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Showing posts with label FDA. Show all posts
Showing posts with label FDA. Show all posts

Tuesday, January 3, 2012

Sensa (R) ... Have You Heard About it?

The other day I had my first impression of Sensa(R) via a T.V. commercial - my first thought was "What the hell??" and then my next thought was "Oh No!"  I still haven't quite made up my mind if this new manmade creation is a good thing or not and I can only decide that for myself.  Either way here's what I am having issues with, if you're curious:

1)  The creator of this taste/olfactory (smell) enhancer is a neurologist and has a so-called team of medical professionals listed on the website, all of which do not include ANOTHER neurologist.  I wonder why that is...no, really...I wonder why?

2)  Anything that claims to be a taste or smell enhancer, my hackles get raised because the red light in my brain goes off with the thought of it being an excitotoxin (also known as MSG or MSG derivative/relation). For those of you that don't know my stand on this, let me refer you to an older blog entry "Flavor Enhancers" - and the short of it is I DON'T LIKE THEM nor do I like what they cause to happen in our bodies (migraines and elevated heart rate for me).

3)  The website shows clinical studies information but these seem to have all been conducted by the Sensa(R) creator, Dr. Alan Hirsch - I'd like to see some clinical trials conducted by other neurologists and specialists using the scientific method.

4)  Not that I wholeheartedly trust the government but this seems to be labeled as a supplement (I've searched on the FDA's website and there's no mention of it) which means it doesn't have to really prove that it does what it says it does, nor does it need enough scientific research to be placed on the market. I know that goes for most of the vitamins on the market now too but still, it's something to think about.

5)  Did a little bit of web surfing on it and found Henry the Health Hound's website had an interesting article about Sensa (R) - you can check it out here. Also, see what WebMD has to say about it here.  Lastly, Consumer Affairs has their say about it here. But don't stop there, if you're really thinking about trying this out, make sure you do P-L-E-N-T-Y of research beforehand.

So to be a pain, I emailed the company and requested their ingredient list -- we'll see if I hear back from them or not.  I'll update the blog when and if I hear from them.  In the meantime, be careful of miracles because they're usually not what they seem like on the surface.



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Friday, December 16, 2011

*Steps on Soap Box*

Drugs. Drugs. Drugs. Drugs.  You take them. I take them (though I keep them to a minimum, hence my vegan lifestyle). Everyone's taking them, right?  The FDA says they're okay or they wouldn't be on the market, right? Doctors prescribe them left and right so that must mean they're safe, right?  W.R.O.N.G.!!  Safe is such a tricky word.  Most medical schools do not require pharmacology as a graduation requirement so if you want real, knowledgeable answers about the drugs prescribed by your friendly doctor or the evil Dr. Oh-you-mean-if-I-write-100-prescriptions-for-your-drug-you'll-send-me-to-Jamaica-for-a-drug-conference-wink-wink you should talk to your pharmacist or a bio-chemist.  Sigh.

Drug pushers or as they're really known, pharmaceutical sales associates...did you know that my physician assistant that I see had applied for a job with one of the big pharma companies as a sales associate when she was in school but they turned her down because they were looking for people who had NO medical background??  Hmmm, wonder why they'd want that...doesn't it make you just a bit uncomfortable to know that they're looking for people to "sell" their product who won't really know any better than what they're told to say?  Yeah, not making my insides all warm and cozy, in fact, it makes me feel like there's a snake slithering up my back every time I see one of those go into my doctor's office.  So why do people not even QUESTION the health validity of these prescriptions?

Here's a pill for your blood pressure, one for your cholesterol, one for your acid reflux, one for your blood sugar, one for your kidneys, one for your gall bladder, one for your thyroid, one to make you happy, one to give you energy, one to help you sleep, one to calm you down (after the energy one of course), one to make you less hungry... REALLY? This is where we're headed as humans if we don't learn to put a stop to it all! FOOD - the first drug we ever put into our bodies - regulate that, and the rest may well fall into place!
As my husband said to me this week after I went off about two people looking for the quick fixes for two different problems: "humans are inherently lazy".  Period.  He's right too. But, aren't we better than that?  Isn't that one of the things that sets us apart from the other animals, the ability to make choices and overcome our instinctive natures?  It just seems that more and more people around me keep looking for the easy way or the quick-fix and it angers me and saddens me to see these people go down that rabbit hole.  Once you start giving in to the quick-fix, then, like the druggie on the corner, you're constantly looking for the next quick-fix, probably to fix the side effects of the first quick-fix...and so on... and so on... and so on...

