Monday, February 01, 2016

FDA Recalls Skinny Latina Million Dollar Marinade Over Undeclared Ingredient

New of a recent recall of Skinny Latina Million Dollar Marinade bottles from stores for containing undeclared soy. People who are allergic to soy should not consume the product.

The product is available in clear 12-ounce glass bottles with a label on the back stating when it is best consumed. All bottles with the label, “Best By 12-15-15” or earlier, are being recalled. The bottles did not include the corrected labels stating that these contain soy.
The recall was triggered by the discovery of soy in its gluten-free teriyaki sauce ingredient, without the packaging indicating its presence. It is important to note that Skinny Latina Foods Inc. voluntarily recalled the distributed products immediately after, the same press release states.
http://www.latinpost.com/articles/109995/20160120/fda-recalls-skinny-latina-million-dollar-marinade-over-undeclared-ingredient.htm


Tuesday, January 26, 2016

FDA recalls cough syrup brand, says it contains morphine -Master's Herbs Licorice Cough Liquid



According to the FDA: Consumers using this product may not be aware they are ingesting morphine. The unware ingestion of morphine can lead to life-threatening respiratory depression and death. Because the morphine contained in this product is not identified on the label there is a risk that patients who are hypersensitive to morphine could suffer severe allergic reactions. In addition young children with a respiratory illness are vulnerable to respiratory depression from opioids and should not be exposed to morphine in any event. To this date Master Herbs, Inc. is not aware of adverse events associated with use of the product.

Friday, January 15, 2016

Chipotle to close locations for national meeting on Feb. 8


Chipotle Mexican Grill will briefly close locations Feb. 8 when it hosts a national team meeting where the agenda will include food safety changes, a company spokesman said, in the wake of a series of norovirus and E. coli outbreaks that sickened dozens and drove down sales.

http://www.bostonglobe.com/business/2016/01/15/chipotle-close-locations-for-national-meeting-feb/5sXGhddM59MaKYrHWewHAO/story.html

Should Sugary Drinks have a Warning Label?

From CNN:

Bills are under consideration in New York and California that would require sugar-sweetened beverages to feature health warning labels on their packaging, similar to tobacco warning labels in the United States and many other countries. San Francisco has passed a law, which has not gone into effect yet, that requires advertisements for sugary drinks to include warning labels.
http://www.cnn.com/2016/01/14/health/warning-labels-sugary-drinks/

Bad idea- do you agree?

Thursday, January 14, 2016

FDA Issues Urgent Drug Recall of Certain Weight Loss Dietary Supplements - Trim Plus, Jenesis and Oasis

BeeXtreme LLC is recalling all lots of La' Trim Plus, Jenesis and Oasis products from the market. Recent Analysis by the Food and Drug Administration has found undeclared Sibutramine and Phenolphthalein in the Dietary Supplement "La' Trim Plus", “Oasis”, and “Jenesis”.  The recall includes all lots and expiration dates.
BACKGROUND: Sibutramine and Phenolphthalein pose a significant health hazard. Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010. It 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. 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. Health risks associated with phenolphthalein could include potentially serious, gastrointestinal disturbances, irregular heartbeat, and cancer with long-term use.
RECOMMENDATION: Please determine if you have any of the above products on hand. If so, please discontinue selling the products and do not consume them. Please promptly dispose of all identified products. If you have further distributed La' Trim, Jenesis and/or Oasis, please contact your customers if possible and advise them of the recall situation. Provide them with a copy of this notice. Have them return their outstanding recalled stocks to you. If you have any questions regarding this recall please contact beextremellc@gmail.com or call 814-771-4377.

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm478890.htm

Chromium Mineral Supplements May Cause Cancer: Other Health Risks Of Dietary Supplements

In a new study, Australian researchers discovered that chromium, which is commonly taken by bodybuilders and dieters, partiallyconverts into a carcinogen when it enters cells.

More at the link: http://www.techtimes.com/articles/123924/20160113/chromium-mineral-supplements-may-cause-cancer-other-health-risks-of-dietary-supplements.htm

Tuesday, January 12, 2016

R Thomas Marketing recalls numerous dietary supplements

R Thomas Marketing is recalling all lots of the following products:
  • Black Ant: BIG BOX (20 small boxes / 4 capsules per box / 80 capsules total)
  • Herb Viagra: BIG BOX (20 small boxes / 4 capsules per box / 80 capsules)
  • Real Skill: BIG BOX (20 small boxes / 4 capsules per box / 80 capsules)
  • Stree Overlord: BIG BOX (20 small boxes / 4 capsules per box / 80 capsules)
  • Weekend Prince: BIG BOX (24 individual cards / 2 capsules per card / 48 capsules)
  • African Black Ant: BIG BOX (8 small boxes / 6 capsules per box / 48 capsules)
The products contain Sildenafil, a PDE-5 Inhibitor which is the active ingredient in an FDA-approved drug for erectile dysfunction (ED) making this tainted dietary supplement and unapproved drug. Sildenafil is not listed on the product labels.

