Sunday, April 13, 2014

FDA Warns Dewmar International Over Melatonin in Lean



Here's the FDA Warning Letter:

The FDA has reviewed the regulatory status of the ingredients declared on the label of your beverage products, Lean Slow Motion…Potion (Easta Pink, Purp, and Yella varieties) and has determined your products are adulterated under Section 402(a)(2)(C) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 United States Code (USC) 342(a)(2)(C)] because they bear or contain an unsafe food additive.  Specifically, the products contain melatonin (5-methoxy-N-acetyltryptamine, CAS Reg. No. 73-31-4), which is a neurohormone and is an unapproved food additive under Section 409 of the Act [21 USC 348]. The regulations pertaining to the general provisions for food additives are located in Title 21, Code of Federal Regulations, Part 170 (21 CFR 170).
Additionally, based on our review of your product labels, your Lean Slow Motion…Potion (Easta Pink, Purp, and Yella) products are misbranded within the meaning of Section 403 of the Act [21 USC 343]. You may find the Act and FDA regulations through links at FDA’s Internet home page at www.fda.gov
Your Lean Slow Motion…Potion (Easta Pink, Purp, and Yella) products are represented for use as conventional foods, and accordingly are not dietary supplements, as defined under Section 201(ff) of the Act [21 USC 321(ff)].  The Act excludes from the definition of a dietary supplement a product represented for use as a conventional food or as a sole item of a meal or the diet [21 USC 321(ff)(2)(B)].  Your use of the term “dietary supplement” below the Nutrition Facts panel on your product labels does not make your products dietary supplements, because your Lean Slow Motion…Potion products are represented for use as conventional foods.  Examples of factors and information that establish that the products are represented for use as conventional foods are as follows:
  • Your products are described as beverages on the information panels of the cans.
  • The “Products” page on your website describes your Yella product as for people who like “pineapple-based Fanta” carbonated soft drink, your Purp product as for people who “like it raw mixed with Sprite” carbonated soft drink and your Easta Pink product as inspired by “Sprite Easta Pink.”
  • The homepage of your website, www.slowmotionpotion.com, refers to your line of products as, “#1 relaxation beverage” and “the most potent relaxation drink.”
  • The “Products” page on your website describes the flavor of your Yella product as having a “hint of red Jolly Rancher flavor” and “unique flavor combination that is ranked number 1 in blind taste tests.” The page describes the flavor of your Purp product as including “grape Jolly Rancher candy.” The page describes the flavor of your Easta Pink product as “a secret flavor combination” that “creates the sweetest of the Leans.”
  • Your products, sold in single-serving pop-top aluminum cans, have the appearance and packaging of carbonated soft drinks.
  • Your products contain a Nutrition Facts label.
  • Your products are comprised of typical ingredients for carbonated soft drinks (carbonated water, sugar, citric acid, natural flavor, potassium sorbate, sodium benzoate) plus melatonin and extracts.
  • The president’s message on your company website at www.dewmarinternational.com/presidents-message/ refers to your products as “relaxation beverages” and a “beverage brand.”
Unapproved Food Additive
Any substance added to a conventional food, such as your Lean Slow Motion…Potion (Easta Pink, Purp, and Yella) beverage products, must be used in accordance with a food additive regulation, unless the substance is the subject of a prior sanction or is generally recognized as General Recognized As Safe (GRAS) among qualified experts for its use in foods [21 CFR 170.30(g)]. There is no food additive regulation that authorizes the use of melatonin.  We are not aware of any information to indicate that melatonin is the subject of a prior sanction (see 21 CFR 181). As explained below, we are not aware of any basis to conclude that melatonin is GRAS for use in conventional foods.
FDA's regulations in 21 CFR 170.30(a)-(c) describe criteria for eligibility for classification of a food ingredient as GRAS. General recognition of safety must be based only on the views of qualified experts.  The basis of such views may be either (1) scientific procedures, or (2) in the case of a substance used in food prior to January 1, 1958, through experience based on common use in food. In addition, general recognition of safety requires common knowledge about the substance throughout the scientific community knowledgeable about the safety of substances directly or indirectly added to food.

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm390967.htm

Lite Fit USA: Public Notification - Undeclared Drug Ingredient (FDA)

News from the FDA on an over the counter supplement:


The FDA is advising consumers not to purchase or use Lite Fit USA. FDA laboratory analysis confirmed that Lite Fit USA contains sibutramine. Sibutramine is a controlled substance that was removed from the market in October 2010 for safety reasons. The product poses a threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke. 
 
These products may also interact, in life-threatening ways, with other medications a consumer may be taking.
BACKGROUND: Lite Fit USA is promoted and sold for weight loss on various websites, including www.herbsultimate.com, and in some retail stores.   
RECOMMENDATION: Healthcare 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:
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Tuesday, April 08, 2014

Wisconsin Lawyer Jay Urban: Investigating Crave Brothers Farmstead Cheese Company Illnesses -Cheese Recall Lawsuits




My friend Jay Urban, whose practice is in Milwaukee, WI is investigating a listeriosis outbreak involving Crave Brothers Cheese Company.  His number is  414-906-1700.

The Listeriosis outbreak was linked to contaminated soft cheeses made by Crave Brothers Farmstead Cheese Company of Waterloo, Wis. 

If you have been diagnosed with this medical condition and think that the recalled product is the culprit, call Jay.  



