BioAnue Laboratories, Inc. Warning Letter

Gloria Raber
BioAnue Laboratories, Inc.
123 Wood Tech Drive
Rochelle, GA 31 079

Dear Ms. Raber:
 

This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your websites at http://www.tumorx.com, http://www.cancerx.org, http://www.hopewelltechnologieslimited.com, and http://www.vmhe.com in February 2012 and has determined that your “Bovine Cartilage,” “TumorX BioEnerGenics Co-Enzyme -Q1O,” “TumorX Cardio Clean,” “Diabetic Mender,” “TumorX Formula CX,” and “Stroke Mender” products are promoted for conditions that cause these products to be drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)]. The therapeutic claims on your websites, http://www.tumorx.com, http://www.cancerx.org, and  http://www.hopewelltechnologieslimited.com, establish that these products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of your products with these claims violates the Act. You may find the Act and FDA’s regulations through links on FDA’s home page at http://www.fda.gov.

Your websites, http://www.tumorx.com, http://www.cancerx.org, and http://www.hopewelltechnologies.com, link to your website, http://www.vmhe.com, where consumers can purchase your products.

On your websites, http://www.tumorx.com, http://www.cancerx.org, and http://www.hopewelltechnologieslimited.com, the tab called “Cancers” opens to a list of various cancers (e.g., Breast Cancer, Pancreatic Cancer, Throat Cancer, Vaginal Cancer, Acute Lymphocytic Leukemia, Hodgkin’s Lymphoma, Lung Cancer, and Uterine Cancer, etc.) that hyperlink to Tumor X Protocols and products your firm recommends for the treatment of cancer.

Examples of some of the claims observed on your websites, http://www.tumorx.com, http://www.cancerx.org, and http://www.hopewelltechnologieslimited.com, including the following:

“Bovine Cartilage”

• “Bovine Cartilage Stops Tumor Growth”

• “Bovine cartilage has been demonstrated … to stop/inhibit the spread, growth and proliferation of cancer cells.”

• “Bovine cartilage is used to prevent and treat cancer and treat HIV/AIDS … “

• “[B]ovine cartilage has antitumor and immunoregulatory effects.”

• “TumorX Brand products aid in the structure and function of the body; this allows deficiency induced diseases such as cancer, heart disease, diabetes and Alzheimer’s, just to name a few, to be reversed …. “

“TumorX BioEnerGenics Co-Enzyme -010” (product name is an implied claim)

• “Co-Enzyme Q10: Squamos cell carcinoma can be reversed and cured using this natural substance.”

• “[T]umorX BioEnerGetics CoQ-10, an immune stimulant that has been proven to defeat cancers.”

• “[C]o-Enzyme Q1O in the prevention and treatment of heart disease is due to its ability to .. .inhibit blood clot formation …. “

• “[C]o-Enzyme Q10 supplements help reduce swelling in the legs, enhance breathing by reducing fluid in the lungs …. “

• “[C]o-Enzyme Ql0 may lower blood pressure.”

• “[C]o-Enzyme Q1O may help prevent heart damage caused by certain chemotherapy drugs …. “

• “[C]o-Enzyme Q1O prior to heart surgery, including bypass surgery and heart transplantation, can reduce damage caused by free radicals, strengthen heart function, and lower the incidence of irregular heart beat (arrhythmias) during the recovery phase.”

• “[C]o-Enzyme Q10 supplements … may shrink tumors, reduce pain associated with the condition, and cause partial remission in some individuals.”

• [C]o-Enzyme Q1O may:

o “Improve immune function in individuals with immune deficiencies (such as acquired immunodeficiency syndrome or AIDS) and chronic infections (such as yeast, bacteria, and viral infections.)”

o “Be used as part of the treatment for Alzheimer’s disease and Parkinson’s disease”

o “Reduce damage from stroke”

“Tumor X Cardio Clean” (product name is an implied drug claim)

• “Cardio Clean can be used when a build up of fat in arteries has occurred, you have high cholesterol or high triglycerides …. [C]lean out your arteries and eliminate high cholesterol and triglycerides.”

