The Food and Drug Administration (FDA) has just caught 11 fake sexual enhancement products being purported as “all natural” by the manufacturers. In recent consumer updates, the FDA is advising people not to purchase the Anaconda Strong Formula, Boss-Rhino Gold X-tra Strength, Super Bull 6000, Libigirl, Power Spring XXX Oral Liquid, Weili or Yi Pao Dao, The Golden Roots, Super Shangai, Ziyinzhuangyang, Shangai Ultra X and De Guo Hei Bei (徳国黑倍) since they contain sildenafil, the active ingredient of Viagra, that can interact with other medications.
The products were found by the FDA as part of their international mail shipment examination and have been given warning letters to cease their fraudulent activities.
“We’re finding an alarming number of these products sold online and in retail stores,” says Gary Coody, RPh, FDA’s national health fraud coordinator.
According to the Johns Hopkins Bloomberg School of Public Health, more than 18 million men in the US are currently afflicted with erectile dysfunction, also commonly known as impotency. Such individuals develop the condition due to various other health problems like diabetes or heart diseases.
Therefore, when they see products posing as all natural solutions to their sexual predicament, they buy them without realizing their health implications. The prevalence of impotency in the western society is another reason why the fraudulent sex enhancement dietary supplement industry has been booming in a multitude of western countries.
The eleven counterfeit products masquerading as male sexual boosters were all found to contain the chemical substance called ‘sildenafil’. Sildenafil is a chemical ingredient found in the prescription drug Viagra.
Although the drug Viagra is approved by the FDA for the treatment of erectile dysfunction (ED), it cannot be consumed without proper physical consultation as its irresponsible use can pose serious health issues.
Male patients suffering from diabetes, high blood pressure, high cholesterol, and other heart disease are at danger from taking these products. Such patients may presume these products to be ‘all natural’ but the presence of sildenafil may pose danger to them, as sildenafil can interact with nitrates, like nitroglycerin, usually found in prescription medicines of heart patients. Remember the interactions between nitroglycerin and sildenafil can lower the blood pressure to a dangerous level.
Sildenafil can also lead to side effects like headache, flushing, indigestion, nasal congestion, and impaired or blurred vision. If consumers of sexual enhancement products experience any of these symptoms, they should stop taking the medication and report the product to the FDA at once. In rare cases, sildenafil also has the potential to cause vision impairment.
“If consumers are taking products that have undeclared drug ingredients, this leaves patients vulnerable to potentially serious drug interactions,” says M Daniel Dos Santos, of FDA’s Division of Dietary Supplement Programs.
The warning letters sent by FDA to the manufacturers of all 11 fake products has asked them to stop the production and sale of these illegal products. Otherwise, they will be breaking US federal laws. The FDA has also asked the involved parties to voluntarily recall or destroy the harmful counterfeit products. If the producers fail to meet the demands of the FDA letters, they can be subjected to product seizures, import alerts, injunctions, recalls and even criminal prosecutions under the Food, Drug and Cosmetic Act.
Currently though, the supplements do not come under the FDA regulations. According to 1994 Dietary and Supplement Health and Education Act, supplements are regarded as “food” and not “drugs” and therefore do not need any approval from the FDA. The dietary supplement industry has flourished to $36.7 billion in the US.
The FDA is specially advising men to beware of such fraudulent products which may contain hidden synthetic drug ingredients and may damage their health. Such products can contain ingredients from prescription drugs like Viagra, Cialis and Levitra. The ingredients can also be present in high doses or a mixture of dangerous ingredients.
The labeling of such products usually features false claims like ‘natural’ or ‘herbal’ and can be misleading. Male consumers often have no way of knowing if the products are real and only reading the label is no guarantee. According to the FDA, products which make promises like results within 30 to 40 minutes or advertise as an alternative to prescription drugs approved by the FDA, are usually fake. The FDA is also strongly advising against buying such products from retail stores, gas stations or via unsolicited emails and foreign websites.
The FDA does not know how and where all such products are manufactured and by law does not have the right to regulate them. A majority of such drugs are produced in overseas facilities and are not inspected by the FDA.
“Some of the ingredients in these products have chemicals that have never undergone any type of safety analysis in the United States. You just don’t know what you’re getting,” says Brad Pace, regulatory counsel at FDA’s Health Fraud Branch.
The best solution is to consult a professional physician before consuming any sort of dietary supplement no matter what the label says.