The U.S. Food and Drug Administration (FDA) has found that many bodybuilding (workout) products may contain anabolic steroids or steroid-like substances in their composition. Such ingredients included illegally or not declared by manufacturers may pose serious health risks to consumers, for example, severe liver (hepatic) injury, kidney damage, heart attack, stroke, pulmonary embolism, deep vein thrombosis, severe acne, hair loss, irritability, aggressiveness, depression, among others.

These types of products are promoted as concentrates with hormones or substitutes for anabolic steroids to increase muscle mass in a short time; however, they may contain steroids in their composition.

The FDA does not evaluate the efficacy or safety of these products before they reach the consumer market. In addition, they are usually sold online, in gyms, or by catalog, which makes control difficult. In Peru, all dietary products or supplements are rigorously evaluated by the General Directorate of Medicines, Supplies, and Drugs (Digemid) before and after entering the country, through a process called registration, in which the complete composition of the product is declared, and the nutritional or physiological effect of each active ingredient is assessed.

Source: FDA

Contact us on WhatsApp by clicking here or drop us a line at info@pharmaconsulting.pe to get more information about our Dietary Supplement registration service in Peru.

The General Directorate of Medicines, Supplies, and Drugs (DIGEMID), during the first “Virtual technical meeting on the registration process of nutritional supplements and sweeteners”, established some criteria to be taken into account by users interested in registering these products.

• The registration is granted by product name, pharmaceutical form, amount of active ingredient, manufacturer, and country of origin.

• Technical specifications of the finished product. The technical specifications of the product must include the tests carried out on the finished product

• Certificate of Free Sale (FSC) issued by the competent authority in the country of origin

• Product formula indicating its basic and secondary ingredients

• Stability studies

• Labeling projects and package label

• Good Manufacturing Practices (GMP) Certificate

From now on, the registration or re-registration of dietary supplements in the General Directorate of Environmental Health (DIGESA) will not be allowed.

Authorization is requested virtually to the Ministry of Health.

Source: DIGEMID

Contact us at 997556699 or by mail info@pharmaconsulting.pe and learn more about dietary supplement and sweeteners registration in Peru.

The FDA warned 10 companies for illegally selling dietary supplements that claim to cure, treat, mitigate, or prevent chronic diseases, like diabetes mellitus. The Administration urges consumers not to consume products that have not been evaluated by the FDA to be safe or effective for their intended use.

In Perú, the General Directorate of Medicines, Supplies, and Drugs (DIGEMID) oversees the dietary supplement market. The agency registers nutritional supplements, inspects manufacturing facilities and warehouses, monitors product testing, and drafts policies and laws regarding supplements imported to and sold in Perú.