So-called natural remedies for erectile dysfunction may not be as natural as they claim to be. Caveat emptor is the byword when shopping for dietary supplements.
What could possibly be wrong with a product with the reassuring name of Miracle Honey? Plenty, according to the U.S. Food and Drug Administration, which in late 2018 issued a consumer warning about such a product.
More specifically, the FDA targeted a product called Leopard Secret Miracle Honey. Marketed in energy bar form as a sexual enhancement supplement, the product contains a couple of the natural herbs that have long been associated with the treatment of male impotence.
Listed Ingredients
The product’s listed ingredients include flower honey, said to make up 48 percent of its overall content, glucose (45 percent), tongkat ali root (2.5 percent), cinnamon powder (1.5 percent), Panax ginseng root (1.5 percent), and carob powder (1.5 percent).
Both ginseng and tongkat ali have long been used by folk medicine practitioners and herbalists to treat erectile dysfunction. And there are a few studies — although relatively small in scale — that suggest that ginseng actually can help to improve erectile function.
Unlisted Ingredients
But it was none of those listed ingredients that prompted the U.S. drug regulatory agency to warn against this seemingly benign herbal product. Rather the FDA took exception to an unlisted ingredient that could have disastrous consequences for men who took the product unaware that it was present.
FDA laboratory analysis of the Miracle Honey energy bars detected the presence of sildenafil citrate which is the active ingredient in Viagra.
The Leopard product, touted as an “all-natural” remedy to combat not just ED but male infertility as well, turns out not to be as all-natural as advertised.
Taboo for Nitrate Users
Men who regularly take nitrate-based drugs for the treatment of angina pectoris and hard-to-control high blood pressure are warned never to take Viagra, Cialis, or any of the other so-called PDE5 inhibitors sold to treat ED. Because both nitrates and PDE5 inhibitors have potent vasodilating properties, taking them together could cause a life-threatening drop in blood pressure.
Such men and others who have been warned to avoid the use of PDE5 inhibitors for health reasons might reasonably be attracted to purportedly “all-natural” products to treat ED problems. However, using products such as Miracle Honey that contain unlisted ingredients such as sildenafil would expose them to significant health hazards with no warning.
Promotional Information Misleading
Ironically, some of the promotional information on the Leopard Honey website touts the product as a safe alternative to “synthetic chemical drugs” and “their dangerous side effects.”
Unlike prescription drugs, which must undergo stringent testing before FDA approves them to be marketed in the United States, dietary supplements are not tested prior to their introduction. FDA’s regulation of these supplements is limited to after-the-fact consumer warnings only when the agency becomes aware that a currently marketed supplement is adulterated or improperly branded.
Supplements Aren’t Closely Regulated
As large as the FDA is, its overall responsibilities for overseeing the efficacy and safety of prescription drugs and food products are overwhelming, leaving it little time and manpower to police dietary supplements.
Its product alert about the unlisted ingredients in Leopard Secret Miracle Honey should serve as a broader warning against the blind acceptance of product claims by so-called natural remedies.
And although it took a few months, the FDA’s warning about Miracle Honey’s hidden ingredient prompted USA Less, the product’s U.S. distributor, to voluntarily recall the product in late March 2019.
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