FDA takes action against 14 companies for selling illegal cancer treatments

The U.S. Food and Drug Administration today posted warning letters addressed to 14 U.S.-based companies 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.

“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 W. Stearn, director of the Office of Enforcement and Import Operations in the 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 health care 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.

Warning and Online Advisory Letters

Company NameCancer Product Name1 and Image2
Warning Letters
AIE Pharmaceuticals, Inc.Cevrogindisclaimer icon, Cholestrien, ImmunProdisclaimer icon, and Livral Complex
Amazing Sour Sop, Inc.Sour Sop Capsulesdisclaimer icon, Sour Sop Leavesdisclaimer icon, and Sour Sop Tea Bagsdisclaimer icon
BioStar Technology International, LLCAngiostop, Ashwagandha, Asparagus Extract, OliveLeafQi, and Revivin
Caudill Seed & Warehouse Inc.Vitalicadisclaimer icon
DoctorVicks.comFreeda 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 HerbsCleavers, Inkberry, Korean Ginseng, Lapachodisclaimer icon, Red Clover, and Whole Apricot
Hawk Dok Natural Salve, LLCSkin Cancer Treatmentdisclaimer icon, 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 CorporationProtandim NRF2 Synergizerdisclaimer icon
Nature’s Treasure, Inc.Colostrum LD® Capsules, Dysbiocide, KR22 Oxicelldisclaimer icon, and Matcha Tea
Oxygen Health Systems, LLCGraviola, Graviola Max, Liposomal Complete Complex Plus, Liposomal Curcumin, Liposomal Vitamin B17 Amygdalin, Liposomal Vitamin C, Palladium Lipoic Complex, Premium Flax, Rerum Bluedisclaimer icon, and Super Liposomal Plus
Sunstone, Inc.Chelated Boron, Circulatory Detox & Support Syrup, Essiac Tea, Fermented Yeast Culture, Premium Organic, 8 oz., Virxcan-X Salvedisclaimer icon, and Virxcan-X Tablets
The Vibrant Health Store, LLC dba Dr. Christopher’s HerbsBlack 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 FoundationCardio-C, Chewables Vitamin C, Sodium Ascorbate, True Liposomal Vitamin C, and World’s Finest Vitamin C Powder
Online Advisory Letters
CellMark Biopharma LLCCellAssure
Landis Revin, LLCTrevinol ES Fibrin Defense Systemic Enzyme, Trevinol ES Health Joint & Inflammation Support, Trevinol Professional Blend
Nathans NaturalLevodyn
www.healinginabottle.comImmuno Boost Eximiusdisclaimer icon

 

1 The other products cited in the warning letters are not listed here.
2 Product name linked to Flickr image when available.

Questions and Answers: FDA alerts companies to stop the illegal sale of products claiming to treat cancer

Q1. What are the types of illegally sold cancer products and where are they found?

A. The products come in many forms, including pills and tablets, creams, syrups, sprays, oils, salves, teas and medical devices, among others. These products make claims related to numerous types of cancer but also target specific cancers including breast cancer, cervical cancer, and prostate cancer. These companies also sell illegal products claiming to treat a variety of cancers in pets.

Q2. How are these products marketed?

A. Companies marketing illegal cancer therapies often use exaggerated and false claims to promote these products. They may claim that individuals can avoid chemotherapy or painful surgery and that their products treat all forms of cancer. They may also claim that some of the products are natural cures, but such products have not been proven to be safe and effective for these uses. Companies often falsely claim that consumers won’t get sick from their treatments and that they’re non-toxic. They also commonly use unproven claims in unconfirmed testimonials on websites or social media to promote their products.

Q3. Where are these products marketed and sold?

A. These products are often marketed and sold on the Internet, including online marketplaces and various social media sites, such as Facebook and Instagram. They may be sold in retail stores or non-traditional marketplaces, such as flea markets or swap meets. The FDA has also discovered companies marketing products with unproven cancer claims at trade shows.

Q4. What are the products cited in the FDA’s recent letters?

A. Please see the warning letters.

Q5. Why should consumers be concerned about these products?

A. Cancer is a class of life-threatening diseases that requires diagnosis and treatment under the supervision of a licensed health care provider. Not only can these illegally sold products be ineffective and cause direct harm, but they can cause indirect harm to cancer patients by delaying the use of or interfering with proven, beneficial treatments.The FDA has received numerous consumer complaints about the safety and availability of illegally marketed cancer treatments. Some have been found to present a direct health risk to consumers. For example, in January 2017, an FDA laboratory discovered the bacteria Variovorax paradoxus in a sample of PNC-27, an unapproved drug product promoted as a treatment or cure for cancer.

Q6. Do these products make only claims related to cancer?

A. No. Many of these illegal products make claims related to many serious conditions, including arthritis, diabetes, high blood pressure, Alzheimer’s disease, HIV, AIDS, seizures, erectile dysfunction, and lupus. Many of these products also claim to be cure-alls that treat many different conditions.

Q7. What should consumers do to protect themselves from these products?

A. The FDA continues to monitor the marketing and sale of these unproven treatments to minimize the number of potentially dangerous products on the market. However, we encourage all consumers to exercise caution before using products that have not been approved by the FDA for their intended uses. Consumers should always talk with their licensed health care provider before starting new treatments or adding products to existing cancer treatment plans. See medication health fraud for more information.

Consumers using any of the products mentioned in the FDA warning letters are urged to talk with their licensed health care providers. Consumers who suspect they have experienced adverse events as a result of taking any of these products or other suspicious cancer products should contact their licensed health care provider immediately.

The FDA encourages consumers and health care providers to report any serious adverse event associated with the use of an FDA-regulated drug, biologic, medical device, dietary supplement or cosmetic. Complete and submit the FDA’s MedWatch Online Voluntary Reporting Form.

Q8. Why is the FDA taking this action?

A. This initiative is part of the FDA’s ongoing efforts to remove fraudulent cancer products from the marketplace, especially with the steady popularity of online sellers and social media sites today. Over the past 10 years, the FDA has issued more than 90 warning letters to companies illegally marketing products that falsely promise to prevent, diagnose, treat, mitigate or cure cancer.

Q9. Have there been any enforcement actions taken against companies that claim to prevent, diagnose, treat, mitigate or cure cancer?

A. The FDA has initiated a number of enforcement actions against companies that illegally market products that claim to prevent, diagnose, treat, mitigate or cure cancer. In addition to warning letters, several firms have been subject to permanent injunctions and criminal prosecutions.

Q10. How can I get more information about health fraud scams?

A. To learn more about identifying and avoiding health fraud scams, visit www.fda.gov/healthfraud.

Source: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm554698.htm

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