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Showing posts with label FDA. Show all posts
Showing posts with label FDA. Show all posts

Monday, December 19, 2011

FDA Warning: Questions and Answers on HCG Products for Weight Loss

1. What action are the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) taking against human chorionic gondatropin (HCG) drug products marketed for weight loss?

FDA and FTC are issuing seven joint warning letters to firms marketing over-the-counter (OTC) HCG drug products that are labeled as homeopathic for weight loss.  The firms are receiving these letters because they are violating the Federal Food, Drug, and Cosmetic Act and the Federal Trade Commission Act by selling unapproved new drugs and misbranded drugs that make unsubstantiated claims about weight loss.

These unapproved “homeopathic” HCG drug products are marketed OTC on websites and in retail stores, and can be in the form of oral drops, pellets, and sprays.  FDA has not evaluated these products for safety or effectiveness.

FDA and FTC will monitor the firms’ responses to the warning letters and take further action as needed.  Firms that do not correct the violations may face enforcement action, possible legal penalties, or criminal prosecution.

2. What is HCG?

Human chorionic gonadotropin (HCG) is a hormone produced by the human placenta and found in the urine of pregnant women.  HCG is FDA-approved for the treatment of select cases of female infertility and hormone treatment in men. FDA-approved HCG products are only available in injection-form and require a prescription from a licensed medical professional.

There are no FDA-approved HCG products for weight loss.

3. Why is FDA concerned about the use of homeopathic HCG drug products marketed for weight loss?

Currently, there are no FDA-approved HCG drug products for weight loss.  HCG has not been demonstrated to be effective therapy in the treatment of obesity.  There is no substantial evidence that HCG increases weight loss.

Additionally, the labeling for the “homeopathic” HCG products states that each product should be taken in conjunction with a very low calorie diet (VLCD).  Consumers on a VLCD are at increased risk for side effects including gallstone formation, electrolyte imbalance, and heart arrhythmias.  A VLCD should only be used under proper medical supervision.

4. Which homeopathic HCG products and manufacturers/distributors are affected?
The following table provides the products and manufacturers/distributors that are the subjects of this action.  This is not an all inclusive list of illegal “homeopathic” HCG products currently on the market.  At this time, all drug products claiming to include “homeopathic” HCG are illegally marketed.   

Manufacturer/Distributor Name
Product Name
HCG Diet Direct, LLCHCG Diet Homeopathic Drops
HCG 1234 LLC (The hCG Drops LLC)Homeopathic HCG
HCG Platinum LLC; RightWay NutritionHCG Platinum
HCG Platinum X-30
HCG Platinum X-14
Nutri Fusion Systems LLCHCG Fusion 30
HCG Fusion 43
www.resetthebody.com; www.theoriginalhcgdrops.comHomeopathic Original HCG
Homeoapthic HCG
Hcg-miracleweightloss.comHCG Extra Weight Loss Homeoapthic Drops
Natural Medical SupplyAlcohol Free hCG Weight Loss Formula

5. Are prescription HCG products safe and effective for weight loss?  

No. FDA-approved uses for prescription HCG products include female fertility and select hormonal treatment in males, and FDA has not approved prescription HCG for any other uses, including weight loss..  Current scientific evidence does not support the claim that HCG is safe and effective for weight loss or for the treatment of obesity.  In fact, FDA labeling for the approved HCG drug products requires the following statement about the use of HCG for weight loss:
“HCG has not been demonstrated to be effective adjunctive therapy in the treatment of obesity.  There is no substantial evidence that it increases weight loss beyond that resulting from caloric restriction, that it causes a more attractive or ‘normal’ distribution of fat, or that it decreases the hunger and discomfort associated with calorie-restricted diets.”
FDA is aware that healthcare professionals sometimes prescribe prescription injectable HCG for unapproved uses such as weight loss.  FDA understands that sometimes approved products are used to treat conditions that the products were not approved for (i.e., “off-label” uses).  The “off-label” use of products usually presents greater uncertainty about both the risks and benefits because less information is available on safety and effectiveness.  Unexpected adverse events may occur in this context.  FDA has received reports of serious adverse events associated with the use of HCG injections for weight loss including cases of pulmonary embolism, depression, cerebrovascular issues, cardiac arrest, and death.

 6. What should consumers do?    
               
FDA advises consumers who are using “homeopathic” HCG for weight loss to stop using the product, to stop following any labeled dieting instructions, and to discard the product.  Consumers who suspect they have experienced adverse effects as a result of the use of HCG drug products for weight loss should contact a licensed health care professional immediately. 

FDA urges both health care professionals and consumers to report harmful effects experienced from using HCG for weight loss to the FDA’s MedWatch Adverse Event Reporting program by doing one of the following:
  • Complete and submit the report online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
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Tuesday, December 6, 2011

Kids’ Cereals Pack More Sugar Than Twinkies and Cookies


More than three-quarters of the cereals assessed fail proposed federal nutrition standards


Washington, D.C. – Parents have good reason to worry about the sugar content of children’s breakfast cereals, according to an Environmental Working Group review of 84 popular brands.

Kellogg’s Honey Smacks, at nearly 56 percent sugar by weight, leads the list of the 10 worst children’s cereals, according to EWG’s analysis. In fact, a one-cup serving of the brand packs more sugar than a Hostess Twinkie, and one cup of any of the 44 other children’s cereals has more sugar than three Chips Ahoy! cookies.

