In the musical “Oliver!” based on Charles Dickens’ novel, a poor child draws the ire of his caretakers when, after a meager portion of food, he famously holds out his bowl and says, “Please, sir, I want some more.”

Consumer advocates and others would argue today that we don’t necessarily need more food  – but they would hold out their bowl for more food regulation, especially from the FDA.

It’s not as if we need reminders that there are some serious shortcomings when it comes to how some food manufacturers operate (and how the FDA regulates them), but a recall of more than 200 million eggs this week gives us one whether we’d like it or not.

There’s been growing pressure on the agency to tighten its regulation of food, and it is starting to look like proposed federal legislation is going to deliver just that.

Most Capitol Hill watchers are predicting the Food Safety Modernization Act will come to a vote after the Labor Day recess. It’s likely to pass, though there is some debate about a few proposed amendments including one that would ban outright the usage of BPA, the plastic lining found in cans and in other packaging. Some pundits say attaching the BPA ban would kill the whole bill.

The FSMA would give the FDA greater authority regulate food and place a greater legal burden on food manufacturers to be more transparent when it comes to how they control their product from conception to landing on your dining room table. In other words, food manufacturers would have a lot more quality control work on their, well, plate.

A timely summit last week featured representatives from the Pennsylvania Dept of Agriculture and Dept of Health as well as the Grocery Manufacturing Association.  Led by Dr. Rene Massengale, Associate Professor of Biotechnology, who heads Food Safety and Quality Assurance Academic program at Harrisburg University of Science and Technology, Dr Massengale said industry has generally reacted positively to the potential changes coming from Capitol Hill.

While industry is supportive in principle to the idea of increased food regulation, Dr. Massengale said there is some nervousness out there about what kind of regulations finally emerge from any new Congressional law. Another wrinkle: Some manufacturers of relatively lower risk items, say candy versus eggs, are saying to feds “leave us alone, we already do this well,” she says. Her event attracted representatives of companies and organizations participating in the food supply system including agricultural growers and producers, food processors, food distributors/wholesalers/ retailers and members of related trade associations, as well as middle and upper-level managers from small and medium-sized organizations and managers, directors or owners responsible for food safety and product quality, such as HACCP, QA/QC, and process control professionals.

So, is “more” on the way?

It’s beginning to look that way.  Watch this space in the coming months as track the FSMA’s progress on Capitol Hill.

For more information

Request “The New FDA Drive for Food Safety” paper here.

Blog:  http://foodsafetyquality.blogspot.com/

You can follow Dr. Massengale’s frequent updates on Twitter here:  http://twitter.com/RDMassengale

Gotta give the FDA some credit here. In addition to its transparency initiative we’ve talk about before, the agency is also trying to remove some of the mystery about how it handles inspections and other inner workings at the FDA. From where I sit, it appears to be a sincere effort and I believe it is helping outsiders better understand what the FDA is trying to do – and how it is trying to do it.

For example, at the second in a new series of monthly online webinars, FDA’s Michael C. Rogers, deputy director, Office of Regional Operations, said today (March 25, 2010)  tried to outline how an FDA inspection tends to work, and what drives inspectors before, during and after an inspection.

As an aside, Rogers also said that the agency currently has about 1,800 total inspectors across its full portfolio, though food gets the bulk of the bodies. He also said there will be more foreign inspections this year, and that the number should continue to grow.

Inspections are based on risk, Rogers said. In other words, the riskier the potential drug, device or food item, the more likely they will be inspected.

Most inspections are unannounced, Rogers said. Before they go on-site, the inspector on inspection team will look at previous inspection reports and identify what corrective actions were promised during prior inspections. They also prepare inspection tool kits with sampling equipment, info to drive inspection based on guidance documents and the Investigation Operations Manual. They also carry a camera to document evidence.

They also conduct “for cause” inspections driven by consumer complaints or other outside activity.

Typically, the inspection begins with a discussion with management to explain the purpose of the inspection, and they try to learn about the corporate structure and any changes made since last inspection. They also ask about complaints, positive tests or returns. Answers to those questions help FDA inspectors focus their on-site efforts.

Next, they go to the physical manufacturing area. They try to observe and understand the on-site process. They ask about acceptance criteria and want specifics on failures, especially the reasons.

Inspectors also draw a diagram of the facility showing the manufacturing process from start to finish. They’re looking for problems in the system and looking to identify critical control points in the manufacturing process.

FDA inspectors then identify procedures in place and assess if company is actually following them. They also look for controls in place to mitigate any contaminated products.

They also look at training and cleaning programs. They also watch employees while they are actually making the product.

If they find evidence of an adulterated product, they collect evidence based on inspector observations and collect samples to prepare their case for possible legal action in court.

At conclusion of inspection, the FDA team meets again with management. They then inform the top company official what is in the official Form 483. That form documents observations during the inspection but does not include final recommendations. They also ask for the firms corrective actions planned or in place to get into compliance.

These corrective actions are taken into account as agency formulates official recommendations.

After the inspection at the firm, the inspector develops a report back at the home office. It includes evidence collected and what the firm has already agreed to do about any shortcomings.

