Is It Getting Hot in Here?

FDA is fired up about food safety. Companies should ensure their products can stand the heat.

'Ensuring the safety of FDA-regulated products is a shared responsibility"and the FDA is ready to do its share.' Margaret Hamburg made this pledge last August in one of her first speeches as the new Food and Drug Administration (FDA) Commissioner. If the first several months of 2010 are any indication, FDA has not relaxed on its promise to make food safety a priority.

FDA has made a concerted effort to heavily publicize its actions in the name of food security and safety. The agency has been very active in tightening its regulation of food, whether it...s by banging the drum loudly for legislation to expand its regulatory capabilities (with powers such as mandatory-recall authority), touting recently initiated programs like the Reportable Food Registry as examples of successful policy changes, or by making a big splash with increased enforcement of labeling regulations already in place.

For food companies regulated by FDA, this rededication to enforcement warrants a close review. To avoid action from a refocused and aggressive FDA, companies should ensure that all aspects of food operations, from manufacturing and packaging to labeling and marketing, comply with applicable laws and regulations.

Legislation Granting Mandatory-Recall Authority
Recalls continue to be a front-burner topic and a key agenda item for FDA. Last year...s recall of thousands of products containing peanut ingredients that could be traced back to Peanut Corp. of America (PCA) was an unmitigated disaster and had a ripple effect across the industry. The Congressional hearings and media attention involving PCA added fuel to the fire already stoked by FDA.

Subsequent recalls in 2009, such as those involving Setton Pistachios and Plainview Milk, were influenced by the uproar caused by the PCA recall. Many companies were essentially left with no choice but to recall products, even though there was not a single reported case of causally linked illness. Not only did the massive costs associated with implementing the recalls put severe financial strains on companies, the expense of food-borne-illness litigation waged by plaintiffs... attorneys was crippling as well. A recent report issued by Georgetown University in March 2010 estimated the yearly costs of food contamination and foodborne-illness outbreaks at a staggering $152 billion a year.

As FDA has stepped up its enforcement activity over the last year, it has taken every opportunity to call for an increase in its authority and regulatory powers. Mandatory-recall authority is an ever-present part of any discussion. Since being sworn in last May, FDA Commissioner Hamburg has made no secret of her desire to have FDA vested with mandatory-recall authority. As the costs mount and recalls continue to garner more negative publicity, the clamor for mandatory-recall authority has become louder from outside sources as well. Legislation pending in both houses of Congress contains mandatory-recall provisions which could significantly impact the food industry.

Read the full version of this article in the April issue of Nutritional Outlook.