posted April 15, 2000 05:57 PM            

19) How about the possibility of getting arrested for buying steroids by mail order?

Yes, this is an increasingly common way 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 the 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!

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

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, U.S. 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.

21) The second option would be a controlled delivery of the parcel?

Exactly. Customs will enlist the involvement of the DEA and arrange for a federal agent posing as a courier or letter carrier to attempt delivery of the package, supported by a hidden back-up 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, 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.

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

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 where 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 with the police without a lawyer!

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

Many 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 in its web site, 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 U.S. Any drugs, including foreign-made versions of U.S. approved drugs that have not received FDA approval to demonstrate compliance with federal requirements for safety and effectiveness are called unapproved new drugs.

24) What if the drugs are shipped with a foreign prescription?

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 U.S. 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 U.S. 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). So 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).

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

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 U.S. 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.

26) What are the requirements of this "personal use" exception for unapproved new drugs?

It's a discretionary guidance, not a legal exception as is 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 U.S. by those involved in the distribution of the product at issue; 3) the product is considered not to represent an unreasonable risk; and 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 3 month supply) and provides the name and address of the doctor licensed in the U.S. 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 to generally permit, through the exercise of enforcement discretion, medical treatments sought by individuals that are not otherwise available in the U.S. Thus, foreign-made chemical versions of drugs available in the U.S. 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 U.S., the guidance would not apply.

27) What about the proliferation of "on-line" pharmacies that are increasingly popular sources of bodybuilding pharmaceuticals?

This is an area of intense governmental interest. The DEA has at least thirty people on a variety of committees working to come up with comprehensive policies and protocols regarding on-line pharmacies. As you know, the DEA generally concerns itself only with drugs that are scheduled as controlled substances. A DEA Diversion spokeswoman I consulted with recently stated that the DEA views on-line pharmaceutical suppliers to fall 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, where 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 where these on-line pharmacies issued prescriptions and shipped Viagara to children and pets. The DEA's position is that the invisible doctor scenario does not constitute a legitimate doctor-patient relationship, and thus that any prescriptions issued pursuant to this scenario are invalid. The DEA concedes that the ordinary consumer may somewhat reasonably believe that prescriptions obtained through the web sites in this category are legal, and that 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 U.S., that 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.

28) How effectively can the DEA go after these overseas "pharmacies"?

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" web sites, 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 web sites. She in fact did have a legitimate medical need for the medication, and a doctor had previously prescribed it for her. When she accepted the delivery of the package, she was arrested and charged in state court with possession of a controlled substance. The web site was actually a sting operation orchestrated by the U.S. Postal Inspector's office, which arranged the controlled delivery of the parcel. While it is highly questionable whether limited government resources are wisely expended in operations like this, it is likely that we have not seen the last of these.

29) What other efforts at government regulation can we expect to see regarding Internet pharmacies?

Our legislators and law enforcement authorities were unprepared and overwhelmed by the proliferation and variety of on-line pharmaceutical suppliers. They are currently attempting to play "catch up" and to 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 on-line 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 (H.R. 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 on-line pharmacies in order to commence litigation against them similar to the Kansas and Missouri law suits referenced above. Failure to comply with the requirements of the new law would empower authorities to shut down the enterprise and impose sanctions.