FDA Import Alert Logjam Eases On Amino Acids, Vegetable Proteins

FDA has begun to allow Chinese imports of proteins used in products including nutritional supplements and pet supplies after passing tests for melamine, according to agency officials and insiders in the supply industry.

The move represents a shift in the agency's approach to proteins, say the industry insiders.

Since the last week of August, FDA has "modified their decision," Barry Titlow, CEO of Compound Solutions told "The Tan Sheet" Sept. 2. He noted, "Amino acids can now go through."

Melamine was found in wheat gluten and rice protein concentrate produced in China that were linked to the deaths of pets and led to the recall of thousands of pet food products (¹ (Also see "Experts, FDAer Address Issues Set Ablaze By Melamine Contamination" - Pink Sheet, 7 May, 2007.), p. 4). There is no indication of any adverse events in humans as a result of the contamination.

FDA said it is still monitoring the situation closely. Agency spokesman Michael L. Herndon said Sept. 5. that proteins, including amino acids, were being allowed in following testing.

Herndon did not say when the FDA modified its approach. Under terms of 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.

"Amino acids happen to fall into the same code as vegetable proteins and the FDA had put everything on hold in that particular code," Ronald E. Juergens, vice president of Premium Ingredients International, said in an interview. PII supplies ingredients to the nutritional, pharmaceutical, flavor and fragrance industries. "It's very difficult [for FDA] to put anything in writing."

Over the last three months, government officials have revealed the extent of the protein surveillance. As of May 17, the FDA collected 63 samples and visited about 80 establishments, according to the agency (² (Also see "FDA Discusses Industry’s Food Safety Burden, Plans To Knock On Doors" - Pink Sheet, 14 May, 2007.), p. 6).

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 will be passed down the line, insiders in the industry have said (³ (Also see "Costs Mount For Firms As Amino Acids, Vegetable Proteins Sit On Docks" - Pink Sheet, 14 May, 2007.), p. 8).

"It was very frustrating to us in the industry," Titlow, an AOAC International board member, said of the delays. "It totally screwed up factories, and clients need to produce deadlines. The FDA was kicked in the teeth by the media and Congress. Once the dust cleared [FDA] came to their senses. We're starting to catch up."

Reacting to the U.S. concerns over the products, China has increased its own scrutiny as well, causing further delays in shipments, suppliers said.

"We are seeing delays on the other end," Juergens said, referring to Chinese inspections. China "is requiring samples to send to independent Chinese testing programs."

Meanwhile, suppliers' clients are trying to find out first-hand what is happening in China, Juergens said. "We're seeing a virtual explosion of our customers wanting to go to China to audit our suppliers."

In the meantime, FDA has adopted an official method for testing for melamine in vegetable proteins.

The agency has been working with Customs and Border Protection, which has been performing targeted sampling and testing of wheat gluten, corn gluten and rice protein (⁴ (Also see "Delays From Import Alert Highlight Communication, Analytical Testing Issues" - Pink Sheet, 21 May, 2007.), p. 6).

One of the key challenges for FDA is the rapid increase in the volume of imported products - which has doubled in the past five years. Sixty percent of those imported shipments are food. Congress has begun looking into FDA's role in the import process.

One company caught up in the pet food controversy was ChemNutra Inc. of Las Vegas, which recalled all wheat gluten it had imported from one of three Chinese suppliers (⁵ (Also see "Dingell Questions Ingredient Testing Exemption Rule, Cites Supply Climate" - Pink Sheet, 27 Aug, 2007.), p. 5). In March, FDA announced it found melamine in samples of wheat gluten ChemNutra imported.

The company is trying to make adjustments to deal with the issue, said Steve Stern, a spokesman for ChemNutra.

"The owner has expanded the product line as if nothing has happened," Stern said. "I don't think we had problems with how the FDA acted. I would think maybe they should have [acted] earlier."

- Joe Cantlupe