Let's take ADHD for example.  ADHD is the new tonsil fad and it just seems to keep going.  When I was a kid growing up, everyone seemed to be getting their tonsils removed - "oh, Joey has a sore throat - off with his tonsils!".  Later, the medical community realized that they'd made a boo-boo in getting all happy hacksaw... one that lowered the immunity functions of a lot of my peers (because that's part of the tonsils' job).  I say my peers because, luckily, I had a brilliant doctor who said "her tonsils are fine and she doesn't need to go through that bullshit surgery", or something like that.  He was German so I'm sure it's a very close quote :-D  Anyway, enter the 1990's and a bright new beginning of diagnosing ADHD for every child that was/is a little more rambunctious than the "normal" kids, the child that gets bored too easily...oh, and let's allow teachers who are overworked, underpaid and just plain tired to advise parents to get their children tested for ADHD.  Then, let's have a regular pediatrician or general practitioner diagnose them and hand out pretty little pills, that may or may not work and that may have the child going from one zombie stage to another in search of the right "prescription".  Let's not even talk about the mess that this child's kidneys, liver, stomach, and intestines are going to be in in about 20 years of taking their ADHD medications plus anything else they decide to prescribe to him/her in that time, right?  The parents get told their kid has ADHD and BAM, the doctor must be right because they have that nice, shiny degree that says they finished medical school and their residency - they must have my child's health and well-being as a priority... Uh-huh.  Let's face it.  There's so much on top of these doctors as it is, we can't truly expect them to know everything or to even consider all the alternatives.  That's why I think that people should take the time to learn all there is to know first and foremost before saying "yep, sign me up with the drugs...let's speed up those side effects"!  Here's a few ideas: Change the kid's diet to more fruit and vegetables (nix the McDonald's and Doritos), focusing on feeding them foods that DON'T have excitotoxins (see book Excitotoxins: The Taste that Kills by Russell Blaylock).  Get them to exercise but something almost meditative, such as martial arts.  There are alternatives - you just have to try them out...and they are far less dangerous than any pill that child could take!

Unless it's a live or die situation, I tend to wait and try alternative methods for everything before I decide to take the meds and even then, I research the meds to learn about what minerals they'll deplete from my body, what interactions they'll have with the foods I eat and other meds, etc.  That's what I do.  Yes, it would've been easy to have accepted the statin prescription for my cholesterol earlier this year but I chose to change my lifestyle instead and in doing so, dropped my cholesterol levels (to all my doctors' amazement).  I feel better for it too!

So, don't give in to your instincts people...don't be lazy about your health! Research and talk with experts.  Find out what's going to work for you.  No pill can cure diabetes or high cholesterol or heart disease, but you can send those diseases packing with changing your lifestyle!

*Steps off Soapbox*


NOTE: These are all just my opinions and should not be considered medical advice.





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Friday, September 23, 2011

Health Claims on Food Labels (in USA)

Did you know that up until 2003, the FDA (Food and Drug Administration) would make food manufacturers show significant scientific evidence of any health claim they wanted to put onto their product labels?  Yes, I said "up until 2003" because after that, things got stupid and crazy.  Once again we get to see evidence that these manufacturers, those with the "deep pockets", get to play havoc with the public's psyche.

Before 2003, if a food label read "Diets low in sodium may reduce the risk of high blood pressure" we would have known that this couldn't have been published on the label without having enough scientific evidence to back it up - the FDA wouldn't have allowed it. Back then, if there was a claim on something, it came with scientific baggage.

Okay, let's get clear first on what exactly is a "health claim".  According to the FDA, a health claim is: "any claim made on the label or in labeling of a food, including a dietary supplement, that expressly or by implication, including “third party” references, written statements (e.g., a brand name including a term such as “heart”), symbols (e.g., a heart symbol), or vignettes, characterizes the relationship of any substance to a disease or health-related condition. Implied health claims include those statements, symbols, vignettes, or other forms of communication that suggest, within the context in which they are presented, that a relationship exists between the presence or level of a substance in the food and a disease or health-related condition (see 21 CFR 101.14(a)(1)).
Further, health claims are limited to claims about disease risk reduction, and cannot be claims about the diagnosis, cure, mitigation, or treatment of disease. Health claims are required to be reviewed and evaluated by FDA prior to use. An example of an authorized health claim, is: 'Three grams of soluble fiber from oatmeal daily in a diet low in saturated fat and cholesterol may reduce the risk of heart disease. This cereal has 2 grams per serving.'"


Yes, well...it all started with supplements and then the GMA (Grocery Manufacturers Association) decided that they didn't want to be left out in the cold so they challenged the FDA saying that if they didn't get the same treatment that was allotted to the supplements industry in the Pearson ruling that they would also take the FDA to court.  The gist of the argument was that the GMA should be allowed to inform their consumers of possible benefits.  The court ruling read, "Holding only the highest scientific standard for claims interferes with commercial free speech".

In order to accomplish this, while still letting the public know what their stance was on the particular health claim, there was devised a plan...a letter grading policy.  Have you heard about it?  I hadn't until recently because, basically, if I saw a product that read "...has been shown to lower cholesterol", I was assuming it had been scientifically proven and okayed by the FDA.  As far as I can tell, there's no actual letter grade printed on packages but it's the way a claim is worded that's supposed to tell us what the grading is. Uh...what?