THE CHEESES
- Les Frères
- Petit Frère
- Petit Frère with Truffles

Listeriosis, a serious infection usually caused by eating food contaminated with the bacterium Listeria monocytogenes, is an important public health problem in the United States. The disease primarily affects older adults, pregnant women, newborns, and adults with weakened immune systems. However, rarely, persons without these risk factors can also be affected. The risk may be reduced by recommendations for safe food preparation, consumption, and storage.


From a recent CDC report:

On June 27, 2013, the Minnesota Department of Health notified CDC of two patients with invasive Listeria monocytogenes infections (listeriosis) whose clinical isolates had indistinguishable pulsed-field gel electrophoresis (PFGE) patterns. A query of PulseNet, the national molecular subtyping network for foodborne disease surveillance, identified clinical and environmental isolates from other states. On June 28, CDC learned from the Food and Drug Administration's Coordinated Outbreak Response and Evaluation Network that environmental isolates indistinguishable from those of the two patients had been collected from Crave Brothers Farmstead Cheese during 2010–2011. An outbreak-related case was defined as isolation of L. monocytogeneswith the outbreak PFGE pattern from an anatomic site that is normally sterile (e.g., blood or cerebrospinal fluid), or from a product of conception, with an isolate upload date during May 20–June 28, 2013. As of June 28, five cases were identified in four states (Minnesota, two cases; Illinois, Indiana, and Ohio, one each). Median age of the five patients was 58 years (range: 31–67 years). Four patients were female, including one who was pregnant at the time of infection. All five were hospitalized. One death and one miscarriage were reported.
Case–case analysis of Listeria Initiative* data (1) was conducted, comparing food exposure frequencies among the five outbreak-related cases identified by June 28 with food exposure frequencies in 1,735 sporadic listeriosis cases reported to CDC during 2004–2013. The analysis indicated that any soft cheese consumption during the month before illness onset was associated with outbreak-related listeriosis: five of five (100%) in the outbreak-related cases versus 569 of 1,735 (33%) in the sporadic cases (odds ratio = 10.8; 95% confidence interval = 1.8–∞).
The five patients were reinterviewed to assess their cheese exposures. All five patients had definitely or probably eaten one of three varieties of Crave Brothers soft-ripened cheese (Les Frères, Petit Frère, or Petit Frère with truffles). Three patients had purchased the cheese at three different restaurants, and two had purchased the cheese at two different grocery stores. The cheeses were shipped as intact wheels to the three restaurants and two grocery stores, where they had been cut and served or repackaged and sold to customers.
Testing at the Minnesota Department of Agriculture identified the outbreak pattern of L. monocytogenes in two cheese wedges (Les Frères and Petit Frère with truffles) collected from two different grocery stores in Minnesota. Inspection of the cheese-making facility revealed that substantial sanitation deficiencies during the cheese-making process itself, after the milk was pasteurized, likely led to contamination. On July 1, Crave Brothers halted production of Les Frères, Petit Frère, and Petit Frère with truffles. On July 3, Crave Brothers issued a voluntary recall of these products with a production date of July 1, 2013, or earlier. On July 11, the company voluntarily halted production of all cheese products manufactured at the facility. After product recall, one additional case was identified in Texas through whole genome sequencing, bringing the total case count for the outbreak to six.



http://www.cdc.gov/listeria/



Read more: CDC: Listeriosis outbreak by unsanitary cheese-making conditions - KMSP-TV http://www.myfoxtwincities.com/story/25183825/listeriosis-outbreak-unsanitary-cheese-making-conditions#ixzz2yIoYBCqB

Sunday, April 06, 2014

Mark Zamora named NTLA Top 100 Trial Lawyer



I've been writing for this blog for more than five years. And yes, it's me. Not a staffer, or paralegal, or overworked associate. Joining forces with attorney Roger Orlando last year helped to add more forces and lawyers to the very hard and often daunting work we do on behalf of injured consumers. Last month the NTLA gave me the news, and no I didn't seek this recognition, nor did I  apply for membership in this "Top 100" group.   

Apparently the work has not gone unnoticed. From the NTLA Website:
The National Trial Lawyers: Top 100 an invitation-only organization composed of the premier trial lawyers from each state in the nation who meet stringent qualifications as civil plaintiff and/or criminal defense trial lawyers. Selection is based on a thorough multi-phase process which includes peer nominations combined with third-party research. Membership is extended solely to the select few of the most qualified attorneys from each state who demonstrate superior qualifications of leadership, reputation, influence, stature and public profile.

Each of our distinguished Top 100 members possesses the knowledge, skill, experience and success held by only the finest and best lawyers in America.  By combining resources, power, and influence, The National Trial LawyersTop 100 is devoted to preserving and protecting justice for all.

Thanks for reading, and if you stumbled on this blog, I appreciate you reading this far. 

Saturday, April 05, 2014

Safety warning for dieters and athletes: Dexaprine

A troubling wave of new untested products may be invading dietary supplements. 


