Tuesday, August 19, 2014

District Court Enters Permanent Injunction Against New York Dietary Supplement Maker to Prevent Distribution of Adulterated Supplements

The Justice Department announced today that the U.S. District Court for the Eastern District of New York has entered a consent decree of permanent injunction against Applied Polymer Systems dba APS Pharmaco (APS) and its president, Nuka Reddy, all of Lindenhurst, New York, to prevent the distribution of adulterated dietary supplements. 

According to a complaint filed July 21, the defendants violated the Federal Food, Drug, and Cosmetic Act (FDCA) by manufacturing and distributing dietary supplements that were adulterated.  Under the FDCA, dietary supplement manufacturers are required to have systems in place to ensure that their products meet specifications for identity, purity, strength and composition.  The government’s actions resulted from a series of inspections of APS’ manufacturing facility beginning in 2012, which revealed, among other things, that APS failed to perform identity tests or examinations for certain dietary ingredients before using them in their products. 

In conjunction with the filing of the complaint, the defendants agreed to settle the litigation and be bound by a consent decree of permanent injunction that prohibits them from committing violations of the FDCA.  The consent decree requires the dietary supplement manufacturer to cease all operations and requires that if they wish to resume manufacturing dietary supplements in the future, the FDA first must determine that APS’ manufacturing practices have come into compliance with the law.  The consent decree also requires a recall of all products sold since Jan. 1, 2014.   The consent decree was filed with the complaint and was docketed on July 23.








http://www.justice.gov/opa/pr/2014/July/14-civ-776.html

Social Media Discovery

Facebook logo Español: Logotipo de Facebook Fr...
Facebook logo Español: Logotipo de Facebook Français : Logo de Facebook Tiếng Việt: Logo Facebook (Photo credit: Wikipedia)
I get a chance to speak at CLE's across the country on social media discovery. I am amazed by number of lawyers who just have no idea about what is happening when it comes to developing caselaw on this important subject. 

Before searching the internet far and wide, make sure that you have in your briefcase the go to case of  Trail v. Lesko:



The case involved a car wreck that injured one driver.  The parties both asked to have the other side produce Facebook posts and pictures.  Predictably, the parties fought the request, nobody produced anything, and both parties filed motions seeking to compel their opponent to turn over his Facebook password and username.

 The defendant sought access to the plaintiff's Facebook account, claiming that the account "may" contain evidence of the "extent and severity" of the plaintiff's injuries. The defendant supported his motion with pictures of the injured plaintiff "socializing" at a bar and "drinking at a party," which the defendant had obtained from the publicly available portions of the plaintiff's Facebook account.
Judge Wettick waded into the world of Facebook in the opinion.
He first wrote about Facebook and how it works:  "The sheer volume of potentially relevant information is staggering.In the aggregate, users collectively update their “statuses”(a short indication of what’s on a user’s mind at a given moment, posted to the their own profile page) more than 60 million times each day. Individual users create on average 90 pieces of content every month (photos, status updates, comments or other posts) with fully half of all Facebook users accessing their individual profiles on a given day. Facebook users collectively upload 300 million photos to the site each day"
 He wrote that before a requesting party is  granted "access" to a Facebook account, the party must show a "sufficient likelihood" that the non-public postings would contain information that is relevant to the litigation that is "not otherwise available."  Otherwise, the court held, Rule 4011(b), which protects against discovery that is unreasonably annoying or embarrassing, prohibits unfettered access to a social-networking site.
The Judge went on to note - correctly in my opinion - "a court order which gives an opposing party access to Facebook postings that were intended to be available only to persons designated as “Friends” is intrusive because the opposing party is likely to gain access to a great deal of information that  has nothing to do with the litigation and may cause embarrassment if viewed by others."
Read the opinion first. There are useful nuggets in it, and like most cases dealing with discovery, the case is not a one size fits all approach. 

Monday, August 18, 2014

Powdered Caffeine Dangers

The FDA is warning about powdered pure caffeine being marketed directly to consumers, and recommends avoiding these products.  In particular, FDA is concerned about powdered pure caffeine sold in bulk bags over the internet.
The FDA is aware of at least one death of a teenager who used these products.
These products are essentially 100 percent caffeine. A single teaspoon of pure caffeine is roughly equivalent to the amount in 25 cups of coffee.
Pure caffeine is a powerful stimulant and very small amounts may cause accidental overdose. Parents should be aware that these products may be attractive to young people.
Symptoms of caffeine overdose can include rapid or dangerously erratic heartbeat, seizures and death. Vomiting, diarrhea, stupor and disorientation are also symptoms of caffeine toxicity. These symptoms are likely to be much more severe than those resulting from drinking too much coffee, tea or other caffeinated beverages.

