CHINA - SPECIFICATIONS REGARDING THE NAME OF FORMULA FOOD FOR SPECIAL MEDICAL PURPOSES

On July 24, 2017, the CFDA issued the “Notice of General office of China Food and Drug Administration on the public consultation for specifications on the name of formula food for special medical purposes”. The document opens the public consultation with a deadline on August 6, 2017.

The draft specifies the product name of formula food for special medical purposes, and clearly states that the product name shall not include the naming rules of content and the general name.

Before, formula food for special medical purposes did not have a corresponding name under national legislation. The anticipated act will provoke a major change for manufactures and distributors and shall improve the disparities in the market regarding the designation of such products to a certain degree. It will prove important to stay up to date with the regulatory changes.

Product Name

The product name of formula food for special medical purposes is made up of a product name and a general name. Each product can have only one product name which may not be the same as the approved product name for formula food for special medical purposes. Except for trademarks, the product name shall use the standard Chinese characters. The product name can be accompanied by a corresponding English product name. Different parts of the general name shall not be marked separately.

The product name of formula food for special medical purposes may use, among others, a trademark name and a grade name. It shall not be the same as the approved and registered brand name of a drug and health food. Where the trademark is used in the product name, the product name needs to comply with the provisions on the product name. Product names shall not include the following;

(I) False, exaggerated and absolute contents and those in violation of scientific principles, such as “Golden packaged”, “Super”, “Upgrade”, “Special grade”, “Top grade”, â€œUltimate”, “Transcendency”, “Doctor”, “Champion”, â€œSpecial effects”, “Full effect” and “Comprehensive”, etc.;

(II) Particulars concerning the function of prevention, remission and treatment of disease, such as “Reducing blood sugar”, “Losing weight”, “Weight reduction”, “Treatment”, “Anti-inflammation”, etc.;

(III) Elements explicitly or implicitly declaring functions, such as “Beneficial to intellectual development”, “Increase the resistance or immunity” and “Protect the intestinal function”, or “Reinforcing intelligence”, “Probiotics”, “Easily-digestible”, “Gastrointestinal protection”, “Boost immunity”, “Body training”, etc.;

(IV) Words such as “Upper class”, etc.;

(V) Other words that can mislead the consumer.

Naming rules of general name

The general name of formula food for special medical purpose shall reflect the true nature of the food, use the category name or equivalent name specified in the relevant national food safety standards.

According to the product category, the general name shall be named according to the following rules:

(I) The format of general name of infant formula food for special medical purpose is “Special medical purpose + infant formula food + (product category name)”, such as infant formula food for special medical purpose (no lactose formula).

(II) The format of general name of full nutritional formula food is “Special medical purpose+ full nutritional formula food”, such as “Full nutritional formula food for special medical purpose”.

(III) The format of general name of specific full nutritional formula food is “Formula food for special medical purpose+(product category name)”, such as formula food for special medical purpose (full nutritional formula for obesity surgery).

(IV) The format of general name of non-full nutritional formula food is “Non-full nutritional formula food for special medical purpose + (product category name)”, such as non-full nutritional formula food for special medical purpose (Carbohydrate module).