• “Cardio Clean … transforms artery clogging cholesterol into disease fighting substances needed for proper function inside the body.”

“Diabetic Mender” (product name is an implied drug claim)

• “[C]an start to control diabetes for most people within the first 2 capsules of the product.”

• “[W]ill in most people control, repair and reverse their diabetes.”

“Formula CX”

• “Formula CX will reverse wasting disease.”

• “TumorX Formula CX contains the key nutrients allowing the body to reverse wasting disease.”

• “[A]ll cancer patients should supplement with TumorX Formula CX to prevent the poisoning of the body that leads to a wasting syndrome known as cachexia.”

• TumorX Formula CX supplementation is even more important for those patients who have stage two cancer and higher.”

“Stroke Mender” (product name is an implied drug claim)

• “[O]ne can repair the brain using Stroke Mender.”

• “Peer reviewed studies have proven that when Stroke Mender was given to patients, significant positive improvements were shown within the first 90 days of taking Stroke Mender.”

• “Stoke Mender will repair the neurons in the brain, reversing the effects of stroke in the human body.”

• “Studies have shown that Stroke Mender (Citicoline) is effective in helping stroke victims recover.”

Your websites also contains disease claims in the form of personal testimonials. The following are excerpts from your http://www.tumorx.com, http://www.cancerx.org, and http://www.hopewelltechnologieslimited.com homepages under the title “Testimonials”:

 

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm293286.htm

Herman’s Bakery 2/22/12 Warning Letter

 

Herman A. Oestreich

Owner

Herman’s Bakery

130 Main Street South

Cambridge, Minnesota  55008-1621

 

Dear Mr. Oestreich:

 

The United States Food and Drug Administration (FDA) conducted an inspection of your facility located at 130 Main Street South, Cambridge, Minnesota, on September 14-15, 21-22, 27 and 29, 2011.  During the inspection, product labels were collected. Our review of your product labels reveals that your Long Johns, Raspberry Bismarks, Snowballs, and Glazed Raised Donuts products are misbranded within the meaning of section 403, 21 U.S.C. § 343, of the Federal Food, Drug, and Cosmetic Act (the Act) and the implementing regulations contained within Title 21, Code of Federal Regulations, Part 101 (21 CFR 101). You may find the Act and the referenced CFR regulations through links on FDA’s internet home page at www.fda.gov.

 

The significant violations are as follows:

 

1.     Your Long Johns, Raspberry Bismarks, Snowballs and Glazed Raised Donuts are misbranded within the meaning of section 403(w) of the Act, 21 U.S.C. § 343(w), in that the labels for these products fail to declare the known major food allergens, wheat and soy, as specified by the Act.

 

Section 201(qq) of the Act, 21 U.S.C. § 321(qq), defines as “major food allergens” milk, egg, fish, Crustacean shellfish, tree nuts, wheat, peanuts, and soybeans, as well as any food ingredient that contains protein derived from one of these foods, with the exception of highly refined oils. A food is misbranded if it is not a raw agricultural commodity and it is, or it contains an ingredient that bears or contains, a major food allergen, unless either:

 

• the word “Contains,” followed by the name of the food source from which the major food allergen is derived, is printed immediately after or adjacent to the list of ingredients, section 403 (w)(1)(A) of the Act, 21 U.S.C. § 343(w)(1)(A); or
• the common or usual name of the major food allergen in the list of ingredients is followed in parentheses by the name of the food source from which the major food allergen is derived, e.g. “(wheat),” except that the name of the food source is not required when either the common or usual name of the ingredient uses the name of the food source or the name of the food source appears elsewhere in the ingredient list (unless the name of the food source that appears elsewhere in the ingredient list appears as part of the name of an ingredient that is not a major food allergen), section 403(w)(1)(B) of the Act, 21 U.S.C. § 343(w)(1)(B).

 

Your Long Johns, Raspberry Bismarks, Snowballs and Glazed Raised Donuts product formulations reveal that (b)(4) Flour and (b)(4) milk powder, which contain bleached wheat flour and defatted soy flour, respectively, are used in the manufacturing process. However, your finished product labels fail to declare the presence of the major food allergens wheat and soy. 

