New research reveals an astonishingly high rate of vitamin D deficiency across U.S. children and teens. It’s all part of Big Medicine’s big plan, of course — keep the people nutritionally ignorant (and keep ‘em coming back for more medicine).

Read all about it in this  Natural News feature article:

http://www.naturalnews.com/026770_Vitamin_D_health_health_care.html

©2012 An Inconvenient Woman. All Rights Reserved.

It Could Be that You Just Need to Energize Your Diet

Our eating habits play a powerful role in how well we function on every level.

Fatigue-Fighting Nutrition Strategies

Your Mother Was Right — Eat Your breakfast… even if you don’t feel hungry. British researchers at Cardiff University even found that eating a bowl of breakfast cereal every morning is associated with lower levels of the stress hormone cortisol. That is the nasty hormone that causes the belly fat that has been related to heart attacks and some types of stoke.
Studies show that people who eat breakfast feel better both mentally and physically than those who skip their morning meal. BTW, a Danish at the office does not qualify as a morning meal. I’m pretty sure an Egg McMuffin isn’t the answer either.

Eat every three to four hours. My husband calls this eating style “grazing”. He is a natural-born grazer and at 50, can still wear his high-school fencing uniform. Roberta Anding, R.D., American Dietetic Association (ADA) reported that having three smallish meals and two snacks throughout the day can keep your blood sugar and energy levels stable all day long, “Smallish, not Supersized. Big meals demand more of your energy to digest, which can leave you feeling lethargic. At each mini-meal, get a mix of carbohydrates (which the body uses for energy), protein (which helps sustain energy if needed), and healthy fats like those found in fish, nuts, and olives — these fats and protein contribute to meal satisfaction, so you don’t go hunting for sweets an hour later and wind up with a short-lived sugar high and subsequent crash.  I found the South Beach, low glycemic approach to eating easy to follow. But like exercise you have to follow the muse that moves you.

Fill up on more fiber. Fiber has a time-releasing effect on carbs, so they enter your bloodstream at a slow and steady pace, giving your energy staying power. When choosing your mini-meals, include fiber-filled options that add up to the daily recommended 25 to 30 grams of fiber (the average person gets only between 10 and 15 grams). Some suggestions: a bowl of raisin bran (5 grams of fiber per cup); black beans and cheese wrapped in a multigrain tortilla (beans have 7.5 grams per 1/2 cup; one tortilla has 5 grams); air-popped popcorn (3.6 grams per 3 cups); and an apple with the skin (3.3 grams

Fuel your brain with omega-3s. Found in fatty fish (such as tuna and salmon), walnuts, and canola oil, these essential fatty acids play a role in keeping brain cells healthy and helping you feel mentally alert. Another potential bonus: Omega-3s encourage the body to store carbs as glycogen — the storage form of glucose (blood sugar) and the body’s main source of stored fuel — rather than as fat.

Stay hydrated. Studies show that most American women are running on empty. We are dehydrated and that is not a good thing. Water makes up the majority of your blood and other body fluids, and even mild dehydration can cause blood to thicken, forcing the heart to pump harder to carry blood to your cells and organs and resulting in fatigue. Also, ample fluids keep energy-fueling nutrients flowing throughout the body, says Nancy Clark, R.D., author of Nancy Clark’s Sports Nutrition Guidebook. To gauge your hydration, Clark recommends monitoring how often you urinate. You should be going every two to four hours, and your urine should be clear or pale yellow in color. Tip: Besides drinking more, you can also consume foods that naturally contain water, such as yogurt, broccoli, carrots, and juicy fruits, like watermelons, oranges, and grapefruits.
As long as we are talking about liquid intake, think twice before drinking caffeinated drinks after noon. Typically, consuming a moderate amount of caffeine — 200 to 300 mg, the amount found in two to three cups of coffee — can make you more energetic and alert in the hours following, says Anthony L. Komaroff, M.D., a professor of medicine at Harvard Medical School. But when caffeine is consumed in large quantities — or anytime in the afternoon or evening — the quality of your sleep that night can take a nosedive, leaving you with heavy eyelids the next day. One caution for those who are highly sensitive to caffeine: Although switching to a decaf latte in the afternoon sounds like the answer, researchers at the University of Florida found that out of 22 decaffeinated coffee beverages tested, all but one contained some caffeine.

