FDA and Stealth Recalls

Stealth – the act or characteristic of moving with extreme care and quietness, especially so as to avoid detection

Collins English Dictionary – Complete and Unabridged © HarperCollins Publishers 1991, 1994, 1998, 2000, 2003

About 10 days ago, I complained about an unpublicized Class I recall, which was described in FDA’s Weekly Enforcement Report dated February 8, 2012. The recall involved 114 tons of cut leaf “curly” spinach from Tiro Tres Farms, Eagle Pass, TX. The offending spinach was recalled by the manufacturer after the product was found to be contaminated with E. coli O157:H7.

I received some comments – and some flak – about my article, so I decided to see whether this was a one-time incident or whether there have been other Class I recalls about which we consumers were never informed. The following recalls were gleaned from FDA Weekly Enforcement Reports dated on or after November 2, 2011.

  • Nicho Produce Co., Inc. (Edinburg, TX): A CUT ABOVE produce items. Thirty-three (33) different items, including shredded, cut, sliced, diced or cubed salad greens, vegetables and fruits, most of them packed in 5-lb bags. Products were recalled due to potential contamination with Listeria monocytogenes. This was an FDA-initiated Class I recall, announced by letters dated December 9th and 19th, 2011, and involved 9,829.5 “pieces” distributed in Texas.
  • River Ranch Fresh Foods LLC, (Salinas, CA): River Ranch and Hy-Vee bagged salads and coleslaw with Best if Used by date of 4 NOV 2011. Product was recalled after FDA found two environmental sub samples positive for Listeria monocytogenes. This was an FDA-initiated Class I recall that was subsequent to an earlier public recall of Farmers Market and Hy-Vee brands of bagged salads, also produced by River Ranch. This stealth recall involved 588 cases of bagged salads, which were distributed to Indiana, Iowa and Canada.
  • Rio Queen Citrus, Inc. (Mission, TX): TexRio Tomatoes, packed in 20-lb bulk boxes, imported from Mexico. Notification of the company-initiated Class I recall was by telephone on November 25, 2011. Two hundred forty-three (243) boxes were recalled because the tomatoes were potentially contaminated with Salmonella. Distributed to Texas and Missouri.
  • Four Seasons Produce, Inc. (Ephrata, PA): Farm Wey labeled cantaloupes, Lot #32773301 & 32773302, manufactured by Farm-Wey Produce, Inc. (Lakeland, FL). Four Seasons recalled 1,064 cases (15/case) on November 19th by email, telephone and fax after being informed by New York State that the melons were potentially contaminated with Salmonella. The recalled cantaloupes were distributed to New York, Pennsylvania, Puerto Rico and Bermuda.
  • Combs Produce, LP (Dallas, TX): Natures Harvest Grape Tomatoes, recalled by email on November 25, 2011 due to potential contamination with Salmonella. Approximately 400 cases were distributed to Oklahoma and Texas.
  • Supreme Protein (Manasquan, NJ): Supreme Protein Chocolate Caramel Cookie Crunch (0.71 oz/20g bars; Lot B11272A October 2012), manufactured by Belmont Confections Inc. (Youngstown, OH). The firm initiated a recall by email, letter and telephone on October 11, 2012 of 473 bars, because the product was potentially contaminated with Salmonella. The recalled bars were distributed nationwide.

These are just a few examples from less than 4 months’ worth of FDA Enforcement Reports. For brevity and simplicity, I limited myself to Class I microbiological hazards, and did not include undeclared allergens, foreign material contamination (i.e., metal, glass, etc) or undeclared/unapproved additives.

I was taken to task for my February 9th stealth recall ‘rant’ by Jim Prevor of the Perishable Pundit in his February 15th item “Food Safety, Recalls And Why Consumers Don’t Always Need Notification.” What were his gripes, and how do they stack up in light of what I have found?

Prevor theorized that the E. coli O157:H7-contaminated spinach was not destined for direct retail sale; therefore, he concluded, there was “…no need to notify consumers.”

But, USDA’s Food Safety and Inspection Service routinely publicizes recalls of products that are destined strictly for the institutional market. Why should FDA not do likewise?

Prevor also suggests that the recall was not publicized to avoid worrying or confusing consumers, who would not differentiate between the recalled (curly) spinach from Texas and the unaffected (flat leaf) baby spinach from California and Arizona. He concludes that avoiding a public announcement was the responsible path, to prevent crushing “countless farmers and processors”.

