51 replies to this topic

[rwac]

In order to mislead the public about the true nature of this bill, it has been named the Dietary Supplement Safety Act of 2010 (DSSA). Despite nutritional supplements’ safety record, McCain’s bill would give the FDA authority to draw up a list of allowed and disallowed supplements (and supplement potencies). This bill would cause any dietary supplement to be classified as “adulterated” if it is “manufactured, packaged, held, distributed, labeled or licensed by a dietary supplement company not registered with the Secretary.” The “Secretary” in this case is the Secretary of Health and Human Services, the department of the federal government that oversees the FDA.

This is likely to affect all the supplements that we take, so please notify your representatives about how you feel on this issue.

http://www.capwiz.co...lertid=14665781

Link to actual bill: http://mccain.senate...df-8318a24f718f

Edited by rwac, 11 February 2010 - 06:19 AM.

[JLL]

Waiting for the people who said something like this could never happen in them US to chime in...

[OneScrewLoose]

I am currently in Spain and the supplements that are sold here in the pharmacies are of super low quality and are super expensive.

[JLL]

In Finland the quality of supplements is presumably good, but they are indeed super expensive and contain only small amounts of active ingredients.

EDIT: In pharmacies, that is.

Edited by JLL, 11 February 2010 - 08:15 AM.

[DairyProducts]

For those unfamiliar with your politicians:
https://writerep.hou...p/welcome.shtml -- Find your representative.
http://www.senate.go...enators_cfm.cfm --- Find your senators
http://www.ehow.com/...ongressman.html

[Mind]

I am with Bill Faloon on this one.

Choice quote:

The bill supposedly originates from the controversy surrounding the use of steroids by Major League Baseball players. Since some unethical companies illegally sold steroid drugs as “dietary supplements,” certain members of the Senate (i.e., John McCain and Byron Dorgan) appear to have been deceived into believing that the FDA needs to be given additional power to ban dietary supplements across the board.

In these forums I have often mentioned that in the U.S. there is an increased push for regulation/bans of ALL health and performance enhancing supplements just so that no one breaks the baseball home run record. Silly.

Faloon is correct that there is a great deal of innovation going on in the supplement and nutricuetical industry and the FDA will do nothing but get in the way (as seems to be the case with immuno-cancer therapy as well). In addition, the tools for individuals to evaluate supplement providers (quality and safety) are sufficient and increasing.

[chrono]

Anyone who thinks this kind of thing can't happen in the states is still buying the propaganda they sold us in elementary school.

I'm afraid this kind of thing will sound all-too-reasonable to the regulation-happy political elite of this country; if they can tie dietary supplements to any kind of illegal "drug," it will probably sound reasonable to 90% of the population.

What are some good arguments to present to a so-called representative, who is mainly interested in the opinion of those with money, power, and the ability to elect them (moreso than preserving my ability to explore largely experimental compounds)?

[JLL]

I think the whole "I'm going to write to my congressman and hope he's going to do the right thing instead of accepting a million dollars from that nasty lobbyist guy" approach is pretty childish, but hey, let's hope I'm wrong...

[Logan]

I think the whole "I'm going to write to my congressman and hope he's going to do the right thing instead of accepting a million dollars from that nasty lobbyist guy" approach is pretty childish, but hey, let's hope I'm wrong...

Umm childish? A child wouldn't take that kind of initiative. Maybe you think that someone must be childish by thinking it's going to make a difference. Well, I bet if enough people did it, it just might have some kind of impact. At least it might influence congressmen to say something on the matter and bring awareness to the issue, whether it changes things or not.

[rwac]

I think the whole "I'm going to write to my congressman and hope he's going to do the right thing instead of accepting a million dollars from that nasty lobbyist guy" approach is pretty childish, but hey, let's hope I'm wrong...

Well about 54% of Americans use supplements daily.
And a significant percent of that are old people who vote.

For every person who bothers to mail in a protest letter, lots of people won't bother, so there's an amplification factor.

A million dollars in campaign funds isn't much use if you annoy your constituents.

[DairyProducts]

Is this only about the baseball thing? Are pharmaceutical companies behind this? If not, the supplement industry has fairly good lobbyists and I doubt they would let this thing harm them unless an even bigger industry was lobbying against them.

