FDA, FTC act to remove “homeopathic” HCG weight loss Product

by: continuum wellness - December 12th, 2011   Filed under: FDA, weight loss Add Comment

oh, woo-hoo, I don’t know if this is such a good idea.  Don’t we have brains to decide what products to use.  The FDA is the agency that recommended over the counter birth control for young pre-teens and teen girls.  That is a product fraught with risk on physical and emotional levels.  Excellent research is available demonstrating how the brain is not fully developed until about the age of 27.  But to our rescue the FDA wants to remove a weight loss product that is used at your discretion, by adults.  By the way, substances can be produced using a homeopathic method.  That has little in common with homeopathic prescribing for health concerns.  These should not be confused.

I know of someone who used this type product, HCG for weight loss.  A rather astute person.  And no, it was not me.   She used common sense and it helped her lose weight.  Is it good for everyone?  Probably not.  But should you be allowed to decide for yourself?  It is amazing how so many ‘approved’ drugs harm  people, but that seems to be ok.

Here is the press release. and below.

FDA, FTC act to remove “homeopathic” HCG weight loss products from the market

Joint action is first step in halting sale of the products

The U.S. Food and Drug Administration and the Federal Trade Commission (FTC) today issued seven Warning Letters to companies marketing over-the counter (OTC) HCG products that are labeled as “homeopathic” for weight loss.

Human chorionic gonadotropin (HCG) is a hormone produced by the human placenta and found in the urine of pregnant women. HCG is FDA-approved as an injectable prescription drug for the treatment of some cases of female infertility and other medical conditions.

The letters warn the companies that they are violating federal law by selling drugs that have not been approved, and by making unsupported claims for the substances. There are no FDA-approved HCG drug products for weight loss.

The joint action is the first step in keeping the unproven and potentially unsafe products from being marketed online and in retail outlets as oral drops, pellets, and sprays.

The labeling for the “homeopathic” HCG products states that each product should be taken in conjunction with a very low calorie diet. There is no substantial evidence HCG increases weight loss beyond that resulting from the recommended caloric restriction.  Consumers on a very low calorie diet are at increased risk for side effects including gallstone formation, electrolyte imbalance, and heart arrhythmias.

“These HCG products marketed over-the-counter are unproven to help with weight loss and are potentially dangerous even if taken as directed,” said Ilisa Bernstein, acting director of the Office of Compliance in FDA’s Center for Drug Evaluation and Research. “And a very low calorie diet should only be used under proper medical supervision.”

“Deceptive advertising about weight loss products is one of the most prevalent types of fraud,” said David Vladeck, director of the FTC’s Bureau of Consumer Protection. “Any advertiser who makes health claims about a product is required by federal law to back them up with competent and reliable scientific evidence, so consumers have the accurate information they need to make good decisions.”

According to the Warning Letters, the companies have 15 days to notify the FDA of the steps they have taken to correct the violations cited. Failure to do so may result in legal action, including seizure and injunction, or criminal prosecution.
Consumers and health care professionals are encouraged to report adverse events (side effects) that may be related to the use of these products to MedWatch, the FDA’s voluntary reporting program, by calling 800-FDA-1088, or electronically at www.fda.gov/medwatch/report.htm1.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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The FDA Stands Behind Apple Juice, Should You?

by: continuum wellness - September 18th, 2011   Filed under: FDA, food, nutrition, wellness Add Comment

A recent Dr. Oz show, involved testing apple juice for arsenic.  Apple juice is a popular beverage and at least 60% of it is imported from China.  The standards for arsenic in foods and governmental regulations vary among countries.  What the show attempted to show is that the apple juice may have higher than acceptable amounts of arsenic than allowed by the FDA.  The FDA has issued a statement stating that apple juice is safe to drink (here).

China has been engaged in controversy in numerous instances, from unacceptable amounts of lead in children toys, to recycling waste oil as cooking oil, and even adulterating toothpaste.  Perhaps the FDA is well-meaning.  But chances are they are understaffed and this issue may not have received necessary attention.  Food safety is an important issue to often glossed over, with the “trust us, we are the experts” line.

This issue also highlights the importance of buying local.

Here is information on the apple juice testing (here).

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The True Journey from the Farm to You: A Review of Food, Inc.

by: continuum wellness - July 9th, 2009   Filed under: African American, causes of allergies, FDA, food, Health, healthy eating Add Comment

Food Inc: Michael Pollan and Friends Reveal the Food Industry’s Darkest Secrets

The new film Food Inc. is a shocking look at the health, human rights and the environmental nightmare that lands on our plate each meal.