Sorry, Jim, but how does that justification extrapolate to the “Branded” products I’ve cited above – especially those that were sold in retail-sized packaging bearing lot number identification and/or expiration dates?

Finally, Prevor ends his article with the following statement:

One suspects that the decision to not announce recalls when the announcement would not enhance public health is motivated by the desire to protect another value: Maintaining viable farms, industries, jobs, etc.

Interesting. I always thought that the primary responsibility of FDA was to protect public health.

FDA relies on consumers and consumer advocates to help it carry out its broad mandate. The agency has no choice – it cannot afford to inspect more than a tiny fraction of food producers and processors in the USA. But, like it or not, the flip side of this dependency is the need to keep consumers informed. Naive consumers, or those who are ignorant of existing recalls, are more likely to become casualties than collaborators.

When President Obama took office, he promised “transparency” in his administration. I grant that the workings of FDA, USDA and other US agencies are more open than those in many – perhaps most – other countries. Nevertheless, the President’s promise raised the bar for FDA. At the very least, there should be a consistent – and transparent – policy guiding the agency’s decisions on when and how to release information about recalls. This is especially true for FDA-initiated recalls.

Speaking as a consumer, and as a food safety microbiologist with more than 30 years of experience – several of them with Canada’s food safety regulatory agency – I strongly believe that all Class I recalls should be posted promptly on the government’s food safety website.

Consumers deserve – and should demand – no less.

FDA’s – And Obama’s – Broken Promises

“There are certain things that only a government can do. And one of those things is ensuring that the foods we eat …are safe and don’t cause us harm.”

President Barack Obama, March 14, 2009

Anyone who believes that the Food Safety Modernization Act protects this nation’s consumers from foodborne disease outbreaks is dreaming in Technicolor. And anyone who believes that the Federal Food, Drug and Cosmetics Act protects consumers from harmful drugs, cosmetics and medical devices is equally self-delusional.

Consider this:

  • Jensen Farms, the source of Listeria monocytogenes-contaminated cantaloupes that are responsible for 125 illnesses and 27 deaths, registered with FDA in 2011. FDA officials, speaking during a media teleconference last week, confirmed that the company’s operations had never been inspected by FDA, and that Jensen Farms was not scheduled for inspection until sometime between 2015 and 2017 – 5 to 7 years after registration – as specified under the Food Safety Modernization Act.
  • Larry Schultz Organic Farm, a free-range shell-egg producer that was linked last week to six cases of Salmonella Enteritidis infections in Minnesota, was not covered under FDA’s Egg Safety Rule, because the company maintains fewer than 3,000 laying hens. In contrast, the “small producer” definition in the United Kingdom is fewer than 350 laying hens. FDA has no plans to inspect shell egg producers that maintain fewer than 3,000 hens.
  • CooperVision, a contact lens manufacturer and distributor, initiated an international recall of certain of its contact lenses on August 19, 2011. Recall notices were posted on government web sites in Hong Kong, Australia, Spain and Italy. The company successfully resisted FDA’s “request” to issue a public recall notice in the USA for almost two months. The Voluntary Recall was announced on October 13, 2011 – only after the shares of CooperVision’s parent company tanked as a result of publicity generated by eFoodAlert and by MSNBC.com’s JoNel Aleccia.
  • Insight Pharmaceuticals issued a “stealth recall” of more than 34,000 bottles of Nostrilla Nasal Decongestant nasal spray on September 19, 2011. Although a few retailers of the OTC nasal spray posted recall notices, the company only went public with its recall on October 19, 2011, explaining that the product was contaminated with Burkholderia cepacia – a microbe that is capable of causing very serious infections in people with compromised immune systems or chronic lung conditions. Insight exposed its customers to an unnecessary risk for a full month before publicizing its recall. Where was FDA while this was taking place?

The so-called Food Safety Modernization Act – a last-minute “compromise” to salvage a worthwhile project that was being sandbagged by certain”Congresscritters” – has buried FDA and the food industry in a quagmire of mandates and regulatory red tape that threatens to choke off any real progress toward a safer food supply. The situation is no better in the drug, cosmetic and device divisions of FDA, where mandatory recall authority is so tied up in “process” that it is non-existent.

Our tax dollars are being frittered away by pissant politicians who believe it more important to make speeches about the repugnancy of their opponents’ ideas than to reach practical and effective bipartisan solutions to our pressing health and safety problems.

At this rate, we might as well disband FDA’s Food Safety operations and take our chances with the free market. The money we save can be used to defray the medical costs resulting from foodborne disease outbreaks.