Drug Firms Model Ensuring Import Safety; China's Inconsistencies Worry FDA

Firms using Chinese imports to make dietary supplements and other products can look to drug firms for lessons on ensuring the safety of raw materials from China, where adherence to food and drug production regulations remains inconsistent, current and former FDA executives tell a Senate panel.

Scott Gottlieb, former FDA deputy commissioner for policy, and Murray Lumpkin, FDA's deputy commissioner for international and special programs, made presentations to the Senate Commerce Committee on July 18.

The committee asked experts for statements "on the consumer impacts from and federal agency responses to unsafe Chinese imports entering the United States."

Dr. Gottlieb, now with the American Enterprise Institute, said while U.S. firms using imported food products are "taking a more active role in policing their own supply chain," they can learn from drug firms who acquire raw materials from China.

Many of these drug firms "do not simply purchase their bulk drug product ... from Chinese producers on the open wholesale market," he said. "Instead, they go into China and control or play a prominent role in almost every aspect of the production process."

Ratchet Up Supply Chain Control

Drug firms' control of their supply chain frequently spans from constructing raw material manufacturing facilities to inspecting operations, and from managing the shipment of goods to the U.S. to having the materials inspected by FDA.

Gottlieb pointed out U.S. Pharmacopeia has opened an office in China to help U.S. firms certify and inspect their manufacturing operations there ("The Tan Sheet" July 23, 2007, In Brief).

U.S. nutritional and supplement product firms as well as other companies using Chinese food products "will need to control or exert oversight of more aspects of the production process for their raw goods, even if that means going onto Chinese farms, for example, and helping to develop better production methods and oversee processing," Gottlieb said.

The importance for U.S. firms to tighten control of their supply chain's Chinese components was made clear in Dr. Lumpkin's description of FDA's understanding of drug and food manufacturing practices in the country.

Lumpkin referred to Chinese regulators not requiring the registration of chemicals that can be used in both industrial chemical products and drug products, either to be used in China or exported.

"With respect to dual-use chemicals, this systemic problem increasingly can pose a hazard to the U.S. drug supply if these products are exported as chemicals but used as starting products for the production of pharmaceuticals," Lumpkin said.

Chinese firms' exports of diethylene glycol intended for use in industrial chemicals but labeled for use in toothpastes is a recurring example of problems with drug products linked to lax regulatory practices there, he added ("The Tan Sheet" July 16, 2007, p. 9).

However, supplement manufacturing experts say they expect China to become a world leader in food safety ("The Tan Sheet" June 4, 2007, p. 12).

Vigilance On Food Product Imports

FDA also maintains heightened scrutiny of food products imported from China because of the inconsistent application of regulatory enforcement there, Lumpkin said.

While the country's food and drug regulatory agencies prohibit the use of nitrofurans and malachite green in seafood farms, "these and other unapproved drugs and chemicals continue to be found in farm-raised species of seafood from China," he said.

Since November 2001 FDA has been testing shipments of farm-raised seafood from China and has placed specific firms on import alerts when their shipments test positive for antibiotic residues. This testing led to the agency's "countrywide import alert" of five species of farm-raised fish from China on June 28 ("The Tan Sheet" July 9, 2007, p. 7).

"These additional import controls placed on seafood from China will last as long as appropriate," Lumpkin said.

However, FDA's capability to ensure the safety of imports from China and other countries will not last under the agency's current strategies and with its current staffing level, Gottlieb said.

In addition to increasing its workforce, FDA needs Congress's endorsement of Commissioner Andrew von Eschenbach's "policy reforms," including a planned reorganization of the Office of Regulatory Affairs, he said ("The Tan Sheet" July 16, 2007, p. 6).

Von Eschebach's plans will "develop a system for better identifying and prioritizing risks from imported products all along their life cycle, and not just at the border," Gottlieb said.

FDA "needs to be able to be given the flexibility to implement its plans for re-organizing its current staffing model, in particular certain aspects of its highly trained field force, to make sure that its resources are aligned with emerging risks," he added.

"As the set of issues that FDA confronts changes over time, and as scientific advances give the agency new opportunities to more efficiently manage these risks, the agency needs the flexibility to re-direct its experts and its resources to meet new challenges and also needs the resources to invest in training its staff."

However, the U.S. does not need a "separate food agency" to increase the safety of its food supply, Gottlieb added, saying the "agency's unique culture of public health protection and promotion and its scientific tradition is ideally suited to fulfilling the food protection mission."

Increasing funding for the Center for Food Safety and Applied Nutrition is "also needed so the food center can continue to be able to keep up with other workload responsibilities, such as the need to issue rules, especially those that govern food safety issues, such as regulations on testing protocols, record retention, and quality assurance and control," he said.

Lumpkin reminded the committee of work by FDA and other agencies to negotiate a memorandum of understanding on food safety with Chinese regulators.

The MOU should be signed in early December and will "include actions in many areas of food and feed production that should increase Americans' confidence in the safety of these Chinese products that are exported to the U.S.," he said.

- Malcolm Spicer

This article is reprinted from "The Tan Sheet" – July 30, 2007

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