The AMA says is not clear how dietary changes affect PMS. Some studies show that drinking tea and increasing carbohydrates during the weeks preceding menstruation is helpful. Carbohydrates increase the level of the neurotransmitter serotonin (the low level of serotonin has been linked to PMS-related depression). Some nutritionists recommend vitamins, especially vitamin B6. Chinese medicine recommends reducing or eliminating alcohol, caffeine, refined sugar, chocolate salt, dairy products, and some animal fats.  It’s your body and the best study is one you conduct your self. Chart your periods, make incremental changes in your diet and see if you get relief from your symptoms. Eating well and carefully can’t hurt and most likely will help.  Personally, I’d rather support my local Farmers’ Market that BIG PHARMA’s income statement.

©2012 An Inconvenient Woman. All Rights Reserved.

There Is An Alternative Way.

1. Every person has cancer cells in the body. These cancer cells do not show up in the standard tests until they have multiplied to a few billion. When doctors tell cancer patients that there are no more cancer cells in their bodies after treatment, it just means the tests are unable to detect the cancer cells because they have not reached the detectable size.

2. Cancer cells occur between 6 to more than 10 times in a person’s lifetime.

3. When the person’s immune system is strong the cancer cells will be destroyed and prevented from multiplying and forming tumours.

4. When a person has cancer it indicates the person has multiple nutritional deficiencies. These could be due to genetic, environmental,

food and lifestyle factors.

5.. To overcome the multiple nutritional deficiencies, changing diet and including supplements will strengthen the immune system.

6. Chemotherapy involves poisoning the rapidly-growing cancer cells and also destroys rapidly-growing healthy cells in the bone marrow,

gastro-intestinal tract etc, and can cause organ damage, like liver, kidneys, heart, lungs etc.

7. Radiation while destroying cancer cells also burns, scars and damages healthy cells, tissues and organs.

8. Initial treatment with chemotherapy and radiation will often reduce tumour size. However prolonged use of chemotherapy and radiation do not

result in more tumour destruction.

9. When the body has too much toxic burden from chemotherapy and radiation the immune system is either compromised or destroyed, hence

the person can succumb to various kinds of infections and complications.

10. Chemotherapy and radiation can cause cancer cells to mutate and become resistant and difficult to destroy. Surgery can also cause cancer cells to spread to other sites.

11. An effective way to battle cancer is to starve the cancer cells by not feeding it with the foods it needs to multiply.

What Cancer Cells Feed On:

a. Sugar is a cancer-feeder. By cutting off sugar it cuts off one important food supply to the cancer cells. Sugar substitutes like NutraSweet, Equal,Spoonful etc are made with Aspartame and it is harmful. A better natural substitute would be Manuka honey or molasses but only in very small amounts. Table salt has a chemical added to make it white in colour. Better alternative is Bragg’s aminos or sea salt.

b. Milk causes the body to produce mucus, especially in the gastro-intestinal tract. Cancer feeds on mucus. By cutting off milk and substituting with unsweetened soya milk, cancer cells are being starved.

c. Cancer cells thrive in an acid environment. A meat-based diet is acidic and it is best to eat fish, and a little chicken rather than beef or pork. Meat also contains livestock antibiotics, growth hormones and parasites, which are all harmful, especially to people with cancer.

d. A diet made of 80% fresh vegetables and juice, whole grains, seeds, nuts and a little fruits help put the body into an alkaline environment. About 20% can be from cooked food including beans. Fresh vegetable juices provide live enzymes that are easily absorbed and reach down to cellular levels within 15 minutes to no urish and enhance growth of healthy cells. To obtain live enzymes for building healthy cells try

and drink fresh vegetable juice (most vegetables including bean sprouts) and eat some raw vegetables 2 or 3 times a day. Enzymes are destroyed at temperatures of 104 degrees F (40 degrees C).

e. Avoid coffee, tea, and chocolate, which have high caffeine. Green tea is a better alternative and has cancer-fighting properties.Water-

12. Meat protein is difficult to digest and requires a lot of digestive enzymes. Undigested meat remaining in the intestines become putrefied and leads to more toxic build-up.

13. Cancer cell walls have a tough protein covering. By refraining from or eating less meat it frees more enzymes to attack the protein walls of cancer cells and allows the body’s killer cells to destroy the cancer cells.

14. Some supplements build up the immune system (IP6, Flor-ssence, Essiac, anti-oxidants, vitamins, minerals, EFAs etc.) to enable the body’s own killer cells to destroy cancer cells. Other supplements like vitamin E are known to cause apoptosis, or programmed cell death, the body’s normal method of disposing of damaged, unwanted, or unneeded cells.

