Recall of ED Supplement because of Dangerous Ingredient
September 1, 2008
Jack Distribution, LLC announced that they are conducting a voluntary nationwide recall of all lot numbers of the company’s supplement products sold under the brand names Rize 2 The Occasion and Rose 4 Her. New lots of Rize 2 and Rose 4 her (not subject to this recall) will contain lot numbers beginning in “BL”.
Jack Distribution, LLC, is conducting this recall after being informed by representatives of the Food and Drug Administration (FDA) that lab analysis by FDA of Rize 2 and Rose 4 Her samples of random lots found the product contains potentially harmful, undeclared ingredients. FDA asserts that its chemical analysis revealed that Rize 2 The Occasion and Rose 4 Her contain thiomethisosildenafil, an analog of sildenafil, the active ingredient of a FDA-approved drug used for Erectile Dysfunction (ED). FDA maintains that this ingredient is close in structure to sildenafil and is expected to possess a similar pharmacological and adverse event profile. This undeclared chemical poses a potential threat to consumers because it may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels.
Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. ED is a common problem in men with these conditions, and consumers may seek these types of products to enhance sexual performance.
Popularity: 4% [?]
HPV Vaccine Associated with Serious Adverse Effects
August 30, 2008
As of June 30, 2008, there have been 9,749 VAERS reports of adverse events following Gardasil vaccination. Of these, 94% were classified as reports of non-serious events, and 6% as serious events.
Concerns have been raised about reports of deaths occurring in individuals after receiving Gardasil. As of June 30, 2008, 20 deaths had been reported to VAERS. There was not a common pattern to the deaths that would suggest they were caused by the vaccine. In cases where autopsy, death certificate and medical records were available, the cause of death was explained by factors other than the vaccine.
Guillain-Barre Syndrome (GBS) has also been reported in individuals following vaccination with Gardasil. GBS is a rare neurological disorder that causes muscle weakness. It occurs spontaneously in unvaccinated individuals after a variety of specific infections. FDA and CDC have reviewed the reports of GBS that have been submitted to VAERS. To date, there is no evidence that Gardasil has increased the rate of GBS above that expected in the population. While FDA continues to carefully analyze all reports of GBS submitted to VAERS, the data do not currently suggest an association between Gardasil and GBS.
Thromboembolic disorders (blood clots) have been reported to VAERS in people who have received Gardasil. Most of these individuals had risk factors for blood clots such as use of oral contraceptives which are known to increase the risk of clotting. Thromboembolic disorders as well as other medical events are being studied through the VSD in previously planned controlled studies. The manufacturer has also committed to conduct a large postmarketing study to further assess the vaccine’s safety.
ALERT - NEW INFORMATION LINKS HPV VACCINE WITH PRECANCEROUS LESIONS
Check out this interesting video for an alternative view on the association between HPV and Cervical Cancer
Popularity: 30% [?]
Xiadafil VIP Tablets Forced Off Market
July 25, 2008
At the request of the U.S. Food and Drug Administration, U.S. Marshals seized nearly $74,000 worth of Xiadafil VIP tablets, Lots 6K029 and 6K209-SEI, distributed by SEI Pharmaceuticals, Inc. of Miami, Fla. Although marketed as a dietary supplement to treat erectile dysfunction (ED) and for sexual enhancement, these lots represent an illegally marketed drug containing an undeclared ingredient.
Today’s action follows a formal FDA request to SEI Pharmaceuticals (SEI) on May 27, 2008, to recall the lots of Xiadafil VIP tablets. The products were given away at trade shows and sold in eight tablet bottles (Lot # 6K029) and blister cards of two tablets (Lot # 6K029-SEI) bearing an expiration date of September 2009 (09/09). The company, however, refused to recall these products, making the seizure action necessary to prevent additional, illegal Xiadafil VIP products from entering the marketplace.
The FDA’s chemical analysis of Xiadafil VIP tablets Lots # 6K029/6K029-SEI found that the product contains hydroxyhomosildenafil, which is chemically similar to sildenafil. Sildenafil is the active ingredient in Viagra, an FDA-approved prescription drug for ED. The FDA has not approved Xiadafil VIP for ED or any other drug use, and the safety and effectiveness of this product is unknown. Although offered for sale as dietary supplements, the seized articles are new drugs that may not be introduced into interstate commerce without an approved new drug application filed with FDA.