In response to the exploding childhood obesity epidemic and aggressive food company advertising pitches to kids, Congress formed the federal Interagency Working Group on Food Marketed to Children to propose standards to Congress to curb marketing of kids’ foods with too much sugar, salt and fat.
But EWG has found that only one in four children’s cereals meets the government panel’s voluntary proposed guidelines, which recommend no more than 26 percent added sugar by weight. EWG has been calling for an even lower cap on the maximum amount of sugar in children’s cereals.

“When I went to medical school in the 1960s, the consensus view was sugar provided ‘empty calories’ devoid of vitamins, minerals or fiber,” said health expert Dr. Andrew Weil. “Aside from that, it was not deemed harmful. But 50 years of nutrition research has confirmed that sugar is actually the single most health-destructive component of the standard American diet. The fact that a children's breakfast cereal is 56 percent sugar by weight – and many others are not far behind – should cause national outrage.”
“Cereal companies have spent fortunes on convincing parents that a kid’s breakfast means cereal, and that sugary cereals are fun, benign, and all kids will eat,” said noted NYU nutrition professor Marion Nestle. “The cereals on the EWG highest-sugar list are among the most profitable for their makers, who back up their investment with advertising budgets of $20 million a year or more. No public health agency has anywhere near the education budget equivalent to that spent on a single cereal. Kids should not be eating sugar for breakfast. They should be eating real food.”

“As a mom of two, I was stunned to discover just how much sugar comes in a box of children’s cereal,” said Jane Houlihan, EWG’s Senior Vice President of Research. “The bottom line: most parents would never serve dessert for breakfast, but many children’s cereals have just as much sugar, or more.”
Studies suggest that children who eat breakfasts that are high in sugar have more problems at school. They become more frustrated and have a harder time working independently than kids who eat lower-sugar breakfasts. By lunchtime they have less energy, are hungrier, show attention deficits and make more mistakes on their work.

About one in five American children is obese, according to the federal Centers for Disease Control and Prevention, which has reported that childhood obesity has tripled over the past 30 years.

“It has been said that exploding rates of obesity and type 2 diabetes in today's children will lead them to be the first in American history to have shorter lifespans than their parents,” Weil said. “That tragedy strikes me as a real possibility unless parents make some dramatic changes in their children's lives.”

“Nearly 20 percent of our children and one-third of adults in this country are obese. Our children face a future of declining health, and may be the first generation to have a shorter lifespan than their parents. We must provide consumers with the information they need to make healthier choices and prevent misleading claims about the nutritional contents of food,” said Congresswoman Rosa DeLauro (D-CT). “Cereal is a prime example of this—we know that children do better in school if they have breakfast. But we also know that the type of breakfast matters. And yet, as the Environment Working Group’s report shows, many children’s cereals have sugar content levels that are above 40 percent by weight. Our children deserve better, and it is critical that we take action to combat America’s obesity epidemic.” Congresswoman DeLauro serves on the appropriations subcommittee responsible for the Food and Drug Administration and agriculture, where she oversees drug and food safety.

10 Worst Children’s Cereals
Based on percent sugar by weight
1.) Kellogg’s Honey Smacks 55.6%
2.) Post Golden Crisp 51.9%
3.) Kellogg’s Froot Loops Marshmallow 48.3%
4.) Quaker Oats Cap’n Crunch’s OOPS! All Berries 46.9%
5.) Quaker Oats Cap’n Crunch Original 44.4%
6.) Quaker Oats Oh!s 44.4%
7.) Kellogg’s Smorz 43.3%
8.) Kellogg’s Apple Jacks 42.9%
9.) Quaker Oats Cap’n Crunch’s Crunch Berries 42.3%
10.) Kellogg’s Froot Loops Original 41.4%

Some cereals are better than others. Nutrition expert Marion Nestle recommends:
  1. Cereals with a short ingredient list (added vitamins and minerals are okay).
  2. Cereals high in fiber.
  3. Cereals with little or no added sugars (added sugars are ingredients such as honey, molasses, fruit juice concentrate, brown sugar, corn sweetener, sucrose, lactose, glucose, high-fructose corn syrup and malt syrup).
Among the best simple-to-prepare breakfasts for children are fresh fruit and high-fiber, lower-sugar cereals. Better yet, pair fruit with homemade oatmeal.

Source
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Wednesday, October 5, 2011

Many 'natural' foods are loaded with GMOs

(NaturalNews) Weed killer is thriving biologically inside most conventional crops as they grow in the fields of America, only to be sprayed with more heavy doses of Roundup, and then shipped to the world's supermarkets as "all natural," with absolutely no GMO disclaimer or warning. Even vegetarian products have been infiltrated by this cancer-causing "Trojan horse."

Corn and soy based products infiltrate the American "norm" for daily general consumption, and the healthcare industry loves the results. Hundreds of thousands of Americans are suffering from infections, serious gluten allergy reactions, headaches, dizzy spells, kidney stones, bowel irregularities, and worst of all, mutagenic cell production leading to cancer. Monsanto's GMO farm land has increased from just 4 million acres in 1997 to over 330 million acres now, most of which is United States soil. Brazil and India are now popular GMO breeding grounds also.

Veggie burgers are no exception, so no more of that for your vegetarian cookouts. Forget about all the soy-based items that are boxed, bagged and bottled in the center aisles of the grocery store. The only place where you should be looking for food in the grocery store is around the outer walls, where the fresh fruits and vegetables are being rinsed. There's no safety in numbers anymore, and the FDA is grasping for straws, constantly changing the names of poisons as more and more educated consumers know where the toxins are and how to read the tricky labels.

