Archive for the ‘Steroids’ Category

Just recently, CMG partner Rick Collins was named to a high profile list of the country’s “Most Controversial Health Figures” – coming in at  #8 (just below  Dr. Oz, but above celebrities like Richard Simmons, Jamie Oliver and Kim Kardashian – see the whole list here: http://www.livestrong.com/slideshow/546327-most-controversial-health-figures/?utm_source=newsletter&utm_medium=email&utm_campaign=111011#slide-18 ).  Rick is one of the country’s leading legal experts when it comes to anabolic steroids and has recommended a more practical and sensible approach to controlling their use – one that balances preserving fairness in sports, protecting adolescents from drug abuse, and enhancing adult liberties regarding personal health.  Given that steroids continue to be one of the most heatedly controversial topics today, his inclusion on this list of controversial health figures is not surprising.

Unlike many of the others who “made the list” due to their involvement in conflicts of interest, questionable promotions/endorsements, and/or unfounded health claims, Rick’s inclusion on this list has nothing to do with any of that.  He made the list by simply “telling the truth” as he sees it and speaking out vocally (and rationally) on a highly controversial subject – proving the notion that “controversy sells” and bringing more attention to this timely topic. Read the rest of this entry »

Chinese media sources (www.xinhuanet.com) report that China’s State Food and Drug Administration (SFDA) issued a circular on Friday requiring manufacturers of dietary supplements to tighten quality control over raw materials by reviewing the qualifications of raw material suppliers and inspecting the suppliers’ products regularly. The suppliers must improve the quality control of raw materials and manufacturers are directed to develop detailed records of raw material purchases to assist tracking the sources of raw materials. The SFDA also asked its local branches to more closely supervise manufacturers who use expensive and rare extractions from animals and plants and imported raw materials. The document threatened serious punishments for Chinese supplement manufacturers that use substandard raw materials. The agency pledged to both publicize and stop the distribution of unsafe supplements in China. 

Cross-contaminated raw materials from Chinese suppliers have long troubled the American supplement industry, prompting negative media reports, product recalls, and even criminal investigations. Recognition that tainted ingredients pose a serious problem is certainly a step in the right direction for Chinese authorities. Let’s hope quality control is improved not only for Chinese products, but for those raw materials that make their way across the Pacific to our shores.

Senator Patrick Leahy has re-introduced a bill that aims to impose strict penalties on people who knowingly distribute contaminated food.  The bill would allow prison terms of up to 10 years.  While most people will look at this bill as addressing the salmonella issue commonly associated with eggs, peanuts, and other foods often seen in the headlines, one must not forget that dietary supplements are categorized as food.  It would be a simple step to use this bill, if it passes, to prosecute those distributors of supplements who knowingly distribute products that are contaminated with illegal steroids or prescription drugs.  We will keep you advised of the bill’s progress.

Last month it was reported that about one-third of FDA’s 90 dietary supplement Good Manufacturing Practices (GMP) inspections in fiscal 2010 revealed severe compliance problems.  The most common GMP problem was reportedly “inadequate identity testing.”  Undoubtedly, relying on certificates of analysis from the raw materials supplier without further testing, or failing to conduct identity testing of a finished product, can result in the creation of a product that contains something it shouldn’t – such as synthetic chemicals or even pharmaceutical drugs.  However, a recent article in The Tan Sheet (10/11/10, page 4) refers to all of these products as “spiked” – even in situations where the presence of the undeclared ingredient is inadvertent.  The indiscriminate use of the term “spiked” by The Tan Sheet only serves to confuse the situation.  The most common use of the term refers to intentionally putting alcohol or drugs into someone else’s drink.  “Spiking” a product connotes intentionally slipping a powerful but undeclared ingredient into it to cause a desired or enhanced effect.  And that’s simply not always the case; particularly when you consider that some of the undeclared substances that have been reportedly discovered in some dietary supplement products are either contrary to, or would not enhance, the desired effect of the product and have been found in an amount that is unlikely to have any physiological effect.

 Certainly, there have been situations in the supplement industry wherein a domestic manufacturer, or even a raw materials supplier, has intentionally added an undeclared drug or chemical to the product to enhance its effect.  This is true “spiking” and it is our recommendation that the term be applied only to this scenario.  This is clearly a criminal act.  Manufacturers who “spike” products do so in violation of the FD&C, and if the undeclared ingredient is a controlled substance, the DEA also has jurisdiction. 

Read the rest of this entry »

The Center for Drug Evaluation and Research (CDER) has indicated that among its’ enforcement priorities, CDER will take special aim at the manufacturers of dietary supplements found to be spiked with pharmaceuticals. Echoing the sentiments of FDA Principal Deputy Commissioner Josh Sharfstein, CDER has indicated that the areas identified within the industry as having the highest number of offenses are “weight loss, sexual enhancement, and bodybuilding,” with over 200 tainted products discovered by FDA. CDER’s newly formed Division of New Drugs and Labeling Compliance urges the supplement industry to stay vigilant and hold itself accountable for the products they sell by remaining informed about the materials they buy, the suppliers they are buying from, and what is added to the products.

