FDA Public Health Advisory: Serious liver injury, pulmonary embolism with steroid-containing body-building supplements

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We've spoken here every few months about so-called natural dietary supplements being adulterated with prescription drugs used for similar indications. The most common of these of late have been erectile dysfunction supplements which have been repeatedly found to contain the active compounds present in prescription E.D. products such as Viagra and Cialis.

The latest public health advisory from the US FDA concerns what appears to be a much more serious case of adulterations, this time with steroids in body-building supplements marketed as containing "steroid-like" compounds:

The FDA is notifying the public about new safety information concerning products marketed for body building and increasing muscle mass. The FDA has sent a Warning Letter to a manufacturer of body building supplements that claim to contain steroid-like ingredients, but in fact contain synthetic steroids. The products named in the Warning Letter are marketed by American Cellular Laboratories, Inc., and include "TREN-Xtreme," "MASS Xtreme," "ESTRO Xtreme," "AH-89-Xtreme," "HMG Xtreme," "MMA-3 Xtreme," "VNS-9 Xtreme," and "TT-40-Xtreme."

The FDA has received reports of serious adverse events associated with the use of these products and other similar products. Products like these are frequently marketed as alternatives to anabolic steroids for increasing muscle mass and strength and are sold both online and in retail stores. They are often promoted to athletes to improve sports performance and to aid in recovery from training and sporting events. Although products containing synthetic steroids are frequently marketed as dietary supplements, they are NOT dietary supplements, but instead are unapproved new drugs that have not been reviewed by the FDA for safety and effectiveness.

Adverse event reports received by the FDA for body building products that are labeled to contain steroids or steroid alternatives involve men (ages 22-55) and include cases of serious liver injury, stroke, kidney failure and pulmonary embolism (blockage of an artery in the lung). [emphasis mine]

Here is the consumer FAQ from FDA and here is the actual warning letter to the manufacturer. For those readers working in this research area, the warning letter lists the IUPAC names of the actual compounds found in each supplement.

What makes this particular recall notable relative to others we've covered is that the FDA has received actual adverse event reports for very serious toxicities associated with use of these supplements. The only other such warning in recent memory here was the case of the body-building supplement Teston-6; a group at the University of Texas published a 2008 paper in Clinical Cancer Research that associated this brand of supplement contaminated with steroids with cases of very aggressive prostate cancer.

A major loophole in US dietary supplement regulatory legislation allows these potentially dangerous products to be sold legally until adverse reactions and/or body counts enable the FDA to issue warnings and market withdrawals.

Note: as of the time of this post, the American Cellular Labs website is still up without any notice as to the FDA warning letter.

Photo source: FDA Consumer Update page.

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Your statement that "A major loophole in US dietary supplement regulatory legislation allows these potentially dangerous products to be sold legally until adverse reactions and/or body counts enable the FDA to issue warnings and market withdrawals" indicates a fundamental misunderstanding of the Federal Food Drug and Cosmetic Act, as well as a failure to read the FDA's announcement.

As FDA itself noted, the products in question ARE NOT dietary supplements, they are illegal unapproved new drugs. There is no need for FDA to wait for "body counts" or consumer injury of any kind prior to taking enforcement action.

It appears that you have over 500 "followers" on Twitter. Don't you think they deserve accurate information?

Sure, Marc, except that if you call something a supplement, the FDA has no prima facie reason to inspect it. You think that the FDA's an organization with adequate funding, or something?

Hi Marc. Perhaps the text of the FDA warning wasn't clear to you. The reason they are taking action is exactly because the company represented the products as dietary supplements when, in fact, they are misbranded or unapproved drugs.

DSHEA absolves manufacturers of proving prospectively that their supplement is safe. Therefore, FDA cannot request removal of a product from the market until reports of adverse reactions accumulate that provide a body of evidence consistent with causation.

Please do re-read the links that you cited me as misreading. And I'd be delighted if you'd follow me on Twitter.

I saw a patient this year, a young guy, who walked in jaundiced. His bilirubin was in the high teens. Negative infectious hepatitis workup. After days of workup he admitted to using a bodybuilding sup.

