WEEK SIX :: Should There Be MORE Or Less Regulation On Supplements?

[admin]

TOPIC: Should There Be MORE Or Less Regulation On Supplements?

For the week of: Nov. 15th - Nov 21st.

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The FDA is working on some new possible rules for regulating dietary supplements, and in the past year, many popular supplements have been banned. Should the FDA put more regulations on supplements and supplement manufacturers to keep the consumers safe from dangerous products (or dangerous marketing tactics)? Or should the FDA leave the market alone and give the the consumers the freedom to decide what they want to use?

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Don't discuss any other topic in this section. ONLY discuss the question above.

The best response will get $50 in credit to use in our online store! The other good responses will be used in an article on the main Bodybuilding.com site, with the poster's forum name listed by it.

Thanks!
Bodybuilding.com

[Lok7y]

I don't really think you can paint this as a 'black-and-white' issue. There really are shades and gradations when it comes to issues such as these.

Now, regarding supplements themselves, I tend to take a very libertarian view of supplement-use. It's your body--you should have every right to be able to put what you choose to into your body, assuming you know the consequences.

However, why I can't state the above as an absolute is because of that final clause, the "consequences" part. And this is where it gets extremely tricky. Invariably, when one has a product with appeal, it will be picked up and used by some who have not taken the time to adequately inform themselves about the product. Case-in-point: I have seen post after post on various boards across the internet detailing 17aa-1-Testosterone usage by individuals who clearly a.) do not understand that it is a steroid, b.) are ignorant about proper protocol for using ANY steroid, and c.) essentially picked it up solely on word of mouth without doing any investigative research into it before beginning their cycle. But, at the same time, I feel that even something as potent as M-1-T CAN conveivably be used 'safely' in the hands of an individual who takes the proper precautions and is extremely versed in what they are doing.

So in general, I would like to see:

1. No amendments to the DSHEA or anything that deprives the market of specific 'supplements' so that--as I said above--individuals can make informed decisions about what is available to them and use it.

2. Stricter guidelines regarding label-claims. The industry is rife with products that either a.) don't meet label claims, b.) make label claims that cannot be corroborated &/or are not backed by any valid scientific research, and/or c.) are pure hyperbole. I think this is one area where the FDA could be doing a far better job in actively assuring quality and that products actually a.) are what they claim to be and b.) provide the benefits they claim to provide. Obviously, I understand this is a business, and some degree of 'marketing our products' has to be allowed for. All the same, there are some gross and egregious acts of exaggeration and deception that have occurred in this industry, and I think it's easily time a stop is put to the vast majority of them.

3. An age-ban on androgens/anabolic substances. 18 (perhaps 21). I realize that age =! maturity or intelligence, but--generally-- I think this would have been beneficial had it been instituted long ago. Obviously now this last point is moot in light of the upcoming ban. Shame too.


Just my .02.

[NosLliWhsoj]

Today, every bodybuilder and athlete is looking to get ahead of his or her competitors. The new 'fad' has become performance-enhancing supplements that are used by all types of people. The problem arises when those uneducated individuals use certain products. I remember back in high school everyone started getting into creatine because they heard it would make the stronger and help them grow bigger muscles. Unfortunately, they did not know the risks or the appropriate dosages and usage. One of my close friends was diagnosed with partial kidney failure that the doctors attributed to the use of supplements. Although he did gain the mass he was looking for, he could not play sports for the remainder of his senior year.

I think problems like these are more likely than many would like to imagine. Others do not even know what these products could actually be doing to them. Today, it is more common to disregard the warnings on the label, and just start "getting bigger."


The FDA should regulate supplements, as the true effects of most supplements still remain unknown. I would not risk my future health in an attempt to raise my performance. People have already died from Ephedra/Ephedrine and similar products. For now, I'm sticking with the ageless quote, "It's better to be safe than sorry." There are other ways to make gains. It's time to stop cheating ourselves and to rely on our own self-motivation for success.