Harkin and Hatch are pretty high ranking senators and they were behind DSHAE, but you never know how things will turn out with bills like this. Just trying to figure out the likelihood of this thing passing.

[DairyProducts]

Well about 54% of Americans use supplements daily.
And a significant percent of that are old people who vote.

I'm sure a fair amount of senators use supplements too, although maybe they won't even look at the bill they are voting on.

For every person who bothers to mail in a protest letter, lots of people won't bother, so there's an amplification factor.
A million dollars in campaign funds isn't much use if you annoy your constituents.

You're right rwac. A lot of people underestimate the power of contacting representatives, especially when its about a bill that isn't getting a lot of media attention.

[OneScrewLoose]

I am willing to bet that representitives are really uninformed on this matter, and could go either way. That means, if they are going to vote on an issues that they know nothing about, and there are enough pissed off constituents, the rep is going to go with the constituents.

[chrono]

Sure, writing to congress has a questionable effect unless a lot of people do it. It's all a numbers game. It is a good way to collect form-letter responses, though.

What I'm wondering is what to say if one does decide to try this. In other words, from a regulator's perspective, what is so bad about allowing the FDA to decide what supplements are safe and ethical?

Edited by chrono, 12 February 2010 - 08:25 PM.

[Chaos Theory]

I personally can't see this happening. The supplement industry in the U.S. is massive and rakes in billions each year. All of the corporations and nationwide chains involved would stand to lose a great deal of money, if not be forced out of business entirely, by any significant amount of regulation.

I seriously doubt GNC, vitamin shoppe, Bodybuilding.com, Iherb, as well as all of the manufacturers are going to sit idle while a bill like this is passed. That's in addition to the ever growing, health conscious, voting demographic who would really be up in arms over this.

I've never been much for political activism, but this would push me far over the edge.

[yoyo]

Anyone who thinks this kind of thing can't happen in the states is still buying the propaganda they sold us in elementary school.

What? I remember anti-drug propaganda in elementary school (DARE), and hey, say thing again.

[niner]

Has anyone actually read the bill? I just read it and it doesn't look all that bad. What exact part of it are people objecting to?

[Chaos Theory]

Has anyone actually read the bill? I just read it and it doesn't look all that bad. What exact part of it are people objecting to?

I didn't go through the entire bill but as it is written it seems that they want everything to be cleared with the FDA before it can be sold. It said that clinical studies have to be presented to "prove" a supplement is safe before it can be sold. It would be at their discretion what is "safe" and what is not.

As great as it sounds for only safe supplements to be on the market, I fear it would result in many supplements disappearing entirely. Who is going to pay for the safety trials? It's also no secret that the FDA works with big pharma. As much as I hate to discredit my post by pointing it out, I do fear that some supplements which effectively replace prescription drugs would be blocked from the market. Then you also have the problem of "safe" doses which could reduce the effectiveness of the products that do reach the market.

The worst case scenario is that this bill goes through and the demand for supplements creates a massive grey market. Vitamins being sold as "research chemicals" or maybe we'll be picking them up with our overseas prescription orders.. That would be quite ironic and also typical if their overzealous control actually forces people to obtain supplements of more questionable purity from overseas.

Edited by Chaos Theory, 13 February 2010 - 08:02 AM.

[nightlight]

I personally can't see this happening. The supplement industry in the U.S. is massive and rakes in billions each year. All of the corporations and nationwide chains involved would stand to lose a great deal of money, if not be forced out of business entirely, by any significant amount of regulation.

The big players in supplement business may see an opportunity in higher regulation to squeeze out the little players and increase their profits by back-stabbing their customers (as big tobacco did repeatedly in recent years). After all the greatest supporter of FDA & other "health" bureacracies is the big pharma (also the biggest among big tobacco - Altria/PM), which has coopted the nominally noble goals of imporved drug safety and has transformed these bureacracies into mafia style enforcers, working hard for the big pharma to keep the competition out, the drug prices high and the consumer protection at the bottom of the FDA priority list.

Edited by nightlight, 13 February 2010 - 08:25 AM.

[Mind]

Has anyone actually read the bill? I just read it and it doesn't look all that bad. What exact part of it are people objecting to?

