Finally, FDA Acts Before More Poeple Die

How many deaths did it take for FDA to flex a little muscle? How many more people will end up in the emergency rooms or die due to consumption of products with no caffeine ingredient disclosures. How many more thousands of hours will the FDA spend in trying to calculate how many angels dance on the front panel lettering of food products, despite no one but a Registered Dietitian understands the information? How many of man-hours will be spent in endless meetings debating whether parents have an obligation to turn off "offensive" television advertising to children or leave it to the federal government to set rules governing what food companies can tell what consumers at what time of the day?

To to give the devil his due,yesterday the Food and Drug Administration halted operations of Sunland Peanut Butter, the country's largest organic peanut butter processor, that supplies product to companies such as Trader Joe's, Whole Foods, Safeway, Target and other large grocery chains after 41 people in 20 states, most of them children, were sickened by peanut butter manufactured at the plant in Portale. FDA cracked down on salmonella poisoning for the first time with new enforcement authority the agency gained in a 2011 food safety law, although other legal experts claim the agency could have acted much soonerf it has showed  a little backbone.

FDA is an agency that lives in black-and-white. It cannot distinguish shades of gray and therefore the agency waited until Congress gave it new authority to suspend a company's registration when food manufactured or held there has a "reasonable probability" of causing serious health problems or death. Before the food safety law was enacted early last year, the FDA would have had to go to court to suspend a company's registration. To a non-lawyer, presenting a reasonable case to a judge that a plant was producing food that had "reasonable probability"of killing people was not a high legal hurdle.

A few years short and many deaths later, Michael Taylor, the FDA's deputy commissioner for foods, said the agency's ability to suspend a registration like this one is a major step forward for the agency.
"Consumers can be assured that products will not leave this facility until we determine they have implemented preventive measures that are effective to produce safe products," Taylor said. I'm confident Taylor's new found enthusiam will be of great comfort to those families that lost parents, children, aunts, and uncles and who know that FDA fiddled as Rome burned.

In the Washington world or regulation, FDA typically looks for a deep pocket company on which to enforce new statutory authority.

During a month-long investigation, after the outbreak linked to processor Sunland and to Trader Joe's, FDA inspectors found samples of salmonella in 28 different locations in the plant, in 13 nut butter samples and in one sample of raw peanuts.The agency also found improper handling of the products, unclean equipment and uncovered trailers of peanuts outside the facility that were exposed to rain and birds.The FDA said that over the past three years, the company shipped products even though portions of their lots, or daily production runs, tested positive for salmonella in internal tests. The agency also found that the internal tests failed to find salmonella when it was present. FDA inspectors found many of the same problems – including employees putting their bare fingers in empty jars before they were filled, open bags of ingredients, unclean equipment, and many other violations – in a 2007 inspection. Similar problems were recorded by inspectors in 2009, 2010 and 2011, though government officials didn't take any action or release the results of those inspections until after the illnesses were discovered this year.

Sunland's president and chief executive officer, Jimmie Shearer, denied the company knowingly shipped tainted products.

So, does this tell us? FDA knew for a very long time the Sunland plant was a problem. They collected data but took no action. Then, armed with new legislative authority. It swooped in and shut the plant down and issued a press release. How many people died in the meantime?

New Media Relations Rules for Future Candidates

Now that the election is over, here are a few new rules (with apologies to Bill Maher) for future candidates and their media relations sherpas:


New Rule: In an interview, debate or conversation NEVER say anything you would not want your mother to see on the first page of her morning paper.

New Rule: Whether you are gay, straight, transgender or bi-sexual, a CIA Director, Army General, Governor, Senator or Member of the House of Representatives, if you plan to run for office or hold high office, take off your pants for your spouse or companion and your doctor, and nobody else. No one but Bill Clinton can carry off multiple infidelities and come back.

New Rule: Know your shit. "Oops" is not an acceptable third message point, no matter what Texas Governor Rick Perry says to the contrary.

New Rule: In a debate, when your opponent says, "Governor, please proceed...," SLAM ON THE BRAKES, shut your mouth, breathe and turn around to see the knife that is just about to stab you in your heart.

New Rule: When an interviewer or opponent includes "bayonets and horses" immediately step back from the question. Do not walk into the issue.

New Rule: Answer the damn question, before leaping into your memorized message point, it's not that hard. It's "yes that's right," or "No, that's wrong and let me tell you why," or "That's an excellent question, let me get back to you." Only POTUS has the right to ignore your question as Marine One prepares for takeoff from the South lawn of The White House.

New Rule: Under no circumstance try to change Newton's law of motion -- that’s the one about creating an equal and opposite reaction, just in case you skipped that class in college. If you try to suppress the vote, the people whose vote is threatened will come out in mass numbers and kill you at the voting booth.

New Rule: If you are going to lie, stick to it. Do NOT flip-flop, waffle, walk back, or try to parse, your words. The correct answer is, "That's what I said and I am sticking to it." The only exception is when you really fuck up and then you say "I am sorry, my staff gave me bad information."

New Rule: If you are an old, angry, rich white guy, just forget about running for national office AND if you are a old, angry, rich white guy forget about giving ANYBODY millions of dollars in contributions, except a legitimate charity.