[Smithbrat]

Because this subject is truly wide reaching I am one who is between the cracks (so to speak). I am 60 years old and have lived with a condition that only in the last 20 years have been able to really cope with in my own way. The solution that I found that has served me well has now been removed from me this last spring. I am referring of course the infamous 'ephedra'.
Now I am not a bodybuilder. I'm just an ordinary housewife who has to care for others and that requires my ablility to think, and drive, and stay in a fairly cognitive state most of the time. My condition in the medical field has no cure only a support regimine that would make me a junky the rest of my life. I have chosen NOT to go that route, this is the route the government and medical profession would condone. I don't understand this country sometimes. Ma Hung or whatever it is called is a plant that God created. It is not synthetic. Why on earth does our government think they have a right to stop anyone from using something natural that was Godgiven if used in a responsible way. They would pump us full of chemical concoctions that most of the time end up hurting and killing and this is proven fact. Anything can kill! I took 2 Alieve and went into anaphylactic shock. I didn't know I was allergic to it. They advertise this all the time on TV. It makes me laugh. It alieves pain. Boy it worked for me, almost permanently. Ephedra or aspirin, or a bee sting can kill. If it is your time to go your gonna go. I'm sorry but that is life. Sure there are stupid people who don't read directions or are just out there to get a high on stuff. There have been those kind since the beginning of time and there will always be. The goverment will never be able to stop people like this. Intelligent people who I hope are the majority have a right to take care of there own bodies. It is a Godgiven right. It is the only thing left out of the constitution which should have been there. If it had we wouldn't have this monstrosity called the AMA.
As it is I have had to use this ephedrine stuff with that ingredient in it that is causing me great distress because I almost drown in the stuff coming out of my lungs. I don't smoke and I don't have lung or bronchical problems. If the ephedrine is legal I need to find it in a state alone without being attached to something I don't need. I use gensing with the ephedrine and it seems to allow me to drive and read and work on the computer without my brain going into a holding pattern. Oh,by the way, I am 200 lbs and have been for most of my life. I was using your Ephedra 850. It worked great for me.
I thank you for letting me vent. I know there is nothing that can be done now before my time is up but I think personally that our country and it's ego and self important stance is going to get it's butt kicked one of these days and then I suppose we will all be out of luck when it come to just being able to get the products we have access to now.

[1MikeD]

With less regulation we the people have more personal freedoms and that is what the founding farthers intended.

[JSMB]

Before answering the questions posed for this week, it’s important to take a look at exactly what the regulations are that the FDA plans to implement. Without that information, formulating an informed opinion is somewhat difficult, if not impossible.

FDA’s task is to ensure that dietary supplements, when used under conditions recommended by the labeling, or, in the absence of labeling, under normal conditions, do not pose an “unreasonable risk of illness or injury.” In making these decisions, the agency relies most heavily on history of use, aggregated reports of adverse events, and reliable, proven studies of the product or ingredient in question. Their decisions are not made for arbitrary or political reasons.

The FDA announced a regulatory strategy for further implementation of the Dietary Supplement Health and Education Act of 1994 (DSHEA) on November 4 (See: http://www.fda.gov/bbs/topics/news/2004/NEW01130.html). Their strategy can be broken into three areas: 1) monitoring and evaluation of product and ingredient safety, 2) assurance of product quality by finalizing a regulation governing “current good manufacturing practice” and 3) monitoring and evaluation of product labeling.

Until passage of DSHEA the FDA did not make a determination as to whether a supplement posed an unreasonable risk, until after that product was on the market. However, DSHEA required the Agency to begin making pre-market determinations for any product introduced after October 15, 1994 that contained a “new dietary ingredient”

A supplement is by law deemed to be adulterated unless it includes an NDI that “has been present in the food supply as an article used for food in a form in which the food has not been chemically altered,” or “[A] history of use or other evidence of safety establishing that the dietary ingredient when used under the conditions recommended or suggested in the labeling of the dietary supplement will reasonably be expected to be safe,” and the company producing the supplement has provided the FDA with information, including any citation to published articles, which is the basis on which the manufacturer or distributor has concluded that a dietary supplement containing such dietary ingredient will reasonably be expected to be safe.

