Michael Causey, Editor & Publisher, eDataIntegrityReport.com

To salt or not to salt? That is the question. Well, it’s one of the questions.

It’s actually bigger than a battle over a popular condiment, according to some folks who oppose what they say is the FDA overplaying its regulatory hand.

We’re not going to settle this controversy here, but some experts suggest you may be able to sprinkle a little salt on your food without feeling guilty about increasing your risk of heart disease and high blood pressure.

However, some say the FDA has gotten too activist and one-sided in its approach to the condiment – and that it’s just another sign that the FDA in 2012 will be more strident with regulatory overreach that won’t help food consumers and will harm food manufacturers.

The FDA is generally following the lead of a 2010 report from the IOM that says salt contributes to serious health problems. The agency is working on a guidance now that would promote ways to reduce salt consumption by Americans in their diet.

“I think the FDA is adding unnecessary bureaucratic layers” that aren’t improving food safety and are in fact making it harder for food manufacturers to do business, says Julie Gunlock, a senior fellow at the Independent Women’s Forum, a non-partisan research and educational institution that seeks to combat what they say is the too-common presumption that women want and benefit from big government. In the case of salt, for example, Gunlock says the FDA is ignoring more recent studies that at least question the strong connection between salt and the health problems.

Gunlock has written extensively about what she calls “the damage” caused by intrusive FDA regulations. She focuses on the harm to food processors and manufacturers, and the role of parents in making dietary decisions on behalf of their children.

For Gunlock, it’s more than just a battle over salt. She sees this issue as just another example of the FDA taking authority away from state regulators and telling consumers what they can eat. “Unfortunately, I think we’ll see tougher FDA actions in 2012 against a food supply chain that is already safe and probably doesn’t need additional regulation like this.”

When trying to predict what will happen in 2012, it’s important to recall that the Food Safety Modernization Act, signed in January 2011, ushered in a new era of increased security measures, processes and controls for food safety officials; most orchestrated by the FDA, notes Don Hsieh, director of commercial and industrial marketing with ADT Security Services. He works to educate brands on how to build a proactive food defense program and how food officials can effectively comply with FDA regulations.

Simply put, the FSMA is the” most significant expansion of food safety requirements and FDA food safety authority in over 70 years, since the original Food Drug & Cosmetic Act in 1938,” Hsieh says.

And FDA is clear on its intent. “The historic FSMA is aimed at transforming our food safety efforts toward prevention and based on risk analysis” said LeeAnne Jackson, PhD, Health Science Policy Adviser, FDA.

Hsieh reminds us that recalls are bad for business, to put it mildly. One of the largest food recalls was the recall of peanut products produced by Peanut Corporation of America. What resulted from this mass distribution of contaminated product were 714 confirmed infections, nine deaths and $1 billion in losses to the United States peanut industry. The Peanut Corporation of America filed for Chapter 7 bankruptcy and its owner and CEO appeared before Congress under Congressional subpoena. Although the cause of the outbreak was one firm and did not involve major peanut butter brands, consumers reacted by avoiding the peanut butter category and sales plunged 25% after the recall announcement. “This points out the importance of not only protecting the food supply chain for your company’s products but being able to prove that your supply chain was not impacted by a specific incident,” he sums up.

But are food processors ready for 2012? Doesn’t sound like it. As Hsieh points out, for most food manufacturers, “documentation is typically done by a person with a clipboard checking off items on a paper check-off list. Given FDA’s mandate of providing documentation of compliance, these documents may not accurately reflect compliance and are difficult to access and compile.”

Looking ahead to 2012, that’s probably an understatement.

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

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.