The FDA Went After Black Salve, an Unproven Cancer 'Cure.' It Failed to Finish the Job.

The agency has serious concerns about the product but it remains readily available for consumers

Indian Herb, a black-salve product made by McDaniel Water
Indian Herb, a black-salve product made by McDaniel Water.
Photo: Consumer Reports

In late October 2018, a 50-year-old woman filed a complaint with the Food and Drug Administration, claiming that a topical salve she’d purchased to remove a spot on her nose had a horrifying, disfiguring side effect. The paste, called Indian Herb, wound up “eroding” her nose, she said, burning a hole through her skin.

FDA inspectors were dispatched two weeks later to visit the product’s manufacturer, McDaniel Life-Line. But if they were expecting to find a legitimate manufacturing operation when they arrived in tiny Felt, Okla. (pop. 149) that November, they may have been surprised to find that Indian Herb was being prepared in an ordinary kitchen, using a blender and other household utensils, by Bruce McDaniel and his wife, as the FDA wrote later in a letter to the company. The blender was stored in a trash bag kept in the garage when not in use, the letter noted.

Indian Herb—the McDaniels’ brand name for a substance known more commonly as black salve—has its roots in folk medicine and has been pitched as a cure for skin cancer and other abnormal lesions for over 100 years. Variations of it are sold by numerous companies in this country and abroad, and the FDA has raised alarm about it before.

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The key ingredients of black salve, typically, are a plant called bloodroot and zinc chloride, a caustic chemical that is corrosive to metal. Consumer Reports is unaware of any scientific evidence that it’s an effective treatment for skin cancer and other skin lesions.

Moreover, researchers say, people who use black salve instead of conventional therapies may be allowing the disease to progress while also taking the risk of getting deep, disfiguring scars.

Indeed, the FDA has listed some black-salve products as a fake cancer “cures” that consumers should avoid. And as recently as September, scientists from the agency published a report in the journal Drugs & Therapy Perspectives that called on doctors to discourage patients from using black salve, citing case reports that resulted in “permanent cosmetic disfigurement.”

McDaniel tells CR that he never received a complaint in 35 years of business and thousands of sales “until that gal” complained to the FDA, though he acknowledged that the ingredients of black salve could pose a risk.

“It’s all up to the person putting it on,” he says matter-of-factly. “If they’re not competent enough to do it right, it’ll burn their skin.”

Several months after the FDA inspection, the agency issued a warning that Indian Herb was made in unsanitary conditions and that its two websites made illegal claims about its health benefits, including that it could cure cancer.

At the FDA’s urging, McDaniel issued a recall. He also decided to close up his business. “I’m too old to mess with them,” he says of the FDA.

That might have been the end of his story. But in May 2019, McDaniel notified the FDA that one of the two cited websites wasn’t his, according to records obtained by CR through the Freedom of Information Act. As it turns out, that website—apparently unbeknownst to McDaniel—was operated by his sister, from whom he had been estranged for many years. Her company, McDaniel Water, was also selling a black-salve product and continues to do so unfettered today, even as it claims a key ingredient “has been found to be a potent anti-cancer agent.”

Why would the FDA fail to take similar action against a company selling a product that it believes poses a safety risk? The agency did not provide answers to a list of questions sent by CR about the availability of black salve and why it hadn’t taken enforcement action against McDaniel Water.

Instead, FDA spokesperson Jeremy Kahn tells CR, “The FDA remains vigilant about black salve and will continue to take action when issues arise. Generally, the FDA does not comment on potential or pending investigations or specific companies.”

But the circumstances surrounding the McDaniel family businesses raise questions about the FDA’s ability to manage even the dangers it knows about, much less ones that fly under its radar. And it shows how unproven cancer cures can easily remain available for sale, even as reports of harm mount. Indeed, CR was able to readily purchase this product, and the FDA says it has identified two dozen cases of adverse events overall associated with black salve, including permanent disfiguration, cancer progression, and at least one death.