 

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm292989.htm

FDA Warns Schwabe For Homeopathic Ingredientss

Michael Devereux
Chief Executive Officer
Schwabe North America, Inc.
825 Challenger Drive
Green Bay, Wisconsin 54311
 

Dear Mr. Devereux:

This letter is to advise you that the United States Food and Drug Administration (FDA or Agency) has reviewed your Schwabe North America, Inc. and Nature’s Way Products, Inc. websites at http://www.naturesway.com and http://www.umcka.com. FDA reviewed your firm’s labeling and marketing information for the “Umcka®” line of products including (but not limited to): ColdCare Original Drops, ColdCare Alcohol Free Drops, ColdCare Syrup (Mint-Menthol), ColdCare Syrup (Cherry), ColdCare Sugar-Free Syrup (Grape), ColdCare Soothing Hot Drink (Lemon), ColdCare Chewable (Mint-Menthol), ColdCare Chewable (Cherry), ColdCare FastActives™ Powder Packets (Cherry), ColdCare Children’s Syrup (Cherry), ColdCare Children’s FastActives™ Powder Packets (Cherry), Cold+Flu Syrup (Berry), Cold+Flu Syrup (Orange), Cold+Flu Chewable (Berry), Cold+Flu Chewable (Orange), and Cold+Flu FastActives™ Powder Packets (Berry) (collectively referred to as “Umcka products”). Based on our review of your websites and the labeling for these products, the Umcka products are unapproved new drugs in violation of sections 301 and 505 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. §§ 331 and 355). Further, the products are misbranded in violation of sections 301 and 503 of the Act(21 U.S.C. §§331 and 353).

Statements on your website http://www.umcka.com documenting the intended uses of the Umcka ColdCare line of products include, but are not limited to, the following:

“Umcka ColdCare is a 1X tincture of Pelargonium sidoides (EPs 7630), a medicinal plant unique to South Africa. In clinical studies, EPs 7630 not only relieves symptoms associated with common colds, but also shortens the duration and reduces severity of throat, sinus and bronchial irritations.”

“In an evaluation study, over 90% of patients and doctors rated EPs 7630 as an effective treatment for colds and upper respiratory irritations.”

“Umcka goes beyond symptom relief and actually helps you recover faster -which means you can get back to life faster, too.”

“The formula is a clinically proven preparation of EPs 7630, and the name [Umcka] is derived from the African word “umKhulkane” (meaning respiratory infection.)”

Statements on your website http://www.umcka.com documenting the intended uses of your Umcka Cold+Flu line of products include, but are not limited to, the following:

“Umcka Cold+Flu formulas combine two clinically-effective natural medicines (Umcka P. sidoides and the Alpha® CF blend) to tackle both cold and flu viruses.”

“Trust these products for maximum relief from:

• Aches/Pains
• Congestion
• Cough
• Fever
• Runny Nose
• Sore Throat

Statements on your website http://www.umcka.com and/or the labeling for your products that document the intended uses of the Umcka products include, but are not limited to, the following:

Umcka® ColdCare Chewable Tablets (Mint-Menthol):

“Umcka ColdCare

SHORTENS DURATION & REDUCES SEVERITY

Cough, Congestion, Sore Throat, Sinus & Bronchial Infections”

“You can feel confident knowing that the EPs 7630 found within Umcka has been widely studied by various clinical organizations in the treatment of the common cold, acute bronchitis and other upper respiratory concerns.”

Umcka® ColdCare Children’s Syrup (Cherry):

“A children’s liquid formula that shortens the duration and reduces the severity of throat, sinus, and bronchial irritations.”

Umcka® ColdCare Syrup (Cherry):

“Shortens duration and reduces severity of symptoms associated with common colds and throat/sinus/bronchial infections: congestion, cough, headache, hoarseness, minor aches, sore throat[.]

Helps loosen phlegm (mucus)to make cough more productive.”