It turns out that figuring out the most simple thing — like what’s on your dinner plate, and where it came from — is actually a pretty subversive act.

That’s what director Robert Kenner found out while spending six years putting together the amazing new documentary, Food Inc., which features prominent food writers Michael Pollan (The Omnivore’s Dilemma) and Eric Schlosser (Fast Food Nation).

Warning: Food Inc. is not for the faint of heart. While its focus is not on the gory images of slaughterhouse floors and filthy feedlots, what it does show about the journey of our food from “farm” to plate is not pretty.

The story’s main narrative chronicles the consolidation of our vast food industry into the hands of a few powerful corporations that have worked to limit the public’s understanding of where its food comes from, what’s in it and how safe it may be.

But it’s also a larger story about the people that have gotten in the way of the stampeding corporate herd — like farmer Joel Salatin (also profiled in Pollan’s Omnivore’s Dilemma), who has bravely bucked the trend to go corporate.

Read the rest of the interview here

People think if they can’t do it all the time they don’t have to do anything. Change one meal. But then we have to stop subsidizing food that is making us sick, we have to change the national school-lunch program. If we supported local farms and got that to the school systems and spent a dollar there, we’d save a a fortune in medicine and train kids to eat right, and we’d have better communities.

To see Food Inc., find a theater near you.

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Is Raw Food Under Attack? Alfalfa Seed Contamination

by: continuum wellness - April 28th, 2009   Filed under: FDA, food, healthy eating, nutrition Add Comment

What is going on with the food supply? Unprocessed legumes, nuts and alfalfa have all variously put on the carpet as being potentially dangerous to eat due to possible salmonella poisoning. Pistachios, which by the way I recently ate with gusto (from Whole Foods Market) were on the “danger” list. Peanuts have been on the recall list too. If more of the population moved away from such a heavily meat based diet less animal waste and it byproducts would be produced. And if we bring back small farms and grew more of our own food, we would all be better off.

Read below about the alfalfa sprouts…

FDA News

FOR IMMEDIATE RELEASE
April 26, 2009
The U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) today recommended that consumers not eat raw alfalfa sprouts, including sprout blends containing alfalfa sprouts, until further notice because the product has been linked to Salmonella serotype Saintpaul contamination. Other types of sprouts have not been implicated at this time.

The investigation indicates that the problem may be linked to contamination of seeds for alfalfa sprouts. Because suspect lots of seeds may be sold around the country and may account for a large proportion of the alfalfa seeds currently being used by sprout growers, and cases of illness are spread across multiple states, FDA and CDC are issuing this general advisory.

FDA will work with the alfalfa sprout industry to help identify which seeds and alfalfa sprouts are not connected with this contamination, so that this advisory can be changed as quickly as possible.

CDC, FDA and six State and local authorities have associated this outbreak with eating raw alfalfa sprouts. Michigan, Minnesota, Pennsylvania, South Dakota, Utah, and West Virginia have reported 31 cases of illness with the outbreak strain of Salmonella Saintpaul to CDC. Most of those who became ill reported eating raw alfalfa sprouts. Some reported eating raw sprouts at restaurants; others reported purchasing the raw sprouts at the retail level.

The illnesses began in mid-March. Cases are still being reported, and possible cases are in various stages of laboratory testing, so illnesses may appear in other states. No deaths have been reported. The number of infected people may be higher than currently reported because some illnesses have not yet been confirmed with laboratory testing.

The CDC and FDA recommend at all times that persons at high risk for complications, such as the elderly, young children, and those with compromised immune systems, not eat raw sprouts because of the risk of contamination with Salmonella or other bacteria. Salmonella is an organism that can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy individuals 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 meningitis and bone infections.

Initial investigation results trace the contaminated raw alfalfa sprouts to multiple sprout growers in multiple states. This suggests a potential problem with the seeds used, as well as the possible failure of the sprout growers involved to appropriately and consistently follow the FDA Sprout Guidance issued in 1999 http://www.cfsan.fda.gov/~dms/sprougd1.html. The guidance recommends an effective seed disinfection treatment immediately before the start of sprouting (such as treating seed in 20,000 parts per million Calcium hypochlorite solution with agitation for 15 minutes) and regularly testing the water used for every batch of sprouts for Salmonella and E coli O157:H7 contamination.