Do you know what the grading policy is exactly? Here's an ABC/Health News article from that time that excitedly shares the information and cites a lot of experts that were excited for the change and those that were not. I have to side with the "were not" ones, especially when they said that consumers wouldn't pay attention to the letter grades but just the health claim. Really?  You think??  Let's face it, as human nature goes, we're far too busy to read the nutrition label AND follow up on the health claim grade too, right?

In case you do want to know but only want the highlights, the grading policy goes like this:
Grade A: High: Significant scientific agreement - no disclaimer needed.
Grade B: Moderate: Evidence is supportive but not conclusive - must have this statement after the health claim: "Although there is scientific evidence supporting this claim, the evidence is not conclusive."
Grade C: Low: Evidence is limited & not conclusive - must contain this statement: "Some scientific evidence suggests [enter health claim here]. However, FDA has determined that this evidence is limited and not conclusive."
Grade D: Very low: Little scientific evidence supporting this claim - must have this statement: "Very limited and preliminary scientific research suggests [enter health claim here].  FDA concludes that there is little scientific evidence supporting this claim."

Okay, so I just checked out my box of Kashi Lean cereal and snapped a picture of their health claim:
So it says "25 grams of soy protein a day, as part of a diet low in saturated fat and cholesterol, may reduce the risk of heart disease."  There's none of those other disclaimers on there so we can assume that this health claim has an "A" grade, meaning there's "significant scientific agreement" to their claim! Whew! That's good to know, 'cause I just had some for a snack :-D   I was looking for a different claim but couldn't find any in my pantry - guess that's what I get for buying healthy foods.

Besides these "health claims" on packages, there are other claims that are completely different categories - nutrient claims and structure-function claims.


Nutrient claims are those phrases like "good source of fiber" or "rich in calcium" or "low in sodium" because they single out a particular nutrient to focus on for marketing purposes (of course).  It works though, doesn't it?  If you know that eating more fiber helps you lose weight and lower your risk for heart disease, when you see that tag "good source of fiber" or "high in fiber", you'll be tempted to grab it, won't you? Still, these have to meet FDA definitions, and let me tell you that there are A LOT of definition guidelines for these claims!  Let's take my fiber example - "good source of fiber"...in order to claim that on the package the product must provide between 10% - 19% of the Daily Value for fiber, per serving.   But change the claim to "high in fiber" and then the product needs to be 20% or more of the Daily Value for fiber per serving (this goes for the words "rich in" and "excellent source" interchangeably).  Ya, words - who knew that just changing the words "good source" to "high" would mean a difference in the amounts of a particular nutrient?  Oh, and just so you know, the words "fat-free" aren't 100% true -- something can say that it's "fat-free" and still contain up to .5grams of fat per serving...eat 5 servings and that's 2.5 grams of fat...not that it's all that much, but fat is fat, is fat... If you want more information on the wordings and what you're really getting, you can go to the FDA labeling website by clicking here.

Structure-function claims are the most unusual of the lot - hold on to your hats for this one -- they can be made WITHOUT any FDA approval!  These claims can be made WITHOUT any proof - none, zip, nada!   The only requirement is that the claim cannot mention a disease.  Look at the following statements:
A) "May reduce the risk of heart disease."
B) "Promotes a healthy heart."
Statement (A) is definitely a health claim whereas statement (B) is a structure-function claim - can you tell the difference?  If you saw statement (B) on a box of cereal, would your thought be "This might prevent me from having a heart attack - I think I'll buy it"?  Or would it be "Huh, there's no actual health claim here maybe I should look for a cereal that does have an actual heart disease prevention health claim"?  Honestly, consumers don't usually know that there's a difference.  I sure as heck didn't know.  Here's the link to the FDA's information on structure-function claims if you want more information.

So, now that I've shared all of this information with you, what are you going to do with it?  I hope you share it with those who are close to you.  There's more to reading labels than just reading the nutrition panel and, as much as I hate to think about it this way, there are big, money-making food manufacturers out there to make even more money and to trick you into buying their products by using the laws to their advantage.  Make an effort to beat them at their game by getting educated on what it is you're putting into your body because food, whether you want to think of it that way or not, is a chemical - and there are bad chemicals and there are good chemicals (there are some that are the Switzerland of chemicals but that's another story) so fuel your body with "premium unleaded" food instead of "regular" almost-food products.



Hahaha!  Here's MY disclaimer now:
All information on this blog is my own pursuit of information on the road to getting my BS in Nutrition Science and as a mode of studying.  Most information and data was taken from my textbook "Understanding Normal and Clinical Nutrition" by Rolfes, Pinna, & Whitney, ISBN-13: 978-0-495-55646-6


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