Today, let’s continue from apart-I, this part continues to introduce the industry access, advertising, and marketing managements.

Industry access

In China, obtaining the registration certificate and food production license for FSMPs production is a necessary condition for domestic enterprises. China implements product formula registration management for FSMPs. Whether it is domestically produced or imported products, applicants who want to apply for formula registration should submit materials to the State Administration for Market Regulation (SAMR). After obtaining formula food registration certificates, a food production license for the corresponding product is also needed before domestic production enterprises produce FSMPs.

There are no relevant audit requirements for medical foods before they are marketed in EU. But, in order to facilitate the efficient official monitoring of FSMPs, EU requires that food business operators placing food for special medical purposes on the market should provide the national competent authorities with a model of the label used and all relevant information considered necessary to demonstrate compliance with (EU) 2016/128, unless Member States have a different efficient monitoring system.

Product advertising

In terms of advertising management, China has stricter management. According to the "Regulations on the Implementation of the Food Safety Law of the People's Republic of China", advertisements for nutritionally complete foods are managed in accordance with prescription drug advertisements, and advertisements for other types of FSMP are managed in accordance with non-prescription drug advertisements.

In EU, advertising, promotional and commercial practice managements for infant FSMP by government are similar to those applicable to infant formula and follow-on formula for healthy infants. For example, the advertising of infant formula and follow-on formula shall not use the terms “humanized”, “maternalised”, “adapted”, or terms similar to them. Moreover, the use of nutrition and health claims should not be allowed for FSMPs in EU and advertising of FSMPs developed to satisfy the nutritional requirements of infants shall be restricted to publications specialising in baby care and scientific publications and should not be on point-of-sale.


Sale channels

FSMP are different from common foods in China, nutritionally complete foods should be sold to consumers through medical institutions or pharmaceutical retail enterprises. There are no clear regulations on the sales channels of other FSMPs, but a food business license is necessary for the company that want to sell FSMPs, and they cannot be mixed with common food or drugs during selling.

There are no clear regulations on the sales channels of FSMP in EU, and EU does not specify that FSMPs must be sold by prescription or in pharmacies. But, it does specify that FSMP should be consumed under medical guidance.

Summary

In summary, China has stricter regulations on FSMPs and has a clear classification; EU also has special provision for infant FSMPs, but all FSMPs is uniformly classified: nutritionally complete food, nutritionally complete food with a nutrient-adapted formulation specific for a medical condition, and nutritionally incomplete food.

Regarding the regulatory model, China's FSMPs are subject to production licensing and registration management, and advertising are managed in accordance with drug advertisements. Nutritionally complete food should be sold to consumers through medical institutions or drug retail enterprises. In EU, there are no relevant audit requirements for FSMPs launched on market, but, EU requires food business operators should provide a model of the label used and all relevant information considered to government.

Recommend Article:
Comparison of the management of formula food for special medical purposes in China and European Union-part I

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Business Division of Food Safety and Regulatory Compliance of Global Foodmate provides food standards & regulations research, labelling compliance consulting/Chinese label design, industry public opinion monitoring and analysis, registration services (of Infant formula, FSMP, Health food, Novel Food Ingredients, Novel Food Additives, New Varieties of Food-Related Products and Overseas manufacturers of imported food) and other comprehensive food safety solutions for domestic and overseas enterprises and institutions in food industry. 

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