This is a great way to see the posts right in your calendar. It’s easy to do.

Just add http://iconicwoman.com/?ical as an external iCal calendar to whatever calendar application you are using.

In Google Calendar, for example, go to ‘Add’ and then ‘Add by URL’, and then just add http://iconicwoman.com/?ical to the input box and hit Enter! And it’s done!

If you want to only show posts from a specific category, then add &category= to the end of the URL, with the category’s name at the end. An example would be http://iconicwoman.com/?ical&category=Gardasil

Enjoy!

©2012 An Inconvenient Woman. All Rights Reserved.

And Let Them Know Why

No matter where you stand in the American political color schema, red, blue, or purple, the children of politicians must be off-limits.

The minor children of politicians are private citizens who are in the public view due to the career choice of their parents. Politicians are public figures and therefore ripe targets for satirists, comedians, and the writers of Saturday Night Live.

Each election cycle, some commentator says something stupid and hurtful about someone’s child, usually a girl child.

Amy Carter was ridiculed for being awkward and bookish. Ken Hamblin, a popular Denver radio host, referred to Chelsea Clinton as the homeliest first daughter, ever. It should be noted, that he was genuinely amazed to find himself in the middle of an angry firestorm of condemnation, and nearly lost his gig. He apologized.  God only knows what would have happened if he would have inferred that the President Clinton’s daughter was a slut.

It took sixteen more years for the public discourse to descend to the level that an aging talk-show host felt a completely inappropriate, perverted joke about the 14-year old daughter of Sara Palin, was humorous.

Letterman’s blatantly, sexist jokes targeted Alaska governor Sarah Palin and one of her daughters, who were visiting New York City. Leering into the camera, Letterman recounted, “One awkward moment for Sarah Palin at the Yankee game, during the seventh inning, her daughter was knocked up by Alex Rodriguez.” Noting that Palin’s 14-year old daughter, Willow, accompanied her to the baseball game. Parsing that sentence out, he is accusing Rodriguez of statutory rape. In all the furor of the mean-spirited comment, I was personally surprised that Rodriguez’s lawyer didn’t visit papers over Letterman’s balding head.

Palin responded by calling the jokes “sexually perverted comments.” On the show following the incident, Letterman stated “these are not jokes made about her 14-year old daughter” and that he “would never, never joke about raping a 14-year old.” He said that jokes were about Palin’s 18-year-old daughter, Bristol Palin, while acknowledging the joke was “ugly,” “cheap,” and “in poor taste.”

As I listened to him stammer on, I just blinked my eyes.

So any woman who has a child out of wedlock is a slut and an easy target for degradation.  Fascinating worldview, considering this aging roué has a live-in girlfriend and a son born out of wedlock. Based on his viciously judgmental comments about 18-year old Bristol, does Letterman consider the mother of his son, his mistress, a whore? In a previous time in American culture, all of Letterman’s millions would not protect his “illegitimate” son from the label of bastard. Today’s culture recognizes that that appellation should be reserved for the father of the innocent child.

The following week, Letterman further addressed the situation, stating that the joke was “beyond flawed” and accepting full responsibility. He apologized to Palin’s daughters Bristol and Willow by name, as well as to “the governor and her family, and everybody else who was outraged by the joke.” Letterman said he would try to do better in the future. Following the broadcast, Palin issued a statement saying that she accepted Letterman’s apology.

Letterman reached so far into the muck, he will never be able to wash the scent of mean-spirited misogyny from his public persona.

Sexism against one woman, degrades ALL WOMEN

I was deeply disappointed and disturbed about Arianna Huffington’s comment that Palin was displaying “manufactured outrage” over Letterman’s disgusting sex jokes.  Women protect their young, period. American politics is a quid pro quo environment, a more-or-less equal exchange of pain and humiliation — “tit for tat”; or in this case, “you scratch my eyes out, and I’ll scratch yours”. Women must not help men sexually objectify or trivialized other women — not if any one of us hopes to be taken seriously.

If Letterman had used the exact same joke, but featured Michelle Obama and Malia, instead of Palin and Willow. Obama’s outrage would be no more manufactured than Palin’s. CBS would be carrying the has-been, unfunny man out of the Ed Sullivan Theater on his shield, to be interned, after a very short, private service,  in the general vicinity of New Jersey’s  Meadowlands. Women protect their young, period.

In the mean time, we do what we can to educate both men and women the value of protecting girls and young women. In Texas there is an expression, “You can’t fix stupid.” However, I believe with a united effort, one can make stupid uncomfortable enough to retire from public view. Please contact CBS and ALL of Letterman’s sponsors. It’s time to put Letterman in time out for bad behavior.

Letterman must experience a tangible downside to his behavior; otherwise it emboldens and perhaps encourages the next generation of “Wise-Guys” to attack another girl or woman.

The following list was developed by the Political Satire site HillBuzz. Visit and support them. They prove you can be snarky and smart, instead of snarkynd mean.

List of David Letterman’s Advertisers

Posted by hillbuzz under CBS advertisers, David Letterman sponsor, David Letterman sponsors, David Letterman’s Advertisers,
Tags: Hellmann’s Mayo supports statutory rape, Kelloggs supports statutory rape, Mars Candy supports statutory rape, The Olive Garden supports statutory rape, What products should I no longer buy?, Which companies and products support raping 14 year old girls?, Who are David Letterman’s advertisers? |

On June 8th, 2009 David Letterman “joked” about 33-year old Alex Rodriguez of the New York Yankees statutory-raping 14 year-old Willow Palin during the game at the new Yankees Stadium.  Willow Palin was the only Palin daughter at the game with her mother, Alaska Governor Sarah Palin.  Letterman “joked” that Palin’s “daughter got knocked up by Alex Rodriguez” during the game.  Sex between a 33 year-old and a 14 year-old is statutory rape.  Letterman then followed this vulgarity up on June 9th, 2009 by comparing 14 year-old Willow Palin to one of disgraced former Governor Eliot Spitzer’s prostitutes, while calling Governor Palin herself “a slutty flight attendant”.

Every day, add the advertisers you see on David Letterman or his website to this thread so a constantly updated running list is maintained.

Tell the following four companies you will no longer be patronizing them so long as they continue to advertise on Letterman:

Mars Candy (click for address and C-suite names)

The Olive Garden (click for address and full list of C-suite execs at Darden Restaurant group, owners of Olive Garden)

Kellogg’s (click for address and full list of C-suite execs)

Johnson + Johnson

We’ll have better results if we focus all our might on the four advertisers (like Olive Garden, Mars Candy, Kelloggs, and Johnson + Johnson), but here are other advertisers of David Letterman as well. As one poster put it, “Aside from the cars and electronics, most of Letterman’s ads are for baldness, sexual dysfunction, pain relief, and vitamins.  What does that tell you about the man?”

