Formula Contamination Prompts Mandatory Recall Power In China

China's new food safety law, enacted in response to melamine contamination of infant formula, gives the country's regulators mandatory recall authority.

Lawmakers in China passed the Food Safety Law to detail multiple departments' responsibilities to enforce food safety.

The Ministry Of Health will be responsible for handling food safety monitoring, evaluation and investigation of food safety emergencies, Deputy Director Chen Xiaohong told reporters March 2.

Under the law that takes effect June 1, "there will be a new standard for dairy products including milk formula, which might be much stricter than the current standard," said Gao Huijun, director of Shanghai Institute for Food and Drug Safety under Shanghai FDA.

"The key point is how to set a reasonable standard for the manufacturers and ensure safety at the same time," Gao noted.

Gao added State Council departments have discussed food safety for around five years, but due to the melamine problem, lawmakers only recently added regulation of milk formula product to the law.

Frost & Sullivan health care analyst Nina Zhou said the law "pays special attention to food additives" because of the tainted formula scandal.

"No additives, such as the industrial chemical melamine, will be allowed unless they can be proven to be both necessary and safe," Zhou said.

Unlike other regulatory systems, China's supervision of food production and distribution involves multiple government departments, including MOH, the Ministry of Industry and Information Technology, the State Administration for Industry and Commerce, the General Administration of Quality Supervision, Inspection and Quarantine and other departments.

The law will provide a legal basis for regulators to issue compulsory withdrawals to remove from the market products suspected of containing illegal additives until products are proven safe, said Gao, who is working with Yale University to draft details on how to issue such compulsory withdrawals.

The 2008 formula contamination accelerated the approval process of the food safety law (¹ (Also see "Melamine In U.S. Could Pose More Risk To Food Safety Regime Than Infants" - Pink Sheet, 1 Dec, 2008.), p. 13).

The law "emphasizes 'safety' more, compared to 'hygiene,' which was highlighted in the old law, indicating the improvement of supervision on the food market in China," Zhou noted.

Included in the law are "risk evaluation, a monitoring and supervision system, a set of national safety standards, severe punishment for offenders and a product-recall system," Zhou said.

Anyone who promotes unsafe food via public advertisements will be legally liable under the law, according to Zhou.

The Chinese formula market is highly concentrated, with the top 10 brands making up 78.4 percent of the market share, and is dominated by multinational companies such as Wyeth, Mead Johnson Nutrition and Dumex.

"Quality supervision on food imports and exports is highlighted" in the law, which also sets "strict regulations" for international formula brands sold in China, Zhou said.

The U.S. FDA in 2008 opened the first of three offices planned in China in part to serve as a resource for China-based food, drug and device companies looking to export to the U.S. (² (Also see "FDA Foreign Offices Are Only The Start To Improving Import Safety – Experts" - Pink Sheet, 8 Dec, 2008.), p. 6).

Local media recently reported some foreign brands of formula, including those made by Wyeth and Domex, may have led to the formation of kidney stones in babies. Wyeth, Domex and Abbott issued statements on their Chinese Web sites refuting the claims, ensuring consumers that their formula products have passed testing required by China's regulators.

MOH and AQSIQ have confirmed that all the milk formula on the market, including these foreign brands, passed quality tests.

- Dai Jialing ([email protected])