An Indonesian slimming drug with undeclared ingredients causing harm

Area of Science:

• Pharmacovigilance
• Food Safety Regulation
• Herbal Product Analysis

Background:

• Adverse drug reactions (ADRs) linked to herbal supplements pose a public health risk.
• The herbal slimming supplement Sulami® has been implicated in reported ADR cases.
• Regulatory oversight of herbal products is crucial for consumer safety.

Purpose of the Study:

• To identify undeclared pharmaceutical adulterants in the herbal slimming supplement Sulami®.
• To assess the legal implications and safety concerns associated with adulterated herbal products.
• To highlight the importance of regulatory collaboration in managing high-risk food supplements.

Main Methods:

• Analysis of four Sulami® samples reported in ADR cases.
• Identification of adulterants using analytical techniques.
• Review of European General Food Law Regulation regarding food business operator responsibilities.

Main Results:

• Sibutramine and canrenone were detected as adulterants in all analyzed Sulami® samples.
• These adulterants are associated with serious adverse drug reactions.
• Sulami® fails to meet legal safety requirements for food products in the European and Dutch markets.

Conclusions:

• The sale of Sulami® is prohibited due to the presence of undeclared, potentially harmful drugs.
• Food business operators, including online sellers, are legally responsible for the safety of herbal preparations.
• Enhanced collaboration among national and European authorities is essential for effective enforcement and consumer protection against unsafe food supplements.