Consumer Lawyers

BioAnue Laboratories, Inc. Warning Letter

In Uncategorized on February 29, 2012 at 2:14 am

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

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