All consumers seeking caffeinated products should be aware of the potentially high potency of these powdered pure caffeine products. Parents should recognize that teenagers and young adults may be drawn to these products for their perceived benefits.


The death of an Ohio teen after eating caffeine powder prompted the FDA warning. An autopsy of 18-year-old Logan Stiner of LaGrange, OH, detected more than 70 micrograms of caffeine per milliliter in his blood. It is 23 times higher than the amount found in a typical coffee or soda drink.
http://www.hngn.com/articles/36606/20140721/fda-issues-warning-against-caffeine-powder-ohio-teen-found-dead.htm

Dietary supplement maker at center of ex-Va. Gov. McDonnell trial halts sales of Anatabloc

Rock Creek Pharmaceuticals Inc. said it is voluntarily stopping sales of Anatabloc and another supplement called CigRx while it sorts out issues with the Food and Drug Administration.

Late last year, the federal agency sent a warning letter to the company formerly known as Star Scientific saying that its products contain a new dietary ingredient that requires approval before it can be marketed. The company did not seek such approval.

The agency also said the company's website had improperly promoted Anatabloc as a drug by suggesting it can be used to treat various diseases, including ulcerative colitis, multiple sclerosis and Alzheimer's disease.













Read more: http://www.wjla.com/articles/2014/08/firm-halting-sales-of-dietary-supplement-anatabloc-105979.html#ixzz3AkpOOicz
Follow us: @ABC7News on Twitter | WJLATV on Facebook

Friday, August 01, 2014

FDA warns of generic Viagra hidden in "natural" O.M.G. supplement

English: Logo of the .
English: Logo of the . (Photo credit: Wikipedia)
More and more and more. Another supplement with hidden viagra:

The Food and Drug Administration (FDA) is advising consumers not to purchase or use O.M.G., a product promoted and sold for sexual enhancement on various websites, including www.sears.com  disclaimer icon, and possibly in retail stores.
FDA laboratory analysis confirmed that O.M.G. contains sildenafil, the active ingredient in the FDA-approved prescription drug Viagra, used to treat erectile dysfunction (ED). This undeclared ingredient may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Men with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.
Consumers should stop using this product immediately and throw it away. Consumers who have experienced any negative side effects should consult a health care professional as soon as possible. 
Health care professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:
http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/MedicationHealthFraud/ucm406236.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

FDA is Monitoring Certain Foods and Beverages Imported from Taiwan that May Contain Plasticizers

News from the FDA

The U.S. Food and Drug Administration (FDA) is notifying the public about the possible presence of a plasticizer called diethylhexyl-phthalate (DEHP) in certain food and beverages imported from Taiwan.
The Taiwan authorities responsible for food safety have informed the FDA of products shipped to the United States which they believe may be contaminated with DEHP. FDA is screening suspect food products from Taiwan for DEHP and for additional plasticizers such as butylbenzylphthalate, di-n-butylphthalate, dioctyl phthalate, and di-isodecyl phthalate. We expect that the number of suspect products may change as we continue to receive updated information from the Taiwan investigation.
Phthalates such as DEHP are primarily used as plasticizers in polyvinyl chloride (PVC) and polyvinylidene chloride (PVDC) polymers to increase their flexibility. The direct addition of DEHP to food is not permitted in the United States under the U.S. Federal Food, Drug and Cosmetic Act.
Individuals are regularly exposed to plasticizers from a variety of environmental sources. Animal testing has indicated the possibility of adverse effects from long term exposures to DEHP. Little or no adverse health effects are expected from short-term exposure to DEHP at the levels reported to date in food products from Taiwan.
FDA has increased surveillance of food products from Taiwan that are offered for entry into the United States. We are working with Taiwan authorities to continue to identify products that are shipped to the United States that may contain DEHP or other plasticizers. Our review continues and, as we receive additional information, we will conduct further follow up investigations and take actions as warranted.
http://www.fda.gov/Food/RecallsOutbreaksEmergencies/SafetyAlertsAdvisories/ucm260478.htm

FDA Consumer Advice on Powdered Pure Caffeine

The FDA is warning about powdered pure caffeine being marketed directly to consumers, and recommends avoiding these products.  In particular, FDA is concerned about powdered pure caffeine sold in bulk bags over the internet.
The FDA is aware of at least one death of a teenager who used these products.
These products are essentially 100 percent caffeine. A single teaspoon of pure caffeine is roughly equivalent to the amount in 25 cups of coffee.
Pure caffeine is a powerful stimulant and very small amounts may cause accidental overdose. Parents should be aware that these products may be attractive to young people.
Symptoms of caffeine overdose can include rapid or dangerously erratic heartbeat, seizures and death. Vomiting, diarrhea, stupor and disorientation are also symptoms of caffeine toxicity. These symptoms are likely to be much more severe than those resulting from drinking too much coffee, tea or other caffeinated beverages.

