Some of you are following me in my journey to sexy 6 pack abs. Well, it’s come to my attention that there is a side effect that you should be aware of. For those that aren’t training with me, this is still good to know. Not to be alarmed, this is a good thing. Let’s take a closer look.
In my previous entry, I touched on the how and why we age, specifically focusing on the free radical theory of aging. Briefly, the idea behind this theory is that the cellular membranes are damaged by free radical molecules and it is this damage that contributes to the laugh lines, crow’s feet and wrinkles. Free radicals are naturally occurring and are a result from the plethora of chemical reactions that take place in our body, from physical damage, stress, light exposure, metabolism and the inflammatory response (to name a few).
But it turns out that, according to dermatologist Dr. Nicholas Perricone, a diet focused on foods that don’t abruptly raise your blood sugar levels (aka, low glycemic index), may actually help prevent wrinkles, crows feet, laugh lines, etc. So what does this mean? Well, it means that if you’re training with me, following the resistance training, HIIT training and diet, then it looks like you aren’t just going get slimmer, but also look younger! How cool of a side effect is that?
But how exactly does following a low glycemic diet supposedly ward off wrinkles? In youthful skin, there are molecules called collagen, elastin, and fibroblasts and they are all contained within the intracellular matrix. The terms “collagen” and “elastin” should be familiar to you as they’re found in many cosmetic products nowadays. These are the molecules that actually hold the skin tight, giving it that youthful and wrinkle-free appearance.
There is a process that occurs where sugar molecules are added to the skin proteins. This process is called glycosylation. Essentially, the sugar molecules bind to the skin proteins (a glycosylated protein), making it susceptible to free radical damage. Also when two glycosylated proteins make contact, they “cross-link” - preventing them from performing their normal function, which also contributes to skin damage. All this damage contributes to the formation of free-radicals and further interaction of free-radicals with the cross-linked units themselves. At the end of the day, the end result is massive damage of the elastin, collagen and fibroblasts = wrinkles.
This all happens because of sugar. According to Dr. Perricone, if we keep our diet in check, sticking to low glycemic foods, then the sugar available for this glycosylation process will be kept to a minimum. This means eating foods that are whole, natural and score low on the glycemic index. Foods such as fruits, veggies, whole grain breads, nuts and healthy fats are what we should be sticking with (and avoiding processed foods). To add, when you eat colourful fruits, veggies, and healthy fats, they also provide a layer of free-radical protection in the form of antioxidants. Essentially, if we keep blood sugar levels low, there will be less excess sugar available for this glycosylation process.
Bottom Line: Train with me and not only will you feel good and show off some abs, but you’ll even look younger! If you’re not training with me, then I have to tell you to get on it! But if not, then hey, at least you can incorporate a healthy diet into your daily routine and get rid of those wrinkles.
We are now officially in the third stage of my journey to sexy abs! The intensity will be kicked into high gear this week, as we continue the superset format, but increase the reps to test our own limits. HIIT will also be changed starting this week, so be sure to read the new HIIT schedule below. Want progress pictures? Scroll down.
Here's my Week 9 Resistance Training Routine:
Perform the exercises in supersets, aiming for 15-30 reps. I would recommend choosing a resistance where you can perform between 15-20 reps. Then do the exercises as many times as you can but making sure that you can't exceed the 30 rep limit. Perform 2-3 sets of each superset.
Need bands? You can find them here!
A1: Explosive Push Ups
A2: Ball Squat with bands
B1: Chest Fly with bands
B2: One leg curl on ball
C1: Pullup/Chinup
C2: Reverse Lunges with weights/backpack
D1: Seated incline band row
D2: Wall sit with calf raises
E1: Front shoulder raise
E2: Ball crunch with bands
Keep rests to a maximum of 30 seconds.
