FDA enforcement stats and your job

May, 2011

Eric F. Greenberg | Attorney-at-Law

Your boss pops his head over your cubicle wall.

“Yo hey Hugh,” he says to you, “We’re doing budgets for the coming year. Should we spend more on this line item ‘regulatory compliance?’

A responsible packaging professional, you answer, “Yes!”

“Why?” he asks.

“Well,” you explain, “as a food, drug, device, and cosmetic manufacturer, we are regulated by FDA…”

“We are?”

“Yes boss. Duh.”

“Well, fine, but right now we’re looking for ways to cut expenses anywhere we can. Do we need to spend so much on all this cleaning and sanitizing and training and records?”

“Yes, more than ever.”

“You better give some good reasons.”

“Sure, sit down. You see, boss, the perception far and wide has been that the Obama Administration has stepped up FDA enforcement activities, and now the figures for fiscal 2010 prove it. The big court-based actions-seizures, injunctions, and prosecutions-are still in the handful range, 10 seizures, 17 injunctions last year. But Warning Letters, they were up to 673 in 2010, up from 445 in fiscal 2008 and 474 in fiscal 2009.”

“What’s a Warning Letter and why do I care?”

“Well, Warning Letters are one of the most common enforcement actions FDA takes. They often follow inspections where FDA found what they think are violations in a food, drug, device, cosmetic or other type of plant, and they send the Warning Letter if they think what they found is serious. Warning Letters have no teeth on their own, but they tell the company to shape up or face the big stuff: seizures or injunctions, or even prosecutions. Most of the time, the letters induce companies to shape up. The really bad guys and companies who won’t shape up, they face the big stuff, even criminal investigations sometimes, but it’s the Warning Letters that tell the best story about how tough FDA is being.

“FDA’s statistics don’t report the same things every year, so it’s hard to make all the comparisons you’d want to. So for example this year they reported detailed info about recalled products, which is interesting but hard to interpret. They say there were 3,799 ‘recall events,’ affecting 9,361 different products. Recalls are voluntary, remember, except in rare cases, though often are done under pressure from FDA. You can’t tell from the stats how many recalls are really voluntary and how many were based on FDA pressure.

“Also, FDA didn’t include its numbers of inspections as it had in past years’ reports, and that figure is a good measure of its general level of aggression, too. It’s generally understood, though, that inspections are now up regarding food especially, and there will be even more of them if funding comes through for the new food safety law that provides for increased food safety inspections.

“What’s odd about the numbers is that 21 of those Warning Letters last year were tobacco violations-remember Congress recently gave FDA the power to regulate tobacco, too?-to retailers who sold cigarettes to minors and such. With all FDA has to do… I’m just saying.”

“Man, Hugh, you are so good at this stuff. With all these budget cuts, I will tell you one thing: YOU are keeping your job. You’re too knowledgeable and valuable. How do you know all this?”

You smile confidently and tell him, “I read Packaging World.” PW

For more charts and details about the FDA’s recently released fiscal 2010 enforcement statistics, go to packworld.com/article/31635
Eric Greenberg can be reached at [email protected], and visit his firm’s Web site at www.ericfgreenbergpc.com.

This article is informational only and is not intended as, and should not be considered to be, legal advice.

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GRAS Goes to Congress

GRAS Goes to Congress

By Eric F. Greenberg, Attorney-at-law

Remember that whole business involving NGOs and other folks objecting to the legal system that allows companies to self-determine that their uses of substances are Generally Recognized As Safe (“GRAS”)? And remember how some groups had gone to court to get the system declared unlawful, but late last year the court ruled against them? Well, there’s a new chapter to this story. Now, some members of Congress have proposed a bill that would make changes to the law to address those very same objections.

The GRAS pathway to clearance of the use of substances in packaging and in food is crucially important, and this proposed law has the potential to make enormous changes in various legal obligations. For that reason, packagers should keep a close eye on this latest chapter in the ongoing debate over the policy issues surrounding the GRAS system.

In my view, addressing the complaints we’ve heard for years about the GRAS program required changes in the law, so at least the objectors are in the correct forum. There’s been so much criticism of the Food and Drug Administration lately, what with its slow reaction to the infant formula contamination problem, on top of its handling of issues relating to heavy metals in baby food and various complaints about its handling of COVID and other drug approvals, for some examples. But when it comes to the GRAS program, it’s always seemed that most of the objectors’ objections were better directed at Congress than at FDA.

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