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Thursday 20, Oct 2011

  Recall of the dietary supplement

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The Food and Drug Administration notified Superior Metabolic Technologies that Uprizing 2.0 contained a synthetic steroid called superdrol, which is banned by the FDA, as per a press release.

The dietary supplement was sold through retail health food stores in Georgia, Alabama, Arizona, California, Mississippi, New Jersey, South Carolina, and Texas.

The FDA notification led to recall of the dietary supplement.

Thursday 15, Sep 2011

  Products marked as dietary supplements are potentially dangerous

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The U.S. Food and Drug Administration has expressed concern about undeclared or deceptively labeled ingredients in products marketed as dietary supplements, in a letter sent to manufacturers of dietary supplements.

These substances include the active ingredients in FDA-approved drugs or their analogs, or other compounds, such as novel synthetic steroids.

The FDA has also announced a new RSS feed to warn consumers more quickly about tainted products marketed as dietary supplements.

Thursday 01, Sep 2011

  Targeted drug testing guidelines proposed by FDA

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Targeted drug testing guidelines proposed by FDAAccording to a recently proposed policy, targeted drugs or therapies up for regulatory approval would have to be reviewed simultaneously with the diagnostic devices they rely on.

The U.S.F.D.A. (Food and Drug Administration) has proposed rules highlighting that personalized treatments would gain approval only after their accompanying diagnostic devices also receive approval — unless the treatment is for a serious or life-threatening condition.

The FDA is now seeking public comments on the proposal.

Monday 23, Nov 2009

  Irish Medicine Board concerned about their citizen’s health safety

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Irish Medicine Board concerned about their citizen’s health safety  The Irish Medicine Board (IMB) is worried because a small number of Irish consumers may have bought products distributed at www.Bodybuilding.com. The agency has issued a warning regarding the dietary supplements that contained synthetic steroids.

According to IMB, anyone who is currently using the product must immediately discontinue its use. If there are any concerns or health problems arising, immediately contact your physician. Those who have extra supplies of the dietary supplements must store the products in a safe place away from children. Even suppliers were asked by IMB to contact their customers.

IMB Chief executive Pat O’Mahony said that using these steroid-containing supplements might result in adverse effects such as acute liver damage, increase risk of heart disease and strokes.

IMB has already contacted the US FDA regarding this concern. Both IMB and FDA’s concern is that the dietary supplements may contain some forms of steroids such as superdrol, madol, tren, androstenedione and turinabol.

According to bodybuilding.com, the voluntary national and international recall of their products was not due to confirmation of FDA’s concerns. Rather, it is more of a precautionary measure on their part.

O’Mahony further added that certain precautions must be exercised when purchasing products online because it may be potentially dangerous to your health.

Wednesday 11, Nov 2009

  Unregulated supplements still rampant in Boston

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Unregulated supplements still rampant in BostonUnregulated supplements are highly popular in Boston area even though many of the products contain illegal synthetic steroids that can harm the kidneys and liver. These synthetic steroids could also lead to formation of blood clots that could later cause complications such as strokes.

The US Food and Drug Administration showed how powerless they are when it comes to regulation of dietary supplements. Based on the current law, FDA can only take legal actions after the agency receives a formal complaint from consumers on a particular food supplement. However, dietary supplement manufacturing firms are not required to prove the safety of their substance before it could be released in the market. Congress should amend the current law, in order to give more power and authority to FDA to control the dietary supplements industry.

Steroids and performance-enhancing substances are not the only ones identified to contaminate supplements. There are about 140 different substances found to be hazardous to the human body. Dr. Pieter Cohen of Harvard Medical School named some of those ingredients and published an article in The New England Journal of Medicine about these hazardous ingredients. It includes toxic plant material, heavy metals, bacteria, prescription medications, controlled substances, experimental compounds and drugs not approved by FDA due to health safety concerns.

Monday 26, Oct 2009

  Sharfstein agrees more work to be done by FDA when it comes to steroids problem

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Sharfstein agrees more work to be done by FDA when it comes to steroids problemAccording to Joshua Sharfstein, principal deputy commissioner at FDA, there are still a lot of work to be done in terms of dietary supplement safety and regulation.

During the Annual Symposium at the Council for Responsible Nutrition for the Dietary Supplement Industry, Sharfstein said that one of the greatest concern faced by FDA today is the continuous distribution of nutritional supplements contaminated by potentially dangerous pharmaceuticals such as steroids. So far, the steroid problem is the biggest issue faced by the supplement industry at present.

