Questions with a steroid informed attorney

QUESTION: What are the chances of being arrested just for personal-use possession of a steroid?

ATTORNEY: While most steroid investigations by law enforcement target sellers, arrests for personal possession do occur. Often, these arrests arise out of car stops for traffic violations, and the steroids are found during a search of the car.

For example, I recently defended a case in which a police officer stopped my client for speeding, discovered he had a suspended driver's license, and found a few syringes during a search of the car. In New York, the possession of hypodermic instruments is a misdemeanor, and my client was arrested on the spot. Fortunately for the client, the police overlooked a hefty stash of anabolics that was more carefully concealed. While the vast majority of users probably don't get caught, you could be one of the unlucky few. Those who do get caught can suffer serious consequences, not limited to just the possibility of jail.

QUESTION: What sort of other consequences?

ATTORNEY: The consequences of an arrest include being handcuffed, fingerprinted, and hauled before a judge while the effects of a criminal conviction may include preventing or interfering with future employment opportunities in many fields such as law enforcement. Ohio prosecutor John Williams points out:

"The sanctions for the use of anabolic steroids can stretch beyond those which are commonly presumed by lay persons: jail, fines, court costs, and attorney fees. It is often those additional sanctions which can affect a user's future endeavors, and such sanctions must be given adequate consideration in determining whether or not to use steroids."

In both Ohio and New York, anyone convicted of a controlled substance misdemeanor or felony, including the simple possession of anabolic steroids, faces mandatory driver's license suspension—a personal nightmare for those who live in rural and suburban areas. Members of certain professions involving licensing (physicians, lawyers, dentists, pharmacists, teachers, nurses, cosmetologists, public accountants, architects, auctioneers, barbers, and licensed counselors, just to name a few) can expect a conviction to be reported to their state licensing authority, placing current employment in jeopardy. A drug conviction can also bar the ability to own a firearm.

QUESTION: How about the possibility of getting arrested for buying steroids by mail order?

ATTORNEY: Yes, this is an increasingly common way that people get busted, and I've been getting more questions about this situation than any other. As we all know, federal law enforcement authorities monitor international and domestic mails. The Customs Mail Division inspects packages from outside the states, and the Postal Inspector inspects domestic parcels. Suspicious packages can be opened and examined. Packages from "hot" areas like Thailand, Eastern Europe, and Mexico are reportedly often targeted.

Among domestic parcels, those from California and the Southwest to sites on the East Coast can reportedly attract attention. The government keeps records of addresses known to be connected with steroids based upon prior shipments and tries to intercept parcels bearing these origin or destination addresses. Obviously, the sheer volume of mail makes it difficult to inspect every package, and many get through. But there is most certainly a risk. Beware!

QUESTION: Let's talk more about mail order. What happens if Customs identifies the contents of an international package as being steroids?

ATTORNEY: Importing controlled substances is a federal crime. Customs will hold or "seize" the package and exercise one of two options. The first option is to send a "seizure letter" on Department of the Treasury, US Customs Service letterhead to the designated recipient offering the chance to challenge the seizure. If the designated recipient doesn't respond, there will generally be no follow-up (although the addresses of origin and destination and designated recipient's name will be entered into the Customs computerized data system for future reference). A designated recipient who attempts to challenge the seizure could walk himself into an arrest.

QUESTION: The second option would be a controlled delivery of the parcel?

ATTORNEY: Exactly. Customs will enlist the involvement of the DEA and arrange for a federal agent posing as a courier or letter carrier to attempt to deliver the package, supported by a hidden backup team of agents. Once the package is accepted, the agents move in to arrest the recipient, question him, and search his home.

In situations where a mail drop or post office box is the destination, agents will invent some ruse to force the intended recipient to come out and personally claim the package. Or, if necessary, they will stake out the scene to see who comes to pick it up.

Which of the two options is selected in any given case depends upon numerous factors. The larger the size of the shipment (distribution amounts versus personal-use quantities), the more likely that the government will invest its resources toward an investigation and arrest. A record of prior shipments to the destination address will also encourage the more aggressive approach.

Also, the location of the recipient has significance. Due to the heavy narcotics traffic in New York, the Customs offices in the metropolitan area are less likely to arrest for small packages of anabolics (although it does sometimes happen) than agents in other states such as Alabama and Mississippi, for example, who have a lot more time on their hands. After the arrest, the recipient can be charged in state or federal court.

QUESTION: Can a person be prosecuted even if he doesn't sign for the package?

ATTORNEY: Signing for or otherwise accepting the package provides a stronger case for the government by demonstrating the person's intent to receive it. I have seen situations in which the package was not signed for, but the Feds made an arrest anyway, especially when there was other evidence linking the accused to the package.