Over 93% of all U.S. soy products are Monsanto GMO, which are carcinogenic. Stop eating the following: vegetable oil, lecithin (an emulsifier), soy protein concentrates, tofu (soybean curd), soy sauce, teriyaki and tamari sauce, soy flour, soy nuts, soy nut butter, soy isoflavones, soy milk, hydrolyzed vegetable protein (HVP), hydrolyzed soy yeast, soy-based infant formulas, non-dairy frozen yogurt, and soy isolate fiber (SPF). Soy protein isolates, containing up to 92 percent protein, possess the most dangerous amount of "highly refined protein" of all soy products.

Over 86% of all U.S. corn products are Monsanto GMO and are carcinogenic. If you haven't watched the documentary King Corn, it's a must see. The Bush Administration subsidized this GMO food devil the infamous high fructose corn syrup, for ethanol, and also to serve as feed for livestock, which gives animals digestive infections.

Cows are not evolved enough to digest corn, especially Monsanto GMO cancer causing corn, and as soon as corn products become their main diet, farmers must give them antibiotics to fight off digestive infections. That's how the whole cycle of drugs and meat perpetuates.

Stop eating corn starch, corn chips, baking powder, caramel (made from corn syrup), confectioner's sugar, corn flour, corn gluten, corn syrup, corn meal, corn oil, dextrose, dextrin, maltodextrin (synthetic thickening agent), food starch, modified food starch, fructose, gum arabic, GDL (additive in cured meats), invert sugar, invert syrup, malt syrup and extract, mono and di-glycerides, monosodium glutamate (MSG - popular in Chinese foods), sucrose, treacle (mixture of molasses and corn syrup), vegetable protein, vegetable shortening, and of course, xantham gum. If you like corn, eat organic corn on the cob.

Canola oil is GMO and is carcinogenic. It was never meant for human consumption. It comes from the rapeseed plant and is an excellent insect repellant. Canada paid off the FDA to label it as safe. It has been known to disrupt the central nervous system, cause respiratory illness, constipation, low birth weights in infants, and even lung cancer. Canola is not just another oil to choose from. The only reason Canada promotes this is because it is one of the nation's chief export products.

Also watch out for tomatoes, potatoes, beets and alfalfa that are not truly organic. Stick with grocery stores like Trader Joes and your local farmers markets. True organic food prices are coming down quickly now that the word is getting out about GMO corn and soy, and about the labels that are often lies, like "all natural" and "natural flavors added."

Textured vegetable protein, or TVP, is a meat substitute made from soy flour and comes in small flakes or large chunks. This ground meat-looking staple product isn't suitable for animals, much less humans, but the recipe tells you to add it to your favorite soup, chili or pasta sauce. TVP is in most storable foods.

Use olive oil or coconut oil for cooking, and fill your refrigerator and pantry with 100% organic everything. Until you can remember all of the poisons, print this page and put it in your wallet or purse so you'll have it handy at the stores. Change your eating habits now and you will feel the difference immediately, and your body will reward you with renewed energy and vitality.

Sources for this article include:
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Thursday, September 29, 2011

The 10 worst chemicals in cosmetics and personal care products


(NaturalNews) The entire cosmetic industry is in a buyer beware state of alert, thanks to the latest additions to the melting pot of chemicals and pollutants in skin care, above and beyond the usual parabens. Consumers are warned by experts to put on the watch list any makeup which contains synthetic coloring ingredients, emulsifiers, leads, copolymer, triclosan, and "urea as a preservative." Also contributing to the chemical compounds are phthalates, formaldehyde, and petroleum.

Without proper regulations, especially regarding testing how chemicals react to one another in combinations, it is scary how quickly the industry has become a problem for women and men alike. Some lipsticks are loaded with lead. If you think it doesn't matter because it's just on your skin, think again. Deodorants and shampoo must also be included in the equation. There are plenty of solutions to the problem, but where do you begin?

Start by viewing the issues as long term consequences instead of short term benefits. In fact, there are critical trade offs when it comes to using products for beauty and hygiene that contain chemicals. Skin cancer can have roots, and the removal of them can leave scars on your nose or even around your mouth. Consumers shouldn't count on "all natural" labels and similar advertisements because current regulations on the use of those buzzwords are almost non-existent.

In the United States, the personal care industry goes largely unregulated. For starters, the FDA has not set limits for lead in cosmetics unless the lead is used for color additives. Also many fragrances are synthetic. Ever heard of or seen on the ingredients list Diazolidinyl or Imidazolidinyl Urea? One does not have to pronounce them in order to find them on the ingredients list on the back of a box or bottle. Just set it down and keep looking.

Do not leave out the average man in the United States, who might easily put 6 to 8 personal care products on his skin repeatedly every 24 hours. Facial soaps, shampoo, conditioner and deodorants will likely contain at least one of 10 carcinogenic chemicals, and the combination of chemicals seep through the skin, into the bloodstream, creating havoc for healthy cells.

The Safe Cosmetic Act of 2010 uses terminology like aggregate exposure, vulnerable populations, and people with compromised immune systems, but it seems as though everybody fits into at least two categories. Are you still willing to take the same chances?

Synthetic colors are listed as D&C or FD&C, but even though these are regulated by the industry, they are still mostly derived from coal tar, which, when injected in lab mice, causes cancer. Many previously approved colors are now banned across the world because of known carcinogenic properties.

Dibutyl phthalate (DBP), the ingredient which provides that shiny, smooth, varnish look, comes at a steep price, and not just in dollars and cents. Banned in Europe, this dangerous toxin can pose a threat to the nervous system, even by simply inhaling the fumes. Women who sit and relax at salons and boutiques for hours on end might even feel intoxicated when they exit. Pregnant women especially beware. The long term effects include impaired fetal development and deformed male reproductive organs.