Additionally, the company is recalling all lots of the following products, which came from the same vendors as the above-mentioned products, and may contain Sildenafil:
  • Bull: CASE (10 packs / 3 capsules per can / 30 capsules)
  • Bulls Genital: CASE (10 Cans / 10 capsules per can / 100 capsules)
  • Zhonghua Niu Bian: BIG BOX (6 small boxes / 6 capsules per box / 36 capsules)
  • African Superman: BIG BOX (6 small boxes / 8 capsules per box / 48 capsules)
  • Bigger Longer More Time More Sperms: BIG BOX (6 small boxes / 6 capsules per small box / 36 capsules)
  • Black Ant King: BIG BOX (10 capsules / can / 12 cans per box / 120 capsules)
  • Black Storm: SMALL BOX (6 capsules)
  • Germany Niubian: BIG BOX (10 small boxes / 24 capsules per box / 240 capsules)
  • Happy Passengers: BIG BOX (30 small boxes / 1 capsule per box / 30 capsules)
  • Plant Vigra: BIG BOX / (18 cans / 6 capsules per can / 108 capsules)
  • Hard Ten Days: BIG BOX (6 small boxes / 6 capsules per box / 36 capsules)
  • Man King: BIG BOX (8 small boxes / 5 capsules per box / 40 capsules)
  • Mojo Risen: BIG BOX (24 individual cards / 2 capsules per card/ 48 capsules)
  • Night Man: SMALL BOX (6 capsules)
  • Tiger King: BIG BOX (10 small bottles / 10 capsules per bottle / 100 capsules)
  • Samurai-X: BIG BOX (24 individually wrapped capsules)
  • Super Hard: BIG BOX (20 small boxes / 6 capsules per box / 120 capsules)
  • Zhen Gong: BIG BOX (16 small boxes / 2 capsules per box / 32 capsules)
The above products were marketed as dietary supplements for male sexual enhancement, and were sold from September 2013 to the present mainly sold through the following websites:
The company is notifying its customers by directly via email.

Customers who have any of these above mentioned products should stop using them and arrange for return of them to:

Thursday, January 07, 2016

Chipotle served with grand jury subpoena in norovirus outbreak

Chipotle was served with a federal grand jury subpoena as part of a criminal investigation tied to a dangerous norovirus outbreak this summer at one of its restaurants in California, the company announced Wednesday.
The subpoena, received last month, requires the company to produce a broad range of documents tied to the restaurant in Simi Valley. The investigation is being conducted by the U.S. Attorney's Office for the Central District of California in conjunction with the Food and Drug Administration, the company said.

Source: http://www.foxnews.com/us/2016/01/06/chipotle-hit-with-subpoena-in-federal-criminal-investigation.html

Tuesday, December 29, 2015

Arkansas Compounding Pharmacy Recalls Sterile Products

Flagged in recent inspections for apparent safety lapses, a compounding pharmacy in Conway, Arkansas, is voluntarily recalling all lots of its sterile products for humans and animals that were distributed between March 14, 2015, and September 9, 2015, the US Food and Drug Administration (FDA) announced today.
The pharmacy, US Compounding, is taking the action "due to (FDA) concern over a lack of sterility assurance," the company said in a news release posted on the agency's website.
The recalled products for humans — the vast majority are injectables — include testosterone, corticosteroids, glycopyrrolate, fentanyl, and the vasodilator alprostadil. Also on the list are topical ophthalmic drugs. The products were distributed to patients and healthcare providers alike.

http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm339771.htm

Monday, December 28, 2015

BeeXtreme Recalls All Lots of 3 Dietary Supplements

BeeXtreme LLC announced a recall of all lots of La' Trim Plus, Jenesis, and Oasis products from the market. A recent analysis by the Food and Drug Administration (FDA) had shown undeclared sibutramine and phenolphthalein in the Company's 3 dietary supplements.