The Dutch Food and Consumer Product Safety Authority (NVWA) warns consumers of diet pills called Dexaprine and advises them to stop using this product. Dexaprine is a product used by athletes and people who want to lose weight. It is sold in the Netherlands through online shops.
From the National Poisons Information Centre (NVIC) UMC Utrecht and the NVWA there are report of a total of 11 serious complaints from people who used Dexaprine to lose weight. After just one tablet side effects may occur as cardiac arrest, heart palpitations, chest pain, nausea and headaches. 
Site: http://www.nvwa.nl/actueel/nieuws/nieuwsbericht/2036901/veiligheidswaarschuwing-voor-afvallers-en-sporters-slik-geen-dexaprine
Various reports show that Acacia rigidula contains amphetamine and methamphetamine, both of which are marketed as recreational drugs.  In a1998 study with the increasingly popularity of slimming supplements with Acacia rigidula, it prompted researchers at the FDA to take a closer look atAcacia rigidula.
http://www.ergo-log.com/something-fishy-about-acacia-rigidula-supplements.html
More in an abstract:
Extracts of Acacia rigidula leaves are used in weight-loss products sold in vitamin shops and over the internet with little or no published data about their potential biological effects. In our chemical investigations on authenticated A. rigidula plant material, we established a rapid and sensitive LC-MS/MS method for the quantitative determination of several phenethylamine, tyramine and tryptamine derivatives. Stable isotopically labeled compounds were used as internal standards for quantitative analysis. We found total calculated contents of 6 biogenic amines in A. rigidula leaf of 18.6 and 32.9μg/g. The content of selected amines in 21 dietary supplements labeled as containing A. rigidula was determined by a second LC-MS/MS method. Our study revealed significant differences in the amine profiles of authenticated plant materials and dietary supplements. β-Methylphenethylamine, a non-natural compound, was found in 9 of the 21 dietary supplement products. β-Methylphenethylamine was found at levels of 960-60,500μg/g while phenethylamine was found at levels of 710-171,620μg/g. β-Methylphenethylamine is a positional isomer of amphetamine and our results showed that it can be misidentified as amphetamine during LC-MS analysis. An independent GC-MS analysis was used to confirm the presence of β-methylphenethylamine and the absence of amphetamine in dietary supplements labeled as containing A. rigidula. This study demonstrates that confirmations by independent analytical methods are essential to verify findings of unusual or unexpected compounds in dietary supplements.
http://www.ncbi.nlm.nih.gov/pubmed/24176750

Dietary Supplements and Mortality Rate in Older Women

A recent report known as the Iowa Study is out, and the conclusion for older women who take dietary supplements is not good:  Several commonly used dietary vitamin and mineral supplements may be associated with increased total mortality risk; this association is strongest with supplemental iron. In contrast to the findings of many studies, calcium is associated with decreased risk.

From the study: Although we cannot rule out benefits of supplements, such as improved quality of life, our study raises a concern regarding their long-term safety

In the United States, the use of dietary supplements has increased substantially during the past several decades, reaching approximately one-half of adults in 2000, with annual sales of more than $20 billion. Sixty-six percent of women participating in the Iowa Women's Health Studyused at least 1 dietary supplement daily in 1986 at an average age of 62 years; in 2004, the proportion increased to 85%. Moreover, 27% of women reported using 4 or more supplemental products in 2004. At the population level, dietary supplements contributed substantially to the total intake of several nutrients, particularly in elderly individuals.

Read more here.  http://archinte.jamanetwork.com/article.aspx?articleid=1105975


Thursday, April 03, 2014

Today's Must Read: The Power of Gender Equity (Trial Magazine)

If you are like me, you are inundated with magazines, enews, case reports and more each day. There is a temptation to just put the materials in a pile and move on. AAJ publishes Trial Magazine, which is a "stop and read" publication for me. Don't make the mistake of waiting until later to read at least one article from that magazine. (Thanks to AAJ for allowing me to reprint)

This month there is a must read article by my friend Kim Dougherty, titled "The Power of Gender Equity." Take five minutes to read this article.   It's powerful and thought provoking - noting that unconscious gender stereotypes affect how women lawyers are perceived, which can translate into missed opportunities.

Read it here:




Kim asks question that may make some lawyers stop in their tracks: "Does gender equality in the legal profession make me uncomfortable?"

It's a timely article. Two years ago, I was on a conference call with about ten male lawyers and one female lawyer. It was the first call on a complex case. One lawyer became too comfortable in the call and called the woman lawyer "baby doll." Seriously. You probably can conclude what happened next on that call. Shameful to say the least.

Tell Kim what you think after you've read it.  

Supplements: Are Consumers The Experimental Animals?

A news report on Yahoo details the disgraceful lack of oversight by the FDA over dietary supplements in the US. After a hepatitis outbreak allegedly caused by an OTC supplement, it took some time for the product to be recalled. Unfortunately, consumers were the ones who innocently took the product.

Health officials then suspected that a new ingredient called aegeline that was added to the supplement caused the illnesses. Because the FDA regulates supplements only after they come to market, companies are not required to prove that their products are safe and effective before marketing them.

"This really points to the fact that there's no safety testing … before a new ingredient shows up in a supplement in the United States," Cohen said. "Guess who's the experimental animal — the consumer."

Read more here:   http://news.yahoo.com/diet-supplement-causes-nearly-100-hepatitis-cases-215935222.html

GA: Appellate Court Gives a Win to Defendants - Apportionment

News this week from Georgia in Double View v. Polite

 

In the Court's decision, the panel ruled in favor of  the owner and manager of a defendant apartment complex who had lost a $5.25 million jury verdict to a consumer who was injured in a criminal attack as he walked between the complex and a nearby convenience store. The appellate court wrote that  the apartment complex should have been allowed - under Georgia's apportionment statute (OCGA 51-12-33) -  to question the jury to apportion some of the responsibility for what the plaintiff claimed was negligent security to the nearby convenience store, though it was unclear who owned it. The attackers also were included on the jury form, but the jury assigned no responsibility for the plaintiff's injuries to them. The convenience store, according to facts discovered prior to trial, had been the site of at least nine robberies. 

