Recent incidents involving fake vegetable candy (Kera), counterfeit milk powder, and large-scale fake dietary supplements have stirred public outrage and exposed serious regulatory gaps in Decree 15/2018. These events underscore the urgent need for amendments, especially regarding self-declaration, product registration, advertising, post-market inspection, and the accountability of state management agencies.

On July 3, the Food Safety Department (Ministry of Health) announced key updates in the 8th draft amendment of the decree, introducing several major changes.

Mandatory product registration for dietary supplements

According to Clause 5, Article 1 of the draft decree, organizations and individuals responsible for placing products on the market must register product declarations for five categories: health supplements, medical nutrition foods, foods for special dietary uses, dietary supplements, and nutritional products for children up to 36 months.

Currently, dietary supplements are not explicitly listed in Decree 15 as a group requiring product declaration. These products are categorized as pre-packaged processed foods, which allows for self-declaration under local management.

The Food Safety Department notes that this loophole has led many businesses to misclassify products. Numerous health supplements that require product registration are mislabeled as dietary supplements to bypass this obligation. Moreover, because advertising content does not require registration, companies often exaggerate the benefits and effects of their products.

Decree 15 currently requires businesses to commit to complying with food safety regulations and take full legal responsibility for their product declaration documents, quality, and safety. While this simplifies documentation, it has been exploited. Some businesses use ineffective ingredients in health supplements and make misleading claims, disregarding product safety, quality, and actual benefits.

To address this, the draft decree proposes requiring full product registration documentation for these five food groups to ensure control over ingredient combinations, safety and quality indicators, and product functions and claims from research through to pre-market registration.

New requirement to declare product quality indicators, not just safety

Decree 15 currently mandates safety testing (e.g., microbial contamination like Salmonella and E. coli, heavy metals) in product declaration documents but does not require testing for quality indicators such as micronutrient levels, fat, or sugar content.

This oversight has allowed some businesses to misrepresent product quality. For instance, in the Kera vegetable candy case, raw materials should have been sourced from farms meeting VietGAP standards. Instead, the company’s director instructed staff to purchase substandard vegetable powder (only 0.61-0.75%) while falsely advertising it as 28%. Sorbitol made up 35% of the formula, along with other additives not disclosed to consumers.

Similarly, testing on the "Hai Be appetite syrup" revealed key ingredients like vitamin A, calcium, and vitamin C (which determine the product’s effectiveness) were below 70% of declared levels, classifying it as counterfeit.

To strengthen post-market monitoring and enhance product quality, the draft decree also includes provisions for revoking food safety certificates, advertising approvals, product registration confirmations, and removing misleading product information from official government websites.

Clarifying responsibilities of authorities receiving self-declaration files

Decree 15 currently lacks specific regulations assigning oversight responsibilities for self-declared products. This has allowed businesses to self-classify, exaggerate claims, and neglect quality compliance. Often, violations are only discovered after products are widely distributed.

To address this, the draft decree outlines the responsibilities of agencies that receive self-declared files. These include providing feedback on submissions, publishing documents online, conducting post-market checks, and sampling products in circulation to monitor compliance and safety.

Vo Thu