Microsoft (Bing)

Boston Market

Best Buy

Icy Hot

Wyeth (Centrum Vitamins) click here for C-suite exec addresses

Chase Bank

Macy’s

Kia

t-Mobile

Cadillac

Johnson + Johnson (Aveeno & KY Brand)

Merck (Rogaine)

Cricket

Samsung

Sanofi-Aventis (Ambien)

Mazda

Jet-Dry

Saturn

eBay

Intel

Lexus

TV.Com

On the Border Restaurants

CBSsports.com

JohnFreida.com

DiTech

Earn My Degree

True Credit by Trans Union

Bowflex

Rahal Racing (partner with David Letterman in racing ventures that earn him lots of money):

www.rahal.com/corporate

www.indycar.com

http://automobiles.honda.com/ – Honda supplies Letterman’s cars with engines

http://www.bobbyrahal.com

If is far, far more important for you to contact CBS’s advertisers.  Only pressure on CBS’ revenue stream will get the executives there to take action against David Letterman.  Think about it: CBS knows EXACTLY who and what David Letterman is.  They have never had a problem with him or the vulgar, misogynistic things he says and does before.  Only if advertisers abandon the network will CBS rethink its commitment to airing the Late Show with David Letterman. Write to the biggest, family-friendly advertisers above first and foremost, but here’s CBS’ contact information as well, in case you are looking for that too:

CBS Contact Info:  (212) 975-4321

CBS Executives:

Nina Tassler = nina.tassler@cbs.com

Kelly Kahl = kelly.kahl@cbs.com

Kim Sartori = kim.sartori@cbs.com

Les Moonves = lmoonves@cbs.com

Reason: remember when Michael Phelps was caught with his marijuana bong?  Kellogg’s cereal dropped him like a hot potato because its brand image is child-focused for most of its products.  Speedo won’t ever drop Phelps, no matter what he does, but we doubt he’ll ever have his face on a McDonald’s happy meal again either.

No candy company will want to be associate with raping 14 year-olds.

No restaurant chain like Olive Garden will want to be consistently Googled with statutory rape.

Kelloggs won’t want to be involved in another messy advertising relationship after Phelps.

A concerted effort against family-friendly advertisers of Letterman will work, but it will require persistence.

“M&Ms: the candy for people who think rape is super funn!”

“Eat at Olive Garden so you can laugh about rape while eating unlimited salad and breadsticks!”

“Kelloggs:  the breakfast cereal for misogynists and perverts who exploit minor children!”

“Johnson + Johnson: household products for when a 62-year old pig’s own johnson needs statutory rape to get going!”

Now, this should have brand managers racing for the phone if a focus and spirited effort is directed at hammering them each and every day until their ads stop appearing on Letterman’s show and website.

In this economy, a loss of three or four big advertisers like that will indeed be noticed by CBS.

UPDATE #2: Some advertisers, such as Best Western, are claiming they do not advertise on Late Night with David Letterman.  This is apocryphal:  Best Western buys banner ad space on CBS.com, and these ads appear on CBS.com when you click on the David Letterman page on that site.  Best Western, Aerosoles, Paramount’s new Star Trek movie, and other banner ads pop up on every page of David Letterman’s site.  This is paid advertising Best Western and these other companies CHOOSE to buy from CBS.

If you are an advertiser upset people who despise rape and refuse to allow Letterman to get away with promoting the rape of minors in New York, then you need to get on the phone to your ad buy account execs and yank your web ads from CBS.com.

No one believes you do not have the power to do this.  If Best Western has agents who can post here, then you have agents who can call your advertising firms and stop giving your money to CBS and David Letterman.

It was consistently reported that WILLOW Palin, 14 years old, was in New York, attending events with her mother.  Not 18 year old Bristol.

There is NO EXCUSE for Letterman and his writers to “make the mistake” of attacking “the wrong” Palin daughter.

None.

Just as there is no excuse for Best Western or any other advertiser to justify their support for Letterman by claiming, “we only buy ads online, not on TV”.

Best Western: the hotel to stay in if you love jokes about raping minors!

UPDATE #3: Some advice on how to write a good letter to corporate America.

UPDATE #4: Sarah Palin on The Today Show, 6/12/09.  As Palin states, there was only one Palin daughter at that Yankees game: 14 year-old Willow Palin.  Letterman deliberately said the Palin daughter at the Yankees game was impregnated by Alex Rodriguez during the game.  That’s statutory rape of a 14 year-old by a 33 year-old baseball player. Palin calls Letterman out for, days later, trying to spin it that he was talking about “some other daughter” being forcibly impregnated at that baseball game — a daughter who was thousands and thousands of miles away, while 14 year-old Willow was the Palin at the Yankees game, in proximity to Alex Rodriguez.  The joke makes no sense if it was indeed about Bristol, and the fact that Letterman never used “the Palin daughter’s name” seems like he deliberately built wiggle room for himself with his Obots and MSM enablers if he got called out for his joke about statutory rape.

Anyone advertising on Letterman’s program shares accountability for the content of his show because without your ad dollars corporate America, Letterman wouldn’t be on the air.

UPDATE #5: Why Democrats like Al Sharpton effectively use boycotts to affect public policy and corporate responsibility — and why conservatives allow the MSM to attack their own with impunity:  it all boils down to the simple fact that Democrats never give up, never let up the pressure, while Republicans have poor follow through and don’t effectively organize. More on this from Sebastian Gray, with inisight into how David Letterman could inspire Republicans to see all this as a very teachable moment.

Thank you HillBuzz, from Inconvenient Women everywhere

©2012 An Inconvenient Woman. All Rights Reserved.

On this page:

• Genetic Engineering
• Benefits of GE Animals
• GE Animals Regulated Under New Animal Drug Provisions

The Food and Drug Administration (FDA) is inviting the public to comment on draft guidance that discusses FDA’s approach to regulating genetically engineered (GE) animals.

Although the guidance, released Sept. 18, 2008, is aimed at industry, FDA believes it may also help the public gain a better understanding of this important and developing area. The guidance explains the process by which FDA is regulating GE animals.

Genetic Engineering

Genetic engineering is a process in which scientists use recombinant DNA (rDNA) technology to introduce desirable traits into an organism. DNA is the chemical inside the nucleus of a cell that carries the genetic instructions for making living organisms. Scientists use rDNA techniques to manipulate DNA molecules.

Genetic engineering involves producing and introducing a piece of DNA (the rDNA construct) into an organism so new or changed traits can be given to that organism. The rDNA construct can either come from another existing organism, or be synthesized in a laboratory. Although conventional breeding methods have been used for a long time to select for desirable traits in animals, genetic engineering is a much more targeted and powerful method of actually introducing specific desirable traits into animals.

Genetic engineering is not a new technology. It has been widely used in agriculture, for example, to make crops like corn and soy resistant to pests or tolerant to herbicides. In medicine, genetic engineering is used to develop microbes that can produce pharmaceuticals. And in food, genetic engineering is used to produce enzymes that aid in baking, brewing, and cheese making.

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Benefits of GE Animals

GE animals hold great promise for human and animal health, the environment, and agriculture.

• Health protection of animals – Animals are under development to be more resistant to very painful and harmful diseases, such as infection of the udder (mastitis) in dairy cows and bovine spongiform encephalopathy (widely referred to as “mad cow” disease) in all cattle.
• New source of medicines – Animals can be engineered to produce particular substances, such as human antibodies, to make infection-fighting drugs for people. These “biopharm” animals can change the way we treat chronic diseases, such as bleeding disorders, by providing large quantities of safe, health-restoring proteins that previously were available only from human cadavers.
• Transplantation – Pigs are being engineered so that their cells, tissues, or organs could be transplanted into humans with a reduced risk of immune rejection.
• Less environmental impact – Food animals are being engineered to grow more quickly, require less feed, or leave behind less environmentally damaging waste.
• Healthier food – Food animals, such as pigs, are under development to contain increased levels of omega-3 fatty acids, providing a more healthful product. Livestock can also be engineered to provide leaner meat or more milk.