Who should know

All consumers seeking caffeinated products should be aware of the potentially high potency of these powdered pure caffeine products. Parents should recognize that teenagers and young adults may be drawn to these products for their perceived benefits.

What to do

  • The FDA advises consumers to avoid powdered pure caffeine.
  • It is nearly impossible to accurately measure powdered pure caffeine with common kitchen measuring tools and you can easily consume a lethal amount.
  • If you believe that you are having an adverse event related to caffeine, stop using it and seek immediate medical care or advice.
  • The FDA wants to know about adverse events associated with powdered pure caffeine and other highly caffeinated products. You or your health care provider can help by reporting these adverse events to FDA in the following ways:
  • By phone at 240-402-2405
  • By email at CAERS@cfsan.fda.gov

NCAA Concussion Litigation, Court Order issued July 30, 2014

Here's the Order entered this past week:

Tuesday, July 08, 2014

Bausch & Lomb Recalls About 850,000 Tubes of Eye Ointment

Deutsch: Logo der Bausch & Lomb Incorporated
Deutsch: Logo der Bausch & Lomb Incorporated (Photo credit: Wikipedia)
Bausch & Lomb unit has recalled about 850,000 tubes of an eye-care ointment because some tubes contained tiny crystal particles that could injure the cornea.
Bausch & Lomb said  it believed the crystal particles formed when the tubes of Muro 128 ointment were exposed to freezing temperatures during shipments last winter.

http://online.wsj.com/articles/bausch-lomb-recalls-about-850-000-tubes-of-eye-ointment-1404418011

Pfizer recalling 221,000 bottles of Pristiq

Here's the link: http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=D-1409-2014&w=07022014&lang=eng


For the second time in recent months, Pfizer has recalled hundreds of thousands of bottles of a drug when one was found to contain the wrong tablet. Pfizer says a single 100 mg tablet of Pristiq Extended Release was found in a 50 mg bottle but the drugmaker is taking no chances and is recalling four lots of the the antidepressant drug.


Testosterone Use Doesn't Increase Heart Risk, Study Finds

The findings, which were published July 2 in the Annals of Pharmacotherapy, found that testosterone therapy was not linked with any increased risk for heart attack. In fact, men at greater risk for heart problems who used testosterone actually had a lower rate of heart attacks than similar men who did not receive this treatment, the researchers said.

http://online.wsj.com/articles/testosterone-use-doesnt-increase-heart-risk-study-finds-1404423497

Wednesday, June 25, 2014

USA v. Mira



Defendants have a history of violating the act,” the complaint said. “Several of the dietary supplement cGMP deviations observed during the July 2013 inspection ... are the same as, or similar to, those observed by FDA during inspections of defendants’ facility between March 13-23, 2012, and between March 18-22, 2013.

Here's the FDA action versus Mira. More later.

Producer of tainted dietary supplements sentenced in Federal Court

Nikki Haskell, the owner and chief executive officer of Balanced Health Products (BHP), has been sentenced by a United States magistrate judge in Manhattan federal court to a $60,000 fine for distributing dietary supplements that contained a prescription drug.
From at least November 2006 through December 2008, BHP’s primary business was the distribution across the United States of this product, called “Nikki Haskell’s StarCaps” (StarCaps).
BHP advertised StarCaps as weight-loss pills containing only all-natural ingredients including, for example, papaya extract. The company failed to list on the product’s label that the pills also contained bumetanide, a powerful diuretic used clinically to treat heart failure, kidney failure, high blood pressure and swelling (edema). Bumetanide is available in the United States only by prescription from a licensed physician.
In March 2014, Haskell was convicted upon a guilty plea to distributing the misbranded StarCaps from BHP’s New York City-based location. Per Haskell, the company is now defunct and has filed for bankruptcy.
Agents from the FDA’s Office of Criminal Investigations, New York Field Office spearheaded this investigation, which led to the permanent removal of this tainted dietary supplement from the market.
“There is a strict regulatory process in the United States for the distribution and dispensing of prescription drugs, and dietary supplements cannot legally contain such drugs,” said Philip Walsky, acting director of the FDA’s Office of Criminal Investigations. “Consumers rely on the labels of dietary supplements to inform them about any potential health risks. The FDA will continue its vigilance over the dietary supplement market.”
Use of bumetanide is banned by certain professional sports organizations, including the National Football League, in part because bumetanide can mask the presence in the human body of steroids and other banned doping agents.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, and products that give off electronic radiation, and for regulating tobacco products.

