Final Rule Part II Vending Machines

In my last post, I detailed some information related to menu labeling for restaurants and businesses that sell foods for immediate consumption (businesses like movie theatres and bowling alleys).

The FDA published a separate Final Rule to explain the requirements of nutrition labeling for the vending site. There are similarities to the restaurant regulations, but some differences exist.

The nutrition information to be disclosed at the point of sale (i.e., available before the snack is selected from the machine) is calorie content for the entire package.  The information can be placed on the machine, in the machine or on a sign near the machine. It can even be displayed electronically, as long as it is seen before money is spent.  Just like in menu labeling, no state or local law can preempt the federal law for covered vending operators  (i.e., those who own 20 or more vending machines), but the vending rule specifically says that vending operators MAY PROVIDE ADDITIONAL NUTRITIONAL INFO.  To be clear, the state cannot require them to do so, but they are allowed to do so. To put this in perspective, recall the last blog post. In Philadelphia, certain restaurants are required to post calorie and sodium information on the menu, but if those restaurants are covered by the federal law, they can no longer be made to post anything other than calories.  If a vending owner covered by the federal law himself chose to disclose more than calories, for example added sugar grams, for the contents of his machine, he or she could do so.  I don't know, maybe it isn't different than the restaurant rule.  I don't recall reading anything in the restaurant rule about voluntary disclosure, but I am pretty certain if Apple Bees, for example, decided to post sodium content on the menu in their restaurants, they could legally do so.

The Final Rule for vending does not require the qualifying statement regarding 2000 calories a day (but this is information the rule calls 'additional information' that can be added by the vendor as long as any info or statements are accurate.  Vending companies have 2 years, instead of 1, to post their information.

I have talked about package labeling and the need for revisions in the past.  For the most part (90%), vending machine snacks have nutrition information on them (unlike restaurant foods or movie popcorn); the problem is that the customer cannot see the information when the snack is in the machine.  The Final Rule for vending states that a vendor is exempt or a snack machine is exempt, if the customer can easily see and read the Nutrition Facts Panel before they select and purchase the snack.  In addition, if snack packages change and the calorie information - for the entire package - can be clearly seen in a front of pack label, the machine will be exempt.

I am not sure how this could impact the Institute of Medicine's Front of Pack labeling recommendations and the FDAs delay in implementing them.  On the one hand, vending companies and their professional organization, the National Automated Merchandising Association might lobby congress to get FOP labels mandated, in which case, snacks would come prelabeled and the vending companies wouldn't have to do anything.  On the other hand, the Grocery Manufacturers Association might push back -hard -against a front of pack law based on the IOM recommendations, because the IOM recommends a rating system - in other words, the snack could be rated as POOR.  I am for this type of labeling, as you know.  Here is one past post in reference.

I don't generally purchase snacks from vending machines, but I look forward to the implementation of this law. I'd much rather have information available if I needed it than be forced to make a decision without it.

See the rule in the Federal Register 

Federal Nutrition Labeling - Exemption from Preemption?

YES!  I know that the FDA released the final rule for the national restaurant menu and vending machine nutrition (i.e., calorie) labeling law.  I haven't blogged about it yet because I was a little busy and I was trying to find out more, if I could, about the preemption piece.  To be clear, the final rule does a lot of what public health advocates, such as myself, hoped it would do and importantly, it includes movie theaters and prepared foods at grocery and convenience stores. Many reporters and bloggers have been talking about the final rule, and I hope that my post offers a little more than the usual fare (pun intended).

The FDA has a good Q and A page where you can learn more about which places will have calorie info available for you.  Click here to see and search the Q and A.  I went to the website myself to see if I could find out about bowling alleys, which I consider a caloric cesspool; and I found this beautiful paragraph

Establishments such as restaurants that are quick service and/or sit-down, food take-out facilities, pizza delivery establishments, food facilities in entertainment venues (e.g., movie theaters, bowling alleys), cafeterias, coffee shops, superstores, grocery and convenience stores, are covered if they meet the criteria listed above. 

Now there are two important qualifiers to the rule and as I've learned from some friends in King Co Washington and Philadelphia PA; its not as simple as it first seems.  I also spoke - through email - to a legal counsel at Perkins Coie LLP in Colorado.

1) The rules only apply to businesses with 20 or more establishments (re the 'criteria listed above' comment in the FDA paragraph I quoted). So YES to McDonalds and AppleBees and no to that quaint family owned bistro by your house. Yes to the AMF bowling alley with more than 300 lanes in the USA, no to the vending company with 10 machines. [I cannot wait to see the menu boards at bowling alleys (maybe my sister will send me a picture!).  I suddenly feel compelled to research how calorie laws affect the eating habits of bowlers!]

2) As the NRA hoped, the final rule does preempt the 15 or so existing state and local menu labeling laws (there are no vending laws to preempt). On the face of it, preemption means that no state or local law can be different from the national law. The national law says the menu boards, food tags and print menus must list total calories for each item - next to the item and in font the same size as the font listing the price; establishments also have to provide a statement regarding the standard 2000 calories a day contextual statement, and provide additional nutritional information in print, upon request. (Frequent readers of my blog know I think the contextual statement should say many people need closer to 1500/1800 calories a day, but it doesn't).