Triclosan is found in more than a handful of cosmetics, and now even in toothpaste, because it's supposed to kill bacteria. Triclosan was initially developed as a surgical scrub for medical professionals, and not for putting around your eyes or for scrubbing your teeth and gums daily, but somehow the FDA has approved it for general consumption.

Here come two more ingredients the average human being cannot pronounce. Diethanolamine and Triethanolamine, more easily recognized as DEA and TEA, used extensively for emulsifying products. Combine the two chemicals, and if you're a scientist, you're watching the lab rats die from cancerous tumors. The only "panel of experts" out there recommends you only use them in small doses, but what about the cumulative effect that builds up over time and from the laundry list of products that contain them?

Many synthetic nail colors, lipsticks, sunscreens and whitening toothpastes now contain lead and other metals. Titanium dioxide is found in concealers and even diaper ointments. Some metals are used for color, and certain kinds of lip glosses even contain aluminum compounds. The infamous D&C Red 6 may contain mercury and arsenic in addition to the lead. Also, zinc is used in moisturizers, which clogs pores, preventing them from breathing properly.

Petrolatum is basically petroleum and is commonly found in moisturizers. It forms an oily layer on the skin which blocks moisture evaporation. Just as aluminum in antiperspirants dangerously blocks and traps sweat, petroleum has adverse effects on skin; however, since it's so cheap for makeup manufacturers, it's even found in baby creams and wax depilatories.

Now in 2011, there are well over 200 ingredients under the umbrella term "fragrance," and manufacturers are not required to disclose any of the actual ingredients in their formulas. Don't lose hope though, because there are natural, non-toxic preservatives that are both safe and effective.

In the long term, you are saving a fortune when you buy truly natural and organic products in comparison to the health care costs of future treatments, including surgery from using toxins on your face and body. Along with consumer education comes the gradual phase out of the bad guys in the natural skin care industry. Word combinations like sodium lauryl sulfate aren't so hard to pronounce anymore.
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Friday, August 26, 2011

FDA-Approved Vitamins

Overview

While vitamins are a common dietary supplement, they are subject to much less regulatory supervision than medication. Unlike medications and prescription drugs, the Food and Drug Administration, or FDA, does not have to approve or even inspect vitamins sold in the United States. You should always research any vitamin carefully and consult with your physician about the potential effects and health consequences of using a dietary supplement.

 

Vitamins and Dietary Supplements

Federal law classifies vitamins as a dietary supplement, which places them under the general category of food and not drugs. As a dietary supplement, the FDA has no duty or authority to "authorize" a vitamin for sale. A vitamin manufacturer has the duty to ensure the vitamins it sells are safe before entering the market, but the FDA does not have to authorize or approve the vitamin before the manufacturer sells it.

 

Dietary Supplements

The 1994 federal Dietary Supplement Health and Education Act, or DSHEA, allows manufacturers to sell dietary supplements. These supplements are defined as any product taken by mouth intended as a supplement to a person's diet. These products can contain ingredients such as plants, enzymes, minerals and vitamins, but they but cannot contain drugs, controlled substances or harmful ingredients.

 

FDA Actions

Though the FDA is not authorized to require product approval before a manufacturer sells vitamins, it can limit the sale of vitamins if it finds a product is unsafe. Manufacturers have to be sure that the product is safe, and if the manufacturer receives any reports of harmful health effects from people using its product, it has to report those to the FDA. The FDA can then investigate these claims and issue a recall if it concludes a product is unsafe. You should always check with your doctor before taking any vitamins or supplements.

 

Recalls

When the FDA investigates a potentially harmful dietary supplement such as vitamin and issues a recall, it issues a press release and lists the vitamin on the recalled products page on its website, fda.gov. Consumers can check this page to see if any vitamin has been recalled, as well as check any "adverse event" reports the FDA has received from manufacturers about vitamins.

References

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Monday, May 9, 2011

New FTC Proposals, the End of Marketing Junk Food to Kids?

By Fooducate

Consider these 3 frightening facts:

1. The food industry spends close to $2 Billion a year advertising foods to kids
2. Cookies and cakes, pizza, and soft drinks are the top sources of calories in the diets of children 2 through 18.
3. Chips and french fries comprise half of all the vegetables kids eat.

Somebody’s got to do something, right?

Last week, the Federal Trade Commission published a proposal with guidelines for marketing food to children. This, part of a cat and mouse game with the junk food industry, trying to limit kids’ exposure to commercials for foods and beverages of low to negative nutritional value.

The proposal was put forth by the Interagency Working Group on Food Marketed to Children (Working Group), comprised of representatives from the Federal Trade Commission (FTC), the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), and the United States Department of Agriculture (USDA).

Here are 2 principles they’ve put together, which in theory sounds fantastic:

A - Foods marketed to children must make a meaningful contribution to healthful diets, and contain at least one of the healthy food groups: fruits & veggies, whole grains, low fat or fat free dairy, fish, extra lean meat, eggs, nuts & seeds, beans

B - foods should minimize intake of nutrients that could have a negative impact on health or weight. For example, 0 trans-fat.

The proposals are now entering a “waiting for comments from the public” phase, where we can all say our piece, but mostly lobbies for the foods industry will.

As expected, food advertising agencies have already warned:

If companies were to comply with these proposals, the restrictions are sufficiently onerous that they would basically block a substantial amount of advertising.

Duh. That’s the whole point!

Before we congratulate the inter-office working group on these proposals, let’s remind ourselves that there is no legal obligation for the food industry to follow these proposals once they are formally adopted by the government in 2016 (5 years! Boy the government works slowly).

