What do you think 'natural' means?

Remember past blog posts where I discussed the meaningless ‘all natural’ label declaration (see here and here, for example)? Well, it looks like enough people, or I should say, industries, have voiced similar concerns and with their clout, have moved this issue into the FDA action phase.

The FDA comments portal opens tomorrow and you can participate by clicking on this link.  The three main questions posed are:

Is it appropriate (for the FDA) to define the term “natural”?

If so, how should natural be defined (in regards to food/beverage products)?

How should the FDA determine if a manufacturer is using the term correctly on its food or beverage labels?

I have had two broad concerns with the labeling of an item as all natural (because that is the point of this, food companies want to boast a product as all natural, not just natural or containing natural ingredients). The first is that the term gives the product a ‘health halo’ that may not be justified. In other words, all natural just means all natural (except of course we don’t KNOW what that means). It does not mean health promoting, or nutrient rich, or low sodium/salt, or trans-fat free, or low calorie. None of the things that I want my purchases to be are described by the term natural - though I certainly want minimal processing. My second concern is within the parenthetical comment above- we don’t know what natural means! The old standard, but unenforced ethos from the FDA, was that it meant minimally processed, free of artificial dyes and such. That is far too subjective a definition. For something to be truly all natural, I believe it has to be a whole food, maybe it can contain preservatives, but surely it can’t come in a box. There are so many things that natural isn’t that I am of the mind that the word should NOT be allowed on any labels and thus it doesn’t have to be defined by the FDA. I think that is going to be my official comment. Instead of defining the term, I think that it should be banned from labels altogether.

What would your comment be? Speak up here… or the food industry will speak for you!

Update - 11/15/15 Oh my goodness, how could I have forgotten my favorite All Natural product - YES, peanut butter that isn't fortified or processed, that counts :)

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.

Quitting smoking and E cig update

Let me be clear from the onset, this post is not about quitting smoking by using e cigs!  I am merely planning to share two items with you.  This first is a story about quitting that someone told me today and the second, in case you missed it, is the FDA and the Center for Tobacco Products announcement on e cigs.

quitter
I have come to know the bike mechanic at a large sports store near my home (because I buy old bicycles with numerous problems).  One day, maybe last year, I saw the bike mechanic smoking outside the store and this made me sad.  Another day, also last year, he told me that he was considering going to college to study a health profession (pharmacotherapy) - this was after I told him about my work in Public Health.  I was very happy to hear his plans and encouraged him to go for it, while adding, something, I can't remember exactly what, about smoking.  A long discussion on quitting ensued, because in the past I officially helped people to quit smoking, and he seemed interested in hearing about it.

Today I saw him again and he immediately and enthusiastically told me that he had quit smoking.  Not one puff in the last month.  He said that he had been thinking about it for some time and finally it hit him, 'I'm done.'  

I quit in the same fashion, but its rather uncommon (successful cold turkey).  He spoke about the first week or two after he quit, all the junk/gunk he coughed up.  I know why that happened; his cilia (protective, hair like filters at the back of the throat) were coming back to life and doing their job, but most people (smokers) who experience this intense coughing, think that they were better off smoking and go back to it.  Unfortunately, a drag off a cigarette may stop the coughing (because the cilia are killed by tobacco smoke).  My friend, the bike mechanic, did not fall for that!  He saw the coughing for what it was - healing, detox and stayed with the quitting.  Next he noticed that fruits and vegetables actually taste GOOD - so he is also eating better.  I am glad because the antioxidants in fruits and vegetables will help clear up some of the smoking damage.  Plus, he is young.  Quitting while under the age of 30 may allow the smoker's body to become like that of a nonsmoker (over time).  So kudos to him and anyone else - regardless of age - who quits.  There is only one thing better than quitting smoking and that is not starting in the first place.  To see the benefits of quitting smoking time line from the American Lung Association click here.

