Fairwarning News –
Revealed the supposedly all-natural supplements contained one or more of the active ingredients tadalafil, sildenafil, as well as dapoxetine.
In 2015, Nam Hyun Lee, a South Korean living in Southern California, got into the lucrative business of making herbal, over-the-counter sex supplements for men. He put an aggressive-looking rhinoceros on the label, and over the next several years shipped 10,000 capsules of “Rhino 69 9000” or “Rhino 8 8000” to distributors in Maryland and Texas, according an indictment by a federal grand jury in Santa Ana, California.
Lee is now awaiting sentencing after pleading guilty to illegally importing bulk quantities of prescription drugs and faces up to three years in prison. But he was just one of many players profiting from the sale of sex pills with hidden drugs, and his products were a fraction of the questionable supplements still for sale in the U.S.
In recent months, the FDA has issued health warnings about more than 50 sex supplements, including the “Rhino 88 Extreme 9000,” the “Rhino 69 Power 500k,” and the “Rhino 69 Platinum 75000.” The FDA has also warned about brands called “Black Stallion,” “Stiff Nights,” and “Thumbs Up 7,” among others.
Rhino pills, as the many products named for the horned beast are known, are a familiar sight at gas stations all over the country. Men who tried them have reported that they are surprisingly effective. But users have also described troubling side effects like headaches, a common enough problem that some packages boast of a “new formula” that comes with “no headache.” In rare cases, people who took the pills have suffered life-threatening injuries.
A FairWarning review of FDA data since 2018 found 49 reports of problems ranging from penile pain and heart palpitations to congestive heart failure and coma. One death was reported: a 31-year old man believed to have taken a pill called Rhino Male Enhancement before suffering a fatal heart attack. A federal investigation of Lee’s activities—dubbed “Operation Rhino”—revealed why the supposedly all-natural supplements seemed to work: they were spiked with the same active ingredients used in Cialis and Viagra, as well as dapoxetine, which is prescribed for premature ejaculation. But even with their original creator behind bars, rhino pills continue to be sold nationwide. At least one product claims the pills were made in a “FDA registered facility” using such ingredients as “proprietary blend” and “horny goat weed.”
The situation is a testament to the largely unregulated nature of the $45 billion a year U.S. supplement industry. Sellers can easily register new dietary supplements with the FDA without submitting any safety data. The FDA typically tests products only after getting complaints from consumers or if products are seized by customs agents.
Vitamins, minerals, herbs
Under federal law, supplements are supposed to contain ingredients such as vitamins, minerals and herbs, but not pharmaceuticals, and can be sold over-the-counter. But after a supplement is flagged by the FDA as being unsafe or containing hidden drugs, sellers can make a slight name change to “create a new pill that is exactly what they were selling before,” said Steve Lipscomb, an attorney handling a lawsuit against Amazon over pills called the “Rhino 50k.” In 2017, Jeffrey Sapp suffered a heart attack and permanent brain damage after taking the pills, according to his lawsuit. The suit argues that Amazon is liable for the products it sells and is scheduled for trial in 2022. Amazon, which has denied responsibility, did not respond to a request for comment.
In 2019, Walmart agreed to remove one rhino supplement from its website after it was flagged by the FDA as containing hidden drugs and highlighted by a local TV news station. But recently, other sex supplements were still for sale on Walmart.com, including a pill called the Rhino 17 Plus 5000 that retailed for $17.98. Walmart did not respond to a request for comment.
Hiding pharmaceuticals in over-the-counter products is already illegal, and some researchers question why the FDA hasn’t cracked down further on products it knows are in violation of the law. Since 2015, the FDA has identified more than 200 sex supplements with hidden drugs. But an agency database shows only 15 recalls of supplements containing erectile dysfunction drugs. In most cases, the FDA has just issued alerts telling consumers to avoid the products.
“These are illegal products that are just openly being sold, and the FDA is not doing anything about it,” said Dr. Pieter Cohen, an associate professor at Harvard Medical School who has studied the dangers of unregulated supplements for nearly a decade, and who says he has asked FDA officials about taking more aggressive action.
“People say it’s not in my jurisdiction. Within the FDA there is a lot of bureaucratic arguing about who is responsible for taking these products off store shelves,” Cohen said.
In a statement, the FDA said that “the agency faces several challenges in deterring fraudulent marketing of these types of products.”
