Food supplement products offer strong appeal to companies interested in expanding their sales into new markets. In general they are high value products, light in weight, small in size, with a long shelf life. This makes them extremely conducive to be shipped in bulk or individually from one country to another. It is also for this reason that these types of products are very popular on ecommerce marketplaces such as Amazon, eBay, Rakuten or Tmall.
It is easy to see the appeal to access new markets considering as well the overall growth of the food supplement sales globally. On the other side of the coin food supplement regulations are complicated. To begin with they have different given label names in each country such as “dietary supplements” in the United States or “health food” in China each with their own particular definition. These definitions matter because specific food supplement regulations may apply in some cases while in others the normal regulations for food apply.
Beyond that there can at times be a lack of clarity whether the particular product is regulated as a food item or as a pharmaceutical product. This distinction can completely change the relevant government agency responsible and the process for obtaining permission to sell the product in that particular country.
The combination of the sales appeal with the regulatory complexity is why we continue to see a growing request for food supplement brands and retailers looking for help in understanding where to begin. An integral part of the business case for new market expansion certainly includes a grasp of the requirements. And this goes beyond making a “go, no go” decision. The requirements may also dictate how you go in the beginning and then evolve over time in order to increase speed to market.
Therefore we wanted to share here some of the high level considerations for key markets that could be on a sellers shortlist for exporting. Specifically we will share information on Japan, China, and Australia with some initial resources for getting started.
Food Standards Australia and New Zealand (FSANZ) is the statutory authority responsible for developing food standards which make up the Australia New Zealand Food Standards Code (FSC).
Within the FSC legislation there are a set of standards that clearly lay out the requirements for marketing and selling the different types of food supplement products within the country.
Standards 2.9.3, 2.9.4, 2.9.5 and Schedule 4 on nutrition, health and related claims are all valuable food supplement regulatory references to consult depending on the type of product to be sold.
An important point in Australia is that some products may make claims regarding health effects which may not necessarily be treated as a food product under the code. Such products may be considered therapeutic and thus governed by the Therapeutical Goods Administration (TGA). The TGA provides a Food-Medicine Interface Guidance Tool to assist manufacturers and importers to ensure their product is governed by the correct regulations.
China has an interesting approach regarding the (re)sale of food supplements based on whether a product is sold on an online marketplace, e.g. Tmall, or if the product is sold in a more traditional retail manner. In the first instance, the third party reseller can make individual sales directly to the end-consumer by applying the applicable regulations of the original country the product is shipping from.
In the case that a company is looking to enter the market through the normal means of import and export then there are two distinct government approval paths depending mostly on the raw materials being used in the product:
- Currently vitamins or mineral supplements go the route of filing an application after having conducted product stability testing and the other testing parameters included in the specific product standard. This filing procedure is the least complicated of the two
- All other food supplements must follow the registration procedure, which is more time consuming and also requires scientific evidence on the product safety and any specific claims being made.
In addition to the above, it is important to consult the specific list of raw ingredients in the food supplement regulations as some are not approved for use by the Chinese government.
In Japan there are four categories of health foods with different requirements and claims that can be made. An important initial step is determining where your product(s) best fits as that will also determine important aspects like how you market your product in the country. The four categories are:
- Foods for Specified Health Use (FOSHU): The FOSHU applicant has to go to the Consumers Affair Agency (CAA) with scientific data who will then request the Ministry of Health, Labour and Welfare (MHLW) to check the data. After the review the CAA will give an approval.
- Foods with Nutritional Function Claims (FNFC): The FNCF applicant has to check the specification and compare it with the MHLW/CAA guidelines on their own. After that the CAA will give a permission for the nutritional claims.
- Foods with Functional Claims (FFC): The FFC applicant has to prepare scientific data and upload the data on their website. Then the applicant goes to the CAA to get the health claim permission. It is not necessary to have the data checked by the MHLW.
- The final one, known as ‘health foods’ (Japan does not have dedicated food supplement regulations), is for those products that cannot make any claims on the health functions in these foods. We find that most companies often begin selling their product taking this approach since no official registration is required. Over time they gather further scientific evidence and eventually submit their application as an FFC in due course.
Determining the product categorization is an important initial step as outlined above. Once the applicable approach is agreed upon the company can begin to assess the other main compliance requirements and the necessary document made available. These include but are not limited to:
- - Labeling Requirements for packaged food product
- - Restricted Substance Limits for raw ingredients (Botanical and herbs, additives, pesticide MRLs, heavy metals, etc)
- - Food contact material limits for plastic packaging
- - Import Procedures