*please* check out new law about buying supplements

I certainly wouldn't be against imposing certain restrictions on companies that manufacture supplements, but to put them thru the same rigorous process as prescription drugs will do nothing but put these companies out of business. The consumer will never be able to pick that type of tab up to keep them operating. Of course, that is probably the government's motivation.

I'm very cynical when it comes to the US government. From what I've seen, citizens rarely (if ever) take priority over big business. This bill is not to protect us. That much can be taken to the bank!

Look at many drugs on the market already that HAVE been approved by the FDA. I've never been able to understand how a drug can cause (these are examples, not saying any 1 drug does all this), stomach cramping, suicidal tendencies, diarrhea, dizziness, flushing, headache, heartburn, stuffy nose, memory loss, cancer, stroke, and in some cases, an increase in the mortality rate, yet drugs with these types of side effects are taken everyday in this country to treat lesser illnesses than they're being used to treat.

Here was a nice little list I ran across.
http://www.oddee.com/item_96885.aspx

And for the person who asked how much more we'd have to pay? Well, did you fail to read my first post in this thread where I stated that pharmaceutical companies have yearly sales profits that are only surpassed by oil companies? I think you can take it to the bank that your supplements will WAY more than you'll be able to afford. Even if you could afford them, because so many others wouldn't be able to, prices would have to go substantially higher than that for anyone still able to make the purchase. Till the end came around, you would NOT be able to afford them, unless of course you're somehow in the Gates family?
 
I'm very cynical when it comes to the US government. From what I've seen, citizens rarely (if ever) take priority over big business.
As previously noted, the dietary supplement market is a $23.7B business (and growing rapidly) and their members also have sizable industry trade groups with lobbying arms and checkbooks... how is it that they escape your jaundiced view of self-interest?

I think you can take it to the bank that your supplements will WAY more than you'll be able to afford. Even if you could afford them, because so many others wouldn't be able to, prices would have to go substantially higher than that for anyone still able to make the purchase. Till the end came around, you would NOT be able to afford them, unless of course you're somehow in the Gates family?
You can take it to the bank, but your deposit would be returned due to a lack of logical funds. Let me ask you this... Can you afford to buy any of these products: Mylanta, Tylenol, Imodium, Cortaid, Neosporin, Tums, Bayer Aspirin, Philips Milk of Magnesia, Lotrimin, Motrin, Sudafed, Vick's Vap-o-rub, Robitussin, Ex-Lax, or NyQuil??? If you can't afford the name branded versions, how about the store branded versions? ALL of these products (as well as every other OTC drug on the market) are regulated by the same types of regulations now proposed in the new bill for dietary supplements. In fact, after looking at the bill, the regulations are even less strict that those required for OTC drugs (the bill doesn't address efficacy, only safety... looks like "Smilin' Bob" will live on!). So how is it that these products can be sold in roughly the same price range as the dietary supplements I see in one of our local health food stores if they have to follow these supposedly financially oppressive regulations? And before you argue that the products I mentioned are all made by mega-corporations and therefore have economies of scale that dietary supplement makers can't match... turn back to the store branded versions. Many store branded OTC products are made by small pharma companies, and they have to play by the same FDA rules as the big-boys. In fact the largest maker of store branded OTC drugs (Perrigo) is smaller than the largest maker of dietary supplements (Herbalife).
 
I have some mixed feelings about this. I know there are some supplements that make ridiculous claims (Enzyte has already been mentioned). But there are a lot of us taking supplements recommended by doctors and researched by ourselves. IF the FDA will allow these products to remain on the shelves until approval I could live with them taking over regulation of the supplement market.

I currently take a lot of Vitamin D. I am pretty severely deficient if I don't supplement. This isn't guesswork, this is blood tests that show the deficiency. I also take Omega 3 fish oil which is pretty well proven to help with a number of heart issues. This is also taken on my doctor's recommendation. And a lesser known drug - Alpha Lipoic Acid. Helps diabetics with metabolizing sugars and also helps with skin problems. And calcium - most women need more calcium!

My husband cannot take statins. He tried a few and they made him pretty sick. So he is controlling cholesterol with diet, phytoserols, and a variety of B supplements. So far it is working and his doctor approves of the approach and in fact suggested that he give it a try.

