US–China Health Products Association submit recommendations to Chinese FDA


The US–China Health Products Association (USCHPA), an US-based non-profit association for welfare of natural health products industry, has submitted comments to China’s Legislative Office of the State Council in response to China’s Food and Drug Administration (FDA) request for public opinion on the draft of the revised food safety regulations. These recommendations concern approval for new dietary supplements products.

USCHPA has produced a detailed report focusing on the dietary supplement sector, which is referred to as “health food products” in China and regulated by China’s FDA. China’s current regulations for dietary supplements are based on product registration and are said to be among the most restrictive in the world. The registration process requires animal testing and in some cases human trials. One product (SKU) registration can take 2 – 3 years to complete and cost in excess of $50,000, the association says.

USCHPA’s areas of work include dietary supplements, organic foods, natural cosmetics, sports nutrition and traditional herbal products. The association’s primary focus is conducting regulatory advocacy measures and offering its members operational assistant with the U.S. and China markets.

It is expected that China’s FDA will release new regulations for dietary supplements sometime in 2014, said the association.

Recommendations by USCHPA in brief

1. Replace the term health food product with the term dietary supplement. This will help to consolidate the industry and dispel confusion.
2. Replace China FDA’s (CFDA) product registration process with a notification system. Notification would eliminate the need for re-registration and free up CFDA personnel and resources for market surveillance.
3. Dietary supplements approvals should be based on ingredients, not on the products. It would help remove redundancy in testing similar products which are already known to be safe for human consumption.
4. Adopt a function/structure claim system that allows for a broad range of statements to be made about dietary supplement ingredient functions based on scientific evidence. No medical treatment or disease claims should be allowed.
5. Stop testing dietary supplements on animals.
6. Increase transparency of approval process.
7. Overhaul dietary supplement ingredient potency restrictions, or at a minimum alter the restrictions so they are utilized as recommendations that serve as guidelines. Association has urged that the recommendations be made more flexible to coincide with the latest in nutritional science recommendations.
8. CFDA should allow all ingredients that are already approved as new resource food by the country’s Ministry of Health to be used in dietary supplements in commonly used forms such as capsules, tablets and powders.

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