Control and Supervision of Authorized Food Supplements through E-submission System: Case Study in Northeastern Region

Abstract

Objective: To study the control and regulation of dietary supplements authorized by the E-submission ystem of the Provincial Health Office in the Northeast. Method: This study was a descriptive research that collected data using questionnaires and in-depth interviews with 8 purposively selected officials responsible for post marketing control of food products within the Provincial Health Office in the Northeast with food authorization through E-submission in the fiscal year 2017. The study collected information using questionnaires on the issue of post marketing regulation of dietary supplements, problems and restrictions in law enforcement. In depth interviews were conducted to collect the data on the problem of food supplements in the province, restrictions and their opinion on authorization process through E-submission. Results: Seven out of 8 respondents were pharmacists. Every studied agency had inspected manufacturing facilities of food supplements in their responsible area. Half of the studied agencies had a database of dietary supplements licensed through E-submission system. The majority of agencies collected samples of dietary supplements from the production places for surveillances. None of the agencies prosecuted the manufacturers of products failing to meet the standard. However, some prosecuted the wrongdoings regarding labels. The subjects agreed strongly that authorization of dietary supplements through E-submission by the Food and Drug Administration with no notification of authorized product information to the Provincial Health Office where the manufacturing facilities were located, and the increasing number of authorized supplements, caused the difficulty in surveillance. In-depth interviews revealed that the supplements produced in the provinces did not have any quality problems. The Provincial Health Office had measures to handle complaints. However, the budget for the product analysis was insufficient. The informants, therefore, warned and asked the manufacturers to suspend the sale when the drug was detected in the products. However, there were no public announcements of the results on product test. However, the information was forwarded to the Food and Drug Administration and the Provincial Health Office where the production sites were located for further action on the problem. Conclusion: The Food and Drug Administration should improve the E-submission system by informing the public health office on the authorization of products, reviewing criteria for manufacturers to submit product labels for approval before product authorization, establish a licensed product database, and safety alert system for harmful products. All provincial health offices should have a continuous monitoring plan for production and selling places. In addition, the law should be enforced to the manufacturers who do not comply with the Food Act 1979, and the results on product tests should be reported to the public. Furthermore, the food serial numbers should be canceled, and product license revoked.