High Intensity Interval Training
Starting this week onwards, I will now be adding another round of HIIT and another day of HIIT per week. My HIIT training session will look like this:
• 5 minute warm-up
• Each round consists of:
1 minute all out sprint
2 minute jog (60-70% of my all out sprint)
Perform a total of 5 rounds
• 5 minute cool down
My weekly schedule would look like this, for example:
Monday - Resistance Training + HIIT**
Tuesday - HIIT
Wednesday - Resistance Training + HIIT**
Thursday - HIIT
Friday - Resistance Training
Saturday - HIIT
Sunday - rest
**Now on days where I perform resistance and HIIT, I usually do the HIIT immediately after I'm finished resistance training. For myself, I've adjusted the HIIT so that it's not as long and to account for my fatigue. If you're in great shape and can keep to HIIT as laid out above, then go for it. But for me, I modify it this way:
Warm up - 1 minute
Round:
Sprint for 1 minute
Jog for 1 minute
Repeat for a total of 5 rounds.
Cool down - 1 minute
Half Way Progress Pictures
Now, as promised, I will reveal my half-way to sexy 6 packs abs progress pictures. I have tried my best to stick to a good diet and the workout routines. Diet is the hardest for me (I heart food) there\s no doubt, that I can improve in this area. It seems like almost every week there's a reason for me not to follow the diet! But let me make it clear that I do not weigh myself, nor have I since I've started this program. The scale is the enemy and the camera never lies!
Ok, here are the pictures.
For those that have forgotten, here's my picture from week 1:
Here's my picture taken only after the 8 weeks:
I feel stronger, healthier and have way more endurance. The abs are coming along too! Can't wait till the 16th week, just in time for summer! Let's keep this momentum going!
What effect does exercise have on glucose levels?
Why is the effect of exercise on glucose levels important to those with type 2 diabetes?
Some studies demonstrate that patients with diabetes who exercise regularly have better glycemic control compared to those who do not. As insulin sensitivity improves with exercise, patients may need less medication to control blood sugar levels. People with type 2 diabetes are particularly at risk for exercise-induced hypoglycemia during and after exercise. However, some patients with poorly controlled diabetes are at risk for hyperglycemia.
Should patients with type 2 diabetes exercise more often or differently than otherwise healthy people?
Be cautioned that there are some patients of type 2 diabetes that are at risk for developing hypoglycemia. This might be because of exercise. Sometimes, stress happens during and also after exercise, which triggers the hypoglycemia. However, if you think about it people who also have less control over their diabetes can also be at risk for developing hyperglycemia. Professionals recommend around two hours and thirty minutes’ worth of moderate aerobic exercise for those who have type 2 diabetes, or ninety minutes of vigorous exercise several times a week.
What type of exercise is best for type 2 diabetes patients?
Many experts recommend around two hours and thirty minutes of exercise three days each week for moderate aerobic activity. You could also do ninety minutes of vigorous aerobic exercise. Truthfully, the different types of exercise are not the issue as the length of time one spends exercising. Studies show that engaging in both aerobic exercise and weight training gives you more benefits in the end.
When should patients be discouraged from exercising?
Of course, sometimes patients should not engage in vigorous exercise especially when they have cardiac conditions or they are more prone to developing injuries as a result. It is better if they start of slow and get used to a light intensity program instead.
How might a patient be encouraged to exercise?
Encourage patients to start with small changes to their normal routine, like taking the stairs and not the elevator. Suggest activities that the patient finds enjoyable and convenient. Participation in several different activities may keep patients from becoming bored and losing interest. Having a partner or personal trainer can also help patients stay motivated.
My friends, we are half way there! I'm sure some of you are powering through this, while others aren't able to do all the HIIT and resistance training - but as long as you're doing your absolute best, that's all that matters! Give it your best and you will surely feel so much better, and look better, than you did in week 1.
I have to admit, for myself, it's been a challenge especially the diet portion of this training program. I'm not one to follow a strict diet plan and to eat certain meals so I'm just sticking to my principles of low glycemic foods, and keeping calories in check. That said, almost every week so far, I've indulged in foods that are totally the opposite of these principles and that also includes drinking alcoholic beverages. That is life. I am not one for stopping it just for abs - where's the fun in that?