Umcka® Cold+Flu Syrup (Orange):

“Umcka Cold+Flu

Multi-Action Natural Relief

Aches/Pains, Congestion, Cough, Fever, Runny Nose, Sore Throat”

“Shortens duration and reduces severity of symptoms associated with the common cold and throat/sinus/bronchial infections, and temporarily relieves flu symptoms:
 

• chills and fever
• congestion
• cough
• headache
• hoarseness
• minor aches/pains
• sore throat
• stuffy nose
• sneezing/runny nose
• helps loosen phlegm (mucus) to make coughs more productive.”

Further, your website http://www.umcka.com references published studies, and includes summaries of a number of published studies, on a page titled “Umcka® Product Research.” The publications listed on your website all concern therapeutic uses of Pelargonium sidoides, which is identified as an active ingredient in all of the Umcka® products. The page states “The Pelargonium sidoides extract (EPs 7630) within Umcka® has been widely studied by various clinical organizations to not only relieve symptoms associated with common colds, but also shortens the duration and reduces severity of throat, sinus and bronchial irritations.”

The following are examples of published clinical studies and summary statements included for them that are cited on your website in association with the Umcka products:

“Pelargonium sidoides preparation (EPs7630) in the treatment of acute bronchitis in adults and children.”

“In conclusion, EPs 7630 is an effective and well tolerated treatment of acute bronchitis in adults, children and infants outside the strict indication for antibiotic treatment.”

“Treatment of acute rhinosinusitis with the preparation from Pelargonium sidoides EPs 7630: a randomized, double-blind, placebo-controlled trial.”

“EPs 7630 was well tolerated and superior in efficacy compared to placebo in the treatment of acute rhinosinusitis of presumably bacterial origin.”
 

“Efficacy of extract of Pelargonium sidoides in children with acute non-group A beta-hemolytic streptococcus tonsillopharyngitis: a randomized double-blind, placebo controlled trial.”

“EPs 7630 was superior compared to placebo for the treatment of acute non-GABHS tonsillopharyngitis in children. Treatment with EPs 7630 reduced the severity of symptoms and shortened the duration of illness by at least 2 days.”

When scientific publications are used commercially by the seller of a product to promote the product to consumers, such publications may become evidence of the product’s intended use. For example, under 21 C.F.R. 101.93(g)(2)(iv)(C), a citation of a publication or reference in the labeling of a product is considered a claim about disease treatment or prevention if the citation refers to a disease use, and if, in the context of the labeling as a whole, the citation implies treatment or prevention of a disease.

 

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm292680.htm

FDA recalls RegenArouse herbal pills for containing tadalafil

A recall of RegenArouse, a “natural female intimacy enhancement” supplement, is being conducted by its maker, Regeneca, Inc., said the U.S. Food and Drug Administration today. The herbal pills actually contain, tadalafil, the drug found in Cialis and other pills used to treat erectile dysfunction in males.

Tadalafil is an FDA-approved drug for the treatment of ED, however, it interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. And because it is an unlisted ingredient in the RegenArouse herbal supplement, the FDA and Regeneca have announced the voluntary recall.

The recalled affects one lot (Lot Number: 130100) of the RegenArouse drug with an expiration date of 12/5/2013 and a UPC code of 816860010079. The packages of pink pills were sold online directly to consumers in the U.S and Puerto Rico from November 29, 2011 and February 10, 2012.

Consumers with the recalled RegenArouse pills are urged to call Regeneca’s toll-free customer support line (800-690-6958) for instructions on how to return the pills for a full refund.

Regeneca, Inc. Issues A Voluntary Nationwide Recall Of A Specific Lot Of RegenArouse Because Of Potential Health Risks [FDA]

FDA recalls injectable drugs: Phenylephrine HCl injection, USP, 1% 5 mL vial and cytarabine for injection, USP, 1 gram per vial, from Bedford Laboratories

The FDA has announced recalls of two injectable drugs: phenylephrine HCl injection, USP, 1% 5 mL vial, from American Regent, and cytarabine for injection, USP, 1 gram per vial, from Bedford Laboratories. On its Web site, the FDA posted press releases from both companies announcing the nationwide voluntary recalls.

