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...
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.
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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.
FDA Authorized Claims!
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|Summary Of The Key Findings Of Congress Related To The Benefits Of Dietary Supplements (From The Introduction Of The DSHEA, in part)
|CONGRESS finds that:
Improving the health status of United States citizens ranks at the top of the national priorities of the Federal Government; the importance of nutrition and the benefits of dietary supplements to health promotion and disease prevention have been documented increasingly in scientific studies;
There is a link between the ingestion of certain nutrients or dietary supplements and the prevention of chronic diseases such as cancer, heart disease, and osteoporosis; and
Clinical research has shown that several chronic diseases can be prevented simply with a healthful diet, such as a diet that is low in fat, saturated fat, cholesterol, and sodium, with a high proportion of plant-based foods;
Healthful diets may mitigate the need for expensive medical procedures, such as coronary bypass surgery or angioplasty;
Preventive health measures, including education, good nutrition, and appropriate use of safe nutritional supplements will limit the incidence of chronic diseases, and reduce long-term health care expenditures;
Promotion of good health and healthy lifestyles improves and extends lives while reducing health care expenditures; and
Reduction in health care expenditures is of paramount importance to the future of the country and the economic well-being of the country;
There is a growing need for emphasis on the dissemination of information linking nutrition and long-term good health;
Consumers should be empowered to make choices about preventive health care programs based on data from scientific studies of health benefits related to particular dietary supplements;
National surveys have revealed that almost 50 percent of the 260,000,000 Americans regularly consume dietary supplements of vitamins, minerals, or herbs as a means of improving their nutrition; (note: the number of dietary supplement takers has increased since 1994.)
Studies indicate that consumers are placing increased reliance on the use of nontraditional health care providers to avoid the excessive costs of traditional medical services and to obtain more holistic consideration of their needs;
The United States will spend over $1,000,000,000,000 on health care in 1994, which is about 12 percent of the Gross National Product of the United States, and this amount and percentage will continue to increase unless significant efforts are undertaken to reverse the increase;
The nutritional supplement industry is an integral part of the economy of the United States; although the Federal Government should take swift action against products that are unsafe or adulterated, the Federal Government should not take any actions to impose unreasonable regulatory barriers limiting or slowing the flow of safe products and accurate information to consumers;
Dietary supplements are safe within a broad range of intake, and safety problems with the supplements are relatively rare; and
Legislative action that protects the right of access of consumers to safe dietary supplements is necessary in order to promote wellness.
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.
|Definition Of A Dietary Supplement According To DSHEA of 1994
|Definition of Certain Foods as Dietary Supplements. Section 201 (21 U.S.C. 321) is amended by adding at the end the following:
The term "dietary supplement:
- means a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients:
- a vitamin;
- a mineral;
- an herb or other botanical;
- an amino acid;
- a dietary substance for use by man to supplement the diet by increasing the total dietary intake; or
- a concentrate, metabolite, constituent, extract, or combination of any ingredient described in clause (A), (B), (C), (D), or (E);
- means a product that -
- (i) is intended for ingestion in a form described in section 411(c)(1)(B)(i); or (ii) complies with section 411(c)(1)(B)(ii);
- is not represented for use as a conventional food or as a sole item of a meal or the diet; and
- is labeled as a dietary supplement; and
- does -
- include an article that is approved as a new drug under section 505, certified as an antibiotic under section 507, or licensed as a biologic under section 351 of the Public Health Service Act (42 U.S.C. 262) and was, prior to such approval, certification, or license, marketed as a dietary supplement or as a food unless the Secretary has issued a regulation, after notice and comment, finding that the article, when used as or in a dietary supplement under the conditions of use and dosages set forth in the labeling for such dietary supplement, is unlawful under section 402(f); and
- not include -
- an article that is approved as a new drug under section 505, certified as an antibiotic under section 507, or licensed as a biologic under section 351 of the Public Health Service Act (42 U.S.C. 262), or
- an article authorized for investigation as a new drug, antibiotic, or biological for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, which was not before such approval, certification, licensing, or authorization marketed as a dietary supplement or as a food unless the Secretary, in the Secretary's discretion, has issued a regulation, after notice and comment, finding that the article would be lawful under this Act.