Sibutramine is a medication that assists with weight-loss by altering neurotransmitters within the brain. Neurotransmitters are chemicals that are produced and released by nerves in order to communicate with other nerves. Released neurotransmitters may attach to other nerves or they may be taken up again by the nerves that release them, a process termed reuptake.


Monday, December 14, 2015

Lipo Escultura Corp. Issues Nationwide Recall of Lipo Escultura Due to Undeclared Sibutramine and Diclofenac



From the FDA:

Lipo Escultura Corp. of Brooklyn, NY dba JAT Productos Naturales Corp., and JAT Natural Products Corp. are voluntarily recalling all Lipo Escultura within expiry to the consumer level. The Lipo Escultura capsules were tested by the U.S. Food and Drug Administration and have been found to contain two potentially harmful ingredients--sibutramine and diclofenac.
Risk Statement: Sibutramine is an appetite suppressant now a controlled substance that was removed from the market for safety reasons. 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. Diclofenac is a non-steroidal anti-inflammatory drug (commonly referred to as NSAIDs). NSAIDS may cause increased risk of cardiovascular events, such as heart attack and stroked, as well as serious gastrointestinal damage, including bleeding, ulceration, and fatal perforation of the stomach and intestines.
The product is used as a weight loss dietary supplement and is packaged in a white plastic bottle with green and lime labeling with white capsules. Products were sold/distributed Nationwide by JAT Productos Naturales Corp. via internet sales on www.lipoesculturatreatment.com, through Lipo Escultura Corp. 888 Wyckoff Ave. Brooklyn, NY 11237, a retail store and 1360 Hancock Street, Brooklyn, NY 11237, a home office.
The recall was initiated after a consumer illness was reported to the FDA and it was discovered that the product labeling does not reveal the presence of sibutramine or diclofenac.

http://www.fda.gov/Safety/Recalls/ucm475550.htm

Legal: Florida Company Glades Drugs Recalls Multivitamins Recalled for High Vitamin D3




News out of Pahokee this past week. 

The FDA announces a  voluntary recall of compounded multivitamin capsules that have high amounts of Vitamin D3 (Cholecalciferol). The product was distributed nationwide by Glades Drugs in Pahokee, Florida. The FDA has received several reports of adverse reactions that may be associated with this recalled product.

From the FDA site: 
The U.S. Food and Drug Administration is alerting health care professionals and patients of a voluntary recall of compounded multivitamin capsules containing high amounts of Vitamin D3 (Cholecalciferol),  distributed nationwide by Glades Drugs in Pahokee, Florida. FDA has received reports of several adverse events potentially associated with these compounded capsules made by Glades Drugs. Consumption of this product may result in vitamin D toxicity, which may be severe and may lead to life-threatening outcomes if left untreated. Patients suffering adverse effects from high Vitamin D levels (Cholecalciferol) may not initially show symptoms. Therefore, patients who have received these compounded capsules should stop taking this medication and immediately seek medical attention.
BACKGROUND: Symptoms of short-term vitamin D toxicity are due to high calcium levels (also known as hypercalcemia) and include confusion, increased urination, increased thirst, loss of appetite, vomiting, and muscle weakness. Acute hypercalcemia may intensify tendencies for heart arrhythmias and seizures and may increase the effects of certain heart drugs. Long-term toxicity may cause kidney failure, increase in calcium deposits in the blood and soft tissue, bone demineralization and pain. Patients with conditions such as liver disease or chronic kidney failure may be at increased risk for developing vitamin D toxicity.
RECOMMENDATION: Health care providers should quarantine and return any products subject to this recall to the company at: Glades Drugs, 109 S. Lake Ave., Pahokee, FL 33476.  Glades Drugs sent recall letters to patients, attempted to contact them by phone, and called prescribing physicians.
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:


Lucy's Weight Loss Recalls Pink Bikini White Powder Capsules

Lucy's Weight Loss System has voluntarily recalled all lots of Pink Bikini White powder Capsules, 30 white (750MG per capsule) to the consumer level, as it has been found positive for diclofenac after FDA sampling and testing.

Pink Bikini is marketed as a weight loss dietary supplement and is packaged in clear bottle in white powder capsules. The product was distributed nationwide to consumers via PinkBikini.BigCartel.com and Waisted With Lucy Retail store.

Diclofenac is a nonsteroidal anti-inflammatory drug or NSAID. This medicine works by reducing substances in the body that cause pain and inflammation.

Diclofenac can increase the risk of fatal heart attack or stroke, especially if used long term or taken high doses, or if the user has heart disease.
For pregnant women, taking diclofenac during the last three months of pregnancy may harm the unborn baby.

