President, Strategic Communications, LLC

Tuesday, August 28, 2012

Will FDA Preempt Prop 37 and the Dance of Legislation?

In our crazy quilt of food law, pepperoni pizza is regulated by the USDA and cheese pizza is regulated by the FDA. Food labeling requirements promulgated by the USDA preempt all state labeling on meat products, since the Federal Meat Act contains explicit preemption language. Not so, for the Federal Food Drug and Cosmetic Act, although many food law experts believe FDA has implicit authority to preempt state labeling requirements that the Agency believes is not in the public's best interest.

California voters this November will cast a ballot on whether foods containing GMO ingredients should bear a consumer warning, the equivalent of a skull and cross bones, notwithstanding that every public health agency in the world have found these foods to be safe. And, in Europe and in other countries where labeling is required, the politicians and regulators will tell you the decision to label had nothing to do with science but everything to do with the power of the "Green" political movement. Fear of political retaliation, not science forced the decision.

Since 1986 California has been the chief cause of concern about preemption and the chief stumbling block for food industry attempts to have Democratic and Republican Administrations' FDAs create a uniform market for labeling.

Despite the law and practice, the reason why we do not have one uniform national market is the simple political truth -- California has too many electoral votes to mess with.

So, the scientific community, the activists in California and the food industry have been performing a "who will blink first" ballet for years. Each side has honed their skills through endless litigation, rehearsals and intense lobbying.

One example of this foolishness involved the birth defect warning required under Proposition 65, the so-called Consumer Warning Initiative, passed in 1986, which required the state of California to warn consumers of "chemicals known to the state to cause cancer or birth defects." The warnings would be on product labeling and be a figurative skull and cross bones.

In its review of chemcials, the Proposition 65 Scientific Advisory Board (SAB) came across Vitamin A. To make a long story short, it turned out the amount of Vitamin A added to milk sold to school children would have triggered a birth defect warning. Now, this raised a huge problem and the ballet started.

At the end of Act II, the SAB did not want to look like fools to their peers and they were loathe to list Vitamin A but the law is demanding. The dairy industry was aghast, to say the least. The FDA  made it clear it would be very unhappy. Legislation began to move in Congress to preempt the Proposition.

Then, near the end of the production, it dawned on the activists that they may have created a monster, one which will devour them. Federal preemption would kill the California law. As deadlines inched closer, as both sides looked over the precipice, a solution appeared -- the activists agreed to be quiet if Vitamin A magically disappeared from its birth defect warnings list. Presto, chango, Vitamin A was gone. Both sides shifted from warp speed to impulse power.

Then a few years later, FDA was confronted with a similar challenge. This time from rBST, a natural hormone which allows milking cows to produce more milk. Milk produced with rBST is identical in every was to milk produced without rBST. There is no laboratory test that can distinguish between the milk. Ben and Jerry were appalled. Small dairy states besieged the FDA with plans to label milk produced with cows not taking rBST. FDA, as always, took the petitions under advisement.

Lots of time passed. Legislation was introduced, the orchestra began to play the overture and then in a stroke of biblical genius, FDA arrived at a solution. It cut the baby in half, just like King Solomon. It allowed the dairies that did not use rBST to make a factual statement that they did not use it but, the Agency required that a new sentence, a science based disclosure that said, "it didn't matter."
So, today, for example, Special Request Skim Plus milk marketed by Farmland Dairies in Wallington, NJ carries a side panel declaration stating:
*Delicious 100% real milk [as opposed to unreal milk] produced from cows not treated with rBST. The FDA has found no significant difference from milk derived from rBST treated cows and those not treated."

The orchestra stopped.

If President Obama wins reelection and Prop 37 passes, the food industry may once again strike up the tune. FDA will be reluctant, as always, to act, but with GMOs in 80% of processed food they really will not have much of a choice? Perhaps King Solomon will be called on again.

However, now may be the best time since 1986 for the food industry to strike. With the "Knuckle Draggers" as Speaker John Boehner (R-OH) fondly calls his Tea Party Caucus, firmly in control of the House, preemption legislation could zip ripe through. The GOP Leader in the Senate would jump at the chance to give FDA and the Obama Administration more problems that either one of them need. Of yes, California Sen. Barbara Boxer will scream, but who cares -- California's electoral votes will not be in play for three years.

If Gov. Romney gets elected, an order to FDA to preempt is certainly possible.

In the spirit of transparency, I do not have a dog in this fight - yet.

Thursday, August 23, 2012

Is Nutrition Information Only for the Elites?

In 1990 when the late US Sen. Ted Kennedy (D-MA) and his GOP BFF, Sen. Orrin Hatch (UT), began marking up the Nutrition Labeling and Education Act everyone in the Senate Labor and Human Resources Committee room knew food labeling was about to change, with a new "Nutrition Facts" box. It had taken years to lobby and iron out the details. Everyone also knew there would be no sustained effort to educate the public about what information was on the box, despite the title of the law.
Then the federal government got into the information and education business. Soon we had the Food Guide Pyramid and then a revised version, which was supposed to help educate and inform consumers about the nutritional content of the food they were eating.

