Supplements - to Take or Not to Take?

[sunking]

Heard from a serious fitness buff friend of mine that Ephedrine is back on the market legally in the US. Can anybody confirm this?

 

[spitzky]

PACKAGING DIGEST

May 2005

Page 22

 

Ephedrine saga: News reports can be of little help

 

This month's practical advice is: Don't believe everything you hear on TV or radio or read in the papers about legal and regulatory issues. Ask an informed lawyer to sort it out for you.

 

It was with great interest that on Thurs., April 14, I read a whole series of online headlines. They noted that a judge "Strikes down FDA ban on Ephedra [ABC News, Fox News]," and "Utah judge strikes down ephedra ban [Associated Press]" and "Ephedra gets a reprieve, may be sold again [Washington Times]."

 

The federal judge in Utah did no such thing. That is, her ruling only applied to a limited range of products containing ephedrine. So, a few words here explain what really happened, and then we add a bit of media criticism.

 

Judge Tena Campbell, in the case of Nutraceutical Corporation v. Crawford, only ruled that the U.S. Food and Drug Administration's ban was invalid on those ephedra products with 10 mg or less of ephedra alkaloids per daily dose (which is what the plaintiff in the Utah case sold). Many ephedra products sold before the ban last year had much higher doses than that. The ruling doesn't affect the ban on those other products a whit. It's misleading at best to headline a story by saying the ban was overturned.

 

The agency's dramatic action against ephedrine-containing products, which FDA had associated with serious heart and other health problems in some people, took effect just about one year ago, after many years in which FDA examined the evidence (see PD, Feb. '04, p. 22).

 

FDA had previously proposed to restrict the product at one point, only to withdraw the proposal under pressure from other federal officials. It then went back, collected more evidence and then proposed the ban that went into effect last year. But according to Campbell, FDA's evidence of the product's danger at doses of 10 mg or below was still inadequate to justify outlawing the product.

 

That's in part because Congress, correctly surmising that dietary supplements were—generally speaking—usually safe, created a regulatory scheme that allowed products to go onto the market without prior vetting by FDA, and required the agency to prove that the products were unsafe if it wanted to pull them off of the market.

 

According to Judge Campbell, FDA's evidence of the product's danger at doses of 10 mg or less was inadequate to justify outlawing the product.

 

"The statute requires an affirmative demonstration of 'significant or unreasonable' risk at a particular dose level to support a finding of adulteration," wrote Campbell. The judge added, "There is not sufficient evidence in the administrative record to establish that the risks identified by the FDA are associated with the intake of low-dose [ephedrine-containing dietary supplements]."

 

Said the judge, for evidence of the dangers of low doses of ephedrine-containing products, FDA had relied primarily on a study in which a doctor compared the safety of ephedrine to the safety of intravenous injections of epinephrine, and had relied on a model of the expected effects based on the known effects of epinephrine.

 

The judge read the law and said that its plain language "requires a dose-specific analysis" by FDA, quoting a Senate report about the law back when it was proposed that said, "a safety finding cannot be entered against a supplement based upon a dosage not recommended to consumers in the labeling."

 

The judge continued, saying that with this product, "there is no specific data involving the oral ingestion of 10 milligrams per day of [ephedrine dietary supplements]."

 

Campbell sent the case back to FDA, ordering it to take further action "consistent with this order," which might mean that FDA looks at the evidence again and decides that 10 mg or less is not clearly unsafe, therefore can be sold. It also might mean FDA scrounges around for more evidence that those low doses are dangerous and uses that evidence to again ban them. Or it might appeal the case to the federal appeals court, arguing that Campbell's decision was not well reasoned on the facts or law.

 

In the meantime, Campbell ordered FDA not to take any enforcement action against Nutraceutical Corporation should they sell ephedrine products with doses of 10 mg or less, which they might again do.

 

So the decision clearly has no relevance at all to products with more than a 10-mg-per-day recommended dose. Therefore, a key question is: Why couldn't news reporters and editors report the facts?

 

Nowadays, when science and technology are ever more central to our lives, so that we need to understand them to judge how best to deal with them, and when a battle over "out-of-control judges" is brewing, so that we need to understand the legal system and what judges do in order to choose sides in that battle, the public needs sufficient information more than ever. And yet, too often when it comes to legal and regulatory issues, the TV and radio media in particular not only are short on details, but they also lack facts.

 

How many times has a TV reporter told you someone sued someone else, but didn't tell you what they sued for (I sometimes wonder if reporters even know there is always a written complaint filed by the plaintiff that they could read and analyze before trying to explain a lawsuit.)? If they tell you what they sued for, how often do they give you some idea of whether it's a typical case or a theory from Mars?

 

And on matters regulatory, how many times have news stories left you baffled about what the rules are, for example, about the environment or FDA regulations of drugs or foods?

 

My theory is that too few reporters who cover these issues understand the most fundamental facts about the law and the legal system, and end up misleading you when they report on it. In this instance, the explanation might be as simple as that the writers of the initial stories and headlines about this court decision never even read the judge's decision.

 

Meanwhile, some lawmakers want to strengthen FDA's powers in this area to avoid rulings like this, perhaps placing the burden of proving safety onto manufacturers. We haven't nearly heard the end of this ephedrine saga.

 

Eric F. Greenberg is principal attorney with Eric F. Greenberg, PC, with a practice concentrated in food and drug law, packaging law and commercial litigation. Visit his firm's website at www.ericfgreenbergpc.com. Contact him by e-mail at efgreenberg@uhlaw.com, or by phone at 312/977-4647.

