Health supplements are regulated by the China Food and Drug Administration (CFDA) and divided into two categories: nutritional supplements and health foods. Herbal products that are commonly seen on the North American market can either be classified as health foods or drugs.
Nutritional supplements include vitamins and minerals and are subject to the notification/recording system. Products in this category are governed for maximum and minimum daily dosages and manufacturing procedures. The most important thing to note is after the new Food Safety Law went into force in 2014, the proposed notification/recording system remains unclear to date. In-depth details within this new framework are still unsettled and unclear. Selling products in this category also requires a record of at least 1 year marketing overseas which can be problematic for foreign companies (such as those in the United States), who sell products at potencies higher than those allowable in China.
Health foods are registered through “blue-hat” registration, requiring the full evaluation of efficacy, safety, toxicity, quality, and health claim assessment. This process usually takes two to three years to complete, and at times can take upwards of five years. Registration costs are upwards of $100,000 USD per SKU, which means very few nutraceutical suppliers pursue this. Also, most of the blue hat registrations have been for domestic products, not imported products. For this reason, most suppliers wanting to export products to China do so by selling them online in China. Online sales of nutraceuticals, food and cosmetics in China do not require any registration (rather, general due diligence about logistics and labelling). Our company has partners in China that can develop your online sales in what is the second largest nutraceutical market in the world.
Cosmetics are regulated by the CFDA as well, and can be categorized into two types: general cosmetics and functional cosmetics. Functional cosmetics refer to those aiding in dying hair, hair removal, sunscreen, etc. Before marketing in China, general cosmetics need to be notified/recorded with CFDA and functional cosmetics need to be registered. Notification and registration processes are similar except that functional cosmetics are required to be evaluated and approved by the expert committee and therefore will take to gain approval. Also, animal testing is mandatory for all cosmetics entering China. Products of both types are required to be tested for safety, quality and efficacy (if product is a functional cosmetic) in a CFDA authorized lab before an application can be submitted. For these reasons, as well as due to the high registration/compliance costs, most imported cosmetics enter the online channels as their primary entry point.
NHP Consulting will provide all regulatory documentation and due diligence to achieve market compliance for the China marketplace. We can achieve blue-hat registrations if desired, and/or business development services for exporting products to China.