Wednesday, April 02, 2014

Arctic Cat Recalls Off-Highway Utility Vehicles Due to Fuel Leak and Fire Hazard



Arctic Cat Prowler 500 HDX (Red)
This recall includes Model Year 2014 Arctic Cat Prowler 500 HDX Recreational Off-Highway Vehicle (ROV). The two-seat vehicles come in four colors: green, red, vibrant red metallic or emerald green metallic. The vehicles have “Arctic Cat” printed on each side of the hood and on the cargo box tail gate, “500” printed on each side of the front fenders and “HDX” printed on each side of the rear cargo box.

Read more here:  http://www.cpsc.gov/en/Recalls/Recall-Alerts/2014/Arctic-Cat-Recalls-Off-Highway-Utility-Vehicles/

Massachusetts bans FDA-approved Painkiller Zohydro

Zohydro ER is an opioid agonist, extended-release, oral formulation of hydrocodone bitartrate indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve Zohydro ER for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
Zohydro ER is not indicated for use as an as-needed analgesic.
"Zohydro is a dangerously addictive pharmaceutical painkiller, approved by the FDA recently over the objection of their scientific advisory council, and is not available in an abuse-deterrent form," Patrick said in a recent speech announcing the ban.

"Until it is available in an abuse-deterrent form, or better, until the secretary of [Health and Human Services] or the Congress has acted on the requests to overturn the FDA, Zohydro will not be available in Massachusetts," he said.

The news from Massachusetts comes after a long line of criticism has been directed at the FDA over its approval of Zohydro.
“Zohydro is basically pure synthetic heroin and comes in pills as large as 50 milligrams,” said Avi Israel, a North Buffalo resident whose son, Michael, committed suicide in 2011 after struggling with an addiction to prescription painkillers for the treatment of Crohn’s disease.
Unlike other pharmaceutical opiate pain medications, Zohydro, an extended time-release capsule, consists of hydrocodone without the familiar additives of aspirin or acetaminophen, making it stronger than other painkillers.
http://www.buffalonews.com/city-region/impending-debut-of-potent-prescription-painkiller-zohydro-fuels-debate-over-dangers-20140304



FDA issues warnings to three New York importers

The New York office of the Food and Drug Administration (FDA) sent warning letters earlier this month to three fish importers in Brooklyn and Queens over concerns their products were not being processed under the same conditions required of domestic producers.
Their dried filefish, dried anchovy, and herring fillets were all refused entry into the US based on testing by FDA laboratories before the FDA inspected their facilities and sent them warning letters calling for immediate correction of violations.
Read more here. http://www.foodsafetynews.com/2014/03/fda-warning-letters-follow-imported-fish-blocked-at-border-after-lab-tests/#.UzwhavldWCm

Tuesday, April 01, 2014

Super Fat Burner, Maxi Gold, and Esmeralda Dietary Supplements by New Life Nutritional Center Recalled due to Undeclared Drug Ingredients

New Life Nutritional Center is recalling all lots of “Super Fat Burner capsules, Maxi Gold capsules and Esmeralda softgels” to the user level after FDA analysis revealed the products contain undeclared active pharmaceutical ingredients: sibutramine, phenolphthalein or a combination of both sibutramine and phenolphthalein.

Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010 (due to increased risk of seizures, heart attacks, arrhythmia and strokes). Phenolphthalein is an ingredient previously used in over-the-counter laxatives, but because of concerns of carcinogenicity, it is not currently approved for marketing in the United States. These undeclared ingredients make these products unapproved new drugs for which safety and efficacy have not been established. At this time no illnesses or injuries have been reported to New Life Nutritional Center in connection with these products.

These products are used as weight loss aids and are packaged in 30 capsule bottles. All lots of these products are being recalled. New Life Nutritional Center distributed these products to customers residing in NY, NJ, LA, TX, VA, and MA via retail stores and internet sales through their website.


 http://www.fda.gov/Safety/Recalls/ucm391045.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

Nova Products: Recall of African Black Ant, Black Ant, XZen Gold, ZXen Platinum, XZen 1200, and XZone Gold

Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling the following products: African Black Ant (Lot# 2006-000926), Black Ant (Lot# 2006-3627878), XZen Gold (Lot# 130310GL), ZXen Platinum (Lot# 130520PL), XZen 1200 (Lot# 13051012), XZone Gold (Lot# 131110GL), and XZone 1200 (Lot# 13071012) at the retail level. Lot numbers are identified on the back or side of each product. FDA laboratory analysis on these products has determined that they contain undeclared amounts of sildenafil and tadalafil, active ingredients of FDA-approved drugs used to treat erectile dysfunction.

These undeclared active ingredients pose a threat to consumers because they can interact with nitrates found in some prescription drugs (such as nitroglycerin), resulting in decreased blood pressure. 

Prescription drugs containing nitrates are frequently prescribed for individuals with diabetes, high blood pressure, high cholesterol, or heart disease. Additionally, these products may cause side effects such as headaches and flushing.