E Cigs
The Center for Tobacco Products will be regulating e cigs in the same manner as cigarettes, smokeless tobacco and the like.  This means, for starters, e cigs cannot be sold or marketed to children, flavors might be forbidden (flavored tobacco, with the exception of menthol, has been outlawed by the Family Smoking Prevention and Tobacco Control Act of 2009), and the companies selling/marketing e cigs cannot imply health benefits or cessation efficacy without providing  scientific evidence to back such claims.  In addition, makers of the products will have to file reports which disclose the smoke or vapor constituents(chemicals) and quantities from their product.  WHEN this will happen or when the info will be available to you, is not yet known.  Read the press release here.

Labeling Rules ~ The FDA has us all in limbo

Any day now, or more likely, sometime in 2014, the FDA will release the final rule for the national nutrition/menu labeling law officially meant to apply to restaurants (sit down and counter chains), vending companies, and similar retail establishments.

As of today, the consumer (you and I),  health advocates (myself,  CSPI, the RUDD Center,  many others), the National Restaurant Association, the National Grocers Association, the Association for Convenience and Fuel Retailing, pizza restaurants and other food selling/entertainment venues (e.g., bowling alleys, cinemas) remain unawares and unprepared for what will be required.

Of those listed above, the consumer interest groups (and thus a majority of the general public), public health folks and the National Restaurant Association supported the menu labeling law, but the others did not nor did they expect to get caught up in it.  My personal belief is that anyone selling ready to eat, unpackaged food has an obligation to share with the buyer of that food, pertinent nutrition information.  I would include food sold from steam tables in grocery stores, hot dogs and the like sold in convenience stores and items sold from concession stands at bowling alleys, sports arenas and movie theaters.

I do think that pizza joints should get some leeway in how they present the information due to the individual, made to order nature of pizza.

Once the FDA makes its announcement, retailers will have 6 mos to 1 year to comply.  Then the next battle begins.  Updating the nutrition facts panels on packaged foods. In this case, the concern 
(of food companies) is whether the update is going to mandate  labels that imply a foods goodness, e.g., star ratings or multiple traffic lights.

Really - the Sunscreen Laws are Here

On June 14th of 2011, I wrote this post and referred to another I had written in 2009 - both were about the changes in how sunscreen products in the United States could be labeled. Alas, the day has arrived (or will next month) - and most of what I told you in those past posts is now law.  There is one great exception - one great, unfortunate exception which speaks to the power of industry and the discretion of the FDA.  [this is of special concern to me because the same thing is happening with the law that mandates nutrition disclosures at restaurants... the law was passed years ago, and the FDA has the responsibility and the authority for the final rule but industry is pushing back hard... yet, so are scientists, so maybe this time the changes will be in our favor - she said in a major side bar]

The unfortunate label change no go for sunscreen is the ban on claiming SPF - sun factor protection - greater than 50.

First let me tell you what did survive from the original law:
No company can advertise its sunscreen as waterproof (sweat proof, or call itself a sun block).
I thought that all sunscreens would have to provide UV A (the kind most associated with cancer) and UV B (associated with burning) protection, but I just double checked the FDA website and now I am as confused as ever by their final rule (I am also losing faith in this government agency).

Anyway, instead of everyone having to provide both forms of protection, only those that do can call themselves Broad Spectrum.  Bottom line:if the product says Broad Spectrum and is SPF 15 or higher - that is the one you want to buy.

Broad Spectrum sunscreen protects against both types of UV Rays.

Mass confusion continues over what SPF actually means.  I will do my best to explain it in a moment, but science tells us that for a product to offer adequate protection the values should be between 15 and 50, but 30 is likely sufficient.  There is no evidence to support that SPF over 50 makes a difference, makes a clinically important difference, but the industry of sunscreen makers is still fighting to use the higher numbers.

As I understand it, the amount of time that a person can be in the sunlight, unprotected without beginning to burn is quite individualized.  It depends on the time of year, where you are physically located and your skin's pigment (fair or olive, e.g.).  It does not have anything to do with whether or not you have a 'base tan!'