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GE Animals Regulated Under New Animal Drug Provisions

FDA regulates GE animals under the new animal drug provisions of the law, and the agency must approve them before they are allowed on the market. Food and animal feed from GE animals will undergo FDA review before the food or feed can be marketed. The Federal Food, Drug, and Cosmetic Act defines a drug as “an article (other than food) intended to affect the structure or any function of the body of man or other animals.” Therefore, the rDNA construct intended to change the structure or function of the body of the GE animal is a drug.

FDA may exercise “enforcement discretion” over some GE animals, based on their potential risk and on a case-by-case basis. This means that the agency may not require premarket approval for a low-risk animal. For example, the agency is not requiring premarket approval for GE lab animals used for research, and did not require approval of a GE aquarium fish that glows in the dark. FDA does not expect to exercise enforcement discretion for animal species traditionally consumed as food.

This guidance will help industry comply with FDA’s requirements and will help the public understand FDA’s oversight of GE animals and food from such animals.

This article appears on FDA’s Consumer Health Information Web page (www.fda.gov/consumer), which features the latest updates on FDA-regulated products. Sign up for free e-mail subscriptions at www.fda.gov/consumer/consumerenews.html.

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For More Information

FDA welcomes comments on its 25-page draft guidance document at www.fda.gov/dockets/ecomments or www.regulations.gov. Once on this Internet site, select Docket No. FDA-2008-D-0394 and follow the directions. All written comments should be identified with Docket No. FDA-2008-D-0394. The comment period runs for 60 days and closes Nov. 18, 2008.

FDA has developed a number of publications to help inform consumers about the technology of GE animals and the agency’s regulation of these animals. Please visit www.fda.gov/cvm/GEAnimals.htm.

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Date Posted: September 18, 2008Science

©2012 An Inconvenient Woman. All Rights Reserved.

In June of 2006, my writing partner, Leslie Botha, and I, started writing articles cautioning women against the use of Gardasil® for girls and young women. We cited the limited nature of the clinical trials (the number, and ages of women tested) and the length of time from the clinical trials and the FDA approval; which in our opinion precluded a reasonable amount of time to follow-up for adverse reaction to the injection.

The RUSH-TO-APPROVAL, combined with MERCK’s, MEGA-Money State and Federal legislative-lobbying efforts, made us very nervous. Anytime a State or Federal agency mandates the use of a vaccine, the manufacturer is essentially, held harmless. That means adverse reaction victims cannot sue them directly. MERCK gets hide behind the shield of the very government agencies WE pay to protect us.

In our articles, Leslie and I cited European researchers who questioned not only the efficacy of the HPV vaccination plan, but the cost effectiveness of what could be one of the largest transfers of public money to private industry in history. With early detection, cervical cancer can be successfully treated; and the best early detection tool is the inexpensive, easily attainable PAP test.

“In developed countries, Pap smear screening and treatment have effectively reduced cervical cancer death rates to very low levels already. There are 3,600 deaths annually from cervical cancer in the United States, 1,000 in France and 400 in Britain.”

Each of those women were mothers, daughters and sisters, and very dear to their families. Most of the deaths were a result of lack of access to preventive medical care. The poor and uninsured can’t get a $30 PAP test, but our public heath officials think its justifiable to mandate BILLIONS of dollars to inoculate young girls with a vaccine that could do more harm than good.

MERCK has sold $1.5 BILLION worth of Gardasil® vaccine in less than two years. Those Gardasil® sales are saving their Vioxx-ravaged balance sheet. How many PAP tests would that amount provide women who have limited, or no, access to preventative care? If the safety of young girls doesn’t make you want to take action and stop this madness, how about cost-effect, use of limited health care resources?

Breast cancer kills hundreds of thousands of women every year…and the numbers are rising. Would 1.5 BILLION dollars be better spent on breast cancer research? We think so.

Spending 1.5 billion on Gardasil®, chasing the ghost of “possible cancer” in the distant future, is not good stewardship of time, talent and treasure — unless you own MERCK stock.

Two years ago Leslie and I sent information to major media outlets, asking that they at least investigate the possibility that HPV vaccines might not be effective or safe for young girls.

We felt like the mythical Cassandra…no one was interested in the news.

To date, there have been 17-deaths and thousands of reported hospitalizations of previously healthy young women and girls. As adverse reactions started to be recorded to the NVIC database, investigative reporters began questioning the HPV vaccine’s safety and cost-effectiveness. Harvard just published a “Follow the Money” report delineating the cost benefit of the mostly, publicly, funded HPV-vaccination initiative.

In the fall of 2006, using published US census data, Leslie and I estimated the number of targeted girls and women (nine to twenty-six year old) and the reported cost of the series of three of the Gardasil® inoculation and estimated the cost to public health budgets. I was sure some bean counter in the bowls of MERCK had preformed the same calculations, with far better resources, when determining the Lobbying budget that got Gardasil® approved.

I wish I could say, we are please to report that with about 20-hrs work, an old calculator and a new MAC laptop we came within a $60K of the Harvard study; but it is actually kind of depressing. All it proves is that we need more inconvenient women, asking more questions, more often, with greater insistence.

Excerpt of Harvard Study

“The vaccines, which require three shots for a complete series, cost about $400 to about $1,000, depending on the country and the fees for doctors’ visits. Unlike older vaccines that save money by preventing costly disease, these vaccines cost health systems money.

The Harvard study concluded that giving the vaccine to 12-year-olds would cost $43,600 for every “quality adjusted year of life” it saved by preventing a cancer death; that price would often be considered acceptable by health officials in wealthy countries, experts say.

But if the vaccine were given to all girls and women up to age 21, the cost per year of life saved would be far higher — $120,400, the Harvard study concluded. And if the vaccines prove to require a booster shot, as many critics believe, that cost rises to $140,000. In such cases it might make more economic sense to rely on Pap smear screening alone, the researchers said.”

Read the full text of following NY Times article.

Email the links to as many women, and health professions as you can.

Inconvenient Women take ACTION!

Click here for the full ELISABETH ROSENTHAL’s NY Times article on Gardasil®, Published: August 20, 2008

“Two vaccines against cervical cancer are being widely used without sufficient evidence about whether they are worth their high cost or even whether they will effectively stop women from getting the disease, two articles in this week’s New England Journal of Medicine conclude.”

“The two vaccines, Gardasil by Merck Sharp & Dohme and Cervarix by GlaxoSmithKline, target two strains of the virus that together cause an estimated 70 percent of cervical cancers. Gardasil also prevents infection with two other strains that cause some proportion of genital warts. Both vaccines have become quick best sellers since they were licensed two years ago in the United States and Europe, given to tens of millions of girls and women.

“Despite great expectations and promising results of clinical trials, we still lack sufficient evidence of an effective vaccine against cervical cancer,” Dr. Charlotte J. Haug, editor of The Journal of the Norwegian Medical Association, wrote in an editorial in Thursday’s issue of The New England Journal. “With so many essential questions still unanswered, there is good reason to be cautious.”

In her article, Dr. Haug points out the vaccines have been studied for a relatively short period — both were licensed in 2006 and have been studied in clinical trails for at most six and a half years. Researchers have not yet demonstrated how long the immunity will last, or whether eliminating some strains of cancer-causing virus will decrease the body’s natural immunity to other strains.

