DHEA has been available by prescription from compounding pharmacies for more than ten years. The practice of compounding involves the formulation of custom medications for patients with particular needs. As this practice predates the passage of the 1938 Food Drug & Cosmetic Act, these pharmacies have a lot of latitude to formulate medicines that would otherwise not be easily available. Many doctors for the past few years had been prescribing DHEA to their patients who obtained this steroid through these pharmacies. But all this changed in 1994.
In November of 1994, after an arduous legal battle, a new law was passed by Congress called the Dietary Supplement Health & Education Act (DSHEA). For the first time in its history, Congress defined dietary supplements as vitamins, minerals, amino acids, other dietary constituents, and herbs (and concentrates, extracts and derivatives of the above). More importantly, dietary supplements were to be considered foods, not drugs. The FDA regards a drug as any medicine that “alters the structure or function of the human body” or because it is intended to “treat, prevent, cure or mitigate a disease.”
An example of a supplement that is now more readily available for sale in the US as a consequence of the passage of the DSHEA law is the hormone melatonin, a derivative of the amino acid tryptophan. In order for the FDA to challenge melatonin’s over-the-counter status, it has to prove that this hormone is not safe. Since the passage of DSHEA, the burden of proof for a substance not being safe now rests on the FDA, not the producers or retailers. This shift has both positive and negative consequences for the consumer. A wider selection of supplements are now on the shelves of the health food stores or through mail order firms, but less of a guarantee that these have been thoroughly evaluated before being marketed. The consumer now has to make an even greater attempt to self-educate before casually swallowing the newest pills on the market.
The DSHEA on DHEA
With the new law in place, what is the legal status of DHEA? A drug because it “alters the structure or function of the human body” or because it is intended to “treat, prevent, cure or mitigate a disease”? A drug can be regulated by the FDA. Or is DHEA a dietary supplement because it is a derivative of cholesterol, which is itself a constituent of food, and not under the FDA’s jurisdiction?
According to experts who have studied the law, DHEA falls under the category of a dietary supplement.
The DEA on DHEA
As DHEA started entering the over-the-counter US supplement market, there were hints that the Drug Enforcement Agency (DEA) was considering classifying it as an anabolic steroid. The Controlled Substances Act requires that any substance that is structurally related to testosterone and has testosterone-like anabolic properties to be scheduled as an anabolic steroid. DHEA is a precursor to testosterone, and so it has a structural similarity to testosterone. But so is cholesterol; it is also a precursor to DHEA and testosterone and structurally related.
The DEA eventually chose not to pursue any plans to schedule DHEA as a controlled substance.
The FDA on DHEA
For now the FDA seems to have taken a laissez-faire attitude with DHEA by not interfering with its over-the-counter sale. Will they continue to keep their distance as the popularity of DHEA increases? Time will tell.