There are a lot of supplements that have proven benefits. They should not have restricted access during the approval process. Other than that, I think I could live with the FDA regulating the marketplace. As mentioned, they already regulate other OTC drugs (which is really what supplements are) and the prices are not outrageous.
 
Okay, donning my "tin foil" hat here...;)

I have *heard* that one of the reasons for this bill is that it is being pushed by pharmaceutical companies. There are various supplements (Vitamin D comes to mind as well as probiotics) that they are chomping at the bit to have pulled off the shelves from the average person so that they can market a "drug" for it and make tons of money. As you know, the Vitamin D market and it costs pennies to treat people with this. Pribiotics are the same. If the FDA doesn't regulate it, they can't *study* it and make a wildly expensive drug for it.

The active ingredient in Red Yeast Rice is the same. For the most part, it's been pulled from U.S. shelves because it was competing with Zocor and Crestor and the like. Even docs were advising patients to use it when they were having side effects from the stronger, prescriptions forms.

What a shocker! People will have to become smarter about nutrition when this bill gets passed. The pharm companies cannot own and prescribe food. If we eat nutritiously and organic, that will cover a lot of these supplements.
 

The email re. this 'proposed bill' started circulating in 2005, it's very outdated and just won't die. Here's what snopes.com says:

http://www.snopes.com/politics/medical/vitamins.asp
That is incorrect. While I agree that the OP's hyperbole is unfounded, the bill posted by the OP is current and very real. Here's the speech announcing the bill on the Senate's web site:
SENATOR JOHN MCCAIN INTRODUCES THE DIETARY SUPPLEMENT SAFETY ACT OF 2010
February 3, 2010

· Like many of you, I am looking forward to watching the Super Bowl this Sunday and the Winter Olympics later this month. However, a little over a year ago the NFL suspended six players, including two players from one of the teams competing this Sunday, for violating the league’s anti-doping policy. Several of the players were surprised that they tested positive for a banned substance because they used a dietary supplement they believed to be safe and legal.

It is for precisely this reason that today Senators Dorgan and I are proud to introduce the Dietary Supplement Safety Act of 2010. All Americans should know the exact ingredients of any dietary supplement they use and the FDA must have the tools necessary to ensure the safety of dietary supplements.


· This legislation would require dietary supplement manufactures to register with the FDA and fully disclose the ingredients contained in the supplement. Surveys have found that a majority of dietary supplement users believe the FDA approves the safety of dietary supplements prior to market introduction. However, that is not the case. In fact, dietary supplement manufacturers’ advertised claims of safety and effectiveness are not reviewed or approved by the FDA.

· Last January, the GAO published a comprehensive report entitled, “The FDA Should Take Further Actions to Improve Oversight and Consumer Understanding of Dietary Supplements.” The report stated, “…several factors limit the agency’s ability to detect concerns and remove products from the market. For example, FDA has limited information on the number and location of dietary supplement firms, the types of products currently available in the marketplace, and … once FDA has identified a safety concern, the agency’s ability to remove a product from the market is hindered by a lack of mandatory recall authority…”


· Lastly, the proposed legislation provides the FDA with mandatory recall authority if a product is found to be unsafe or harmful. It took the FDA ten years to ban ephedra – a dietary ingredient used for weight loss and bodybuilding that was found to cause serious medical risks to users including death. It has been reported that use of ephedra contributed to the deaths of Baltimore Orioles pitcher Steve Bechler and Minnesota Vikings player Korey Stringer. Additionally, there are numerous stories of amateur athletes who took this supplement and experienced serious health problems.

· It is my hope that this legislation will ensure that all Americans, including athletes, have all the information necessary to make informed decision when choosing whether to use a dietary supplement, and that the FDA has the ability to remove any harmful dietary supplements from the market.

