FDA seizes 'Viagra' supplement after supplier ignores recall plea

The seizure of an illegal dietary supplement containing an ingredient found in Viagra was a "welcome step" that would act as a deterrent to others, according to Loren Israelsen, executive director of the United Natural Products Alliance.

The US Food & Drug Administration said officials had seized supplies of SEI Pharmaceuticals' Xiadafil VIP supplement, marketed as a treatment for erectile dysfunction, after the company refused to recall the product.

Tests carried out by the FDA earlier this year found Xiadafil VIP to contain hydroxyhomosildenafil, which is chemically similar to sildenafil, the active ingredient in Viagra.

The FDA said that while Viagra was an approved prescription drug for erectile dysfunction, it had not approved Xiadafil VIP for any drug use, and the safety and effectiveness of the product was unknown. As well as the inclusion of hydroxyhomosildenafil being unlawful, the ingredient was undeclared on the product label, it added.

On 22 April SEI was advised of the FDA's findings. Although the company committed to halting distribution of the product and deactivated its internet site, it refused to recall the product already in the market.

A formal FDA request for a recall was lodged with Miami-based SEI on 27 May. The company, however, refused to comply, said the FDA, making the seizure action "necessary to prevent additional, illegal Xiadafil VIP products from entering the marketplace." On 24 July, at the request of the FDA, US marshals seized nearly $74,000 worth of Xiadafil VIP tablets.

"[This] seizure action shows that FDA will take enforcement action to protect the public from dietary supplements that contain prescription drug ingredients that are potentially harmful to consumers," said Margaret O'K Glavin, associate commissioner of the FDA's Office of Regulatory Affairs. "FDA will not tolerate a company's failure to take voluntary action to protect the public health after being given the opportunity by FDA to do so."

The action was backed by Israelsen, who is also president of consultancy LDI Group. "FDA's recent action to seize SEI Pharmaceuticals' erectile dysfunction 'supplement' is a welcome step to make clear to all other companies engaging in similar practices that enforcement is here and the public's safety matters," he said. "Why this company decided to defy FDA when the evidence of spiking their product was clear is beyond me. In personal conversations with senior FDA officials they have been crystal clear that the sale of spiked supplements containing active pharmaceutical ingredients is their highest enforcement priority in the supplement sector. I agree with this and likewise regard the elimination of all such products as the dietary supplement industry's top safety objective."

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