The Food and Drug Administration (FDA) has found three more fake sexual enhancement dietary supplements — Master Zone 1500, Love4Long and One More Knight 1750 — containing hidden chemical compounds (sildenafil, tadalfil and dapoxetine). Not only does this make the claim that these products are dietary supplements false but it also poses dangers of serious health risks. The FDA has advised consumers not to purchase these three products from any retail store or online sites, not even from Amazon.com.
“These products are not harmless or recreational,” said M Daniel Dos Santos, PharmD, PhD, of FDA’s Division of Dietary Supplement Programs. “They often claim to have the same effects as drugs that are FDA-approved for the treatment of erectile dysfunction (ED), such as Cialis and Viagra, promising to work quickly — within 30 to 40 minutes. That’s a red flag.”
Laboratory analysis of these three products carried out by the FDA found these three products containing sildenafil, tadalfil and dapoxetine, which can be found in prescription drugs like Viagra and Cialis, used to treat ED. These compounds can be especially harmful for the health of people with metabolic diseases like diabetes, high blood pressure, high cholesterol or heart disease. For instance, if someone is taking prescription drugs which contain nitrates like nitroglycerin, then taking these fake ‘all-natural’ dietary supplements can lower their blood pressure to dangerous levels.
According to the Federal Food, Drug, and Cosmetic Act of 2004, a dietary supplement is a natural product containing a vitamin, mineral, herb, botanical extract, amino acids etc which can only supplement the diet. A dietary supplement can also be a concentrate, metabolite, constituent, extract or a combination of a natural substance. Keep in mind dietary supplements cannot treat, diagnose, prevent or cure diseases and if they do so, they are most probably fraudulent. Different dietary supplements can be found in the form of tablets, capsules, softgels, gelcaps, powders and even liquids.
The Dietary Supplement Health and Education Act (DSHEA) of 1994 allows the FDA to take action against fraudulent dietary supplements. But only after they have hit the market and someone has reported adverse effects, and the agency has established the presence of an illegal or banned substance. The FDA can also take legal action against such product due to misbranding which means a dietary supplement has been falsely labeled. FDA can take the dietary supplement off the market if it is found to be counterfeit.
FDA is not allowed to review or examine the safety and effectiveness of dietary supplements before they are marketed. The responsibility of making sure the dietary supplements is safe falls on the manufacturers and distributors. However, the manufacturer is supposed to inform the FDA if they have added a ‘new’ ingredient in their product before selling. The dietary supplement manufacturers are also supposed to produce them in a way which meets the quality control specified by the FDA, along with accurate labeling in accordance to the Good Manufacturing Practice (GMP) and labeling regulations.
To date the FDA has caught more than 300 fraudulent products posing as dietary supplements. Other than containing one drug, these products can also contain high doses of mixed chemical ingredients which can pose unknown dangers to health. Since these doses have never been studied before, even the FDA doesn’t know about the dangers they pose to the health.
The FDA routinely publishes Consumer Updates where they warn people about the wisdom of purchasing such products. People who are about to consume or routinely consume dietary supplements should stay notified of the updates published by the FDA. These updates also provide information on how to recognize potential warning signs on fraudulent dietary supplement products.
“We need consumers to be aware of these dangerous products and to learn how to identify and avoid them,” says Michael Levy, director of FDA’s Division of New Drugs and Labeling Compliance.
For instance, products which claim to be natural alternatives of FDA-approved prescription drugs are fake and they can contain illegal compounds like anabolic steroids. Similarly, people should beware of products which are labeled in a foreign language and are only available for order from online websites. Likewise, sexual enhancement products which have labels claiming to provide rapid results within minutes or hours cannot qualify as dietary supplements and almost always have drugs in them. Usually unrealistic claims on fraudulent dietary supplements can be listed as “all-natural”, “quick and effective”, “cure-all”, “can treat or cure diseases” or “totally safe”.
If someone wants to consume dietary supplements, they should first consult their healthcare provider or a registered dietitian (RD) as to the safety and efficacy of the nutrient they want to consume. If a person wants to consume some specific dietary supplement product, they should show the product to their healthcare provider and ask for advice.