Products not approved by FDA

[afrazier5]

mods - I'm putting this in the legislative section as I believe this will help a bit in the fight against our legislature and the FDA.

I'd like to start compiling a list here on products sold on the 'open' market that are either not FDA approved or not approved for the purpose they are being marketed for. Had that proverbial light bulb today after watching a TV commercial for the new Worx Energy shot. If you look at the TV commercial on this link and scroll to 31 seconds and pause it. You will see the following statement: These statements have not been evaluated by the FDA. This product is not intended to diagnose, treat, cure or prevent any disease.

This leads me to wonder, how many other products are out there for a specific purpose where the FDA has not approved it for said purpose. If it's good enough for some companies, why not e-cigarettes and liquid?

I vaguely recall seeing similar labels on food consumption products sold at stores like Whole Foods but honestly I don't shop there. Please post any products you may have or have seen similar disclaimers.

 

[afrazier5]

Here's an interesting article. I'm not sure how accurate this is or if it's simple rhetoric but it's an interesting read none the less. NOT FDA APPROVED « Justmytruth's Weblog

 

[Vocalek]

Hmmm... The Fraud and Death Administration. Good one!

 

[rothenbj]

An interesting read. The one thing that is definitely accurate is the fact that there is a close association between the FDA and BF. The same association is now being established between them and BA which some seem to believe is fine, but I have a problem with their future control of our food supply.

Personal decision making should remain the right of the individual. If I want to use alternative medicine rather than their approved therapies, that should be my right. If I want to buy locally produced foods, that should be my right. We have a legal system in place to correct abuses by product vendors. A bad business will not stay on the market long if they are causing harm, unless, of course, they are so large that they can withstand the cost of lawsuits. Who has that sustainability? The major clients of the FDA, the clients they protect. Lawsuits may effect their bottom line, but unless they so grossly offer products that become major lawsuits, they just pay the "fine", build the expense into their product line and continue "business as usual".

I have no problem with FDA approved products, but they should not be the only products available. JMHO

 

[Vocalek]

I am going to be really pi$$ed if the FDA decides to remove suppliements like slow-release niacin (e.g. Slo-Niacin) from the market -- $13 for 100 tablets -- and force me to buy Big Pharma's new Rx version, Niaspan for $215.50 for 90 tablets. This is the same drug. Active ingredient is niacin.

I started taking Niacin for my cholesterol after a statin drug gave me sharp pains across my back. After months of this, and even spending $1000 on a new mattress, I read that statins can cause muscle pain and even kiidney failure. As an experiment, I stopped taking the statin and w/i three days the pain was gone! I waited about a week and started taking the pills again and the pain came back (this is called "rechallenging" -- a method of checking whether what you thought might be causing the problem actually was causing the problem.) So I stopped taking the statin and started researching natural ways of controlling cholesterol. That's when I found that Niacin can keep the bad cholesterol levels down.

I think it is interesting that when you Google "statin kidney damage" there are all kinds of results that talk about kidney problems being caused by statins, and then there is this article by Cleveland Clinic that states "We think some patients with chronic kidney disease should take a statin, particularly those in stages 1 through 4 (ie, not yet on dialysis)".

Huh?

Renoprotective effects

Besides their cardiovascular effects, statins may slow the progression of kidney disease.

A subgroup analysis of the Greek Atorvastatin and Coronary Heart Disease Evaluation (GREACE) trial8 showed a 12% increase in creatinine clearance in the group receiving atorvastatin (Lipitor) (P = .0001). In comparison, creatinine clearance decreased by 4% in the placebo group.

One Minute Consult | Should All Patients with Chronic Kidney Disease Take a Statin?