FDA faces the task of establishing criteria for how manufacturers inform the Agency of the “other evidence of safety” proving that their product is reasonably safe. The FDA has also begun moving to examine products introduced after October 15, 1994, that contain NDIs and for which the manufacturer has not provided adequate reason to deem them unadulterated. That, really, is the crux of the issue. Obtaining that data, for a new product, one that truly has no history within the food supply, can be extremely expensive and those costs would be passed on to consumers. On the upside, it certainly would weed out any company trying to sell bodybuilders a bunch of snake oil. The trade off is between paying more for supplements that have been shown to be at least reasonably safe and not terribly likely to kill or injury you and paying less for supplements that may or may not be dangerous. The effectiveness of the products, on the other hand, is another question unto itself. Supplement manufacturers can refuse to overtly affirm that their product will result in a given effect but hint at it in their advertising (in which case, it becomes an issue for the FTC and the FDA together, i.e., false advertising).

The second aspect of the FDA’s regulatory initiative is to ensure good manufacturing practices in the facilities that manufacture the things bodybuilders and others are going to be putting into their mouths. For example, are the plants ensuring that their manufacturing processes monitor and correct for problems with superpotent and subpotent products, wrong ingredients, presence of contaminants (e.g., bacteria, pesticide, glass, and lead), underfilled containers, foreign material in a container, improper packaging, and mislabeling. All of these requirements cost money, of course, which will be passed on in the form of higher prices to the consumer, but I for one, would rather not be stirring rat droppings into my protein shake in the mornings and am willing to pay a few more cents for a reasonable assurance that the manufacturer is looking out for such things and will, if I find one, at least be fined, or disciplined by the FDA.

The third aspect of the regulatory initiative is to ensure the accuracy of labeling. Labeled claims about the effect of the supplement on the structure or function of the body, general well-being from consumption and benefits related to classical nutrient deficiency diseases are not subject to pre-market approval by FDA (although they require pre-market notification to the FDA and a disclaimer statement on the label stating that those claims have not been validated by the FDA). However, claims about use of the supplement to diagnose, prevent, mitigate, treat, or cure any non-nutrient deficiency disease are prohibited. The FDA is concerned that individuals with serious diseases could be mislead by labels on dietary supplements and the will be working to ensure that supplement manufacturers comply with the law in this regard.

So, there’s what the regulatory initiative is all about.

If you want to read more about the whole thing, you can read the text of the statute the regulations are based on at: http://thomas.loc.gov It's Public Law 103-417).

You can read a description of the regulatory initiative here: http://www.cfsan.fda.gov/~dms/ds3strat.html

And, more important, if you want, you can actually participate in the regulatory process. The Administrative Procedures Act requires Federal agencies issuing regulations to accept public comments on most of their proposed regulations and guidelines. The FDA has solicited public comment on the criteria it should use for establishing whether or not an NDI has been shown to be reasonably safe. Many companies are providing the Agency with information to demonstrate the safety of their supplements, but there are no consistent guidelines for what that information should consist of, or how it should be validated. The Agency, therefore, has asked that the interested public let it know what their thoughts are. These criteria, as mentioned above, are the real crux of the issue. If these guidelines are very stringent, it will cost supplement manufacturers a great deal to prove the safety of their NDIs and those costs will be passed on. If those guidelines are more general, then the cost of proving their safety will be lower.