More to the point, because cervical cancer develops only after years of chronic infection with HPV, Dr. Haug said there was not yet absolute proof that protection against these two strains of the virus would ultimately reduce rates of cervical cancer — although in theory it should do so.

Both vaccines target the human papillomavirus, a common sexually transmitted virus that usually causes no symptoms and is cleared by the immune system, but which can in very rare cases become chronic and cause cervical cancer”

For more information read:

The Evidence Gap: Drug Makers’ Push Leads to Cancer Vaccines’ Rise (August 20, 2008)

Send these links out to anyone who cares about the health issues of women and girls!

Inconvenient Women do not get angry…We get ACTIVE!!

©2012 An Inconvenient Woman. All Rights Reserved.

I was doing some research for a fiend whose child had just been “diagnosed” Deficit Hyperactivity Disorder (ADHD) by a school nurse who suggested drug therapy. My first thought was a Kindergarten version of ‘One Flew Over the Cuckoo’s Nest’…dazed and compliant preschoolers.

In the past decade, ADHD, ”Deficit Hyperactivity Disorder, a neurobehavioral developmental disorder has become one of the most commonly diagnosed conditions of childhood, and is being increasingly diagnosed in adults. ADHD is characterized by a persistent pattern of inattention and/or hyperactivity, as well as forgetfulness, poor impulse control or impulsivity, and distractibility. The pharmaceutical medical industrial complex currently considers ADHD a “persistent and chronic condition for which no medical cure is available. Methods of treatment usually involve some combination of medications, behavior modifications, life style changes, and counseling. (BTW side effects aside, MEDICAL TREATMENT is spelled with two-cha-chings!)

So how do most ‘school nurses’, Physicians’ assistants and doctors come up with the very common ADHD diagnosis? Most medical professions use the “Desk Reference to the Diagnostic Criteria From DSM-IV-TR®”, compiled by American Psychiatric Association. Available in a spiral-bound book, and online accessible by computer, or PDA, the diagnostic criteria from DSM-IV-TR® is one of the most commonly used tools used by Physicians and other “prescribing” health care professions. Another ‘tool’, Desk Reference (PDR), which includes every prescription drug package insert. The guides serve as ‘medical cliff notes’, listing symptoms, probably diagnosis, suggested drug protocols, prescription drug side effect information and possible drug interactions.

Guidelines issued by the American Academy of Pediatrics recommend medications like CONCERTA® among first-line therapies for children with ADHD as part of a comprehensive treatment program. Go to the CONCERTA® website(1), READ the SIDE EFFECTS.

What rational person would suggest a little kid’s developing brain be put at risk, to assure social compliance? I knew there had to be a better way to deal with “the fidgets” so I did what Inconvenient Women do best, I looked stuff up, and sent the results out to a few thousand of my closets friends.

In September of 2007, William Atkins did a brillant, if little noted, piece on hyperactivity in children. I found it on IWIRE one of my favorite obscure resource sources. For the full article go to: http://www.itwire.com/content/view/14399/1066/

Study links hyper kids with artificial preservatives and colorings

Sodium benzoate and other food preservatives and colorings have been linked with hyperactivity in children. Although such ingredients have been thought in the past to produce adverse behavior in children, this study is considered the first scientific evidence of its kind.

The British study from researchers at the University of Southampton, England, has found that the food preservative sodium benzoate (also called benzoate of soda, with chemical formula C₆H₅COONa), when found with food dyes and colorings, can increase hyperactive behavior in children. Jim Stevenson, psychologist at the University of Southampton, and lead researcher of the study states, “We now have clear evidence that mixtures of certain food colors and benzoate preservative can adversely influence the behavior of children. We have now shown that for a large group of children in the general population, consumption of certain mixtures of artificial food colors and benzoate preservative can influence their hyperactive behavior.”

Food colorings and preservatives–which are often found in sweets such as ice cream, candy, and soda, what children love to eat–were studied. For six weeks over one hundred fifty randomly three-year-olds and over one hundred forty randomly eight-year-olds, in Southampton, England, were studied as to their diet.

The children displayed behaviors previous to the study ranging from normal to hyperactive.

They were provided food that was free of additives. Each day they were given one drink, either fruit juice or one of two mixtures of sodium benzoate preservative and food colorings. One mixture contained sodium benzoate and sunset yellow, tartrazine, carmoisine, and ponceau. The other mixture contained sunset yellow quinoline yellow, carmoisine, and allura red. They were not told which they were given, the fruit juice or one of the two mixtures.

The children who were given the benzoate preservative and food coloring mixtures showed, in some cases, more hyperactive behavior than the children given fruit juice. However, the increases in hyperactive behavior were not consistent between the two mixtures. The researchers contend that the hyperactive behavior may be linked to sodium benzoate and one or more of the specific artificial colorings, rather than to all of the colorings.

The U.S.$1.5 million study was funded by the British Food Standards Agency (FSA) and written up on September 6, 2007, in the journal The Lancet.

From the website of the Food Standards Agency comes this advise, “Parents of children showing signs of hyperactivity are being advised that cutting certain artificial colours from their diets might have some beneficial effects. The colours – Sunset yellow (E110), Quinoline yellow (E104), Carmoisine (E122), Allura red (E129), Tartrazine (E102) Ponceau 4R (E124), and Sodium benzonate (E211) – were studied as part of new FSA-commissioned research.”

Within the Friday, September 7, 2007, FSA article “Agency revises advice on certain artificial colours”, Andrew Wadge, the FSA’s Chief Scientist, said: “This study is a helpful additional contribution to our knowledge of the possible effects of artificial food colours on children’s behaviour.”

“After considering the COT’s [Committee on Toxicity (COT)] opinion on the research findings we have revised our advice to consumers: if a child shows signs of hyperactivity or Attention Deficit Hyperactivity Disorder (ADHD) then eliminating the colours used in the Southampton study from their diet might have some beneficial effects.”

“However, we need to remember that there are many factors associated with hyperactive behaviour in children. These are thought to include genetic factors, being born prematurely, or environment and upbringing.”

“The Agency has shared these research findings with the European Food Safety Authority (EFSA), which is currently conducting a review of the safety of all food colours that are approved for use in the European Union, at the request of the European Commission. This review is being undertaken because of the amount of time that has elapsed since these colours were first evaluated.”

“If parents are concerned about any additives they should remember that, by law, food additives must be listed on the label so they can make the choice to avoid the product if they want to.”

[William Atkins' note: When buying foods, always LOOK at the labels. What you don’t read may hurt you and your loved ones when you consume such foods.]

Inconvenient Women take action. If you know a mom who is drugging their child at the suggestion of a school nurse or family doctor, ask her to take this or other nutritional research to them and at least try to change their child’s diet before resorting to the BIG PHARM option.

If the child is a little girl, get her to a female pediatrician, specializing in precocious puberty. Girls as young as four and five years old are experiencing what their moms dealt with at twelve and thirteen. (See precocious puberty in IconicWoman article archive and go to: http://www.HolyHormones.com)

Explore every option before “medicating” compliant behavior.

(1) CONCERTA® and OROS® are registered trademarks of ALZA Corporation

This site and its contents are intended for USA audiences only.

©2012 An Inconvenient Woman. All Rights Reserved.

