Former FDAer: ‘Sweeping’ Food Regulations Will Challenge Entire Industry

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Michael Causey, Editor & Publisher,

The most sweeping food regulation since the days of Franklin Delano Roosevelt is about to catch some unsuspecting companies off guard, warns former FDA Associate Commissioner of Foods Dr. David Acheson. “Companies need to update their compliance systems to meet a new mindset and new regulations,” he stressed.

The Food Safety Modernization Act, signed into law in January, will go into effect in stages in the next few years. The final rule is expected to be enacted in July 2012, with a ramp up time for companies to comply. It’s worth noting that, unlike its work with, say, 21 CFR Part 11 and eMDR, the FDA has in fact hit every regulatory deadline it has given itself. “That doesn’t give you very long to understand and navigate the change,” Acheson said.

But as with pharma and medical device industries, the bigger food companies tend to have a jumpstart in terms of compliance when compared with smaller companies, notes Plex’s Executive Vice President, Tom Mackey. Big companies had a hand in writing the law and are generally supportive of its provisions, he adds.

FDA, reacting to some high-profile recalls with cantaloupes, peanuts and other food products, is now preaching a mantra of “prevention, prevention, prevention,” Acheson said this week at a Webinar sponsored by Plex Online.

Acheson, now managing director food and import safety with Leavitt Partners, warned food industry players that “protecting the brand today is different than it was five years ago…and these new regulations are just icing on the cake.” New challenges for the food industry include higher consumer expectations and more aggressive social media that can damage a brand almost instantly.

We’re in a new world of global risk and supply chains, Acheson warned. Food companies that don’t get it, are going to get it from the FDA.

While he doesn’t expect FDA food inspections to increase for at least another year or two domestically, they are already on the rise internationally. He noted, too, that FDA inspectors today are focusing more on how well companies have a handle on CAPA and root cause analysis. “The FDA really expects you to understand what went wrong,” he said.

For example, in a typical inspection, an FDA inspector will now ask to see your food safety plan. He won’t read it cover to cover, but he will focus on a particular point, then ask you to demonstrate what’s gone wrong in your system in the last six months and ask you to show your root cause analysis capability, too.

“This is a great way to inspect, and the FDA has a heavy emphasis on verification and knowing that your plan is working,” Acheson said. All components must be continuously documented.

Oh, and expect more warning letters and recall notices, too, as a result of the Act and FDA’s new emphasis.

“It’s a heavy lift [to comply] but there are many ways to make it easier, including staying informed and using technological innovations” to get a better handle on your supply chain and your operations, he said.

But don’t get complacent just because you have some time before you need to comply, he suggested. Instead, use this time to get ahead of the curve.

Start by identifying a team in your firm to spearhead compliance, conduct a gas assessment, determine the best way to close those gaps, examine if your current business practices conform to these new regulatory demands, set priorities based on risk and resources, and establish a system to stay informed internally and one that can be used to demonstrate to FDA inspectors that you are on top of it.

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