Health Alert: Products for Weight Loss No. 128-2024

Publicado mayo 20, 2024

Directorate of Medicines and Biological Products

Product name: GRAZITIN, OTORYX, BEINSHAPE, PREME, SLIM, CARBLOCKER, CRISTALYX, LIPOBLUE, ULTRALIPO, LIPOBLUE ADVANCE, SUPREME ABS, ULTRA 8K, ULTRA LIPO ORANGE
Source of the alert: Complaint
Internal identification No.: MA2405-079
Alert No. 128-2024
Bogotá, May 20, 2024

The National Institute for Food and Drug Surveillance (INVIMA) warns the public about the fraudulent marketing, through various commercial channels such as social media and websites, of the products “Grazitin, Otoryx, Beinshape, Preme, Slim, Carblocker, Cristalyx, Lipoblue, Ultralipo, Lipoblue Advance, Supreme ABS, Ultra 8K, Ultra Lipo Orange.” These products are being promoted for weight loss and body fat reduction; however, they are not covered by a health registration issued by the competent authority, and therefore their sale in Colombia is illegal.

These products do not have a sanitary registration approved by INVIMA, making their sale in Colombia illegal.

It is important to note that the products “Grazitin, Otoryx, Beinshape, Preme, Slim, Carblocker, Cristalyx, Lipoblue, Ultralipo, Lipoblue Advance, Supreme ABS, Ultra 8K, Ultra Lipo Orange” do not correspond to any product authorized by INVIMA’s Directorate of Medicines and Biological Products.

Since they do not comply with current regulations—namely, Decree 677 of 1995, “which partially regulates the system of registrations and licenses, quality control, as well as the sanitary surveillance regime for medicines, cosmetics, pharmaceutical preparations based on natural resources, cleaning and hygiene products, and other household-use products, and establishes other related provisions.”

As these products are NOT approved by INVIMA, the presence of undeclared substances that may pose a risk to consumers’ health is unknown. Substances commonly used as ingredients in these types of products (promoted for weight loss and body fat reduction) may cause adverse events such as insomnia, anxiety, high blood pressure, nausea, diarrhea or constipation, and increased heart rate.

According to current health regulations, these are fraudulent products which, not being covered by a sanitary registration, do not guarantee quality, safety, or efficacy and therefore represent a risk to consumers. Additionally, their actual contents, traceability, and storage and transportation conditions are unknown.

INVIMA has issued alerts and communications regarding the risks associated with these types of products, highlighting the danger they pose to consumers’ health. These communications also refer to unauthorized claims that create false expectations about the true nature, origin, composition, or quality of the products.

Likewise, the public is urged to always verify a product’s sanitary registration number before using it, confirming its authenticity through the following link: https://www.invima.gov.co/, by selecting the product category (medicine, dietary supplement, etc.) and searching by product name, sanitary registration, or active ingredient.

Recommendations (DM-PF1-CG):

Refrain from purchasing the products “Grazitin, Otoryx, Beinshape, Preme, Slim, Carblocker, Cristalyx, Lipoblue, Ultralipo, Lipoblue Advance, Supreme ABS, Ultra 8K, Ultra Lipo Orange,” with the characteristics described above.
Do not buy medicines or dietary supplements without a valid sanitary registration, as these products may contain ingredients that pose a risk to your health. Note that many of these fraudulent products are marketed through websites, social media, and WhatsApp chains.
If you are consuming this product:
a) Stop using it immediately due to the risks it may pose to your health.
b) Immediately inform INVIMA or local health authorities of any information you have about places where this product is distributed or sold.
c) If you have experienced any adverse event associated with its use, report it immediately via email at [email protected].
Immediately inform INVIMA or local health authorities if, for any reason, you become aware of places where this product is distributed or sold.

Measures for the general public

Refrain from purchasing the products “Grazitin, Otoryx, Beinshape, Preme, Slim, Carblocker, Cristalyx, Lipoblue, Ultralipo, Lipoblue Advance, Supreme ABS, Ultra 8K, Ultra Lipo Orange” (sexual enhancement), with the characteristics described above.
Do not purchase medicines or dietary supplements without a valid sanitary registration, as these products may contain ingredients that pose a risk to your health. Keep in mind that many of these fraudulent products are marketed through websites, social media, and WhatsApp chains.
If you are consuming this product:
a) Stop using it immediately due to the risks it may pose to your health.
b) Immediately inform INVIMA or local health authorities of any information you have about places where this product is distributed or sold.
c) If you have experienced any adverse event associated with its use, report it immediately via email at [email protected].
Immediately inform INVIMA or local health authorities if, for any reason, you become aware of places where this product is distributed or sold.

Measures for departmental, district, and municipal health authorities

Carry out inspection, surveillance, and control activities in establishments under your jurisdiction where this product may potentially be marketed.
Take the necessary measures as appropriate and arrange for its destruction.
Inform INVIMA if this product is found in any establishment or online channel.
Replicate or disseminate this alert to Health Benefit Plan Administrators (EAPB), Health Service Provider Institutions (IPS), and other relevant stakeholders within your jurisdiction in the health sector.

Measures for Health Service Provider Institutions (IPS) and healthcare professionals

If patients are found to be consuming these products, they should be advised to stop using them and informed about the potential health risks that may arise.
Notify INVIMA about the acquisition of the mentioned product, including any information provided by patients regarding the location and method through which the fraudulent product was obtained.

To license holders, distributors, and retailers

Refrain from distributing and marketing the aforementioned product, as its commercialization may result in the application of sanitary safety measures.

Measures for the National Pharmacovigilance Network

INVIMA requests that, through institutional Pharmacovigilance programs, active surveillance be conducted to detect adverse reactions involving the aforementioned product, and that these be reported to INVIMA.