And here's the text of the bill in question: S3002
 
I wasn't familiar with this issue, so I did a bit of digging. Not surprising, the story behind the banning of certain types of Red Yeast Rice isn't as intriguing as it may sound. Red Yeast Rice didn't contain some natural alternative that worked like a cholesterol lowering statin drug... it contained a statin drug itself. Certain processed forms of the rice contains monacolin K. This is same as mevinolin or lovastatin, which is the active pharmaceutical ingredient in the prescription drug Mevacor. So the FDA ruled that when health food stores were found to be selling red yeast rice extract marketed as a cholesterol lowering agent, they weren't really selling a "dietary supplement", they were selling the prescription drug itself and making a drug claim to boot!

Here's what I know about monacolin. It has been a part of Red Yeast Rice for a long time and was widely used in Asia (eastern medicine) to lower cholesterol. In the U.S. the pharmaceutical companies jumped on this, followed up with their own studies, and created a drug from a substance that had been used in eastern medicine for probably hundreds of years. It was also being sold here until the FDA, probably with the help of the pharms, latched on to that. According to a doctor that I went to, it didn't have as much punch as the pharmaceutical grade, but it was a good sub for people who couldn't tolerate it. The active component in the Red Yeast Rice was the same but to a lesser degree. Now, you can't get Red Yeast Rice with the active ingredient. Not sure how I feel about this. Honestly, it was in the "natural" med first. It wasn't the other way around.
 
Honestly, it was in the "natural" med first. It wasn't the other way around.
Look, here's the problem... "natural" doesn't mean "safe". Let's say for the sake of argument that your doctor was right and red yeast rice is a less potent form of Mevacor. Here's the rub, it's still a statin. Statin's have a well defined track record to trying to kill the livers of a certain percentage of people that take them. I'm on my third different statin now due to this issue. In order to keep this from happening, you need to have periodic blood tests to check your levels of liver enzymes. Drug labeling indicates that about 2% of people that take Mevacor will have problems with their livers. Use of alcohol will also elevate that risk. Even though red yeast rice may be less "potent" and may be tolerated by more people, there will still be a number of people who's livers cannot handle it... just fewer than if they'd taken Mevacor instead.

This is the reason that statin products will never be switched to OTC status. You need to be under a doctor's care to use statins as they need to order periodic blood work to make sure the statin isn't damaging your liver. The problem is that while the doctor that recommended red yeast rice to you could have also ordered the blood tests needed for your safety, the same isn't true for others that just walk into their health food stores and buy it on their own. A certain number of those people would be at risk for liver failure if they continued to use the product over time in an effort to self-medicate for high cholesterol... and there are documented cases of this happening, as well as cases of the other life-threatening condition associated with statins, myopathy. This is why the FDA took exception to certain red yeast rice products, not to protect Merck's bottom-line. And there's another fact that undercuts the notion that it was done for Merck's sake... the ban went into effect approximately when Merck's patent expired and Mevacor went generic.
 
As previously noted, the dietary supplement market is a $23.7B business (and growing rapidly) and their members also have sizable industry trade groups with lobbying arms and checkbooks... how is it that they escape your jaundiced view of self-interest?

You can take it to the bank, but your deposit would be returned due to a lack of logical funds. Let me ask you this... Can you afford to buy any of these products: Mylanta, Tylenol, Imodium, Cortaid, Neosporin, Tums, Bayer Aspirin, Philips Milk of Magnesia, Lotrimin, Motrin, Sudafed, Vick's Vap-o-rub, Robitussin, Ex-Lax, or NyQuil??? If you can't afford the name branded versions, how about the store branded versions? ALL of these products (as well as every other OTC drug on the market) are regulated by the same types of regulations now proposed in the new bill for dietary supplements. In fact, after looking at the bill, the regulations are even less strict that those required for OTC drugs (the bill doesn't address efficacy, only safety... looks like "Smilin' Bob" will live on!). So how is it that these products can be sold in roughly the same price range as the dietary supplements I see in one of our local health food stores if they have to follow these supposedly financially oppressive regulations? And before you argue that the products I mentioned are all made by mega-corporations and therefore have economies of scale that dietary supplement makers can't match... turn back to the store branded versions. Many store branded OTC products are made by small pharma companies, and they have to play by the same FDA rules as the big-boys. In fact the largest maker of store branded OTC drugs (Perrigo) is smaller than the largest maker of dietary supplements (Herbalife).