“Today’s seizure action shows that FDA will take enforcement action to protect the public from dietary supplements that contain prescription drug ingredients that are potentially harmful to consumers,” said Margaret O’K Glavin, associate commissioner of the FDA’s Office of Regulatory Affairs. “FDA will not tolerate a company’s failure to take voluntary action to protect the public health after being given the opportunity by FDA to do so,” she added.
On April 22, 2008, the FDA initiated an inspection at SEI Pharmaceuticals following its analysis of the Xiadafil VIP tablets. The company was advised of the FDA’s findings and informed of the potential adverse health risks the product posed to unsuspecting consumers. The FDA also warned the company of possible legal actions, including seizure and/or injunction if corrective and preventive actions were not implemented. Although the company committed to halting distribution of the product and deactivated its Internet site, it refused to recall the product already in the market.
On May 13, 2008, Florida state officials issued a “stop sale” action at SEI’s distribution facility to keep the illegal product out of the marketplace. This action required SEI to hold, intact, violative Xiadafil VIP tablets found at the facility.
ED is a common problem in men who have diabetes, high blood pressure, high cholesterol, or heart disease. Because they may have been advised against taking ED drugs, men with these conditions may seek alternative products like Xiadafil VIP tablets because they are marketed as “all natural” or as not containing the active ingredients in approved, prescribed ED drugs. Furthermore, because the manufacturing source of the active ingredients in many of these alternative products is unknown, consumers should also be aware that the safety, efficacy, and purity of these ingredients have not been verified by the FDA.
Consumers should discontinue the use of Xiadafil VIP tablets immediately and consult their health care professional if they have experienced adverse events that they believe may be related to the use of this product.
Popularity: 16% [?]
Erectile Dysfunction Supplements Seized by U.S. Marshals
April 10, 2008
At the request of the U.S. Food and Drug Administration, today U.S. Marshals seized more than 14,000 dosage units of Shangai Regular, Shangai Ultra, Super Shangai, Naturalë Super Plus, and Lady Shangai. Although labeled as natural supplements, the seized products were all marketed to treat erectile dysfunction (ED), impotency, and/or to provide sexual enhancement, which caused them to be drugs under the Federal Food, Drug, and Cosmetic Act.
The seized products, valued at more than $100,000, contain undeclared active ingredients found in FDA-approved prescription drugs for ED, or similar substances. Use of these products may result in serious side effects and may interact in dangerous ways with medications that a consumer may already be taking.
“The FDA will not tolerate companies marketing unapproved drugs — products that have not proven to be safe or effective — as dietary supplements,” said Margaret O’K. Glavin, associate commissioner for regulatory affairs. “The agency will pursue necessary legal action to make sure companies and their executives manufacture and distribute safe drug products.”
The seized products, which originated in China, are packaged and distributed by Shangai Distributors, Inc. of Coamo, Puerto Rico. Although the products’ labels state they are natural supplements, these products are drugs and their sale is illegal without FDA approval. Before a new drug product may be legally marketed, it must be shown to be safe and effective.
In response to a consumer complaint, the FDA conducted an inspection of Shangai Distributors Inc., in November 2007. The FDA’s investigation and testing revealed that the seized products contained active drug ingredients found in FDA-approved ED prescription drugs and/or a substance with a structure similar to such drugs that may cause similar side effects and drug interactions. None of the drug ingredients are listed on the labels of any of the seized products.
The undeclared ingredients in these products may interact with nitrates found in some prescription drugs (such as nitroglycerin) and can lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. ED is a common problem in men with these medical conditions. Because they may have been advised against taking ED drugs, they may seek out products like these because they are marketed as “all natural” or as not containing the active ingredients in approved, prescribed ED drugs. Additionally, because the manufacturing source of the active ingredients in these products is unknown, consumers should be aware that the safety, efficacy, and purity of these ingredients can not be validated.
Despite being advised of the findings and the potential adverse health risk posed by the seized products and that regulatory action was possible, the company did not take any action to correct the violations. The FDA issued a press release on December 28, 2007 advising consumers not to buy or use the products. Prior to the seizure, the Puerto Rico Department of Health embargoed the seized products to protect the citizens of Puerto Rico and to support the FDA’s enforcement actions.