Only one lot, Lot 0693, exp. date October 2012, was recalled of phenylephrine HCl injection, USP, 1% (10mg/mL), 5 mL vial NDC #0517-0405-25. The recall was prompted by potential safety concerns resulting from the identification of visible particles in some retained samples of the lot, according to the FDA. American Regent stated “it has not received any reports of adverse events related to this recall.”Potential adverse events after IV administration of solutions containing particulates may include disruption of blood flow within small blood vessels in the lung, localized inflammation, and granuloma formation, the FDA press release stated. Phenylephrine HCl injection is intended, among other uses, for the maintenance of adequate blood pressure during spinal and inhalation anesthesia, and treatment of vascular failure in shock, shock-like states, and drug-induced hypotension or hypersensitivity.

Three lots of the anticancer drug cytarabine for injection, USP, 1 gram per vial NDC #55390-133-01, were recalled: Lot 2066986, exp. date March 31, 2014; Lot 2111675, exp. date April 30, 2014; and Lot 2131148, exp. date May 31, 2014. Bedford Laboratories initiated the recall due to “a post-release investigation of the manufacturing area which determined a potential elevated risk of a lack of sterility assurance for these specific lots,” the FDA press release stated. Cytarabine is used in acute non-lymphocytic leukemia, acute lymphocytic leukemia, chronic myelocytic leukemia, and meningeal leukemia.

Both companies advise that healthcare facilities and providers should not use the recalled product lots and should immediately quarantine any product for return.

 

http://www.pharmacypracticenews.com/ViewArticle.aspx?d=Clinical&d_id=50&i=February+2012&i_id=810&a_id=20248

Regeneca recalls all lots of single capsule packet RegenErec

Regeneca has issued a voluntary recall of all lots of single capsule packet RegenErect, labeled as a dietary supplement.

 

RegenErect is a blue capsule sold individually in foil packets with a UPC code of 816860010055.

The company has confirmed the presence of Tadalafil, an FDA-approved drug used as treatment for male erectile dysfunction, making these products unapproved new drugs.

The active drug ingredient is not listed on the label for these products, the company said.

The products may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous level.

 

http://packaging.pharmaceutical-business-review.com/news/regeneca-recalls-all-lots-of-single-capsule-packet-regenerect-270212

February 27,2012 Vaginal Mesh News for GA and FL

Background

Vaginal mesh is a medical device that is surgically implanted to treat pelvic organ prolapse.

Manufacturers

 

• C.R. Bard Avaulta
• AMS Elevate Prolapse Repair System
• AMS Apogee Valut Suspension Systm
• AMS Perigee System
• AMS Monarc Sling System
• AMS Sparc Sling System
• Johnson & Johnson (Ethicon) Gynecare Gynemesh
• Johnson & Johnson (Ethicon) Gynecare Prolene Soft Mesh
• Johnson & Johnson (Ethicon) Gynecare Prolift Pelvic Floor Repair System
• Johnson & Johnson (Ethicon) Gynecare TVT Transvaginal Sling
• Boston Scientific Pinnacle Pelvic Floor Repair Kit
• Boston Scientific Uphold Vaginal Support System
• UGYTEX Dual Knit Mesh
• Covidien IVS Tunneler Sling

Glaxo recalls some lots of Ca-channel blocker DynaCirc CR

GlaxoSmithKline has recalled >394 000 bottles of its calcium-channel blockerisradipine (DynaCirc CR) for hypertension, news outlets are reporting based on statements from the company.

The media reports follow a February 22 enforcement report from the FDA that stated that the company-initiated recall was based on irregularities with the product packing process at a Novartis factory in Lincoln, NE . Novartis manufactured the drug there for Glaxo.

The Wall Street Journal reported Friday that the Nebraska plant recently closed in order to respond to a problem identified by regulators. “Among the observations cited by FDA inspectors were reports of tablets of certain medicines being placed in bottles labeled for other products.”

Glaxo was informed by Novartis of the potential for DynaCirc CR “tablet mix-ups” at the plant but “has received no reports of adverse events or any complaints of foreign products or tablet mix-ups in any batches of DynaCirc,” according to a GlaxoSmithKline spokesperson quoted in the paper’s story.