SPF is related to the time it takes you to burn.  So whatever that time is, say I start to burn after 30 minutes because of my olive skin - if I use SPF 15, 15 x 30 = 450 or just over 7 hours.  I could be in the sun for over 7 hours wearing SPF 15 with reasonable assurance of not being burned (UVB protection) and as long as I have on Broad Spectrum SPF 15 - I should also be protected from the UVA rays during that time.

If I chose a 30 SPF, then I could stay in the sun longer (30 x 30) without beginning to burn.  
If I were a fairer skinned person, I might begin to burn in 15 minutes, and the math would be different.  SPF 15, 15 x 15 = 225 minutes so almost 4 hours;  SPF 30, 30 x 15 = as above.

Key to this protection is that the lotion be applied thoroughly and in a sufficient amount.  Any time one sweats, goes in the water and/or towels off, the lotion needs to be reapplied. Therefore, the labels advise that you reapply every two hours.

Sunscreens that are sprayed on may not be as effective.  The research is still pending (due to the body coverage issue) and there may be concern about breathing the fumes from the spray.

It is also important to limit your time in the sun, regardless of protection - 7 hours in full sun would be dangerous.  The best protection comes form hats, glasses, clothes and shade. 

 Of course, some time in the sun is necessary for Vitamin D production  - YAY!

Once again I link you to the Skin Cancer Foundation for more information.  I am sending you to the page with a sun safety quiz!  You better get a 100!

Menu Labeling - Just What IS a Similar Establishment?

   The final rule for the restaurant (and similar establishment) menu labeling law (sec. 4205, pl 111-148), has yet to be published.  We are waiting on the FDA.  As of today, restaurants do not know the logistics of how  to present the information nor when the deadline for compliance is (6 months after the rule is published).
   The latest contention (there are so many) is what counts or what should count as a similar establishment.  As expected, public health professionals, consumer advocates and restaurants want an inclusive definition and individual industries want to an exclusive one.  The Food Market Institute, via its council Erik Lieberman, argues that grocery stores, for instance, should be excluded while myself, Rudd (Center for Food Policy), and CSPI argue that entertainment venues should be included and forced to comply.
   The problem is two fold and related to the way similar has been defined.  The FDA defines an establishment as NOT being similar to a restaurant if it serves the same type of food (like a prepared meal) but its primary business purpose is NOT the sale of food.  From this definition it is clear how grocery stores get included and movie theaters and bowling alleys do not.  
    The issues I see are these:

1. Grocery stores which sell food as their primary purpose provide predominently packaged products.  Those products, even the ones sold in the deli and bakery, should be covered by the NLEA (1990).  The ready to eat meals that they serve, well - I don't see the argument for not including them under the new law (2010).  Just put the calorie counts on the steam table and order boards.  I understand that the FMI is fighting being included in section 4205 of the ACA.  What I find dubious is the argument that putting nutrition information on packaged cookies in the bakery is too burdensome.  Those cookies were NEVER meant to be excluded from the original labeling law.
2. Entertainment venues like movie theaters, sports arenas and bowling alleys sell precisely the type of foods that the new law was meant to address.  They sell calorically dense, nutrient poor foods which are high in added sugar and saturated fats.  These foods are associated with the rise of obesity in the USA and other countries.  One strategy for reducing the rate of obesity in the USA is providing nutrition information at the point of purchase or sale.  This should mean the place of ALL food sales.  How much sense does it make to include a vending machine and not a cinema?  We, as consumers, need nutrition information available to us at all the places we make food choices. 

An article by Josh Long on a website called Food Products Design inspired this post.
 
   

Phases and Rule Making (informed eating initiatives)

It seems that the deeper I get into my paper, the one I am writing for no real reason except that I think that it will help me accomplish some of my goals - oh that is a good reason, isn't it?  Well, I am nearing the end, but realize that I need to become more familiar with one of the reports that has been released regarding front of pack labeling in this country. 

I did want to tell you these two things so that you know where "we" are with regard to menu/vending labeling and package front signposting, or FOP labeling.

I may have said this already, but in regards to menu and vending machine calorie content disclosure mandated by the Affordable Care Act, the FDA will continue to take comments and expects to have a final rule for the establishments/operators by the end of this year.  Once they have the final rule(guidance) in place, the restaurants will have six months to comply.  The vending machine companies will have one year.  The rule will say, among other things, what has to be on the signs; just calories, or other nutrient info as well.

