The National Institute for Food and Medication Surveillance (INVIMA) issued an urgent health alert after detecting the presence of unauthorized pharmacological substances in four widely marketed dietary supplements in Colombia. The products involved are Vifer Max, Vitafer-L, Vitafer-L Gold and X-Bull, All promoted as sexual enhancers or energy supplements, but that contain compounds that represent a serious risk to consumers’ health.
According to the analysis carried out by the Invima Laboratories and Quality Control Office, the first three products contain tadalafilo, An active substance used in medical treatments for erectile dysfunction, which requires medical prescription and professional supervision.
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This substance is not allowed in dietary supplements, and its presence was not declared in the labeling of the products. The fourth supplement, X-Bull, was found with Sildenafil, Another medication used to treat erectile dysfunction, also without a statement on its label.
The product that is prohibited.
Sergio Acero Yate – El Tiempo
For its part, the Food and Medicines Administration (FDA), had already alerted in August 2024 about the components of said product (consumed by men, generally), explaining in its web portal, that Tadalafilo is the active ingredient of Cialis, “A prescribed medication approved by the FDA and used to treat erectile dysfunction. The approval of Cialis by the FDA is limited to its use under the supervision of an authorized health professional“
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This ingredient not declared “It can interact with nitrates present in some prescription medications, such as nitroglycerin, and can reduce blood pressure to dangerous levels. People with diabetes, hypertension, high cholesterol or heart disease usually take nitrates“The FDA points out.
In this regard, William Saza, coordinator of the Invima Pharmacovigilance Group, described the discovery as “serious”, and explained that the detection of these substances forces the immediate cancellation of the sanitary record of the products, as well as their retirement from the market without the possibility of inventory exhaustion. “We invite citizens not to consume them, immediately suspend its use and report any adverse event”, Said the official.
The products were identified in marketer and distributing establishments in Bogotá and Cali, including JC Farma Sas, which does not have good manufacturing practices certification (BPM) and whose renewal of sanitary registration was denied by motivated resolution. The affected presentations include 10 ml shakes, 20 ml jel and 500 ml jarscorresponding to specific lots that are already being removed.
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The Invima also warned that the consumption of these supplements can generate Serious complications, especially in people with a history of ischemic stroke, heart or hepatic insufficiency, non -controlled arrhythmias, unrelated arterial hypertension or hypotension. In addition, the use of tadalafilo and sildenafil without medical supervision can cause dangerous interactions with other medications, such as nitrates.
The entity made an urgent call to consumers to verify the sanitary record of the products before acquiring them, already Distributors to suspend advertising, withdraw inventories and cease their marketing. He also urged health professionals to recommend the suspension of consumption in patients who use these products and report distribution channels to INVIMA.
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Citizens can Report adverse events or points of sale where these products are still marketed to the official email: [email protected]. This alert adds to a series of actions that the Invima has been advancing to protect public health against the proliferation of fraudulent products and dietary supplements that do not comply with the health standards required by law.
Valentina Delgadillo Abello
Portfolio journalist
