Rhino 7 3000, “Male Enhancement Drug” Recalled

Michael GrossmanNovember 09, 2015 5 minutes

We were originally going to let this one slide, because so-called "male enhancement supplements" are junk products with no scientific backing whatsoever. However, last Wednesday, all Rhino 7 3000, both the regular and the platinum capsules were recalled by Premiere Sales Group. This wouldn't be all that newsworthy if there wasn't also a recall of Rhino 7 by TF Supplements of Houston. As best we can tell it is the same product, distributed by two different companies. The product is recalled because it contains two undeclared drugs not even licensed by the FDA.

Who makes this product?

It is unclear who actually makes this product. It appears that Premiere Sales Group and TF Supplements only distributed the product. We could be wrong about this, because the information is very sketchy, even in the FDA recall notices.

Which products are affected?

Any product that says Rhino 7 is affected by the recall.

How widespread is the problem?

There is really no way to know. Sales numbers for the product are not publicly available and the recall notices do not mention how many of the pills are on the market.

What can be done about it?

First, do not take the pills, especially if you have a medical condition and have to take nitrates, or use a erectile dysfunction medicine such as Cialis or Viagra. The combination of those medicines with this product could lead to an unsafe drop in blood pressure. Since there are two different companies involved in the recall, it would be best to call them up, just to make sure you do not mail back your pills to the wrong company. Premiere Sales Group can be reached at 888-55-8621, while TF Supplements can be contacted at 866-620-3586.

What this means.

It means that two companies were distributing a "supplement" that contained potentially dangerous undeclared drugs. The worst part is that the "supplement" contains a combination of two drugs whose interactions together are not known. Doctors and pharmacists are trained professionals, constantly on the look-out for potential drug interactions. The reason drugs are generally sold separately, and not in combination, is because of the potential for some interactions to be fatal.

The two drugs in this unlicensed cocktail are desmethyl carbodenafil and dapoxetine. Desmethyl carbodenafil is a PDE5 inhibitor, which means it acts like Viagra or Cialis. However, unlike those two drugs, it has not been approved by the FDA. While is may seem like a small distinction, it means that desmethyl carbodenafil has not undergone the rigorous trials necessary to be declared safe for human consumption.

Unlike desmethyl carbodenafil, dapoxetine, while not approved in the U.S., is legally available in other countries. It is classified as an SSRI, a type of medicine common to treating depression. Unlike most approved SSRIs, dapoxetine breaks down very quickly in the body, making it pretty useless for treating depression. One of the unintended side effects may be an increase in male stamina in the bedroom. However, let me be perfectly clear, the drug has not been approved by the FDA. While in clinical studies the drug has been shown not to interact with other ED drugs, as best I can tell, it was not tested with desmethyl carbodenafil, so we cannot say for that there are no unexpected side effects using the two together.

The far bigger concern is the drop in blood pressure caused by desmethyl carbodenafil. However, since Rhino 7 was marketed as a supplement, you cannot be sure how much of either drug is even in the pill. Best case scenario, they are trace amounts and have no effect, along with all the other junk the dietary supplement witch doctors decided to put in the pill. The other extreme would be that there are dosages that are far higher than anything one would find in their legal counterparts. This second scenario is the worse of the two, because it could magnify the blood pressure drop with potentially tragic consequences. In fairness, I am not a doctor, just an educated layman reading through the literature, so if you have taken these pills, consult an actual doctor.

Luckily, there have not been any reported injuries. Hopefully, it will stay that way, but given the sensitive nature of the condition these "supplements" were designed to treat, it is quite possible that people were hurt and even their partners would not have known that this garbage was involved. It certainly bears watching.

On an unrelated note, while I am not normally one who favors a stronger government hand in the marketplace, these products do not belong in the marketplace. It is one thing for the snake oil salesmen to push their supplements that don't do a thing (I am sorry if you think yours work, but the medical literature is pretty clear, at best these things are worthless), but when they cross the line by putting real drugs into these products that are not approved for use in this country, it makes me sick. They are committing a fraud on the public. I understand the FDA is constrained from acting because they do not have jurisdiction over dietary supplements, but when people are distributing actual drugs the FDA has every right to step in. Hopefully, the FDA Office of Criminal Investigations will step in and hold these folks accountable.

Dietary supplement companies do not fall under FDA jurisdiction. That is how these products get on the market in the first place. However, when they end up containing actual drugs, these companies either were lying about their product, or had improper quality controls to ensure that their product contained what they thought it contained. Then the FDA can step in and stop the sale of the supplement. Either way, many supplement producers are operating in a gray area that lets "supplement" makers put out whatever they please, as long as it does not make a medical claim, or contain actual drugs. The law is a bit more perverse in that the only sanctions available to the FDA are to bar these companies and their employees from working in the pharmaceutical industry, which they are not technically a part of. Sure the Department of Justice could launch their own case, but with a War on Terror, a War on Drugs, and whatever wars are current, it is easy to see how dishonest supplement manufacturers slip through the cracks.

If anyone was injured by these products, their only realistic remedy is civil court. While certain people complain about frivolous lawsuits, they conveniently neglect that a lot of unscrupulous supplement companies injure people everyday. If the FDA does not, or cannot step in, the only way folks injured by these fake drugs can get any measure of justice is through the civil courts. Some will say that arbitration would work just as well, but if I am Joe Sixpack, I don't have the money to fund the necessary investigation to expose these potential fakes for what they are. Sure an arbitration hearing is great if all the facts are available to the public, but that assumes that supplement companies can't hide their tracks. In many instances subpoena power, and deposing company executives under oath is the only way that the truth gets out. So folks can disparage personal injury law firms all they like, all that each of us do is come to work everyday and look for justice for the injured and the truth, how many other companies can say that?