American Labs' Pepsin Under Scrutiny

LEONIA, N.J.--Solgar's April 28 recall of its Digestive Aid tablets has raised questions regarding the raw material instigating the recall--pepsin. The recall was the result of a routine sampling program conducted by Omaha, Neb.-based American Laboratories Inc. (the supplier of the pepsin to Solgar), which found that the ingredient may be contaminated with salmonella. However, Solgar stated that it has re-tested its products and found them to be salmonella-free.

Pepsin is a naturally occurring digestive enzyme catalyzed from protein and found in the stomachs of such animals as hogs and calves, although no one is certain as to how this salmonella contamination came about. Each company used the microbial testing methods USP/AOAC that also test for salmonella, and certificates of analysis for the product and ingredient were issued by both Solgar and American Labs.

However, the lot numbers cited in the recall (31993 and 30957) produced the digestive aid, and according to Solgar, it does not appear that they received any contaminated pepsin. In fact, Solgar cross-checked both the pepsin and the finished products for salmonella contamination, but everything tested clean. The question remains as to what companies may have received the tainted pepsin from American Labs.

The Food and Drug Administration (FDA), when reached for comment, explained that it is American Labs' responsibility to re-examine its distribution chain and report what products containing the affected pepsin it was able to retrieve. FDA also stated that it is the manufacturer, such as Solgar, who issues a recall of its products, not FDA (unless the manufacturer resists this action). As it remains, American Labs and any affected manufacturers are the only ones who have the power to inform the FDA, and ultimately the public, about potentially contaminated products.

"American Labs has been around a long time, and we apply fairly rigorous testing to their raw materials," said Jeff Whipple, public relations manager at Solgar. He added that Solgar has a long-standing relationship with the company. Nonetheless, in a move that was both precautionary and staying in line with FDA's rules and regulations, Solgar automatically removed all 100-count Digestive Aid from store shelves. "Solgar is doing everything that we can to serve and protect our consumers."

A spokesperson for American Labs stated that the company had no comment on this matter as it continued to investigate the situation. For a copy of Solgar's press release, visit www.solgar.com.