This outbreak appears to be an extension of an earlier outbreak in 2009. In February and March, an outbreak of Salmonella Saintpaul infections occurred in Nebraska, South Dakota, Iowa, Kansas, and Minnesota. This outbreak was linked to raw alfalfa sprouts, and the outbreak strain was indistinguishable from that of these recently reported cases. A separate outbreak of Listeria monocytogenes infections was also linked to sprouts in 2009. In the 1990s, a number of outbreaks related to sprouts led FDA to issue its guidance. Experience over the past decade has shown that the likelihood of Salmonella in sprouts can be minimized when recommendations from FDA’s Sprout Guidance are followed.

Preventive controls are very important in the growing of all raw sprouts. FDA reminds sprout growers to be vigilant in their food safety practices and strongly encourages sprout growers to follow the Agency’s Sprout Guidance. Additionally, the United Fresh Produce Association has advised all of its members to follow FDA’s guidance on sprouts. FDA appreciates that the produce industry has reinforced this message and reminds retailers that it is prudent to sell sprouts from growers who follow FDA’s recommendations.

For persons who continue to eat sprouts, visit (U.S. Food and Drug Administration, 2002 consumer advisory, available at http://www.cfsan.fda.gov/~lrd/tpsprout.html).

For more information on food safety, visit www.fda.gov .

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Keep Our Food Supply Free

by: continuum wellness - March 15th, 2009   Filed under: economy, FDA, Health Add Comment

Congressional Bill HR 875 was introduced by Congresswoman Rosa DeLauro,
whose husband Stanley Greenburg works for Monsanto. The bill is
essentially a giant gift package for Monsanto, mandating the
criminalization of seed banking, prison terms and confiscatory fines for
small farmers and 24 hour GPS tracking of their animals, and of
“industrial” standards to independent farms.

The corporations want nothing less than full control of the land, the
end of normal animals so they can substitute patented genetically
engineered ones, and the end of normal seeds and thus of seed banking by
farmers or individuals.

And now Monsanto wants its own employee, Michael Taylor (the man who
forced genetically engineered rBGH on the country when the Clintons
placed him over “food safety” in the 90’s) back in government, this time
to act with massive police power as a “food safety tsar”. HR 875 would
give him immense power over what is done on every single farm in the
country and massive police state power to wield over farmers.

Rosa DeLauro and Stanley Greenburg have a great deal to account for in
attempting to force through a mislabeled “food safety” bill with hidden
intent to wipe out farmers and harm everyone.

http://www.govtrack.us/congress/bill.xpd?bill=h111-875

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Why you should read the drug package inserts

by: continuum wellness - March 4th, 2009   Filed under: children, drugs, family, FDA, girls, Health, health care, medications, medicine, prescription drugs, women, women's health Add Comment

If for some reason you need to take pharmaceutical drugs, protect yourself and loved ones by reading the package inserts. According to this research adverse drug events happen to the the tune of $3.5 billion dollars, and those are the reported incidents.

The new Food and Drug Administration drug package insert: implications for patient safety and clinical care.

Watson KT, Barash PG.
Department of Anesthesiology, Yale University School of Medicine, New Haven, Connecticut 06520-8051, USA.

The United States Food and Drug Administration (FDA) is the scientific, regulatory, and public health agency that regulates many products, including food products, drugs, medical devices, radiation emitting devices, and cosmetics for the federal government of the United States. The FDA’s mission is to assure that consumer products made and sold in the United States are safe, effective, and pure. The purpose of the package insert (also known as prescription drug product insert or professional labeling) is to provide detailed drug information compiled and distributed by the drug manufacturer, after FDA review and approval.

In 2006, the standard format for the package insert was changed in an attempt to make it more user-friendly and a more efficient resource tool for practitioners.

According to the Institute of Medicine, in-hospital adverse drug reactions occur at a rate of 400,000 per year and incur $3.5 billion of extra hospital expense. It is expected that the new package insert format will enhance rapid access to important pharmacologic information and improve patient safety by decreasing medication errors.

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FDA Overview: Products with potential Melamine contamination

by: continuum wellness - December 2nd, 2008   Filed under: FDA, food, Health, infants Add Comment

The Food and Drug Administration (FDA) has stated that there is no known threat of contamination of infant formula manufactured by companies that have met the requirements to sell such products in the United States. However, the following is a list of companies and their products being recalled because of detected melamine contamination:

Lotte USA Inc., of Battle Creek, Mich.

* All flavors of Koala March Cookies. Distributed nationwide and to Canada through wholesale distributors and retail stores. The products are packaged in a plastic overwrap.

Hua Xia Food Trade USA Inc. of Flushing, N.Y.