The most recent set of Dietary Guidelines effectively recalled the crumbling Pyramid and introduced us to the "My Plate" program, where consumers are supposed to fill half their plates with fruits and veggies, a tough thing to do when most consumers have no idea that a potato is a vegetable, much less one packed with potassium (and why is that important?) But, before the ink was dry on the feds new plan, the ivory tower folks at Harvard released had their own different plan and stole most of the media attention. Lesson: power brands, like Harvard, trump federal science.

Now, everyone is fighting about front panel labeling. In a bold tactical move, food manufacturers and retailers unveiled their own proposed plan and voluntarily began to use it, setting FDA and the "Big Food" critics back on their heels. Not to be outdone, the food fundamentalists, the "food police," or the so-called Center for Science in the Public Interest have issued their own color coded, traffic light proposal, which has the proverbial snowball chance in Hell of being adopted. The one thing they all have in common is that they are all different.
The result of 20 years of all this activity -- the nation is more obese than ever.

So now, the "you are too dumb to know what to eat people, the experts and academics" are taking their whack at the issue, hoping simple "tax and forbid" government solutions will solve a complex problem.

Specifically, New York Mayor Michael Bloomberg wants to ban "bad" large soft drinks sold in city restaurants, stadiums and movie theaters, but on August 22 The New York Times (NYT) released a poll of New Yorkers, regarding Mayor Bloomberg’s plan. A whopping 60% were against it. The reaction by the politically appointed head of the city's health department basically was, "We know what's good for you," and said he expected the proposal to be adopted in about three weeks. So much for the messy business of democracy. NYC soda drinkers will just buy two cups of soda, instead of one large one.

Just a few days earlier, in an interview with CBS News about the Administration's new school lunch reform initiative, Kevin Concannon, who is in charge of the school lunch program at USDA, said: "The industry, I think, had a lot of anxiety about this. That's the kindest thing I can say about that." "The kindest thing?" Give me a break. In effect, he washed his purest hands of the politics that his Department was supposed to manage. Congress stepped in and gave every side a bit of what they wanted, something Washington once called a "compromise," before Speaker Boehner's "knuckle draggers," as he affectionately calls the Tea Partyers of his caucus, came to town.

This November California consumers will be voting on Prop 37, an initiative, that if passed, would require food that contains GMO ingredients to be labeled, despite the fact that for nearly 20 years every public health organization in the world have found GMO foods to be safe. FDA firmly believes a warning that 80% of the food supply contains GMOs would be a warning on nothing and would imply non-GMO foods were safer or more nutritious, something that is absolutely wrong and illegal under the Federal Food, Drug and Cosmetic Act.

So what do consumers want to know about their food? No no surprise, consumer polling and focus group results have not changed in many years. According to the International Food Information Council's (IFIC) 2012 Food and Health Survey, taste is number one. Ever try one of the very low fat cheese products. Yuck! I vote for Julia Child and please pass the butter. Price is number two and healthfulness comes in third.

The IFIC data reveals most consumers find it easier to figure out their tax return than it is to figure out what they should and shouldn’t eat to be healthier. No surprise there either.

Declaration of Independence

Most importantly, consumers do not want to be told what or what not to eat and they certainly do not want government making those decisions for them and their families, something to do with a strong belief in the right to "Life, Liberty and the pursuit of Happiness" as spelled out by the Declaration of Independence, I guess.

My RD friends continue to tell me people cannot be coerced or taxed into compliance. They have to want to make a major change in their life and it is a tough, life-long fight. Why are they not being heard by policy makers?

So, where are we? Obesity, diabetes and heart disease are at epidemic rates. Consumers are interested in health but understandably confused. Manufacturers are touting health benefits of a wide range of ingredients in advertising and activist groups do not want food companies to advertise anything but broccoli to kids.

In the meantime, the experts will argue policy with each other and the academics will talk about the latest NHANES study to each other. Consumers are on their own.

Wednesday, August 15, 2012

Competitive Foods and Obesity - Be Very Careful

Mix funding from the Robert Wood Johnson Charitable Trust with the branding of Harvard and you have a recipe for making news from scratch, no added sugars here. So it is not surprising that a new pediatric obesity study shows that laws strictly curbing school sales of  so-called junk food and sweetened drinks may [emphasis added] play a role in slowing childhood obesity received wide coverage across the country.

The Associated Press (AP) coverage, which most papers across the country used, noted, "even obesity experts who praised the study acknowledge the measures are a political hot potato, smacking of a 'nanny state' and opposed by industry and cash-strapped schools relying on food processors' money. Buried deep down in the AP copy, perhaps by an editor, is the one paragraph of "balance" provided by Boston University statistician Mark Glickman who said, "the study design makes it difficult to reach any convincing conclusions.