It’s Summer: Time to Clean Up the Bikini Car Wash

By Kimberly Gadette – WeNews commentator

Editor’s Note: The following is a commentary. The opinions expressed are those of the author and not necessarily the views of Women’s Enews.

(WOMENSENEWS)–Ah, the sights of summer: movie lines snaking ’round the cineplex, kids splashing in wading pools and scantily clad young ladies at busy intersections holding hand-lettered signs reading “Car Wash Today!”

Bikinis are their work uniforms and their job is to dance, jiggle, wave and sing out; anything to lure customers to the fundraising car wash for their schools, youth clubs or churches. These teen queens’ acts of solicitation are more than merely tolerated; they’re fully sanctioned by their teachers, ministers and parents.

The men driving by often slow down to a crawl in order to take a good, long look at this show from female teens. But have any of the teens’ authority figures similarly taken a good look? At themselves?

If this is the charity that begins at home, perhaps it’s time to call in child services.

According to the Web site of Green Girls Global, an international pro-environment, people and animals group, “The car wash fundraiser is about as American as apple pie. I don’t know of a student, boy-girl scout, or church group that hasn’t participated in one.”

But with the young ladies dressed in no more that string-tied halter tops, shorts cut down-to-there while up-to-here, is this apple pie? Or, rather, underage cheesecake?

This supposedly innocent, altruistic activity has recently trickled down to my own sleepy suburban neighborhood. For the past few weekends, I couldn’t help but notice a group of teens–a dance team from a nearby high school–performing energetic choreography, signs in hand, at a heavy-traffic intersection.

Arresting Antics

Though I knew they wouldn’t be able to hear me over their sing-song shouts, I wanted to say, “Careful, girls, watch all that jumping around in those loose halter tops and teeny low-riding shorts. The goal is to be ‘arresting,’ not ‘arrested.’”

Instead, I walked over to the woman in charge, an enthusiastic mom who seemed happy to answer my questions. But she withheld her name, saying, “I’ve gotten in trouble from speaking up before.”

It turns out that though this dance team had made it to the Top 4 in state competitions in the past, this year the club wanted to capture first place. To do so, the mom explained, the team needed extra dollars for better costumes, an outside choreographer and a rental bus to transport the team to meets. “If we didn’t want to be as good, we wouldn’t do this.”

I pointed to the teens feverishly jiggling at the primarily male drivers cruising by. Was she concerned about the spectacle of the young women dressed in sex outfits, literally working the street for the almighty dollar?

“It’s a learning experience”–she paused, struggling for the right word–”in advertising. After all, they’re always going to have to market themselves.” She smiled broadly. “Besides, the girls are so pretty. People want to help the kids.”

Was this her idea? Nope. I found a number of Web sites that offered definitions of the different varieties of car wash available: “manual,” “automatic” and “bikini.” One, a la a Hooters car wash, is considered commercial, in which bikini-clad young women charge a fee for the entertainment given to the car owners.

Bikini Wash-Out

The other variety was right on the money: “This car wash system is usually done in summer in the United States and Canada . . . A fund is generally raised in the name of a school, sport association or for charity purposes. The pretty school girls in bikinis call by the donors at the roadside with colorful cardboard signs and the cars are then washed by their male and female classmates at a nearby place.”

In this case, it was the middle-aged mothers dressed in baggy T-shirts and loose shorts who were assigned to wash the cars. The young ladies were simply used as bait. “You should see how the guys’ faces fall when they pull up and see it’s us instead of the girls,” the mom laughed.

I didn’t know which “bad signal” was worse: a) the expectation that the young women were expected to service strange men’s cars, doing the literal dirty work, or b) the fact that because they possessed the requisite desirable anatomy, they were exempt from the physical labor. Ignorant of the idea that it’s the very act of displaying, strutting, luring that is, in itself, the dirty work.

I wondered at the questions this type of event might leave buried in the mind. (E.g., “Though I get what I want by parading myself, I’m only a body. What happens when I’m older, does anyone credit me for having a brain?”)

I noticed a few young ladies assigned to take the donations, cart water bottles to the car-washing moms, replace the dirty water buckets for clean ones, etc. They were a bit chubby, some of them plainer than their streetwalking sisters. I assumed that they probably didn’t make the cut. How were they taking that rejection? It’s easy to say they were lucky, but many might not take it that way.

Distorted Concepts

Distorted concepts of sex appeal, body image and self-esteem are examined by many female awareness groups, including the National Organization for Women, which is planning a self-acceptance event on Oct. 15 entitled “Love Your Body Day”  http://loveyourbody.nowfoundation.org/.

Also available on NOW’s Web site is “Sex, Stereotypes and Beauty: The ABCs and Ds of Commercial Images of Women,” a get-the-facts project that takes a hard look at over 70 ads that demean the female. In particular Gucci, Dolce and Gabbana, and Lucky Brand cast females in the role of the eager server, bent on catering to the male’s every whim.

With that kind of media conditioning, it’s no wonder that the guy’s face fell when he realized that the Lolita-like teen who waved him in wouldn’t be working up a lather while personally massaging each one of his oh-so-impressive rims.

Not that there aren’t objections raised about these do-it-yourself carwashes. But these concerns are strictly environmental, with many green-minded groups objecting to the problems of untreated chemical runoff discharging into the storm water system, seeping into nearby streams, rivers and lakes.

If only there were a similar outcry as to a whole other pollution: that of the highly-impressionable, adolescent brain.

Ideally, such an outcry just might drown out the confusing body image concepts bombarding today’s young woman. Outcries from her trusted authority figures: her teachers, her minister, her parents. But when they, too, send a mixed message as clouded as the runoff from the car wash, then it’s time for them to rethink their priorities. And clean up their act.

A freelance writer based in Hillsboro, Ore., Kimberly Gadette’s writings encompass politics, film, sports, travel, dating and dogs (though dogs seldom date). Her twice-weekly film reviews can be found on Rotten Tomatoes.

Reprinted with permission:Women’s eNews welcomes your comments. E-mail us at editors@womensenews.org . -

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©2012 An Inconvenient Woman. All Rights Reserved.

In the July 20, 2008 edition of the, New York Post, SUSAN EDELMAN told Jessica Ericzon’s story. It serves as a cautionary tale for girls, their mothers and guardians. In my opinion it should be required reading for every state official who controls public health policy, every school nurse and every pediatrician, gynecologist and family practice physician. Email it to your local, state and congressional representatives. Bring it to PTA meetings. Send it to anyone who loves his or her daughters, sister, mother, and wife. Jessica’s chance to be a wife, a mom, and a grandmother has been taken from her by a system more focused on profi,t than patient safety. It is past time we stand up to the lobbyist that grease the wheels of government with cash and favors and the representatives more concerned with the next campaign donation than the health and welfare of their most vulnerable constituents.

TRAGIC: Jessica Ericzon collapsed dead days after receiving a shot of the cervical-cancer vaccine Gardasil.

She loved SpaghettiO’s, pepperoni, lilies, listening to her iPod and making her pals laugh.

In her senior yearbook, she wrote, “The best things in life aren’t things, they’re friends.”

Now that’s the quote chiseled into her gravestone.

Jessica Ericzon, 17, was “an all-American teenager,” as described by one of her upstate LaFargeville teachers.

Last February, she was working on her softball pitches, getting ready for a class trip to Universal Studios in Florida and hitting the slopes to snowboard with her older brother.