* YILI Brand Sour Milk Drink. Distributed to New York City through Asian retail grocery stores and packaged in 250 ml flexible paperboard boxes with blue, red and green Chinese writing. There is a picture of an Asian man in a green shirt and white tie.
* YILI Brand Pure Milk Drink. Distributed to New York City through Asian retail grocery stores and packaged in 250 ml flexible paperboard boxes with black, red and white writing in English and Chinese. There is a picture of two cows playing a sport on the face of the box.
Tristar Food Wholesale Co. Inc. of Jersey City, N.J.

* Blue Cat Flavor Drink. Sold nationwide in Asian grocery stores, the product comes in 100 ml plastic bottles with a logo of blue cat on the back of the bottle and the word “blue cat” in Chinese on the front.
QFCO Inc. of Burlingame, Calif.

* White Rabbit Candy. Sold through wholesale distributors to retail stores in California, Georgia, Hawaii, Illinois, Minnesota, New York, Oregon, Texas and Washington.
Sunny Maid Corp. of Monterey Park, Calif.

* Mr. Brown instant coffee and milk tea products. Mr. Brown 3-in-1 and 2-in-1 powdered packets were sold in plastic bags, each containing 30 individual packets. Flavors include Mandheling Blend, Arabica, Blue Mountain Blend, Caramel Macchiato, French Vanilla and Milk Tea.

The FDA is advising consumers not to consume the following products because of possible melamine contamination:

* Fresh and Crispy Jacobina Biscuits
* Koala’s March Crème filled Cookies
* YILI Brand Sour Milk Drink
* YILI Brand Pure Milk Drink
* Blue Cat Flavored Drinks
* White Rabbit Candies
* Mr. Brown Mandehling Blend Instant Coffee (3-in-1)
* Mr. Brown Arabica Instant Coffee (3-in-1)
* Mr. Brown Blue Mountain Blend Instant Coffee (3-in-1)
* Mr. Brown Caramel Macchiato Instant Coffee (3-in-1)
* Mr. Brown French Vanilla Instant Coffee (3-in-1)
* Mr. Brown Mandheling Blend instant Coffee (2-in-1)
* Mr. Brown Milk Tea (3-in-1)
* Infant formula manufactured in China

Consumers should stop using these products and return them to the place of purchase for a refund.

FDA Statement (here)
Melamine Contamination in China (here)

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Tomato Warning Update

by: continuum wellness - June 10th, 2008   Filed under: FDA, food, Uncategorized Add Comment

The FDA has indicated that tomatoes from the following sources are not associated with the outbreak:

* Alabama
* Arkansas
* California
* Georgia
* Hawaii
* Louisiana
* Maine
* Maryland
* Minnesota
* Mississippi
* New York
* Nebraska
* North Carolina
* Ohio
* Pennsylvania
* South Carolina
* Tennessee
* Texas
* West Virginia
* Belgium
* Canada
* Dominican Republic
* Guatemala
* Israel
* Netherlands
* Puerto Rico

FDA recommends that retailers, restaurateurs, and food service operators offer only fresh and fresh cut red Roma, red plum, and round red tomatoes and food products made from these tomatoes for sale or service from the sources listed above.

FDA further recommends that retailers, restaurateurs, and food service operators continue to offer cherry tomatoes, grape tomatoes, and tomatoes sold with the vine still attached, from any source.

This means that you will have to know what state the tomato is grown. And while we all know growing your own tomatoes is best, there are reasons we need to buy them from other growers.

Warning on Certain Types of Raw Red Tomatoes

The Food and Drug Administration (FDA) is alerting consumers in New Mexico and Texas that a salmonellosis outbreak appears to be linked to consumption of certain types of raw red tomatoes and products containing raw red tomatoes. The bacteria causing the illnesses are Salmonella serotype Saintpaul, an uncommon type of Salmonella.

Salmonella can cause serious and sometimes fatal infections particularly in young children, frail or elderly people, and those with weakened immune systems. Healthy people often experience fever, diarrhea (which may be bloody), nausea, vomiting, and abdominal pain. In rare circumstances, the organism can get into the bloodstream and produce more severe illnesses.
Preliminary Data

The specific type and source of tomatoes are under investigation. However, preliminary data suggest that raw red plum, red Roma, or round red tomatoes are the cause.