In some cases firms can offer voluntary corrections. But sometimes the agency decides it needs enforcement action such as a warning letter, and can also impose civil and/or monetary penalties.

The webinar was extremely popular. In fact, it “sold out” so many who tried to join it could not get in to the live event. There will be a recording available on Monday March 29.

UPDATE: Slides are now available from this event here in PDF format.

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:

The early part of the 21st century was a tough time for the FDA. Its budget was curtailed, it lost some important personnel, and the word “acting” kept appearing on people’s business cards.

But 2009 just might be going down in history as the Year of the FDA Turnaround.

In October, the agency announced a long-overdue hiring binge that signals an even stronger FDA is on tap for 2010.

Watch for the agency to get a bigger budget in the coming years – though much of that emphasis will be on the food side and perhaps less on the drug and device side. For FY 2010, the FDA requested a total budget of $3.2 billion. This amount is $511 million more than FY 2009 and represents a 19 percent increase — the largest ever in FDA history. They won’t get it all, but they’ll probably come close.

Here are some other FDA highlights in a big year:

FDA Finally Gets Tobacco

It took years of lobbying and a new President, but in June 2009 the FDA was given the power to regulate tobacco products. This is a huge victory for the agency. It remains to be seen how the FDA will use this new power, but its surge of activity in the second half of 2009 suggests they want to seize the initiative.

Lawrence Deyton, M.S.P.H., M.D., joined the U.S. Food and Drug Administration (FDA) on Sept. 14, 2009, as director of the agency’s new Center for Tobacco Products. He hit the ground running.

“Our objective is to use the best available science to develop and put into action effective public health strategies to reduce the enormous toll of illness and death caused by tobacco products,” Deyton said .

Deyton was also asked how the tobacco regulation differs from FDA’s regulation of drugs or medical devices?

“FDA’s regulatory role for drugs and medical devices is usually based on a safety and effectiveness standard. The tobacco act establishes a new standard: to regulate tobacco products based on a public health and population health standard.

Deyton noted that when FDA gets an application for a new drug to treat a disease, the agency normally considers studies of patients who have the disease. ”But when we get an application for a new tobacco product, the law tells us we have to consider whether permitting the product’s marketing protects the public health and we have to evaluate the effects of the product on the population as a whole. We’re directed to consider both users and nonusers, and whether our action might encourage people who don’t use tobacco products to begin using them, or encourage people who might otherwise quit to continue using them.”

Bottom-line: It was a huge turf battle victory for the FDA and increases the agency’s overall regulatory clout.

Risk Communications

The agency also took big strides forward in how it gets the word out to industry and the public regarding risk. In its Strategic Plan the agency spelled out its perceived role in communicating the risks of regulated product use, defining risk communication anew for a 21st century in which evolving technologies have enabled increased patient and consumer involvement in managing their health and well-being. The document defines the three key areas (science, capacity, and policy) in which strategic actions, in collaboration with relevant domestic and international stakeholders, can improve the generation, dissemination, and regulation of risk communication about regulated products. It also identifies and details 14 specific strategies.

“FDA is showing its commitment to the goals of the plan not just by identifying the strategies it will implement, but also by identifying over 70 actions the agency plans to take within the next few years to improve risk communication,” it says in the Strategic Plan. The document also identifies 14 of those actions that FDA plans to accomplish within the next 12 months.

Clearing Up Transparency

Echoing an Obama campaign promise to make government more open and accountable to taxpayers, the FDA also walked the walked and talked the talk with its new “transparency”  initiative with public meetings in June and November. The agency also opened a blog that, so far, has had a fair amount of uncensored comment both pro and con about agency performance.

Here (Finally) Comes the eMDR Guidance

In August, the FDA unveiled their proposed guidance for ultimately mandating electronic submission of mandatory adverse event reports. It took a long time to come to fruition, and some are lobbying the agency to push it back another year or two, but the simple fact that it was released was a big deal in 2009.

Guidance on Presenting Risk Info

Before unveiling the eMDR rule, the agency also issued  in May the important draft Guidance for Industry: Presenting Risk Information in Prescription Drug and Medical Device Promotion. The guidance is important on several levels, but perhaps the most important is that it addresses factors the FDA considers when evaluating ads and promotional labeling for prescription drugs, ads for restricted medical devices, and promotional labeling for all medical devices for their compliance with the Federal Food, Drug, and Cosmetic Act and relevant regulations.

In doing so, it cleared up a lot of confusion in the industry and signaled a revitalized FDA that was on the way back.

Putting The ‘Food’ Back In Food & Drug Administration

Responding in part to pressure from Congress and consumer groups over beef and other food contamination recalls, the FDA also revitalized its food enforcement in 2009, and this is also an area where the smart money says they’ll be even more active in 2010. In September, the agency capped a number of new food initiatives by unveiling a new reporting system that gives the agency new enforcement teeth when it comes to the food chain.

Here’s a prediction: FDA historians of the future are probably going to see 2009 as the year the agency picked itself up off the ground and started to flex its regulatory muscle again.

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”.