Next week I will have progress pictures for you to check out. Hopefully something's noticeable. Many have said that when I started, I wasn't that out of shape, so I'm hoping that progress is noticeable in terms of toning and tightening. I'll let you be the judge!
That said, I feel much more stronger and healthier than 2 months ago! I feel great!
Ok, let's get to the week 8 resistance routine:
All exercises are to be performed in supersets. So perform exercises A1 then move onto A2 without a break. Take a rest. then back to A1/A2, then rest, A1/A2, (for a total of 3 rounds of A1/A2 supersets) rest then B1/B2 and so on...
For all exercises below aim for 15-20 reps. Perform 3 to 4 sets of each superset.
A1: Elevated Push Up on Ball
A2: One Legged Ball Squat
B1: Push Up with Feet on Ball
B2: Single Leg Hip Thrusts
C1: Pull Up/Chin Up
C2: Wall Sit (40 seconds)
D1: Upright Row with Bands
D2: Calf Raise
E1: Bicep Curl
E2: Knee Lifts with Ball
Rest for NO LONGER than 30 seconds.
From here on out, the workouts are going to get harder than the last 7 weeks. It's going demand more out of you, but you'll build more muscle this round. Your results are going to increase more significantly than in the last 7 weeks.
If you are finding pushups/pullups to be a bit too much, feel free to adjust them to suit your needs - the key here is that you're challenging the same muscle groups. This is where the bands come in really handy! (Need some? Contact me!) As fatigue sets in, I've had to group them in chunks of 6, 5, 4 and so on to get to the total reps.
HIIT Training:
Stick to the same routine of 4 rounds of HIIT, 4 times per week. You can see my week 5 post for all the details.
Don't forget - progress pictures next week!!
Probiotic gum breaks its way into the Canadian natural health product market - brought to you by CulturedCare. Let's take a look at this innovative product.
Over the last 6 years, critics of Health Canada’s natural health product regulations have argued that the regulations will destroy the industry. When the government of Canada states that proprietary blends (for the most part) are not allowed and that clinical trial evidence is the only measure of evidence accepted, the future of innovative products seem bleak.
But there is wiggle room. Innovation can come at a level beyond the latest marketing health claim or formulation. CulturedCare Probiotic Gum with BlisK12 does just that. While the rest of industry screams at Health Canada to change the regulations to suit their own agenda, CulturedCare has managed to produce a product that adapts to the regulations, while providing its consumers a cool new product never before seen in Canada.
Product Label and Design
The packaging couldn’t be any better. It’s clean, bright, grabs your attention and, most importantly, it’s fun! Every pack of the probiotic gum has a “preview pane” of the gum you’re about to chew. It’s reminiscent of those Hot Wheel toys, where they’re packaged to let the kids “try it out” by pressing an exposed button that makes a cool car sound!
The font is huge (which I like) as it makes it very easy to read, both up front and on the shelf. Maybe a bit too much writing, at second glance, but overall I really like the packaging.
As for the blister pack, it makes for convenient dispensing of the gum too. Very much like Excel gum, for example. I had no problems accessing the gum – there were no cases of me having to push the gum out so hard that it would end up shooting onto the floor. The blister packs are finely made.
Health Claim:
The health claims on the label read “Promotes oral health/Fights bad breath.” For those of you not aware, probiotics are the “good bacteria” in our body and, over the last few years, have garnered a lot of attention of its use in yogurt to help sustain the good bacteria in your intestinal tract.
Similarly, there is good bacteria that lives in our mouth. This good bacteria prevents overgrowth of the bad bacteria and is also the first line of defense against infections that enter through the oral cavity. CulturedCare Probiotic Gum with BlisK12 provides this good bacteria, also known as “oral probiotics”, to maintain oral health and fight bad breath. The product is also used to restore oral bacteria after the use of antibiotics.
Directions of use are fairly straight forward: Chew one piece for 5-10 minutes.