Among the obstacles, the FDA said, are that ”even after recall and enforcement action against one distributor, a number of other distributors of a product may continue to sell it.”
The FDA also said that dietary supplements tainted with drugs are considered drugs under the law and the agency ”does not have mandatory recall authority” over them.
“Despite these challenges, the FDA recognizes the seriousness of this problem and continues to act within its resources and authorities to address this problem as best it can,” said agency spokesman Jeremy Kahn.
Viagra, the brand name for sildenafil, made history in 1998 as the first drug approved to treat erectile dysfunction. Its competitor Cialis, made with tadalafil, was approved in 2003. Not long after, herbal supplements hiding those ingredients became popular worldwide. Consumers choose over-the-counter products because they are cheaper and easier to obtain. Some people may also be swayed by the idea of taking a supplement they are told is all-natural.
Unknowingly ingesting tadalafil or sildenafil is dangerous because the drugs can have negative interactions with other medications or with alcohol. Lab tests have found that the dosage in the over-the-counter supplements is not uniform, and can often be higher than in prescription pills. Another concern is that the pills may be made with analogues, or experimental variations of existing drugs that have not been tested for safety. As of 2012, at least 46 analogues of erectile dysfunction drugs were in use worldwide, according to researchers in the Netherlands. For reasons that are unclear, supplement manufacturers have also mixed erectile dysfunction medicine with glyburide, a drug normally used in diabetes medication The combination can be toxic and was linked to more than a dozen deaths in Hong Kong and Singapore in 2007 and 2008.
Closer to home, in 2019 in Virginia 17 men were hospitalized with hypoglycemia, a life-threatening drop in blood sugar, after ingesting supplements called “V8 male enhancement.” The drugs were marketed as all-natural but found to contain erectile dysfunction medication and glyburide. Officials with the Virginia Department of Public Health seized the supplements from local stores, a spokesman for the agency says.
Nam Hyun Lee, who is in his sixties, looked tired but calm at a recent court hearing over Zoom. Dressed in an orange prison jumpsuit, he held a listening device to his ear, straining to hear a Korean interpreter relay information from the hearing. His sentencing is scheduled for February 9.
Lee was not the first to sell adulterated sex pills in the U.S., but prosecutors say he was the first to market rhino pills specifically. The distinctive design of a holographic rhino staring back at buyers has made the pills synonymous with over-the-counter sex pills. A search of the phrase “pop a rhino” on Twitter turns up dozens of jokes about their effects.
Lee was arrested in 2018, and the rhino pills being sold today were probably made by someone else. A spokesman for the U.S. Attorney’s office in Los Angeles says that most likely “someone else, or perhaps even multiple individuals, started marketing Rhino products” after Lee’s arrest.
In letters to the judge, Lee’s children say the family had enjoyed a comfortable middle-class life in Orange County. They describe Lee as self-employed throughout their childhood and active in his community and church. According to Lee’s daughter, a social worker, her father would go through periods of reckless behavior, including heavy drinking and gambling. He never received mental health treatment, according to the daughter, but she suspected he suffered from bipolar disorder. His symptoms worsened over time, leading to “the behaviors that led to his current incarceration,” his daughter wrote to the judge. An attorney for Lee declined to comment on the case.
Emails obtained by prosecutors show that in 2016, Lee asked wholesalers in China for a quote on sildenafil and tadalafil. He stressed that he cared about “SAFETY and PURITY.” A wholesaler in China assured him that the drugs can easily be shipped in bulk to the U.S.
“We will change the name on the product label to make it easier to pass the USA customs,” the Chinese seller wrote, adding that the drugs would be shipped via FedEx, “just like we always do.”
Lee made the capsules at warehouses in Southern California before shipping them across the country, according to his indictment. He fell into the federal crosshairs in 2018, when customs agents seized a package of white powder from China addressed to him and labeled as “Acrylic Paint.” Lab tests revealed that the powder actually contained erectile dysfunction drugs. By the time of his arrest, prosecutors say he had netted between $3 million and $9 million in sales.
His family has requested that Lee be deported to South Korea rather than serving the recommended three year prison sentence. But a prison sentence, prosecutors have argued, will “deter others from engaging in similar conduct or continuing defendant’s operations now that he is in custody.”Adulterated Drug Importation Fraud Patient Harm Rx Fraud Safety Alert