FDA Issues Warning On DMAA Workout Supplements


Posted on 13th April 2013 by gjohnson in Uncategorized

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The Food and Drug Administration (FDA) how lowered the boom on the controversial workout boosters Jack3d and OxyElite Pro, issuing a warning last Wednesday that the stimulant they contain – dimethylamylamine, or DMAA – is illegal.


The FDA said that it was using all the tools at its disposal to ensure that dietary supplements containing DMAA are no longer distributed and available for sale to consumers in the marketplace. GNC and Vitamin Shoppe have been selling the products for years.

I blogged on this topic when The New York Times did an investigative piece about the dangers of DMAA.DMAA is most commonly used in supplements promising weight loss, muscle building and performance enhancement. According to the FDA, it can elevate blood pressure and could lead to cardiovascular problems, including heart attack, shortness of breath and tightening of the chest.

“Given the known biological activity of DMAA, the ingredient may be particularly dangerous when used with caffeine,” the FDA said. In its warning, the FDA reported that it had received 86 reports of illnesses and deaths associated with supplements containing DMAA.

“The majority are voluntary reports from consumers and healthcare practitioners,” the warning said. “The illnesses reported include heart problems and nervous system or psychiatric disorders. Note, however, that a report is not proof that the product actually caused the problem.”

The FDA said that is has warned companies known to be using DMAA in dietary supplements that those products containing this ingredient are illegal. It said that such warnings offer the quickest way for the FDA to halt the further distribution of dietary supplements containing DMAA in the marketplace.

All but one of the companies sent an FDA warning letter have agreed to stop using DMAA as an ingredient in their dietary supplements, according to the agency.

The company that hasn’t agreed, USPLabs, has responded to FDA’s warning by submitting published studies that purport to challenge FDA’s conclusions.

“However, after reviewing the studies provided by USPLabs, FDA has found the information insufficient to defend the use of DMAA as an ingredient in dietary supplements,” the FDA said.

“FDA is finalizing a formal response to the firm to reflect its findings, according to Daniel Fabricant, director of FDA’s Division of Dietary Supplement Program.

The FDA said that its authority over dietary supplements is very different from its authority over drugs and other medical products. FDA is required to undertake what are usually lengthy scientific and legal steps in order to force the removal of dietary supplements that may be unsafe or are otherwise illegal if companies don’t voluntarily comply.

The FDA said that as it continues the process needed to get DMAA off the market, it is urging consumers to check labels and avoid any dietary supplements containing DMAA, which is referred to on different product labels by 10 possible names. The agency said that its response to the use of DMAA “illustrates the challenges that the agency faces in addressing incidents involving potentially dangerous dietary supplements.”

That effort is increasingly important as the use of dietary supplements increases worldwide, the FDA said. A 2011 study found that more than half of U.S. adults used a dietary supplement between 2003 and 2006, compared to 40 percent between 1988 and 1994.

In recent years, the FDA has alerted consumers to hundreds of tainted products marketed as dietary supplements. Consumers should be aware that dietary supplements are subject to different oversight than drugs and other medical products.

“Consumers may mistakenly look at a capsule and think that FDA has signed off on that product as safe and effective prior to that product appearing on the market, as we do with drugs and other medical products,” Fabricant said. “In contrast, with dietary supplements, there is no pre-market approval, and once a product is on the market, the burden is on the FDA to prove that a product is unsafe.”

The FDA’s role in overseeing dietary supplements is laid out in a 1994 law and subsequent amendments, and its enforcement capabilities range from issuing warning letters seeking voluntary cooperation bringing criminal charges.

In recent years, FDA enforcement actions involving dietary supplements have included banning products, executing injunctions, working with U.S. marshals to seize products, and issuing safety alerts and consent decrees—which are agreements approved and enforced by a federal court, the agency said.

In many cases, the FDA has acted when dietary supplements were found to contain ingredients approved for use in prescription drugs. DMAA was approved in 1948 for use as a nasal decongestant, but the approval was withdrawn in 1983, according to the agency.

The products cited in the warning letter to USPLabs are Oxy Elite Pro and Jack3d. These products claim, among other things, to be fat-burning and performance-enhancing supplements, respectively.

While action in that case in pending, the FDA said it is following up to ensure that other companies which promised to cease using DMAA as an ingredient in their dietary supplements are actually doing so.

The agency is also looking to see if there are other dietary supplement products containing DMAA in the marketplace, and will continue to act to ensure that such products, when identified, are no longer distributed and available for sale to consumers.

Energy-Supplement Dangers Put Under Microscope


Posted on 18th March 2013 by gjohnson in Uncategorized

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Energy boosters and other performance supplements appear to fall through the cracks of federal safety regulators, leaving products like Jack3d on retail shelves, according to the Sunday New York Times.


The Times did a lengthy story outlining the legal issues raised by the sale Jack3d — or “jacked,” as in “jacked up” — a supplement that Leanne Sparling blames for the death of her son Michael, who was in the Army. After taking the workout supplement, he collapsed and later died of cardiac arrest while running in a military drill.