Doctor's Best Red Yeast Rice Recalled

Doctor's Best is a well known vitamin supplement manufacture, so there is big news that the company is recalling more than 7,300 bottles of its "Best Red Yeast Rice" supplement because FDA testing revealed it contains lovastatin, a cholesterol-lowering medication. 

The supplement can be dangerous for people already taking medications to treat their cholesterol or may cause drug interactions.

In rare cases, using the supplements that contain lovastatin could result in serious muscle injury, particularly in people already taking prescription "statins" such as lovastatin, simvastatin (known by brand name Zocor), or atorvastatin (known by brand name Lipitor). The supplements also pose a risk to pregnant women, and patients with pre-existing liver disease, who may be at an increased risk for liver injury following chronic use of statins, according to the release.

The company has not yet received any reports of illness related to use of the supplement. 

Red yeast rice, a traditional Chinese culinary and medicinal product, can contain substantial amounts of monacolin K, which is chemically identical to the active ingredient in the cholesterol-lowering drug lovastatin (known by the brand name Mevacor). Other red yeast rice products contain little or no monacolin K, but the amount of the substance is not disclosed on the supplement's label and consumers have no way of distinguishing between them, according to the National Center for Complementary and Alternative Medicine (NCCAM).

Link here: http://www.cleveland.com/healthfit/index.ssf/2014/06/doctors_best_recalls_red_yeast.html

Are you a Jerk to the Invisible People in Office Buildings?

NYC: Empire State Building
NYC: Empire State Building (Photo credit: wallyg)
I work in a tall building in Atlanta. I also travel a lot and go into and out of of tall buildings. My personality is such that I almost always smile, greet, and say hello to those who make those big buildings run. You know the people - the security person at the door, the folks who clean the bathrooms, the company that cleans offices. Because I speak spanish (but don't "look" it) I almost always surprise a hispanic person cleaning during the day or evening.

A simple hello, or holding the door for one of them, or a smile is just the decent thing to do.

Then you have the self important assholes.

I see these types a lot - are you one of them? This morning I used the service elevator, loaded with workers. A guy in a suit, on the phone, pushed his way in. Became angry when his suit brushed up against a stationary moving cart. He snarled something, all the while on his phone. He exited, and all was quiet. I said "pendejo" after he left, and the folks started laughing and smiling. The folks on that elevator were invisible to the asshole, until he felt annoyed.

It's not very hard to do the simple things for the people around you.To me, how a stranger treats someone like the cleaning people - in that brief snapshot of time - tells me a lot of what that person is usually about.

So I watched all of this unfold on some non descript day. I was in jeans and a golf shirt, not the usual business wear. I saw three people decide that each didn't want to hold the elevator for a worker. I saw folks decide that it was not worth the effort to hold the door open for a person with a cleaning cart. I saw a guy be a total asshole to a diminutive person who was from Uruguay ( I asked her where she was from after he left- her name is Clara and she has 2 kids in summer school).    I even saw a woman dressed to the nines look me up and down, disapprovingly because I "appeared" to be just a worker.

I know that for many people each day is a battle. I know it's hard sometimes to be polite, but making someone else feel as if she is a human with dignity, and worth acknowleding, if even just for a brief second, is the right thing to do. Best of all, it's free.


Tuesday, June 24, 2014

FDA calls for testosterone products to carry blood clot warning

The U.S. Food and Drug Administration said all testosterone products on the market should include in their labels a general warning about the risk of blood clots in veins. The regulator cited post-market reports of such clots for the warning.
Testosterone is a hormone essential to the development of male growth and masculine characteristics. Testosterone products are FDA-approved only for use in men who lack or have low testosterone levels in conjunction with an associated medical condition. Examples of these conditions include failure of the testicles to produce testosterone because of reasons such as genetic problems or chemotherapy. Other examples include problems with brain structures, called the hypothalamus and pituitary, that control the production of testosterone by the testicles.
None of the FDA-approved testosterone products are approved for use in men with low testosterone levels who lack an associated medical condition. FDA-approved testosterone formulations include the topical gel, transdermal patch, buccal system (applied to upper gum or inner cheek), and injection.

Friday, June 13, 2014

A tragedy in Hooper Nebraska


Here is a compelling blog post from my good friend Chris Welsh...

The small town of Hooper, Nebraska is grieving over yet another heartbreaking loss at the intersection of US Highway 77 and Nebraska Highway 91.

In 2011, 16 year-old Bryn Dirkschneider died in a crash at the intersection. Today, his memorial cross is joined by two more memorials for young boys, Bryan Huff, 17, and Dalan Brandt, 15.
*http://www.jrn.com/kmtv/news/Teens-Killed-in-Crash-near-Fremont--2619559...

