Here Comes the FDA

The overseas office of the U.S. Food and Drug Administration (FDA) unveiled its logo on November 19th in Beijing, which is the first time the U.S. has established a food and drug investigation organization outside of the U.S. territory. The FDA will open other overseas offices later in Guangzhou and Shanghai. Shao Mingli, the chief of State Food and Drug Administration (SFDA) indicated that advancing the inspection from destination to pre-shipment is an act of pre-emption. The commentator of the China Central Television (CCTV) thinks that “forestalling the potential problems is necessary and more effective than remedying the lethal aftermath.” In the meantime, whether the FDA is trying to take the wind out of China’s sails is also something needs to be viewed objectively.

The First Whack at China

Is China the sole destination where the FDA has set up an overseas office? According to the FDA spokesman, their following goal is to establish offices in India, South America, the Middle East and Europe. As for the reason why it started with China, the FDA only states that on June 30, President Bush had already examined and approved 20 million dollars in funding for the establishment of the five branch organizations within India and China. It emphasizes that “setting up oversea offices is to intensify the strong supervision of imported food and drugs…it is not about targeting at China.” The Secretary of Health and Human Service, Michael Leavitt, explains: “China is the most valuable trading partner of the U.S. For every six dollars of imported goods, there is one dollar from China.” The establishment of overseas offices represents that on the field of food and drug supervision, the two countries have reached a new era. “That allows us to have better communication and closer collaboration with the manufacturers and authorities of the resident countries. We could share experience and further ensure that from producing to consuming, the safety and quality-oriented concept has been thoroughly practiced in every procedure,” Mr. Shao stated. With the development of economic globalization and trade diversification, food and drug safety is already an international issue that needs to be handled by all regulatory authorities. The establishment of the FDA offices in China has further improved the interaction and collaboration. Minister of Health Chen Zhu stated that the cooperation of food safety supervision between the U.S. and China is based on mutual willingness. The Chinese government, who holds a sincere and open-minded attitude, would reinforce its interchange with its U.S. counterpart and be cooperative under the principle of transparency and mutual trust.

Given that internationalized food and drug is an inevitable trend, reinforcing cooperation between nations is essential. From the official announcement, the approach of the FDA’s Chinese office is conducted under China’s consent, ruling out the saying of “having the first whack.” Nevertheless, there must be reasons why the same procedure did not simultaneously apply to India. I personally think there are four points: firstly, while China is the biggest importing country of the U.S, the massive trade deficit has always been one of the U.S.’s great concerns. Hence, it is reasonable for them to tighten up the supervision on imported goods. Secondly, in the WTO dispute, America has been stringent with China. Besides, problems had indeed occurred on China’s exporting food. Accidents like the Sudan Red G and the contaminated milk powder of Sanlu Group have triggered devastating impact and arouse America’s anxiety. Finally, the FDA has been harshly criticized for being an insufficient administor within America, which is exactly the reason why it needs to open overseas offices.

Correspond to China’s Will

According to the media, the FDA will dispatch eight diplomatic staffs to the three overseas offices in China. Apart from the director, experts in the fields such as food, drug and medical devices will also be stationed. They have four main responsibilities: first, working as a mediator among the FDA and relative divisions in China, such as SFDA, General Administration of Quality Supervision, Inspection and Quarantine of the PRC (GAQSIQ) and etc. Second, introduce U.S. importing standards to China. Third, assist China in fortifying its supervision ability. Fourth is to examine the imported food and drug from China. The measures above are also accordant with China’s consent. In terms of safety accidents on food and drug that happen quite frequently, China is taking various measures to strengthen its ability of food safety examination. A scheme of boosting food safety will commence under the leadership of the State Council of PRC. The scheme includes: rearranging the use of food additives. Further reinforce the law of food safety and establish a fundamental drug system that fully applies to China. Finally, consolidate the government’s responsibility of examining the drug safety by establishing safety inspection and assessment organizations. It will also form a national risk assessment committee of food safety and meanwhile expand its oversight network to every province of China. Mr. Chen stated that “under the leadership of the Chinese government, we are confident to straighten up companies and fulfill our duty of supervision.” The residency of the FDA will be helpful for China to put those measures above into practice and to boost the ability to inspect the safety of food and drug.

On one hand, some people agree with that view above. Mr. Zhang, from Jiangxi Huayi Food Co. Ltd, thinks “In the past, the cost of communication between companies and the FDA was sky high. Now since the FDA resides in China, we can communicate more directly.” “Some of the inspection items and methods conducted by the U.S. were not transparent,” he cited, such as examining the chemical residue crystal violet. The FDA only released the examining criteria but not the methods. Once the FDA has resided in China, companies can consulted with the technical staffs directly. Mr. Chang of the Jiangxi Huayi Food Co. Ltd expressed it like this: “As a matter of fact, the FDA’s residence benefits the exporting companies. Chinese enterprises can therefore learn more about the FDA standards and be in line with international practice.” Needless to say, the inspection is highly random. That would be a problem if the results of examination from two sides are inconsistent, which is something that Mr. Zhang could not deny.

Enterprise’s Disagreement

On the other hand, doubts still exist. When interviewed with “Dasheng” magazine, Li Shu Gwang, the international trade manager of the Guangdong Evergreen Group has said, “What the FDA is really up to is to get well-prepared for American products entering into Chinese market. They simply want to understand the inspection measures in China. All the FDA is concerned with is merely America’s interests. They set up many ways to restrict Chinese imported products, including increasing the technical barriers and raising the standard of chemical residue. For China’s interest, they do not even bother.” He believed the FDA would not meet people’s expectation. As for reports from the media, he also believed that “Undoubtedly, it is a kind of humiliation for China. This action means that China has lost its authorities on the field of food and drug inspection. The U.S. does not trust in China’s inspection abilities anymore. Instead, they dispatch their own personnel to China and undergo this supervision in order to cut down the thorny problem of Chinese food safety at the early stage. Even if the U.S. has reiterated that this measure does not target China, insiders generally think it would give China the first shot.”

In my opinion, no matter what people think, the crucial thing is whether the FDA can keep its promise. The “mutual interests” should not merely be a slogan, but they should really work on it. The Americans are quite notorious for their egoistic finesse. For the worry about FDA’s arrival as crying wolf, the division officer of the U.S. Ministry of Foreign Affairs has said that “China has already taken these problems into account. The FDA branch institutions in China would not cause severe impact on the Chinese exporting companies.”