You can review a comprehensive list of proposed guidelines that the FDA is considering here: http://www.fda.gov/OHRMS/DOCKETS/98fr/04-23439.htm under Section IV. If you want to comment on the proposed guidelines, you should go here: http://www.accessdata.fda.gov/script...ID=&AGENCY=FDA

Keep in mind, when you comment, that you must be specific and to the point. You must cite the exact proposed guideline you wish to comment on and stick to that issue. Speaking as someone who has reviewed public comments on regulatory issues, I can tell you that if you go off on a rant about Congress and the regulatory process in general, your comments will have no impact, because they simply cannot be directly applied to a specific proposal. So don’t start raving about how it’s your body and if you want to get all hopped up on dimethylethylproplywhatsitol, then that’s your own business. The comment period ends on December 3, 2004.

Now, as to whether the FDA should impose more regulations on supplement manufacturers, or let people decide on their own what they’re going to ingest? In one sense, this question is a moot point, since the law requires such regulations and there is nothing the Agency can do to avoid that. So if you REALLY want this all to go away, you’d have to start a serious lobbying campaign for legislative change, which is only slightly more likely to happen than President Bush mailing off a gold embossed invitation to Osama Bin Laden to join him for tea and biscuits in the Rose Garden.

The real issue is how stringent the requirements will be for manufacturers trying to prove the safety of their new dietary ingredients, and how firmly they will enforce the good manufacturing practices and the labeling requirements, because the FDA does have administrative lattitude in deciding those issues.

With regard to the first question, I am in favor of stronger, rather than more lax requirements. When it comes to my personal health and safety, I’d rather be on the safe side and am willing to pay a few more cents to have the peace of mind that comes from an adequate regulatory scheme. But that is also a reflection of the fact that I have made a firm decision not to use any supplements other than whey powder, flax oil and occasionally a children’s multi-vitamin. I would feel like I was somehow cheating myself out of the lessons of weightlifting, out of the achievement of it, if my success was dependent on something other than my own will power, dedication and hard work.

On the latter two questions, I am more in favor of strong regulations. I’d like to be reasonably assured that the products I’m getting are accurately represented on their labels so that I can at least have an uninterested party to counter all of the marketing hoopla. I’d also like to be sure that the manufacturing processes engaged in to produce those supplements result in a safe product. One without any rat droppings, or human thumbs, that actually weighs 5 pounds, not 4.75.

Everyone is, of course, free to read the documents I’ve cited and make up their own mind.

[chewwy]

^^^ well, you've saved me an hour of my time tomorrow. everything i was going to say has been said, and has actually been backed up. very well done. i might post my rather daintier article which i started yesterday anyway...

[MHawks]

Do they need more regulations on suppliments that is a tough one. Unfortunately people that are left to there own devices will screw things up. I believe suppliment companies put sufficent warnings on the lable , but people been people will go over the top . Ephedra for example , the lable says DO NOT EXCEED 4 TABLETS A DAY , what do they do , take ten , I have used pro hormones and ephedra , and various other suppliments and have never had any bad reactions , and i would say most people wouldnt . but hey there are alot of idiots out there and they stuff it up for every one . Then on the other hand people are aloud to smoke and drink and this causes no end of trouble health wise but do government agencies bother with these problems . It seems to me that they are on a suppliment witch hunt why who knows . I believe there should be less regulation on suppliments , as long as the product is safe under certain guidelines , if an individual decides to push those boundries that is his or her problem . Who knows where it might end , they may decide there are to many obese people so they may regulate how much fast food you are aloud to eat , dont laugh it may happen , i think we will all lose more freedom of choice , think about it after the tenth of January if you get caught taking a pro hormone of have them in your possession you could face a year in prison , if you get caught selling them you could face 5 years in jail , only a day before you could still take them legally . whats next .multi vitamins .

[chewwy]

The bodybuilding industry is now saturated with products in a wide array of potencies, all claiming to increase growth, recovery time etc. These go from the natural, essential supplements such as whey protein, to the dangerous and drastic synthol. Where to draw the line as to what is acceptable for an athlete to legally use is a debatable issue, and one we will discuss in this article.