[Guest k....]

oh yeah you did say casein over why a few mos back. then again i just take the stuff + creatine before and after hitting the gym. nothing beats the orgasmic sensations of eating real food

whey is probably not d best choice for meal replacement... i need something with casein... whey gets absorbed way too quickly, so its ideal after training but not for a snack

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[spitzky]

^ur bulking up?

[Olympus]

Tailor Made Nutrition:

 

part 1: http://www.t-nation.com/readTopic.do?id=856188

part 2: http://www.t-nation.com/readTopic.do?id=862942

part 3: http://www.t-nation.com/readTopic.do?id=869278

[moneyball]

I bought BSN's Nitrix and NO-Xplode (any of you guys familiar with this?). May creatine content ang dalawa (dicreatine malate), at yung NO-Xplode may glycocyamine (which I learned sa isag website na nagiging creatine rin daw ito sa kidneys, since parang precursor daw ng creatine ang glycocyamine), among other things. Pero ito lang: walang creatine monohydrate na mahahanap, kasi mainly nitric oxide talaga ang dalawang produkto.

 

So far, I'm impressed with what I'm seeing. Mas naging batak ako e, labas ang mga ugat ko, at sobrang kagulo na ang binubuhat ko, as in! Para ngang nadagdagan ng 10-20% ang kaya kong buhatin, alam niyo yun. Naging mas focused nga ako (as advertised), di ako masyadong pagod after workouts, at mas mabilis din ang recovery period ko... But the thing is, hindi ko alam kung yung dicreatine malate ay pwedeng pamalit dun sa creatine monohydrate. I totally stopped taking creatine monohydrate more than 2 months ago (EAS phosphagen), kasi nga may creatine content din ang mga bagong bili ko. Guys, what do you think?

 

At ano rin ang pinakamalupit at pinakasulit na whey protein na available ngayon? First time ko lang gagamitin yun kasi if ever bumili ako. Di kasi ako lumalaki e, nagiging bato lang ang katawan ko. Parang sayang lang ginagawa ko.

[mark_ng_angeles]

mga pips tanong ko lang ANO KASI SCIENTIFIC NAME SA MGA TAONG MADALING TUMABA - MAHIRAP PUMAYAT, MADILING PUMAYAT - MAHIRAP MAGPADAPA.... tinanong ko na kay pareng GOOGLE di nya alam e .salamat

[mark_ng_angeles]

tanong ko lang anong tawag sa taong madaling tumaba pero mahirap pumayat, at madaling pumayat pero mahirap magpataba, scientific name nun.thanks

[Olympus]

there is no scientific name but there is such a thing as a somatotype that best describes the characteristics you metioned

[mark_ng_angeles]

hmmmmmm wala ba talaga? SOMATOTYPE hmmmmm... sige pre hanap ko dito sa forums alam ko nabasa ko yun dito e.. kakainis kasi ang bilis kong pumayat..wala naman akong bisyo, bihira lang ako magtikol. kain naman ako ng kain. tapos nagpuyat lang ako ng 2 araw lang hiya pumayat na daw ako. kaya gusto kong sabihin sa kanila yun na IM SOMATOTYPE KASI ...tama ba?

[Guest k....]

nop. i was under the impression that when you bulk, you take the C stuff 3x (or 4x? i cant remember what's on the label)/day for 4 straight days, then back down to 1x for maintenance. This once a month

 

^ur bulking up?

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[Olympus]

I assume you're under 130 lbs? Most likely you have the characteristics of an ectomorph. I may be wrong, but based on your descriptions, it leads to that.

 

hmmmmmm wala ba talaga? SOMATOTYPE hmmmmm... sige pre hanap ko dito sa forums alam ko nabasa ko yun dito e.. kakainis kasi ang bilis kong pumayat..wala naman akong bisyo, bihira lang ako magtikol. kain naman ako ng kain. tapos nagpuyat lang ako ng 2 araw lang hiya pumayat na daw ako. kaya gusto kong sabihin sa kanila yun na IM SOMATOTYPE KASI ...tama ba?

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[Guest k....]

Bulking in the next four days:

 

5 am- gising. first meal of the day. protein shake with creatine first serving

6.00 am- hatid mom sa work. uwi at 6.45 am tulog til 8.30 a

9.30 am to 11 am- hit the gym. upper&lower body on alternate days. creatine second serving at 9 am taken with apple juice from 7-11

12 pm- lunch. creatine third serving at 1 pm, most likely with carrot smoothie from fruit magic

2 pm to 11 p- work schedule. creatine fourth serving at 5 pm, taken with Fruit Magic/Nutty Oaty smoothie

12 a-5 am tulog ulit

 

Question: this will be my first time to load/cycle creatine. am I doing anything wrong? (aside from the obvious inadequate lack of sleep, which I farcially attempt to make up with the 6:45-8:30 sleep)

[Olympus]

You don't need to load creatine.

 

Bulking in the next four days:

 

5 am- gising. first meal of the day. protein shake with creatine first serving

6.00 am- hatid mom sa work. uwi at 6.45 am tulog til 8.30 a

9.30 am to 11 am- hit the gym. upper&lower body on alternate days. creatine second serving at 9 am taken with apple juice from 7-11

12 pm- lunch. creatine third serving at 1 pm, most likely with carrot smoothie from fruit magic

2 pm to 11 p- work schedule. creatine fourth serving at 5 pm, taken with Fruit Magic/Nutty Oaty smoothie

12 a-5 am tulog ulit

 

Question: this will be my first time to load/cycle creatine. am I doing anything wrong? (aside from the obvious inadequate lack of sleep, which I farcially attempt to make up with the 6:45-8:30 sleep)

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[spitzky]

You don't need to load creatine.

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well u do if u wanna get more of it in ur pee