Both young men were students at Logan View High School in Hooper. They had just met at their work for the summer. Huff was driving with passenger Brandt on a lunch break around 1:00 pm when they crashed into a semitrailer. The driver, Byron Morrow, 51, of Tekamah, was not physically injured.

Local news investigation by KMTV News 3 laments that the memorials are not slowing traffic at the dangerous intersection. The station inquired to the Nebraska Department of Roads about traffic lights and improved safety in response to the tragedies. They have not received a reply.

Dalan Brandt’s grandfather, Jim Brandt, asks what can be done to fix the issue, "I would love to see traffic lights there but it's not going to happen.” Many fear that another accident will happen before the Department of Roads re-evaluates the intersection.

Trucking safety is another concern involving the crash and a potential cause in all trucking accidents. Fatigue and distracted driving are serious problems for drivers, who are paid by the mile. This payment system encourages drivers to make long trips in order to meet delivery deadlines and make more money. In the rush to do so, safety regulations and careful driving are neglected. This is especially concerning considering that for every semi on the road, the risk of accident increases (http://www.tandfonline.com/doi/full/10.1080/.U5c2m5RdVg8#.U5imIpRdVg8). In dangerous intersections like that of Highway 77 and 91, it is necessary for drivers to be awake and driving responsibly.

In 2012, there were 333,000 large truck crashes that claimed the lives of 3,802 Americans ( http://www-nrd.nhtsa.dot.gov/Pubs/812032.pdf ) If you or a loved has been injured in a car accident, or you believe that a road in your community is unsafe, speak out for support. Every concern should be heard, especially when it means that your family is safer on the road.

A tragedy in Hooper Nebraska


Here is a compelling blog post from my good friend Chris Welsh...

The small town of Hooper, Nebraska is grieving over yet another heartbreaking loss at the intersection of US Highway 77 and Nebraska Highway 91.

Wed, 06/11/2014 - 16:30 - webmaster
In 2011, 16 year-old Bryn Dirkschneider died in a crash at the intersection. Today, his memorial cross is joined by two more memorials for young boys, Bryan Huff, 17, and Dalan Brandt, 15.
*http://www.jrn.com/kmtv/news/Teens-Killed-in-Crash-near-Fremont--2619559...

Both young men were students at Logan View High School in Hooper. They had just met at their work for the summer. Huff was driving with passenger Brandt on a lunch break around 1:00 pm when they crashed into a semitrailer. The driver, Byron Morrow, 51, of Tekamah, was not physically injured.

Local news investigation by KMTV News 3 laments that the memorials are not slowing traffic at the dangerous intersection. The station inquired to the Nebraska Department of Roads about traffic lights and improved safety in response to the tragedies. They have not received a reply.

Dalan Brandt’s grandfather, Jim Brandt, asks what can be done to fix the issue, "I would love to see traffic lights there but it's not going to happen.” Many fear that another accident will happen before the Department of Roads re-evaluates the intersection.

Trucking safety is another concern involving the crash and a potential cause in all trucking accidents. Fatigue and distracted driving are serious problems for drivers, who are paid by the mile. This payment system encourages drivers to make long trips in order to meet delivery deadlines and make more money. In the rush to do so, safety regulations and careful driving are neglected. This is especially concerning considering that for every semi on the road, the risk of accident increases (http://www.tandfonline.com/doi/full/10.1080/.U5c2m5RdVg8#.U5imIpRdVg8). In dangerous intersections like that of Highway 77 and 91, it is necessary for drivers to be awake and driving responsibly.

In 2012, there were 333,000 large truck crashes that claimed the lives of 3,802 Americans ( http://www-nrd.nhtsa.dot.gov/Pubs/812032.pdf ) If you or a loved has been injured in a car accident, or you believe that a road in your community is unsafe, speak out for support. Every concern should be heard, especially when it means that your family is safer on the road.

Thursday, June 05, 2014

FDA: New advice on mercury levels in Seafood

English: Logo of the .
English: Logo of the . (Photo credit: Wikipedia)
The U.S. Food and Drug Administration is updating its advice for pregnant women on the appropriate levels of mercury in seafood. Commissioner Margaret Hamburg says the agency won't require mercury labels on seafood packages.