These products are marketed as dietary supplements for sexual enhancement and packaged in blister packs, envelopes, bottles, and/or boxes distributed to consumers nationwide at retail stores. Nova Products, Inc. has discontinued distribution and sales of these products.
Nova Products, Inc. is notifying its distributors by mail of this voluntary recall. Consumers that possess these products should stop using them immediately and can return the products to Nova Products, Inc., 5 Mount Pleasant Road, Aston, Pennsylvania.

 http://www.fda.gov/Safety/Recalls/ucm391045.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

4/1/14: Georgia Androgel, Low Testosterone Litigation: Attorneys Petition for MDL Status

Late Friday lawyers for several parties filed a Petition in the JPML seeking centralization of all cases involving low testosterone claimed injuries:




Abbot and AbbVie filed a Reponse, here:

 


A  study was funded by  National Institutes of Health and published in the journal of PLOS ONE. The study evaluated more than 50,000 men and indicated that prescription Testosterone Therapy (also commonly known as Low T Treatment) significantly increased the risk of heart attacks in men over the age of 65 and, in younger men with a history of heart disease.

The study concluded that the risk of heart attacks in the first three months of testosterone therapy is doubled in men over age 65 with no prior heart conditions and the risk of heart attack in men below 65 with a history of heart disease is almost tripled.


Currently, the labels of these products that are being used by tens of millions of American men contain no warning an increased risk of cardiac or cardiovascular events. On January 30, 2014, after the release of these two studies, the FDA issued a "Drug Safety Communication" announcing it is reassessing the safety of these products and continuing to evaluate available data regarding an increased risk of cardiovascular events.


Testosterone Therapy can come in several forms, such as: gels, patches, under arm topical solutions, pellets, and injections, and include the following brands:
  • Androgel®
  • Axiron®
  • Fortesta®
  • Testim®
  • Testopel®
  • Androderm®
  • Depo-Testosterone®
  • Striant®
  • Bio-T-Gel®
  • Delatestryl®

Saturday, March 29, 2014

FDA Seeks Input on Information to be Submitted to FDA’s Reportable Food Registry and Used to Notify Consumers in Grocery Stores

Interesting news from the FDA. FDA is publishing an advance notice of proposed rulemaking (ANPRM) which seeks input to assist the Agency in implementing section 211 of the FDA Food Safety Modernization Act (FSMA), which added new provisions to the Reportable Food Registry (RFR) requirements of the Federal Food, Drug, and Cosmetic Act. Such amendments are intended to help keep consumers notified and safe from foodborne illness. In general, section 211 of FSMA provides that FDA may require a responsible party to submit to the Agency “consumer-oriented” information regarding a “reportable food” (with the exception of fruits and vegetables that are raw agricultural commodities), including information necessary to enable a consumer to accurately identify whether the consumer is in possession of a reportable food. A reportable food is defined as a food (other than dietary supplements or infant formula) for which there is a reasonable probability that use of, or exposure to, such food will cause serious adverse health consequences or death to humans or animals.

 In addition, section 211 of FSMA directs FDA to use such “consumer-oriented” information to create one-page summaries that would be posted on FDA’s website for the purposes of consumer notification. Further, grocery stores with 15 or more physical locations, that sold the reportable food, would be required to prominently display the one-page FDA summary, or information from the summary, within 24 hours of FDA’s web posting. Grocery stores would also be required to display the information for 14 days. Through the ANPRM, FDA is seeking input to help determine, among other things: what information should be required in consumer notifications so that consumers can determine whether a food in their possession is a reportable food; the format in which the information should be presented; what types of retail establishments FDA should consider to be “grocery stores” subject to the consumer notification requirements; how grocery stores should be made aware that the information has been published on FDA’s website; what constitutes prominent display or sharing of the information by a grocery store with its customers; the impact on grocery stores from posting the information; if consumers should be notified that this type of information will not be generated for dietary supplements, infant formula, and fruits and vegetables that are raw agricultural commodities; and if FDA should require industry to submit consumer-oriented information to FDA, even if the food will not be available for sale to consumers at the retail level. FDA will consider input received in implementing section 211 of FSMA.

FDA believes that the information it obtains through the ANPRM will assist the Agency in implementing and efficiently enforcing the amendments under section 211 of FSMA. All interested parties are invited to comment on the ANPRM. http://www.fda.gov/Food/NewsEvents/ConstituentUpdates/ucm390447.htm

Bella Vi, Super Fat Burner contain dangerous drugs: Tainted dietary supplements

The products listed below were recalled because the product maker included Sibutramine and Phenolphthalein, Phenolphthalein has been used for over a century as a laxative, but is now being removed from over-the-counter laxatives because of concerns over carcinogenicity. Sibutramine is a centrally-acting serotonin-norepinephrine reuptake inhibitor structurally related to amphetamines. All affected products are marketed as dietary supplements for weight loss and were packaged and distributed as follows: Bella Vi Insane Bee Pollen Capsules is packaged in bottles of 60 capsules with lot # 201303 EXP: 14/03/07. Bella Vi Insane was distributed to consumers and distributors nationwide from March 1, 2013 – August 31, 2013. Bella Vi BTrim Max is packaged in bottles of 60 capsules with lot # BTX13 EXP: 2015/08/15. Bella Vi Btrim Max was distributed to consumers and distributors nationwide from August 31, 2013 – September 31, 2013. Bella Vi BTrim Ultimate Boost is packaged in bottles of 30 capsules with lot # BTRM3452 EXP: 2015/07/03. Bella Vi Btrim was distributed to consumers and distributors nationwide from July 1, 2013 – September 31, 2013. Bella Vi Extreme Accelerator is packaged in bottles of 30 capsules with lot # BTRX7654 EXP: 2015/07/08. Bella Vi Extreme was distributed to consumers and distributors nationwide from July 1, 2013 – September 31, 2013. Bella Vi Insane Amp’d is packaged in bottles of 60 capsules with lot # VINA2013 EXP: 2015/06/12. Bella Vi Insane Amp’d was distributed to consumers and distributors nationwide from June 1, 2013 – September 31, 2013. Bella Vi Amp’d Up is packaged in bottles of 60 capsules with lot # AU2013AB EXP: 2015/05/20 and lot #BVAU813 EXP: 2015/08/12. Bella Vi Amp’d Up was distributed to consumers and distributors nationwide from May 1, 2013 – September 31, 2013.