The entire bill. Under it, all determinations on dietary supplements are at the arbitrary discretion of the FDA. There is no clear definition of what is "generally considered safe". Which means, as others have pointed out, the process of regulating the dietary supplement industry will be either uneven and arbitrary/nonsensical or politically/financially manipulated.

I am perfectly capable of deciding which supplements are safe for me (and taking responsibility for those decisions) but even more importantly, the FDA has admitted that it is incompetent. They specifically admit that they can't keep up with "new science" and "new products". It would be foolish in my view to pile more duties on top of a regulatory body that doesn't know what it is doing. Talk about a recipe for disaster.

[AgeVivo]

It would be nice to have lifespan tests performed in mice or rats (but not limited to ages below 2y): in the name of long term toxicity we would know what may extend or reduce lifespan; in mice and rats of course, but that would drastically change our knowledge of what should be taken or avoided for a long life.

Now, I don't know how realistic it is to believe that we could lobby to put such tests in place...

Edited by AgeVivo, 13 February 2010 - 05:11 PM.

[niner]

Has anyone actually read the bill? I just read it and it doesn't look all that bad. What exact part of it are people objecting to?

I didn't go through the entire bill but as it is written it seems that they want everything to be cleared with the FDA before it can be sold. It said that clinical studies have to be presented to "prove" a supplement is safe before it can be sold. It would be at their discretion what is "safe" and what is not.

Well, there's this:

1 ‘‘(a) IN GENERAL.—A dietary supplement which con2
tains a new dietary ingredient shall be deemed adulterated
3 under section 402(f) unless there is a history of use or
4 other evidence of safety establishing that the dietary ingre-
5 dient when used under the conditions recommended or
6 suggested in the labeling of the dietary supplement will
7 reasonably be expected to be safe and, at least 75 days
8 before being introduced or delivered for introduction into
9 interstate commerce, the manufacturer or distributor of
10 the dietary ingredient or dietary supplement provides the
11 Secretary with information, including any citation to pub-
12 lished articles, which is the basis on which the manufac-
13 turer or distributor has concluded that a dietary supple-
14 ment containing such dietary ingredient will reasonably be
15 expected to be safe. The Secretary shall keep confidential
16 any information provided under this subsection for 90
17 days following its receipt. After the expiration of such 90
18 days, the Secretary shall place such information on public
19 display, except matters in the information which are trade
20 secrets or otherwise confidential, commercial informa-
21 tion.’’;

But I didn't see any requirement for clinical trials.

The worst case scenario is that this bill goes through and the demand for supplements creates a massive grey market. Vitamins being sold as "research chemicals" or maybe we'll be picking them up with our overseas prescription orders.. That would be quite ironic and also typical if their overzealous control actually forces people to obtain supplements of more questionable purity from overseas.

Yes, that's a concern. There's a tension between people like us who know what we're doing (mostly) and want access to everything, and those naive youngsters who buy something on the net thinking that it's "safe" because it's a "supplement", not a "drug". I would argue that the penalty for their naivete shouldn't be death, merely because some unscrupulous supplement peddler was out to make a quick buck. Unfortunately, the cost of protecting them might be me not being able to get something that I want. If this is implemented correctly, it should provide a little protection for the knuckleheads without inconveniencing us. If it's done stupidly, then we will suffer, and we may see the worst case scenario that Chaos Theory describes. The easy thing to do would be to say I don't want any laws at all. It's tougher to come up with a scenario where the truly dangerous supplements are gone, and the really flaky low quality producers find another line of work, but we still get what we want. I have to say, I'm torn on this. I don't want to get hosed, but I'm not entirely comfortable just throwing the innocent public to the wolves.

[chrono]

But I didn't see any requirement for clinical trials.

"at least 75 days before being introduced or delivered for introduction into interstate commerce, the manufacturer or distributor of the dietary ingredient or dietary supplement provides the Secretary 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."

I doubt the FDA will accept anecdotal evidence for this requirement.

I would argue that the penalty for their naivete shouldn't be death, merely because some unscrupulous supplement peddler was out to make a quick buck. Unfortunately, the cost of protecting them might be me not being able to get something that I want.

I'm not sure what kind of situation you're picturing here, which wouldn't already be covered under truth in claims/labeling laws. If you're talking about the kind of person who just pops a pill without knowing its effects, I'd say a more reasonable remedy is education in some form, maybe stricter requirements for warnings.