Regulatory Compliance
It is important to remember that even though this is a “gum”, we have to keep in mind that this is a natural health product. The probiotic gum contains medicinal ingredients at therapeutic levels and should be treated as such, rather than as a typical chewing gum, where you can chew as many pieces as you desire.
There is currently no Health Canada NPN (natural product number), at the time of writing. That said, I’ve confirmed with CulturedCare that the product is manufactured in a GMP compliant facility and their application for an NPN has been submitted and is currently under review.
One thing I did notice right away: the directions of use indicate to chew one piece for 5-10 minutes, yet there doesn’t seem to be a maximum number of pieces I am allowed to chew per day. Does that mean I can chew all 8 pieces per day? or maybe only 4? I’m not too sure…
The label also states that each piece can provide 500 million CFU of the BlisK12 bacteria at the time of manufacturing. Just a heads up to CulturedCare, and any other probiotic company out there, that Health Canada will, if they haven’t already, be asking for the CFU of probiotics at the time of expiry, not manufacturing.
Appearance/Taste
The gum itself is very well made. The pieces are round and symmetrical, with a nice shine to it. They look clean and very comparable to any other top of the line gum out there. In terms of taste, it doesn’t really taste like mango or guava at all. It tastes more like sugar – it tastes like the type of gum you get out of a gum ball machine, although less sweet. It’s not bad tasting at all, but just not mango or guava flavoured.
I’m on my 5th piece and I’ve timed how long the flavour actually lasts. I would say it’s probably around 30 seconds, which is really too bad. I had higher expectations. But then again, the directions of use indicate that I chew the gum for 5 to 10 minutes, which is easily bearable for rather flavourless gum. .
Does the product work?
So that leaves me one option: investigate its ability to fight bad breath. Here’s how it went down.
Baseline:
Limited by the number of gum I had left, I chose three colleagues to participate in this little experiment. After they all had lunch, I had to take a whiff of their breath (the sacrifices I make for getting you these reviews!) and rate it on a scale of 1 to 7, where 1 is the cleanest, freshest breath and 7 is the worse, harshest, breath.
Here are my findings:
Colleague #1 – sandwich, coffee for lunch: Breath scale of 6
Colleague #2 – chicken chow mein (hold the onions) and water, for lunch: Breath scale of 5
Colleague #3 – garden salad with grilled chicken and tea, for lunch: Breath scale of 3.5
Experiment:So does the gum work? I would say it did help! Whether this is a result of the probiotics or from the general action of chewing a piece of gum, I’ll leave that to the experts. No doubt coffee breath is hard to eliminate, but the gum did tone it down a bit.
I then gave each colleague one piece of gum and instructed them to chew on it for the next 10 minutes. They were then instructed to spit the gum out. I then took a whiff of their breath again.
Colleague #1 – breath scale of 5
Colleague #2 – breath scale of 3
Colleague #3 – breath scale of 2
As for the claims of efficacy of BlisK12 probiotics on oral health, I’d like to direct you to the CulturedCare references website, where a plethora of references are available. There is a lot of research done on this BlisK12 probiotic strain regarding safety, efficacy and mechanism of action. It’s great to see such science behind the claims.
Bottom Line: CulturedCare Probiotic Gum with BlisK12 breaks new ground on the natural health product front. It manages to take a new approach to probiotic delivery, in a fun and refreshing way. Although some improvements can be made on the product development side (eg. longer lasting flavour), CulturedCare Probiotic Gum has demonstrated that, even within the restrictive confines of the current Natural Health Product Regulations, innovative products can exist in this market. I look forward to the future of this product line.
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No doubt last week was a challenge! My body is feeling stronger and, although I haven't even stepped on a scale, there is progress that I can see!
This week, week 7, will be an amazing test of endurance, mental will and physical demand. The workout will be much shorter last week's, but intensity will be high. Guys and gals, I know it's not always possible to follow the diet, and the HIIT. I'm doing the best I can, but almost every week, I find myself indulging in some kind of food or meal that's not too "abs-friendly." Oh well, that's life. Just do the best you can! There's still about 10 weeks left, so let's get ourselves back on track.
