Featured Product
This Week in Quality Digest Live
FDA Compliance Features
Jill Roberts
Another way to know what’s too old to eat
Patricia Santos-Serrao
Four pharma quality trends
Del Williams
Preventing damage caused by large, suspended particles
Kari Miller
An effective strategy requires recruiting qualified personnel familiar with the process and technology

More Features

FDA Compliance News
Now is not the time to skip critical factory audits and supply chain assessments
Google Docs collaboration, more efficient management of quality deviations
Delivers time, cost, and efficiency savings while streamlining compliance activity
First trial module of learning tool focuses on ISO 9001 and is available now
Free education source for global medical device community
Good quality is adding an average of 11 percent to organizations’ revenue growth
Further enhances change management capabilities
Creates adaptive system for managing product development and post-market quality for devices with software elements
VQIP allows for expedited review and importation for approved applicants that demonstrate safe supply chains

More News

Michael Causey

FDA Compliance

FDA Offers Salty Recipe for Increased Food Regulation

To salt or not to salt? That is the question. Well, one of them.

Published: Friday, January 6, 2012 - 13:11

It’s actually bigger than a battle over a popular condiment, according to some folks who oppose what they say is the Food and Drug Administration (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 nonpartisan research and educational institution that seeks to combat the 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,” says Gunlock.

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 the FDA is clear on its intent. “The historic FSMA is aimed at transforming our food safety efforts toward prevention and based on risk analysis,” says Lee Anne Jackson, Ph.D., a health science policy adviser with the 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 U.S. 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 percent 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,” Hsieh sums up.

But are food processors ready for 2012? It 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.

This article first appeared in the Jan. 3, 2012, edition of the AssurXblog.


About The Author

Michael Causey’s picture

Michael Causey

James Michael Causey’s been a journalist since he started his own neighborhood newspaper in the 1970s. In addition to quizzing FDA officials for the past 10+ years, he’s also interviewed political satirist Art Buchwald, FCC Chairman Reed Hundt, SEC Chairwoman Mary Schapiro, and is the past president of the Washington Independent Writers. Causey is the editor and publisher of eDataIntegrityReport.com and is a contributing writer on the AssurXblog.