My gosh, supplements today already run WAY past the cost of the medications you're referencing here. Take a little walk into GNC one day. It can run $30 per person per month right now to take CoQ10 alone. Wow, didn't realize Tylenol had gone up that much! You think GNC is going to be able to sell that after the rigorous process you want imposed is law? Gosh, I hope no one expects to be able to buy CoQ10 and fish oil too (another $20 plus per person). In this economy, that's the solution, put more people out of a job!!!

Here, check some prices out yourself. You seem to informed. I think I could buy all of the above mentioned drugs for the price of just the 2 I mentioned above.
http://www.gnc.com/home/index.jsp
 
Wow, didn't realize Tylenol had gone up that much! You think GNC is going to be able to sell that after the rigorous process you want imposed is law?
Seeing as how Perrigo is able to somehow meet a similarly "rigorous process" burden and still make a profit manufacturing 100 ct. bottles of generic Tylenol that retails for $4 at Walmart, I think it's safe to say that adding the likely 2 to 3 cents per bottle to the price CoQ10 to cover the cost of compliance isn't something that will make GNC's customers lose a lot of sleep over.
 
Look, here's the problem... "natural" doesn't mean "safe".


Oh, you are preaching to the choir here! I rarely take ANY supplements for that reason.

My main concern, though, is that simple things like probiotics and vitamin D will be turned into prescription only "medications."
 
Seeing as how Perrigo is able to somehow meet a similarly "rigorous process" burden and still make a profit manufacturing 100 ct. bottles of generic Tylenol that retails for $4 at Walmart, I think it's safe to say that adding the likely 2 to 3 cents per bottle to the price CoQ10 to cover the cost of compliance isn't something that will make GNC's customers lose a lot of sleep over.

Maybe that's because you don't understand the process? See, when the generic drugs are released, they've already been put thru the vigorous process (AS NON GENERIC FORMS), thus can be manufactured at the point in time, economically.

This is the entire crux of FDA regulations, and this post tells me that you're more interested in basing opinion on emotion rather than real knowledge.
 
Oh, you are preaching to the choir here! I rarely take ANY supplements for that reason.

My main concern, though, is that simple things like probiotics and vitamin D will be turned into prescription only "medications."

Yep - don't go playing in puddles unless you can see the bottom...

28b0f0d860f5b76b8d6e2fce282526c37651665.gif
 
Oh, you are preaching to the choir here! I rarely take ANY supplements for that reason.

My main concern, though, is that simple things like probiotics and vitamin D will be turned into prescription only "medications."

I don't think anyone should just start taking anything without talking to their doctor first. There is no question that just because certain drugs are out there that it makes them safe. That's not the crux of the argument here. There are a heck of a lot of over the counter drugs that shouldn't be just taken because they can be either. Heck, take enough Tylenol and see what your liver thinks about that.
 
Maybe that's because you don't understand the process? See, when the generic drugs are released, they've already been put thru the vigorous process (AS NON GENERIC FORMS), thus can be manufactured at the point in time, economically.

This is the entire crux of FDA regulations, and this post tells me that you're more interested in basing opinion on emotion rather than real knowledge.

Uh, no if you'd actually look at the proposed bill you'd see that it doesn't require that supplement makers conduct clinical trials or do anything like compile a New Drug Application. This is were the big regulatory costs are. There are also a lot of additional regulatory costs associated with doing an Rx to OTC switch such as additional safety studies that the FDA may require, and labeling design. It's true that once an OTC monograph has been set by the FDA the costs of other makers launching their own versions of the drug are smaller, but it appears that the analog would be true for supplements as the FDA appears to have their own set of supplement ingredients that are grandfathered as OK to market.

The proposed bill mostly deals with requiring makers register their products, disclose the contents of their products, file information on any self-determination of safety, and require full adverse advent reporting instead of just serious events, and give the FDA full recall authority. The reglatory costs of compliance for supplement makers would be on par with those of store brand OTC drugs. If you feel differently, please provide some specific examples.
 
Uh, no if you'd actually look at the proposed bill you'd see that it doesn't require that supplement makers conduct clinical trials or do anything like compile a New Drug Application. This is were the big regulatory costs are. There are also a lot of additional regulatory costs associated with doing an Rx to OTC switch such as additional safety studies that the FDA may require, and labeling design. It's true that once an OTC monograph has been set by the FDA the costs of other makers launching their own versions of the drug are smaller, but it appears that the analog would be true for supplements as the FDA appears to have their own set of supplement ingredients that are grandfathered as OK to market.