 

[ctourtelot]

Stop by any local GNC store. The shelves are filled with products "not evaluated or approved by the FDA"

 

[afrazier5]

Stop by any local GNC store. The shelves are filled with products "not evaluated or approved by the FDA"

Excellent point. Does anyone shop at GNC? If so, I'd be curious to ask the question of someone there what the most dangerous product is if it is not taken according to directions. Explain you are asking for a research project on OTC supplements so they don't think you're up to no good

 

[Bill Godshall]

The problem is that CTFK/ACS/AHA/ALA and some anti-tobacco extremist legislators are trying to ban the sale and/or use of e-cigarettes by labeling them "unapproved" or "unregulated" products by the FDA.

E-cigarette prohibitionists don't care about unapproved FDA products, but rather are using this jargon to deceitfully portray themselves as public health advocates and as allies of FDA, to scare the public, and to portray harm reduction advocates as opponents of public health.

 

[Sassyonemeis]

It would much easier to discuss products that HAVE been FDA approved, then killed thousands of people, some of which are still FDA approved and on the market.

 

[afrazier5]

Bill I agree but would the same argument not hold true with any unapproved or unregulated products which GNC sells to the open market? Some of which can be deadly when not used by the directions and when stored within reach of young children?

Sassy I too agree with your statement. I would like to see approved products which result in accidental deaths, injuries and poisoning along with documented numbers of people.

I'm trying to compile all this of the as quickly as possible as we have one hell of a fight ahead of us here in Utah. The representative which lost recently with HB170 has come out in public and stated he will be pushing to get this on the October ballot measures in November. We have much more time to prepare for this but we need to start getting the REAL truth out to the health departments, PTA's, Legislators, Governor, AG, etc. I'd love to have a 'press' pack compiled by July of this year that we can begin to send and email out. I would love to have NPR do another more in depth story. I want to get members of our vaping community on a few local radio shows (morning and afternoon).

 

[renstyle]

Excellent point. Does anyone shop at GNC? If so, I'd be curious to ask the question of someone there what the most dangerous product is if it is not taken according to directions. Explain you are asking for a research project on OTC supplements so they don't think you're up to no good

Just stopped by there earlier this week for some Fenugreek. Wife is breast feeding and this helps boost milk production. Not evaluated by the FDA.

It was hilarious when I walked in the door somewhat cow-eyed, lost. The counter guy asked what I was looking for. "Something greek for my wife", and he took me right to it. Apparently it is recommended by the local doctors quite heavily, they have a small section which looked like it had been ransacked by a coupon stampede at the supermarket! They sell quite alot of it.

I can see why, my wife says the stuff REALLY works!

 

[Vocalek]

Another product that works is Turmeric. I was plagued by a recurring sebaceous cyst and got sick and tired of having to go to the doctor to get it lanced. I started doing a little research and found out that Turmeric (yes, it is a spice) comes in capsule form and is considered quite effective for skin problems. I begain taking a capsule a day and have not had a single recurrence.

 

[Docliv]

Another product that works is Turmeric. I was plagued by a recurring sebaceous cyst and got sick and tired of having to go to the doctor to get it lanced. I started doing a little research and found out that Turmeric (yes, it is a spice) comes in capsule form and is considered quite effective for skin problems. I begain taking a capsule a day and have not had a single recurrence.

Hi Vocalek,

I've been taking 20mg of Simvastatin every evening for over 4 years now and all my blood test confirm my kidneys are doing great. This is because I've also been taking 50mg of CoQ10 every morning. A better form of this is Ubiquinol which contains a better form of the "active antioxidant" in CoQ10. Hope this helps as I have never had muscle aches during this period of time either.

 

[Vocalek]

Hi Vocalek,

I've been taking 20mg of Simvastatin every evening for over 4 years now and all my blood test confirm my kidneys are doing great. This is because I've also been taking 50mg of CoQ10 every morning. A better form of this is Ubiquinol which contains a better form of the "active antioxidant" in CoQ10. Hope this helps as I have never had muscle aches during this period of time either.

I think for now I will stick with the Slo-Niacin. I am also taking CoQ10 with it (just in case).