The governing body regarding this issue in the United States is Food and Drug Administration, or FDA for short. While this organisation in principle only has the power to change laws in the USA, it usual for other countries to follow suit. Furthermore, if a product is to be made illegal in the USA, this gets rid of a large chunk of the producers market, and so the product may be discontinued.

The case FOR more regulation:

Of course, in order to be banned, a product must actually be attributed to health risks, and it is widely acknowledged that these substances that are banned are banned for a reason. In fact, most people accept that a lot of legal substances indeed cause unsightly health problems, and that they all too often fall into the hands of young, uneducated bodybuilders looking for a quick way to get big. Dangerous substances are easily and relatively cheaply available to those who want to use them, and this situation means problems are rife to occur.

Most supplements, especially the newly emerging ones, with the most drastic results, are very much unresearched, meaning the full extent of its side-effects remains unknown. In this day and age, where the culture of the law-suit is rife, it is sensible for the FDA to ban any products which potentially cause health problems, if nothing else to be safe.

The case AGAINST:

This side of the argument revolves mainly around the point that it is the athlete’s own choice what substances they wish to put inside them. It should be noted that the FDA controls what products are deemed suitable for ‘everyday use, and that sporting associations, for example the IFBB, have the right disallow or conveniently disregard whatever substances they deem suitable for their competitions, and this article is not discussing that issue.

It should be expected among any serious athlete that they will have researched all affects of whatever they plan on taking, and concluded that any negative side-affects are outweighed by the product’s positive selling point. Any damage done will only be upon the athlete’s own body, and so it seems ridiculous that people are still allowed to purchase guns and other deadly weapons over the counter, while products such as Ephedera and Androstenedione, which at the most pose(d) mild health risks to the individual, according to sometimes circumstantial evidence, are outlawed.

Nowadays, everything known to man has been proven one way or another to negatively affect one’s health and through articles freely available to the public, everyday people make choices as to what to put inside them, knowing of the consequences. We cannot live our lives wrapped up in cotton wool, protected from everything with adverse side-affects. If this was so, and was what our governing bodies actually wanted, then smoking, alcohol, and fatty foods would all have been banned long ago.

Compromise?

The fact is, if people really want to get their hands on the most powerful steroids, they will, regardless of the law. So, rather than banning them completely, and creating an underground trade network, the persona of these substances should be changed. The reputation of steroids has been hyped up over the past few decades, to the point where they are the supposed staple diet of pros. This is due mainly to people in general, and their reasoning of how people get to that size, rather than the big companies behind these products. This attitude needs to be changed, not only to solve this problem, but also for the greater good of the sport, which currently has the ugly aura of steroids looming over it, casting all of it’s greatness in darkness.

Rather than an all-out ban on substances, it would be wiser for the FDA to ensure stricter product labelling and advertising procedures, and possibly make certain substances only available ‘prescription only’, ie. after an interview with a qualified professional, like a personal trainer/nutritionist.

[Audioslave]

Originally Posted by JSMB

I have made a firm decision not to use any supplements other than whey powder, flax oil and occasionally a children’s multi-vitamin

Exactly how old are you? Pretty damn good article if you are a child

[NosLliWhsoj]

Originally Posted by 1MikeD

With less regulation we the people have more personal freedoms and that is what the founding farthers intended.

Even though it may be harmful to your health?

[1MikeD]

Originally Posted by NosLliWhsoj

Even though it may be harmful to your health?

The founding farthers believed that a government that governs the least governs the best. The real question is do you want more laws telling you what to do or do you want to make your own choices?

[JSMB]

Originally Posted by Audioslave

Exactly how old are you? Pretty damn good article if you are a child

Mid-thirties. I take the children's vitamin because we already have them for the kids (and they taste better :-)). I eat a pretty balanced diet with a fair bit of whole grains, veggies and fruit and I figure I get pretty much everything I need from that and taking an adult vitamin would be sort of overkill.