Then one day, the blond, blue-eyed honors student collapsed dead in her bathroom.

It started with a pain in the back of her head. On the advice of her family doctor, Jessie had taken a series of three Gardasil shots. The vaccine, marketed for females ages 9 to 26, is the first found to ward off strains of the sexually transmitted human papillomavirus, or HPV, which can cause cervical cancer.

Jessie got the first injection in July 2007. After her second shot in September, she complained of a pain in the back of her head, fatigue and soreness in some joints, said her mom, Lisa.

On Feb. 20, while on winter break from school, she got her third and final dose of the vaccine.The next night, “she told me the spot on the back of her head was bothering her again,” her mom said. The next morning, Feb. 22, Lisa, a hospital technician, left for work just after 5 a.m., leaving Jessie asleep.

Jessie never showed up for the class she was taking at Jefferson Community College.

When her mom got home at 3:20 p.m., she found Jessie sprawled on her back on the bathroom floor, with blood spots on her head where it had hit a flowerpot.

Jefferson County Medical Examiner Samuel Livingstone is stumped. “She was essentially dead by the time she hit the floor. Whatever it was, it was instantaneous,” Livingstone said. His autopsy found no cause. He speculates she suffered a cardiac arrhythmia, or irregular heartbeat, extremely rare in young people.

Jessie had been on birth-control pills for a year to treat acne, records show.

Livingstone reported Jessie’s death to the federal Vaccine Adverse Events Reporting System. Run by the FDA and the Centers for Disease Control and Prevention, it has collected 8,000 reports of problems after Gardasil shots, including paralysis, seizures and miscarriages.

Seventeen other deaths following the vaccine have been reported since Merck & Co. introduced it in 2006.

Officials have confirmed 11 of the reported deaths so far, said CDC spokesman Curtis Allen.They have found “no pattern or connection” to Gardasil in eight deaths and are still reviewing three, he said.

Lisa Ericzon now feels her daughter was “a guinea pig” for Gardasil, and is urging parents to research the vaccine before letting their daughters get it.

“I want other mothers to know,” said Lisa, the first parent of a girl who died after Gardasil to speak publicly.

“I don’t want them to go through what I went through.”

Jessie planned to major in psychology at SUNY Plattsburgh and pursue her greatest ambition – to become a New York state trooper. Just six days before she died, she got to ride along with a trooper canine unit. She was ecstatic.

The full article can be found at:

http://www.nypost.com/seven/07202008/news/regionalnews/my_girl_died_as_guinea_pig_for_gardasil_120737.htm

Read it. Become an Inconvenient Woman — Don’t Get Angry — Get Active!

Send this article link to every mom you know.

©2012 An Inconvenient Woman. All Rights Reserved.

FDA regulates dietary supplements under a different set of regulations than those covering “conventional” foods and drug products (prescription and Over-the-Counter). Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), the dietary supplement manufacturer is responsible for ensuring that a dietary supplement is safe before it is marketed. FDA is responsible for taking action against any unsafe dietary supplement product after it reaches the market. Generally, manufacturers do not need to register their products with FDA nor get FDA approval before producing or selling dietary supplements.^* Manufacturers must make sure that product label information is truthful and not misleading.

FDA’s post-marketing responsibilities include monitoring safety, e.g. voluntary dietary supplement adverse event reporting, and product information, such as labeling, claims, package inserts, and accompanying literature. The Federal Trade Commission regulates dietary supplement advertising.

^*Domestic and foreign facilities that manufacture/process, pack, or hold food for human or animal consumption in the United States are required to register their facility with the FDA. For more information, see Registration of Food Facilities.

About the Office of Nutritional Products, Labeling, and Dietary Supplements

• Office of Nutritional Products, Labeling, and Dietary Supplements November 2004; Updated January 2006

FDA-DSFL Electronic Newsletter

• How to Subscribe to the Dietary Supplement and Food Labeling Electronic Newsletter or Obtain Past Issues

Recent Announcements

• Buying Fake ED Products Online January 4, 2008; Updated: March 27, 2008 (Consumer Update)
• Fortify Your Knowledge About Vitamins November 2007 (Consumer Update)
• Satellite Broadcast: Overview of the Implementation of the Current Good Manufacturing Practices for Dietary Supplements Guidance for Industry October 5, 2007

Frequently Requested Information

• What is a dietary supplement?
• What is FDA’s role in regulating dietary supplements versus the manufacturer’s responsibility for marketing them?
• Where can I get information about a specific dietary supplement?
• Who has the responsibility for ensuring that a dietary supplement is safe?
• Dietary Supplement Health and Education Act of 1994
• Consolidated Information on Dietary Supplement Labeling
• Consolidated Information on Ephedrine Alkaloids
• Responses to Questions about Codex and Dietary Supplements August 2005

©2012 An Inconvenient Woman. All Rights Reserved.

As Big Phama lobbies “Your” Congressional representatives to “control” the American public’s access to natural, “food-based” supplements it is probably a good thing to review the “LAW” that has been in place since 1994. Recently Congress has shown an alarming propensity to write new law instead of adequately enforcing existing legislation. Today’s food supply is often chemically compromised. The average Western diet is comprised of over-processed foods that simply do not meet the nutritional requirements of healthy cell regeneration.

If you take ANY type of nutritional supplement, be an informed consumer. If you feel having a natural alternative to the “Better Living True Chemistry” solution being currently lobbied to “your” congressional representative is important, do something. Read the current legislation (see below) and contact your representatives and let them know how you feel. Big Pharma has had its way with Congress because, for the most part the average American does not pat attention to the posturing and preening until our “personal ox is gored”.

Inconvenient women get informed, take a stand, and GET Active!

Remind your representative that her or she needs your vote, more than they need Big Pharma campaign contribution.

U. S. Food and Drug Administration

Center for Food Safety and Applied Nutrition

December 1, 1995

DIETARY SUPPLEMENT

HEALTH AND EDUCATION ACT OF 1994

For decades, the Food and Drug Administration regulated dietary supplements as foods, in most circumstances, to ensure that they were safe and wholesome, and that their labeling was truthful and not misleading. An important facet of ensuring safety was FDA’s evaluation of the safety of all new ingredients, including those used in dietary supplements, under the 1958 Food Additive Amendments to the Federal Food, Drug, and Cosmetic Act (FD&C Act). However, with passage of the Dietary Supplement Health and Education Act of 1994 (DSHEA), Congress amended the FD&C Act to include several provisions that apply only to dietary supplements and dietary ingredients of dietary supplements. As a result of these provisions, dietary ingredients used in dietary supplements are no longer subject to the premarket safety evaluations required of other new food ingredients or for new uses of old food ingredients. They must, however, meet the requirements of other safety provisions.

Signed by President Clinton on October 25, 1994, the DSHEA acknowledges that millions of consumers believe dietary supplements may help to augment daily diets and provide health benefits. Congress’s intent in enacting the DSHEA was to meet the concerns of consumers and manufacturers to help ensure that safe and appropriately labeled products remain available to those who want to use them. In the findings associated with the DSHEA, Congress stated that there may be a positive relationship between sound dietary practice and good health, and that, although further scientific research is needed, there may be a connection between dietary supplement use, reduced health-care expenses, and disease prevention.

