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Medical News and Perspectives
June 4, 2003

FDA Issues Warning on "All-Natural" Herbal Product Found to Contain Viagra

JAMA. 2003;289(21):2786. doi:10.1001/jama.289.21.2786

Put Hindo lotus seed, eucommia bark, wolfberry, and other ingredients into a tablet and you can sell the "all-natural herbal product," claiming it can "enhance the sexual experience for both men and women." But if the Food and Drug Administration (FDA) discovers it contains sildenafil (Viagra), then you can expect a recall notice and possible criminal investigations.

In early April, the FDA issued a class 1 recall for Vinarol tablets—a product being marketed as a dietary supplement by Ultra Health Laboratories Inc and Bionate International Inc of Phoenix, Ariz. The FDA describes a class 1 recall as "a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death."

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