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

Amid continuing debate about the timing and shape of the Senate’s food safety bill (the House passed a version in July 2009), comes a new issue that affects companies in the food, drug, device and cosmetic industries.

Several months ago, FDA Deputy Chief Counsel for Litigation Eric Blumberg told industry representatives at the FDLI Annual Conference that the agency is prepared to dust off the three-decade-old “Park Doctrine” to augment FDA’s continuing efforts to ratchet up its enforcement profile. The doctrine stems from the United States Supreme Court’s decision in United States v. Park, 421 U.S. 658 (1975). In principle, it allows the government to pursue misdemeanor charges against a corporate officer for alleged violations of the Federal Food, Drug, and Cosmetic Act, regardless of whether the officer is aware of the existence of a violation, as long as the officer holds a position of responsibility so that that individual could have initiated preventive or corrective action and, for whatever reason, failed to do so.

Park represents a strict liability standard, so no warning letter is required. FDA need only request that the Department of Justice file charges based on FDA’s conclusion that an officer is guilty of misconduct, which is effectively defined as failing to know what FDA believes one should have known. In sum, what an executive does not know can be more than harmful.

The scale of punishment for misdemeanors ranges from one year in prison and/or a maximum fine of $100,000 for each count, ranging to much higher where injury or death are involved. Courts can impose mandatory prison sentences, and if FDA believes a substantial risk of injury or death is involved, judges can increase the length of prison sentences.

At a time when corporate resources are stretched, the entire spectrum of regulatory compliance issues has become every bit as critical for senior management and counsel as the other bet-the-company issues that confront each company on a day-to-day basis.

Mark Mansour is a partner in the firm, Bryan Cave, LLP

FDA Extends Comment Period for Proposed Neurological Device Regulations
The FDA has announced that it is reopening until September 7, 2010, the comment period for the proposed rule and guidance published in the Federal Register of April 5, 2010 (75 FR 17093). The document proposed to amend certain neurological and physical medicine device regulations to establish special controls for these class II devices and to exempt some of these devices from premarket notification requirements. More information is available here and here.

Device Industry Calls for Closer Coordination Between FDA, CMS
Members of the device industry are calling for closer coordination between FDA and CMS related to the competitive bidding process. Stakeholders have said that the two agencies sometimes send mixed messages, due to their different approaches to devices, and particularly for sophisticated therapy products for home use, with CMS focused on pricing and the FDA focused on support services and safety issues, including labeling and training. Members of industry have indicated that they hope that new FDA guidelines on home-use devices will make certain that suppliers ensure that training and support are provided as part of their bids.

FDA Weighs New Approach to Regulation of DTC Genetic Tests
In the wake of a recent GAO report finding that direct-to-consumer genetic tests are providing inaccurate results to the public, the FDA has indicated that it is considering an approach to regulating the tests that would increase oversight without creating heavy reporting burdens on individual companies. The agency’s potential approach, as currently envisioned, would not require the developers of certain diagnostics to submit data on their individual diagnostics, if a manufacturer had previously provided information on the overall indication of the diagnostic to the FDA.

Pharmacies Calling for Removal of Reimportation Amendment from Food Safety Bill
Pharmacies are ramping up their efforts to encourage lawmakers to remove an amendment to the food safety legislation, offered by senator Byron Dorgan, that would allow for the reimportation of drugs from Canada and Mexico into the United States. Pharmacies are stating that the safety of such drugs cannot be ensured and that the use of reimportation means that individuals would not be consulting with a pharmacist at the time that they obtain the drug. Some are speculating that the amendment, which Dorgan also attempted to introduce in the health reform legislation, could prevent the passage of the overall bill, and are thus encouraging its removal.

Mark Mansour is a partner in the firm, Bryan Cave, LLP

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: