FDA’s recent actions aim to protect public healthRecently, the US Food and Drug Administration have been involved in several cases of illegal drug importation, misbranding of dug products and mislabeling of dietary supplements.

The agency has been working hard to protect public health by ensuring a tougher enforcement of its policies and regulations.

According to US Food and Drug Commissioner Margaret Hamburg, the agency must be strategic, vigilant, quick and visible, especially in these times where illegal drug activity seems to be rising fast.

Several investigations conducted by the agency involved a man from Lyn, Massachusetts, who was sentenced to a three-year imprisonment plus three years of supervised release for illegal importation and distribution of bodybuilding substances without a prescription.

Christopher Chase was indicted on July 27, 2009 for selling anabolic steroids, HGH and IGF-1 as bodybuilding substances. Chase and his team sold the substances through various websites without a prescription. The drugs were found to be smuggled from China. He was also charged with money laundering and conspiracy, along with two other co-defendants.

Included among the agency’s six point action plan were setting post inspection deadlines, speeding the Warning Letter process and working more closely with FDA’s regulatory partners in an effort to protect the consumers.

According to PharmTech Talk:

Last month, US Food and Drug Administration Commissioner Margaret Hamburg announced the agency’s six-point plan for tougher enforcement of its policies and regulations as means of protecting public health. The plan, which includes actions like setting postinspection deadlines, speeding the Warning Letter process, and working more closely with FDA’s regulatory partners, was designed to “to prevent harm to the American people,” as Hamburg said in an FDA release.

Severe health risks associated with HGH abuseHuman growth hormone, also known as HGH to the world, has been hailed as one of the safest and effective drugs when used in accordance with medical advice. But, it can lead to serious health risks when abused by its users.

Dr. Alan Rogol, while testifying before the U.S. House of Representatives Government Reform Committee on behalf of The Endocrine Society, summarized the legitimate medical use of HGH and its probable health risks when abused by sportsmen, individuals, and celebrities to prevent aging.

From News-Medical.Net:

“There are a number of safe and legitimate FDA-approved uses of growth hormone in adults and children,” said Dr. Rogol. “The off-label use of growth hormone, which primarily is in the anti-aging and body image or athletic market, comes with increased risks.”

One risk factor is that most off-label users are usually unaware of the correct doses. “One can assume that the dose administered would be much greater than that given for legitimate purposes,” said Dr. Rogol.

At higher HGH dosages, it is possible to achieve levels similar to those found in the endocrine disease acromegaly, which is caused by too much growth hormone in the body. This condition can lead to severe muscle weakness and even heart disease.

According to Dr. Rogol, perhaps the most insidious off-label use is by athletes and others who believe they are using actual growth hormone, when in fact they may be receiving an entirely different substance.

“Magazines and the internet are replete with advertisements for substances marketed as ‘growth hormone’,” said Dr. Rogol. “Growth hormone, however, can only work if injected, and many of these preparations are taken orally, so they cannot possibly be HGH.”

It was also remarked that growth hormone, made from human tissue, has already been removed from the drug market due to rare but fatal Creutzfeldt-Jakob disease.