Sparling, a private, bought his Jack3d, which contains the stimulant dimethylamylamine, or DMAA, at a GNC shop. Last month his parents filed a wrongful death suit against the maker of Jack3d, Dallas-based USPlabs, and GNC, The Times reported.

GNC maintains that the supplement is safe, and it certainly is legal: The Food and Drug Administration (FDA) hasn’t pulled the supplement from the market. But it’s raised enough safety concerns that the Defense Department took all products that contain DMAA from stores on military bases in 2011, The Times reported. And seven countries have banned supplements containing DMAA.

After filing a Freedom of Information Act request, The Times learned that from January 2009 to present the FDA received 80 reports of people having health problems after taking DMAA supplements, including five deaths.

Amidst this all, GNC defended the safety of Jack3d and argued that it should not be liable for selling a product that is legal, according to The Times.

Mother Leanne Sparling disagrees.

Congress Issues Subpoena, Sets Nov. 14 Hearing On Meningitis Outbreak


Posted on 7th November 2012 by gjohnson in Uncategorized

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Maybe Washington is going to actually to crack down on compounding pharmacies, the apparent culprits in a fungal meningitis outbreak that has killed more than two dozen people.

Continuing its investigation of the public health tragedy, U.S. House Energy and Commerce Committee leaders this week announced that the Subcommittee on Oversight and Investigations will convene a hearing on Nov. 14.


In its original press release, the subcommittee said it had also invited James Coffey, Director of the Massachusetts Board of Registration in Pharmacy, and Barry Cadden, Director of Pharmacy and owner of the New England Compounding Center (NECC), to appear at the hearing. That is the facility that was the source of a tainted steroid that had caused deaths and sickened hundreds of people.

Although Cadden was invited, he apparently didn’t want to come. So on Tuesday House Energy and Commerce Committee Chairman Fred Upton, after consulting with ranking member Henry Waxman, issued a subpoena for  Cadden to testify at next week’s hearing.

“Through his counsel, Cadden has declined to appear voluntarily,” the committee said in a press release.


Upton and Waxman also issued a joint statement.

“With more than 400 people infected and 30 deaths, it is critical that we hear directly from the head of the facility linked to the outbreak,” they said. “Since Mr. Cadden has indicated he will not appear voluntarily, we are left with no choice but to issue a subpoena. We urge Barry Cadden to put the public health first and answer the committee’s questions about the deadly outbreak.”

FDA Commissioner Margaret Hamburg is also scheduled to testify next week. Apparently, she didn’t have to be subpoenaed.

Upton,  Waxman, Subcommittee Chairman Cliff Stearns, and Subcommittee Ranking Member Diana DeGette put out a joint statement Monday.

“Our committee has a long, bipartisan history of conducting drug safety oversight,” they said.

“Since the meningitis outbreak, we have been in close contact with the involved agencies and parties, but many unanswered questions remain. The NECC has a history of problems, some of which were documented in an FDA warning letter in 2006 – we want to know what went wrong at this facility, the views and actions of its regulators, and what steps can be taken to ensure such an outbreak never happens again.”

The FDA has virtually no authority over compounding pharmacies, a situation that several lawmakers want to remedy with new legislation,


Bill Looks To Regulate Pharmacies Linked To Meningitis Outbreak


Posted on 2nd November 2012 by gjohnson in Uncategorized

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It only took 28 deaths, but our astute lawmakers in Washington are drafting legislation that would finally empower the Food and Drug Administration to regulate so-called compounding pharmacies, like the one that produced the batches of tainted steroids linked to a meningitis breakout.

According to The Wall Street Journal Friday, U.S. Rep. Ed Markey, D-Mass., was going to introduce a law mandating that compounding pharmacies, which create customized drugs, meet the same sterility and manufacturing standards as traditional pharmaceutical makers. His bill is being co-sponsored by Reps. Steve Cohen, D-Tenn., and Louise Slaughter, D-New York.


Rep. Rosa DeLauro, D-Conn., also plans to sponsor similar legislation, The Journal reported. Congress is probing the fatal fungal meningitis outbreak, with a hearing scheduled for after the Presidential Election.

The brouhaha comes in the wake of 28 dying and nearly 400 made ill after receiving contaminated steroid shots, medicine manufactured by the New England Compounding Center (NECC) of Framingham, Mass. The Journal reported that on Thursday, federal health officials announced that two other NECC products had been tested and had bacteria.

Compounding pharmacies have essentially fallen through the cracks when it comes to control and safety, “governed by fragmented regulations for too long, leading to the worst public-health disaster in recent memory,” The Journal quoted Markey as saying.

As the law stands now, states are supposed to regulate compounding pharmacies, but the problem is operations like NECC have grown too large for states to effectively control, according to The Journal. And currently the FDA can inspect compounding pharmacies, but can’t make them to adhere to safe drug-manufacturing standards.

Under Markey’s proposed legislation, the FDA could regulate pharmacies “partially based on their volumes,” according to The Journal. The bill draws a distinction between pharmacies that only make small amounts of drugs for individual patients and those that manufacture large quantities for use across the nation.



