Legalities of Ar-Research?

Quote:

Originally Posted by scotttiger54

exactly how can AR-research openly discuss and advertise on this board? i realize the supplied supplements aren't scheduled, but are still by prescription only. im just curious as to how all this works.... :shrug:

ST54

http://www.steroidlaw.com/page.php?p...esearch%20chem

An Interview with Rick Collins by Citruscide*

The proliferation of chemical products being sold online “for research purposes only” has generated countless inquiries about what’s legal and what’s not. Nobody wants to get busted out of ignorance, of course. I sat down with Rick Collins, New York lawyer, founder of www.SteroidLaw.com, and author of the definitive book on anabolic steroids and bodybuilding drugs, Legal Muscle, in an effort to shine a little light into this very dark area.

Citruscide (C): Thanks for offering to share your thoughts on this topic. I can imagine what your schedule is like.

Rick (R): Well, thanks to you for taking the time to do this interview and to offer your thoughts as well, big guy.

C: Let’s start with this: What’s wrong with buying and selling chemical products?

R: Generally, nothing. Chemicals are bought and sold every day. Hydrogen peroxide, ammonium hydroxide, benzyl alcohol, and on and on and on. But, as you know, there are some restrictions.

C: Such as controlled substances, for example?

R: Yes. Any chemicals that are designated as a “controlled substance,” “controlled substance analogue,” or “listed chemical” have restrictions on them. Those terms are defined by Section 802 of Title 21 of the United States Code. The Code is our big book of the laws passed by Congress. Unless we indicate otherwise, people can find all the sections of federal law that we’re going to talk about in Title 21 of the Code.

C: Obviously, the DEA has an interest in any illegal conduct involving controlled substance chemicals or their analogues. What about the FDA? What interest does the FDA have in chemicals?

R: None, unless the chemicals are food, drugs, devices, cosmetics, or dietary supplements for humans or animals. And there has to be the interstate commerce aspect. But the chemical products we’re discussing aren’t being explicitly sold as any of these things. They’re being sold purportedly as chemicals for research purposes only.

C: So they fall outside the jurisdiction of the FDA?

R: Yes, as long as they don’t fit the definition of any of those articles that the FDA has jurisdiction over. But here’s the problem. And it could become a big problem for someone in the future. The FDA’s opinion on the issue may differ from somebody else’s. The product may be sold as one thing, but the FDA may say it’s something else – for example, they may say it’s a drug.

C: What exactly is a “drug”?

R: Check out Section 321(g) of that Title 21 we mentioned. The current definition is there in its entirety. Basically, any chemical or product recognized as a drug by the United States Pharmacopoeia or other official compendium is a drug. But official recognition is only one way that a chemical can be a drug. Let me say that again. Just because it’s not in the official books or approved by the FDA doesn’t mean it’s not a drug. The other way that an article can be deemed to be a drug is if it is intended to be used as a drug.

C: How does the law define when something is intended to be used as a drug?

R: Well, in two ways. Again, it’s in Section 321(g). The term “drug” means “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals.” It also means “articles (other than food) intended to affect the structure or any function of the body of man or other animals.” So, prescription medicines are drugs, but so are many over-the-counter products including fluoride toothpaste, dandruff shampoos and sunscreens.

C: So, if you sell a chemical product claiming it will cure or prevent heart disease or treat kidney dysfunction or make you grow taller, you can turn it into a drug under the law?

R: Yes. Just by the claims. The crucial issue is what the product is intended to do. Dietary supplement companies have to be careful about what claims they make. Otherwise, they can be targeted by the FDA and have to argue over whether their product is a dietary supplement or an unapproved and illegal new drug.

C: Okay, so as far as chemical products which are clearly not intended for consumption or administration to humans or animals at all, how could the FDA claim to have jurisdiction? The products aren’t food, drugs, devices, cosmetics or dietary supplements.

R: They can’t as long as it’s clear. That’s the rub. Sometimes, it’s not so clear what they’re intended for, and it can be a point of argument. Take the substance IGF-1, for example. You might claim say it’s being sold just for research purposes, but the FDA might claim otherwise.

C: But if the supplier explicitly labels the product, “Not For Human Consumption” or words to that effect, how can the government argue otherwise?

R: The perfect example is 1,4-butanediol. Many people were arrested last year in an Internet-based DEA investigation into sales of the chemical. That’s because the government decided that butanediol fits the definition of a controlled substance analogue due to its similarities to GHB, a scheduled controlled substance. In situations where an analogue is intended for human consumption, it can be treated just like a controlled substance. But here’s the interesting part. Many of the people selling butanediol had web site disclaimers and product warning labels explicitly telling people not to consume it. They were prosecuted anyway, and many of them have been convicted.