The proposed bill mostly deals with requiring makers register their products, disclose the contents of their products, file information on any self-determination of safety, and require full adverse advent reporting instead of just serious events, and give the FDA full recall authority. The reglatory costs of compliance for supplement makers would be on par with those of store brand OTC drugs. If you feel differently, please provide some specific examples.

You might want to look at the authority that the FDA already holds where supplements are concerned. This new law will mandate companies list ingredients? How sweet when ingredients already have to be listed (and the FDA could enforce current law if a company chooses to ignore listing them).

Current law already gives the FDA the authority to recall a supplement that has been known to cause "serious adverse event," but they want terminology changed "adverse event." Oh, the consumer is SO better protected. Why give the government carte blache with such broad terminology? All this is going to do is give cause for the FDA to pull anything they'd like from our shelves based on any reason they see fit (coo for pharmaceutical companies who have been padding lots of pockets for this type of victory for a LONG time).

And what I find to be the most troubling aspect of this entire bill is, it was proposed because athletes stated they took supplements and popped positive on steroid testing. Well guess what? The bill doesn't even begin to tackle the steroid problem. Why? Because the FDA already has the authority to investigate these cases and pull said products off the market. All it has to do is enforce the laws that have been passed LONG ago.

Let's not even delve into the fact that the FDA is already being run so thin because of the responsibilities it has everyday of the week.

Just as the government went on the attack of red yeast rice (as mentioned already in the thread), the same thing happened last year to a natural form of b6 (pyridoxamine). I'm sure those suffering from diabetes were just thrilled with that. Heaven forbid, bit phama not be in on the profit of such a money maker.

All this hoopla when it's unquestionable that more deaths occur each year from aspirin than supplements?

This bill is so poorly written and so ridiculously broad that it's asinine that it's even being proposed, IMO. There are MANY other issues I could raise, but I have to get up early.
 
You might want to look at the authority that the FDA already holds where supplements are concerned. This new law will mandate companies list ingredients? How sweet when ingredients already have to be listed (and the FDA could enforce current law if a company chooses to ignore listing them).
For starters, the FDA has no control over the mislabeling of dietary supplements. Federal labeling laws covering supplements are policed by the FTC under the banner of "false advertising". It's also incorrect that supplement makers are required to disclose every ingredient in their products. They can get busted by the FTC if their label says that it contains something it doesn't (or in the amounts stated), but the opposite isn't necessarily true. Being a "dietary supplement" means that legally their products are treated as a "food item". If what you say is true about the legal requirements to name all ingredients, then to learn ALL of the ingredients of Coke we'd just have to look at the label on a bottle instead of breaking into Coca-Cola's safe in Atlanta!

US made dietary supplement labeling is so unreliably incomplete that the IOC has gone to far as to warn all athletes to avoid dietary supplements sold in this country if they don't want to risk their eligibility:
At last summer's Olympic games in Sydney, Australia, Norwegian wrestler Fritz Aanes suffered two heartbreaks: He lost the bronze medal, and then he was banned from competing internationally for two years, after testing positive for the potent anabolic steroid nandrolone. Although he couldn't do much about losing his medal, Aanes protested vehemently about his drug test, arguing that he had not taken steroids. The problem, he claimed, stemmed from another source: mislabeled dietary supplements manufactured in Utah.

Aanes made a compelling case. Nandrolone had been banned since 1975, and because it was easily detected for up to a year after only one injection, it had largely disappeared from pro sports. Athletes really bent on cheating had much better (and harder to detect) drugs to choose from. Later, a lab in Cologne, Germany, confirmed that there were trace amounts of nandrolone in Aanes's Utah supplement that weren't listed on the label.

Aanes wasn't the first athlete to blame tainted American dietary supplements for a positive drug test. Three others headed for or competing in the 2000 Olympics also tested positive just for nandrolone. And the International Olympic Committee (IOC) had been getting reports about the possible supplement-steroid link since 1999, when more than 350 athletes competing around the world tested positive for the curiously pervasive compound.