What bothers me is that Lindsey Tanner, a very good AP medical writer based in Chicago, goes out and rounds up the usual food critics for comment. Dr. David Lustig is quoted as saying, "if the laws have even a tiny effect, 'what are the downsides of improving the food environment for children today?' He concluded, "The challenge is that there are a great many factors that coalesce to influence body weight. Disentangling these influences and looking at the independent effects of just one is a methodological nightmare." Then Dr. Virginia Stallings adds her two-cents worth, "This is the first real evidence that the laws are likely to have an impact." Stallings, an out-spoken industry critic,  chaired an Institute of Medicine panel that urged standards for making snack foods and drinks sold in schools more healthful.

On the merits of the issue, the children in the study gained less weight from fifth through eighth grades if they lived in states with strong, consistent laws versus no laws governing snacks available in schools. For example, kids who were 5 feet tall and 100 pounds gained on average 2.2 fewer pounds if they lived in states with strong laws in the three years studied. Also, children who were overweight or obese in fifth grade were more likely to reach a healthy weight by eighth grade if they lived in states with the strongest laws.

Importantly, the effects weren't huge, and the study isn't proof that the laws influenced kids' weight.
If a fraction of the time and money spent on pushing taxes and food bans were applied to nutrition 101 for kids in school, K-12 and the freshman year in college we would make some progress. As my RD friends remind me, you cannot force a person to change what he or she eats. Once they decide to change, then RDs and other health professionals can help. And, yet another study funded by a big charity that shows mix results at best is really not news.

The authors of the study, released online Monday in the journal Pediatrics.

Sunday, August 5, 2012

"Added Sugars," Labeling, Give Me a F------ Break

The presidential election political silly season is upon us and Congress is in recess until after Labor Day.

The USA Olympic Champions are getting covered in tats, the Tea Partyers are having Mark Twain's joke, "No man's life, liberty, or property are safe while the legislature is in session," etched on their foreheads; and, the Democrats continue to hope that Sir Winston Churchill was right was he commented,"It has been said that democracy is the worst form of government except all the others that have been tried."

The country is facing perhaps the most important election since 1968, and what is the the FDA doing, considering whether to require "added sugar" labeling to foods. Give me a break. Oh yes, this news comes on the heals of two major microbiological contamination recalls involving onions and cantaloupes that led food safety experts to cite recent CDC reports that the country is not meeting its goals for reducing food borne illnesses such as salmonella and listeria. Consumer advocates complained that the government has been too slow to implement the Food Safety Modernization Act, which should help prevent food borne illness. The only good news here is that nobody has died, yet.

So, with not enough funds to do its work, with a House of Representatives, axe in hand, prepared to slash FDA dollars, where, you might wonder is the Agency is spending the few resources it has -- to beat the dead horse of "added sugars" again.

The LA Times immediately jumped into the fray with: "Snorre… I mean, Man the Barricades! Put a Stop to This/Get This Done ASAP!"

Let's not let three facts intrude. First, sugar is a required listing in the Nutrition Facts Box. Second, there is general scientific agreement (is that an oxymoron?) that the body does not distinguish one kind of sugar from another -- sugar is sugar is sugar. Sure, honey and pure evaporate cane juice give us a warm and fuzzy feeling compared to HFCS and granulated white sugar, but, metabolically speaking, there is no nutritional difference. And, third, have you ever tried to drink a cup of straight cranberry juice? I tried, and I could not do it, way too tart for me and most consumers which is why the industry sweetens the drink with other, cheaper sugars. Apple juice, Mother Nature's junk food, is a popular choice. Take off the peel and all you have is sugar and a modicum of vitamins.

When HFCS began, to borrow another DC phrase, "to twist slowly in the wind," smart companies found more consumer friendly alternatives, even if they did not meet the strict standard of identity established by the FDA for sugar. Cane juice consumption jumped and some companies actually advertised "contains real sugar" as opposed the sugar that comes from a factory of corn going in one end, lots of pipes and syrup coming out the other end.

Just for the record, the last two rounds of Dietary Guidelines (DG) declined to recommend the "added sugar" approach. Oh sure, the DG panel was dominated by industry and despite the East Wing of the White House's  Let's Move campaign, big, bad industry won. Which brings us back to why the food fundamentalists are trying to end run the DG process and have FDA change the regulations.

FDA is a risk adverse, deliberative Agency, to say the least. They should carefully and painstakingly review the comments and then stick them in a place where the sun does not shine, in a backroom storage facility with no windows.

After all it is excessive calories people consume from a wide variety of foods, just not sugar that provides the risk factor for obesity, CVD and diabetes. Brownell and his usual suspects know, if you consume more calories than you expend, you will put on weight. Perhaps, that is where they ought to focus their personal efforts and let FDA worry about the really important stuff, like surviving.