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.
|New Dietary Supplement Ingredients
|SEC. 413. (a) IN GENERAL.- A dietary supplement which contains a new dietary ingredient shall be deemed adulterated under section 402(f) unless it meets one of the following requirements:
- The dietary supplement contains only dietary ingredients which have been present in the food supply as an article used for food in a form in which the food has not been chemically altered.
- There is a history of use or other evidence of safety establishing that the dietary ingredient when used under the conditions recommended or suggested in the labeling of the dietary supplement will reasonably be expected to be safe and, at least 75 days before being introduced or delivered for introduction into interstate commerce, the manufacturer or distributor of the dietary ingredient or dietary supplement provides the Secretary with information, including any citation to published articles, which is the basis on which the manufacturer or distributor has concluded that a dietary supplement containing such dietary ingredient will reasonably be expected to be safe.
The Secretary shall keep confidential any information provided under paragraph (2) for 90 days following its receipt. After the expiration of such 90 days, the Secretary shall place such information on public display, except matters in the information which are trade secrets or otherwise confidential, commercial information.
(b) PETITION. - Any person may file with the Secretary a petition proposing the issuance of an order prescribing the conditions under which a new dietary ingredient under its intended conditions of use will reasonably be expected to be safe. The Secretary shall make a decision on such petition within 180 days of the date the petition is filed with the Secretary. For purposes of chapter 7 of title 5, United States Code, the decision of the Secretary shall be considered final agency action.
(c) DEFINITION. - For purposes of this section, the term "new dietary ingredient" means a dietary ingredient that was not marketed in the United States before October 15, 1994 and does not include any dietary ingredient which was marketed in the United States before October 15, 1994.".
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.
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".
The Act was signed by President Bush, and the ban will take effect in January 2005. The following is a list of substances that will be included in the ban, in addition to substances already included in the definition of anabolic steroid.
|Anabolic Steroid Control Act Of 2004
("anabolic steroid" definition expanded to include androstenedione & related steroid compounds.)
|This Act revised the term 'anabolic steroid' to mean any drug or hormonal substance, chemically and pharmacologically related to testosterone (other than estrogens, progestins, corticosteroids, and dehydroepiandrosterone), and includes-
(I) 3b,17b-dihydroxy-5a-androstane; and
(ii) androstanedione (5a-androstan-3,17-dione);
(I) 1-androstenediol (3b,17b-dihydroxy-5a-androst-1-ene);
(II) 1-androstenediol (3a,17b-dihydroxy-5a-androst-1-ene);
(III) 4-androstenediol (3b,17b-dihydroxy-androst-4-ene); and
(IV) 5-androstenediol (3b,17b-dihydroxy-androst-5-ene);
(iv) androstenedione -
(I) 1-androstenedione ([5a]-androst-1-en-3,17-dione);
(II) 4-androstenedione (androst-4-en-3,17-dione); and
(III) 5-androstenedione (androst-5-en-3,17-dione);
(v) bolasterone (7a,17a-dimethyl-17b-hydroxyandrost-4-en-3-one);