The FDA advises consumers who have used any of these products to discontinue use and consult their health care providers if they have experienced any adverse events that they believe are related to the use of these products.
Popularity: 81% [?]
Hazardous Levels of Selenium in “Total Body Formula” and”Total Body Mega Formula”
April 10, 2008
The U.S. Food and Drug Administration announced today that it has found hazardous levels of selenium in samples of certain flavors of the dietary supplement products “Total Body Formula” and “Total Body Mega Formula.” The FDA has received 43 reports of persons from nine states who experienced serious adverse reactions using these products.
On March 27, the FDA warned consumers not to purchase or use “Total Body Formula” in flavors Tropical Orange and Peach Nectar and “Total Body Mega Formula” in the Orange/Tangerine flavor of these products after receiving reports of adverse reactions in users in Florida and Tennessee . The adverse reactions generally occurred after five to 10 days of daily ingestion of the product, and included significant hair loss, muscle cramps, diarrhea, joint pain, deformed fingernails, and fatigue.
Selenium, a naturally occurring mineral, is needed only in very small amounts for good health. Selenium can boost the immune system. Generally, normal consumption of food and water provides adequate selenium to support good health. Excessive intake of selenium is known to cause symptoms to include significant hair loss, muscle cramps, diarrhea, joint pain, fatigue, loss of finger nails and blistering skin.
Popularity: 80% [?]
Making Nanotubes Without Harming the Environment
April 9, 2008
They are 10,000 times thinner than a strand of human hair, yet stronger than steel, more durable than diamonds, and able to conduct heat and electricity with efficiency that rivals copper wires and silicon chips.
Ever since their discovery in the early 1990s, carbon nanotubes have been hailed as a new “wonder material.” They are tiny building blocks with mammoth potential to make fibers, films, filaments, wires, and circuits for a wide spectrum of industrial applications—from reinforced concrete, tear-resistant clothes, and stronger, lighter tennis rackets and bicycle parts to revolutionary electronics at the core of numerous multibillion-dollar industries in the 21st century. In a headlong rush to capitalize, the nanotube industry is projected to more than double every year.
“I predict (carbon nanotubes) will be as pervasive as plastic,” said Phil Gschwend, an environmental chemist at the Massachusetts Institute of Technology. “Before we know it, they will be everywhere.”
But that’s exactly what gives pause for concern to Gschwend and his colleagues—Chris Reddy of Woods Hole Oceanographic Institution and MIT/WHOI graduate student Desirée Plata. Because as useful as nanotubes may turn out to be, the process of making them may have unintentional harmful impacts on the environment and public health.
So before the carbon nanotube industry truly ramps up, the three researchers are championing a new paradigm: “We are trying to encourage forethought and collaboration—academia and industry working together during the design phase to develop methods that pre-empt potential dangers and maximize the safe use of new materials,” Plata said.
The MIT/WHOI team has been tracking these possibilities from the beginning. Last year, at the American Chemical Society meeting, Plata reported research in which she monitored common carbon nanotube manufacturing processes in MIT labs. She found the synthetic process also produced several cancer-causing compounds and substances that can contribute to ozone and smog formation, both of which cause respiratory ailments.
In new research, published online April 3 in the journal Nanotechnology, Plata, Gschwend, and Reddy analyzed 10 commercially made carbon nanotubes to examine what metals and organic residues are co-produced with these nanotubes, and thereby potentially released to the environment. Notably, they found that all carbon nanotubes are not created equal: Different manufacturing processes produce a diversity of chemical signatures, making it harder to trace nanotubes’ impacts in the environment.
“The problem is that when we make materials, the pieces that compose those materials don’t stay in the products themselves, they end up in our oceans, in our atmosphere, and just about everywhere,” Gschwend said.
DDT, PCB, CFCs, MBTE, etc.
For decades, industry has produced an alphabet soup of useful chemicals that have often also had unintended deleterious effects. Perhaps the most famous, or infamous, is DDT, a pesticide that has helped eradicate malaria and other deadly mosquito-borne diseases in some places. But this insecticide has also left lingering harmful impacts throughout the food chain, from single-celled animals to birds and humans. Rachel Carson highlighted the problem in her seminal 1962 book Silent Spring and is often credited with sparking the modern environmental movement.