Strategic Communications, LLC is prepared to work with you now for a modest amount to help you master these new rules. And, I am more than willing to work with you for a whole lot more money, if you ignore these rules.

What does the election mean for the food industry?

Looking at last night's election from 30,000 feet presents a different long-term vision of the nation than a view from the trenches; however, one thing is certain, both views have changed.

On the national level, GOP leaders, such as U.S. Senator Lindsey Graham (SC), realize, in this striking defeat, that his party is now comprised of  old, white, rich, angry men, dinosaurs. Without a massive restructuring, it may have lost the ability to elect any candidate to national office. The GOP also learned that Jim Crow voting repression efforts put Newton's law of motion into play and created an "equal and opposite reaction." I guess Rove and friends slept through that class.

A view from the trenches brings a somewhat more familiar vision. The food industry has a marvelous track record of identifying changing consumer needs, producing new products and marketing them with cutting edge technology to all consumers. It strikes me as somewhat ironic that food companies, which market to every kind of consumer, do not share any common political values with their customers.

In practical terms the question is - How fast will the folks, who work in mahogany offices, figure out the real issue is not what is on the front nutrition panel, since nobody but an RD understands it, but how quickly they can get the information on their products in Spanish, for a start? Remember, the California election ballot, for example, was printed in eight languages from American Indian to Vietnamese.

All this is good news for food industry trade associations, which can take dues dollars, form coalitions and slow down the pace of change, permitting member companies the freedom to create their own branded initiatives to address consumer health and safety issues.

Let's look at what the election may mean to just a few of the major issues facing the industry:

FDA
It is certain that FDA's budget will be cut. Absent a grand bargain on the budget, an 8.2% sequestration will cut FDA's budget by about $320 million - $205 million from the Treasury and about $115 million from industry user fees. FDA would have to cut or furlough about 1,000 staffers. Importantly, no matter how much is cut, no regulatory responsibilities will be reduced. An Agency plagued for years with having too much to do with too few resources will have to pick and choose much more carefully where it spends its time and money.

Many Agency watchers have concluded the "F" in FDA has been MIA for years. The budget cuts will make matters worse since all the major food health and safety issues are complex and controversial. Here is how I think they may break out:

Most Do
Now that POTUS has been re-elected, there is no longer any reason for OMB to hold the very expensive food safety modernization regulations, an effort that will save lives and prevent serious illnesses.

Will Have To Do Something
Front panel nutritional labeling. The question here is whether the industry's peremptory strike has enough science behind it so FDA can tinker with it rather than overhaul it. A proactive social media campaign focused on health professionals would help.

Caffeine content transparency - Yes, I know these products are diet supplements and are subject to different rules but energy drink products owned by major beverage companies voluntarily disclose caffeine content. Why not spend some political capitol and encourage FDA to require caffeine and stimulant disclosure, establishing a level competitive playing field? The industry would win major kuddos from the public health community.

Forget It
California's overwhelming rejection of Proposition 37's mandatory labeling of GMO foods should put this issue back in the freezer for the FDA. If you are an investor in the "super-sized salmon" you have my sympathies, but a huge amount of preparing the marketplace work needs to be done with health and nutrition experts before FDA needs to tackle this one. Just one footnote, except more action on this issue at the state level.

USDA
The Farm Bill - While the GOP retains control of the House, the Tea Party has been weakened. Perhaps the industry should take a fresh look at the nutrition and sugar programs and try to restore the old McGovern-Dole Agreement. And, despite personal politics, that fact is no domestic sugar producer or state (Florida is still too close to call) voted for the president. The Administration owes nothing to them and revenge is a dish best served sweet, I mean "cold."

White House, MyPlate and Dietary Guidelines - No change in policy is expected from the East Wing of the White House or the nutritional nonsense eminating from its chef. What is really interesting to me is that many in the nutrition community believe the current regulatory regimen is fatally flawed and there is a growing social media discussion about how to change it before the next round of the DG begin. Now is the time for industry to jump on board, and encourage this discussion.

FTC                                           
Kid-Vid Advertising - Control of advertising is a fall on your sword and bleed out issue. The industry is using the old chestnut of working with the Better Business Bureau. It has hired a former high Ranking FTC staffer to run the effort, but will the industry's current positioning be able to withstand the coming onslaught of attacks, because the activist community knows this is the game for all the marbles, too? Here's another opportunity to build support through social media aimed at health professionals.

CSPI, Marion Nestle, Mark Bittman, Virginia Stallings, Rachel Johnson, FNS, maybe AND

It's November, and just as trade associations begin to draft their dues letters, the activists will be drafting their own, which will stress the need to have the resources to drive home many of their issues, since POTUS and FLOTUS are now free of political considerations. Look for an uptick in their "now is the time" rhetoric, fundraising, communications and lobbying. 

In sum, lots of challenges with opportunities to play offense and defense. Of course, this can all change if the Administration decides to make obesity prevention a cornerstone of its second term. Remember, the Obama team are now thinking about how historians will view it. So, we end up where we began, at 30,000 feet.

To talk about health professional social media efforts shoot me a note or give me a call.