These 2 things (businesses included and preemption) play into each other in a way you might not expect, and in a way I didn't really see until someone pointed it out to me.  First, it is believed that a restaurant under the jurisdiction of the federal law, like AppleBees, cannot be made to display anything more than calorie content. Two local laws that I am aware of, one in King Co Washington and the other in Philadelphia PA, mandate that restaurants of certain size, also display fat grams and sodium mg on their print menus. It is possible that the federal law has a floor preemption instead of a ceiling.  IN other words, the law could mean that restaurants have to have calorie info but state and local laws could require more.  Most people (including two lawyers) have assured me that the preemption is a ceiling and states/localities can't require more than calorie disclosure. States and localities who want to force restaurants, by law, to disclose other nutrient information can petition the FDA for an exemption from preemption (great phrase!).  Stay tuned for more on King Co and Philadelphia's laws.  I will say that Philadelphia has a strong health related case for forcing the disclosure of sodium, and they know it.

But here is the clever part(and I am not sure who bested who on this one, the FDA or the National Restaurant Association).  States and localities can require establishments that are not under the FDA rule (i.e., local, small chains) to comply with a more involved law - and establishments that are not under the FDA's jurisdiction can OPT IN to the FDA rule.  Restaurants (or vending companies for that matter) that operate less than 20 establishments can make themselves fall under the FDA law.  If they opt in, then they cannot be targeted by state and local law.  SO, the new rule actually encourages restaurants to get on board because it can protect them from having to disclose, on their menu and menu board, more information. That sort of thing was exactly what the Restaurant Association was trying to shield their members from - having to comply with a patchwork of laws.


*** BTW making a company tell its customers what is in the products it sells is NOT an infringement on liberty!  Watch out for that kind of fear mongering spin - consumers have always had a right to know the contents of their purchases.

Nutrition Labels: Calories and Sugar

I am a little disappointed in the scientific rigor of the two studies I mention below, especially because they address two issues of importance to me - and you; restaurant menu and food package labeling. The study designs/methods make it hard, no impossible, to make causal inferences.  We can't say x caused y, in either study - but to be fair, the second study was only meant to describe peoples perceptions.  Unfortunately, the people surveyed are not representative of the larger US population.

The first study (from the University of Glasgow in Scotland) compared the average weight gain of two different groups of college students - during two different years.  The first group may or may not have eaten at the cafeteria when no calorie labels were present and the second group may or may not have eaten at the cafeteria when calorie labels were present.  The first group gained 8 pounds during 36 weeks (perhaps a semester) and the second group gained 4 pounds during the 36 weeks they were assessed.  There is absolutely no way to say that the calorie labels were responsible for the weight gain differences - none.  And I am 100% pro labeling. However, during the second year when calorie labels were on the menus, the customers did purchase less calories than when the labels were not on the menus - during this one time period.  That is important.

The second study - a very small, internet survey- strove to answer the question of whether or not Americans would be confused by the addition of an added sugar declaration on the Nutrition Facts Panel (the panel on the back of packaged foods).  The rationale for this study was the assertion by anti- added sugar labeling folks that consumers would not find the additional nutrition information helpful - on the contrary, naysayers say - added sugar information will confuse the public.

The assertion that more information is bad really gets under my skin, because again, I am pro labeling.  However, there is evidence from studies on nutrition information that suggests we cannot apply available nutrition information in the context of our personal, daily needs.  That is why the IOM and others have recommended more intuitive labels, ones that highlight a few nutrients of concern, like salt, sugar and overall calories- in color coded front of the package schemas.

But the FDA is considering changes to the Nutrition Facts Panel(NFP) on the back, including an added sugar declaration - read more here.  Ted Kyle and his colleague surveyed a small group of internet users, a couple hundred, and asked them if the added sugar section of the NFP was helpful or confusing.  The survey respondents looked at a make believe label before answering the question.  Most of the people who participated said that the additional information was helpful.  I think this is probably right, however, the survey doesn't really tell us anything about what people will do when the labels actually contain this information, we need a different kind of study for that.

You can read a popular press write up about the Glasgow study here, and an over view of the added sugar survey results can be found here.  The ConscienHealth blog written/maintained by Ted Kyle focuses on more rigorous studies than the added sugar survey  and is one of my favorites.

Prevent Obesity w/ More exercise - less fast food

Morales, Gordon-Larson and Guilkey (2014) conducted a simulation experiment where they statistically modeled several factors that are related to the probability of a person being obese in the future.  The model tested their assumptions by predicting who would become obese. You can read the study here .- Several statistical equations were used to simulate decisions about smoking, physical activity, starting a family, and fast food consumption.  In addition, the researchers added a neighborhood level factor.

The data used were real - information came from the National Study of Adolescent Health (USA) which contains several years of information following people from high school through young adult hood.  During those years, people in the study usually transition from a home environment chosen by their parents, to one they chose themselves.  The choice of environment is based on some unknown personal preferences or necessities of the person.  Since many researchers speculate that where a person lives has a direct impact on whether or not that person becomes obese, these researchers felt it important to capture neighborhood choice in their model predicting obesity.  In fact, Morales, et al knew exactly where the participants lived at all times and added the number of parks, complete streets and fast food restaurants in each persons neighborhood to their simulation model.

The results of the study are interesting and give public health advocates, researchers, policy makers and the general public some things to consider.  The researchers tracked people over time in their simulation model, too, so they carried forward things about the person that had been learned at the previous time point.  They found that the best or most powerful predictor of whether or not a person would be obese at time 2 or 3 or 4 was whether or not they were obese the time before that.  In fact, the researchers assert that the most important thing to do is prevent obesity in the first place, because a reversal just isn't seen.  In other words, if a person was obese at any of the previous times it is very unlikely that they will be normal weight at any point in the future.  I agree that prevention is the key.

Other findings that seemed important to me, include; the more fast foods a person consumed the more likely they were to be obese; and physical activity reduced the probability of obesity, but in a nuanced way.  The researchers found that at least 30 minutes of physical activity 5 days a week were needed to keep a person from becoming obese and that the greatest impact on weight - or the best chance of not being obese - came from maintaining that level of physical activity from adolescence (i.e., high school) throughout adulthood.

