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The madness of recalls, FDA style

NOTE: This gem of an article was unearthed from my dusty old Drafts file. Although the recalled products news is ancient history (January 2013), the rest of the article is still relevant and contains important information about the inexplicable madness of how recalls are conducted. Not only that, jerky pet treats are still on the market today.

Today, [January, 2013] on the FDA Recalls, Market Withdrawals, & Safety Alerts web page, Hartz Mountain Corporation announced the withdrawal of two treat products for illegal drug residue. Last week, Hartz issued a press release of the withdrawal, following the discovery of drug residues in Purina’s imported pet treats. However, Purina’s press release never materialized on the FDA recall page, nor is it likely to ever materialize. Nearly three weeks has passed since Purina’s problems, so what’s the hold-up?

The dirty little secret

Believe it or not, Purina’s problems will probably never hit the FDA web pages, because they knew a little secret. See if you can follow me here, because it is a kerfuffle: Hartz and Purina both announced the withdrawal of their products via press releases, yet only Hartz’ notice appears on the FDA website.

What’s the difference?

Hartz provided the FDA with a press release – Purina didn’t.

Why?

Because Purina didn’t have to.

Confused?

Of course you are. I don’t blame you.

You’re probably asking yourself right now, how come Hartz got thrown under the FDA bus and Purina’s Waggin’ Train and Canyon Creek Ranch treats product withdrawals (for the very same problem mind you: illegal drug residue) escaped the FDA’s noose?

Well, I’ll tell you.

Simple… for a bureaucrat

The answer is simple. To a bureaucrat.

Had the recalls been classified as a Class l Recall (the most serious kind), Purina would have been required to inform the FDA of a dangerous product.

Plain-old, garden-variety hum-drum Class ll and Class lll recalls are not required to appear on the FDA Recalls, Market Withdrawals, & Safety Alerts page. That is, unless the manufacturer provides the FDA with that information.

Although, on the FDA website regarding recall notices, it says:

The list [below] provides information gathered from press releases and other public notices about certain recalls of FDA-regulated products.

Make sense now?

Probably not.

But that’s OK, the FDA has a general outline about recalls, called FDA 101: Product Recalls.

This handy little one-page guide should give you the gist about recalls:

Recalls 101: FDA style

“FDA seeks publicity about a recall only when it believes the public needs to be alerted to a serious hazard. When a recalled product has been widely distributed, the news media is a very effective way to reach large numbers of people. FDA can hold press conferences, issue press releases, and post updates to its Web site regularly, to alert people.

Not all recalls are announced in the media. But all recalls go into FDA’s weekly Enforcement Report. This document lists each recall according to classification (see “Recall Classifications” box), with the specific action taken by the recalling firm.”

Translation/clarification: Withdrawals are not classified as recalls unless the withdrawing manufacturer tells the FDA they are withdrawing a product. Example: Purina withdraws treats from the market, doesn’t have to tell the FDA therefore it will never appear in the FDA weekly ER.

Get it?

No, of course not. It is utter madness.

Sh*t on the shelves

How do they know if all the shit is off the shelves? Answer: The FDA will conduct ‘Effectiveness Checks’:

“FDA evaluates whether all reasonable efforts have been made to remove or correct a product. A recall is considered complete after all of the company’s corrective actions are reviewed by FDA and deemed appropriate. After a recall is completed, FDA makes sure that the product is destroyed or suitably reconditioned, and investigates why the product was defective in the first place.”

How bad is the sh*t?

But how does the FDA decide how bad the recall is?

Answer: The FDA classifies them into three categories:

“These guidelines categorize all recalls into one of three classes, according to the level of hazard involved:

Class I: Dangerous or defective products that predictably could cause serious health problems or death. Examples include: food found to contain botulinum toxin, food with undeclared allergens, a label mix-up on a lifesaving drug, or a defective artificial heart valve.

Class II: Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.

Class III: Products that are unlikely to cause any adverse health reaction, but that violate FDA labeling or manufacturing laws. Examples include: a minor container defect and lack of English labeling in a retail food.”

Hartz under the bus

The Hartz Mountain Corporation is voluntarily withdrawing its Hartz Chicken Chews and Hartz Oinkies Pig Skin Twists wrapped with Chicken for dogs

FOR IMMEDIATE RELEASE – January 25, 2013 — The Hartz Mountain Corporation is voluntarily withdrawing its Hartz Chicken Chews and Hartz Oinkies Pig Skin Twists wrapped with Chicken for dogs in the United States because they contain trace amounts of unapproved antibiotic residue.

We are taking this action after recent Hartz testing found trace amounts of unapproved antibiotic residue in samples of Hartz® Chicken Chews™ and Oinkies® Pig Skin Twists wrapped with Chicken products. Even though two-thirds of the products we tested did not contain antibiotic residues, we would rather be overly cautious by voluntarily withdrawing these products from the market.

These antibiotics are approved for use in poultry in China and other countries, including European Union member states, but are not among those approved in the U.S. Based on the FDA’s review of the New York State Department of Agriculture & Markets (NYSDAM) results, there is no evidence that raises health concerns, and these results are highly unlikely to be related to the reports of illnesses FDA has received related to jerky pet treats.

Immediately upon learning of this finding, Hartz contacted the FDA to share our test results and execute a nationwide voluntary withdrawal. There have been no known illnesses to date associated with the consumption of these products.

“Upon learning about the nationwide voluntary withdrawal of several other brands of chicken jerky products through media reports, Hartz acted immediately to begin additional testing to determine if the same unapproved antibiotic residues were present in our products,” said Sean McNear, Sr. Director of Quality and Regulatory at Hartz Mountain.

There is no indication that the trace amounts of unapproved antibiotic residue are linked to the FDA’s ongoing investigation of chicken jerky products produced in China. The trace amounts of antibiotic residue do not pose a health or pet safety risk.

No other Hartz products are affected by this withdrawal.

If you have these products contact the Hartz Consumer Affairs team (24 hours/day 7 days/week) at 1-800-275-1414 for a refund.

Consumer Resources & Information About Recalls (from the FDA)
Recalls, Market Withdrawals, & Safety Alerts
Recalled Product Photos on Flickr
Your Guide to Reporting Problems to FDA

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Mollie Morrissette

Mollie Morrissette, the author of Poisoned Pets, is an animal food safety expert and consumer advisor. Help support her work by making a donation today.

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