China Cracks Down on Illegal Addition of Bisacodyl in Food

China authorities have announced stricter measures relating to the illegal addition of Bisacodyl and its derivatives in food with the issuance of Notice No. 12 [2025] by the State Administration for Market Regulation (SAMR). Effective June 10, 2025, the regulation introduces official inspection methods and expert toxicological standards to support enforcement actions. International food manufacturers are advised to review product formulations to ensure compliance and avoid regulatory or market access risks.

Background and Significance

Bisacodyl is used as a stimulant laxative drug. Since a "whistleblower" reported the popular TiQ Prune Juice for containing laxative ingredients in 2024 leading to the revocation of the US beverage manufacturer Jerry & Sons Pharmaceutical Inc.'s registration from the Chinese market, as well as the trend for weight-loss drugs, more scrutiny has been focused by regulators on this product area.

Main Content of the Notice

Clarification of Inspection Methods: The notice includes the "Enforcement Inspection Method for Bisacodyl Propionyl Substitutes in Food." The establishment of this inspection method provides market supervision departments and inspection and testing institutions with clear technical means to accurately detect whether the involved food contains bisacodyl and its derivatives. This provides strong technical support for law enforcement agencies when investigating related cases, ensuring the scientific and accurate nature of law enforcement. The inspection results will serve as important references for case characterization, penalty discretion, and sentencing.
Toxicity and Harmfulness Determination: The notice also contains two expert opinions: "Expert Opinion on the Toxicity and Harmfulness of Illegally Added Bisacodyl and Its Derivatives in Food" and "Expert Opinion on the Toxicity and Harmfulness of Bisacodyl and Its Derivatives in Food." These opinions professionally clarify the toxicity and harmfulness of bisacodyl and its derivatives. Experts point out that bisacodyl and its derivatives have the same or similar core pharmacophores and clinical effects, posing similar health hazards to humans. These expert opinions will serve as supporting materials for similar cases transferred to judicial authorities, helping them provide scientific basis when identifying toxic and harmful substances and implementing sentencing.
Law Enforcement Requirements: The notice emphasizes that market supervision departments at all levels must strictly investigate and deal with such cases in accordance with the "four strictest" requirements, namely the strictest standards, the strictest supervision, the strictest penalties, and the strictest accountability. Cases suspected of criminal offenses will be transferred to public security organs for handling. This requirement reflects the Chinese government's zero-tolerance attitude towards food safety issues and its determination to protect public health and maintain market order.

Integration into China's Broader Regulatory Framework

China's food safety regulatory system is constantly being improved and refined, and the issuance of this notice is an important part of this process. From a macro perspective, it is in line with the core principles of the "Food Safety Law of the People's Republic of China." The Food Safety Law clearly stipulates that food shall not contain drugs, and bisacodyl and its derivatives have never been approved as food additives or new food ingredients, nor as health food ingredients. Therefore, the detection of such substances in food is considered illegal addition. This notice further refines the law enforcement procedures by clarifying specific inspection methods and toxicity and harmfulness determination standards, providing more targeted legal basis for combating illegal food addition.

Compared with existing regulations, the key changes in this notice are the precise targeting of new types of illegal additives. Previous regulations focused more on traditional illegal additives, while this notice targets the new type of illegal additive, bisacodyl and its derivatives, clarifying their detection methods and hazard determination standards. This shows that China's food safety regulatory system is constantly adapting to new market changes and technological challenges, timely filling regulatory gaps to ensure that food safety supervision leaves no blind spots.

Impact on International Manufacturers and Recommendations

Impact:

Strengthened Enforcement: China's food safety regulatory efforts are continuously strengthening, and any attempts to gain market benefits through the illegal addition of substances will be severely punished. International manufacturers must ensure full compliance or face consequences such as product recalls, fines, and criminal penalties.
Stricter Inspections: Clear inspection methods and toxicity determination standards mean stricter inspection and quarantine procedures. Detection of bisacodyl and its derivatives may damage reputation and hinder market operations.

Recommendations:

Strict Compliance with Regulations: Study and comply with China's food safety regulations to avoid illegal additives. Exercise caution with products claimed to have "weight loss" functions.
Strengthen Quality Control: Establish strict quality inspections from raw materials to final products, using third-party testing when necessary.
Monitor Regulatory Dynamics: Track updates to China's food safety laws and adjust production processes accordingly.
Consult Professional Agencies: Work with experts like Cisema for regulatory interpretation, compliance advice, and market access support.

Further Information

To read the original announcement of the Notice on Cracking Down on the Illegal Addition of Bisacodyl and Its Derivatives in Food (No. 12 [2025]) released by the State Administration for Market Regulation of China, please click here.

If you are a food manufacturer with questions about how long it takes or how much it costs to ensure your product complies with Chinese food safety regulations, please contact Cisema.