The litany of useful chemicals with downsides doesn’t end there. In machinery, PCBs helped make fabulous transformers and hydraulic systems; in rivers, they made fabulous pollutants. CFCs (chlorofluorocarbons) are excellent refrigerants that also turned out to destroy stratospheric ozone. MTBE in gasoline helped solve air pollution problems, before causing widespread groundwater contamination. Few materials are as nonflammable and, unfortunately, effective at destroying lungs, as asbestos. A more recent example are PBDEs, polybrominated diphenyl ethers, used as flame retardants.
“It is the indiscriminant use of poorly understood chemicals that causes environmental and public health costs to outweigh societal benefits,” Plata said.
“We want to work proactively with the carbon nanotube industry to avoid repeating environmental mistakes of the past,” she said. “Instead of reacting to problems, we hope to avoid them altogether.” Moreover, they hope to save the industry from future expenditures involved with litigation and environmental cleanup.
The approach turns on its head the way manufacturers have often handled such situations in the past: mass-producing chemicals for years before scientists discovered problems, then pulling everything from the shelves.
“Historically environmental chemists have been playing the sheriff in that we find a contaminant, we publish papers that say how companies caused the hazardous problem, and we force them to make things right,” Reddy said. “With our approach, we’re going in the front door and saying, ‘You know what? Let’s do this the right way from the beginning.’ ”
A closer relationship between academia and industry, the researchers say, is long overdue.
Nanotubes 101
As their name implies, carbon nanotubes are made mostly of carbon, the same element found in diamonds and in No. 2 pencils (graphite). Diamonds and graphite are allotropes of carbon, meaning they are made of the same stuff but with their atoms bonded together in different arrangements that give the allotropes different properties. Nanotubes belong to the third carbon allotrope, the fullerenes.
You might think nanotubes get their strength from resembling diamonds, but in fact they are more similar to graphite, whose carbon atoms are arranged as flat sheets in hexagons. Now imagine the flat sheets are rolled into slim cylinders, or tubes, whose lengths (measured in micro- or millimeters, or millionths or thousandths of a meter) greatly exceed their width (measured in nanometers, or billionths of a meter). When the hexagons come together in a cylindrical pattern, they take on interesting mechanical and electrical properties.
A rush of research has gone into understanding these properties and into investigating how to manufacture nanotubes. One method, with the imposing name of catalytic chemical vapor deposition, or CVD, involves reacting gases containing carbon on catalytic surfaces made of metals such as nickel, cobalt or iron, to form the carbon in the desired tubular pattern.
If it sounds complex, it is, and the science is so new, Reddy said, that the cookbook hasn’t been written yet. Manufacturers are experimenting with various recipes. And that’s where he, Plata, and Gschwend have come in: taking a look at what’s going on in the oven and what’s coming out.
Manufacturing nanotubes: what’s cooking?
Plata began this research by working with materials scientists at MIT to make nanotubes herself. With the help of laser displacement sensors that monitored the process, she was able to look at what was happening to materials during the reaction in real time, and then analyze the byproducts.
She found that the process produced emissions that contained at least 15 aromatic hydrocarbons, including four different kinds of toxic polycyclic aromatic hydrocarbons (PAHs) similar to those found in cigarette smoke and automobile tailpipe emissions.
Much more striking, however, was her finding that the process was very inefficient: An overwhelming amount of carbon that went into the pot remained unused and was vented right out into the atmosphere.
“There’s no way you can not have a ‘leaky faucet’ in making this stuff,” Reddy said. Byproducts from carbon nanotube manufacturing “may be out there in trace amounts right now, but there could be a lot more in 20 years. So a critical question becomes ‘How do we measure what’s out there? ’ ”
The research published in Nanotechnology provides the first data to help researchers identify the diversity of chemical byproducts that can emerge from a diversity of carbon nanotubes—and then to help track what becomes of them in the environment. For example, nanotube byproducts have properties that are chemically similar to the soot that comes out of tailpipes and smokestacks, Reddy said, and researchers must figure out a way to distinguish the two.
“This is a huge challenge right now,” Plata said. “You can’t gauge the effect of a toxin, or even tell if it is sitting in your back yard, if you don’t know how to find it in the Earth. Over time, if all goes well, we’ll be able not only to figure out how to find where these toxins are, but also what they’re doing there.”
