Currently browsing posts about: FDA

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

Competition in the food service industry must be fierce these days.

My colleagues who are members of the Academy of Nutrition and Dietetics recently received this letter from a public relations firm working for Panera.

Subject: Panera’s Quest to #RespectTheEgg

Did you know 50% of the top 10 fast casual restaurants that sell breakfast have an “egg” made of at least five ingredients, often more? That’s why Panera has officially petitioned the FDA to establish a clear definition for the term “egg,” in an effort to improve standards and transparency throughout the food industry.

In the meantime, customers can rest assured that when they order an egg at Panera, that’s exactly what they’re getting. Panera has launched a line of new breakfast sandwiches featuring 100% real, freshly cracked, cooked-to-order eggs with no additives at all.

In case this is a fit for anything you’re working on, here is a link to more materials and images, including:

• Panera’s Official Press Release
• An Infographic Comparing Competitor’s Eggs and Breakfast Sandwiches (print size and JPG for social sharing)
• Images of Panera’s Breakfast Sandwiches
• The FDA Petition
• Panera’s New & Improved Breakfast Menu

You can also find detailed nutrition info on Panera’s new breakfast sandwiches here. Please let me know if you have any questions on Panera’s quest to #RespectTheEgg!

The press release does not say what evil additives are used by Panera’s competitors.  Fortunately, Forbes has a list.  Its top prize goes to Subway, but the others don’t look much better.

Here’s the ingredient list for Subway’s Egg Omelet Patty (Regular):

Whole eggs, egg whites, water, nonfat dry milk, premium egg blend (isolated pea product, salt, citric acid, dextrose, guar gum, xanthan gum, extractive of spice, propylene glycol and not more than 2% calcium silicate and glycerin to prevent caking), soybean oil, butter alternative (liquid and hydrogenated soybean oil, salt, soy lecithin, natural and artificial flavors, beta carotene (color), TBHQ and citric acid added to protect flavor, dimethylpolysiloxane (antifoaming agent added), salt, beta-carotene (color).

Hey—eggs are the first ingredient.

Panera isn’t really asking for a standard of identity for eggs.  It’s asking not to count an egg as an egg if these kinds of things are added to it.

I can’t wait to see what the FDA does with this one or if it even tries to attempt to draw the line between the items in the non-egg “premium egg blend” and additives like salt and pepper.

Let’s start with the report issued by the Department of Health and Human Services’ Office of the Inspector General (OIG).  Now that the Food Safety Modernization Act gave the FDA the authority to issue recalls of unsafe food, the OIG wanted to know how it was using that authority.  OIG’s opinion:

FDA did not always have an efficient and effective food-recall process that ensured the safety of the Nation’s food supply. We identified deficiencies in FDA’s oversight of recall initiation, monitoring of recalls, and the recall information captured and maintained in FDA’s electronic recall data system, the Recall Enterprise System (RES). Specifically, we found that FDA could not always ensure that firms initiated recalls promptly and that FDA did not always

(1) evaluate health hazards in a timely manner,

(2) issue audit check assignments at the appropriate level, (

3) complete audit checks in accordance with its procedures,

(4) collect timely and complete status reports from firms that have issued recalls,

(5) track key recall data in the RES, and (6) maintain accurate recall data in the RES.

FDA Commissioner Scott Gottlieb responded to the OIG report.

The FDA has authority to act in a variety of ways when it is made aware of an unsafe food product. But often the fastest and most efficient way to ensure unsafe foods are recalled quickly is by working directly with the involved companies while simultaneously providing the public with timely, accurate information that they can act on….Fortunately, most companies are cooperative and rapidly initiate a voluntary recall of a hazardous food product. On average, the recall occurs within four calendar days of the problem being discovered…Sometimes the recall process does not work as well as we’d like.’

In that response, he explains that the FDA has more work to do.   He also says so on Twitter.

Politico’s Dan Diamond interviewed Gottlieb last week. As Politico Morning Agriculture puts it, “Pour coffee & listen here” to the interview.

In the meantime, CSPI and other food-safety advocacy groups are asking the FDA to reveal the names of retailers that are selling recalled products.  What they—and food safety lawyer Bill Marler—are also arguing is that the FDA needs to release the names of retailers who are selling recalled goods as a measure to help consumers protect themselves.  The FDA appears to consider this information proprietary.  If so, it is putting business profits above public health and should rethink that policy.

As the Washington Post puts it, the FDA’s interpretation

differs from that of other agencies in the federal food safety system, an overlapping and often illogical network of regulatory fiefdoms. The system, which is responsible for keeping food free of bacteria and other pathogens, frequently has to weigh the very real interests of private food companies against potential risks to the public. In the case of releasing retailer lists during major outbreaks, the FDA has historically sided with business, ruling that such lists constitute “confidential commercial information” and thus should not be available for public consumption.

Documents 

• The OIG’s preliminary findings in 2016
• The OIG report summary 
• The full OIG report
• USA Today’s account
• The New York Times’ account

The FDA announced last week that it is terminating its Food Advisory Committee (see the Federal Register notice) 

The U.S. Food and Drug Administration today announced it will not renew the charter of the Food Advisory Committee. FDA instead will address relevant issues using other standing committees and consulting with individual additional experts in appropriate subjects as needed. In addition, the agency will continue its robust stakeholder engagement program and to solicit broad public and expert input on its policy documents and regulations.

The FDA’s Food Advisory Committee has held only a handful of meetings over the past several years and has not met since 2015. Therefore, FDA has determined that the effort and expense of maintaining the advisory committee is no longer justified…The Food Advisory Committee was established on March 6, 1992. The termination of the Food Advisory Committee is effective December 12, 2017.

I was a member of the first Food Advisory Committee from 1992-1994—as one of four consumer representatives on a committee of about 30.  We were there during the time the FDA was approving genetically modified bovine somatotropin and the Flavr Savr tomato.  The four of us did all we could to get the FDA to label GMOs, but no luck.

My abiding memory of this committee was our debriefing when we rotated off it.  By that time, we were puzzled as to the committee’s purpose (since the FDA never seemed to pay much attention to our recommendations).

The answer: the purpose of the committee was to give the FDA early insight into how its decisions—decisions it had already made—would be perceived.

Oh.

Nevertheless, I co-signed a letter to the FDA calling for retention of the committee and for making it more useful.

CFSAN [FDA] has indicated that it will continue to hold workshops, meetings, conferences, and webinars to engage with its stakeholders. While we appreciate the outreach FDA does, only an advisory committee meeting can provide helpful recommendations to the agency that are the result of interactive discussion among stakeholders. Moreover, industry and academic experts may speak with an independent voice when they are members of advisory committee meetings, while in public meetings, they may be representing the view of companies that employ or fund them.  Most importantly, many of the alternative forms of outreach identified by the FDA will not be subject to the transparency and conflict-of-interest requirements associated with advisory committees.

This committee could help the FDA with the many challenges it faces carrying out its food and nutrition mandates.  But this looks like another FDA decision already made.