Thursday, March 27, 2014

NLRB Decision allowing Football Players to Unionize

Terra-Medica Recall Specified Lots of Pleo Homeopathic Drug Products

Terra-Medica, Inc. is voluntarily recalling 56 lots of Pleo-FORT, Pleo-QUENT, Pleo-NOT, Pleo-STOLO, Pleo-NOTA-QUENT, and Pleo-EX homeopathic drug products in liquid, tablet, capsule, ointment, and suppository forms to the consumer level. FDA has determined that these products have the potential to contain penicillin or derivatives of penicillin, which may be produced during the fermentation process.
In patients who are allergic to beta-lactam antibiotics, even at low levels, exposure to penicillin can result in a range of allergic reactions from mild rashes to severe and life-threatening anaphylactic reactions. To date, Terra-Medica has not received any reports of adverse events related to this recall, nor any reports of product tests indicating penicillin content in the products.
The products are used as homeopathic drugs and have a label stating “Distributed by SANUM USA Corp.” The affected products are identified by package size, batch (lot) number and expiry date (ranging from March 2014 – May 2018) in the table accompanying this release. The batch number can be located at the side panel on the label. The affected products were distributed nationwide through health care practitioners, who may have sold the products through websites.
Terra-Medica is notifying its customers by letter and email and is arranging for return of all recalled products. Consumers and distributors that have product which is subject to the recall should stop using the products and return them to the point of purchase.

http://www.fda.gov/Safety/Recalls/ucm389832.htm

New Life Nutritional Center Issues Recalls Super Fat Burner, Maxi Gold and Esmeralda

New Life Nutritional Center is recalling all lots of “Super Fat Burner capsules, Maxi Gold capsules and Esmeralda softgels” to the user level after FDA analysis revealed the products contain undeclared active pharmaceutical ingredients: sibutramine, phenolphthalein or a combination of both sibutramine and phenolphthalein.
Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010 (due to increased risk of seizures, heart attacks, arrhythmia and strokes). Phenolphthalein is an ingredient previously used in over-the-counter laxatives, but because of concerns of carcinogenicity, it is not currently approved for marketing in the United States. These undeclared ingredients make these products unapproved new drugs for which safety and efficacy have not been established. At this time no illnesses or injuries have been reported to New Life Nutritional Center in connection with these products.
These products are used as weight loss aids and are packaged in 30 capsule bottles. All lots of these products are being recalled. New Life Nutritional Center distributed these products to customers residing in NY, NJ, LA, TX, VA, and MA via retail stores and internet sales through their website at www.newlifenutritional.com.

http://www.fda.gov/Safety/Recalls/ucm390608.htm

Pure Edge Nutrition, LLC Recalls Bella Vi Brand Products Due to Undeclared Sibutramine and Phenolphthalein

Toms River, NJ, Pure Edge Nutrition, LLC is voluntarily recalling one lot of each: Bella Vi Insane Bee Pollen Capsules, Bella Vi BTrim Ultimate Boost, Bella Vi BTrim Max, Bella Vi Extreme Accelerator, Bella Vi Insane Amp’d, and two lots of Bella Vi Amp’d Up to the consumer level. The products have been found to contain undeclared Sibutramine or a combination of both Sibutramine and Phenolphthalein through FDA laboratory analyses. Sibutramine a previously approved controlled substance, was removed from the US market in October 2010 for safety reasons, Phenophthalein is used medicinally as a laxative and not approved for marketing in the US. Therefore, these products are unapproved new drugs.
Products containing sibutramine and phenophthalein pose a threat to consumers because Sibutramine can increase blood pressure and/or pulse rate in some patients and may present a risk for those with a history of coronary artery disease, congestive heart failure, arrhymias or stroke. These products may also interact in life threatening ways with other medications a consumer may be taking. To date, the company has not received any reports of adverse events related to this recall. The recall was initiated after discovering the Sibutramine and Phenophthalein were included as ingredients by the manufacturer.
All affected products are marketed as dietary supplements for weight loss and were packaged and distributed as follows:
Bella Vi Insane Bee Pollen Capsules is packaged in bottles of 60 capsules with lot # 201303 EXP: 14/03/07. Bella Vi Insane was distributed to consumers and distributors nationwide from March 1, 2013 – August 31, 2013.
Bella Vi BTrim Max is packaged in bottles of 60 capsules with lot # BTX13 EXP: 2015/08/15. Bella Vi Btrim Max was distributed to consumers and distributors nationwide from August 31, 2013 – September 31, 2013.
Bella Vi BTrim Ultimate Boost is packaged in bottles of 30 capsules with lot # BTRM3452 EXP: 2015/07/03. Bella Vi Btrim was distributed to consumers and distributors nationwide from July 1, 2013 – September 31, 2013.
Bella Vi Extreme Accelerator is packaged in bottles of 30 capsules with lot # BTRX7654 EXP: 2015/07/08. Bella Vi Extreme was distributed to consumers and distributors nationwide from July 1, 2013 – September 31, 2013.
Bella Vi Insane Amp’d is packaged in bottles of 60 capsules with lot # VINA2013 EXP: 2015/06/12. Bella Vi Insane Amp’d was distributed to consumers and distributors nationwide from June 1, 2013 – September 31, 2013.
Bella Vi Amp’d Up is packaged in bottles of 60 capsules with lot # AU2013AB EXP: 2015/05/20 and lot #BVAU813 EXP: 2015/08/12. Bella Vi Amp’d Up was distributed to consumers and distributors nationwide from May 1, 2013 – September 31, 2013.
Pure Edge Nutrition, LLC is notifying its distributors and customers by email and is arranging for return of all recalled products. Consumers and distributors that have product which is being recalled should stop using and return products to Pure Edge Nutrition, LLC.
Consumers with questions regarding this recall can contact Pure Edge Nutrition, LLC at (888) 417-3613 Monday – Friday 10:00 a.m. – 2:00 p.m. EST or email info@pureedgenutrition.com. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