“Given the sheer enormity of these types of products on the market, there’s an implicit understanding that the FDA does not possess the resources to identify and pursue every dangerous product,” says Brian Ronholm, CR’s director of food policy. “However, by failing to act decisively on circumstances they do become aware of, the agency runs the risk of exacerbating an already harmful situation.”

Harry M. Hoxsey (above), who has been selling cancer "medicines" and claiming cures for some 30 years, was the object of a special warning issued by the U.S. Food and Drug Administration in Washington. The warning, first of its kind ever issued by the government, warned the public to beware of the so-called Hoxsey treatment for internal cancer. Hoxsey now operates cancer clinics in Dallas, Texas and Pohtage, Pa. He has treated patients from all over the country. In 1927 and 1930, Hoxsey pleaded guilty three times to practicing medicine without a license.
Harry M. Hoxsey, who sold a black-salve-like product, was deemed a "cancer charlatan" by the American Medical Association.

Bettmann Bettmann

Cancer Charlatans

One of the first public and prominent mentions of black salve appears in an 1857 book by Jesse Weldon Fell, an American surgeon. Called “A Treatise on Cancer, and Its Treatment,” the book details Fell’s discovery of bloodroot, a plant that Native Americans are believed to have used to treat cancer. Fell combined bloodroot with zinc chloride and called the formula “Fell’s Paste.”

Even then the medical establishment wasn’t buying it. A June 1857 review of Fell’s book in the British Medical Journal said his claims were not supported by evidence. And yet Fell’s creation got what it perhaps needed to not fade away: publicity.

A month after the disparaging review, The New York Times (then The New-York Daily Times) published a letter from a reader praising Fell and claiming he had firsthand knowledge of patients being cured within 10 to 15 days, “with but little pain.” The letter went on to provide readers a step-by-step guide on how to make the cure themselves.

The following century saw many high-profile examples of hucksters selling similar treatments. The American Medical Association waged war against one of them, an insurance salesman named Harry Hoxsey, who treated patients with his variation of black salve at clinics across the U.S. In a 1947 editorial, the association called him a “cancer charlatan.” The FDA, which formally came into existence in 1906, also placed warnings about Hoxsey’s formulas at 46,000 post offices across the country.

Selling Black Salve: A Brief History
Jesse Weldon Fell, an American surgeon, publishes a book suggesting that a paste containing bloodroot and zinc chloride could cure skin cancer. The book is slammed in a British Medical Journal review.
Illinois insurance salesman Harry Hoxsey begins opening clinics across the U.S., administering black-salve treatments.
Frederic Mohs, a surgeon later famous for developing a technique for removing skin cancer lesions, creates a black-salve-like product but eventually abandons it when he finds it ineffective.
The American Medical Association calls Hoxsey a “cancer charlatan.”
Pearlie Savely, a black-salve entrepreneur, is jailed for practicing medicine without a license and selling a misbranded product.
Portuguese doctor Almeida Goncalves studies with Mohs and creates his own black-salve product, but finds patients face risk of residual cancer.
Oklahoman Russell McDaniel launches McDaniel & McDaniel, which later sells Indian Herb, the family’s black-salve recipe.
Greg Caton, a businessman, markets a variation on black salve and is later imprisoned for mail fraud and selling an unapproved drug.
At the FDA’s urging, a McDaniel successor recalls its unregulated black salve and shuts shop.
FDA researchers publish an article on the risks of black salve, but the agency takes no action against a McDaniel-related enterprise that continues to sell it.

A decade later, authorities charged a California man named Pearlie Savely for selling a similar mixture of zinc chloride and bloodroot, as well as galangal root. He claimed that he could identify whether a spot on someone was cancer by simply applying his salve. Savely was eventually fined and jailed for practicing medicine without a license and selling a misbranded product, and his “cure” was highlighted in a 1964 congressional report on health frauds and quackery.

Even Frederic Mohs, a physician and surgeon who pioneered a technique for removing skin cancer in the 1930s that is still used to this day, treated patients with his own version of black salve, before eventually abandoning the practice because he found it to be ineffective.

“It’s ethically irresponsible to not assess the carcinogenic potential of a therapeutic being used by individuals.”