Schwa, What percentage of OTC drugs sold pursuant to a monograph do you think FDA "inspects" before they are place on the market? T

Abel, DSHA does not absolve a manufacturer from needing to have proof that their supplement is safe. Since it was adopted in 1938, the FDCA has prohibited the marketing of any adulterated (containing a harmful or putrid ingredient) food, drug, cosmetic or device. The FDCA is also a STRICT CRIMINAL liability statute. Nothing in DSHEA changed either of those provisions of the law. If you market a product and don't know that it is safe, you risk going to jail. In fact, FDA was recently involved in prosecuting an individual for "spiking" as supplement with a drug ingredient. Maybe if the agency brought more of these cases products like this would disappear.

Marc Ullman is right. The FDA does NOT have to wait for serious adverse events to take legal action against the manufacturer. The problem is not with DSHEA but with the FDA's non-enforcement of existing law. Please get your facts straight Pharmboy.

Under DSHEA, anabolic steroids are not even legal dietary ingredients, i.e., they cannot be legally included in dietary supplements, period. DSHEA further provides that a dietary supplement containing a ânew dietary ingredient (NDI)â that is marketed without complying with the NDI notification process is adulterated under the Act, and it FURTHER PROVIDES THAT ANY FOOD (INCLUDING SUPPLEMENTS) THAT IS ADULTERATED IS SUBJECT TO A RANGE OF PENALTIES INCLUDING SEIZURE, FINES AND IMPRISONMENT FOR THE MANUFACTURER. Completely independent of DEAâs jurisdiction in this area, FDA has clear and powerful authority to address supplements that contain performance-enhancing drugs or anabolic steroids. These various new chemical cocktails are illegal under DSHEA simply because no NDI has been filed for them or because they are not legal dietary ingredients in the first place. But curiously, we are not aware that FDA has ever initiated an enforcement action because a dietary supplement failed to comply with the NDI notification requirements. Just as the evasion of tax laws were ultimately used to bring down many notorious gangsters of old, the NDI provisions of the law offer a convenient and effective way to get anabolic steroids and human growth hormone and their related analogs out of the supplement aisle once and for allâand this can be accomplished under DSHEA when the FDA chooses to act.

Publishing online diatribes against DSHEA has become a popular pastime in the last few months. It's clear most of the authors have never read DSHEA or simply don't understand it. Companies who adulterate supplements with anabolic steroids are committing a serious violation of the law. Most supplement makers would love to see the FDA put these criminals out of business. It's incomprehensible why American Cellular Laboratories receives only a warning letter. The FDA should use its legal authority to take much stronger enforcement action.

@Marc - Thanks for providing more detailed information. It's clear that you have substantial expertise in the area. My concern is that while the 1938 FD&C Act made criminal such adulteration, neither that nor DSHEA requires supplement manufacturers to prospectively demonstrate safety. I agree completely with your statement, "If you market a product and don't know that it is safe, you risk going to jail," but what measures are in place to ensure adulteration is not occurring prior to marketing?

@John - I do agree with you wholeheartedly that it's a travesty for American Cellular Labs to receive only a warning letter. There is, as of yet, no recall. I also have some pharmacognosy colleagues in the industry who would also like to see such criminal activity put out of business.

But one point here: I ask that you not comment without proper attribution. Your second paragraph in #6 is lifted in near-entirety from a statement by Council for Responsible Nutrition president and CEO, Steve Mister, in his May 2009 letter to Sports Illustrated.

I suppose it's true that they are "steroid-like" - like steroids, right down to the side effects.

More seriously, I wonder how true it is to say that they misrepresented these drugs to the public? I suspect the buyers bought them precisely because they were a legal way to acquire what they knew or suspected to be anabolic steroids...

Not that it makes it any less irresponsible.

@Abel - The responsibility is on the manufacturer, marketer, or anyone else who puts the regulated product into interstate commerce. If FDA was serious about enforcement and would refer a couple of these cases to the appropriate US Attorney's Office for prosecution, maybe there would we would see some sort of deterrent effect - the way all law enforcement is supposed to work.

Crazy market economy double standards for supplements and pharmaceuticals.
Sadly I wonder if this announcement will increase or decrease sales for the company.