The front of pack initiative is being driven by a congressional directive as well.  At this time, the Institute of Medicine is completing Phase II of their two phase task.  The report from Phase I has been published.  That is the report I need to spend more time reviewing as it does come with a number of "conclusions."  Those conclusions regard whether it makes sense to have a FOP standard, what should be included in the symbol, who the label should be for, and such.  In Phase II the different types of sign posts and the working criteria the IOM has in place will be tested with consumers.  Part of the initiative involves consumer ease of use, preference and comprehension of the new labeling .  In fact, the letter that the director of  Office of Nutrition, Labeling and Dietary Supplements sent to food providers is available here. 
I called the IOM this week and they assured me that NO one was going to be privy to early results or leanings on which symbol they'd recommend (i.e. the multiple traffic light), but that the report on this research and recommendations to go forward should come out this fall.

Today I had a very productive meeting with the university vending machine contract director (head honcho) and we are a go for some type of machine initiative on campus that is related to informed eating.  I am very jazzed about this :)

ECT - Shock Therapy - Proof of Safety?

Electroconvulsive Therapy or ECT or Shock Treatment has been used to treat mental illness at least since the 1940s though the concept of shocking the brain or body to treat maladies is much much older.  Instead of going the way of bleeding and leeching; however, ECT has been revised.  It is now conducted under more human conditions.

Longtime readers would recall that when I started my weekly newsletters, I was a psychiatric social worker and in fact, worked with people who received ECT.  I did not blog about it of course.  I supported the treatment decisions of patients and their families and I respected the psychiatrists and psychologists with whom I worked.  At the same time - after witnessing the treatment itself (in an hospital room, with anesthesia, muscle relaxants and the monitoring of vitals - electrodes are attached to the head - shock can be unilateral or bilateral and lasts a minute at most) and seeing the affects on mood (it usually worked) and memory (it sometimes impaired it) I went home and made sure that my living will excluded the use of ECT.  I think I may have written that I had to be on the verge of death with no chance of recovery before it could be considered.

ECT is primarily meant for the treatment of severe, resistant and recurring depression.  Some persons who suffer a nihilistic type of depression will think that they are already dead or will die.  They lose touch with reality, are unable to function, and stop eating.  I have written letters to support emergency ECT in such cases noting that without the treatment the patient might require feeding tubes and such to sustain life.

But I do not like ECT.  And I am not comfortable with studies that compare ECT with antidepressants and with nothing and then say it is better.  I was not an emerging scientist when I worked at the hospital - but I am now and the research is flawed.  Where is the study that compares it with exercise, for example? 

Another concern is that ECT as a medical device/treatment was approved under the 1976 FDA legislation that allowed current drugs to stay on the market temporarily.  The new FDA would henceforth require standardized, rigorous clinically controlled trials before deciding on whether to grant approval to any drug or device maker to unleash its product on the people of the USA.  The PMA status or premarket approval - was meant to be a temporary stay - the companies were supposed to submit the safety and efficacy data for after market approval - no one did.

The gig is up.  The FDA has requested this information and a hearing is to be held this month.  Here are links to some FDA documents pertaining to the issue.  This one lists several devices that are being asked to provide information. If you scroll down, you will see what that information must contain.

The agenda for the ECT meeting is as follows:
On January 27 and 28, 2011, the committee will discuss and make recommendations regarding the possible reclassification of devices indicated for use in electroconvulsive therapy.

And this is the link to PMA policy.

If you or a loved one has had ECT and found it to be helpful then it WAS helpful.  If you are concerned about the treatment for yourself or another, check out the announcement again.  There are means by which the public can comment and of course, follow up to see what information was provided to the FDA on the safety and efficacy and review the subsequent panel recommendations.

Radiate me NOT

Well, how interesting for me that two issues I have oft addressed appear in the same news story!

The issues are colon cancer screening and radiation from medical testing.

