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The FDA did something quite unusual.  It issued an apparently frank description of where it is in investigating the Romaine lettuce E. coli outbreak that has sickened 197 people, put 89 in the hospital, and killed five—so far.

It published a chart summarizing what the agency has learned about the various distribution channels along the way to the contaminated lettuce that made people sick.

As the FDA explains:

As can be seen in the diagram, in the current outbreak, and based on the information we have to date, there are still no obvious points of convergence along the supply chain…These pathways lead back to different farms, sometimes many farms, where possibly contaminated lettuce could have been harvested during the timeframe of interest.  The only point of commonality in our traceback efforts to date is that all of the farms are located in the Yuma growing region…What does this traceback diagram tell us?  It says that there isn’t a simple or obvious explanation for how this outbreak occurred within the supply chain…The contamination likely happened at, or close to, the Yuma growing area.  Our task now is to investigate what happened.

I used “apparently” with reference to the FDA’s frankness because food safety lawyer Bill Marler, who represents many of the victims of this outbreak,* points out that the FDA must know the names of the farms, distributors, and sellers of the contaminated lettuce, but refuses to say who they are.  Of his own work, Marler says:

We are in the unique position to know many, but not all, of the “points of sale” – restaurants and grocery stores – involved in the E. coli O157:H7 outbreak linked to romaine lettuce. Having over 100 clients allows us to dig deep into their purchase history and consumption history.

We have already determined clusters of illnesses linked to Panera, Texas Roadhouse, Red Lobsters and Papa Murphy’s. We also have identified a processor – Freshway Foods.

If you knew the names of places selling contaminated lettuce, wouldn’t you have sense enough not to eat in them?

• Here is Marler’s video of one of the children sickened in this outbreak.  Heartbreaking.

You have to have some sympathy for egg producers.  Egg consumption has been declining for years.

Egg producers blame the decline on cholesterol concerns; eggs are by far the largest dietary source of cholesterol.

Now Pete and Gerry’s Organic Eggs is petitioning the FDA to forget about cholesterol and update its definition of “healthy” so the company can advertise its eggs as “healthy.”

FDA Commissioner Scott Gottlieb said in a speech last month that the FDA would be updating the definition.

I, of course, think “healthy” is a slippery slope best avoided, and that Congress never should have allowed health claims on foods in the first place.,

But too late for that.

I don’t envy the FDA’s challenge here.  The petition is based on the dietary guidelines, but what the guidelines say about dietary cholesterol, and therefore eggs, is extremely confusing.

As I explained in a previous post, the guidelines no longer recommend a cap on dietary cholesterol of 300 mg/day (the equivalent of 1.5 eggs), but do say that people should eat as little cholesterol as possible.

Good luck on this one.

On May 4, the FDA gave food companies a gift when it announced a 1.5-year extension of compliance dates for the Nutrition Facts label.

We are taking this action because, after careful consideration, we have determined that additional time would help ensure that all manufacturers covered by the final rules have guidance from FDA to address, for example, certain technical questions we received after publication of the final rules, and that they have sufficient time to complete and print updated Nutrition Facts labels for their products before they are expected to be in compliance with the final rules.

On its website, the FDA now says:

The FDA extended the compliance dates for the Nutrition Facts and Supplement Facts label final rule and the Serving Size final rule, from July 26, 2018 to January 1, 2020, for manufacturers with $10 million or more in annual food sales. Manufacturers with less than $10 million in annual food sales would receive an extra year to comply – until January 1, 2021.

CSPI, understandably, is miffed:

The reality is that the labels are already on more than 29,000 products on grocery shelves, and more appear weekly.  So today’s announcement should be a call to action for companies to provide consumers the information they want now, rather than waiting for the legal deadline.

I’ve been following the E. coli 0157:H7 outbreak caused by eating romaine lettuce grown in Yuma, Arizona.

The CDC says the body count so far is:

• Cases = 121
• Hospitalizations = 52
• Deaths = 1

Where the cases have been found:

What the “epi curve” looks like:

What’s happening with the FDA’s investigation:

The FDA has identified one farm [Harrison Farms of Yuma, Arizona] as the source of the whole-head romaine lettuce that sickened several people at a correctional facility in Alaska. However, the agency has not determined where in the supply chain the contamination occurred…All of the lettuce in question from this farm was harvested during March 5-16 and is past its 21-day shelf life. Because the growing season in the Yuma region is at its end, the farm is not growing any lettuce at this time.

Most of the illnesses in this outbreak are not linked to romaine lettuce from this farm, and are associated with chopped romaine lettuce. The agency is investigating dozens of other fields as potential sources of the chopped romaine lettuce and will share information as it becomes available.