No matter what the government regulators do get approved, creative marketers will always find a way to get to our kids. And with so many technology based options to touch kids these days (facebook, youtube, video games) don’t doubt for a second that children will continue to be exposed to massive amounts of junk food ads before they can even spell Froot Loops.

So your best bet is to fooducate your kids from an early age about the meaning of advertising and commercials, and help them critically view messages aimed at them.

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Wednesday, April 27, 2011

Airplane Food Gets Even More Revolting

By Fooducate, by Chef Rob Endelman.

As if airline food isn’t awful enough, those still eating the carriers’ meals (when offered) now have unsanitary conditions on the aircraft themselves to worry about.

The following is an excerpt from a warning letter the Food and Drug Administration sent to Delta Airlines a few weeks ago:

To comply with 21 CFR 1250.30(a), all places where food is prepared, served, or stored shall be constructed and maintained as to be clean and free from flies, rodents, and other vermin. However, our investigator observed the following evidence of rodent activity on your aircraft:

•Approximately 8-11 rodent excreta pellets above the right door panel in the forward galley (G1) where food is prepared by flight personnel;

•Approximately 10-20 rodent excreta pellets above the left door panel in the forward galley (G1) where food is prepared by flight personnel;

•Approximately 9-15 rodent excreta pellets on the right aisle of the aircraft over seats C3-C7;

•Rodent excreta pellets (too numerous to count) in three areas in ceiling panels located in the middle cross over galley G2, which is directly over places where food and drinks are stored in the aircraft; and

•Mammalian urine in six areas on ceiling panels located in the middle cross over galley G2.

Our laboratory analysis of samples collected during the inspection confirmed the presence of rodent excreta pellets and rodent urine stains in the aircraft.

Instead of relying on the airlines’ food, here are some ideas for easy-to-make meals that work great for air travel:

•Sliced chicken breast sandwich with avocado, cheese, tomato, lettuce, mustard. Feel free to substitute sliced steak for chicken or leave out meat for vegetarian version.

•Sautéed or raw vegetables and (pick a protein) over brown rice or quinoa.

•Whole wheat pasta with meat sauce. (It’s better than you think at room temperature.)

What are your favorite carry-on airplane meals?

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Sunday, March 20, 2011

Latest News: 22 Brands of Whey Protein Recalled Due to Salmonella Concern

From Consumerlab.com

The FDA posted a recall notice involving 22 brands of whey protein powder due to potential contamination with salmonella. The recall was voluntarily initiated on March 10, 2011 by the manufacturer of the products, Vitalabs, Inc. of Jonesboro, GA, which sells the products under its own brand and makes it for other brands listed below.

Salmonella is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (e.g., infected aneurysms), endocarditis and arthritis.

This recall extends to various parts of the United States including Alabama, Arizona, California, Colorado, Georgia, Florida, Illinois, Kentucky, Louisiana, Maryland, Missouri, New Mexico, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Utah, and Washington and outside the United States in Aruba, Ontario and Poland. The recalled product was offered through a variety of distribution channels including health food stores, clinics, fitness centers and internet based companies.

Following are the lot numbers involved in this recall: Vanilla Whey Isolate: Lot Number 3473; Vanilla Whey Isolate: Lot Number 0131 Chocolate Whey Isolate: Lot Number 3477; Strawberry Whey Isolate: Lot Number 3364

Following are the brand names under which these lot numbers were offered:

Donne Hale’s Whey-26 Vanilla 840 Gram Plastic Bottles Lot # 0131 with Exp. Date 01-2013

Dr. Bill’s Choice Whey Protein Vanilla 420 Gram Plastic Bottles Lot # 3473 with Exp. Date 01-2013; Dr. Bill’s Choice Whey Protein Chocolate 420 Gram Plastic Bottles Lot # 3477 with Exp. Date 01-2013

HCG Buy Direct Whey-26 Protein Vanilla 420 Gram Plastic Bottles Lot # 3473 with Exp. Date 01-2013; HCG Buy Direct Whey-26 Protein Chocolate 420 Gram Plastic Bottles Lot # 3477 with Exp. Date 01-2013

The Healthy Way Protein Vanilla 420 Gram Plastic Bottles Lot # 3473 with Exp. Date 01-2013 UPC Code 0 92617 00002 3; The Healthy Way Protein Vanilla 840 Gram Plastic Bottles Lot # 3473 with Exp. Date 01-2013 UPC Code 0 92617 00001 6; The Healthy Way Protein Chocolate 420 Gram Plastic Bottles Lot # 3477 with Exp. Date 01-2013 UPC Code 0 92617 00004 7; The Healthy Way Protein Chocolate 840 Gram Plastic Bottles Lot # 3477 with Exp. Date 01-2013 UPC Code 0 92617 00003 0

Innovative Nutra Labs Nutrapure Whey Protein Isolate Chocolate 840 Gram Plastic Bottles Lot # 3477 with Exp. Date 01-2013 UPC Code 0 92617 00011 7

Iron Mag Labs Whey Isolate Protein Vanilla 840 Gram Plastic Bottles Lot # 3473 with Exp. Date 01-2013 UPC Code 0 92617 01101 2; Iron Mag Labs Whey Isolate Protein Chocolate 840 Gram Plastic Bottles Lot # 3477 with Exp. Date 01-2013 UPC Code 0 92617 01102 9

Len Rossi’s Whey Protein Vanilla 840 Gram Plastic Bottles Lot # 3473 with Exp. Date 01-2013; Len Rossi’s Whey Protein Vanilla 420 Gram Plastic Bottles Lot # 3473 with Exp. Date 01-2013