In a wide-ranging interview last week with The Associated Press, Hamburg said the agency will update guidance on mercury in different varieties of seafood and what that means, a long awaited move aimed at helping women better understand what to eat when they're pregnant.

http://www.thestarphoenix.com/health/issues+advice+mercury+levels+seafood/9905526/story.html
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Driven Sports and lawsuit over Craze pre-workout supplement

Driven Sports, a New York-based business, is part of litigation involving its Craze pre workout supplement. The company lists items like creatine, citrulline and caffeine in the supplement facts for Craze, but does not list N,α-dimethylphenethylamine, or N,α-DEPEA.
N,α-DEPEA has “a potency somewhere between methamphetamine and ephedrine, both of which are banned substances,” according to a lawsuit.
Craze’s inclusion of this compound was reported earlier in an article by NSF International, Harvard Medical School and the National Institute for Public Health and the Environment in the Netherlands in the journal “Drug Testing and Analysis.”
The authors of the article call the compound a potentially dangerous. Regarding the report, 
 “Alarmingly we have found a drug in a mainstream sports supplement that has never been studied in humans,” says Dr. Pieter Cohen, an assistant professor of medicine at Harvard Medical School who has conducted extensive research on supplements. “The health risk of using supplements adulterated with a drug should not be underestimated.”
In separate testing, NSF International scientists also detected N,a-DEPEA in a different supplement called Detonate by Gaspari Nutrition. Regulators may want to consider taking action to warn consumers.
“We urge consumers to remain vigilant about the dietary supplement products they choose, especially since products including Craze and Detonate are available in stores and online, and encourage them to look for certification as a sign that the product has been tested and certified to be free of harmful levels of contaminants,” said Ed Wyszumiala, General Manager of NSF International’s Dietary Supplement Certification Program, which helps protect consumers by verifying what is on the dietary supplement label is in the package and that the product does not contain unsafe levels of contaminants.
This collaborative testing project was developed in response to several failed urine drug tests by professional athletes after taking an over-the-counter workout product called Craze marketed by Driven Sports, Inc.  After extensive testing and a review of the product’s label at NSF International’s laboratory in Ann Arbor, Mich., scientists at NSF International, HMS and NIPHE confirmed that the substance N,N-diethylphenylethylamine was listed on the label but N,a-DEPEA, an emerging and potentially harmful designer stimulant, was found.  A review of this substance shows that N,a-DEPEA is likely less potent than methamphetamine but greater than ephedrine.

http://www.nsf.com/newsroom/emerging-and-potentially-harmful-adulterant-depea-found-in-supplements/
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Tanning Beds get a New Warning

The Food and Drug Administration (FDA or the Agency) is reclassifying ultraviolet (UV) lamps intended to tan the skin from class I (general controls) exempt from premarket notification to class II (special controls) and subject to premarket notification, and renaming them sunlamp products and UV lamps intended for use in sunlamp products. FDA is designating special controls that are necessary to provide a reasonable assurance of safety and effectiveness of the device. FDA is reclassifying this device on its own initiative based on new information.

https://www.federalregister.gov/articles/2014/06/02/2014-12546/general-and-plastic-surgery-devices-reclassification-of-ultraviolet-lamps-for-tanning-henceforth-to

Viagra Poses Skin Cancer Risk For Men, Researchers Say

viagra is a commercial produced medicine conta...
 (Photo credit: Wikipedia)
According to a new study published inJAMA Internal Medicine, researchers have identified a link between sildenafil (more commonly known as Viagra) and melanoma. Not only is there an association between the two, but the authors of the study say the drug may increase a man’s risk for melanoma by up to 84%.

From the study:

Importance  The RAS/RAF/mitogen-activated protein kinase and extracellular signal–regulated kinase (ERK) kinase/ERK cascade plays a crucial role in melanoma cell proliferation and survival. Sildenafil citrate (Viagra) is a phosphodiesterase (PDE) 5A inhibitor commonly used for erectile dysfunction. Recent studies have shown that BRAF activation down-regulates PDE5A levels, and low PDE5A expression by BRAF activation or sildenafil use increases the invasiveness of melanoma cells, which raises the possible adverse effect of sildenafil use on melanoma risk.
Objective  To evaluate the association between sildenafil use and risk of incident melanoma among men in the United States.
Design, Setting, and Participants  Our study is a prospective cohort study. In 2000, participants in the Health Professionals’ Follow-up Study were questioned regarding sildenafil use for erectile dysfunction. Participants who reported cancers at baseline were excluded. A total of 25 848 men remained in the analysis.
Main Outcomes and Measures  The incidence of skin cancers, including melanoma, squamous cell carcinoma (SCC), and basal cell carcinoma (BCC), was obtained in the self-reported questionnaires biennially. The diagnosis of melanoma and SCC was pathologically confirmed.
Results  We identified 142 melanoma, 580 SCC, and 3030 BCC cases during follow-up (2000-2010). Recent sildenafil use at baseline was significantly associated with an increased risk of subsequent melanoma with a multivariate-adjusted hazard ratio (HR) of 1.84 (95% CI, 1.04-3.22). In contrast, we did not observe an increase in risk of SCC (HR, 0.84; 95% CI, 0.59-1.20) or BCC (1.08; 0.93-1.25) associated with sildenafil use. Moreover, erectile function itself was not associated with an altered risk of melanoma. Ever use of sildenafil was also associated with a higher risk of melanoma (HR, 1.92; 95% CI, 1.14-3.22). A secondary analysis excluding those reporting major chronic diseases at baseline did not appreciably change the findings; the HR of melanoma was 2.24 (95% CI, 1.05-4.78) for sildenafil use at baseline and 2.77 (1.32-5.85) for ever use.
Conclusions and Relevance  Sildenafil use may be associated with an increased risk of developing melanoma. Although this study is insufficient to alter clinical recommendations, we support a need for continued investigation of this association.
http://archinte.jamanetwork.com/article.aspx?articleid=1857095&resultClick=3


