Functional Food Rules in Vietnam: Circular 43 Explained

Functional food rules in Vietnam have a new base text. Circular 43/2014/TT-BYT, signed on November 24, 2014 by the Ministry of Health, took effect on January 15, 2015. It replaces Circular 08/2004/TT-BYT. Buyers who import or stock supplements should know what it asks of makers and what must show on a label.

What the circular covers

The circular governs production, trading, product announcement, labeling and instructions for functional foods. It names four groups: supplemented foods, health supplements, medical foods, and foods for special dietary uses. Nutritional formula for children is left out. That product follows its own technical rules.

It rests on the Law on Food Safety of June 17, 2010 and on Decree 38/2012/ND-CP of April 25, 2012, which explains how parts of that law work.

Sources: Circular 43/2014/TT-BYT, Articles 1 and 2, Ministry of Health.

Registration before sale

Every functional food, made at home or imported, must be declared before it reaches the market. The route depends on the product. If a technical regulation covers it, the maker files a declaration of conformity. If no technical regulation covers it, the maker files a declaration of compliance with food safety rules. Both are registered with the Vietnam Food Administration, part of the Ministry of Health.

The steps follow Decree 38/2012/ND-CP and Circular 19/2012/TT-BYT of November 9, 2012. Testing for these files also follows Circular 19/2012. Where the main active ingredient can be measured by a Vietnamese laboratory, its amount in the product must be measured.

Old certificates stay valid. A product that had a declaration certificate before January 15, 2015 keeps it until that certificate expires.

Sources: Circular 43/2014/TT-BYT, Articles 3, 5 and 20.

When a product must be tested on people

The circular lists the cases that need a report on effects on human health. They include a product that claims to help treat disease, a product with a new effect not yet recognized by other countries, and a product with a new active ingredient that has not been permitted. A supplement sold for the first time with a formula unlike others that have scientific support also needs one.

The test must be run by an institution licensed to do medical research. A product that claims a treatment effect must be tested at a provincial hospital or higher that holds such a license. A test done abroad must come from an agency accredited in its home country, or the results must appear in an academic journal. The Vietnam Food Administration sets up a Scientific Council of experts to review these reports.

Sources: Circular 43/2014/TT-BYT, Article 4.

What a label must show

Every functional food label must meet the general rules in Joint Circular 34/2014/TTLT-BYT-BNNPTNT-BCT of October 27, 2014 on packaged food labels. The product name and every label statement must match the claims in the declaration file. Any risk warning must be on the label.

Each group then has its own words on the main side of the label.

• Supplemented foods carry the phrase "Supplement foods".
• Health supplements carry the phrase "Health supplement", to set them apart from medicines. They also carry this notice right after the stated effects: "Attention: This product is not a medicine, and is not a substitute for medicines." The letters must contrast with the background and be at least 1.2 millimeters tall, or 0.9 millimeters if one side of the pack is under 80 square centimeters.
• Medical foods carry the phrase "medical foods" and the sentence "used under the supervision of health workers".
• Foods for special dietary uses carry "dietary products (for specific users)".

A health supplement label may not state how the product behaves in the body. Its main ingredient must be listed first with full name and content.

Sources: Circular 43/2014/TT-BYT, Articles 6, 9, 11 and 13.

Claims, ads and shops

Claims are tied to numbers. If a substance is below 10 percent of the recommended nutrition intake for Vietnamese people, its content may not be announced on a supplemented food. A health claim about an added substance is allowed only at 10 percent or more, and only with specific scientific evidence. Vitamin and mineral levels may not pass the maximums in the circular's second appendix.

For health supplements, a claim about an ingredient must match the scientific documents on file. The same goes for the stated users and usage. Prohibited users must be listed. Audio and video ads for health supplements must also carry the notice that the item is no drug and cannot stand in for medicines.

Shops face a rule too. Health supplements must be sold apart from other foods. A pharmacy needs a separate area for them. Pharmaceutical plants with a Good Manufacturing Practice certificate do not need a separate food safety certificate to make these products.

Sources: Circular 43/2014/TT-BYT, Articles 7, 8, 10, 14 and 15.

What buyers should do now

Ask each maker or importer for the registration paper from the Vietnam Food Administration. Check that the name on the pack matches the name on that paper. Read the label for the group phrase and the "not a medicine" notice. Ask for the effects report if the product claims something new.

The circular also covers recalls. A product must be recalled if it has expired, fails a technical standard, or is sold with information that differs from its registered claims. The maker or seller pays for the recall and for disposal. This is why a clear paper trail matters to a buyer.

Sources: Circular 43/2014/TT-BYT, Articles 16 to 18.

Sources

Circular No. 43/2014/TT-BYT of November 24, 2014 of the Ministry of Health, as issued. Also cited by that text: Law on Food Safety (June 17, 2010), Decree 38/2012/ND-CP (April 25, 2012), Circular 19/2012/TT-BYT (November 9, 2012), Circular 16/2012/TT-BYT (October 22, 2012).