Posted 26 April 2017
FDA cracks down on companies pushing fraudulent cancer claims
By Laurie McGinley April 25 at 4:55 PM
The Food and Drug Administration ordered 14 companies to stop making bogus claims about cancer cures – including asparagus extract, exotic teas and topical creams for pets – or face possible product seizures and criminal prosecution.
The letters covered more than five-dozen unapproved products that the companies touted as preventing, treating or curing cancer, a violation of federal law, the agency said. The items included pills, ointments, oils, drops, teas and diagnostic devices.
“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 lifesaving cancer diagnosis or treatment,” said Douglas Stearn, director of the FDA’s Office of Enforcement and Import Operations.
One of the companies, Sunstone, based in Pleasant Grove, Utah, sells a product called Essiac Tea. Its website said that “cancer and AIDS sufferers or other ill people may wish to take 2 fluid ounces of the tea twice daily on an empty stomach,” the FDA warning letter said. Eight ounces of the tea costs $11, according to the firm’s website.
Another Sunstone product, Virxcan-X Salve, is marketed for “liver congestion, arthritis, malignant growths, respiratory and urinary tract infection,” according to the FDA. The price is $34 for one ounce. Asked to respond to the warning letter, a man at the company who identified himself as “Eric” declined to comment.
In a letter to Nature’s Treasures, based in Glendale, Calif., the FDA noted that the company website made this claim about its topical cream KR22 Oxicell: “If you (or your pet) are suffering from liver problems, cancer, arthritis, kidney disease or other inflammatory conditions, this product can really help.” The agency said the product wasn’t approved for either humans or animals.
Elsewhere on the company’s website, the FDA noted, the firm is promoting “thermography,” which uses digital infrared thermal imaging, as an unapproved device to detect breast cancer. The company says, for example, that “thermography is far more sensitive than mammography.”
Company official Raya Shanazarian declined to comment.
BioStar Technology International in Los Angeles was cited by the FDA for saying that its Asparagus Extract “should be taken by everyone for heart, cancer prevention.” The company also claimed that its Revivin herbal blend “attacks cancer at the DNA level. This results in a more comprehensive cancer inhibition therapy.”
Ulysses Angulo, the owner of BioStar, said, “The only thing we can do is comply and remove the verbiage. It removes information for the public to make informed decisions about products that could help them.”
The agency gave the companies 15 days to correct the violations or provide a plan on how they will correct them. Since the violations pertain to marketing claims, the most likely fixes are removal of the offending language. If the firms do not respond to the agency, they face further action, including court injunctions on the sale of their products.
The agency said it has issued more than 90 warning letters in 10 years to companies marketing hundreds of fraudulent products making cancer claims on websites, on social media and in stores. But it acknowledged that while the warnings sometimes stopped the sales, the companies sometimes just moved the products to new websites.
In one disturbing trend, the agency is seeing a rise in phony cancer treatments for pets. “Increasingly, bogus remedies claiming to cure cancer in cats and dogs are showing up online,” said Nicole Kornspan, a consumer safety officer at the agency.
Questions and Answers: FDA alerts companies to stop the illegal sale of products claiming to treat cancer
The FDA has issued warning letters to a number of domestic companies illegally selling products that they claim can prevent, diagnose, treat, mitigate or cure cancer. The agency has asked the companies to provide written responses to address the violations covered in the warning letters. Companies that fail to respond and make adequate corrections could be subject to further actions, including seizure, injunction, and criminal prosecution.
Q1. What are the types of illegally sold cancer products and where are they found?
- 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?
- 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?
- 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?
- Please see the warning letters.
Q5. Why should consumers be concerned about these products?
- 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?
- 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?
- 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?
- To learn more about identifying and avoiding health fraud scams, visit www.fda.gov/healthfraud.
Additional information about cancer fraud is also available from the Federal Trade Commission.