Andrew Croaker, PhD candidate at the School of Health and Human Sciences at Southern Cross University in Lismore, Australia, who has studied black salve

Nowadays, black salve is sold to consumers primarily through the internet, says Andrew Croaker, a PhD candidate at the School of Health and Human Sciences at Southern Cross University in Lismore, Australia, who has extensively researched the product.

In 2019, Croaker co-authored a study in the Journal of Herbal Medicine that analyzed 13 black-salve products from eight manufacturers and found that most had zinc chloride at levels “known to kill normal human tissue.” One of the products also contained lead, a toxic heavy metal, at levels 25 times the FDA’s recommended limit for cosmetic products. Lead has been linked to high blood pressure and kidney disease in adults.

Croaker added that another ingredient often found in black salve—sanguinarine, a compound found in plants like bloodroot—is suspected by some to be carcinogenic, and his study found the presence of that compound at excessively high levels. Croaker says he believes the medical community should further analyze the carcinogenicity of black-salve products.

“It’s ethically irresponsible to not assess the carcinogenic potential of a therapeutic being used by individuals,” he says.

'More Common Than You Would Expect'

The reasons consumers turn to products like black salve can vary. Croaker speculates that some are gullible to testimonials or are persuaded by its low cost compared with surgery. Kristin Eastman, MD, an Alaska dermatologist, believes some patients find it appealing because it is an alternative to modern medicine.

“I think people have an idea in their minds that modern medicine is bad or wrong,” and turn to “natural” remedies as alternatives, she says. Eastman co-published a review of black salve in the Journal of Alternative and Complementary Medicine in 2014. The paper detailed the case of a patient of hers who used the product for a “self-diagnosed skin cancer on the left side of his nose.”

His treatment resulted in the permanent loss of part of his nose. But underscoring the degree to which some consumers buy into alternative medicine, the patient, despite his cosmetic defect, “continued to support the use of black salve for skin cancer,” the paper says.

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Permanent disfiguration isn’t the only risk of using black salve, Eastman says. “You have the possibility of undertreating and skin cancer being left behind,” or self-diagnosing and mistreating a benign lesion as skin cancer.

While the internet is one of the main ways to buy black salve, some consumers may also get it from “naturopathic physicians” who may have training in natural therapies but aren’t generally recognized as medical doctors.

That’s what happened to Tina McColl in February 2012, when she visited a Montana naturopath who suggested a product to remove a blemish she’d noticed on her nose, court records show. The naturopath applied black salve and instructed McColl to return a few days later, when he applied it again.

A day later, according to her lawsuit, McColl woke early in the morning because her face was hurting and swollen. She went to urgent care, where she was diagnosed and treated for an infected third-degree burn on her nose that was 4 millimeters deep and the size of a dime.

“She was pretty shocked,” says Geoffrey Angel, a lawyer who represented McColl in a lawsuit she later brought against the doctor. “She was following the doctor’s advice.”

McColl ultimately underwent plastic surgery to repair the appearance of her nose, court records say, and continues to require surgical injections twice a year to ensure that no scar remains.

Angel blames the internet for making products like black salve so easily available but says he even found a local store selling it in Bozeman, Mont., where he’s based.

“It’s actually a lot more common than you would expect,” he says.
The ingredient page (highlighting added by CR) for Indian Herb, a black-salve product, sold on

A Family Fight

Families like the McDaniels are part of the reason that is so.

Making black salve is a longtime family enterprise. Bruce McDaniel’s father, Russell, incorporated a company called McDaniel & McDaniel in 1980, records show, to market several natural products, and eventually obtained the formula for what became Indian Herb from a third party.

But tensions bubbled up after Bruce’s mother, Pattie, died in June 2001. Russell McDaniel began the process to dissolve McDaniel & McDaniel, transferring the assets to a new company called McDaniel Life-Line, which he put in the hands of two of his children, Kathleen Parsley and Bruce McDaniel.