C: Even though they gave disclaimers and warnings not to consume it?

R: Yes. The government’s theory was that in some instances the disclaimers and warnings were a sham. The government asserted that the words were not put there to actually warn consumers, but were just an attempt to evade a criminal prosecution.

C: They would have needed evidence to back that up.

R: Absolutely. Frankly, in some cases I suspect that the defense lawyers failed to aggressively punch holes in the prosecution theories. But, generally, the government built their prosecutions on circumstantial evidence. In some cases, the product had previously been sold as a dietary supplement, with marketing hype about its nutritional benefits. Then, when GHB was scheduled, the product was re-labeled as a “cleaning solution” with no change in the formula. The products were continued to be sold on web sites having nothing to do with household cleaning, but focused on human nutrition and fitness. They were sometimes infused with pina colada or other fruity additives, alleged to be “scents” but arguably flavoring. They were sold at prices that the government argued nobody would ever pay for cleaning products. But most damaging of all, some defendant-suppliers made private statements, recorded by the government or preserved in emails or discussion board posts, about how to consume the product.

C: So, they directly contradicted their own disclaimers and warnings?

R: Yes. Saying the product is intended only for cleaning or research purposes doesn’t automatically protect the supplier, if he’s caught saying otherwise elsewhere.

C: The DEA went after butanediol as a claimed analogue of the controlled substance, GHB. Would they be interested in chemicals that are not controlled substances or analogues of controlled substances?

R: No. It would generally be an issue for the FDA, and for the Postal Inspector if the mail were involved. An exception, by the way, is human growth hormone, which is not a federally controlled substance but the DEA is specifically authorized to investigate distribution offenses.

C: What about the situation where a chemical might be a recognized drug, but it’s sold in a raw or liquid form for research purposes?

R: It depends whether the chemical fits the definition of a drug in its raw or liquid form. That can depend on whether the government buys the argument that the chemical really is intended for research purposes, or whether, as in the butanediol cases, it’s really intended for human consumption. It would be an issue to be determined on a case by case basis.

C: What sorts of factors might the government look at, other than things the supplier himself might have said about consuming it?

R: The nature and wording of the disclaimers on the web site, for starters, and the screening and ordering process. Let’s look at what a legitimate chemical supply house would do. A legitimate supply company would try to ensure the products are not being purchased for use as drugs, right? Some companies require an account to be set up and references checked, and will not sell to individuals. But the government might also look at where and to whom the products were being marketed, and the nature of the other products being sold on the site, in assessing the legitimacy of the “research” explanation. I’m not going to go through all the possible factors. You can figure them out, and so can the FDA if they’re so inclined. I’m not interested in giving the FDA a blueprint. They have their own lawyers to sort it out.

C: But selling a research chemical with a host of vitamins on a bodybuilding web site might be one factor?

R: Yes. In combination with other factors, hypothetically, that’s how the government could build a case.

C: What about what other people say about the products? Could the government take into account the fact that the discussion boards are filled with postings about how people are using the products?

R: Well, if one guy said in an obscure online forum somewhere that he consumed a liquid research chemical despite all the warnings and disclaimers, the supplier could hardly be expected to be aware of it, much less accountable for it. But it might be different if lots of people are talking all about it on the boards, particularly if the boards are associated or affiliated with the supplier.

C: But isn’t it possible that the supplier may intend the product to be used for research purposes only, but individual purchasers may have other ideas?

R: Quite possible.

C: Then to what extent is the supplier responsible for the purchaser’s intentions?

R: He’s not. He’s responsible for his own conduct and intent. But if he knows or has reason to know that the purchaser had these “other ideas,” it may reflect upon his own intent in supplying the product.

C: Doesn’t the theory of “Don’t ask, don’t tell” offer some protection?

R: Not necessarily, if the supplier is consciously avoiding the knowledge of his customers’ obvious uses of the products. You can reach a point where you can’t purposely stick your head in the sand like an ostrich to undermine proof of your knowledge of a fact. That kind of willful blindness doesn’t exempt you from prosecution.

C: Okay, let’s assume the government doesn’t buy the claim that the chemical product is really intended for research purposes. Then what?

R: Maybe nothing, I guess, but one option would be for the FDA to assert that the product violated the law regarding misbranded drugs under Title 21, Section 331. They could send out warning letters to suppliers, or just institute prosecutions.

C: What’s a misbranded drug?

R: Check out Section 352. A drug sold without adequate directions or warnings for safe consumption, for example, is deemed misbranded. Since these chemical products we’re discussing are supposedly for research only, they obviously bear no such directions or warnings.