 

[Jacinda222]

Yes, there are tons of supplements which aren't approved by the FDA for a certain purpose, but which are sold and used for that purpose anyway.

Not to mention all of the prescription drugs which are provided for purposes other than what they have been approved for. One example is HCG injections. They are not approved to help with weight loss, yet everywhere I go I see advertisements for doctors who will prescribe them for that purpose. (I won't go into my opinion about this particular practice, that's a whole different story.)

But the FDA doesn't seem to have any interest in stopping that from going on. Hmm...

 

[afrazier5]

Exactly my point Jacinda - I think if we can get some of this documented, it will go a long way towards the fight against our legislature and their hanging on the words of the FDA with our liquids and devices. Also would be a good fight against the FDA directly should Chafetz decide to do something....

 

[0smitty]

Excellent point. Does anyone shop at GNC? If so, I'd be curious to ask the question of someone there what the most dangerous product is if it is not taken according to directions. Explain you are asking for a research project on OTC supplements so they don't think you're up to no good

I pretty much *live* at GNC, and yes, there are A LOT of products on the shelves that can be dangerous in the wrong hands. For example, one of my favorite pre-workout products, N.O. Loaded, contains 400mg of caffeine anhydrous per scoop!!! Interestingly, caffeine is only the tip of the iceberg: next-gen supps like to use a cocktail of stims rather than just one. Some days of the week, I'm sure my caffeine intake exceeds 2 grams, and a large part of this is from the supps.

Yohimbe bark extract is another interesting ingredient: a while back, I was doing some research on it, and what I found was that yohimbe can be toxic if the dosage is slightly over what's recommended. Again, a large number of pre-workout formulas and some fat-burners contain yohimbe bark extract.

While I'm unsure as to the extent of danger some of the products at GNC could pose, I can honestly say that I've never experienced anything major. Maybe some heart palpitations here and there, but that's to be expected from someone of my kind of lifestyle. Oh, and the new Ravage gives me some *serious* tingles ~15min. into a workout..Even so, that's still to be expected from something containing a crap-ton of niacin and beta alanine. Not joking, I've either tried or religiously taken about everything on the shelves of GNC's sports nutrition section, but I have yet to experience any true adverse effects. Then again, I'm also one of those people that researches every substance I put into my body before taking it, and I never purchase anything without going over the ingredients.

In conclusion, I'm sure there are plenty of dangerous substances on the shelves at GNC...but this is no different from our nic juice: in the wrong hands, anything can be harmful or fatal. If you do some research, you'll find that the FDA has been looking for ways to put further strangleholds on the supp industry, too. I think the bill's number S-510? Don't quote me on this, but this one's very recent...and for the same reason the FDA wants control of our juice: money.

 

[DataPhreak]

Being in the military, i've heard a lot of horror stories about people using suplements instead of steroids to build body mass. Probably the creepiest one is creatine(sp?) abuse. Apparently it helps bulk muscles by increasing water retention. One soldier was using it so much that his muscles turned into liquid while on a run. Apparently the vibration caused his waterbloated muscle cells to rupture and separate. (Story unconfirmed.)

 

[0smitty]

Being in the military, i've heard a lot of horror stories about people using suplements instead of steroids to build body mass. Probably the creepiest one is creatine(sp?) abuse. Apparently it helps bulk muscles by increasing water retention. One soldier was using it so much that his muscles turned into liquid while on a run. Apparently the vibration caused his waterbloated muscle cells to rupture and separate. (Story unconfirmed.)

Whomever told that one...ugh. Do the research: the body can only absorb so much creatine at a time, especially on a cellular level. While creatine does increase water retention of muscle cells (i.e. sarcoplasmic volume increases), the primary/intended effect of creatine is the provision of more readily-available ATP via conversion of said creatine. The *slight* bloat is only a side-effect.

 

[Bill Godshall]

I'm not an expert on Dietary Supplements, but its my understanding that Congress specifically exempted Dietary Supplements from being regulated by the FDA as food or drugs.