Some of the McDaniels’ other seven children filed a lawsuit, starting a bitter four-year battle in part to clarify who had a stake in Indian Herb. The case was settled in 2008, after which a sister, Ruth Shields, and brother, Gary McDaniel, incorporated McDaniel Water and began selling Indian Herb and other products. Bruce McDaniel claimed to be unaware that his sister had been selling the family’s products until CR reached him by phone in October.

“You have the possibility of undertreating and skin cancer being left behind.”

Kristin Eastman, MD, Alaska dermatologist

For years, the competing McDaniel firms appear to have operated without any trouble from regulators, until the FDA received the complaint from the woman whose nose was damaged after using Indian Herb purchased from McDaniel Life-Line.

What isn’t clear is why, exactly, even after Bruce McDaniel pointed out to the FDA that McDaniel Water and McDaniel Life-Line were not one and the same, the agency did not appear to go after his siblings’ company.

Indeed, CR could find no record of inspections for McDaniel Water. Reached by phone by CR, a woman who said her name was Ruth said McDaniel Water had “nothing to do with the warning letter.”

“That was their mistake,” Ruth said of the FDA’s decision to cite the company’s website in the warning letter. (Corporation records list a person named Ruth Shields as a manager of the company.)

Ruth claimed her company does not advertise that Indian Herb can cure cancer, even though its website describes bloodroot as being “highly effective for skin conditions” and “a potent anti-cancer agent.” The website also cites unspecified studies about galangal, another ingredient in McDaniel Water’s Indian Herb, as having shown that it possesses “anti-cancer activities.”

If shoppers still weren’t sure about the potential of Indian Herb, the website also provides a link to an article on Natural News, which plainly calls it a “magical cancer cure.”

The FDA did not respond to CR’s specific question about why the agency had not reached out or taken action against McDaniel Water.

blood root plant
Bloodroot, a plant that's one of the main ingredients in black salve.

Boston Globe Boston Globe

What Should Be Done About Black Salve

Current laws seem to prevent the FDA from easily removing some dangerous products like black salve from the market, says Pieter Cohen, MD, an associate professor of medicine at Harvard Medical School whose research has shown how FDA regulations for dietary supplements can leave consumers exposed to potentially unsafe products. He says the FDA should be advocating for legislative changes or, at a minimum, communicating the threat to the public more effectively.

“If the FDA cannot get this off the market, then they need to be doing a very aggressive communication with clinicians and consumers,” he says.

The September FDA article called on doctors to discourage patients from using black salve. And in October, the agency issued a renewed consumer alert, warning consumers against using any black-salve products, specifically those that declare on the label to include the ingredients sanguinarine, Sanguinaria canadensis, or bloodroot—with or without zinc chloride.

Alan Boyd, MD, a professor of dermatology at Vanderbilt University in Nashville, Tenn., agrees that black salve should be avoided and says that individuals experiencing scarring after using it could be looking at five-figure sums for plastic surgery. Traditional medicine has developed numerous surgical and nonsurgical therapies for skin cancers “with very good results,” Boyd says.

“Anyone who doesn’t want to avail themselves of that is not helping themselves,” he says.

Croaker, the Australian researcher, says regulation for alternative medicine products should be overhauled. He suggests requiring companies that sell natural therapies to pay a tax to fund independent research to assess the toxicity and efficacy of their products.

“The public deserves transparency and independent scrutiny on the therapeutic goods they use,” he says.

Back in Oklahoma, Bruce McDaniel, who now works as a day laborer, reflected on his time selling Indian Herb. “I always thought it was a good product,” he says. He seemed pleased to know that his sister had been keeping the family brand alive under McDaniel Water.

“Well, that’s good,” he says. “People who need it can get it.”

Head shot of Ryan Felton, a CR author of investigative reports and special projects

Ryan Felton

I'm an investigative journalist with an appetite to cover anything and everything. My job and goal is to dig into complicated issues that affect people's health, safety, and bottom line. I've covered everything from dangerous tires to subprime lending to corporate malfeasance. Got a tip? Drop me an email (, or follow me on Twitter ( @ryanfelton) for my contact info on Signal.