Hope my rather long winded article was of some use.

[Audioslave]

Originally Posted by JSMB

Mid-thirties. I take the children's vitamin because we already have them for the kids (and they taste better :-)). I eat a pretty balanced diet with a fair bit of whole grains, veggies and fruit and I figure I get pretty much everything I need from that and taking an adult vitamin would be sort of overkill.

Hope my rather long winded article was of some use.

Oh, that makes sense
Your article was very good, and very informative.

[NosLliWhsoj]

Originally Posted by 1MikeD

The founding farthers believed that a government that governs the least governs the best. The real question is do you want more laws telling you what to do or do you want to make your own choices?

Then why is heroin illegal? and j-walking?

[Lok7y]

FDA’s task is to ensure that dietary supplements, when used under conditions recommended by the labeling, or, in the absence of labeling, under normal conditions, do not pose an “unreasonable risk of illness or injury.” In making these decisions, the agency relies most heavily on history of use, aggregated reports of adverse events, and reliable, proven studies of the product or ingredient in question. Their decisions are not made for arbitrary or political reasons.

Not trying to be a polemic, but I'm a tad skeptical of this claim. One need look no further than the pending investigation into the FDA regarding Vioxx, Crestor, Serevent, Meridia, et al, all corporate pharmaceutical drugs that have posed far more "unreasonable risk of illness or injury" than their supplement counterparts like ephedra or synephrine, and yet which ones are we seeing repeatedly on the chopping block?

Just think about--at least in recent years--how many "supplements" have been pulled, sued, banned, or reclassified in relation to the amount of widely-circulated pharmaceutical offerings that have repeatedly been shown to elicit negative physiological contraindications even in generally healthy individuals. I mean, the double-standard at work here is atrocious. It's deemed fundamentally unsafe for an informed individual such as myself to use a sypathomimetic like E/C for workout energy & mental clarity, and yet my six year old little cousin can get 4-different amphetamine salts rendered into an OTC tablet so he can play nice with his peers in the sand-box? That's why I generally find such contentions laughable. Oh, but wait, as long as my ephedrine is bonded to hydrochloride salts and I'm taking it with 200 concurrent milligrams of caffeine to "mitigate some asthma" I'm golden. And, ironically enough, the safety profile of E/C is far better than many actual prescription asthma medications like Serevent, which clinical interim analysis has demonstrated increases a patients risk of suffering from life-threatening, asthma-related episodes. I'm not kidding, people have literally died in clinical settings with a Serevent inhaler in their hands. And yet, since the 'potential benefits' outweight the 'potential gains' in GlaxoSmithKline handly little moral calculator, they kindly opted to take the admirably utilitarian step of bringing Serevent to market. And the FDA let them go right along and do it.

Just to add insult to injury, the most adverse health reports the FDA gets annually are related to aspartame use. And yet soccer moms and waifish 'health-conscious' adolescents across the land are able to freely inundate themselves with enough Diet Pepsi per year to fill a kiddie-pool to its metric limits. I would denounce the FDA as a bunch of hypocrits, except for the fact that there's so much tension and in-fighting in the organization that I don't even think the administration itself can articulate much of a coherent position on anything, except when they get lucky every now and then and manage to actual shape litigation like the soon-to-be-enacted DSHEA amendments. I mean, just the other day on capital hill Graham (who's the reviewer for the Food and Drug Administration's Office of Drug Safety) testified before the Senate Finance Committee that we may be "faced with what may be the single greatest drug safety catastrophe in the history of this country or the history of the world." And yet you want to put overwhelming faith in the FDA to litigate and regulate our supplements? Check please...

[JSMB]

You make some good points here.