Some interesting aspects of this and other leafy green outbreaks:

• It takes two to three weeks from the time a case is first reported until it is confirmed.
• There have been about six dozen outbreaks traced to leafy greens since 1995, many unsolved.
• Because CDC and FDA can’t figure out the source, they have not issued a recall.
• The lack of traceability is a heads up for the produce industry.

In the meantime, the CDC’s advice to you:

• Do not eat or buy romaine lettuce unless you are sure it was not grown anywhere near Yuma.
• Do not eat or buy romaine lettuce if you cannot tell where it was grown.
• Do not eat salad mixes unless you are sure it is free of romaine lettuce.
• This applies to romaine lettuce in any form: heads, hearts, chopped, baby, organic, in salads or salad mixes.

But Consumer Reports says to avoid romaine lettuce entirely.

Seems like good advice until this one gets figured out.

Remember menu labeling?  In 2010, Congress said fast food places should reveal calories on their menus (New York City required this in 2008).

Food companies fought the measure and got delays, but the eight-year delay is up.  Menu labeling goes national today.

In a blog post, FDA Commissioner Scott Gottlieb explained FDA thinking about such matters: the agency is pro-consumer and pro-market.

Information about how healthy our food is gives us the chance to make better choices about our diets. This same information also inspires competition among producers to formulate food in ways that make it more healthful…. food producers should be able to compete on the ability to develop foods that are healthier, and make reliable, science-based claims about these attributes to consumers.  So at FDA, we’re reforming our policies to make it more efficient to develop these claims. This clarity may encourage more manufacturers to invest in making foods healthier.

Uh oh.  More health claims (these, I insist, are about marketing, not health).  So that’s the trade-off; we get menu labeling at the price of more and inevitably misleading health claims.

Gottlieb defended the measure on Fox News.

If you have information on menu labels, the average consumer will reduce their caloric intake to 30-50 calories a day,” Gottlieb said during the interview. “That turns out to be about 3 to 5 pounds per year that you can lose just by having better information.

This is correct in theory, if you assume that one pound of fat contains about 3500 calories (this estimate comes from multiplying 454 grams per pound by 9 calories per gram for fat and rounding off).  Then it will take 3500 divided by 50 = 70 days to lose one pound.

In practice, such small calorie deficits are hardly measurable.  Most estimates suggest that losing weight requires a deficit of 300 to 500 calories a day (My co-author and I discuss all this in our book, Why Calories Count: From Science to Politics).

For an quick summary of the studies of menu labeling, JAMA has a useful review.

It’s great that Commissioner Gottlieb defended menu labeling on Fox News.  Looking at the calories on menu items is fun!

And it most definitely works for me.  If I see a muffin labeling at 700 calories, I share it with friends.

Remember way back when the FDA proposed updating the Nutrition Facts label?  It’s hard to keep track of the delays but the label, first proposed in 2016, is scheduled to appear in supermarkets near you by January 1. 2020 for manufacturers with $10 million or more in annual food sales and to January 1, 2021 for those below that amount.

In March, FDA Commissioner Scott Gottlieb announced new guidances for perplexed food makers who still can’t figure out what they are supposed to say on labels.

• Guidance for Industry: Scientific Evaluation of the Evidence on the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates Submitted as a Citizen Petition (i.e., Fiber)
• Draft Guidance for Industry: Declaration of Added Sugars on Honey, Maple Syrup, and Certain Cranberry Products
• Guidance for Industry: Proper Labeling of Honey and Honey Products
• Guidance for Industry: Reference Amounts Customarily Consumed: List of Products for Each Product Category
• Guidance for Industry: Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed at One Eating Occasion; Small Entity Compliance Guide

The fiber guidance is particularly interesting.  FDA wants “dietary fiber” to have a proven health benefit, thereby excluding substances like chicory root, oat hulls, or other added plant components.

CSPI points out that the guidance is plenty clear enough, many food manufacturers are already using the new label, and the long delay is unnecessary.

I agree.  FDA: stop dilly-dallying on the food label.  The absurd delay makes it look like you are caving in to industry objectiosn.

Last week, FDA Commissioner Scott Gottlieb spoke at the National Food Policy Conference in Washington, DC where he announced FDA’s Nutrition Innovation Strategy.

His speech, Reducing the Burden of Chronic Disease, specifies five areas that FDA intends to consider (meaning, at best, proposing suggestions for public comment and going through FDA’s interminable rulemaking process):

• Modernizing health claims
• Modernizing ingredient labels
• Modernizing standards of identity
• Implementing the Nutrition Facts Label and Menu Labeling
• Reducing sodium

The documents:

• Commissioner Speech: https://www.fda.gov/NewsEvents/Speeches/ucm603057.htm
• FDA Nutrition Innovation Strategy: https://www.fda.gov/Food/LabelingNutrition/ucm602651.htm

My immediate reactions: sounds good, but short on commitment.