I am very concerned about exposure to radiation and do not believe that we should submit ourselves to a CT scan every time something hurts nor do I think that CT scans or x rays should be used as preventative devices or screening tools. This has long been my stance – five years at least.

It has only been in the past year however that the concern about use of radiation and the adverse consequences – cancer- has been gaining momentum. The FDA has been called upon to look into this matter, especially after the incidents of acute radiation poisoning that occurred in California this past year. The FDA began an exploratory review this week. As I have said before, of great concern is the frequency of scans that occur over a lifespan. The current under age 30 population has had and will have a lot more access to this type of radiation than the over 60 population. Because the scans begin earlier, are used more often and are used over lifetimes, the risk of cancer (and that cancer does not occur immediately after an Xray, but often in the next decade) is significant. We do not have time to wait until our children are middle aged and terminally ill before addressing the issue. The FDA can weigh the evidence and make a statement with regard to the use of CT scan and other medical radiation.

As you know, the FDA has to approve medications and medical devices. They usually convene expert panels to review a new product and then take those recommendations into consideration when making a final decision. After which, that medicine or device can be used as a clinician sees fit, but can only be advertised or marketed to treat what the FDA approved it to treat or test. I had known this, but had not made the same “off label” connection in my mind when it comes to devices.

This brings me to the second issue. Colon or colorectal cancer is one that can be prevented if polyps that might turn cancerous are found and removed. The gold standard for this screening is the colonoscopy. In case you haven’t heard, that involves being sedated while a tiny camera searches your colon or intestines – the day before your test you are told to drink a beverage referred to as bowel prep – in other words, you clean yourself out. The day before is said to be worse than the procedure itself. The colonoscopy is generally recommended at age 50. Enter the virtual colonoscopy – I have described it elsewhere. I have been vocal in my hopes that the virtual colonoscopy or something like it will be perfected and accepted for use prior to my 50th birthday. I have, in my explanation of it, promoted it – in a way. but for the small fact that it involves a CT scan.

Back to the story. The FDA began addressing the radiation issue as a former FDA employee spoke out about his job loss possibly related to his refusal to go along with a recommendation for the CT scanner to be used for colon cancer screening. The device maker would be the one asking for the new FDA approval so that they could begin marketing the machine for this test. Dr. Julian Nicholas has been vocal in his concern that the amount of radiation that people are exposed to is NOT an acceptable amount. He contends that we certainly do not need to add another source, especially because we have an accurate test for this condition that does not use ANY radiation. He has also stated that 1.5 to 2% of all cancers are related to CT scanning. I was pretty shocked because in reading the story, it seemed that the manufacturer of the device had been putting a lot of pressure on the FDA in general, to get it approved.

I expect that we will hear more about radiation in medical testing as the year progresses and the scientists, under additional scrutiny for possible industry ties and bias, look into the matter.

At this time, I do want to clarify that I would NOT take the virtual colonoscopy over the standard version unless it did not involve any radiation.

Also, I have spoken out against airport scanners and tanning beds, but not laser therapy. Why would I? I am not sure, but when I was at a “spa” to get a message, I saw a sign on a door behind which people were getting laser hair removal and the sign warned of radiation! So I have to look into that one.

The FDA does have information on all devices that emit radiation and I invite you to check it out. I have to say that I was unaware of the link until today and am just fascinated by all the different devices that emit radiation. Click on some of the tabs when you go to this site. There are tables that divide the products by use and by radiation type. You can learn about risks and benefits of each procedure as well. I have forgotten about cell phones, but they are here. Also you can find information on laser therapy and laser lights, like in an electronic pointer. Tanning beds and MRI machines are also on the list. In fact, I noticed that ultrasounds were listed as well and that made me wonder if the traditional colonoscopy did expose us to some amount of radiation. I still am unclear – in that I do not know what is used to see the “movie” during the colonoscopy. However, the ultrasound machines use non ionizing radiation which is not the kind linked to cancer. Of course, in light of what Dr. Nicholas was offering today, I can’t be confident that the safety information provided here is trustworthy.