C: And if they were to be adequately labeled for human use, they’d no longer be arguably for research purposes only.

R: Then they’d clearly be drugs and more easily prosecuted.

C: Right. So, theoretically, what offenses could the government possibly hit a supplier with?

R: If they were inclined to take action, the government could charge introducing misbranded drugs into interstate commerce under Sections 331(a) and 333(b). They could also charge conspiring to defraud the FDA in violation of Title 18 of the Code, Section 371, and/or with mail fraud in violation of Title 18, Section 1341.

C: All right, what kind of penalties are we talking about?

R: The penalties for misbranded drug violations are found in Section 333(a). Under 333(a)(1), neither knowledge nor intent is required for a misdemeanor violation. To make it a felony under 333(a)(2), the requisite additional element is just the intent to defraud or mislead, or having a previous similar conviction. The felony carries a maximum term of imprisonment of three years.

C: What about conspiracy and mail fraud charges?

R: Sure, look at the cases involving the illegal sales of DNP. Defendants got hit with the misbranded drug charges as well as conspiracy to commit mail fraud. The maximum imprisonment for conspiracy to commit mail fraud is five years.

C: Do you think the FDA is presently aware of what’s going on?

R: I’m almost positive that they are.

C: What if the factors they need to make a case against most of these suppliers just aren’t there?

R: Great question. If the government still thinks it’s all a sham, they could try to do specific sting operations, or find other ways to make life tough for these companies. If federal regulatory agencies really want to mess with you, they can usually find ways. And if the agencies find that under the existing law they can’t stop you from illegal conduct, they’ll consider issuing new regulations to help them or they’ll ask Congress to amend a law or pass a new one.

C: Like what’s going on with prohormones right now.

R: Yes, they’ve helped fuel the new bills attacking the supplement industry, particularly prohormones. A good place to learn about that issue is www.usfa.biz. Even people who don’t use prohormones should be aware that their nutritional freedoms are under siege by the government.

C: For sure. Rick, has anyone actually been prosecuted for research chemicals yet?

R: Not that I know of – yet. In practice, the research chemical scenario presents a tougher challenge for the FDA than other misbranded drug cases. More typically, a product is sold for human use or administration and the issue is the adequacy of labels and such. But with research chemicals, the government must instead prove the threshold issue that the product is intended for human consumption – despite express warnings and disclaimers to the contrary.

C: That’s not always easy to do. It’s more investigative work to do it, and a potentially bigger drain for an agency with budget and personnel limitations.

R: That’s right.

C: The DEA did it with butanediol, but maybe they felt it was worthwhile because they considered it to be an analogue of a dangerous claimed “date rape” drug.

R: Maybe. It’s hard to say how the DEA prioritizes its resources. Look at what recently happened to actor Tommy Chong. He got popped in a major DEA sting operation orchestrated to catch people selling bongs over the Internet. At least 55 people were arrested. The prosecutions relied on a Supreme Court decision [Posters ‘N’ Things, Ltd., v. U.S., 511 U.S. 513 (1994)] recognizing, basically, that bongs are items that are specifically designed for use as drug paraphernalia – to smoke marijuana. Chong got hit with a nine-month federal sentence, despite the fact that his site had disclaimers saying the pipes were to be used only for smoking tobacco.

C: Makes you wonder how a future court someday might view conversion kits.

R: Well, yes, but that’s another story. Chong’s bongs may not be completely analogous, but what’s important, I think, is simply that Chong never imagined in his wildest dreams that the government would come after him, especially when he had disclaimers up on the site.

C: He never saw it coming.

R: Right. That’s the lesson. Which brings us back to research chemicals. Up until now, the FDA has chosen to set other priorities. That may continue indefinitely. Or it may change, possibly suddenly and without notice. I can’t give more conclusive answers at this time because these are uncharted waters. Until I possibly wind up arguing these issues in a court somewhere and getting definitive rulings, the best I can do is identify areas of concern and make educated speculations. But for now, I think there’s more risk than most people have thought about.

C: I guess the more blatant the use as drugs of these products becomes, the more likely the FDA will try to get involved. At the same time, the more blatant the drug use of the products, the easier it might be for the FDA to prove its cases.

R: Exactly. That’s definitely something to be concerned about.

C: Thanks for the interview, Rick.

R: Anytime. Knowledge is power.

Citruscide is the web name of a lawyer licensed to practice in Illinois. He has a background as a certified personal trainer and hardcore bodybuilder, and is a mod at the Elite Fitness Bodybuilding and the Law discussion board and at Chemical Muscle.

© 2003. Rick Collins. All rights reserved. For informational purposes only; not to be construed as legal advice.