The cost of delays and analytical tests resulting from FDA's import alert on vegetable protein concentrates and amino acids from China is significant, and the cost will be passed down the line, insiders in the supply industry agree.

FDA announced April 27 all vegetable protein products from China were to be detained without physical examination due to the presence of melamine and melamine analogs in pet food ingredients labeled as wheat gluten and rice protein.

Under the terms of ¹ import alert 99-29, the onus is on the importer or ultimate firm to demonstrate to the agency the product does not contain melamine or melamine-related compounds.

However, analytical test methods for melamine are currently "works in progress" and there have been issues because "some methods work for some protein formulas and not others," Flora Research Laboratories Director James Neal-Kababick told "The Tan Sheet."

"It's important for people to be very vigilant keeping an eye on FDA's Web site for the current protocol because if they've printed something out even a week ago, it's not current," Neal-Kababick said.

FDA updated its April 25 interim gas chromatography/mass spectrometry method for screening and confirmation of melamine and related analogs on May 8. It is available to industry on FDA's Center for Veterinary Medicine Web site.

FDA is "providing methods, and then industry is doing their best to modify them to be practical," Barry Titlow, CEO of supply firm Compound Solutions, Inc., told "The Tan Sheet."

In order get product off the dock, firms should present FDA with "validated tests, paperwork, assurances, and they can be of various types," FDA Assistant Commissioner for Food Protection David Acheson, M.D., said at a May 10 press briefing.

"But we review it on a case-by-case to say yes, this material that's held is okay, free of melamine and melamine-related compounds, and it may proceed," he added.

In an interview with "The Tan Sheet," Acheson addressed industry concerns about presenting FDA with the most current test.

"We're not unreasonable," Acheson said. "There isn't a firm, fixed, you've got to do this, this and this," he said. "There're various ways to get through this." One route firms can take is to work with a certified lab using a method validated by FDA, Acheson said.

"An alternative, potential way is if they could show us in some convincing way that there was some documentation from the country of origin that it was definitely not exposed to melamine through some similar validated testing," he said.

Additionally, according to the alert, once a firm has been released by FDA based on third-party testing at least five times, the firm can "get out" of the import alert if they provide additional documentation, Acheson said.

Namely, a firm must provide a certificate, "such as from [China's] General Administration of Quality, Supervision, Inspection and Quarantine, indicating that an inspection of the manufacturer was conducted and adequate controls are in place," the alert reads. A copy of the inspectional reports and compliance status of the manufacturer must also be included as well as test results for sampled products.

"This is a cooperative effort. I think everybody's on the same page ... they want the outcome to reassure consumers the food supply is safe to the best of our ability and current science," Titlow said.

However, "This whole issue is causing huge delays, and then downstream ... the client base that uses these raw materials now has production problems," Titlow said. Firms are "burning through inventories they have, and then trying to get materials in and getting it tested."

He noted that amino acids are used in a wide variety of dietary supplements, food products, pharmaceuticals, medical foods and infant formula.

"We're heavily dependent on these Chinese products to meet the manufacturing needs," Neal-Kababick added. He noted that sport nutrition products could be particularly impacted.

- Katia Fowler (k.fowler@elsevier.com)

Costs Mount For Firms As Amino Acids, Vegetable Proteins Sit On Docks

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