Week 7 Resistance Workout Routine:
Instructions: this is different from our previous routines. Perform 30 reps of each exercise below and then move onto the next one, performing 30 reps of that exercise and so on. No supersetting, no circuit training, etc. Just do the 30 reps and move on.
The catch? DO NOT REST. Or, at least, try your best to keep going. Keep the rests to the absolute minimum. So catch your breath, and then keep going. For example, for me, as I was doing the pushups, I had to stop at 16 reps, catch my breath and then keep going till I completed a total of 30 reps.
A1: Jump Squat
B1: Staggered Push Ups
C1: Jumping Alternate Lunges
D1: Explosive Push Ups
E1: Prison Squats
F1: Hindu Push Ups
G1: 45 Degree Lat Pulldown
H1: Burpees
I1: Pull Ups/Chin Ups
J1: Double Crunches
For the pull ups/chin ups: for me, 30 reps is a lot. I had to split these up into chunks of 10 or 5 etc. There was a point where I couldn't do anymore, so I did lat pulldowns to get to the 30 reps.
Cardiovascular Training:
Stick to the HIIT routine as laid out in Week 5.
I ran through the week 7 routine before I posted this. My time: 19 minutes and 45 seconds. I hope I can improve this later in the week. What's your total time?
Childhood obesity is on the rise and poses a serious threat to health in the United States. No doubt people are looking for answers. Here’s mine.
The Problem:
So I caught the local news the other day and it was another “childhood” obesity and what-we-should-do-about-it segment. I’ve heard all the “solutions” before and NONE of them will help. Some of the proposed solutions included having junk food taxed, banning junk food from schools, banning junk food advertising targeted to children, and my favorite – better education.
Am I the only one who thinks these “solutions” are a joke? Kids will still eat junk food, kids will get fat and obesity stats will rise. Why? Because the solutions above rely on two premises:
2) Children are not considered.
With regards to the first point. Companies like Nabisco, Kellogg’s, and Kraft aren’t out to get kids fat. Their intention is not to increase the size of kids’ bellies. They just want to sell their potato chips, their cookies, their pizzas, and their cereals. That’s all. If there was a huge demand for some kind of super healthy and nutritious spinach and olive cookie, you can bet these companies would jump on that bandwagon and make the best darn spinach and olive cookies you can get.
Do you remember when that documentary Super Size Me came out? All of a sudden, there was a “hate” for McDonalds and a demand that such fast food joints implement healthier options. When the demand was there, what did McDonalds do? They provided healthier options. They even have nutrition information for their food items. But now take a look at your local McDonalds. The Super Size Me hype has dissipated, people really have no desire to eat salads at a McDonalds, demand drops, so McDonalds focuses back to its burger and fries. Oh and when’s the last time you checked the calorie count on a quarter pounder? Even if you did, did it even stop you from ordering it?
If the demand is there, the companies will supply it. That’s all. The kids demand sugary and salty junk food and so these companies are simply filling it.
With regards to the second point. Taxing junk food, banning advertisements, or having nutrition information at your local restaurants are all so “adult.” Kids don’t care about any of this stuff. They just want something yummy to eat. They don’t care if mom and dad have to pay more for the junk food, they just want that sweet taste of cola candy on their tongue. They don’t care how many calories are in their mac and cheese, they just want to fill their tummy.
And do you really expect kids to read the nutrition table when mom and dad can’t even read it themselves?
I don’t know what organizations, politicians, or activists that are coming up with these new solutions, but they’re all a waste of time.
They’ve even proposed better education in the classroom so that kids can make healthy choices when it comes to eating. Are you kidding me? Kids already know what’s healthy, but they don’t care what’s healthy – they want to eat what’s yummy.
