Delays From Import Alert Highlight Communication, Analytical Testing Issues

Firms have yet to prove any of the nearly 50 shipments of vegetable protein concentrates imported from China since April 27 are free of melamine, Dr. David Acheson, FDA's assistant commissioner for food protection, said May 17.

In the meantime, costs for importers and manufacturers are mounting, according to insiders ( (Also see "Costs Mount For Firms As Amino Acids, Vegetable Proteins Sit On Docks" - Pink Sheet, 14 May, 2007.), p. 8).

Moreover, manufacturers are having difficulty filling customer and consumer orders for products containing the ingredients, a sports nutrition exec told "The Tan Sheet." China produces a large percentage of amino acids and other ingredients, and firms keep a light inventory.

Communication issues between FDA and industry, along with developing analytical testing methods are large contributors to the extended detentions, according to experts.

FDA initiated the import alert detaining all shipments of vegetable protein concentrates from China April 27 following the discovery of melamine and melamine related compounds in pet food ingredients imported from two Chinese firms and labeled as wheat gluten and rice protein.

"When things are held up, we have a hard time filling" orders, Chuck Rudolph, director of research and development at Scivation, said.

Scivation markets Xtend , "a simple branch chain amino acid flavored beverage that a lot of professional athletes use," he said.

Rudolph does not take issue with FDA or Customs and Border Protection's decisions regarding the sampling and testing of products. "I just kind of wish it would go a little faster," he said.

It is too early to tell whether the firm will have to raise the prices of his products for consumers, Rudolph said.

However, one of his suppliers has already raised the price of amino acids 50 cents per kilo, "which drastically cuts into our margin because it's not a big margin product to begin with."

Suppliers are unsure when they will be able to provide their customers with the amino acids. The detentions are adding at least a month of delays to Compound Solutions, Inc.'s shipments, CEO Barry Titlow said.

Analytical lab results on his shipments are expected back in early June, but "we have no idea at this time how long it will take FDA to review the analytical data and documentation and then decide to release the shipment or reject the data submission," Titlow said.

Acheson was also uncertain when the products would be released. Samples from the shipments are "presumably in some stage of being analyzed," Acheson told reporters during a joint FDA press briefing with the Agriculture Department and Customs and Border Protection.

"There may have been some paperwork submitted to FDA. ... I'm not actually aware of the status of that. But, what I can tell you is that so far 46 [shipments have come] in and none have moved on, pending the results of analysis," he said.

"And, before any of these shipments are released, FDA will review the analytical reports for technical accuracy, and we may collect and analyze samples of the product to confirm any submitted reports."

According to FDA, the import alert on vegetable protein concentrates from China is indefinite.

However, the likelihood of amino acids being contaminated with melamine is low, Titlow said, because the price of amino acids is not determined by protein content like the price of wheat gluten.

Industry insiders say the inclusion of amino acids in the import alert is a "knee-jerk reaction."

Unfortunately, testing has presented a particular challenge for importers of amino acids because the FDA method posted on the Center for Veterinary Medicine Web site is for detecting melamine and its analogs in whole proteins, Titlow said.

"I would say that as of today there is confusion about procedures for sampling and documentation as well as uncertainty as to the analytical method to use," Titlow, who is also an AOAC International board member, said.

"It is imperative that companies responding to a detention order inform the lab up front, and they must get in contact with the compliance officer handling their case," expert analytical scientist and Flora Research Laboratories Director James Neal-Kababick said in an e-mail to "The Tan Sheet."

Compliance officers "do not always interpret [Office of Regulatory Affairs] guidelines in the same way," he explained.

"I have clients contacting me who are not getting their testing approved because of violations of ORA Section 7," he said. "Many labs are using older methods or are not documenting the ability to test samples in the matrices that are being sent to them," Neal-Kababick added.

"The data package that FDA requires is extensive and demands a lot of work on the part of the lab. ... We just completed a package for a client to test for one compound in one sample type, and it took a full day to generate, assemble and review the package."

"I am worried about the fact that people are spending a lot of money on testing and losing precious time because the labs they are working with don't understand how demanding the requirements are," Neal-Kababick said.

"Any lab that says it can assemble an ORA 7 compliant data package for its standard fee is suspect."

An additional issue, Neal-Kababick said, is that "there is no such thing as a certified lab for this issue, and, second, the FDA method is not validated."

"I am one of the top experts in validation," he said, "and the method has not undergone validation at a level required to be even single lab [validated, let] alone an Official Method."

"FDA is asking for things that are not possible in this case," Neal-Kababick said.

Acheson noted during the press briefing that if the detained product has been tested by Customs and Border Protection, results of that test showing the ingredient is negative for the compounds certainly fulfill the import alert requirements.

"If the shippers decide to use some other independent lab, which they are perfectly entitled to do, we would certainly require that those results be validated. And, we will review the analytical report, and we may - if we have doubts - go ahead and collect a sample of our own to test ourselves," he said.

CBP has been performing targeted sampling and testing of wheat gluten, corn gluten and rice protein from China since April 30. CBP expanded the sampling efforts to include all countries May 2.

"Since the beginning of the operation, samples representing about 80 percent of all shippers of these products have been taken. CBP lab analysis is complete on about 80 percent of these samples," CBP Executive Director of Commercial Targeting and Enforcement Vera Adams said May 17.

All samples tested thus far have been negative for melamine and its analogs, she said.

As a result of these findings, CBP is working with FDA to determine "if the sampling process can be amended and converted to some sort of random protocol," Adams said. CBP had been targeting "several shipments from each shipper as they entered the U.S. and taking a couple samples from those shipments," she said.

"While we may continue to do very intensive review of, say, the China stuff in conjunction with FDA ... all other countries may revert to something a little more statistically randomly generated, via our automated systems."

"But that is still under discussion at this point, and we will be talking about this with FDA over the next week or two," Adams said.

Acheson also updated reporters on the status of the protein surveillance assignment during the May 17 briefing. FDA has currently collected 63 samples and visited about 80 establishments, according to the agency. The assignment started May 1 ( (Also see "FDA Discusses Industry’s Food Safety Burden, Plans To Knock On Doors" - Pink Sheet, 14 May, 2007.), p. 6).

The samples have come from six states: Arizona, California, Connecticut, Iowa, Minnesota and New Hampshire. "There have been no positive results for melamine on any of the samples collected so far," Acheson said May 17.

Results for 23 of the samples are still pending, he said, and three "could not be analyzed because there was no method to do that." One of those three samples was composed of gel capsules, he said.

- Katia Fowler

This article is reprinted from "The Tan Sheet," May 21, 2007