15. Cancer is a disease of the mind, body, and spirit. A proactive and positive spirit will help the cancer warrior be a survivor. Anger, unforgiveness and bitterness put the body into a stressful and acidic environment. Learn to have a loving and forgiving spirit. Learn to relax and enjoy life.

16. Cancer cells cannot thrive in an oxygenated environment. Exercising daily, and deep breathing help to get more oxygen down to the cellular level. Oxygen therapy is another means employed to destroy cancer cells.

©2012 An Inconvenient Woman. All Rights Reserved.

FOR IMMEDIATE RELEASE

December 1, 2008

Media Inquiries:

Stephanie Kwisnek, 301-827-0955

Consumer Inquiries:

888-INFO-FDA

FDA Reports Significant Progress in Protecting the Food Supply

The One-Year Summary of Progress under the Food Protection Plan describes FDA’s efforts to build safety in the U.S. and global food systems

The U.S. Food and Drug Administration today released a report on its implementation of the Food Protection Plan that was launched a year ago to protect both domestic and imported food from accidental and intentional contamination. The Plan, which outlines strategies for prevention, intervention and response, is designed to address food safety and food defense for both domestic and imported products and covers the full lifecycle of food, by encouraging the building of safety into every step of the food supply chain.

“Science and 21st century technologies help drive the FDA’s efforts to transform our food safety efforts from the Food Protection Plan into a reality,” said Commissioner of Food and Drugs Andrew C. von Eschenbach, M.D. “Every day, the FDA is working with foreign countries, state and local governments, regulated industry and consumer groups to ensure the safety of the food supply. We also continue to work with members of Congress to achieve new authorities requested in the Food Protection Plan.”

Listed below are the highlights of the agency’s accomplishments in implementing the Food Protection Plan’s three core strategies: The prevention of outbreaks of food-borne disease, and intervention and response if they occur:

PREVENTION

• The FDA is establishing offices in five regions that export food and other FDA-regulated products to the United States: China, India, Europe, Latin America, and the Middle East. The FDA has already hired staff for its offices in China and India.
• The FDA was part of a U.S. Department of Health and Human Services (HHS) delegation to China to address food safety issues in both countries and to share ideas to address global food safety. U.S. and Chinese government officials discussed recent outbreak of foodborne illness in the United States related to fresh produce as well as the melamine contamination of dairy products in China.
• The FDA released the CARVER self-assessment tool for industry, to minimize the risk of intentional contamination of food, and conducted training seminars for industry on how to use the tool.
• The FDA held a meeting of with more than 200 federal, state, local, tribal and territorial partners to address the challenges of protecting the nation’s food supply.
• The FDA is hiring an International Notification Coordinator to manage enhanced information exchanges between the agency and foreign counterpart regulatory authorities.
• The FDA approved the use of irradiation of iceberg lettuce and spinach for the control of pathogens, such as Escherichia. coli, in or on those foods.
• The FDA developed methods to detect melamine and cyanuric acid in feed and feed ingredients.
• The FDA is using genetic analysis to identify hundreds of Salmonella strains from seafood imports. The analysis provides information to trace outbreaks of Salmonella outbreaks and implement surveillance programs to ensure food safety.

INTERVENTION

• The FDA completed inspections of 5,930 high-risk domestic food establishments during the Fiscal Year (FY) 2008.
• The FDA piloted the program for inspection and sampling of high-risk companies in Denver and Minneapolis during the Democratic and Republican National Conventions.
• A targeted, risk-based inspection of a canning facility in 2008 identified cans with viable Clostridium botulinum spores and a recall was initiated. The FDA initiated this inspection, along with inspections of other Low Acid Canned Food (LACF) manufacturers, following four cases of botulism in consumers in 2007. The FDA increased inspection efforts to ensure that manufacturers of all types of LACF products are adhering to applicable FDA requirements. These actions illustrate the need for companies to operate under adequate preventive control systems.
• The FDA issued “Draft Guidance for Industry on Voluntary Third-Party Certification Programs for Food and Feed.” Docket FDA-2008-D-0381 is available for viewing at www.regulations.gov.
• The FDA has developed a rapid detection method that uses flow cytometry to identify E. coli and Salmonella in food, now in use in poultry-processing facilities to detect and prevent bacterial contamination during food processing.
• The FDA is expanding its database of adverse drug events to include adverse feed events, which will allow the agency to respond faster to outbreaks of feedborne disease in animals, contamination episodes, and/or product defects.
• The FDA and U.S. Customs and Border Protection jointly issued a final rule on Prior Notice of Imported Food Shipments, and an accompanying Compliance Policy Guide (CPG) on Oct. 31, 2008; the rule and CPG were published in the Federal Register on Nov. 7, 2008.