Neighborhood characteristics, a main focus of this study, did have an impact on the probability of being obese, but the magnitude of the effect was much smaller than physical activity and fast food consumption.

Breaks in Sedentary Time

There are two, no three, disease or health related lifestyle factors that I pay the most attention to when scanning research updates: dietary intake, tobacco use and sedentary behavior.  Sedentary behavior is any activity that keeps the body relatively still, e.g., sitting  and- typing a blog post, watching TV, playing cards, reading a book, listening to an instructor/speaker, playing video games.  Past research has shown that the more a person sits the worse it is for their health, with health defined as all-cause mortality, chronic disease, metabolic dysfunction (high blood pressure, blood sugar, etc.).  I have already talked about the past studies, but to review (and I don’t recall who was in the sample studied, i.e., men, women, young, old, black, white), sitting for more than an hour without taking a break -getting up and moving - is associated with poor health outcomes and this is still true (with a weaker effect) if the person doing the uninterrupted sitting also exercises for an hour or so a day.  So physical activity is good, sedentary behavior is bad, and sedentary behavior is bad (deleterious) for inactive AND active people.

So that was old news.  This week I read another study about the benefits of breaking up sedentary time.  The study by Sardinha, Santos, Silva, Baptista, & Owen (2014) specifically focused on Portuguese adults between the ages of 65 and 94, but it is likely that the same metabolic processes happen in older adults of other races/nationalities though the effect may be higher or lower.  An example; if sedentary behavior increased the risk of all-cause mortality by 2% in one group, it would probably increase the risk in a similar group, but the increase (effect) might be 1% or 5% instead.  Sedentary behavior is still bad, just more or less so.

The current study was a little different from those that came before, and that is a good thing, because it makes the evidence stronger.  Here the researchers included measures specific to an older person’s physical activity level, physical functioning and physical independence.  The participants wore accelerometers on their hips during the day for four days.  The accelerators recorded information on movement that the researchers could turn into activity levels.  The researchers took several measures of physical functioning, including, how many times a person could sit and stand from a chair in 30sec, how many dumbbell curls they could do in 30sec, and how far they could walk in 6 minutes.  The researchers measured physical independence with a 12 item scale with a total of 0 to 24 points.  Items include questions about one’s ability to do an activity with or without assistance, e.g., bathe, do laundry, walk, etc.  I found an example of both tests, if you’d like to see them click here for the physical function test and here for independence test.

For the outcome of interest, Sardinha et al focused on differences in persons’ physical functioning abilities (e.g., the dumbbell activity) and a score that totaled all those physical function abilities. These measures matter because they are important indicators of successful vs usual aging.  Sardinha et al compared the functional measures, while controlling for persons’ physical activity levels (do they get the recommend 30 minutes a day of moderate to vigorous physical activity/ yes or no; based on the accelerometer data), independence test scores (described in the above paragraph), BMI, sex and some other things.  They wanted to see if peoples’ scores were different based on the amount of time they spent in sedentary behavior (sb) and whether or not that time is broken up; breaks in sedentary behavior (BST).

And of course, the scores were different.  In the analysis of the physical function components and the overall score, there were higher scores in the dumbbell curl, the chair test and the overall score, when people took breaks in their sedentary time. The researchers also looked at the direct and independent effect of moderate-vigorous physical activity (cycling, aerobics, running), sedentary time and breaks in sedentary time on the total physical function score and found that people who engage in at least 30 min of moderate to vigorous physical activity a day have higher scores, people who spend the most time in sedentary behavior have the lowest scores and those who take breaks have higher scores than those who do not.

I leave you with a quote from the authors’ conclusion section:

Therefore, PA [physical activity] guidelines for older adults might emphasize more strongly these two distinct behaviors to be considered together, such that even if a person were to comply with 30 min/d of MVPA, they should avoid too much sitting for the rest of the day. Periodic and small interruptions to SB [sedentary behavior] are likely to be of importance in preventing a decline in physical function.

Sardinha, L. B., Santos, D. A., Silva, A. M., Baptista, F., & Owen, N. (2014). Breaking-up Sedentary Time Is Associated With Physical Function in Older Adults. The Journals of Gerontology Series A: Biological Sciences and Medical Sciences, glu193.

What's the story behind the calories + activity labels for soda?

Another study meant to test the effect of providing nutrition information at the point of sale has been published in a respected peer reviewed journal.  In addition, the results of the study are reported in the popular press and as often occurs, the popular press is reporting selectively.  It’s unfortunate that reporters would be selective or misrepresentative because the actual findings are impressive without embellishment or obfuscation. 

Here it is in a nutshell.  In 2012/2013, Sara Bleich and colleagues Barry, Gary-Webb and Herring conducted a study in Baltimore, MD. They introduced 4 beverage related nutrition disclosures (or treatments) to a small sample (n=6) of corner stores that were in walking distance to nearby middle and high schools. All 6 stores received each of the 4 nutrition treatments for about two weeks– but in random order.  The nutrition disclosures, which were placed on signs on beverage cases were 1) Did you know that a bottle of soda or fruit juice has about 250 calories? Or 2) Did you know that a bottle of soda or fruit juice has about 16 teaspoons of sugar? Or 3) Did you know that working off a bottle of soda or fruit juice takes about 50 minutes of running? Or, 4) Did you know that working off a bottle of soda or fruit juice takes about 5 miles of walking?  [Note that the exercise examples are not equivalent, a flaw the researchers note in the limitations section of their paper.  Why does it matter?  People may not know how long it takes them to walk five miles, for me it would be more than 90 minutes.  In addition, the calorie expenditure data was based on a male or female adolescent weighing about 110 pounds.  The individualistic nature of calorie expenditure is one of the reasons I prefer multiple traffic light labels over exercise equivalents for an informative information disclosure.]  While the nutrition treatments were in place (i.e., the randomly selected sign was posted) research assistants collected sales receipts from a random sample of purchases at each store.  To be included in the random sample, the sales receipt had to be associated with someone who appeared to be between the ages of 12 and 18 and black.  This is important because the results of the study are generalizable to black adolescents in a Northeastern US city – not other kids, not adults, not other types of locations(e.g., a rural town).  The headlines in popular press do not make this distinction and only focus on one thing.  The headlines promulgate the findings that telling a person how much activity they will have to do to burn the calories in a soda or fruit juice leads to a change in the number of sugar sweetened beverages purchased, the size of sugar sweetened beverages purchased, and the average number of calories purchased. 

