FDA Warns Consumers About Proto-Steroids Marketed As Nutritional Supplements
You should avoid nutritional supplements that claim to have steroid-like effects, no matter how many flames are pictured on the label. Earlier this week, the FDA sent a warning letter to Americell-Labs, the manufacturer of many popular lines of such supplements, and also warned consumers to stay away from the products. The "supplements" claim to act a little too much like steroids, and should be tested and sold as drugs if they are, y'know, drugs. If they're anabolic steroids, they shouldn't be sold at all.
And it's hard to argue that your product is being sold as a "supplement" when it makes claims like these:
• "PRO-ANABOLIC/ANTI-ESTROGEN"
• "DRY LEAN HARD"
• "The compound in HMG-Xtreme™ binds to muscle androgen receptors causing increased protein synthesis rate while also binding muscle stem cells causing them to become activated. Together these two anabolic actions increase potential muscle repair and growth."
• "Besides the anabolic effect, HMG-XtremeTM is a tissue specific estrogen blocker. This means that HMG-Xtreme™ only binds to 17B-estradiol receptors in certain tissues such as mammary (breast). This can significantly reduce and/or even reverse gynecomastia caused by temporary elevations in estrogen.HMG-Xtreme™ specifically blocks estrogen in mammary (breast) tissue resulting in reduced size, even shrinking the tissue to pre-gynecomastia levels."
The best part of the FDA letter compares product labels with the warning labels.
Additionally, your website contains claims that "TREN-Xtreme," "MASS Xtreme," "AH-89Xtreme," "HMG Xtreme," "MMA-3 Xtreme," "VNS-9 Xtreme," and "TT-40-Xtreme" minimize or are free from certain side effects, such as "No Estrogen Conversion," "decreases estrogen production," "without a lot of unwanted androgenic effects," "No Hair Loss," and "No Acne."
At the same time, the products all contain "WARNINGS" similar to the following:
WARNING: Consult a Physician before using this product if you have, or have a family history of, prostate enlargement/cancer, heart disease, high cholesterol, kidney, liver, or hormone problems or if you are using any other dietary supplement, prescription or OTC drug. Exceeding recommended serving may cause adverse health effects. Possible side effects include acne, hair loss, facial hair growth (women), aggressiveness, irritability, and increased levels of estrogen. Discontinue use and call a Physician immediately if you experience adverse events.
Side effects reported to the FDA include serious liver injury, stroke, kidney failure, and pulmonary embolism. So, yeah, don't use these products.
(Also, check out the company's flame-tastic official Web site.)
FDA: Stop using body-building products that make steroid-like claims [Consumer Reports Health]
Americall-labs.com VMG Global Inc 7/27/09 [FDA]
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Comments:
I continue taking my Stimutax then. They're all natural, and mostly kelp.
Ah, nothing says SEXY like Vesuvius-sized acne craters scarring across your entire back.
The problem with FDA statements like this is that they have the adverse effect of what they want. Body builders will now flock to this stuff because the FDA says that it actually works like steroids, but isn't technically steroids. Unless the FDA forces them to remove their products from the market, then this will only help their sales.
@Xerloq:
Well, I'm covered, but...
and increased levels of estrogen
I think everyone else is when all is said and done.
@Applyin'Sunscreen_GitEmSteveDave: They're so much more effective too. I like being able to dig my toes into the ceiling to support myself when doing suspended sit ups...
I prefer "Jimmy Tango's Fatbusters"... RIDE THE SNAKE
@osiris73: Not to mention the likely probability that no one knew about the product before hand and suddenly, they've gained a new market of buyers.
@osiris73: More likely the types of bodybuilders who would flock to this stuff would just as soon (illicitly) get real steroids.
I'm currently reading Marion Nestle's "Food Politics", the latter half of which is devoted to the legislation and tactics used by the supplement industry to avoid regulation by the FDA. It's really a fascinating read although portions of it may be out of date since its 7 years old now.
One of many complications is that unlike with drug products, instead of having to prove a claim through clinical research, a supplement basically states a claim, along with some shred of supporting evidence, then its up to the FDA to counter that claim within 120 days, or it is approved automatically.
Then there's the FTC which also partially regulates supplements, but they are not concerned with scientific veracity at all, only concerned with whether a particular statement is misleading or not.
i thought pro-hormones were BS anyway? That they did nothing but drain your wallet.
@osiris73: I don't know... this product seems to be trying to hard to 'be' steroid like... Someone like me who buys this type of product - I would stay away from it after reading the claims myself...
If it's too good to be true....
@PSUSkier: Yeah, it's like you have the strength of a bear, that has the strength of two bears. And are you digging this air?!
How come we can get some ghetto testosterone but not estrogen? I wanna grow me some boobies!
@ludwigk: In my opinion, the entire "supplement" classification is nothing more than a scam used to avoid regulation.
Flaxomax!
@aloria:
Estrogen isn't a controlled substance, so I'm sure that you can get it all over the internet easily and (mostly) legally. IIRC, you can even get herbal supplements with plant estrogens in them (soy maybe?)
Let's see, at worst you have a product that does nothing except give you kidney stones, and at best you have a product which gives significant strength gains (until you stop taking it), with all kinds of fun testicle-shrinking, manboob-growing side effects. How can you lose?
@Stephmo: Hair, like everything else, is effected by gravity, with age it goes down, away from the top of the head and towards the ears, face, and back. These "Supplements" merely accelerate this process.
@Applyin'Sunscreen_GitEmSteveDave:
You can't test drugs on humans! There are rules, procedures. It has to be tested on animals first. A rat doesn't wear lipstick okay? A rabbit doesn't use hairspray! A monkey doesn't need pills, to get ramped up for hot monkey sex! It's people, man! We're miserable! So why shouldn't we try it all first?
Oh yeah, I completely trust the FDA when they approve wonderfully safe drugs like Vioxx and Celebrex. No thanks, leave the supplement industry alone, it doesn't need 'government regulation'. Next thing we'll have to get a subscription for vitamin C tablets...
Laura, mega-props on the "no matter how many flames are pictured on the label" line! Hilarious!
Evertime I see steroid's stories like this Chris Benoit comes to my head :( that stuff seriously messes you up
So, I can go bald and get a mustache at the same time?