The FDA final rule “establishing current good manufacturing practice requirements (CGMPs) ” in June 2008 was just the beginning of the lid being blown off the dietary supplements industry. It has become more than apparent that the impact of Dietary Health and Supplement Education Act (DSHEA) has surfaced and it is just the beginning of startling headlines of illness and death associated with OTC supplements.

The new FDA Rule requires the industry to report all serious dietary supplement adverse events to FDA and evaluate the identity, purity, quality, strength, and composition of dietary supplements.

Although Federal law placed anabolic steroids in Schedule III of the Controlled Substances Act (CSA) as of February 27, 1991 and The Anabolic Steroid Control Act of 2004 – placed 32 additional steroids in Schedule III and expanded DEA’s regulatory and enforcement authority regarding steroids.

What we are seeing in an entire “subculture” are “dietary supplement steroid” or “pro-hormones” in a large population that includes teens. It appears that those with the means and motive have found a very grey area in the supplement industry. Maybe the FDA was asleep at the wheel but not the DEA. In May 2008 the DEA reported that 22 Dietary Supplements were identified as containing dangerous Anabolic Steroids published in the Federal Register.

” According to the DEA, the following three steroids meet the criteria for “anabolic steroids” under the Anabolic Steroid Control Act of 2004 (“Classification of Three Steroids as Schedule III Anabolic Steroids Under the Controlled Substances Act,” April 25).”

· Boldione (aka androsta-1,4-diene-3,17-dione)
· Desoxymethyltestosterone (aka DMT and 17a-methyl-5a-androst-2-en-  17b-ol)
· 19-nor-4,9(10)-androstadienedione (aka 19-norandrosta-4,9(10)-diene-3,17-dione and esta-4,9(10)-diene-3,17-dione)�

A recent study revealed contamination of approximately 25% of popular dietary supplements in the U.S. with low levels of steroids that were not declared on the product label. The International Olympic Committee (IOC ) conducted a study between 2000 and 2002 that revealed “15% of dietary supplements purchased in various countries contained undeclared steroid and/or prohormone ingredients.”

Loren Israelsen a lobbyist for the supplement industry was quoted “It’s a sad and unfortunate day for the supplement industry when Major League Baseball has more credibility than supplement industry leaders.” The DEA responded “YES, they do sell steroids in the supplement aisle and the supplement industry is no better at self-regulating than MLB; at least the MLB finally acknowledged they have a steroid problem” It is no surprise that this is all bad news for the supplement industry (see “The DEA Has Their Eye on Online Supplement Retailers,” April 30).

Some explanations for high incidence of steroids and stimulants found in sports supplements according to the DEA are:

1. Intentional contamination. There have been allegations that some supplement companies may have added some undeclared ingredients, usually by the addition of a stimulant, so that the consumer actually “feels” that the product is working. The overall success of the sports nutrition supplement industry is largely due to the “placebo effect” – if the consumer “feels” something from the supplement, they think it is working. If they think it is working, it may actually have benefit (placebo) and they will continue to buy the product.

2. Cross-contamination. Many factories manufacturer various different categories of supplements in the same facility.  For example, ephedrine products may be processed on the same equipment as vitamin and mineral products; hormonal products may be processed on same line as protein powders. If the equipment is not cleaned properly, contamination could result.

3. Contaminated raw material. Supplement manufacturers often import raw materials from Asia, India and Eastern Europe. This could be contaminated with impurities.

Edward Lazkowski MD of Mayo Clinic advises “many people are unaware that these natural steroid supplements, such as DHEA, are anabolic steroids. The only difference between natural and synthetic steroids is that synthetic steroids are made in a lab and chemically altered in some way. Because natural steroids contain “natural” substances that aren’t chemically altered, they can be marketed as dietary supplements that increase strength and build muscle. As supplements, they’re subjected to limited regulation by the Food and Drug Administration. “”Although anabolic steroids can enhance certain types of performance or physical appearance, they are dangerous drugs. When used inappropriately, they can cause a variety of severe, long-lasting and often irreversible health problems, including:

· Aggressive behaviors, rage or violence

· Severe acne

· Baldness

· Infertility

· Liver disease

· High cholesterol �

This entry was posted on Monday, August 25th, 2008 at 10:00 am and is filed under Product Defect. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response.