In the study, (see table 1 if you can access it) the average beverage calories sold when no information was posted was 207; the average calories sold during the calorie only treatment was 185; the teaspoons of sugar treatment, 188; the minutes of running treatment, 193; the minutes of walking treatment, 187.  In this analysis, for this outcome, the best treatment was the calorie only disclosure.  The average percent of sugar sweetened beverages purchased when no information was posted was 97%; for all of the different treatments the percent of sugar sweetened beverages purchased was between 88.3% and 89.1% - more than a 10% drop from the no information treatment, but similar across information types.  The purchase of sugar sweetened beverages greater than 16 ounces (recallthis post about the portion size cap) was around 53% when no information was posted and a much lower 38% with the calorie only treatment, 42.7% with the teaspoons of sugar treatment and 46.7% and 47.9% with the running and walking treatments, respectively.  As you can see, there is no earth shattering headline about exercise equivalents in the overall results of this study and in fact, the results are an exception to previous findings that calorie disclosures alone did not work.  However, in the analysis I just described, the types of disclosure or treatments were not directly compared to each other. 

In a sub analyses (with adjustment), the researchers did compare the treatments and found a significant (real) but modest (about 6 calories) superiority for the treatment that listed the number of miles it would take to walk off a bottle of soda or juice compared to the average across all treatment conditions.  For example, in the analysis of all the beverage sales,  the average calories sold for any information treatment was 184 (compared to 203 without information), but the average calories sold in the walking 5 miles treatment was 179.

During the last week of information disclosure, the researchers conducted exit surveys with a small group of randomly selected beverage customers (who were black adolescents). The surveys explored whether or not the youth saw, understood, believed and considered the information.  Please see the full article to read about the findings.¹

Lastly, and importantly, the researchers continued to track sales for 6 weeks after removing all of the nutrition signs.  They did this to test lasting effects and indeed all of the outcomes, though attenuated, remained in effect.

I am a researcher in this same area – though my focus is on nutrition labeling law. I understand that calorie only disclosures are not always effective or as effective as public health advocates would like them to be and I find the literature on multiple traffic light labeling more promising.  Others find the literature on exercise equivalents, to which the Bleich et al study belongs, to be equally or more promising.  So, I think that is what the press is capitalizing on – exercise equivalents did change behavior in this study, but the press isn’t doing a good job of telling the rest of the story.  In this sample of black youth, who as a population have a disproportionate prevalence of obesity and soda consumption, just providing a calorie disclosure at the point of sale led to positive changes in all outcomes.  That is GREAT news!   As the federal law now stands, the only disclosure mandated is calories and Bleich et al give us hope that even if we can’t modify the law's directive, nutrition labeling could still positively impact a high risk group.

¹Am J Public Health. Published online ahead of print October 16, 2014: e1–e8. doi:10.2105/AJPH.2014.302150

Rethink Butts.

For me, and perhaps many of you, no place soothes my soul more than the sea - specifically the shore.  I love the sand, the sun, the sound of the waves and the great, vast, body of water that looms before me.  I am protective of my beautiful place - of the earth in general  - and I most passionately and avidly promote tobacco free beaches, parks and trails.

If I could be responsible for passing one law - it would not be diet related - it would be one that led to Tobacco Free Beaches USA.

Today I heard a public service announcement from a Legacy Foundation and Leave No Trace Center for Outdoor Ethics partnership.  The PSA was launched over a year ago, in honor of Earth Day 2013.  I am sharing the PSA with you so you will consider joining in the effort to rid the earth of toxic cigarette waste.  If you are a smoker, I hope you are like many I see who respect the earth and dispose of their butts responsibly (i.e., not out the car window or on the ground).  {I have to add, if you are a smoker, quitting smoking is hard, but doable and it will change your life! Click here for help.}

Cigarette butts are not readily biodegradable; they don't break down and harmlessly evaporate into the air.  The filters breakdown (after many years) into particles of a harmful plastic compound and the chemical components are absorbed into the soil or worse, children and or animals (dogs, cats, fish, etc) come into contact with the discarded cigarettes and are poisoned by them. 

Please listen to the PSA by clicking on the arrow and to learn more, go to the rethinkbutts website here.

Stay Tuned!

Just a quick note to let you know that I am in transition ~ enthusiastically beginning a post doc fellowship where I will learn to robustly study the effects of US public health laws.

I will return to semi-regular blogging as soon as possible, but this weekend I leave for Philly and once there will need a little acclimation time.

Please continue to promote your health by staying active and eating nutritiously within your caloric limits.

Should smokers exercise?

   Smoking is an independent cause of heart disease.  One possible link between smoking and heart disease is that smokers’ arteries tend to be stiffer than the arteries of non-smokers, even when controlling for other factors that might lead to this condition, e.g., having a family hx of heart disease.  Physical activity is also independently related to heart disease - being active reduces the risk and sitting around increases it - to be clear - sitting around for extended periods of time (independent of how active you are otherwise) is associated with the risk of heart disease.