One of the primary reasons for public support of the creation of the FDA in 1906, oddly enough, was the publication of Upton Sinclair’s book, “The Jungle,” in 1905. He meant to write a novel about the misery of the immigrant population, and his main character worked in a meat packing plant. As the saying goes, he aimed at the nation’s heart, and hit it in the stomach, with his unappetizing descriptions of how the meat they ate was processed. I don’t think there’s much argument about whether setting standards for safety of food and drugs is a good idea. Your criticism of the approval of Serevent would seem to indicate that you agree that some sort of controls should be put onto what can and cannot be sold and how those products can be represented to the public.

If we accept that such controls are necessary then, within the U.S. setting, that requires the creation of an executive entity with adequate statutory authority to accomplish this goal, i.e., the FDA. The situation with Vioxx certainly highlights that the FDA is not perfect and that there are internal disagreements about how it executes its tasks. One need only read Mr. Graham’s testimony (see: http://finance.senate.gov/hearings/t...1804dgtest.pdf ) to see that, at the very least, the Office of New Drugs and the Office of Drug Safety within FDA are not exactly on the same page. However, if the FDA does not always seem to be carrying out its statutorily mandated tasks in the most capable manner, it does not necessarily follow that we should do away with the entire agency.

If there was no FDA and no regulation of the supplement industry whatsoever, where would we be? Would we prefer to have the industry self-police, or wait for the media to start reporting on adverse events for us? Would we trust the information in the marketing materials (because, remember, without the FDA, there would be no nutrition labels)? These are rhetorical questions, really, because I don’t think many of us would truly be happy with such a situation.

So, let’s say we keep the FDA, understanding that Congress will need to keep its eye on the agency and that it will not always perfectly execute the law of the land. Where does that leave us with supplements?

Promulgating regulation is not an easy process. It’s always a balancing act and no matter what an agency does, it will always step on someone’s toes, either the consumer protection groups, or the manufacturers, or the purchasers. In some ways, stepping on toes is precisely what an agency is supposed to do. Federal agencies can’t just dream up regulation. They put those things out when the Congress writes a law requiring them to do so and the President signs that law. Sometimes they even irritate the Congress when they interpret the laws in a more lenient fashion than, say, the sponsor of the legislation intended them to.

When we discuss the FDA’s regulatory efforts, I do think it’s important to be very specific about what we’re talking about and not make sweeping judgments about a particular initiative based on poorly executed and somewhat unrelated functions (i.e., approval of Vioxx) within the same agency. That’s why I took so much time in my original post to detail what it was we’re looking at. I’m generally in favor of the initiative, as I laid out in my earlier post.

The beauty of the American system is that if you don’t like it, you can comment to the FDA and tell them they should make those information requirements for supplement companies including a new dietary ingredient in their product, as lenient as possible. You still have a chance to do so, and the Agency is required to respond to your comments. Doesn’t mean they’ll do what you say (they do have to stick with the statute and consider the comments of everyone else who speaks up too), but if you do stick to the point, they’ll have to take your comments into consideration.

So, go read the proposed guidelines at: http://www.fda.gov/OHRMS/DOCKETS/98fr/04-23439.htm and make your comments at: http://www.accessdata.fda.gov/script...ID=&AGENCY=FDA

And hey, if that doesn’t work and you’re really, really anxious to change things, then start writing your Representative and your Senators, although, given that it passed both the House and Senate on a voice vote (i.e., no one objected, at all), your chances of repealing the law are….. Well, like I said, Osama Bin Laden will be in the Rose Garden before the bill repealing that legislation will.

[Lok7y]

However, if the FDA does not always seem to be carrying out its statutorily mandated tasks in the most capable manner, it does not necessarily follow that we should do away with the entire agency.

Never said that, and I believe it would be folly to just up and "efface" the FDA. My criticisms were leveled to point out:

1.) the glaring flaws in methodology & ideology that the FDA seem to have adopted as an operative credo, one that takes an actively anti-libertarian view of dietary supplements (one that is often wholly unfounded, if not in the least slightly tendentious) and yet allows Big Pharma to essentially run its agenda, irregardless of the potential detriment to American consumers.