Has anyone ever considered education at the parental level instead? I just can’t stand it when I’m sitting in a Chinese restaurant where a family at the table next to me is scarfing down the barbecue pork, vegetable spring rolls, lemon chicken and broccoli and beef. As the dishes arrive, the mom says “Eat up kids! This stuff is healthy for you! It’s Chinese food!” (I’m not making this up. I’ve witnessed this too many times.)
Taxing junk food is always a government favorite - brings in more money to government. If they really were against junk food like they are against alcohol, drugs or even porn or even R rated movies, then there will be real restrictions. There’s no “R-rated movie tax!” I don’t see a “drive-below-the-age-of-16” tax!” Government knows parents will buy stuff to keep their kids happy. Government is counting on parents paying the extra tax and the kids keep eating, but at least they look like they give a damn about childhood obesity. The truth is they really don’t care about obesity all that much.
The Answer
So that’s the problem. What’s the solution?
The solution starts at square one – with the kids. They know what they like to eat, they know what they want to eat, and they know what they don’t like or want to eat. Anyone ever considered consulting them, the end-user?
We (whoever “we” are), need to start thinking like kids. What makes for yummy food? What makes children want to eat one food over the other? What flavours taste good? What flavours satisfy?
Now we need to take all this information and design a food that’s nutritious, that’s not calorie dense, that is of low glycemic index and, yet, tastes like junk food. It’s food innovation, the next generation. Forget education. Forget taxation or advertisement bans. This is such old school thinking. Think forward, think new, think BIG. The future of “junk food” is healthy food that tastes like junk food. It’s food design - redefined.
And there’s no doubt in my mind that, should a company like Kraft ever find such a food, they will make sure kids and parents buy it. Even if that meant kids don’t get fat from eating it.
But of course, this is just one piece of the puzzle. When you have parents that don’t know how to cook a proper meal (where they are relying on frozen pizza to feed the family), or don’t encourage a healthy and active lifestyle (too tired from work to play with the kids, too lazy to take part in karate class with them, or even go shopping for fresh foods at the local market), kids are already on the road to obesity even if they plan on eating apples and oranges all day.
Bottom Line: If we really want to tackle childhood obesity at the food/consumer level, the solution starts with thinking like children. They want yummy food. That’s it. Let’s give it to them. Banning advertising, taxing junk food and increasing classroom education won’t help. These types of solutions don’t account for the thinking at the “child” level. Start with the children. They have the answers.
I will be sticking to circuit training for week 6. Boy, did I feel it for week 5. Changing it up every week keeps your body guessing. I want to also stress that if you're doing HIIT and resistance training on the same day, be sure to perform the resistance training portion BEFORE cardio training.
Don't forget that as of week 5, I'm adding an extra round of HIIT per session and an extra day of HIIT for a total of 4 HIIT days.
Ok, let's get on with it.
Week 6 Resistance Circuit Training Workout:A1: Pushups (feet on ball)
A2: Explosive Jumps (lift your knees up)
A3: Decline back row with bands
A4: Stationary lunges with bands (60 sec/side)
A5: Dips
A6: Walking lunges with weights (you can use dumbbells, milk jugs, backpack, etc.)
A7: Tricep extensions (60 sec/side. Keep to form, don't move the elbow!)
A8: Toe touch
A9: Concentration curl with bands (60 sec/side)
Perform the circuit as follows;
Beginner:
30 seconds per exercise station
30 second break between exercises
Perform a total of 2-3 circuits
Intermediate:
45 seconds per exercise station
15 second break between exercises
Perform a total of 3-4 circuits
Advance:
60 seconds per exercise station
10 break between exercises
Perform a total of 4-5 circuits
Any questions, let me know! Have fun everyone!
Having problems getting an NPN for your product or proprietary ingredient? Health Canada has approved CLA and there are 5 things we can learn from this to help you with your submission.
Or, what it really means: “CLA might do something and whatever that something might be, it’ll be very minimal.”