   New research from a small study of young men¹ suggests that smokers who engage in regular physical activity have less stiffness of large arteries than smokers who do not engage in regular physical activity.  However, the stiffness in active smokers was worse than that of active non-smokers, and clearly the best option is not to smoke.

   When I read the study conclusion, I wondered how they measured smoking?  For instance, did they say, ‘in the last month have you had at least one cigarette’ and then put all the yes's in the smoking group and the no's in the nonsmoking group?  If that were the case, I would discount the validity of the conclusion because a person who is physically active and otherwise healthy, might by chance, have had one cigarette in the last month, whereas a physically inactive smoker might have smoked 2 packs a day. That was not the case; the researchers categorized smokers as those who had at least 8 to 10 cigarettes every day during the past two years.  

   Unfortunately, there were other limitations of the study which give me pause, though they do not diminish my faith in the benefits of exercise.  In this small study, the inactive smokers were different in other ways that could lead to heart disease, i.e., they were older, had higher % body fat and smoked more cigarettes per day than the active smokers.  In addition, the average age of the participants in the study was 22 and artery stiffness and other markers of heart disease usually occur later - even those associated with smoking.

   Still: Physical Activity is the sine qua non of health and experts recommend it for EVERYONE.  Smoking is the sine qua non of disease and experts recommend it for NO ONE.  I pride myself in being pro exercise and anti-smoking; but I am not anti-smoker and so I got my dander up when I read the following facebook post of one of my acquaintances.  

Just saw the most bizarre thing ever. Two older ladies walking through (x) Park at a decent pace (clearly here for exercise) then one of them lights up a cigarette and they keep on walking. Why bother exercising?!? At least she can enjoy her death stick in some pretty scenery I guess

   First,  I one hundred percent agree that the park should be tobacco free and I would be furious and loud mouthed about someone smoking near me as I walked, ran or cycled, but that is not what this facebooker was venting.

   The person who started the post, and most of the people who commented on it, wanted to know why the smoker was bothering to exercise - the people speaking on the thread were clearly anti-smoker - if we followed their line of reasoning that a smoker shouldn’t bother to exercise (because they were killing themselves with the cigarettes), then smokers should also stop wearing seat belts or looking both ways when crossing the street.  Ridiculous, judgmental, nonfactual discourse.

   For goodness sakes - EVERYONE should exercise and not all smokers die from smoking related diseases…. maybe because they are otherwise healthy or genetically protected – still, it is not smart to smoke, but it is even less smart to do all the other reckless things on top of it.

Now, put those cigarettes down and go take a walk.

¹ Park, W., Miyachi, M., & Tanaka, H. (2014). Does Aerobic Exercise Mitigatethe Effects of Cigarette Smoking on Arterial Stiffness? The Journal ofClinical Hypertension.

Colon Cancer: New Test Approved

Long time readers of this blog will recall that I am 1) a strong advocate for evidence-based health screenings (e.g., pap smears), 2) approaching the age of 50 -when certain health screenings should begin- and 3) holding out hope that something noninvasive will replace the colonoscopy.  The colonoscopy is currently the gold standard for detection of precancerous tissues (polyps) that form in the intestines or rectum and can lead to cancer (colorectal cancer).

This month, in an unprecedented move, Medicare approved coverage for a new test at the same time that the FDA approved its use.  The unprecedented part is that the approval and coverage occurred at the same time - which is the result of a new pilot parallel research program that I am not going to discuss here. My focus is the new colon cancer screening test, which is conducted on a persons stool (bowel movement).

The test, Cologuard, is different from currently approved and recommended fecal occult tests because it also tests the stool for DNA found in the cells of cancerous polyps (adenomas). The FDA press release explains how shedding cancerous cells can be collected by the stool as it passes through the body for elimination. 

Currently, the American Cancer Society, CDC and the US Preventive Task Force recommend three screening tests for colorectal cancer, but only one diagnostic test - the colonoscopy.  The three tests are the Fecal Occult Blood Test (FOBT), the flexible sigmoidoscopy and the colonoscopy.  The tests are repeated at different intervals, the least invasive one, the FOBT, is done yearly; the next least uncomfortable, the sigmoidoscopy, every five years; and the colonoscopy, which allows for the removal of polyps if they are found during the procedure, is currently recommended every ten years.  For most people, the screening should begin at age 50.

So far, the only insurance company to approve coverage of the new DNA test is Medicare and most people must be age 65 to receive Medicare; however; private insurance companies usually follow the same guidelines as Medicare - so I'd keep a watch on that.

You can see the screening recommendations here, but keep in mind, they have not been updated to included the Cologuard test - (yet?)

Using Fear to Change Behavior; Fear Appeals in Context

   My first love, before public health law, was health communications. A health communication in its simplest form is a PSA - think - Slip, Slap, Slop; Buckle Up Saves Lives; 1% or Less is Best.  Health communications become trickier to pull off when the goal is to change a complicated behavior, such as eating less fried food, getting more physical activity or quitting smoking.  To move people towards change in these areas some health advocates will use fear appeals embedded in a health communication.  I love a well-done fear appeal!  By well-done I mean that the fear message is constructed using a theory/model that has been tested and found effective, for example the Extended Parallel Process Model (see e.g., (Witte, 1992; Witte & Allen, 2000). 

   The most important components of the Extended Parallel Process Model are the constructs that, when taken into consideration, move the target audience towards danger control (e.g., quitting smoking to prevent lung disease (the feared outcome)) instead of fear control (e.g., smoking more).  There are four constructs that, though not unique to the EPPM, are especially important because without careful attention to these four constructs, a fear appraisal can backfire.