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Thursday, May 29, 2014

Hi Tech Pharmaceuticals Ordered to Pay $40M in Sanctions

A USDCT Judge in Georgia has imposed a $40 million sanctions against Hi-Tech Pharmaceuticals, Inc. (“Hi-Tech”), Jared Wheat, Sean Smith, and Dr. Terrell Mark Wright. The sanction arose from the defendants’ failure to comply with orders obtained by the U.S. Federal Trade Commission (FTC) requiring that they cease making unsubstantiated claims about their products and include a health-risk warning on products containing yohimbe.
On November 11, 2004, the FTC filed a complaint alleging that several defendants had violated Sections 5 and 12 of the Federal Trade Commission Act (hereinafter “the FTC Act”), 15 U.S.C. §§ 45(a) and 52, by making false
and unsubstantiated claims in connection with their advertising and sale of various dietary supplements.
The court entered two separate final judgment and permanent injunctions against the defendants on December 16, 2008, enjoining them from several activities related to their previous violations of the FTC Act. The first final judgment and permanent injunction is against National Urological Group, Inc., Hi-Tech, Wheat, Thomasz Holda, and Smith hereinafter “the Hi-Tech Order”). The second final judgment and permanent injunction is against Wright (hereinafter “the Wright Order.”) Section II of each of the injunction orders prohibied the defendants from advertising weight-loss products using claims that the products cause rapid or substantial weight loss and fat loss or claims that the products affect metabolism, appetite, or fat unless those claims are substantiated with “competent and reliable scientific evidence.”

Here's the Order:

Wednesday, May 28, 2014

Eugene Oregon, Inc. Issues Nationwide Expansion Of The Recall Of All Lots Of African Black Ant, Black Ant, And Mojo Risen Dietary Supplements Which May Contain Undeclared Active Pharmaceutical Ingredients

English: Logo of the .
English: Logo of the . (Photo credit: Wikipedia)
May 28, 2014 (Revised from May 5, 2014) Press Release - Eugene Oregon, Inc. of Levittown, Pennsylvania is voluntarily expanding the recall of the following products to the consumer level:
 Product Name Lot NumberPackaging Packaging Coloring Quantity Per Package 
 African
Black Ant
All lots Small boxes
inside large
box 
Red,
black, and
silver 
6 capsules per box, 8 boxes per display
unit. 
 Black AntAll lots Small boxes
/ tins inside
large box 
Green 4 capsules per small box, 20 boxes
display unit. Also packaged in 10 tablets
and 10 capsules in a metal tin. 
 Mojo Risen All lots 
Envelopes
inside box
 Red and white 2 capsules per envelope, 24 envelopes
per display box.
This recall is a revised version of the recall issued on May 5, 2014 and is revised to reflect the recall of ALL LOTS of the recalled products. Misinformation about the Black Ant product codes and packaging description may have been included in the original press release and this information is intended to clarify any ambiguity and expand the recall to all lots of all recalled products.
Eugene Oregon, Inc. is voluntarily conducting this recall because FDA analysis of these products distributed to a third party revealed that the distributed products contained undeclared amounts of the active pharmaceutical ingredients sildenafil and tadalafil—FDA-approved pharmaceutical ingredients used to treat erectile dysfunction. Conclusive testing has not been done to confirm that the recalled products do, in fact, contain sildenafil and/or tadalafil and this recall is being executed as a precautionary measure.
Sildenafil and tadalafil can pose a threat to consumers because they can 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, and heart disease often take nitrates. To date, Eugene Oregon, Inc. has not received any reports of adverse events related to this recall.
These products are marketed as dietary supplements for sexual enhancement and packaged in tins, envelopes, and/or boxes and were distributed to consumers nationwide at retail stores. Eugene Oregon, Inc. has discontinued the distribution of these products and is notifying its distributors by mail of this voluntary recall. Consumers that possess these products should stop using them immediately.
http://www.fda.gov/Safety/Recalls/ucm399144.htm?utm_source=twitterfeed&utm_medium=twitter