For example, a recent and still pending case involves a package of steroids bearing a phony name which was delivered to an office with numerous employees. Federal agents arrived with the package, seeking someone to claim it. The only bodybuilder in the company was summoned and questioned, making a few regrettable oral statements about past steroid use with a valid prescription. While he emphatically denied knowing anything about the package, he was arrested anyway.

If a person categorically refuses the package and states that he didn't order it, and the government lacks other evidence linking him to it, the Feds can be prevented from making a case. Some importers have developed practices in an effort to weaken any potential prosecutions, such as always printing "refused," "return to sender," or "addressee unknown" on the package and leaving it unopened on the front porch. Obviously, if one is contacted by law enforcement authorities, it is crucial to refuse any comment and immediately consult a criminal lawyer. Again, don't speak to the police without a lawyer!

QUESTION What is the legality of importing non-controlled substances like clomid, tamoxifen, and clenbuterol by mail order?

ATTORNEY: Any of the ancillary medications used by bodybuilders to stimulate natural testosterone production, treat acne, or control gynecomastia are prescription drugs. As such, they fall under the jurisdiction of the Food and Drug Administration (FDA) which oversees extensive regulations dealing with all aspects of prescription medications. As stated at its website, the FDA's mission is "to enforce the Federal Food, Drug, and Cosmetic Act and other laws which are designed to protect consumers' health, safety, and pocketbook. These laws apply equally to domestic and imported products."

Prescription drugs must be FDA-approved for use in the US. Any drugs, including foreign-made versions of US-approved drugs that have not received FDA approval to demonstrate compliance with federal requirements for safety and effectiveness, are called unapproved new drugs.

QUESTION: What if the drugs are shipped with a foreign prescription?

ATTORNEY: The FDA focuses on the product itself; therefore, issues regarding the presence, validity, or absence of a prescription are irrelevant. Non-approved medications are subject to being detained or refused entry into the US as a violation of the Food, Drug, and Cosmetic Act. As a practical matter, non-approved medications include most pharmaceuticals that can be imported into the country.

For example, foreign versions of approved US drugs are, by definition, non-approved. So foreign-made tamoxifen would be refused. If no approved American version of a drug exists, the foreign product is generally non-approved for a whole list of reasons—from questionable safety and effectiveness to mislabeling (if the label is not in English, the medication is non-approved). Clenbuterol would be refused.

Sometimes the FDA issues special "import alerts" to authorize automatic detention (now called "detention without physical examination") of certain substances. Examples are canthaxanthin oral tanning tablets and, yes, clenbuterol.

QUESTION: How does the FDA actually go about seizing a package of non-controlled pharmaceuticals coming from overseas by mail?

ATTORNEY: While many—if not most—clandestine shipments escape detection, many others are flagged and set aside by Customs inspectors. Customs will notify the FDA of the entry, and the FDA will generally examine the shipment to determine if its contents violate the law. In the metropolitan New York area, for example, the detected shipments are set aside by Customs officials for an FDA field representative who comes by once or twice a week. If the FDA detains the shipment, it will send a letter to the addressee on FDA letterhead stating, in part:

"A mail shipment addressed to you of a drug from a foreign country is being detained at the US Post Office. All products of this kind must meet requirements of the Federal Food, Drug, and Cosmetic Act which is designed to protect you from products that have not been shown to be safe and effective and that are not labeled in a truthful, accurate, and non-misleading manner."

The letter informs that the FDA will consider releasing the product to the addressee if a statement is submitted with documentation that the product meets the requirements of the FDA's discretionary guidance on personal-use importation of unapproved new drugs. Alternatively, the addressee may disregard the notice and give up any claim to the shipment. Of course, this is what most bodybuilders do.

QUESTION: What are the requirements of this "personal-use" exception for unapproved new drugs?

ATTORNEY: It's a discretionary guidance, not a legal exception as commonly believed. FDA officials have broad power to detain and refuse unapproved new drugs. But they can exercise enforcement discretion on a case-by-case basis, particularly in personal-use (three-month supply) situations involving less controversial medicines that are not controlled substances. The FDA, in its regulation procedures manual, has developed a guidance setting forth its enforcement priorities with respect to personal-use importation of unapproved new drugs. The guidance identifies circumstances in which the FDA may consider exercising enforcement discretion and refrain from taking legal action against illegally imported drugs. These circumstances are as follows:

1) The intended use of the drug is unapproved and for a serious condition for which effective treatment may not be available domestically either through commercial or clinical means.

2) There is no known commercialization or promotion to persons residing in the US by those involved in the distribution of the product at issue.

3) The product isn't considered to represent unreasonable risk.

4) The individual seeking to import the product affirms in writing that it is for the patient's own use (generally not more than a three-month supply) and provides the name and address of the doctor licensed in the US responsible for his or her treatment with the product or provides evidence that the product is for the continuation of treatment begun in a foreign country.