The FDA enforcement report said the recalled lots include 30-count bottles of 5-mg and 10-mg controlled-release DynaCirc capsules with expiration dates primarily in 2013: lots 10084536, 10102915, 10102916, 10107157, 10108172, 10087732, 10091069, 10094639, 10102913, and 10109327.

 

http://www.theheart.org/article/1363045.do

More birth control pills recalled due to packaging error

Glenmark Generics is issuing a nationwide recall of seven lots of birth control pills. The pills are labeled “norgestimate and ethinyl estradiol tablets.”

Because of a packaging error, some of the pills were placed in the wrong order within the packs, according to a statement from the Food and Drug Administration. The packs contain three types of pills with varying levels of hormones, designed to be taken at different times during a woman’s cycle.

The pills were rotated 180 degrees within the pack, so the weekly tablet orientation is reversed, and the lot number and expiration date are visible only on the outer pouch, according to the FDA. Any pack for which the lot number and expiry date is not visible is subject to recall

Read more: http://www.foxnews.com/health/2012/02/27/more-birth-control-pills-recalled/?test=latestnews#ixzz1ndmYtDoE

 

 

http://www.foxnews.com/health/2012/02/27/more-birth-control-pills-recalled/?test=latestnews#ixzz1ndmPIcPG

Wisconsin: 29 lawsuits filed 2/23/12 alleged Imprelis-caused damage to trees

Twenty-nine lawsuits were filed Thursday against DuPont in Waukesha County by property owners alleging that the chemical giant’s herbicide Imprelis has killed or is killing their trees.

The lawsuits contend that DuPont marketed the weed killer as being environmentally friendly and safe to use and “that is simply not the truth.”

“In its relatively short time on the market, DuPont’s Imprelis has proven to be a frighteningly effective tree killer,” the suits say.

Coniferous trees are particularly susceptible to being damaged or killed by the herbicide, according to the lawsuits.

Among those who are suing DuPont de Nemours and Co. are Summit Police Chief James Race and Waukesha County Circuit Judge Ralph Ramirez.

DuPont is facing similar lawsuits across the country Imprelis, which was first used in the fall of 2010, over tree death and damage.

The U.S. Environmental Protection Agency in August ordered DuPont to stop the sale and use of the herbicide, which was distributed and sold primarily to lawn care professionals.

Race’s lawsuit states that a lawn care service applied Imprelis to his property in Ottawa beginning in June of last year and that the herbicide was applied five times according to directions supplied by DuPont.

In the fall, a certified arborist examined trees on Race’s property and noted that 25 Norway spruce trees were 75% to 100% brown, dying and twisted, the lawsuit states and that there were other signs of death on all trees on the property.

Trees on a neighboring property also were damaged or dying, the suit says, even though the herbicide was not used on the property. The neighbors, Steven and Janette Zwicke, also are suing DuPont.

“I have 29 trees that are either dead or dying,” Race said Thursday. “I have a group of trees that lost their needles over the winter. DuPont knows they killed a lot of trees. They are not taking responsibility for it.”

The Zwickes lost a couple dozen trees, Race said.

Ramirez’s lawsuit says a lawn service applied Imprelis on the property of his Town of Waukesha residence one time in June and that by October, all eight trees on his property were showing signs of death.

DuPont spokeswoman Kate Childress said Thursday that the company is evaluating its response to the legal complaints.

“DuPont is committed to proper stewardship of all of its products. We are engaged in a comprehensive claims resolution process that fairly addresses claimed damage due to Imprelis,” the statement says.

Attorney Jay Urban, who filed the lawsuits on behalf of the Waukesha County homeowners, said “hundreds and hundreds” of trees have been killed by the herbicide in the county.

“It’s kind of a sad situation,” said Urban, who filed one similar case last fall in Waukesha County. That case was consolidated with cases filed in Pennsylvania, he said.

Urban said he expected to file about 100 more lawsuits in the next two weeks.

Source: http://www.jsonline.com/news/waukesha/29-lawsuits-filed-against-dupont-over-tree-damage-jm4afsh-140211533.html