   The important constructs are relevancy of the threat, severity of the threat, efficacy of the response, and self-efficacy in regards to the response (action to be taken by the population). Relevancy and severity work together.  Staying with the smoking example, the message that smoking causes lung disease is relevant if the person hearing the message is a smoker and believes that lung disease is a serious condition - one that will affect them negatively. The person has to believe that the condition could happen to them and that it is worse than the discomfort of quitting the old behavior or adopting a new one, here the behavior to adopt is quitting smoking. 

   The response/action is whatever the health communication encourages the person to do in order not to “get” the disease or condition they should be ‘afraid’ of getting.  Some examples include, wearing sunscreen, exercising every day, quitting smoking, using condoms.  The efficacy of response refers to whether or not a person believes: sunscreen stops aging or sunburn, quitting smoking reduces lung disease risks, exercise prolongs life or condoms prevent sexually transmitted infections.  I think you can probably guess what self-efficacy in regards to the response is and why it is vital.   If a person does not believe that they have the ability to do the action, AND they have been sufficiently frightened of the outcome if they do not, they could engage in what Witte refers to as fear control - and in the case of lung disease and smoking, that could mean smoking more. (I am scared that I will get a lung disease and die, but I do not think I can quit smoking; this is very stressful, in order to handle my stress, I need to smoke.)

   Though it is not explicit in the model, there is an association among the constructs of relevancy, severity and efficacy and the source of the message itself.  When there is time and money, health educators/advocates create the best fear appeals from formative work with the target audience.  The formative work involves asking people to rate certain sources for their veracity and impact.  A question might be - Where do you go for information about health?  * friend, *partner, *doctor, *coworker etc.

   I have a personal anecdote to offer as an example of the source concept in action.  I live in near the coast in SW Florida  and I visit the beaches as often as I can.  When I first arrived here in 2007, my running friends and I would end our runs near the water. My friends said that the cold water would reduce the inflammation caused by our long runs and help us to remain injury free.  I believed my running friends because they were a reliable source.  Who would know more about keeping the body in running condition than people who run marathons every month?!  But these same friends, and plenty of other people, told me that I should shuffle my feet in the water to avoid getting stung by a sting ray.  Really?  To me that was just asking for trouble, if the sting rays were even there.  (i.e., I did not believe in the threat itself (though I did think a sting ray was VERY scary) and I didn’t think shuffling my feet made any sense.) So…. 7 years later (yesterday)…I was walking the shore at Lido Beach and at each life guard stand there was a sign (see image below) that said “Watch out for Sting Rays, Shuffle your feet!”  That did it - to me, the source was to be trusted and now I believe 1) there are sting rays in these waters and 2) shuffling is the recommended response.  But - and here is where it falls apart.  I am very fearful of the sting rays but not very confident in the response or my ability to do the response correctly.  I am, for the most part, going to engage in fear control.  I will stay out of the water.  This response keeps me from fully enjoying my day at the beach, but it doesn’t increase my risk of the outcome (getting stung), like smoking more would increase the risk of lung disease.  My reaction to the sting ray sign may not be that uncommon.  If I were to create a health communication for sting ray awareness I would build in a component that explains what shuffling the feet accomplishes and show images (via TV) of someone successfully carrying this action out.

Witte, K. (1992). Putting the fear back into fear appeals: The extended parallel process model. Communications Monographs, 59(4), 329-349. doi: 10.1080/03637759209376276

Witte, K., & Allen, M. (2000). A Meta-Analysis of Fear Appeals: Implications for Effective Public Health Campaigns. Health Education & Behavior, 27(5), 591-615. doi: 10.1177/109019810002700506

Has Menu Labeling Had an Impact on TV Ads?

   There is a lot of opinion and a little bit of science for and against the (conspicuously absent) national menu labeling law.  In case you have forgotten - it has been 4 years - the law requires restaurant chains with 20 or more outlets to post calorie information for all standard items at the point of decision making/purchase (i.e., the menu board or menu).  If you have not been following the issue with me, let me state up front that I am a proponent of nutrition disclosures, especially calorie amounts, at all places where food and beverages are sold.  I believe that the information helps certain consumers and harms none.

   What I take away from the many research studies (Krieger & Saelens, 2013; Liu, 2013; Sinclair, Cooper, & Mansfield, 2014; Wei & Miao, 2013) that have tested local laws (and field/lab experiments) is: 1) for some people, the information is helpful and leads them to choose lower calorie options, while others either don’t see the information, don’t know what to do with it (when calorie disclosures come within a context, the information is more meaningful), or see it and actually choose higher calorie meals, and 2) some researchers are assessing whether menu labeling has an impact on weight or BMI, which is a long term goal and not necessarily the primary goal of calorie disclosures.

   What is of greater and more immediate interest to me is 1) whether or not consumer attitudes about and understanding of calories change after the introduction of calorie information and 2) whether or not the items available to purchase become lower in calories.  If you are interested in a good over view of calorie content in major restaurant items circa 2010, see this article by Wu (Wu & Sturm, 2013).

    On that last note - do restaurant owners change their behavior - I have something promising to report.  I have seen at least 3 TV commercials from different restaurants that post the calorie content, out loud, in a caption or both.  For example, McDonald’s states that its egg McMuffin has 300 calories in this TV ad, and Dunkin Donuts promotes a less than 300 calorie breakfast flat bread here.  I am pretty sure that I have seen a Taco Bell ad showing calorie content as well.  This is something new and though I don’t have evidence to back my assertion, it is possible that the state and local laws, along with the national labeling expectations and all this talk about calories, is leading consumers to expect the information and companies to provide it - and in so doing, the restaurant owners realize that they might need to offer lower calorie options.  YES, there are still plenty of ridiculous offerings, see the CSPI Xtreme Eating 2014, but that doesn’t negate the positive.

