The Ban on Andro – What’s It All About?

Dietary supplements are vital for health, longevity, disease prevention, growth, development, and attaining maximum mental and physical performance. Every man, women and child should be taking them.

This is a scientific conclusion, one so unanimous that the United States Congress was compelled to acknowledge this fact and get behind dietary supplements in a big way to ensure they remained freely available to the public.

As you read in this article, you will learn how a decade ago special legislation was passed to help more people get more types of dietary supplements to help prevent diseases, improve the structure and function of their bodies, and to increase health and well-being. However, as time passes, regulations evolve.

Sometimes it takes the regulators years to catch up to straighten things out happening in the market place after new regulations are put in effect. And then there are the proverbial "gray areas" that exist with regulations. You know, when we both read something, and have different interpretations of the same thing.

This article is intended to provide an overview of the issues surrounding the events leading up to the ban on dietary supplement products containing anabolic steroids, and related compounds. Androstenedione (also referred to as 4--androstenedione or 4-androstene-3,17-dione) and the similar substances are now grouped in to this category, and will no longer be permitted for sale in the United States as dietary supplements.

The year 2004 was marked by two major FDA actions concerning dietary supplements. The first occurred on Feb. 6, 2004 when FDA published a final rule prohibiting the sale of dietary supplements containing ephedrine alkaloids (ephedra). The second was initiated on March 11, 2004 when HHS (Health and Human Services department, FDA is part of HHS) Secretary Tommy G. Thompson announced a crackdown on companies that manufacture, market and distribute products containing androstenedione, or, "andro," which acts like a steroid once it is metabolized by the body and therefore may pose similar kinds of health risks as steroids.

Secretary Thompson encouraged Congress to pass legislation sponsored by Senators Orrin Hatch and Joe Biden in the Senate and Reps. James Sensenbrenner, John Sweeney and John Conyers, Jr. in the House that would classify andro-containing products as a controlled substance. Such legislation would enable the U.S. Drug Enforcement Agency (DEA) to regulate these types of products as anabolic steroids under the Controlled Substances Act.

A Step Back In Time.
Dietary supplements have always been regulated as foods. However, because dietary supplements were caught-up in a perpetual tug-of-war between the FDA trying to regulate them as over the counter drugs and the public wanting to keep dietary supplements as foods, this eventually lead to pro-dietary supplement politicians seeking to pass an Act that would regulate dietary supplements as a special subcategory of foods.

In 1994 the Dietary Supplement Health and Education Act was passed by the 103rd Congress; referred to as DSHEA (D'SHEA). Included in this Act were some new aspects about what dietary supplements are and what can be said about them (claims). The following table reviews some of the key points which led the members of Congress to passing the DSHEA.

Definition Of Dietary Supplements According To DSHEA.
As is the case with any Act, definitions are usually established, and in the DSHEA the term dietary supplements was defined. The following table provides a summary of how Congress defined what a dietary supplement is. I will elaborate about the significance of this new definition of dietary supplements after the following definition is reviewed.

Confused By This Definition?
Confused by this definition? Well, this is one of the reasons why puzzlement exists in the dietary supplement industry. Before DSHEA, when dietary supplements (nutritional supplements) were regulated under the conventional foods laws, the ingredients legally permitted in "Foods" were found in approved lists. Even today, conventional foods may only contain ingredients specifically approved and found on certain official FDA lists and in regulations.

Obviously these are long lists that are a result of about 100 years of FDA regulation. The authorized ingredients fall in to a few categories. The big one is the GRAS category, foods and food ingredients that are generally recognized as safe or GRAS. Other food ingredient categories include food additives and food colors.

So before DSHEA, nutritional supplement products could only contain FDA pre-approved/authorized ingredients in them. Makers of dietary supplements historically included ingredients not on the lists, thus the reason for the constant battle between FDA and the supplement industry. Or in many cases the ingredients were on the GRAS list, but only permitted to be used as certain types of foods.

For example, most botanicals were not approved to be used as supplements, only for conventional food uses, as to prepare beverages, for example. So before DSHEA when dietary supplement manufactures started to offer various botanicals as tablets and capsules, this was technically an unapproved use. Furthermore, before DSHEA was passed, andro ingredients were not included in the GRAS list of ingredients or permitted to be in foods as additives or otherwise.

