Aug 27 2009
Dietary Supplements Becomes a Major Concern of FDA Due to Anabolic Steroid Content
The FDA had issued warnings to companies marketing nutritional supplements for possible misbranding of their products. Based on FDA investigation, some dietary supplements contain traces of anabolic steroids or testosterone. This would make these supplement products into a classified drug which could only be taken with legal prescription. In addition, the FDA also issued a public health advisory warning consumers to stop using any bodybuilding supplements which may contain steroids or steroid like substances. Most of these dietary supplements claim to enhance or reduce androgen, estrogen or progestin like effects in the body. They are promoted as a hormone product or alternative to anabolic steroids. FDA stressed that these supplements has not been approved or reviewed by their agency as regards to its safety and effectiveness. Some supplements were also mislabeled because it does not provide adequate directions for use.
Nutritional supplements or dietary supplements continue to capture a wider market because of its popularity among bodybuilders and sports enthusiasts. According to the research of Nutritional Reviews, supplements industry remains to be a large multibillion dollar market. This is despite of the health issues being cast on these products specially sports supplements. Another research firm, BCC Research, estimated that the growth rate for this industry is more than 24% annually. The demand for sports supplements in 2008 is estimated at $31.2 billion. This is a significant growth from the 2007 figure which is $27.8 billion. Moreover, users can easily purchase these supplements over the counter without any medical or expert supervision. These supplements usually help in the muscle development, gaining strength and better body physique. However, FDA is concerned on the possible side effects of these supplements which may include liver injury and other complications.
One of the companies who were already affected by this directive is the American Cellular Laboratory (ACL). They were forced to pull out some of their products from the market last month. The FDA has identified 8 products from American Cellular Labs that contains anabolic steroids and classified them as “misbranded and unapproved new drugs.” In a press release, the FDA said, “Although these products are marketed as dietary supplements, they are not dietary supplements, but instead are unapproved and misbranded drugs.”
In the warning letter of FDA, the following Xtreme products of ACL contain traces of various types of anabolic steroids.
TREN-Xtreme:
Composition: 19-Norandrosta-4,9-diene-3,17 dione
Issue: Marketed as “similar to Trenbolone”
MASS Xtreme:
Composition: 17a-methyl-etioallocholan-2-ene-17b-ol
Issue: marketed as “similar to Methyl Testosterone”
ESTRO Xtreme:
Composition: 4-hydroxyandrostenedione (4-OHA)
AH-89-Xtreme:
Composition: 5a-androstano[3,2-c]pyrazole-3-one-17ß-ol-THP-ether
Issue: marketed as “similar to Stanozolol” or Winstrol
HMG Xtreme:
Composition: 2a,3a-epithio-17a-methyl-17ß-hydroxy-5a-etioallocholane
MMA-3 Xtreme:
Composition: Androsta-1,4-dien-3,17-dione
Issue: marketed as “similar to Boldenone (Equipoise)”
VNS-9 Xtreme:
CompositionL: 17a-methyl-4-chloro-androsta-1,4-diene-3ß,17ß-diol
Issue: marketed as “similar to Turinabol”
TT-40-Xtreme:
Composition: 1-androsterone
Issue: marketed as “very similar to 1-Testosterone” and “converts to 1-Testosterone”
Mark Ullman, chair of the Legal Advisory Council for the Natural Products Foundation said that the supplement industry can and does encourage the FDA to pursue non-compliant, rogue companies. He said that nutritional companies must be careful of the claims that they make for their products and at the same time the substances included in its supplements. “As far as protecting itself, one thing the industry has done is set up a self-regulatory mechanism.” Recently, they have issued their own version of warning letter to its member companies. “Failure to respond to the Foundation will result in a referral of the matter to the FDA and/or FTC (Federal Trade Commission),” said Ullman.
Moreover, the FDA cautions professional athletes taking these nutritional supplements because it could lead them to a positive steroid test.
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