2.) that the FDA is an egregiously flawed regulator and enforcer of 'acceptable standards.'

Promulgating regulation is not an easy process. It’s always a balancing act and no matter what an agency does, it will always step on someone’s toes, either the consumer protection groups, or the manufacturers, or the purchasers. In some ways, stepping on toes is precisely what an agency is supposed to do. Federal agencies can’t just dream up regulation. They put those things out when the Congress writes a law requiring them to do so and the President signs that law. Sometimes they even irritate the Congress when they interpret the laws in a more lenient fashion than, say, the sponsor of the legislation intended them to.

This sounds like some Polly-Anna-ish text-book excerpt on social contract theory in relation to American political workings. Only sort of wrong. You don't think the FDA has free operational franchise via the FFDC&A? The FDA is not on a leash; they don't just sit around in a giant glossy building waiting for congress to pass a law so they can all boot up their computers. They have investigators and inspectors working constantly across the country in the name of upholding standards. They may not be able to enact laws, but they certainly can speed along their validation. And yet, again, as I've stated above, the FDA seems content to practice relativist moral equivalency as it pleases based on how the outcome(s) of said decision(s) will effect certain interest-groups. That's not just stepping on toes. That's going into a crowd and intentionally selecting someone's foot to shatter...

And hey, if that doesn’t work and you’re really, really anxious to change things, then start writing your Representative and your Senators, although, given that it passed both the House and Senate on a voice vote (i.e., no one objected, at all), your chances of repealing the law are….. Well, like I said, Osama Bin Laden will be in the Rose Garden before the bill repealing that legislation will.

Do you make a conscious effort to be this pedantic, or does it just come naturally for you? I worked for my senator, and that's part of the reason by the above--no matter how much you sugar-coat it--just furthers my frustration with the current system.

[JSMB]

Lok7y, you've obviously researched the issue of supplement regulation more than I and I have not meant to offend, so forgive me if I have.

One of the weaknesses of the internet is that it's difficult to know who the audience is, or what their level of knowledge and expertise is and therefore, how to properly pitch one's message. I would hazard the guess that with regard to supplements, you're much more knowledgeable than even most visitors to this board, and my posts have been aimed somewhat lower than your level, and certainly can be seen as pedantic in that sense.

The one thing that I would hope to promote, is public participation in the regulatory process. One of my goals in the posts was to let people know that if they don't like these regs, then there is still time for them to actually do something about it.

Professionally, I have worked as a Committee staffer in the U.S. House in a Subcommittee that had oversight over FDA (among other agencies). I have worked as a lobbyist in a medical trade association where I had responsibility for reviewing, commenting on, and providing education with regard to Medicare regulation and legislation, and currently, I work in the federal agency that oversees Medicare. I have worked directly on the development of regulation from statute, to final rule, and I have seen how at least this agency pays attention to and interacts with the Congress in that work. So my comments were not based simply on book learning, as it were.

Your own expertise and strong opinions are exactly the kind of thing that FDA needs. In fact, if you can draft comments on their proposed guidelines, from the point of view of a bodybuilder who wants reasonable access to supplements, and then share those comments with the rest of the community on these boards, along with precise information on how they can submit those comments to the FDA, that could have a real effect on the rigor of the guidelines they come out with.

Truth is, the guidelines are somewhat complex and providing a convincing response to them, one that the folks on this board could use, that will get the attention of the regs writers at FDA really needs to come from someone like you who can make an articulate, informed response.

I can tell people how to write good comments, and where to go to get them to the FDA, but I really don't have the background necessary to go after their proposed guidelines. You do. If you draft something responding to the FDA's proposed guidelines, I'd be happy to use them in responding to the FDA's request for comments. And if more of us use your draft, the impact will be somewhat greater.

You willing to take a stab at it?