The US-China Health Products Association was one of the parties invited by China’s National People’s Congress legislative department to discuss its draft food law, which includes regulations that oversee the dietary supplement industry.
‘Strong willingness to engage’
The USCHPA’s executive director, Jeff Crowther, joined officials from America, EU countries, Japan and New Zealand to take part in discussions with nine Chinese officials last week.
“I’ve been living in China for nine years working on business development and regulatory advocacy. This is the first time I’ve witnessed such openness and strong willingness to engage with foreign parties. It was a wonderful opportunity for those in attendance to share their suggestions and questions directly with China’s lawmakers.” said Crowther.
Although much of the discussion focused on ongoing issues with infant formula, the USCHPA focused on dietary supplements and urged Chinese authorities to regulate these under food law and on a notification basis, rather than the current system of registration.
“The registration system is not only too costly in both time and fees, but it is also redundant in many cases,” the USCHPA said in a statement. For example, if two identical products from two different manufacturers enter the market, they both must submit to registration procedures costing over US$100,000 each, it explained.
It also argued that China’s food laws refer to dietary supplements as health foods, which is too broad a term. During the discussion, Crowther advised Chinese authorities to seek to replace their terminology with “dietary supplement”, which he said would bring more clarity to government, industry and consumers.
“Health product claims should be replaced with structure function-type claims similar to what is found in the US’s Dietary Supplement Health and Education Act 1994. This will assist in eliminating consumer confusion to the actual functions that dietary supplements play in a healthy diet. At this point in time, many Chinese consumers feel dietary supplements are a type of medicine,” Crowther said.
“China’s Food and Drug Administration is planning to release new regulations this year for dietary supplements that include a notification system. However, this system as it is drafted would only allow individual vitamins and some minerals to enter the market on a notification basis.
More foreign and domestic opportunities
Although the draft is a step in the right direction, it will not really help the industry too much as most dietary supplements are made of multiple ingredients, which can include specialty nutrients such as omega-3, CoQ-10 and botanicals, Crowther added. The CFDA’s position on risk assessment would require products with multiple ingredients to go through registration, as they would not be eligible to proceed through the new draft notification system.
“Currently regulations are also forcing Chinese ingredient suppliers to rely heavily on export-orientated business strategies due to the lack of domestically produced dietary supplements.
“If the regulations become more open and transparent moving towards 100% notification, there would be many more opportunities for both foreign and domestic ingredient suppliers to sell to Chinese manufacturers of dietary supplements.”
The USCHPA also highlighted ingredients that are already approved as food by China’s National Health and Family Planning Commission (NHFPC—formerly the health ministry), such as some probiotics,
“Omega-3s as well as many other botanical and dietary ingredients are not allowed to be sold as dietary supplements without going through another separate registration process with China’s FDA to be sold as a health product,” said Crowther.
“This is redundant, as the NHFPC has already determined that the ingredient is safe for human consumption, NHFPC-approved ingredients should be allowed to be sold as dietary supplements without redundant testing from China’s FDA.”
Following the meeting, which Crowther acknowledged as a “sign of true determination by China to reform and put into practice more streamlined and transparent regulations”, it is expected that China’s State Council will release new regulations for dietary supplements by the end of this year.