The provisions of DSHEA define dietary supplements and dietary ingredients; establish a new framework for assuring safety; outline guidelines for literature displayed where supplements are sold; provide for use of claims and nutritional support statements; require ingredient and nutrition labeling; and grant FDA the authority to establish good manufacturing practice (GMP) regulations. The law also requires formation of an executive level Commission on Dietary Supplement Labels and an Office of Dietary Supplements within the National Institutes of Health.

These specific provisions of the DSHEA are synopsized below.

DEFINITION OF DIETARY SUPPLEMENT

FDA traditionally considered dietary supplements to be composed only of essential nutrients, such as vitamins, minerals, and proteins. The Nutrition Labeling and Education Act of 1990 added “herbs, or similar nutritional substances,” to the term “dietary supplement.” Through the DSHEA, Congress expanded the meaning of the term “dietary supplements” beyond essential nutrients to include such substances as ginseng, garlic, fish oils, psyllium, enzymes, glandulars, and mixtures of these.

The DSHEA established a formal definition of “dietary supplement” using several criteria. A dietary supplement:

• is a product (other than tobacco) that is intended to supplement the diet that bears or contains one or more of the following dietary ingredients: a vitamin, a mineral, an herb or other botanical, an amino acid, a dietary substance for use by man to supplement the diet by increasing the total daily intake, or a concentrate, metabolite, constituent, extract, or combinations of these ingredients.
• is intended for ingestion in pill, capsule, tablet, or liquid form.
• is not represented for use as a conventional food or as the sole item of a meal or diet.
• is labeled as a “dietary supplement.”
• includes products such as an approved new drug, certified antibiotic, or licensed biologic that was marketed as a dietary supplement or food before approval, certification, or license (unless the Secretary of Health and Human Services waives this provision).

SAFETY

The DSHEA amends the adulteration provisions of the FD&C Act. Under DSHEA a dietary supplement is adulterated if it or one of its ingredients presents “a significant or unreasonable risk of illness or injury” when used as directed on the label, or under normal conditions of use (if there are no directions). A dietary supplement that contains a new dietary ingredient (i.e., an ingredient not marketed for dietary supplement use in the U.S. prior to October 15, 1994) may be adulterated when there is inadequate information to provide reasonable assurance that the ingredient will not present a significant or unreasonable risk of illness or injury. The Secretary of HHS may also declare that a dietary supplement or dietary ingredient poses an imminent hazard to public health or safety. However, like any other foods, it is a manufacturer’s responsibility to ensure that its products are safe and properly labeled prior to marketing.

LITERATURE

The DSHEA provides that retail outlets may make available “third-party” material s to help inform consumers about any health-related benefits of dietary supplements. These materials include articles, book chapters, scientific abstracts, or other third-party publications. These provisions stipulate that the information must not be false or misleading; cannot promote a specific supplement brand; must be displayed with other similar materials to present a balanced view; must be displayed separate from supplements; and may not have other information attached (product promotional literature, for example).

NUTRITIONAL SUPPORT STATEMENTS

The DSHEA provides for the use of various types of statements on the label of dietary supplements, although claims may not be made about the use of a dietary supplement to diagnose, prevent, mitigate, treat, or cure a specific disease (unless approved under the new drug provisions of the FD&C Act). For example, a product may not carry the claim “cures cancer” or “treats arthritis.” Appropriate health claims authorized by FDA–such as the claim linking folic acid and reduce risk of neural tube birth defects and the claim that calcium may reduce the risk of osteoporosis–may be made in supplement labeling if the product qualifies to bear the claim. Under DSHEA, firms can make statements about classical nutrient deficiency diseases–as long as these statements disclose the prevalence of the disease in the United States. In addition, manufacturers may describe the supplement’s effects on “structure or function” of the body or the “well-being” achieved by consuming the dietary ingredient. To use these claims, manufacturers must have substantiation that the statements are truthful and not misleading and the product label must bear the statement “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.” Unlike health claims, nutritional support statements need not be approved by FDA before manufacturers market products bearing the statements, however, the agency must be notified no later than 30 days after a product that bears the claim is first marketed.

INGREDIENT AND NUTRITION INFORMATION LABELING

Like other foods, dietary supplement products must bear ingredient labeling. This information must include the name and quantity of each dietary ingredient or, for proprietary blends, the total quantity of all dietary ingredients (excluding inert ingredients) in the blend. The label must also identify the product as a “dietary supplement” (e.g., “Vitamin C Dietary Supplement”). Labeling of products containing herbal and botanical ingredients must state the part of the plant from which the ingredient is derived. If a supplement is covered by specifications in an official compendium and is represented as conforming, it is misbranded if it does not conform to those specifications. Official compendia include the U.S. Pharmacopeia, the Homeopathic Pharmacopeia of the United States, or the National Formulary. If not covered by a compendium, a dietary supplement must be the product identified on the label and have the strength it is represented as having.

Labels also must provide nutrition labeling. This labeling must first list dietary ingredients present in “significant amounts” for which FDA has established daily consumption recommendations, followed by dietary ingredients with no daily intake recommendations. Dietary ingredients that are not present in significant amounts need not be listed. The nutrition labeling must include the quantity per serving for each dietary ingredient (or proprietary blend) and may include the source of a dietary ingredient (for example, “calcium from calcium gluconate”). If an ingredient is listed in the nutrition labeling, it need not appear in the statement of ingredients. Nutrition information must precede ingredient statements on the product label.

NEW DIETARY INGREDIENTS

Supplements may contain new dietary ingredients–those not marketed in the United States before October 15, 1994–only if those ingredients have been present in the food supply as an article used for food in a form in which the food has not been chemically altered or there is a history of use, or some other evidence of safety exists that establishes that there is a reasonable expectation of safety when the product is used according to recommended conditions of use. Supplement manufacturers must notify FDA at least 75 days before marketing products containing new dietary ingredients, providing the agency with the information on which the conclusion that a dietary supplement containing the new dietary ingredient “will reasonably be expected to be safe” was based. Any interested party, including a manufacturer of a dietary supplement, may petition FDA to issue an order prescribing the conditions of use under which a new dietary ingredient will reasonably be expected to be safe.

GOOD MANUFACTURING PRACTICES (GMPs)

DSHEA grants FDA the authority to establish GMP regulations governing the preparation, packing, and holding of dietary supplements under conditions that ensure their safety. These regulations are to be modeled after current good manufacturing practice regulations in effect for the rest of the food industry. FDA intends to work with the supplement industry and other interested persons to develop GMPs and, in doing so, will seek public comment as to their scope.

COMMISSION ON DIETARY SUPPLEMENTS

The DSHEA requires the formation of a Commission to conduct a study and make recommendations on the regulation of label claims and statements for dietary supplements and procedures for the evaluation of the claims. The members of the Commission will evaluate how best to provide truthful, scientifically valid, and not misleading information to consumers so that they can make informed and appropriate health care choices. The Commission will be composed of seven members, appointed by the President, with experience in dietary supplements and in the manufacture, regulation, distribution, and use of supplements. Three members must be qualified by scientific training and experience to evaluate supplements’ health benefits, and one of these must be trained in pharmacognosy, medical botany, traditional herbal medicine, or other related sciences. All Commission members and staff should be unbiased about supplement use.

On October 2, 1995, the White House announced the names of the seven individuals the President intends to appoint to the Commission. The members include nutritionists, industry representatives, a pharmacognosist, and attorneys.