Lifestyle Perfect Protein Chocolate 840 Gram Plastic Bottles Lot # 3477 with Exp. Date 01-2013

Nature’s Pantry Whey Protein Chocolate 420 Gram Plastic Bottles Lot # 3477 with Exp. Date 01-2013 UPC Code 0 92617 26021 2; Nature’s Pantry Whey Protein Chocolate 840 Gram Plastic Bottles Lot # 3477 with Exp. Date 01-2013 UPC Code 0 92617 26022 9; Nature’s Pantry Whey Protein Vanilla 840 Gram Plastic Bottles Lot # 3473 with Exp. Date 01-2013 UPC Code 0 92617 26012 0; Nature’s Pantry Whey Protein Vanilla 2270 Gram Plastic Buckets Lot # 3473 with Exp. Date 01-2013 UPC Code 0 92617 29503 0

Northeast Ohio Endocrinology Whey Protein Powder Chocolate 840 Gram Plastic Bottles Lot # 3477 with Exp. Date 01-2013; Northeast Ohio Endocrinology Whey Protein Powder Vanilla 840 Gram Plastic Bottles Lot # 3473 with Exp. Date 01-2013

Nutrition World Ultra Whey Protein Vanilla 420 Gram Plastic Bottles Lot # 3473 with Exp. Date 01-2013 UPC Code 0 92617 30116 8; Nutrition World Ultra Whey Protein Vanilla 840 Gram Plastic Bottles Lot # 3473 with Exp. Date 01-2013 UPC Code 0 92617 30215 8; Nutrition World Ultra Whey Protein Vanilla 2270 Gram Plastic Buckets Lot # 0131 with Exp. Date 01-2013 UPC Code 0 92617 29916 8; Nutrition World Ultra Whey Protein Chocolate 420 Gram Plastic Bottles Lot # 3477 with Exp. Date 01-2013 UPC Code 0 92617 30314 8; Nutrition World Ultra Whey Protein Chocolate 840 Gram Plastic Bottles Lot # 3477 with Exp. Date 01-2013 UPC Code 0 92617 30413 8

Peachtree Natural Foods Whey Protein Chocolate 840 Gram Plastic Bottles Lot # 3477 with Exp. Date 01-2013 UPC Code 0 92617 85622 4; Peachtree Natural Foods Whey Protein Chocolate 420 Gram Plastic Bottles Lot # 3477 with Exp. Date 01-2013 UPC Code 0 92617 85612 5; Peachtree Natural Foods Whey Protein Vanilla 2270 Gram Plastic Buckets Lot # 3473 with Exp. Date 01-2013 UPC Code 0 92617 85631 6; Peachtree Natural Foods Whey Protein Vanilla 420 Gram Plastic Bottles Lot # 3473 with Exp. Date 01-2013 UPC Code 0 92617 85611 8

Sharp Labs G Booster Plus Vanilla 420 Gram Plastic Bottles Lot # 3473 with Exp. Date 01-2013

SouthFit Supplements Whey To Go Chocolate 2270 Gram Plastic Buckets Lot # 3477 with Exp. Date 01-2013

Susan’s Essential Formulas Daily Whey Isolate Protein 26 Vanilla 840 Gram Plastic Bottles Lot # 3473 with Exp. Date 01-2013 UPC Code 7 05105 70551 4

Team Kattouf Whey Boost Chocolate 420 Gram Plastic Bottles Lot # 3477 with Exp. Date 01-2013 UPC Code 0 92617 50301 2

This Is Bio Shape Shake Vanilla 420 Gram Plastic Bottles Lot # 0131 with Exp. Date 01-2013 UPC Code 0 92617 48479 3

Trainer’s Choice Ultra Whey 26 Vanilla 840 Gram Plastic Bottles Lot # 3473 with Exp. Date 01-2013; Trainer’s Choice Ultra Whey 26 Vanilla 840 Gram Plastic Bottles Lot # 0131 with Exp. Date 01-2013; Trainer’s Choice Ultra Whey 26 Chocolate 840 Gram Plastic Bottles Lot # 3477 with Exp. Date 01-2013 UPC Code 0 92617 24678 0

Unlimited Nutrition Athletic Protein Vanilla 840 Gram Plastic Bottles Lot # 0131 with Exp. Date 01-2013

Vitalabs, Inc. Ultra Whey-26 French Vanilla 420 Gram Plastic Bottles Lot # 0131 with Exp. Date 01-2013 UPC Code 0 92617 26011 3; Vitalabs, Inc. Ultra Whey-26 French Vanilla 840 Gram Plastic Bottles Lot # 0131 with Exp. Date 01-2013 UPC Code 0 92617 26012 0; Vitalabs, Inc. Ultra Whey-26 French Vanilla 2270 Gram Plastic Buckets Lot # 0131 with Exp. Date 01-2013 UPC Code 0 92617 26013 7; Vitalabs, Inc. Ultra Whey-26 French Vanilla 420 Gram Plastic Bottles Lot # 3473 with Exp. Date 01-2013 UPC Code 0 92617 26011 3; Vitalabs, Inc. Ultra Whey-26 French Vanilla 840 Gram Plastic Bottles Lot # 3473 with Exp. Date 01-2013 UPC Code 0 92617 26012 0; Vitalabs, Inc. Ultra Whey-26 French Vanilla 2270 Gram Plastic Buckets Lot # 3473 with Exp. Date 01-2013 UPC Code 0 92617 26013 7; Vitalabs, Inc. Ultra Whey-26 Dutch Chocolate 420 Gram Plastic Bottles Lot # 3477 with Exp. Date 01-2013 UPC Code 0 92617 26021 2; Vitalabs, Inc. Ultra Whey-26 Dutch Chocolate 840 Gram Plastic Bottles Lot # 3477 with Exp. Date 01-2013 UPC Code 0 92617 26022 9; Vitalabs, Inc. Ultra Whey-26 Dutch Chocolate 2270 Gram Plastic Buckets Lot # 3477 with Exp. Date 01-2013 UPC Code 0 92617 26023 6 Vitalabs, Inc. Ultra Whey-26 Strawberry & Crème 420 Gram Plastic Bottles Lot # 3364 with Exp. Date 01-2013 UPC Code 0 92617 26031 1; Vitalabs, Inc. Ultra Whey-26 Strawberry & Crème 840 Gram Plastic Bottles Lot # 3364 with Exp. Date 01-2013 UPC Code 0 92617 26032 8; Vitalabs, Inc. Ultra Whey-26 Strawberry & Crème 2270 Gram Plastic Buckets Lot # 3364 with Exp. Date 01-2013 UPC Code 0 92617 26033 5