How The DSHEA's Definition Of Supplements Change Things?
According to the DSHEA definition of a dietary supplement, the inclusion of words like "botanicals", "concentrates" and "metabolites", in addition to the conventional nutrients (vitamins, minerals, amino acids, etc.) greatly expanded the type and number of ingredients allowed to be used in dietary supplement products. For the first time this gave manufacturers the ability to use a vast array of ingredients not previously permitted.

However, in general, the ingredients that can be used in dietary supplement had to be been present in the food supply on the date the Act was passed or be approved by the FDA as new dietary supplement ingredients. DSHEA includes a procedure for new dietary ingredients to be approved by the FDA for use in dietary supplements. To complicate matters, there was no reference ingredient list of approved dietary supplement ingredients created to help guide supplement manufacturers.

FDA left it up to the manufacturers of dietary supplement to determine if the ingredients were in use prior to the Act being signed in to law. The following table summarizes the criteria established in the DSHEA for determining if an ingredient qualifies to be used in a dietary supplement product, and how to apply to the FDA to get new ingredients approved for use in dietary supplements.

So after this Act was passed in 1994, the dietary supplement manufactures went wild, making thousands of new products that were not previously permitted for use in dietary supplements. However, during the past 10 years many ingredients that did not meet the definition of a dietary supplement and or did not meet the criteria of being a dietary ingredient, made there way in to dietary supplement products. This is where the FDA is playing the enforcement catch-up game.

Walking Contradictions...

Were Andro-Type Ingredients Considered Dietary Ingredients Allowed for Use In Dietary Supplement, or New Dietary Ingredients?

This is the big question that people began to ask when andro containing products become a topic in then news and when states like California passed laws restricting the sales of andro containing products, and required warning statements, etc. On top of media and political attention, sports organizations began a campaign to ban andro containing products from sports.

So why would supplement companies think to use andro in supplements? Technically speaking the body makes certain andro like substances, androstenedione being one of them, which means it is a metabolite. Metabolites are substances made by your body, and included in the definition of dietary supplements. But due to political directives, the FDA wanted to determine if the many androstenedione and related substances being used in dietary supplements had a history of use in foods.

And if not, was there adequate scientific evidence that would satisfy the requirements of approving androstenedione and related ingredients as a new dietary ingredients, after the fact.

So the FDA sent letters to manufactures asking for evidence that androstenedione was marketed as a dietary ingredient in the United States before October 15, 1994. Meanwhile Congress was working to pass a new Act that would include androstenedione related ingredients being sold as dietary supplements, as anabolic steroids. In early October, 2004, the 108th Congress passed the Anabolic Steroid Control Act of 2004, which amended the Controlled Substances Act (21 U.S.C. 802) to include additional substances in the definition of the term "Anabolic Steroid".

In summary, the ban on andro-type supplements was in fact due to a regulatory technicality. The ban was not due to specific health issues, although concern about potential side effects similar to anabolic steroids was expressed by the FDA, Congress and other regulators.

What To Expect When The Ban Is In Effect
When the Anabolic Steroid Control Act of 2004 takes effect in January 2005, there will be severe legal consequences for companies that continue to sell andro-type products, and for people who purchase them for personal use. It shall be unlawful for any person knowingly or intentionally to possess a controlled substance unless such substance was obtained directly, or pursuant to a valid prescription or order, from a practitioner, while acting in the course of his professional practice, or except as otherwise authorized by law.

Any person who violates this law may be sentenced to a term of imprisonment (months to years) and can also be fined a monetary sum (thousands to tens of thousands of dollars). Therefore, now that andro-type products are classified as anabolic steroids, this makes it illegal to possess or sell these types of products.

Note that many types of anabolic steroids were covered by a previous version of an earlier Act, known as the Controlled Substances Act, andro-type ingredients were added to the list in the new Act; the same criminal penalties will apply to androstenedione that apply to possession or selling of traditional anabolic steroids like Dianabol (methandienone). So with a wave of the magic law-passing-wand, what was once legal is now extremely illegal.

Getting The Anabolic Edge - Without Andro!
The good news is that you can still get big gains using time tested sports supplements still available on the market. Androstenedione aside, the science is clear that an integrated program of proper anabolic training, anabolic nutrition and anabolic supplements will result in building muscle mass and strength faster then training alone.

Even when people use the most potent anabolic steroids, their gains are often limited by not training correctly, not eating properly and not taking a comprehensive program of sports supplements. I will be writing about the science behind getting the best "steroid free" muscle building results in future articles.