    Block and Roberto (Block & Roberto, 2014) encourage us to look for myriad positive outcomes of menu labeling as we continue to study the impact of such laws, I think they are right, and I add these commercials to the examples they provided in their recent publication (free on line).

Block, J. P., & Roberto, C. A. (2014). Potential Benefits of Calorie Labeling in Restaurants. JAMA.

Krieger, J. W., & Saelens, B. E. (2013). Impact of menu labeling on consumer behavior: A 2008-2012 update. Minneapolis, MN.

Liu, J. (2013). Menu labeling and food choice: A systematic review of the literature concerning the effects of menu labeling on consumer food choices.

Sinclair, S. E., Cooper, M., & Mansfield, E. D. (2014). The Influence of Menu Labeling on Calories Selected or Consumed: A Systematic Review and Meta-Analysis. Journal of the Academy of Nutrition and Dietetics.

Wei, W., & Miao, L. (2013). Effects of calorie information disclosure on consumers’ food choices at restaurants. International Journal of Hospitality Management, 33(0), 106-117. doi: 10.1016/j.ijhm.2012.06.008

Wu, H. W., & Sturm, R. (2013). What's on the menu? A review of the energy and nutritional content of US chain restaurant menus. Public health nutrition, 16(01), 87-96.

Skin Cancer Gets Serious

   In June I wrote this post regarding the use of sunscreen and the new sunscreen labels, and this post from 2011 is one of many I have written in an effort to educate on the dangers of using tanning beds.
   Last week the US Surgeon General released a 112 page Call to Action in an effort to reduce skin cancer and skin cancer death in the United States - caused by ultraviolet radiation (UV).  According to the report, more Americans are diagnosed with skin cancer each year than all other cancers combined and melanoma, the most common skin cancer in young adults and adolescents, is the most lethal skin cancer, with as many as 9000 deaths attributed to melanoma each year.  
   The acting Surgeon General and the assistant Secretary of Health are both physicians who have treated patients with skin cancer.  Their concern is that in spite of efforts to promote sun protection and reduce intentional tanning, skin cancer incidence and death rates continue to rise, while other cancer rates have declined (e.g., prostate cancer, breast cancer). Skin cancer is expensive to treat, potentially lethal, disfiguring and in most cases PREVENTABLE.
   The Call to Action asks individuals, communities, organizations/employers and policy makers to take specific action in order to meet 5 goals.  The goals are:

• Increase Opportunities for Sun Protection in Outdoor Settings
• Provide Individuals with the Information They Need to Make Informed, Healthy Choices About UV Exposure
• Promote Policies that Advance the National Goal of Preventing Skin Cancer
• Reduce Harms from Indoor Tanning
• Strengthen Research, Surveillance, Monitoring, and Evaluation Related to Skin Cancer Prevention

   The Call to Action includes strategies to reach each of these goals, e.g., schools and businesses could provided shaded areas for outside recreation, health educators, such as myself, could continually promote the use of sun protection products and behaviors, states could ban or limit the use of indoor tanning facilities, health care organizations could offer free skin cancer screenings, researchers, also like myself, could evaluate the outcomes related to these strategies.  
   The 112 page Call to Action is fascinating and contains a lot of important information about most cancer types, the incidence rates of common cancers, sources of UV radiation, risk factors for skin cancer and prevention strategies.  The Call to Action also lists states which have indoor tanning restrictions and details the restrictions themselves. You can read the full report here; in addition, the CDC provides an easy to read, informative booklet (2 pages) that highlights the severity of the problem and what you can do to protect yourself.  Please read and share the booklet.  My post was meant to raise your awareness but it does not contain the level of detail you need to keep yourself and your loved ones safe.
   Remember, there are measures to take while outside, and there are numerous benefits to being outside, even (or especially) in the sunlight.  We cannot, nor should we, avoid being outside, but we can and we absolutely should, avoid tanning beds.

[NB: I cannot speak about sun exposure without reminding you that tanning also accelerates the look of aging.]



Citation:
U.S. Department of Health and Human Services.
The Surgeon General’s Call to Action to Prevent Skin Cancer

.

Washington, DC:
U.S. Dept of Health and Human Services, Office of the Surgeon General; 2014

What about those Fruits and Vegetables? It depends....

I have seen more than one study challenging the utility - and even sensibility - of recommending an increase in the consumption of fruits and vegetables as a means to maintain or lose weight.  In the US, the recommendation is either just a general eat more or a more specific eat at least 5 servings.  In other countries, for example Australia, the recommendation is 2 fruits and 5 vegetables.  Walter Willett and the folks at HSPH recommend more vegetables than fruit.  

To be clear, non-starchy vegetables, specifically, and some fruits have been shown to improve health, possibly through their antioxidant properties.  But recently, using Eat More Fruits and Vegetables as an obesity prevention/treatment strategy, has come into question.  I have been concerned about the recommendation for some time, and that is why I promote Willett’s new food pyramid over the USDAs food guidance.

My concerns about fruit and vegetable promotion and all food related promotion is that people don’t hear, because its seldom said, eat more of this (x) INSTEAD of that (x).  People do not get the message that adding health promoting foods such as fruits, vegetables, whole grains, healthy oils, fish, etc. needs to be qualified.  The healthy foods are particular and only stay healthy if they remain nutrient dense (e.g., potatoes are a starchy vegetable which we do NOT need to increase, and kale is GREAT, kale cooked in fat back/butter is NOT GREAT).