X3 Nutrition X3 Whey 26 Chocolate 840 Gram Plastic Bottles Lot # 3477 with Exp. Date 01-2013

YourHCG.Com Whey Protein Strawberry 420 Gram Plastic Bottles Lot # 3364 with Exp. Date 01-2013; YourHCG.Com Whey Protein Chocolate 420 Gram Plastic Bottles Lot # 3477 with Exp. Date 01-2013; YourHCG.Com Whey Protein Vanilla 420 Gram Plastic Bottles Lot # 3473 with Exp. Date 01-2013; YourHCG.Com Whey Protein Vanilla 420 Gram Plastic Bottles Lot # 0131 with Exp. Date 01-2013

Vitalabs is conducting this recall as an extension of the voluntary recall being performed by the manufacturer of the whey protein isolate. While there have been no positive tests for Salmomella contamination nor have there been any reports of illness related to Vitalabs’ whey protein isolate, Vitalabs is conducting this recall as a precautionary measure. For more information, use the the link below.

http://www.fda.gov/Safety/Recalls/ucm246790.htm
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Friday, January 28, 2011

The Dangers of food coloring dye better known as "artificial" colors added to the foods you eat everyday

The US Food and Drug Administration divides food colorants into two categories:
Certifiable Color Additives which are derived from petroleum distillates or coal tars and are essentially synthetic chemicals created in laboratories. These are often referred to as "artificial" colors.

One is Red 40, commonly used food coloring dye added to a variety of products. While it may make food esthetically pleasing in appearance, it can cause a negative reaction in those who consume it.

Children are most often the ones who have sensitivity to red 40, whether or not their parents have realized it or not. Reactions include temper tantrums, hyperactivity, aggressive behavior,  uncontrollable crying and screaming, kicking nervousness, dizziness, inability to concentrate and sit still among other findings. Physically you may get frequent headaches or migraines, upset stomach and feel ill after ingesting this additive. Often when Red 40 is eliminated from the child's diet a remarkable change is noticed immediately.

Red 40 is used in many food products including kool-aid, orange and other flavored sodas, cheetos and dorito chips, strawberry pop-tarts, any candy with red coloring to it including m&m's, skittles, many chewing gums, etc. Also many children's vitamins and pain relievers/cold medicine have red 40 in the ingredients.

When red 40 was first approved by the FDA as a food coloring additive there was some controversy as to whether or not it caused tumors and cancer. Those claims have been proven to be false but now many parents, Doctors and Teachers are becoming aware of other concerns regarding intake of red 40, especially in young children.

Many times consumable products include both high amounts of sugar as well as red #40 so it can be hard to determine if the child's behavior or reaction is because of the sugar or because of the food dye. Both can cause similar results but it is clear that red 40 can be a culprit on it's own as similar results occur when sugar is not present. Children who have been diagnosed with ADHD (Attention Deficit Hyperactivity Disorder) generally have significant improvements of their behavior and ability to concentrate when artificial additives such as red food dye is removed from their diet. Red 40 can also affect adults; it is a common trigger for migraines. It can also cause an upset stomach and make you feel uncomfortable and jittery.

