Whey Recall Grows, But Plainview Approach May Prevent A Peanut Replay

Plainview's recall of whey protein ingredients ripples through the dietary supplement industry and shows companies must take a risk-based approach to product safety rather than relying on GMPs alone.

The recall of whey protein ingredients rippling its way through the dietary supplement industry shows that companies must take a risk-based approach to product safety and cannot rely on good manufacturing practices alone to protect them.

Some elements of the recall of whey protein from Plainview Milk Products Cooperative of Plainview, Minn., brings to mind the recall of ingredients from supplier Peanut Corp. of America, which helped draw President Obama's attention to food safety.

Plainview announced a voluntary recall June 28 of instant nonfat dried milk, whey protein, stabilizers and thickening agents that it manufactured in the past two years, which were sold to industry customers for redistribution or incorporation into finished products. Plainview's products are not sold directly to the public.

In PCA's case, contamination at the supplier level affected many firms that receive products from the supplier. Likewise, as a supplier, Plainview's recall has a domino effect on its industry customers.

But experts say the whey recall already is playing out differently, and likely will continue to, in part because Plainview is taking a responsible course with rapid action, and there is no indication of an attempt to hide contamination issues as was alleged with PCA.

Plainview "responded very quickly, moved very quickly" to get affected lots recalled, said Natural Products Association VP of Scientific and Regulatory Affairs Daniel Fabricant.

This contrasts with the PCA situation, he notes, where the company was not forthcoming.

With Plainview, the "traceability has been very good, and the information has been there too, whereas with PCA, FDA was waiting and waiting and waiting some more" for information, said Fabricant.

Michael Taylor, incoming FDA senior advisor on food safety, agrees with the observation by many experts that the lesson from PCA is "know your supplier."

PCA is "a good example of how critical it is for not only the company that is producing a product, an ingredient that is used widely, to take responsibility for what they are doing, but also commercial customers who are purchasing ingredients have a really important duty to manage their own supply chains and know where their product is coming from and know it is produced and ensuring it meets the standards," Taylor said in an interview.

"A lot of companies do a very sophisticated job of this and some companies don't, and what we are realizing is, the nature of the food safety problems we are facing these days -- and the structure of the industry -- really requires folks throughout the supply chain to step up what they are doing to be preventive."

Fabricant notes, "It's not enough to have a good GMP system. ...You always have to incorporate that risk based approach."

Whey protein has not been considered a high-risk product, but Fabricant says that will change, at least for the near-term.

"I don't think anyone thought that whey protein could be in the category of a high-risk ingredient for salmonella because we really haven't seen that before and I think there will be an expectation that folks will be testing whey protein for salmonella now," he said.

"There are these kinds of anomalies from time to time and we've got to be able to have a system that detects them and the only way to do that is by taking a risk-based approach."

Since Plainview's initial recall, several supplement firms issued resulting recalls, including beverage powder formulations pitched at body building and sports nutrition. The recalls include products in Max Muscle Sports Nutrition's Big Max line and various flavors of NOW Foods' Whey Protein and Pro Gainer .

NOW acted rapidly because it wanted to "err on the side of caution and get the recall going," said Michael Lelah, the firm's technical director.

"We tried to get in front of this and make sure that our customers understand that doing a recall is not a bad quality thing; it's a good quality thing. And if we are successful in doing that, then the impact on our reputation is less," he said July 10 in an interview at the NPA Marketplace in Las Vegas.

Lelah added the whey protein recall will have less impact than Plainview's dried milk recall, which involves "thousands of customers."

[Editor's note: This story appears courtesy of 'The Tan Sheet,' your source for coverage of nonprescription pharmaceuticals and nutritionals. For a sample copy, call customer service at 800-332-2181.]

- Christopher Walker ([email protected])