 CDER was recently involved in the voluntary recalls initiated by several firms that marketed “aromatase inhibitors.” The Center suggested that these ingredients posed a serious “health hazard” to consumers, an allegation refuted by the companies that marketed those products, citing a lack of adverse event reports that would support such a risk. CDER is also often consulted by Customs Enforcement and FDA Compliance Officers when evaluating dietary ingredient imports. The message to supplement firms is that dietary supplements are a priority for FDA and enforcement may come from a variety of branches.

Manufacturers, beware. FDA has announced plans to utilize the Park Doctrine to bring misdemeanor charges against CEOs and other corporate officers for violations of the Food, Drug and Cosmetic Act. The agency says that it will begin to put increased pressure on federal prosecutors to take misdemeanor cases, hoping that the fear of conviction will be an effective deterrent against criminal behavior.

The Park Doctrine allows the government to hold corporate officers, including but in no way limited to CEOs, accountable for misdemeanor violations regardless of whether or not they had prior knowledge of any wrongdoing. The central principle of the Doctrine is that even if they did not know a violation was being committed, a corporate official, just by virtue of their post, has the power to prevent it.

The Park Doctrine may prove to be a powerful tool for FDA, whose officials have indicated that government sanctions have not been effective in preventing criminal behavior, specifically citing the prevalence of off-label marketing within the pharmaceutical industry. Under the Park Doctrine, prosecutors will have no obligation to prove that a defendant had intent to commit a violation, prior knowledge of a violation, or engaged in negligent conduct. The fact that the defendant is a corporate officer will be enough for the prosecution to gain a conviction.

FDA will most likely begin by targeting off-label promotion within the pharmaceutical industry in its initial cases; however the use of the Park Doctrine sets a new precedent in the manner in which FDA will be pursuing violations. It would not be surprising to see supplement companies pursued in the coming months and years. This move from the FDA should be taken as a wake-up call for the pharma and supplement industries to take decisive action while they’re ahead. Companies that make the decision to be proactive and take a close look at their products and procedures may ultimately escape a potentially costly and embarrassing legal situation further down the road.

Marketers of sports supplements must not only be careful as to who is manufacturing their products, but where they, or their manufacturers, are getting their raw materials. As part of the GMP practices, distributors must also make sure their raw materials are in compliance.

This obligation can be complicated by overseas suppliers where there may be less regulatory oversight. However, a recent development in India shows that this might be changing.

A regional government in India has suspended the license of an herbal drug manufacturing company for allegedly mixing steroids and other pharmaceutical products. In addition, the owner of the company and a distributor were charged criminally.

Why is this important?  While it is good business to try and find your ingredients for the cheapest price possible, one cannot sacrifice quality for price if it will end up being more expensive in the long run. Such a decision could ultimately result in a product recall or costly class action litigation.

Though overseas governments may take action when their laws and policies are violated, one should not and cannot rely on that enforcement. Know your supplier. Have your raw materials tested and validated. It will save a lot in the long run.

Read the full story at: http://www.expressindia.com/latest-news/punjab-suspends-pharma-firms-licence-for-mixing-steroids-in-herbal-drugs/644068/

Some law-makers in Washington have been asking, how did “hidden steroids” get into bodybuilding supplements when the amended steroid law of 2004 was supposed to have solved the problem?  Supplement industry critic Senator Arlen Specter [D-PA] chaired a Senate subcommittee hearing last September (http://judiciary.senate.gov/hearings/hearing.cfm?id=4081) to get some answers from DEA and FDA brass. The Senator appeared committed to solving the problem by reportedly working on a bill tentatively entitled the “Designer Anabolic Steroid Control Act of 2010.”   Read the rest of this entry »

Dr. Margaret Hamburg

In a March 4th letter to Senator Chuck Grassley, the Ranking Member of the Committee on Finance, Commissioner Margaret Hamburg indicated that FDA plans to “increase the appropriate use of misdemeanor prosecutions … to hold responsible corporate officers accountable” and has developed a yet to be released criteria for determining when these criminal prosecutions will be used. This letter was in response to a report released by the Government Accountability Office (GAO) entitled: Food and Drug Administration: Improved Monitoring and Development of Performance Measures Needed to Strengthen Oversight of Criminal Misconduct Investigations. Read the rest of this entry »

After offering the Dietary Supplement Safety Act of 2010, S. 3002, last month to more closely regulate and restrict the supplement industry, Arizona Senator John McCain reportedly has withdrawn his support for the bill and will now work with Senator Orrin Hatch of Utah on a revised legislative initiative.  McCain’s bill was applauded by anti-doping agencies but was perceived as excessively and unnecessarily onerous on industry.  Hatch had expressed “serious concerns” about the bill in a March 4 letter to Sen. McCain.  A timeline for the new bill is not set.