Although not found on the NHPD website just yet, the NHPD has stated that the monograph, sent to its mailing list members, is effective immediately. Following this, an article featuring CLA and its Canadian approval was posted on NutraIngredients.com:
“Health Canada recently issued a monograph for CLA, about six months ago it came close to banning the ingredient. The monograph followed letters that were sent to 106 dietary supplements manufacturers last July, after Health Canada decided to pursue concerns that had been raised in some quarters about the body shaping ingredient’s safety and efficacy"
"The North American divisions of Cognis Nutrition and Lipid Nutrition both worked closely with their dietary supplement customers selling CLA products in Canada to provide information Health Canada has incorporated into the monograph.”
I’m very amazed at this outcome. CLA went from refusal to approval within a 6 month turnaround time. Last time I checked, there were no new studies published that addressed the lack of efficacy, yet somehow, Health Canada approves the ingredient.
What can industry players learn from this? Let’s take a look at 5 things the recently published CLA monograph can teach us.
1) The pressure is on. There is no doubt that Health Canada is feeling the pressure to process the thousands of applications still in queue. CLA is a very popular ingredient and by releasing the monograph, this will allow many of the applications to be funneled through the compendial stream and be processed within 60 days. NHPD has their backs against the wall and are willing to use softer health claims in order to grant products with NPNs.
2) NHPD is willing to work with you. Cognis and Lipid Nutrition went straight to Health Canada to find common ground on CLA. They went from near refusal to a published monograph. Not bad at all. I wonder how much Cognis and Lipid Nutrition had to pay. More importantly, however, it’s good to see that Health Canada is keeping their doors open to industry. Especially, since the pressure is on to alleviate that backlog, there’s no better time than now for industry to start banging on NHPD’s doors to get their ingredients approved.
3) Money talks. I’m not referring to Cognis or Lipid Nutrition having to buy their monograph. I’m referring to NHPD’s inability to outright refuse major industry ingredients such as CLA. Should they have refused this ingredient, many companies would have been negatively impacted, only to hurt the industry even more. That means, product reformulations, loss in sales, re-labeling, re-marketing, etc. = huge $$$ losses at both the industry consumer/retail level and government cost-recovery level. For Health Canada, doing this would be the equivalent of shooting itself in the foot (which they’re probably used to by now).
4) Evidence requirements are STILL inconsistent. Remember the concept of totality of evidence? How about clinical trial evidence? And of course, how can you forget their statistical calculation on the power of a clinical trial? If you take these factors in account, you will no doubt understand why NHPD originally wanted to refuse CLA. The existing evidence out there is weak. I know this because I’ve worked on CLA applications, I’ve seen the evidence and I’ve seen the IRNs. It was not looking good for the CLA suppliers. At that time, NHPD has not welcomed softer claims either. But you can forget that now. Apparently, totality of evidence and strong clinical trial evidence is not required…or is it? Which leads me to…
5) There is no precedent set here. Don’t let this monograph fool you into thinking that softer claims are acceptable from now on. NHPD has a strong history of applying rulings specific to a certain ingredient. Just because they did it once before, doesn’t mean they’ll do it for you. Everything is “case-by-case”. It makes it hard for regulatory departments and consultants to get an idea of what the future holds, but I’ve seen NHPD revoke previously approved claims, wordings, or limits. I’ve seen them go back and forth on written decisions made years ago. They’re indecisive, inconsistent and, well, rather annoying.
It’s great to see that NHPD has let up a little to incorporate softer health claims. Industry has been calling for this since 2005, ever since NHPD went on that “clinical trial evidence only” rampage. During those years up until now, NHPD has been reluctant on granting softer health claims, in particular with the use of the word “may” (they are ok with words like “support” or “promote”). I don’t believe their intentions are to destroy the natural health products industry nor was it ever the plan. I think they’re only starting to realize now what they need to do to satisfy both their own regulatory requirements and industry realities. It’s a good wake up call.
Bottom line: Industry must realize that NHPD is at their most vulnerable right now. If you need to get market approval for your proprietary ingredient, contact NHPD while they’re still bleeding and get yourself a monograph. That said, no promises can be made! Everything is “case-by-case” with NHPD.