I was impressed that Gottlieb focused on public health and prevention:

We can’t lose site of the public health basics – better diet, more exercise, and smoking prevention and cessation…The public health gains of such efforts would almost certainly dwarf any single medical innovation or intervention we could discover.

Yes!

I was particularly interested in two initiatives under consideration:

Front-of-package icon for “healthy”

This is to be based on a food-based definition that focuses on the healthful attributes of a food product—not, apparently, on its content of sugar, salt, or saturated fat.  Only healthful attributes?

This sounds like a highly pro-industry position, since research on front-of-package labeling is pretty clear that warning labels about unhealthful attributes (salt, sugar, saturated fat) are most effective in discouraging purchases of “ultraprocessed” foods.  The warning labels used in Chile, for example, are proving to be highly effective.

Gottlieb did not mention the the FDA-sponsored reports on front-of-package labeling performed by the Institute of Medicine early on in the Obama administration.  Those were serious attempts to develop an effective front-of-package labeling system that identified nutrients to be avoided.  The FDA seems to have forgotten about those reports.

Reduce sodium

This is the item that got the most attention.  Gottlieb said: “There remains no single more effective public health action related to nutrition than the reduction of sodium in the diet.”

OK, but if that’s true, how about ensuring that food companies gradually reduce sodium in their products, as was done in the UK.  No such luck.  Instead: “I’m committed to advancing the short‐term voluntary sodium targets” (my emphasis).

I suppose “voluntary” could work, but if sodium reduction isn’t across the board, companies will have little incentive to risk changing their formulas.

In short, Gottlieb’s words reflect modern public health thinking the good news) and it’s great that FDA is considering taking these actions (also good news).  Now, let’s see what the agency actually does.

Nutrition labels may seem self-evident but it takes volumes of Federal Register notices to explain how every word works.  When it comes to food labels, the devil is in those details.

Take “Added Sugars,” coming soon to a food label near you.

How does the term apply to honey and maple syrup or, for that matter, sugar itself.  These are sugars ready to add.

Pure honey and maple syrup producers are worried that when you see grams of Added Sugars on their labels, you will think that these natural products have been adulterated with—gasp—High Fructose Corn Syrup.

The producers of sugar-sweetened cranberry products are also concerned.  They worry that the added sugars will discourage you from buying cranberries.

Here is how the FDA suggests dealing with these “problems,” in quotes because they are problems for producers, not you and me—we know what “added” means.

The purpose of this draft guidance is to advise food manufacturers of our intent to exercise enforcement discretion related to the use in the Nutrition Facts label of a symbol “†” immediately after the added sugars percent Daily Value information on single ingredient packages and/or containers of pure honey or pure maple syrup and on certain dried cranberry and cranberry juice products that are sweetened with added sugars and that contain total sugars at levels no greater than comparable products with endogenous (inherent) sugars, but no added sugars.

Got that?

Pure honey and maple syrup get a “†” indicating that they have no more sugar than any other comparable sugar.

Cranberries are more complicated:

With respect to the labeling of certain cranberry products, cranberries are a naturally tart fruit, and certain dried cranberries and cranberry juice products have added sugars added to them to bring the total sugars per serving up to levels comparable to the levels of non-cranberry competitor products that contain equivalent amounts of total sugars, but whose labels list zero “added sugars” because their fruit products are inherently sweet.

Did you get that?

If I read this FDA-speak correctly, the FDA is making an exception for cranberries.  It agrees that the Added Sugars in cranberries also deserve a “†”.

Why is FDA allowing this?  The Draft Guidance explains:

We received comments from the cranberry industry to the final rule and subsequent correspondence that the added sugars declaration would be detrimental to the cranberry industry by implying that cranberry products are less nutritious than competitive products that have similar amounts of total sugars and nutrients.

These comments were similar to those we received which noted that grape juice contains 36 grams of total sugar with no added sugars while cranberry cocktail, with sugars added for palatability because cranberries are naturally tart, generally contains 28 grams of total sugars including 25 grams of added sugars and has 30 fewer calories per serving than 100% grape juice.

Likewise, comments explained that sweetened dried cranberries contain 29 grams of total sugars including 25 grams of added sugars per serving while raisins contain 29 grams of total sugars with no added sugars per serving. Both sweetened dried cranberries and raisins have the same number of calories per serving and a similar nutrient profile.

In translation, you are not supposed to be concerned about the Added Sugars in cranberries.

But couldn’t you could buy real cranberries and add a whole lot less sugar than that?

Chalk this as a win for cranberry lobbyists.

The documents

• Download the Draft Guidance 
• Federal Register Notice
• Constituent Update
• Changes to the Nutrition Facts Label
• Additional Labeling Guidance