It’s Official! China Redrafting Regulatory Process for Dietary Supplements

China is officially on its way to reforming its regulatory process for dietary supplements. As it stands today, both foreign and domestic dietary supplement companies must clear unwieldy-and often insurmountable-hurdles with China’s Food and Drug Administration (CFDA) in order to sell supplement products in China. In fact, most foreign countries have stopped exporting supplements to China in light of the country’s prohibitive product-registration process. But the U.S.–China Health Products Association (USCHPA; Lewes, DE)-a group devoted to promoting commerce between the two countries-reports that on July 1, China’s National People’s Congress passed draft reform of China’s Food Safety Law that would effectively turn China’s dietary supplement registration process into a notification-based system for some types of dietary supplements.

“At this early time, what we can report is that the new law has a notification amendment, which will allow certain supplements to simply record their products with CFDA,” USCHPA stated via press release.

A notification process is a big change from what currently exists. Today, the supplement-registration process is what’s deemed as a “blue hat” system (named for the registration symbol’s blue hat logo). This process is onerous, lengthy, and expensive. USCHPA says the administrative process can take up to three years and can cost companies up to $100,000 per registration and require companies to invest in clinical trials, as well. (Read more about the problems with China's current regulatory process for dietary supplements.) Although USCHPA is still reviewing the entirety of the Food Safety Law proposal, the association said that under a notification process, companies would need to notify China’s FDA on new products entering the market, without having to go through pre-registration, similar to the U.S. DSHEA process.

Not all ingredients will be allowed to go through the notification process, however. Only select categories of ingredients would qualify for this route, USCHPA’s executive director, Jeff Crowther, tells Nutritional Outlook.

“China’s FDA will only allow certain ingredients that are well documented for safety and efficacy, such as single-ingredient vitamins and minerals, to go through this notification system,” he says. “Blue hat registration will still be required for companies that have complex formulas or formulas that contain ingredients that are not yet available in the China market.” Also, he says, companies will still need to undergo the blue hat system if they want to make a health claim for a product.

CFDA plans to release a list of approved ingredients that can be used in dietary supplements-a list CFDA will keep updated, Crowther says.

CFDA is now accepting comments on the newly proposed law, until July 31. Companies interested in commenting are welcome to contact USCHPA at info@uschinahpa.org.

Opening up the Playing Field

By simplifying the regulatory process and cutting companies’ financial burden and the time required to go through blue hat pre-registration, the notification system would help level and expand the playing field in China's supplements market. The import channel would also unclog.

“At this time, Chinese domestic companies and foreign direct-sales companies hold the lion’s share of the market,” Crowther says. “A notification system will allow smaller and medium-size domestic and foreign companies to compete on a more level playing field. Reform of the system is widely supported by foreign companies, as well as many domestic companies."

In fact, the only companies that might resist these reforms are those that have already invested in the blue hat process and that currently monopolize China's market. These companies aren't likely to welcome the entry of more competitors.

But even these companies stand to benefit from the huge market potential in China, which represents the largest consumer base in the world, Crowther says. For instance, as more supplement companies enter the market and help to educate consumers about supplements and expand the retail base, even current blue hat companies may see an uptick in business. “Although market share will decrease for some, their actual sales volume will increase as the market expands,” Crowther points out.

Opening up the regulatory process will also attract new investors to the Chinese market, Crowther says. Until now, “because the regulations were so strict and the industry in general lacks transparency, most felt it was not a safe investment. The opening of China’s dietary supplement industry will create an environment that will attract investment, which would do many great things to develop the industry.” Over the last five years, USCHPA has received many inquiries from companies looking to invest in China’s dietary supplement industry. U.S. investors, especially, may be looking for opportunities outside of America’s already mature supplements market, he adds.

“China is a key region that can help companies increase their global footprint. In the future, foreign dietary supplement companies will see a much larger share of their profits being generated in the China market,” he predicts.

Revised regulations will also help clear up the currently “confusing landscape” of dietary supplements in China, USCHPA further points out. For instance, some supplement products are sold as OTC drugs, some as blue hat–registered supplements, and some as general food. As USCHPA wrote in its “Export Potential Report,” sent to China’s Legislative Office of the State Council in April, “The ambiguous nature of the current regulatory system and market environment has created a confusing overall experience for consumers and sends mixed messages about the role of health food products. In fact, most consumers in China believe that health food products are a type of medicine due to their history of being sold in pharmacies as OTC, as well as some unscrupulous companies overstating their functions.”

One thing is clear: change is needed, USCHPA says. “Unfortunately, the [current] regulations have been keeping the industry at bay and have essentially been stalling the explosive growth of the industry that one would expect.”

Jennifer Grebow
Editor-in-Chief
Nutritional Outlook magazine
jennifer.grebow@ubm.com