Cooperation instead of confrontation
When Plata presented her research at the American Chemical Society meeting in August 2007, some media seized on the story and sensationalized the potential perils of nanotubes. That antagonized manufacturers who did not like publicity that could stymie the budding nanotube industry and that summarily cast them in the role of villainous polluters.
At the same time, in some manufacturers’ eyes, the MIT/WHOI researchers appeared to be adversarial crusaders—a role the researchers strongly deny.
“I’m not trying to put these companies out of business; I’m trying to help them get to a point where their investments pay off down the road,” said Gschwend. “We just want to maximize the benefits and minimize the damages for everyone—industry and the public.”
Plata, Gschwend, and Reddy see a novel opportunity: in the infancy of the industry, to share their expertise and work with manufacturers in preventative research. They seek to develop methods to make carbon nanotube production more efficient, curtail potential toxins, and answer other questions during the design phase—that is, the step in which recipes for making these nanotubes are tried and tested before large-scale production is begun.
Historically, manufacturing designs are evaluated on the performance of the product and the cost to make it. The scientists are seeking to add “avoidance of environmental damages” as a factor for optimizing design, Gschwend said. In other words, to manufacture and use these materials, but do so in a smart way from start to finish.
The three researchers have worked hard to thaw the adversarial chill and persuade manufacturers to shake hands instead of trading punches. In the next phase of Plata’s work, she will collect real-time data from an actual nanotube manufacturing facility in Europe, perhaps operating under the so-called precautionary principle, that is willing to let her come in and set up on their equipment the same monitors she used in the lab at MIT.
Independent scientists agree that this is a step in the right direction that could lead to a paradigm shift in the way academia and industry work together—at least on nanotubes. Because the materials are so new, they afford scientists a perfect opportunity to change the approach from the very beginning, said Andrew Maynard, chief science advisor for the Project on Emerging Nanotechnologies at the federally funded Woodrow Wilson International Center for Scholars in Washington, D.C.
“It’s so easy to get so narrow-sighted into new technology that you forget about the process that goes into making the new material,” he said. “[Reddy, Gschwend, and Plata] are asking the right questions: How do these new processes impact people’s health? How do they impact the environment? Most important, if the processes are not safe, how can we make them safer?”
Popularity: 100% [?]
Adulterated Dietary Supplements Seized by Federal Agents
April 7, 2008
At the request of the U.S. Food and Drug Administration, on Wednesday U.S. Marshals seized more than $1,301,712 of dietary supplements from LG Sciences, LLC, of Brighton, Mich., because the products contain unapproved food additives and/or new dietary ingredients that cause the products to violate the law. Labeled as dietary supplements, the products are marketed for use by body builders.
The dietary supplements seized were marketed and distributed on-line and in retail stores under the names “Methyl 1-D,” “Methyl 1-D XL,” and “Formadrol Extreme XL.”
The seized products previously were tested and found to contain one or more unapproved food additives and/or new dietary ingredients for which there is inadequate information to provide reasonable assurance that the ingredients do not present a significant or unreasonable risk of illness or injury.
“The FDA takes seriously its responsibility to protect Americans from unsafe dietary supplements,” said Margaret Glavin, FDA’s Associate Commissioner of the Office of Regulatory Affairs. “Wednesday’s action shows FDA’s commitment to protecting consumers from potentially harmful products.”
“Working with the FDA, we are taking prompt civil action to protect the public health by seizing these illegal products and forestalling their shipment into the stream of commerce in any manner that could create harm to the public,” said U.S. Attorney Stephen J. Murphy. “I commend the professionalism and swift action of the FDA investigators who discovered and investigated this serious problem, and I am glad our lawyers could provide the legal muscle needed to support the seizure.”
FDA has not received scientific information on the safety of the seized products and cannot determine, at this time, whether they represent a hazard to consumers. Therefore, consumers who still have the products should strongly consider discussing the use of these products with their health care professionals. FDA also recommends that consumers consult their health care professionals if they have experienced any adverse events that they suspect are related to the products’ use.
On March 2006, the FDA warned Legal Gear (the predecessor of LG Sciences) to cease distribution of a different product that was marketed as a dietary supplement but was actually an unapproved new drug containing synthetic steroids.
Popularity: 65% [?]