The U.S. Food and Drug Administration has notified 14 US-based companies they are illegally selling more than 65 products that fraudulently claim to prevent, diagnose, treat or cure cancer.
The products are marketed and sold without FDA approval, most commonly on websites and social media platforms.
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“Consumers should not use these or similar unproven products because they may be unsafe and could prevent a person from seeking an appropriate and potentially life-saving cancer diagnosis or treatment,” said Douglas Stearn, of FDA’s Office of Regulatory Affairs. “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. Patients should consult a healthcare professional about proper prevention, diagnosis and treatment of cancer.”
It is a violation of the Federal Food, Drug and Cosmetic Act to market and sell products that claim to prevent, diagnose, treat, mitigate or cure diseases without first demonstrating to the FDA that they are safe and effective for their labeled uses.
The illegally sold products cited in the warning letters posted today include a variety of product types, such as pills, topical creams, ointments, oils, drops, syrups, teas and diagnostics (such as thermography devices). They include products marketed for use by humans or pets that make illegal, unproven claims regarding preventing, reversing or curing cancer; killing/inhibiting cancer cells or tumors; or other similar anti-cancer claims.
The FDA has requested responses from the 14 companies stating how the violations will be corrected. Failure to correct the violations promptly may result in legal action, including product seizure, injunction and/or criminal prosecution.
As part of the FDA’s effort to protect consumers from cancer health fraud, the FDA has issued more than 90 warning letters in the past 10 years to companies marketing hundreds of fraudulent products making cancer claims on websites, social media and in stores. Although many of these companies have stopped selling the products or making fraudulent claims, numerous unsafe and unapproved products continue to be sold directly to consumers due in part to the ease with which companies can move their marketing operations to new websites. The FDA continues to monitor and take action against companies promoting and selling unproven treatments in an effort to minimize the potential dangers to consumers and to educate consumers about the risks.
The FDA encourages health care professionals and consumers to report adverse reactions associated with these or similar products to the agency’s MedWatch program.
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.
Warnings sent to:
- Cevrogin, Cholestrien, ImmunPro and Livral Complex - AIE Pharmaceuticals Inc.
- Sour Sop Capsules, Sour Sop Leaves and Sour Sop Tea Bags - Amazing Sour Sop, Inc.
- Angiostop, Ashwagandha, Asparagus Extract, OliveLeafQi and Revivin - BioStar Technology International LLC
- Vitalica - Caudill Seed & Warehouse Inc.
- 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 - DoctorVicks.com
- Cleavers, Inkberry, Korean Ginseng, Lapacho, Red Clover and Whole Apricot - Everything Herbs
- Skin Cancer Treatment and Smokeless Tobacco Cancer Treatment for Gums and Lip Sores - Hawk Dok Natural Salve LLC
- Astragalus Glycerite, Black Salve, Healthy Prostate & Ovary, Original Herbal Tea Remedy, ProBoost Thymic Protein A and Siberian Chaga Mushroom Extract - Healing Within Products & Services Inc.
- Protandim NRF2 Synergizer - LifeVantage Corporation
- Colostrum LD® Capsules, Dysbiocide, KR22 Oxicell and Matcha Tea - Nature's Treasure Inc.
- 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 - Oxygen Health Systems LLC
- Chelated Boron, Circulatory Detox & Support Syrup, Essiac Tea, Fermented Yeast Culture, Premium Organic, 8 oz., Virxcan-X Salve and Virxcan-X Tablets - Sunstone Inc.
- 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 Vibrant Health Store, LLC dba Dr. Christopher's Herbs
- Cardio-C, Chewables Vitamin C, Sodium Ascorbate, True Liposomal Vitamin C, and World's Finest Vitamin C Powder - The Vitamin C Foundation
Advisory letters sent to:
- CellAssure - CellMark Biopharma LLC
- Trevinol ES Fibrin Defense Systemic Enzyme, Trevinol ES Health Joint & Inflammation Support, Trevinol Professional Blend
- Nathans Natural Levodyn - Landis Revin LLC
- Immuno Boost Eximius - healinginabottle.com