Depriving everyone of a way to improve their quality of life to protect the kinds of people who will find some way to hurt themselves anyway is not the direction society should be heading.

[Chaos Theory]

Well, there's this:

1 ''(a) IN GENERAL.—A dietary supplement which con2
tains a new dietary ingredient shall be deemed adulterated
3 under section 402(f) unless there is a history of use or
4 other evidence of safety establishing that the dietary ingre-
5 dient when used under the conditions recommended or
6 suggested in the labeling of the dietary supplement will
7 reasonably be expected to be safe and, at least 75 days
8 before being introduced or delivered for introduction into
9 interstate commerce, the manufacturer or distributor of
10 the dietary ingredient or dietary supplement provides the
11 Secretary with information, including any citation to pub-
12 lished articles, which is the basis on which the manufac-
13 turer or distributor has concluded that a dietary supple-
14 ment containing such dietary ingredient will reasonably be
15 expected to be safe. The Secretary shall keep confidential
16 any information provided under this subsection for 90
17 days following its receipt. After the expiration of such 90
18 days, the Secretary shall place such information on public
19 display, except matters in the information which are trade
20 secrets or otherwise confidential, commercial informa-
21 tion.'';

But I didn't see any requirement for clinical trials.

The way it is written it still seems that it would be at their discretion whether there is enough "evidence" to support the use of a supplement. I wonder if thousands of years of use by indigenous cultures would be enough to conclude that any herbal supplements are safe. I tend to doubt that would be enough to stand up to their scrutiny.

Could whole herbs fall into the category of supplements or would it have to be an extract?

Even if the extracts were to go that would be a shame. Some whole herbs aren't nearly as effective as the patented extracts.

[N.T.M.]

The FDA always wanted to regulate supps. Thank God they care about us so much. lmao what a fucking facade. I'm tired of all the corruption. :(

[mike250]

I have to say, I'm torn on this. I don't want to get hosed, but I'm not entirely comfortable just throwing the innocent public to the wolves.

as though you are "above" the public. "Guys, what about my slaves? They might get hurt!"

My little ones, you can't possibly look at labels. You can't possibly use Google to search "side-effects of drinking Drain-O"!

Edited by mike250, 17 February 2010 - 02:02 AM.

[DukeNukem]

I just did this.

I rewrote the letter, keeping it short but non-generic, basically saying, "Do NOT take away my RIGHT to buy and take supplements..." I took a very firm tone. I hope others do the same.

[niner]

I have to say, I'm torn on this. I don't want to get hosed, but I'm not entirely comfortable just throwing the innocent public to the wolves.

as though you are "above" the public. "Guys, what about my slaves? They might get hurt!"

My little ones, you can't possibly look at labels. You can't possibly use Google to search "side-effects of drinking Drain-O"!

Giving a shit about anyone besides myself = considering myself "above" everyone else. Right. Well, cowboy, I hope you get your way. I know how to read labels, and how to read the literature. I'm sure the general public will be juuust fiiine. All they need is the google.

[rwac]

Giving a shit about anyone besides myself = considering myself "above" everyone else. Right. Well, cowboy, I hope you get your way. I know how to read labels, and how to read the literature. I'm sure the general public will be juuust fiiine. All they need is the google.

Well, I think we've all been there. People don't usually start out reading ImmInst, atleast I didn't.

I don't know that the general public needs to be coddled here.

[chrono]

Giving a shit about anyone besides myself = considering myself "above" everyone else. Right. Well, cowboy, I hope you get your way. I know how to read labels, and how to read the literature. I'm sure the general public will be juuust fiiine. All they need is the google.

I hardly think "giving a shit" about others is necessarily synonymous with going to extreme lengths to remove every conceivable possibility of harm. Unless you're talking about toddlers, I suppose. But most houses still have knives and laundry detergent, and stairs.

You never answered my question about exactly how the public is being "thrown to the wolves," and presumably has been for the past 15+ years. Are there supplements readily available which might easily kill "naive youngsters," as you suggested? If so, are they being presented anywhere in such a way that someone would be given the idea to purchase them, without having any notion of possible downsides?

Or are you saying that's simply a possibility in the current framework?

Edited by chrono, 17 February 2010 - 08:26 AM.