(vi) boldenone (17b-hydroxyandrost-1,4,-diene-3-one);
(vii) calusterone (7b,17a-dimethyl-17b-hydroxyandrost-4-en-3-one);
(viii) clostebol (4-chloro-17b-hydroxyandrost-4-en-3-one);
(ix) dehydrochloromethyltestosterone (4-chloro-17b-hydroxy-17a-methyl-androst-1,4-dien-3-one);
(x) *1-dihydrotestosterone (a.k.a. `1-testosterone') (17b-hydroxy-5a-androst-1-en-3-one);b
(xi) 4-dihydrotestosterone (17b-hydroxy-androstan-3-one);
(xii) drostanolone (17b-hydroxy-2a-methyl-5a-androstan-3-one);
(xiii) ethylestrenol (17a-ethyl-17b-hydroxyestr-4-ene);
(xiv) fluoxymesterone (9-fluoro-17a-methyl-11b,17b-dihydroxyandrost-4-en-3-one);
(xv) formebolone (2-formyl-17a-methyl-11a,17b-dihydroxyandrost-1,4-dien-3-one);
(xvi) furazabol (17a-methyl-17b-hydroxyandrostano[2,3-c]-furazan);
(xviii) 4-hydroxytestosterone (4,17b-dihydroxy-androst-4-en-3-one);
(xix) 4-hydroxy-19-nortestosterone (4,17b-dihydroxy-estr-4-en-3-one);
(xx) mestanolone (17a-methyl-17b-hydroxy-5a-androstan-3-one);
(xxi) mesterolone (1a-methyl-17b-hydroxy-[5a]-androstan-3-one);
(xxii) methandienone (17a-methyl-17b-hydroxyandrost-1,4-dien-3-one);
(xxiii) methandriol (17a-methyl-3b,17b-dihydroxyandrost-5-ene);
(xxiv) methenolone (1-methyl-17b-hydroxy-5a-androst-1-en-3-one);
(xxv) 17a-methyl-3b, 17b-dihydroxy-5a-androstane;
(xxviii) 17a-methyl-4-hydroxynandrolone (17a-methyl-4-hydroxy-17b-hydroxyestr-4-en-3-one);
(xxix) methyldienolone (17a-methyl-17b-hydroxyestra-4,9(10)-dien-3-one);
(xxx) methyltrienolone (17a-methyl-17b-hydroxyestra-4,9-11-trien-3-one);
(xxxi) methyltestosterone (17a-methyl-17b-hydroxyandrost-4-en-3-one);
(xxxii) mibolerone (7a,17a-dimethyl-17b-hydroxyestr-4-en-3-one);
(xxxiii) 17a-methyl-*1-dihydrotestosterone (17b-hydroxy-17a-methyl-5a-androst-1-en-3-one) (a.k.a. `17-a-methyl-1-testosterone');
(xxxiv) nandrolone (17b-hydroxyestr-4-en-3-one);
(I) 19-nor-4-androstenediol (3b, 17b-dihydroxyestr-4-ene);
(II) 19-nor-4-androstenediol (3a, 17b-dihydroxyestr-4-ene);
(III) 19-nor-5-androstenediol (3b, 17b-dihydroxyestr-5-ene); and
(IV) 19-nor-5-androstenediol (3a, 17b-dihydroxyestr-5-ene);
(I) 19-nor-4-androstenedione (estr-4-en-3,17-dione); and
(II) 19-nor-5-androstenedioine (estr-5-en-3,17-dione;
(xxxvii) norbolethone (13b,17a-diethyl-17b-hydroxygon-4-en-3-one);
(xxxviii) norclostebol (4-chloro-17b-hydroxyestr-4-en-3-one);
(xxxix) norethandrolone (17a-ethyl-17b-hydroxyestr-4-en-3-one);
(xl) normethandrolone (17a-methyl-17b-hydroxyestr-4-en-3-one);
(xli) oxandrolone (17a-methyl-17b-hydroxy-2-oxa-[5a]-androstan-3-one);
(xlii) oxymesterone (17a-methyl-4,17b-dihydroxyandrost-4-en-3-one);
(xliii) oxymetholone (17a-methyl-2-hydroxymethylene-17b-hydroxy-[5a]-androstan-3-one);
(xliv) stanozolol (17a-methyl-17a-hydroxy-[5a]-androst-2-eno[3,2-c]-pyrazole);
(xlv) stenbolone (17b-hydroxy-2-methyl-[5a]-androst-1-en-3-one);
(xlvi) testolactone (13-hydroxy-3-oxo-13,17-secoandrosta-1,4-dien-17-oic acid lactone);
(xlvii) testosterone (17b-hydroxyandrost-4-en-3-one);
(xlviii) tetrahydrogestrinone (13b,17a-diethyl-17b-hydroxygon-4,9,11-trien-3-one);
(xlix) trenbolone (17b-hydroxyestr-4,9,11-trien-3-one); and
(xlx) any salt, ester, or ether of a drug or substance described in this paragraph.
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.
Author: Daniel Gastelu, M.S., MFS
Reprinted with Permission. ?Copyright 2004 SUPPLEMENTFACTS International LLC. All rights reserved. This article is not intended to replace medical advice; consult your doctor for all matters related to your health.
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