Painkillers Darvon, Darvocet Withdrawn From Market Due To Heart Issues


Posted on 19th November 2010 by gjohnson in Uncategorized

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The painkillers Darvon and Darvocet, the brand version of the prescription pain medication propoxyphene, are being pulled from the U.S. market because they’ve been blamed for causing lethal heart rhythms, federal regulators said Friday.

Xanodyne Pharmaceuticals Inc., which manufactures the drug, agreed to withdraw the medication at the request of the U.S. Food and Drug Administration, the federal agency said in a press release.


Propoxyphene is an opioid used to treat mild to moderate pain. Xanodyne is based in Newport, Ky.

The FDA has also informed the generic manufacturers of propoxyphene-containing products of Xanodyne’s decision and requested that they voluntarily remove their products as well.

The federal agency sought to ban  propoxyphene after receiving new clinical data showing that the drug puts patients at risk of potentially serious or even fatal heart rhythm abnormalities, the press release said . As a result of these data, combined with other information, including new epidemiological data, the agency concluded that the risks of the medication outweigh the benefits.

“The FDA is pleased by Xanodyne’s decision to voluntarily remove its products from the U.S. market,” Dr.  John Jenkins, director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research (CDER), said in a prepared statement. “These new heart data significantly alter propoxyphene’s risk-benefit profile. The drug’s effectiveness in reducing pain is no longer enough to outweigh the drug’s serious potential heart risks.”

The FDA is also advising doctors to stop prescribing propoxyphene to their patients, and patients who are currently taking the drug should contact their health care professional as soon as possible to discuss switching to another pain management therapy.

First approved by the FDA in 1957, propoxophene is sold by prescription under various names both alone (e.g., Darvon) or in combination with acetaminophen (e.g., Darvocet).

Since 1978, the FDA has received two requests to remove propoxyphene from the market. Until now, the FDA had concluded that the benefits of propoxyphene for pain relief at recommended doses outweighed the safety risks of the drug.

In January 2009, the FDA held an advisory committee meeting to address the efficacy and safety of propoxyphene. After considering the data submitted with the original drug applications for propoxyphene, as well as subsequent medical literature and postmarketing safety databases, the committee voted 14 to 12 against the continued marketing of propoxyphene products. In making this recommendation, the committee noted that additional information about the drug’s cardiac effects would be relevant in weighing its risks and benefits.

In June 2009, the European Medicines Agency (EMEA) recommended that the marketing authorizations for propoxyphene be withdrawn across the European Union. A phased withdrawal of propoxyphene is under way.

In July 2009, the FDA decided to permit continued marketing, but required that a new boxed warning be added to the drug label alerting patients and health care professionals to the risk of a fatal overdose. In addition, the agency required Xanodyne to conduct a new safety study assessing unanswered questions about the effects of propoxyphene on the heart.

The agency now has reviewed the data from that study, which show that, even when taken at recommended doses, propoxyphene causes significant changes to the electrical activity of the heart. These changes, which can be seen on an electrocardiogram (ECG), can increase the risk for serious abnormal heart rhythms that have been linked to serious adverse effects, including sudden death.

The available data also indicate that the risk of adverse events for any particular patient (even patients who have taken the drug for many years) is subject to change based on small changes in the health status of the patient, such as dehydration, a change in medications, or decreased kidney function.

“With the new study results, for the first time we now have data showing that the standard therapeutic dose of propoxyphene can be harmful to the heart,” Dr. Gerald Dal Pan, CDER director, said in a prepared statement.  “However, long-time users of the drug need to know that these changes to the heart’s electrical activity are not cumulative. Once patients stop taking propoxyphene, the risk will go away.”

Still at least one group, the Public Citizen, Friday blasted the FDA for taking so long to ban propoxyphene.


“Since the time of the UK announcement in January 2005 of a phased, two-year withdrawal of this drug (which was followed by an immediate steep decline in use), approximately 120 million retail prescriptions have been filled in the U.S. for propoxyphene-containing drugs,” the Public Citizen said in a statement. 

“Due to FDA negligence, at least 1,000 to 2,000 or more people in the U.S. have died from using propoxyphene since time the UK ban was announced,” the statement continued. “The best forensic data, the kind relied upon in those countries for the UK and European bans, come from Florida where, because of routine drug testing required by the state medical examiner as part of many autopsies, deaths are categorized as being ’caused’ by certain drugs if the levels found are to be above a certain level. From 2005 through 2009, in Florida alone, 395 deaths were “caused” by propoxyphene. If data from 2007 are representative, in that year, 78 percent of the Florida deaths caused by propoxyphene were ruled accidental.” 

The Public Citizen said it will call for a congressional investigation “into whom in the FDA, specifically in the Center for Drug Evaluation and Research, was responsible for the loss of so many lives in this country. It is clear that long before today, many drug safety experts in the Office of Surveillance and Epidemiology had decided the drug should be removed from the market.”