From April 23 though June 1, 2008, there have been 57 reported cases of salmonellosis caused by Salmonella Saintpaul in New Mexico and Texas, including 17 hospitalizations. Approximately 30 reports of illness in Arizona, Colorado, Idaho, Illinois, Indiana, Kansas, and Utah are currently being investigated to determine whether they are also linked to tomatoes. There are no reported deaths.
Advice for Consumers

* At this time, consumers in New Mexico and Texas should limit their tomato consumption to tomatoes that have not been implicated in the outbreak. These include cherry tomatoes, grape tomatoes, tomatoes sold with the vine still attached, and tomatoes grown at home.
* Consumers in New Mexico and Texas who have recently eaten raw tomatoes or foods containing raw tomatoes and are experiencing any of these symptoms should contact their health care provider. All Salmonella infections should be reported to state or local health authorities.

Investigation Continues

FDA recognizes that the source of the contaminated tomatoes may be limited to a single grower or packer or tomatoes from a specific geographic area. FDA also recognizes that there are many tomato crops across the country and in foreign countries that are just becoming ready for harvest or will become ready in the coming months.

To ensure that consumers can continue to enjoy tomatoes that are safe to eat, FDA is working diligently with the states, the Centers for Disease Control and Prevention, the Indian Health Service, and various food industry trade associations to quickly determine the source and type of the contaminated tomatoes. As more information becomes available, FDA will update this warning.
For More Information

FDA’s Tomato Consumer Page
http://www.fda.gov/oc/opacom/hottopics/tomatoes.html

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Mercury Free Dentistry

by: continuum wellness - June 6th, 2008   Filed under: children, family, FDA, Health, health care, Uncategorized 2 Comments

Your diet is healthy, you stretch and exercise what else might you need to look at if you want to detox your body? Open your mouth and say a-a-h. Do you have any mercury fillings in your mouth? Moms against Mercury recently won against the FDA regarding the safety of amalgams. They will now have to at least admit that they are not totally safe.

FDA now states, for example:

“Dental amalgams contain mercury, which may have neurotoxic effects
on the nervous systems of developing children and fetus.” “Pregnant
women and persons who may have a health condition that makes them
more sensitive to mercury exposure, including individuals with
existing high levels of mercury bioburden, should not avoid seeking
dental care, but should discuss options with their health practitioner.”

For the FDA statement here
Toxic Teeth is a grassroots organization dedicated to mercury free dentistry, check them out for additional information.

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FDA Probing Possible Link Between Asthma Drug and Suicide Risk

by: continuum wellness - March 28th, 2008   Filed under: adverse events, allergies, asthma, common cold, depression, drugs, FDA, mood changes, side effects, Singulair, suicide 3 Comments

FDA is investigating a possible association between the use of Singulair and behavior/mood changes, suicidality (suicidal thinking and behavior) and suicide. Singulair is a medicine in the drug class known as leukotriene receptor antagonists. Singulair is used to treat asthma and the symptoms of allergic rhinitis (sneezing, stuffy nose, runny nose, itching of the nose) and to prevent exercise-induced asthma.

Over the past year, the maker of Singulair, Merck & Co, Inc., has updated the prescribing information and patient information for Singulair to include the following post-marketing adverse events: tremor (March 2007), depression (April 2007), suicidality (suicidal thinking and behavior) (October 2007), and anxiousness (February 2008).

In February 2008, FDA and Merck discussed how best to communicate these labeling changes to prescriber’s and patients. Merck plans to highlight the recent changes in the prescribing information in face-to-face interactions with prescriber’s and provide prescriber’s with patient information leaflets about Singulair. The Singulair website includes the most current prescribing information and patient information for Singulair (www.singulair.com).

FDA is working with Merck to further evaluate a possible link between the use of Singulair and behavior/mood changes, suicidality and suicide in response to inquiries received by FDA. FDA has requested that Merck evaluate Singulair study data for more information about suicidality and suicide. FDA is reviewing the postmarketing reports it has received of behavior/mood changes, suicidality and suicide in patients who took Singulair.

Due to the complexity of the analyses, FDA anticipates that it may take up to 9 months to complete the ongoing evaluations. As soon as this review is complete, FDA will communicate the conclusions and recommendations to the public.

Other leukotriene modifying medications include zafirlukast (Accolate), which is also a leukotriene receptor antagonist and zileuton (Zyflo and Zyflo CR), which is a leukotriene synthesis inhibitor. FDA is reviewing postmarketing reports it has received of behavior/mood changes, suicidality and suicide in patients who took Accolate, Zyflo, and Zyflo CR and will assess whether further investigation is warranted.

This early communication is in keeping with FDA’s commitment to inform the public about its ongoing safety reviews of drugs.

The FDA urges both healthcare professionals and patients to report side effects from the use of Singulair, Accolate, Zyflo, and Zyflo CR to the FDA’s MedWatch Adverse Event Reporting program

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