RESPONSE

• The FDA is working with industry and the public to identify best practices for tracing fresh produce throughout the supply chain.
• The FDA has enhanced the agency’s ability to coordinate a comprehensive response to foodborne illness events by authoring tools used to track emergency response resources and other locations of interest.
• The FDA hired two emergency /complaint-response coordinators to improve its response to emergencies that involve animal feed, including pet food.
• Following the detection of melamine in infant formula and milk products from China, the FDA worked with its state and local counterparts to rapidly canvas over 2,100 vendors of Asian products to remove any Chinese infant formula from the market and to sample milk-derived Chinese products to check for melamine contamination. The FDA also provided regular updates on its Web site, advising consumers which products to avoid because of melamine contamination.
• The FDA held regular briefing calls for consumer organizations during the outbreak of Salmonella Saintpaul in the summer of 2008, and regularly updated a Web page that provided information on the investigation into the outbreak, and advised consumers how they could protect themselves and their families.
• The FDA has signed cooperative agreements with six U.S. states to form a Rapid Response Team to develop, implement, exercise, and integrate an all-hazards response capability for food and foodborne illness responses, to react more rapidly react to potential threats to our food supply.
• After reports from China of melamine-contaminated infant formula, the FDA worked with its state and local counterparts to quickly canvas over 2,100 Asian markets to remove any infant formula from China that might be available and to sample milk-derived products to check for melamine contamination.

The entire One-Year Summary of Progress under the Food Protection Plan is posted at www.fda.gov/oc/initiatives/advance/food/progressreport1108.html, and the Food Protection Plan is available at www.fda.gov/oc/initiatives/advance/food/plan.html.

The Food Protection Plan complements the Action Plan on Import Safety the President’s Working Group On Import Safety unveiled one year ago to improve the safety of all imported products. HHS Secretary Mike Leavitt heads The Working Group. For additional information on the FDA’s activities under the Action Plan for Import Safety, please visit: www.fda.gov/oc/initiatives/advance/imports/activities.html.

©2012 An Inconvenient Woman. All Rights Reserved.

We’ve done it to ourselves. As a nation we’re over-medicated and undernourished. We’re overly obsessed with how we look and undervalue how we feel. We put an overemphasis on getting an immediate remedy, while we ignore the underlying problem that got us there in the first place.”

— Dr. Mark Stengler: Naturopathic doctor

©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.

Broccoli may undo diabetes damage

Broccoli may help ward off prostate cancer

Eating broccoli could reverse the damage caused by diabetes to heart blood vessels, research suggests.

A University of Warwick team believe the key is a compound found in the vegetable, called sulforaphane.

It encourages production of enzymes which protect the blood vessels, and a reduction in high levels of molecules which cause significant cell damage.

Brassica vegetables such as broccoli have previously been linked to a lower risk of heart attacks and strokes.

Our study suggests that compounds such as sulforaphane from broccoli may help counter processes linked to the development of vascular disease in diabetes Professor Paul Thornalley University of Warwick

People with diabetes are up to five times more likely to develop cardiovascular diseases such as heart attacks and strokes; both are linked to damaged blood vessels.

The Warwick team, whose work is reported in the journal Diabetes, tested the effects of sulforaphane on blood vessel cells damaged by high glucose levels (hyperglycaemia), which are associated with diabetes.

They recorded a 73% reduction of molecules in the body called Reactive Oxygen Species (ROS).

Hyperglycaemia can cause levels of ROS to increase three-fold and such high levels can damage human cells.

The researchers also found that sulforaphane activated a protein in the body called nrf2, which protects cells and tissues from damage by activating protective antioxidant and detoxifying enzymes.

Countering vascular disease

Lead researcher Professor Paul Thornalley said: “Our study suggests that compounds such as sulforaphane from broccoli may help counter processes linked to the development of vascular disease in diabetes.

“In future, it will be important to test if eating a diet rich in brassica vegetables has health benefits for diabetic patients. We expect that it will.”

Dr Iain Frame, director of research at the charity Diabetes UK, stressed that research carried out on cells in the lab was a long way from the real life situation.

However, he said: “It is encouraging to see that Professor Thornalley and his team have identified a potentially important substance that may protect and repair blood vessels from the damaging effects of diabetes.

“It also may help add some scientific weight to the argument that eating broccoli is good for you.”

©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.

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.

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