http://www.fda.gov/Safety/Recalls/ucm390693.htm

Purely Pomegranate, Inc. Recalls GOKNUR Organic Frozen/IQF Pomegranate Arils

Purely Pomegranate, Inc. is recalling GOKNUR Organic Frozen/IQF Pomegranate Arils (seeds) because they may be contaminated with the Hepatitis A virus. The lot code is 21-15-13-2-1-O, with production date 17.10.2012, crop year 2012 and carton number 8721.

http://www.fda.gov/Safety/Recalls/default.htm

Sunday, March 16, 2014

SNI National Recalls Kratom XL, Maeng Da Kratom, Max Kratom

2 bottles of kratom (Mitragyna speciosa) extra...
2 bottles of kratom (Mitragyna speciosa) extract (Thai Kratom Red Veine), each bottle 20ml. (Photo credit: Wikipedia)
NI National is recalling all Kratom products,including Kratom XL 4 Pack, Maeng Da Kratom 10 Pack, Max Kratom 20 Pack, and Bali Kratom 40 Pack, from distributors and retail locations. These products contain Kratom (Mitragyna Speciosa).
Kratom is a botanical that qualifies as a dietary ingredient under section 201(ff)(1) of the Federal Food, Drug, and Cosmetic Act . When marketed as a dietary ingredient, FDA considers kratom to be a new dietary ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury. Furthermore, scientific literature discloses serious concerns regarding the toxicity of Kratom in multiple organ systems. Consumption of Kratom can lead to a number of health impacts, including respiratory depression, nervousness, agitation, aggression, sleeplessness, hallucinations, delusions, tremors, loss of libido, constipation, skin hyperpigmentation, nausea, vomiting, and severe withdrawal signs and symptoms.
http://www.fda.gov/Safety/Recalls/ucm389350.htm
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Pain Free By Nature recalls Reumofan Plus Arthritis Supplement

Fda
Fda (Photo credit: Wikipedia)
Woodland Park, CO. Pain Free By Nature is recalling "Reumofan Plus" Tablets purchased through their website at www.painfreebynature.com, because they contain undeclared active pharmaceutical ingredients: methocarbamol and diclofenac. Use of this product could result in serious and life-threatening injuries.
Reumofan Plus is used as a treatment for muscle pain, arthritis, osteoporosis, bone cancer and other conditions. This product comes in thirty (30) tablet containers and is packaged in a green and gold box. Reumofan Plus was distributed nationwide through internet sales.
The recall was initiated after the US Food and Drug Administration discovered that the product was distributed in packaging that did not reveal the presence of the active pharmaceutical ingredients, making it an unapproved drug.
Pain Free By Nature did not manufacture the product but did distribute to customers nationwide. Distribution has been completely terminated by the company.
http://www.fda.gov/Safety/Recalls/ucm389049.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

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Study on Glucosamine: No Cure for Knee Pain

English: Right knee.

A regular  glucosamine liquid supplement won't prevent deterioration of knee cartilage, cut down on bone bruises or lessen knee pain, say the authors  of a recent study. 

Glucosamine is an amino sugar and a prominent precursor in the biochemical synthesis of glycosylated proteins and lipids. Glucosamine is part of the structure of the polysaccharides chitosan and chitin, which compose the exoskeletons of crustaceans and other arthropods, as well as the cell walls of fungi and many higher organisms

The study found no evidence that drinking glucosamine supplement reduced knee cartilage damage, relieved pain or improved function in people who complained of chronic knee pain, acording to Dr. C. Kent Kwoh, professor of medicine and medical imaging at the University of Arizona College of Medicine.

http://onlinelibrary.wiley.com/doi/10.1002/art.38314/abstract
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Statins: Risk of Diabetes is Real

Diabetes Awareness
Diabetes Awareness (Photo credit: charliebarker)
Says an article posted on NPR:

Diabetes is the only harmful side effect linked to statins, a study found, with 3 percent of people on statins being newly diagnosed with diabetes, compared with 2.4 percent of people taking placebos. That means that for every five new cases of diabetes in people taking statins, one is caused by the drug.