The Commission will submit a final report including recommendations and legislation related to label claims for dietary supplements to the President and Congress within two years of convening.

OFFICE OF DIETARY SUPPLEMENTS

The HHS Secretary will establish an office within the National Institutes of Health to explore the potential role of supplements to improve health care in the U.S. The office will also promote scientific study of supplements and their value in preventing chronic diseases; collect and compile scientific research, including data from foreign sources and the NIH Office of Alternative Medicine; serve as a scientific adviser to HHS and FDA; and compile a database of scientific research on supplements and individual nutrients.

EFFECTIVE DATE

DSHEA’s provisions for use of nutritional support statements and third-party literature became effective when the law was signed. The effective date for other labeling provisions and any FDA implementing regulations is after December 31, 1996, although manufacturers may label their products consistent with provisions of DSHEA until that date.

©2012 An Inconvenient Woman. All Rights Reserved.

On this page:

• Consumer Complaint Reporting
• Reporting Problems Can Spur Action
• MedWatch Reporting
• How to Report to MedWatch
• Problems to Report to MedWatch
• Reporting Emergencies
• FDA Consumer Complaint Coordinators (regions and telephone numbers)

If you have a complaint about a product regulated by the Food and Drug Administration (FDA), the agency wants to hear about it.

FDA offers a number of ways to report a complaint. Two of the main reporting systems available to consumers are the Consumer Complaint Reporting system and MedWatch.

1. Consumer Complaint Reporting

FDA’s Consumer Complaint Coordinators (CCC’s) located in FDA offices throughout the United States and Puerto Rico will listen, document your complaint about an FDA-regulated product, and follow up as necessary. Consumers should report problems to the CCC for their geographic region. (See the accompanying list of CCC’s. The list is also on FDA’s Web site at www.fda.gov/opacom/backgrounders/complain.html.)

Some examples of complaints that your CCC wants to hear about are

• food-related illnesses, especially when a specific food is suspected
• allergic reactions when a person has a known allergy to a food ingredient not identified on the product label
• problems related to infant formula
• problems related to baby food
• swollen or leaking canned goods
• suspected product tampering
• adverse events after taking dietary supplements
• problems related to prescription or over-the-counter medications
• problems related to pet food and treats

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Reporting Problems Can Spur Action

If a person reports an illness or injury that appears likely to be caused by an FDA-regulated product, FDA acts immediately. Depending on the seriousness of the problem, an FDA investigator may visit the person who made the complaint, collect product samples, and initiate inspections.

“Just a few complaints can make a difference,” says Joan Trankle, FDA’s National CCC. For example:

• CCC’s in different parts of the country received three reports of allergic reactions to a type of soymilk. FDA followed up with an inspection of the soymilk company. The product did not declare the allergenic substance, milk protein, on the label, and the company recalled the product.
• CCC’s received two complaints in one week about skin burns after use of an adhesive patch that generates heat to relieve muscle and joint pain. “When that second complaint arrived, we sprang into action,” says Trankle. “We contacted the firm and, based on our follow-up, the firm recalled the product.”

Complaints of a less serious nature, or those that appear to be isolated incidents, are monitored and the information is used during a future inspection of a company to help FDA identify problem areas in a production plant. The complaints are also discussed with company management during these inspections.

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2. MedWatch Reporting

MedWatch is for reporting any adverse events (unexpected side effects) that occur while using human health care products and some other FDA-regulated products such as

• human drugs (both prescription and over-the-counter)
• medical devices (for example, contact lenses, glucose tests, pacemakers, and medical x-rays)
• blood products, human cell and tissue products, and other biologics (except vaccines, which are reported to another system)
• special nutritional products (dietary supplements, infant formulas, and medical foods such as nutritional supplements used under medical supervision)
• cosmetics

When FDA approves a medical product, the agency has determined that the benefits of the product outweigh the risks. “But every product that FDA approves carries some risk,” says Norman Marks, M.D., Medical Director of FDA’s MedWatch Program. “Sometimes there are risks that only come to light after a medical product gets on the market and is used in a larger number of patients, for a longer period of time, and in patients whose health characteristics are different from those of the patients studied before approval.” So continued monitoring of adverse events is essential and depends on reporting of these events to FDA so they can be entered in MedWatch.

Every MedWatch report is important and is recorded in an FDA database for review and comparison to similar previous reports. When added together, reports can signal a safety problem and lead to an FDA action to protect the public, says Marks. “Reporting can help you, a family member, or someone else avoid harm, serious illness, or even death.”

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How to Report to MedWatch

Reporting to MedWatch is easy, confidential, and secure. You provide information about your experience on a MedWatch form. FDA encourages you to have your health care professional either complete the form for you or help you complete the form yourself. “Health care professionals have test results and other clinical information that will help us better evaluate the report,” says Marks.

Reporting by health care professionals is voluntary. If they choose not to report, or if you’d rather file the report yourself, you may use one of these methods:

• Online – Use the interactive form at www.fda.gov/medwatch/report.htm. FDA encourages online reporting because it is the quickest and most direct route.
• Mail – Download the pre-addressed, postage-paid form (FDA Form 3500) at www.fda.gov/medwatch/getforms.htm or call 1-800-FDA-1088 to request the form.
• Fax – Get the form (as above) and fax to 1-800-FDA-0178.
• Phone – Call 1-800-FDA-1088 Mon–Fri between 8:00 a.m. and 4:30 p.m. EST.

If you or your health care professional does not want to complete a MedWatch report, you may report a problem with a health care product to your CCC. “There are times when consumers want to explain their problem and have us record the complaint,” says Trankle. “This gives us the advantage of being able to ask questions and obtain important information that we might not get if they were filling out a MedWatch report.”

CCC’s and MedWatch are for reporting problems; neither provides medical advice. If you experience an adverse event, you should contact your health care professional first and then report the problem to FDA.

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What Happens After Reporting to MedWatch?

• FDA staff enter the report into a database so that it is available for review and comparison to other reports.
• An FDA safety evaluator, often a pharmacist, doctor, or nurse, reviews the report and examines the database for similar reports.
• FDA monitors the data for trends and conducts an investigation if appropriate.
• FDA takes necessary action to protect public health.

FDA actions may include

• issuing safety alerts advising the public and health care professionals to monitor a product’s use, adjust the way it is used, or stop using it
• updating the product labeling to reflect new warnings
• requiring a product to have a Medication Guide—a consumer-friendly instruction sheet provided to patients each time they fill a prescription to help them use the drug safely
• requesting a change in the product’s design, manufacturing process, packaging, or distribution
• requesting a company to recall a product or requiring a manufacturer to conduct further studies to demonstrate the product’s safety prior to allowing the product back on the market

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Reporting Emergencies

If you have a medical emergency, call your health care professional for medical advice. If you wish to report a serious, life-threatening adverse event related to the use of an FDA-regulated product, call FDA’s 24-hour emergency line at 301-443-1240 or call your local FDA Consumer Complaint Coordinator.

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For More Information

Your Guide to Reporting Problems to FDA

www.fda.gov/consumer/updates/reporting_guide061008.html

MedWatch Reporting by Consumers

www.fda.gov/medwatch/report/consumer/consumer.htm

Sign Up for Free MedWatch Safety Alerts by Email

www.fda.gov/medwatch/elist.htm

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Date Posted: June 10, 2008

©2012 An Inconvenient Woman. All Rights Reserved.