APIs in banned sex supplements sold openly online says regulator
Erectile dysfunction supplements sold without a prescription over the internet and marketed as ‘herbal’ and ‘all-natural’ actually contain sildenafil, sulfosildenafil vardenafil, tadalafil, tadalafil, or dimethylacetildenafil – the active ingredients in Viagra, Cialis, and other approved erectile dysfunction drugs – according to FDA tests.
in-Pharmatechnologist.com asked the Director of Counterfeiting Prevention at the Italian Medicines Agency how makers of illegal sexual enhancement pills get their hands on active pharmaceutical ingredients. He told us sourcing the active pharmaceutical ingredients doesn’t mean going through underground channels.
“There are plenty of available sources on the web, supplying these kinds of ingredients,”said Domenico Di Giorgio, AIFA.
He pointed us to the mammoth Chinese B2B commerce site Alibaba.com, which reported 52.5bn Yuan ($8.6bn) in revenue last year.
A search for sildenafil, the API in Pfizer’s Viagra, returned dozens of vendors offering to sell the ingredient in powder form for around $100/kg, and several below $25/kg.
Almost all sellers were based in China or India, and offered to ship to North America and Europe.
One vendor claimed it has supplied sildenafil to US, Sweden, Canada, Turkey, Malaysia, and Romania. It called the API a “pharmaceutical raw material, indicated for the treatment of erectile dysfunction” and said its raw materials are “products that can not [sic] be detected.”
The same company advertised other raw materials for the manufacture of sexual enhancement drugs: tadalafil (the API in Cialis), vardenafil (used in Levitra, Staxyn and Vivanza), acetildenafil (a synthetic version of sildenafil), adrafinil (an anti-tiredness agent not approved by the FDA), and others. The seller also advertised APIs for manufacturing weight loss drugs.
The vendor claimed to be a Chinese company with more than 50 staff, of which over 11 work in R&D, and more than 5 work in Quality Control. The company has an annual turnover of $10m-$50m, it said.
Hosting site AliBaba.com broke records with its IPO last September, which raised $25bn. The company is the largest business-to-business trading platform for small firms.
When we showed the ingredients listings to the company, it told us its security team would investigate the entries. A spokesperson told us the site is “an open, user-generated-content platform which strongly supports and abides by all international laws and rules” and the company “will cooperate with law enforcement authorities worldwide to remove problematic product listings promptly upon receipt of notice.” Prescription drugs are banned from sale on the website.
FDA warning
The Italian Medicines Agency’s Di Giorgio also called in-Pharmatechnologist.com’s attention to sales on Alibaba.com of finished pills – “‘food supplements’ pretending to have an effect against ED [erectile dysfunction].”
“If there are suppliers which routinely ‘contaminate’ their food supplements with pharmaceutical ingredients, the product reaching the USA or EU could be a complete food supplement, instead of an ingredient,” he said.
Several of the brand names warned against by the FDA appeared for sale on AliBaba.com, including African Superman and Stiff Nights, which the agency seized from international mail shipments and found to contain sildenafil.
“This undeclared ingredient may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Men with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates,” said the FDA.
