That is according to Jeff Crowther, executive director of the US-China Health Products Association, who in a circular to members has warned that the move will cause many multinationals to pull out of the Chinese market, thereby bringing a halt to millions of dollars in foreign imports.
Currently, companies can enter the market with their dietary supplements as “food” as it is supervised by the Administration of Quality Supervision Inspection and Quarantine, rather than the CFDA, as it is faster and less expensive.
Those who choose to enter as “health food”, however, must be registered with the CFDA through a process that takes two to three years to complete and costs around US$50,000 per product.
But now the Chinese government is making a number of changes to dietary supplement regulations, including the stipulation that any product that has a limited dosage per day in the form of tablet, soft gel, liquid in bottle, powder or pill cannot be imported as general food, and must have CFDA “blue hat” registration.
This will come into effect on January 1, 2014, although any product imported before that date can be sold in China till the product expiration date.
“Those in the dietary supplement industry that are doing or have attempted doing business in China will know it is not an easy affair,” said Crowther.
“Many foreign companies that come to the China market expect to find a set of rules and regulations they can follow and industry people that can answer their questions definitively.
“However, the reality is some follow the rules, some don’t and others seem to make up their own. If you ask 10 people to answer a regulatory question, you’ll get 20 different answers. The industry is a real mess and is in need of reform.”
Crowther says that the health food industry must pull together to encourage the CFDA to put in place a system that “benefits consumers, the industry and the government in that order”.
In this way, the US-China HPA has been working with the US Department of Commerce to encourage the CFDA to work towards a more “transparent structure” that is based on notification similar to that of the United States’ Dietary Supplement Health and Education Act of 1994.
“If the CFDA goes down the current path, the only entities that will profit will be a handfull of domestic companies and a select few foreign companies that actually have CFDA registrations,” said Crowther
Illegal importers, too, will be quick to fill the void left behind by the exiting foreign companies through the black market, he added.