One of the reasons FDA has difficulty in taking action on dietary supplements containing steroids is that the claim for enhancing muscle bulk is not enough as evidence for false or misleading information. In order for them to take action, they must be able to establish that steroids are indeed present in these supplements.

He suggested new tools and approaches as answers to regulatory dilemma. It includes tools given by DSHEA for improving the safety and quality of dietary supplements. However, he agreed that there is still more work to be done when it comes to their agency’s authority on new dietary ingredient (NDI) rules, which usually requires a 75-day pre-market notification of any new dietary ingredient.

Friday 23, Oct 2009

  Congress examining supplements with steroids

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Congress examining supplements with steroidsThe Food and Drug Administration (FDA) recently told the Congress that it had limited capabilities when it comes to preventing dietary supplements with steroids from hitting the market shelves.

The subcommittee chairman, Sen. Arlen Specter, a Pennsylvania Democrat and Philadelphia Phillies fan, remarked before the hearing was initiated that his interest was piqued in some part by the case of Phillies pitcher J.C. Romero, who was handed a suspension of 50 games this season, after being tested positive for Androstendione, a substance that was also used by Mark McGwire in the 1990s.

It is worth noting here that the Major League Baseball Players Association has been pressing the Congress to formulate stringent reporting requirements for supplement manufacturers and hard penalties for repeat offenders.

Saturday 05, Sep 2009

  FDA’s recent action plan for illegal drug prescription drugs

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FDA’s recent action plan for illegal drug prescription drugs  In order to prevent harm and protect the public health, US Food and Drug Commissioner Margaret Hamburg announced their plans for a stricter implementation of FDA policies and regulations.

Recent cases involving illegal importation and sales, drug diversion, misbranding of drug products and mislabeling of nutritional supplements have kept the agency busy.

FDA conducted criminal investigations related to the above cases in partnership with other government offices.

Last July 27, Christopher Chase of Massachusetts received a sentence of three years imprisonment with three years of supervised release due to illegal importation of anabolic steroids and other performance enhancing drugs.

The drugs were sourced from China and sold in the United States by Chase and his team as bodybuilding substances through websites. Substances such as anabolic steroids, HGH and IGF-1 were available online without a prescription. Clenbuterol, a known drug not approved by the FDA for human consumption, was also among those drugs sold by Chase’s team.

According to Hamburg, the agency must be vigilant, strategic, and quick and must be visible these days.

Among the FDA’s plan include setting post inspection deadlines, speeding the Warning Letter process, and working more closely with regulatory partners of the agency.

Tuesday 19, May 2009

  Most Sports-Supplements Contain Steroids

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Most Sports-Supplements Contain SteroidsThe Centers for Disease Control and Prevention has documented that steroid use among high school athletes has more than doubled in the past two decades. This shows that sports-supplements industry is growing beyond control because teenagers can easily purchase these performance-enhancing supplements through local drugstores and online shops. Among the best sellers are weight loss supplements and workout enhancers.

David Epstein and George Dohrmann of Sports Illustrated have reported that a study revealed that 25 percent of the 58 sports supplements tested contained steroids or stimulants that had been banned by the World Anti-Doping Agency.

Since FDA does not need to approve these types of supplements, President Barack Obama has talked about the need to revamp the FDA, and appealed that the agency should regulate the supplement industry.

Some supplement manufacturers offer beneficial products. However, some manufacturers deceive consumers by putting steroids components to the products, and then attack the American market with their enticing marketing pitches.

Thursday 14, May 2009

  FDA Seized Dietary Products Containing Steroids

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FDA Seized Dietary Products Containing SteroidsThe U.S. Food and Drug Administration (FDA) requested the U.S Marshals to seize about 23,300 bottles of three dietary supplement products distributed by LG Sciences LLC, of Brighton, Michigan. The confiscated dietary supplements worth $1.3 million were sold to bodybuilders and distributed on the Internet and in retail stores under the names: “Methyl 1-D,” “Methyl 1-D XL,” and “Formadrol Extreme XL.

According to the agency, the supplements contain androstatriene and androstenetrione which are both steroids that inhibit the activity of the enzyme aromatase. The supplements claim to stimulate the production of testosterone.

The FDA warned LG Sciences to stop distributing dietary supplements that are unapproved and that contain steroid compounds. This is to protect the consumers from the potential health hazards or injuries.

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