Abstract: Objective： The paper compared the definition， pre-market supervision， labeling， post-marketing supervision of the fatty acid drugs and the fatty acids dietary supplements in the United States， and to provide reference for the regulation on the same substance that is registered as a drug but also registered as health food in our country. Methods： The literature research methods and comparative research methods were used to introduce and compare the definition， pre-market supervision， label labeling and post-market supervision of fatty acid products in the United States. Results & Conclusion： China should deal with the definition of drugs and health food to be clearly defined. Our country′s health food regulatory model should be translate the whole regulatory into the risk control transition. Our country should restrict the health claims and unified the content of the health food.