4/26/17

FDA Warns 14 Companies For Selling Unproven Cancer ‘Cures’

Treating cancer can be a painful, drawn-out process, and there’s no guarantee of a cure. Unfortunately, there’s no magic pill that can get rid of cancer, or prevent it from occurring in the first place. That hasn’t stopped a number of companies from making unproven promises about products they claim will remedy everything from AIDS to diabetes.

The Food and Drug Administration announced Wednesday that it sent letters this week to the manufacturers of more than 65 products notifying them that the sale of the pills, ointments, drops, oils, syrups, teas, and diagnostic devices is in violation of the FDA rules.

Under the Federal Food, Drug, and Cosmetic Act, it is a violation to market or sell products that claim to prevent, diagnose, treat, mitigate, or cure diseases without first demonstrating to the FDA that the products are safe and effective for their labeled uses.

According to the FDA letters, a review of the companies’ websites found that the products were being illegally marketed and sold via websites and social media platforms.

Specifically, the companies were found to make unproven claims regarding the product’s ability to prevent, reverse, or cure cancer; kill or inhibit cancer cells or tumors; or other similar anti-cancer claims, the FDA notes.

In one case, the FDA sent a letter to AIE Pharmaceuticals, Inc. — the company behind Cevrogin, Cholestrien, ImmunPro, Livral Complex, and Prozidan — claiming the products are not generally recognized as safe and effective for the conditions, prescribed, recommended, or suggested on their labels.

For example, the FDA claims that AIE made claims on its website that its Cevrogin product included dandelion root, which has “also been shown to have potential for fighting cancer,” and that its ImmunPro product is “proven to still be effective against cancer.”

The FDA notes that because it did not provide approval of these products, they are considered “new drugs,” and can not be “legally introduced or delivered introduction into interstate commerce without prior approval from the FDA.”

The agency requested responses from the 14 companies stating how the violations will be corrected. Failure to correct the issues promptly could result in legal action, including seizure of products or criminal prosecution, the agency says.

The FDA warns that claims used by the companies could do more harm for consumers than good.

Such claims could prevent people from seeking an appropriate and potentially life-saving cancer diagnosis or treatment, Douglas W. Stearn, director of the Office of Enforcement and Import Operations in the FDA’s Office of Regulatory Affairs, said in a statement.

“We encourage people to remain vigilant whether online or in a store, and avoid purchasing products marketed to treat cancer without any proof they will work,” Stearn warns, adding that patients should consult a health care professional about proper prevention, diagnosis and treatment of cancer.”

A full list of the companies and products receiving letters from the FDA: 

Company Name Product Name
AIE Pharmaceuticals, Inc. Cevrogin, Cholestrien, ImmunPro, and Livral Complex
Amazing Sour Sop, Inc. Sour Sop Capsules, Sour Sop Leaves, and Sour Sop Tea Bags
BioStar Technology International, LLC Angiostop, Ashwagandha, Asparagus Extract, OliveLeafQi, and Revivin
Caudill Seed & Warehouse Inc. Vitalica
DoctorVicks.com Freeda Vitamins – Garlic 400 mg, Freeda Vitamins – Quercetin 50 mg, Freeda Vitamins – Vitamin B2 (Riboflavin) 50 mg, Maxi Health – Livamax with Milk Thistle, Maxi Health – Maxi Omega-3 2000, Maxi Health – Triple Maxi Omega-3 Concentrate with D3 2000IU, and Maxi Health – Maxi Resveratrol – Kosher Heart & Memory Formula
Everything Herbs Cleavers, Inkberry, Korean Ginseng, Lapacho, Red Clover, and Whole Apricot
Hawk Dok Natural Salve, LLC Skin Cancer Treatment, and Smokeless Tobacco Cancer Treatment for Gums, and Lip Sores
Healing Within Products & Services, Inc. Astragalus Glycerite, Black Salve, Healthy Prostate & Ovary, Original Herbal Tea Remedy, ProBoost Thymic Protein A, and Siberian Chaga Mushroom Extract
LifeVantage Corporation Protandim NRF2 Synergizer
Nature’s Treasure, Inc. Colostrum LD Capsules, Dysbiocide, KR22 Oxicell, and Matcha Tea
Oxygen Health Systems, LLC Graviola, Graviola Max, Liposomal Complete Complex Plus, Liposomal Curcumin, Liposomal Vitamin B17 Amygdalin, Liposomal Vitamin C, Palladium Lipoic Complex, Premium Flax, Rerum Blue, and Super Liposomal Plus
Sunstone, Inc. Chelated Boron, Circulatory Detox & Support Syrup, Essiac Tea, Fermented Yeast Culture, Premium Organic, 8 oz., Virxcan-X Salve, and Virxcan-X Tablets
The Vibrant Health Store, LLC dba Dr. Christopher’s Herbs Black Drawing Ointment, Burdock Root, Kid-e-Trac, Liver D-Tox Formula, Rash Ointment, Red Clover Blossoms, Relax-Eze, and St. John’s Wort
The Vitamin C Foundation Cardio-C, Chewables Vitamin C, Sodium Ascorbate, True Liposomal Vitamin C, and World’s Finest Vitamin C Powder
CellMark Biopharma LLC CellAssure
Landis Revin, LLC Trevinol ES Fibrin Defense Systemic Enzyme, Trevinol ES Health Joint & Inflammation Support, Trevinol Professional Blend
Nathans Natural Levodyn
healinginabottle.com Immuno Boost Eximius

 

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