The US Food and Drug Administration‘s Tainted Products Marketed as Dietary Supplements database lists hundreds of products with hidden active ingredients that are unsafe or unstudied. Some are sold in South African pharmacies, even under the same names.
Dr Harris Steinman, editor of CamCheck.co.za who has been on a crusade against pseudo-science and scams for years, says, “Pharmacists who know better are stocking products that are ineffective at best in their stores. It’s buyer beware. Nobody will protect you.”
Between 1865 and 1906, the US experienced a “golden age” of quackery, which saw over 50 000 patent medicines on the market. A toothache was treated with cocaine (which also helped for brainpower, endurance and “throat troubles”); fussy babies were calmed with opiates; paleness ameliorated with “pink pills”, freckles were removed with mercury; and “women’s ailments” were relieved with a punchy mix of cannabis and chloroform. Drugs were bought and sold like any other consumer goods. These contained dangerous, addictive and misidentified ingredients. There was no legal, or ethical, requirement to disclose the contents, nor to list warnings about misuse.
Georgina Crouth, a consumer watchdog, writes in an IoL report that today, with labelling laws as they are, Americans aren’t likely to find such products on the shelf, right? Wrong. Researchers from the California Department of Public Health recently released a report in which they said, from 2007 to 2016, 776 products marketed as dietary supplements contained hidden active ingredients that are unsafe or unstudied.
Crouth says some of these supplements are being sold in South Africa, even under the same names.
The researchers based their findings on an analysis of a US Food and Drug Administration (FDA) database, the Tainted Products Marketed as Dietary Supplements, which is accompanied by a disclaimer, noting: “This list only includes a small fraction of the potentially hazardous products with hidden ingredients marketed to consumers on the internet and in retail establishments. FDA is unable to test and identify all products marketed as dietary supplements on the market that have harmful hidden ingredients. Even if a product is not included in this list, consumers should exercise caution before using certain products. To learn more about how to reduce your risk of encountering a product marketed as a dietary supplement with a hidden ingredient please visit FDA’s Medication Health Fraud web page.”
Crouth writes that the public health researchers found over-the-counter products, whether aimed at helping gym buffs bulk up, make consumers skinny without diet or exercise, give them a jolt of energy, or enhance performance in the bedroom – were often loaded with undeclared, unapproved and unregulated pharmaceutically active ingredients, which are a “serious public health concern”.
She says in the report that the database makes for interesting reading: the Kaboom Action Strips, Herbal Viagra and Erex for “sexual enhancement” contain sulfoaildenafil (a structural analogue to the active ingredient in Viagra which can have dangerous interactions with other prescription drugs and cause dangerously low blood pressure); while the Mince Belle (made by the Healthy People Co), Hot Detox, Jianfeijindan Activity Girl and Lean Body Extreme all contain phenolphthalein (a laxative linked to cancer and skin problems) and/or sibutramine; and in the muscle-building products, steroids or their analogues were discovered.
In March, Crouth writes, Secret Fat Burner a weight-loss product containing naturally derived ingredients as well as a “secret arsenal” of undeclared additives, including sibutramine and three other scheduled ingredients, was widely reported on for causing anxiety, thyroid dysfunction, blood clots, strokes and heart attacks. Sibutramine was banned in many countries, including South Africa, in 2010.
Crouth writes that Dr Harris Steinman, activist and editor of CamCheck.co.za has been on a crusade against pseudo-science and scams for years. He’s got the Advertising Standards Authority to ban advertising for Herbex, been threatened with lawsuits by gym supplement giant USN and tried to get the SA Health Products Regulatory Authority to ban sales of “Wondernut” (also known as Indian walnut), which is not only ineffective at weight loss and cancer treatment, but it’s also dangerous, causing severe gastrointestinal problems, kidney failure, pancreatitis and even death.
Yet, he says, despite the Medicines Control Council issuing a press release that Wondernut has no proof of causing weight-loss, and is potentially highly toxic, the “founders” continue to make false claims about safety and efficacy on their website.
Steinman, a medical doctor, is angry: “These products are available online and, what upsets me the most, sold by your local pharmacy. Pharmacists who know better are stocking products that are ineffective at best in their stores. It’s buyer beware. Nobody will protect you. Effectively, anyone could get away with murder – sell products that kill and there would be no consequences.
“I could sell you sea sand and tell you it’s good for weight loss, or a bar of soap and tell you it will cure Aids, add some undeclared harmful ingredients and get away with it.”
Crouth writes that Dr Pieter Cohen from the Harvard Medical School was similarly scathing in his commentary published alongside the California Public Health study, saying the FDA “didn’t even bother to recall more than half of the potentially hazardous supplements”.
“How could it be that our premier public health agency spends the time and money to detect these hidden ingredients and then doesn’t take the next obvious step, which is to ensure that they are removed from the marketplace?” he asked. “It’s mind-boggling to imagine what’s happening here.”IoL report FDA Tainted Products list