The FDA continues to signal that food enforcement is back in fashion.

Last week at a press-only briefing the agency tried to demonstrate its proactive side, saying it was “taking steps to protect the public following the early identification of Salmonella Tennessee in one company’s supply of hydrolyzed vegetable protein (HVP) and again last week the agency issued an open letter to the food industry calling for more transparent product labels.

So what’s it all mean?

We spoke recently with Kim Egan, partner in the law firm DLA Piper’s Product Liability practice, and a regular source for us on these and other FDA-related matters.

“The food industry is facing a “perfect storm” — high-profile food-borne illnesses continue to plague the global supply chain, prompting President Obama to create the Food Safety Working Group, and the First Lady has declared war on childhood obesity, including a focus on food industry marketing to children, “junk” food in public schools, and the nutritional content of school lunches,” Kim points out.

I happened to see the harrowing film “A Perfect Storm” at my sister’s house last week and if I am an official in the food industry, an expert like Kim using “Perfect Storm” and “Food Industry” in the same sentence would get my attention.

Kim notes that President Obama said in a March 2009 weekly radio address that “At a bare minimum, we should be able to count on our government keeping our kids safe when they eat peanut butter.  That’s what Sasha eats for lunch.”

The Executive Memorandum announcing the First Lady’s Let’s Move campaign said that “[n]early one third of children in America are overweight or obese — a rate that has tripled in adolescents and more than doubled in younger children since 1980.  “Taken together, the new Administration’s focus on food has in turn pushed FDA to renew efforts to improve food safety and more aggressively enforce existing food labeling regulations,” Kim adds.

It’s all part of a more active FDA across the board, Kim notes.

“FDA has stepped up enforcement of existing regulations.  In August 2009, FDA reorganized its food oversight function and moved the Office of Foods into the Office of the Commissioner, giving food safety and food manufacturing enforcement greater visibility.  FDA appears to be focusing particularly on health claims made by food manufacturers, such as its recent warning letter to General Mills that it had no scientific evidence to support cholesterol claims on Cheerios cereal,” Kim adds.

As Kim explains, FDA said that the General Mills claims that Cheerios reduced cholesterol meant that General Mills was advertising Cheerios as a drug, an unapproved one at that.  FDA has also been focusing on health claims made by dietary supplements, the most notable examples of late being dietary supplement products that purported to be effective against the HINI virus.  There is an effort underway to improve front-of-label nutrition information for all food packages, and Senator McCain introduced legislation in February 2010 to strengthen FDA authority to regulate dietary supplements.

Congress has had food safety legislation in the works for a couple of years now.  Highlights of that bill include:

• The Food Safety Modernization Act that is now making its way through Congress will require foreign suppliers to use “risk-based reasonably appropriate preventative controls” to prevent adulteration and reduce hazards.
• FDA would be required to implement new food safety regulations within a year of enactment.  FDA would also have two years from enactment to “expand the technical, scientific and regulatory capacity of foreign governments,” which could include multilateral agreements and international harmonization of the Codex Alimentarius.  FDA would also be required to expend resources on foreign inspections.
• Having said that, however, the majority of food-borne illness outbreaks since 2006 have been caused by domestic products or other products from North America , including fresh spinach, peanuts, jalapeno peppers, and tomatoes.

“In short, we can expect further pressure on food manufacturers to improve quality control,” Kim says.  “We can also expect continued pressure on food manufacturers to adhere strictly to promotional and nutritional labeling requirements, and we can expect those requirements to change in some possibly meaningful respects in the coming years.”

For more information, request “The New FDA Drive for Food Safety” paper here:

Is it just me, or does it seem like someone must have reminded the FDA that the first part of its name starts with the word “Food”? In the past several weeks we’ve seen a very public and very aggressive FDA take some big steps to assure consumers that their food is safe after a bad year or two out there in America’s food chain. Remember lettuce? Beef? Tomatoes? The list goes on and on and…

The latest FDA action is the launch of a Reportable Food Registry (RFR) which requires that facilities that manufacture, process or hold food for consumption in the US now must tell the FDA within 24 hours if they find a reasonable probability that an article of food will cause severe health problems or death to a person or an animal.

The FDA rolled it all out with a big press event Sept 8 – the same day that reporting this way becomes the law of the land, said Michael Taylor, Senior Advisor to the FDA Commissioner on food issues. It will “provide a reliable mechanism” for the FDA to track patterns in food problems and help it act more quickly to fix them. “It’s an important step,” Taylor said. “Our first priority is to prevent food safety problems.”

(It doesn’t include infant formula or dietary supplements, those have separate reporting requirements already on the books.)

This latest FDA move is all part of a wider effort, spearheaded by HHS and USDA, which also just unveiled a new consumer web site: www.foodsafety.gov. It’s designed to help consumers get the latest info on food safety and recalls.

The new site will feature information from all the agencies across the federal government that deal with critical food and food safety information, including preventive tips about how to handle food safely, alerts on life-saving food recalls, and the latest news from the key agencies.

Click here for a copy of ”Food for Thought: The FDA Gets Serious on Electronic Records Management”.

The agency withered during the Bush Administration, with reduced funding, less emphasis on inspections, and a general viewpoint that government should generally get out of the way and let business and the “invisible hand” run the show. On top of that, some of the agency’s “best and brightest” became discouraged and retired or moved to private sector jobs.

But then came salmonella problems, cashew and nut health alerts, meat recalls and a financial market implosion that suddenly made the words “government regulation” less of a dirty term. Now the FDA is under big pressure from lawmakers on Capitol Hill to show it can be proactive and better protect the American public from risks associated with food, medical devices and drugs.

Add a new, more activist president named Obama to the mix, and you’ve got the makings of a revitalized, energetic FDA in 2009 and beyond.

For example, the agency is pushing electronic medical device reporting (eMDR), though the guidance has been delayed for unknown reasons that don’t appear to be related to eMDR itself (Assurx eMDR white paper is available here http://www.assurx.com/emdrebook.html), and has also recently released tighter new import controls that are putting manufacturers on notice that responsibility for quality begins at the very top (get that white paper at http://www.assurx.com/FDAImporterGuidanceWhitePaper.html).

Signs of a new more action-oriented FDA are everywhere, but let’s look at two recent ones that illustrate our point:

• The agency has recently issued high profile recalls of pistachios and announced a more aggressive regulatory regime for medical devices made before 1976. Devices found by the FDA to be of high risk to consumers will be required to undergo the agency’s most stringent pre-market review process. A transcript of the March 30 teleconference the FDA conducted can be found here http://www.fda.gov/bbs/transcripts/2009/transcript033009.pdf
• After a huge peanut recall effort last year, the FDA is now engaged in an expanding recall of pistachios. Information on that is available here: http://www.fda.gov/pistachios/

But remember, this isn’t just about old medical devices and nuts. If the FDA is devoting this much new energy to regulating pistachios and medical devices made before 1976, what kind of regulatory scrutiny should makers of important medical devices and drugs expect today from a “new” FDA?

You know the answer.