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Saturday, May 24, 2014

Synthetic Street Drug Dangers Emerge

A report on synthetic street drugs from a Kansas newspaper is worth a read:

'Many of the synthetic drugs are illegal and can be very toxic, highly variable in dosage and quality control and heavily marketed over the Internet with colorful packaging targeting young people, said Tim Rohrig, director of the Sedgwick County Regional Forensic Science Center. Besides conducting autopsies, the center does drug identification testing for area law enforcement.
The center recorded 115 instances of synthetic cannnabinoid in 2013, Rohrig told law enforcement officers meeting Thursday at the Midwest Law Enforcement Gangs & Drugs Conference at the DoubleTree by Hilton Hotel Wichita Airport.'

http://www.kansas.com/2014/05/22/3470106/local-expert-explains-dangers.html




.http://www.kansas.com/2014/05/22/3470106/local-expert-explains-dangers.html'
Read more here: http://www.kansas.com/2014/05/22/3470106/local-expert-explains-dangers.html#storylink=cpy

AAJ's Report to Congress Included in National September 11 Museum's Collection

I'm a member of AAJ, and today there is this news:

When the National September 11 Memorial & Museum officially opens its doors to the public today, the American Association for Justice’s Trial Lawyers Care report to Congress, “Thousands of Heroes, The Rest of Us Could Only Help,” will be part of the museum’s collection.

Trial Lawyers Care is a non-profit organization created after the 9/11 terrorist attacks to provide free legal services to any family who applied for help from the September 11th Victim Compensation Fund. This effort was the largest pro bono legal representation project in history.

Trial Lawyers Care counseled 4,000 families. More than 1,100 lawyers provided free legal help to more than 1,700 families who applied for financial help. Lawyers provided a combined total of more than 100 years of service on these cases. The report to Congress details the story of this pro bono effort.

“I am so proud of the work American Association for Justice members have done through Trial Lawyers Care, and I am encouraged that their efforts to serve and give voice to the voiceless continue,” said President Burton LeBlanc.

The volunteer spirit of the plaintiff bar continues through the American Association for Justice's present day Trial Lawyers Care initiative, which encourages and highlights the volunteer and community outreach projects of trial lawyers. One of the leading projects is End Distracted Driving (EndDD.org), a non-profit organization started by Philadelphia trial lawyer Joel Feldman. EndDD educates people about the many forms of distracted driving and how to make safer choices when driving. To find out more about additional projects and stories, visit TrialLawyersCare.org.

Thursday, May 22, 2014

Gencor's Testofen an Issue in Litigation

If you've been reading about LowT litigation, here is an offshoot of the cases. The class case alleges that defendants have violated the federal Racketeer Influenced and Corrupt Organizations Act and several California laws, including the Consumer Legal Remedies Act, Unfair Competition Law and False Advertising Law. The lawsuit also alleged breaches of express warranty, implied warranty of merchantability and implied warranty of fitness for a particular purpose.  Testofen is not a drug, but an over the counter product, which is represented this way in the company website:

Testofen® is a fenugreek extract standardized for 50% Fenuside™. 
Testofen is the branded name for Gencor’s fenugreek extract. Fenugreek is a well-known, versatile herb that contains over 100 phytochemical constituents, including Furostanol Saponins and Steroidal Saponins.  While fenugreek has multiple health applications, Testofen has been shown to increase sexual desire, help maintain sexual health and muscle mass and support the immune system.* The group of saponin glycosides that Testofen is standardized to is named Fenuside.
After age 30, most men begin to experience a natural and gradual decline in testosterone levels, which can result in reduced desire and a slow loss of muscle tone and definition. Testofen has been shown to promote free testosterone, up to 98 percent, in an eight-week trial (see below).* 

Incorporate Testofen in product formulations designed to support healthy sexual function and performance in adult males.* 

Clinical research

Both animal and human clinical studies have been conducted on Testofen®.

Animal study

Study results: The 2010 study of Testofen on the reproductive systems of rats demonstrated that Testofen supported an increase in the weight of the ani-levator muscle, which led to support for muscle mass and body weight.* 
Citation: Urmila Aswar et.al, 2010. Effect of Furostanol Glycosides from Trigonella foenum –graecum on the reproductive system of Male Albino Rats. Phytotherapy Research, 24, 1482–1488.

http://www.gencorpacific.com/index.php/featured-ingredients/testofen