Read more here: http://www.npr.org/blogs/health/2014/03/13/289768822/statins-might-not-cause-aching-muscles-but-diabetes-risk-is-real
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Saturday, March 08, 2014

Fake Supplement May Endanger Kids

Food and Drug Administration officials said this week that lots of the supplement L-citrulline sold by the compounding firm Medisca were found not to contain the drug at all. The company voluntarily recalled eight lots of the supplement, which is supplied to hospital and retail pharmacies nationwide.
“Health care professionals should discontinue dispensing from these lots, contact patients and return all unused product to Medisca Inc.,” FDA officials said in a notice.
L-citrulline is an amino acid used to treat certain urea cycle disorders, a genetic problem in which the body lacks one of six enzymes that help clear ammonia from the blood. Without enough L-citrulline, the ammonia builds up, potentially causing life-threatening brain damage and death.
http://www.nbcnews.com/health/health-news/fake-supplement-may-endanger-kids-fda-warns-n31266

Beef Recall Expanded

A Petaluma CA company’s recall of nearly 9 million pounds of beef is now affecting more than 1,000 establishments in 29 states and Canada, according to The Press Democrat. Nestle is voluntarily recalling some of its Hot Pockets because they might contain affected meat from Rancho Feeding Corp. 
The U.S. Department of Agriculture has deemed products made from meat processed at Rancho Feeding Corp. in 2013 unfit for consumption because it processed diseased animals without a full federal inspection. So far, no illnesses have been reported. 
Here is a partial list of specific products that are tied to the recall of meat processed at the Rancho Feeding Corporation in Petaluma. The most recent items are listed at the top:
Certain El Monterey taquitos and tornados, Ruiz Food Products, Dinuba, Calif.
Affected products:
El Monterey Beef & Cheese Taquitos – Flour Tortillas, 20 count; product codes 05/19/2014, 10/14/2014 and 10/17/2014; UPC 0 71007 40650 8
El Monterey Ranchero Steak Tornados, 4.5 lb (24 count); product codes 13 135, 13 281 and 13 287; UPC 1 00 71007 86390 2
Certain beef jerky products, Tillamook Country Smoker, Bay City, Ore.
Affected products:
— Teriyaki Beef Jerky, 75 count; product codes 12053, 22053; UPC 0 51943 25080 9
— Loonies Beef Jerky, 80 count; product codes 11443, 21443, 11573, 21573; UPC 051943 47941 5.
Certain Hot Pockets, Nestlé Prepared Foods, Chatsworth, Calif., facility.
Affected products:
Hot Pocket Philly Steak & Cheese, 9 oz., UPC4369507107, Batch numbers:
- 3021544512 with a best before date of March 2014
- 3029544512 with a best before date of March 2014
- 3197544512 with a best before date of September 2014
- 3240544512 with a best before date of October 2014
Hot Pocket Croissant Crust Philly Steak & Cheese, 9 oz., UPC 4369505634, Batch numbers:
- 3211544512 with a best before date of September 2014
- 3248544512 with a best before date of November 2014
- 3283544512 with a best before date of December 2014
Hot Pocket Philly Steak & Cheese, 54 oz., UPC 4369507520, Batch numbers:
- 3022544513 with a best before date of March 2014
- 3191544512 with a best before date of September 2014
- 3224544512 with a best before date of October 2014
- 3254544512 with a best before date of November 2014
- 3268544512 with a best before date of November 2014

Pfizer recalls antidepressant after report of wrong drug in bottle

Pfizer said it was recalling two lots of its Effexor XR antidepressant and another lot of its generic version of the drug after a pharmacist reported finding one capsule of a different medicine in a bottle of Effexor.
The other drug found by the pharmacist was Tikosyn, which is used to treat a common and potentially dangerous irregular heartbeat known as atrial fibrillation.

http://finance.yahoo.com/news/pfizer-recalls-antidepressant-report-wrong-230838090.html

Monday, February 17, 2014

FDA Issues Recall For L-Citrulline Supplement Used To Treat Urea Cycle Disorders

This is the update from last week:

The FDA alerts health care professionals and patients that Medisca is voluntarily recalling certain lots of its L-citrulline product after testing indicated that it does not contain any L-citrulline
  • Testing by Medisca indicated that L-citrulline, lot numbers 95482/A, 95482/B, 95482/C, 95482/D and 96453/A, 96453/B, 96453/C, 96453/D do not contain L-citrulline. Pharmacists should see updated FDA Statement below for more product details.
  • Medisca is voluntarily recalling all L-citrulline product with the above lot numbers.
  • Health care professionals should discontinue dispensing from these lots, contact patients, and return all unused product to Medisca Inc. 
  • Patients and caregivers should stop using any product with these lot numbers. 
  • FDA has received several adverse event reports associated with Medisca’s L-citrulline product. FDA is investigating reports that may include additional lot numbers, continues to investigate the full scope of this issue and will continue to provide additional information as it becomes available. 
  • Earlier, this information: FDA is notifiying health care professionals, patients, and caregivers of adverse events reported in patients who were administered L-citrulline repackaged and distributed by Medisca Inc. L-citrulline is used to treat certain urea cycle disorders, rare genetic disorders primarily diagnosed in children. FDA has received adverse event reports associated with potentially subpotent L-citrulline. Subpotent L-citrulline in patients with certain urea cycle defects can lead to high ammonia levels, which is serious and potentially life-threatening.In addition to the identified lot number 96453, FDA is investigating reports that may include additional lot numbers.
    BACKGROUND: Medisca supplies pharmacies nationwide with L-citrulline. The product is sold to pharmacies and clinics in containers filled with powdered L-citrulline, and it may be compounded into tablets, capsules, or liquids by pharmacies, or remain a powder.
    RECOMMENDATION: FDA recommends health care professionals quarantine lots of L-citrulline from Medisca and not administer to patients until FDA provides additional information.