Researchers suspected that not only were dietary supplements being mislabeled, but many of the U.S.-produced supplements called pro-hormones actually behaved like steroids, even though they were legally sold over the counter. The surge in positive tests for nandrolone also coincided with the spike in pro-hormone use after St. Louis Cardinals slugger Mark McGwire admitted to using androstenedione---or "andro"---while chasing the single-season home-run record in 1998. (Banned by the IOC, andro is a steroid that the body converts to both testosterone and estrogen.)

After the controversy in Sydney, the IOC warned athletes to avoid American supplements, particularly those manufactured in Utah, the "Cellulose Valley" of the U.S. supplement industry. The IOC also blasted the U.S. for poorly regulating supplement producers and asked then-White House drug czar Gen. Barry McCaffrey to review the Dietary Supplement and Health Education Act (DSHEA), which had deregulated the U.S. supplement industry in 1994.

I asked for examples to back up your assertion that "you can take it to the bank that your supplements will WAY more than you'll be able to afford" if this bill becomes law. However, seeing as how makers of store brand OTC drugs, who you acknowledge are able to sell their products at significantly less cost than current dietary supplement prices, are able to comply with regulations that require them to disclose their ingredients and they are able to keep their prices very low in the process... this argument doesn't support your assertion.

Current law already gives the FDA the authority to recall a supplement that has been known to cause "serious adverse event," but they want terminology changed "adverse event." Oh, the consumer is SO better protected. Why give the government carte blache with such broad terminology? All this is going to do is give cause for the FDA to pull anything they'd like from our shelves based on any reason they see fit (coo for pharmaceutical companies who have been padding lots of pockets for this type of victory for a LONG time).
"Serious adverse drug experience" has a specific legal definition "Death, a life-threatening adverse drug experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect." The FDA has been collecting adverse event reports of ALL types from dietary supplement users directly since 2007, but legally supplement makers have only been required to report serious events since that time. However, many of them do give the FDA all of their reporting data voluntarily (good for them!). But, there is nothing to legally prevent a supplement maker from sitting on adverse reaction reports from users about less-than-lethal events or events that didn't put them in the hospital on an inpatient basis.

So since all supplement makers should have a pharmacovigilance program (or the equivalent to it) in place now to collect and report the legally required events, and many makers already do report ALL events anyway, then again, there's no evidence in this argument that legally requiring makers to report all events would significantly drive up their costs.

And what I find to be the most troubling aspect of this entire bill is, it was proposed because athletes stated they took supplements and popped positive on steroid testing. Well guess what? The bill doesn't even begin to tackle the steroid problem. Why? Because the FDA already has the authority to investigate these cases and pull said products off the market. All it has to do is enforce the laws that have been passed LONG ago.
Steroids aren't necessarily the issue here. In many cases the athlete got in trouble because the supplement they were taking wasn't properly labeled as containing banned substances (either a steroid itself or an ingredient that would mask steroid use in doping tests and is therefore banned too). It's also hard for the FDA to pull stuff off the shelf if they don't have any idea exactly what's in it or know that it's on the market because the makers don't have to register the product with them before marketing it.

Let's not even delve into the fact that the FDA is already being run so thin because of the responsibilities it has everyday of the week.

Just as the government went on the attack of red yeast rice (as mentioned already in the thread), the same thing happened last year to a natural form of b6 (pyridoxamine). I'm sure those suffering from diabetes were just thrilled with that. Heaven forbid, bit phama not be in on the profit of such a money maker.
Again, what does this have to do with cost to market? And as with Red Yeast Rice, if the "supplement" contains the active pharmaceutical ingredient of a prescription drug (or an investigative drug in the case of pyridoxamine), you can't sell it over the counter regardless of it's patented or generic.

All this hoopla when it's unquestionable that more deaths occur each year from aspirin than supplements?
Source please.... and again, what does this have to do with cost to market?

This bill is so poorly written and so ridiculously broad that it's asinine that it's even being proposed, IMO.
Let's hear some chapter and verse...
 
All that you need to know is that the FDA harms Americans everyday to know this is a bad idea...
 





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