There are many others that will shock you below:
Most artificial colorings are synthetic chemicals that do not occur in nature. Because colorings are used almost solely in foods of low nutritional value (candy, soda pop, gelatin desserts, etc.), you should simply avoid all artificially colored foods. In addition to problems mentioned below, colorings cause hyperactivity in some sensitive children. The use of coloring usually indicates that fruit or other natural ingredient has not been used.
Some foods are artificially colored with natural substances, such as beta-carotene and carmine.  Please refer elsewhere in Chemical Cuisine for them.
Caution
BLUE 1
Artificial Coloring: Beverages, candy, baked goods.
Artificial Coloring
One (unpublished) animal test suggested a small cancer risk, and a test-tube study indicated the dye might affect neurons. It also causes occasional allergic reactions. Blue 1 might be safe for people who are not allergic, but it should be better tested.
Avoid
BLUE 2
Artificial Coloring: Pet food, beverages, candy.
Artificial Coloring
Animal studies found some—but not conclusive—evidence that Blue 2 causes brain cancer in male rats, but the Food and Drug Administration concluded that there is "reasonable certainty of no harm.
Caution
CITRUS RED 2
Artificial Coloring: Skin of some Florida oranges only.
Artificial Coloring
The amounts of this rarely used dye that one might consume, even from eating marmalade, are so small that the risk is not worth worrying about.
Avoid
GREEN 3
Artificial Coloring: Candy, beverages.
Artificial Coloring
A 1981 industry-sponsored study gave hints of bladder and testes tumors in male rats, but FDA re-analyzed the data using other statistical tests and concluded that the dye was safe. Fortunately, this possibly carcinogenic dye is not widely used.
Avoid
ORANGE B
Artificial Coloring: Sausage.
Artificial Coloring
Approved for use only in sausage casings, high doses of this dye are harmful to the liver and bile duct. However, that is not worrisome because Orange B has not been used for many years.
Avoid
RED 3
Artificial Coloring: Candy, baked goods.
Artificial Coloring
The evidence that this dye caused thyroid tumors in rats is "convincing," according to a 1983 review committee report requested by FDA. FDA's recommendation that the dye be banned was overruled by pressure from elsewhere in the Reagan Administration. Red 3 used to color maraschino cherries, but it has been replaced there by the less controversial Red 40 dye. It is still used in a smattering of foods ranging from cake icing to fruit roll-ups to chewing gum.
Caution
RED 40
Artificial Coloring: Soda pop, candy, gelatin desserts, pastries, pet food, sausage.
Artificial Coloring
The most widely used food dye. While this is one of the most-tested food dyes, the key mouse tests were flawed and inconclusive. An FDA review committee acknowledged problems, but said evidence of harm was not "consistent" or "substantial." Red 40 can cause allergy-like reactions. Like other dyes, Red 40 is used mainly in junk foods.
Avoid
YELLOW 5
Artificial Coloring: Gelatin dessert, candy, pet food, baked goods.
Artificial Coloring
The second-most-widely used coloring causes allergy-like hypersensitivity reactions, primarily in aspirin-sensitive persons, and triggers hyperactivity in some children. It may be contaminated with such cancer-causing substances as benzidine and 4-aminobiphenyl (or chemicals that the body converts to those substances).
Avoid
YELLOW 6
Artificial Coloring: Beverages, candy, baked goods.
Artificial Coloring
Industry-sponsored animal tests indicated that this dye, the third most widely used, causes tumors of the adrenal gland and kidney. In addition, small amounts of several carcinogens, such as 4-aminobiphenyl and benzidine (or chemicals that the body converts to those substances), contaminate Yellow 6. However, the FDA reviewed those data and found reasons to conclude that Yellow 6 does not pose a significant cancer risk to humans. Yellow 6 may cause occasional, but sometimes-severe hypersensitivity reactions.
Certain People Should Avoid
ARTIFICIAL AND NATURAL FLAVORING
Flavoring: Soda pop, candy, breakfast cereals, gelatin desserts, and many other foods.
Flavoring
Hundreds of chemicals are used to mimic natural flavors; many may be used in a single flavoring, such as for cherry soda pop. Most flavoring chemicals also occur in nature and are probably safe, but they are used almost exclusively in junk foods. Their use indicates that the real thing (often fruit) has been left out. Companies keep the identity of artificial (and natural) flavorings a deep secret. Flavorings may include substances to which some people are sensitive, such as MSG or HVP.

Artifical colorings from http://www.cspinet.org/
Read CSPI's new report, "Food Dyes: A Rainbow of Risks," to learn more.

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Tuesday, January 11, 2011

Donald Rumsfeld and the Strange History of Aspartame

The Huffington Post

The artificial sweetener aspartame (E951), marketed as NutraSweet, AminoSweet, Equal and Canderel, has been the subject of constant controversy since its initial approval by the U.S. Food and Drug Administration (FDA) in 1974. Critics point to the conflicts of interest that marred the FDA's approval of aspartame, the shoddy industry-funded research supporting its safety,[1][2][3] and point to independent research that shows numerous health risks associated with aspartame.

By 1998, aspartame products were the cause of 80% of complaints to the FDA about food additives.[4][5] The complaints included headache, dizziness, change in mood, vomiting or nausea, abdominal pain and cramps, change in vision, diarrhea, seizures/convulsions, memory loss, and fatigue.[4]

Aspartame was found to be safe for human consumption by more than ninety countries,[6][7] however the regulatory agencies have accepted the company-sponsored research without ever having done independent confirmatory studies.

So how does Donald Rumsfeld fit in to all this? A little history:

In 1985, Monsanto purchased G.D. Searle, the chemical company that held the patent to aspartame, the active ingredient in NutraSweet. Monsanto was apparently untroubled by aspartame's clouded past, including the report of a 1980 FDA Board of Inquiry, comprised of three independent scientists, which confirmed that it "might induce brain tumors." The FDA had previously banned aspartame based on this finding, only to have then-Searle Chairman Donald Rumsfeld vow to "call in his markers," to get it approved. Here's how it happened:

Ronald Reagan was sworn in as president January 21, 1981. Rumsfeld, while still CEO at Searle, was part of Reagan's transition team. This team hand-picked Dr. Arthur Hull Hayes, Jr., to be the new FDA commissioner. Dr. Hayes, a pharmacologist, had no previous experience with food additives before being appointed director of the FDA. On January 21, 1981, the day after Ronald Reagan's inauguration, Reagan issued an executive order eliminating the FDA commissioners' authority to take action and Searle re-applied to the FDA for approval to use aspartame in food sweetener. Hayes, Reagan's new FDA commissioner, appointed a 5-person Scientific Commission to review the board of inquiry's decision. It soon became clear that the panel would uphold the ban by a 3-2 decision. So Hayes installed a sixth member on the commission, and the vote became deadlocked. He then personally broke the tie in aspartame's favor.

See the Entire Article

History of Aspartame

 
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