alternative, however, Americans get to pay twice as much for the similar formula, while our friends in Japan and the UK do not. Here's the most recent demand letter from the group keeping the pressure on Johnson and Johnson.
Is it Soap or is it something else?
Did you know that the USDA does not allow non-organic products to be called soap. This includes "bath bars" and "shower bars" and "facial bars" and things like Ivory brand products. Are they soap, you may ask? Nope! It's not SOAP! Only real, pure, organic soap can have the word "soap" on the label. Check out Ivory's newest packaging - Never does the word "soap" appear on the package. You can try this fun exercise in the "soap" aisle of your favorite grocery or chain store. Bet your husband or wife. Sure 5 bucks in your pocket!
So we go back to a simpler time, when soap was just soap and not a bar full of chemicals or shampoo with ingredients that aren't even on the label and perhaps we shouldn't even be putting on our heads....
Won't you Take a Pledge to Live Chemical Free in 2012?
SOAP, not SOAP