The guidance is not, however, a free license to import unapproved (and, therefore, illegal) drugs, even in small, personal-use amounts. Even if all of the circumstances noted in the guidance are present, the drugs remain illegal, and the FDA may decide that such drugs should be refused entry or seized.

The intent of the personal-use importation guidance is to save FDA resources and generally permit, through the exercise of enforcement discretion, medical treatments sought by individuals that are not otherwise available in the US. Thus, foreign-made chemical versions of drugs available in the US are not intended to be covered by the policy. For example, a person might decide that his FDA-approved tamoxifen is cheaper in Mexico and attempt to import the unapproved version of the drug. As the FDA cannot assure proper manufacturing, safety, and effectiveness, and as the product is available in the US, the guidance would not apply.

QUESTION: What about the proliferation of "online" pharmacies that are increasingly popular sources of bodybuilding pharmaceuticals?

ATTORNEY: This is an area of intense governmental interest. The DEA has at least 30 people on a variety of committees working to come up with comprehensive policies and protocols regarding online pharmacies. As you know, the DEA generally concerns itself only with drugs that are scheduled as controlled substances.

A DEA Diversion spokeswoman with whom I recently consulted stated that the DEA views online pharmaceutical suppliers as falling into three general categories. The first category is the legitimate mail-order pharmacy, filling valid prescriptions in accordance with federal and state laws and regulations. The DEA has no interest in these entities.

The second category is the "invisible doctor" scenario in which an unseen physician with no direct patient contact "legitimizes" the delivery of the drugs to conform to "the letter of the law." Recent television broadcasts have reported cases in which these online pharmacies issued prescriptions and shipped Viagra to children and pets. The DEA's position is that the invisible doctor scenario does not constitute a legitimate doctor-patient relationship and, thus, prescriptions issued pursuant to this scenario are invalid. The DEA concedes that the ordinary consumer may somewhat reasonably believe that prescriptions obtained through the websites in this category are legal, and a large-scale public information campaign would necessarily precede any actions taken against the consumer.

The third and final category is the illegal "pharmacy," often an individual operating from outside the US who ships controlled substances and other pharmaceuticals without any prescriptions or doctor consultations. It is likely that the DEA will concentrate its attention most heavily in addressing this situation.

QUESTION: How effectively can the DEA go after these "pharmacies" overseas?

ATTORNEY: The DEA admits that effective actions against these illegal suppliers are hampered by a variety of factors. One of which is that these suppliers, who often operate through discussion boards, anonymous email addresses, and "evaporating" websites, are very hard to locate and identify. Further, the practical and jurisdictional problems in trying to go after faraway, overseas entities can be hard to overcome.

Consequently, the Feds may well try to find other, more creative ways of combating the situation. One way is to go after the consumers (discouraging demand) rather than the suppliers themselves. For example, my firm recently represented a woman who ordered Valium (a controlled substance) from what appeared to be one of these websites. She did, in fact, have a legitimate medical need for the medication, and a doctor had previously prescribed it to her. When she accepted the delivery of the package, she was arrested and charged in state court with possession of a controlled substance. The website was actually a sting operation orchestrated by the US Postal Inspector's office, which arranged the controlled delivery of the parcel. While it is highly questionable whether or not limited government resources are wisely expended in such operations, it is likely that we have not seen the last of these.

QUESTION: What other efforts at government regulation can we expect to see regarding Internet pharmacies?

ATTORNEY: Our legislators and law enforcement authorities were unprepared and overwhelmed by the proliferation and variety of online pharmaceutical suppliers. They are currently attempting to play "catch up" and clarify their positions with respect to the many issues that exist.

In the near future, we can expect some laws, regulations and, hopefully, clear-cut enforcement policies to emerge. In the meantime, there will be some degree of misunderstanding and batches of scattered "test cases" exploring the boundaries of the governmental limitations which can be imposed.

For example, the Attorneys General of Kansas and Missouri have filed suits against several online pharmacies and physicians, obtaining temporary restraining orders to prevent them from selling pharmaceuticals over the Internet. This was after state investigators were allegedly able to obtain prescription-only medications without a prescription or a physician consultation. These pending lawsuits allege that the defendants are engaging in the unauthorized practice of medicine and pharmacy and are violating state merchandising laws by selling prescription drugs to consumers without proper state licensure or registration.

Congress is also getting involved. On August 5, Representative Ron Klink of Pennsylvania introduced the Internet Pharmacy Consumer Protection Act (HR 2763) to amend the Food, Drug, and Cosmetic Act by requiring Internet pharmacies to post the name of the principal practitioner, the address and telephone number of the principal business location, and the states in which the pharmacy and its consulting physicians are licensed to practice. The new law would assist individual states in identifying online pharmacies in order to commence litigation against them similar to the Kansas and Missouri lawsuits referenced above. Failure to comply with the new requirements would empower authorities to shut down the enterprise and impose sanctions.:zzz:

Feds suck.

-moto