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There is a provision of federal drug law that requires dietary ingredient introduced after 1994 to be certified by the government as safe before they are marketed. Andro supplements were not marketed before 1994, yet the FDA never received any requests from its manufacturers for safety certifications. Now, the FDA has issued warning letters to 23 andro supplements manufacturers telling them to immediately pull them from the market because of the serious and irreversible side effect risks.
The drug agency told the 23 andro supplements makers that the failure to comply with the FDA warning could result in their products being seized and civil and legal action against them. Because of the scientific information available on the dangers of andro supplements, the FDA has said it would deny safety certification to andro supplements manufacturers if requested. One particular andro supplements maker called Twinlab Corp., has continued to claim its products are "safe and effective when used as directed."
Andro supplements are known as steroid precursors because of the conversion into a steroid after absorption into the body. After St. Louis Cardinals star Mark McGwire broke the single season home run record in 1998 and admitted his use of andro supplements, sales of the products reached $25 million. By 2001, sales of andro supplements peaked at $55 million and though the number of andro supplements sold has declined over the years as more people realized the dangers of them, its presence on the market was still too much risk.
Dangers of using andro supplements are especially relevant when considering the latest government figures showing 2% of high school sophomores and 2.5% of high school senior used andro products in 2001. The effects that andro supplements can permanently have on children and adolescents can include an early onset of puberty, which can cause a stunt in their adult stature, as well as to disrupt their sexual development. For young people that do not fully understand the long-term effects that supplements can have on their bodies, the need to remove andro supplements from the market is essential.
The FDA andro supplements ban was viewed as a positive step but critics noted the availability of andro products was still present. Andro supplements can still be found at gyms, health stores, and over the Internet but the FDA has not yet ruled on whether or not it would take enforcement against them. Supporters of the andro supplements ban hope the publicity received will allow legislation to get a hearing soon.
There is a Senate bill co-sponsored by Sens. Joe Biden and Orrin Hatch that would strengthen the government''s ability to keep steroid precursors like andro supplements off the shelves. By changing classification of andro supplements to controlled substances, the andro supplements would then have to exist under the same restrictions as prescription drugs and give the government the ability to shut down any manufacturers that try to get around the law. Many people have suffered health problems because of andro supplements.
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