Of course, fruits and vegetable calories are of a higher nutritional value than ones from chips, hotdogs and soda, but 1) the choice of fruit (e.g., a plum vs kiwi) or vegetable, 2) the preparation of that fruit or vegetable, 3) the size of that fruit or vegetable (i.e., jumbo fruits (bananas, oranges, apples = 2 or 3 servings), and 4) the overall amount of calories consumed will determine if adding fruits and vegetables to ones diet aids in weight loss.  The bulky, nutritious, fiber rich peppers, summer squash, onions and mushrooms should bulk up one's plate and reduce the caloric density of a meal– these foods should replace (or reduce) meat and pasta for instance.

Two studies released this month,(Charlton et al., 2014; Kaiser et al., 2014), found that increasing fruit and vegetable intake did not lead to weight loss and in some instances, led to weight gain.  The Kaiser et al study used robust criteria to evaluate randomized control trials (RCT) and though the RCTs themselves had limitations, the review of them was sound.  In the authors’ words, the upshot is this…. 

Purchasing and preparation barriers need to be addressed.  Interventions should provide more instruction on how to prepare vegetables in such a way as to not increase their energy content (such as not preparing vegetables with fat (eg not frying or serving with butter)… and….Although many fruits and vegetables [F/V] have demonstrable positive health benefits, recommending increased F/V consumption to treat or prevent obesity without explicitly combining with methods to reduce intake of other energy sources is unwarranted (Kaiser, et al).

One of the main reasons I started my You Tube channel was to show people how to cook foods without turning them into calorically dense meals or snacks.  So, do eat more fruits and vegetables as you eat LESS meats, breads, and desserts.

Charlton, K., Kowal, P., Soriano, M. M., Williams, S., Banks, E., Vo, K., & Byles, J. (2014). Fruit and Vegetable Intake and Body Mass Index in a Large Sample of Middle-Aged Australian Men and Women. Nutrients, 6(6), 2305-2319.

Kaiser, K. A., Brown, A. W., Brown, M. M. B., Shikany, J. M., Mattes, R. D., & Allison, D. B. (2014). Increased fruit and vegetable intake has no discernible effect on weight loss: a systematic review and meta-analysis. The American journal of clinical nutrition, 100(2), 567-576.

Sugary Beverage Portion Cap : My View

    Recently, the NY State Court of Appeals rejected a request to reinstate the sugary beverage Portion Cap Rule proposed by former NYC Mayor Michael Bloomberg.  The court stated that the rule, which would have limited the serving size of sugary beverages* to no more than 16 ounces, would be an infringement on individual autonomy. If individuals had driven the increase in serving sizes and no evidence existed to support public health law, this would be a fair argument. 

   Economists tell us that in a properly working free market, businesses respond to demand. In this case, it would mean the beverage industry is responding to our demand (i.e., collective autonomy) for super-sized drinks. Of course, the government would be wrong to step in just because our demand made us fat especially if fatness were benign (which it’s not).  I assume that is what the Court is thinking; consumers instigated the new normal. But is that what happened?  It seems to me, and I grew up with the increase in everything, that the beverage industry decided that an 8 ounce cola with about 10 teaspoons of sugar was not sufficient a serving; the beverage industry decided that upwards of 20 ounces and 24 teaspoons of sugar was more appropriate.  You and I did not decide this. 

    Of course, people in NY have a right to as much soda as they like; this is America.  And if this were a soda ban instead of a serving size cap, I’d be one of the loudest voices against it.  It isn’t though.  The rule is an attempt to return us to pre obesity-epidemic portion sizes, sizes that changed unbeknownst and independent of us.  I feel certain no one hoped sodas would have 200 more calories. Very few of us purposefully consume extra empty calories.  So, I have to wonder whose autonomy Judge Pigott and the Court are honoring here.  

    Because I don’t think it’s Mayor Bloomberg and the NYC Board of Health who are trying to manipulate our behavior; I think it’s the beverage industry.  The mighty beverage industry pushes overconsumption and Bloomberg’s mighty brand of paternalism seems just about right to counteract it. In fact, Bloomberg and NYC have a history of doing the right thing for health.  For example, they put a price floor on a pack of cigarettes, banned smoking in restaurants, bars and parks and raised the minimum age to purchase tobacco to 21.  Maybe it is just coincidence, but New York now has one of the lowest rates of adult and youth smoking in the country.  I don’t see any reason why Bloomberg’s efforts to curtail obesity should be any less effective.

    This is how I see the Portion Cap helping.  A 24-ounce soda is a trigger to consume excess calories just like a smoking area is a trigger to smoke.  If the 24- ounce soda is off the table, the lure of value pricing and social norms cancels out and consuming the appropriate amount of calories becomes more likely, feasible and possible.  This is a great help to those who want to control their dietary intake and it does not prevent others from having as many 16-ounce sodas as they choose.

    True, I am a public health policy advocate, but I have also benefited from public health policy on a personal level. I am a former smoker and someone who has maintained a 30-pound weight loss for over 14 years.  I find that whatever makes smoking harder makes quitting easier and whatever makes calorically dense choices harder makes maintaining a health promoting weight easier.  I am not naïve or authoritarian; people who want to smoke will find a means to do so and people who want to drink gallons of sugar-sweetened beverages will do that too.  In America, we have a legal right to make bad choices.  But I am American, too, and I have a right to an environment which enables me to make good choices, an environment where I don’t have to fight the ‘all you can eat and drink, value sizing’ mentality.  That is my autonomy and I’ll take all the Mayor Bloomberg help I can get, thank you very much.

*a sugary beverage is one that contains 25 or more calories per 8 ounces