This undeclared ingredient makes this product an unapproved new drug for which safety and efficacy have not been established.
Lucy's Weight Loss System has not received any reports of adverse events related to this recall.

http://www.rttnews.com/2589876/lucy-s-weight-loss-recalls-pink-bikini-white-powder-capsules.aspx

Sunday, December 13, 2015

Boston Scientific recalls Chariot Guiding Sheaths, citing complications

Boston Scientific Corp.’s Maple Grove campus is recalling its global supply of 7,000 Chariot Guiding Sheaths because parts of the device can break off during medical procedures and obstruct blood flow.
The company says doctors who used the Chariot sheath for minimally invasive procedures in the legs and arms should check back with those patients to make sure they’re doing OK.

More here: http://www.startribune.com/boston-scientific-recalls-chariot-guiding-sheaths-citing-complications/361361441/

Chipotle ecoli outbreak in Georgia, November 2015







Folks across Atlanta and beyond are asking about the supposed outbreak. Here is what we know: 


From the FDA:  
  • Three additional states have reported people infected with the outbreak strain of Shiga toxin-producing Escherichia coli O26 (STEC O26) since the last update, Illinois, Maryland, and Pennsylvania.
  • Fifty-two people infected with the outbreak strain of STEC O26 have now been reported from a total of nine states: California (3), Illinois (1), Maryland (1), Minnesota (2), New York (1), Ohio (3), Oregon (13), Pennsylvania (1), and Washington (27).
  • The epidemiologic evidence available at this time suggests that a common meal item or ingredient served at Chipotle Mexican Grill restaurants in several states is a likely source of this outbreak.
  • The investigation is still ongoing to determine what specific food is linked to illness.

As of December 4, 2015, the The CDC says that a total of 52 people infected with the outbreak strain of STEC O26 from a total of nine states: California (3), Illinois (1), Maryland (1), Minnesota (2), New York (1), Ohio (3), Oregon (13), Pennsylvania (1), and Washington (27). There have been 20 reported hospitalizations. 

Of the three most recent illnesses reported in November, only one ill person, whose illness started on November 10, reported eating at Chipotle Mexican Grill in the week before their illness began.



What are the Signs & Symptoms of E. coli O26?

  • People usually get sick from STEC (Shiga toxin-producing E. coli) 2-8 days (average of 3-4 days) after swallowing the organism (germ).
    • Most people infected with STEC develop diarrhea (often bloody) and abdominal cramps.
    • Most people recover within a week.
  • Some illnesses last longer and can be more severe, resulting in a type of kidney failure called hemolytic uremic syndrome (HUS).
    • HUS can occur in people of any age, but is most common in young children under 5 years, older adults, and people with weakened immune systems.
    • Symptoms of HUS can include fever, abdominal pain, pale skin tone, fatigue and irritability, small, unexplained bruises or bleeding from the nose and mouth, and decreased urination.
    • People who experience these symptoms should seek emergency medical care immediately.
  • STEC infection is usually diagnosed by testing of a stool sample for Shiga toxins.
    • Clinical laboratories are required in some states to send Shiga toxin-positive specimens from ill people to the state public health laboratory for identification of STEC and PulseNet testing.

http://www.fda.gov/Food/RecallsOutbreaksEmergencies/Outbreaks/ucm470410.htm





Wednesday, October 21, 2015

October 20, 2015 Tampa FL VW Recall Lawyers

There  is lots of talk across the south about VW and how it rigged its cars to test emissions lower.  Volkswagen has admitted to lying to government agencies and the people who bought or leased their diesel cars. By now, it's almost impossible to read about this on the Internet and read "class actions" filed. 

Is a class action case in Florida the best or only way to go. NO. So where does the anaylsis start? It starts with who claims to be first in line. 

VW has said they will pay for their illegal activity and false marketing claims. Who will be compensated?
  1. Federal and state governments. In similar cases, the mandatory penalties are paid first.
  2. VW Diesel Owners and Leasees. VW has already broken the trust their customers had in them. Prepare to stand in line.
Don’t forget about the VW Shareholders, who want to make sure their dividends stay intact. Bottom line: If you bought or leased a diesel-fueled 
Volkswagen JettaGolfBeetle,Passat, or Audi A3 sedan manufactured between 2009 and 2015, you need to be represented to fully and fairly recover losses from your devalued vehicle and other potential damages. The list of the named vehicles include:
  • VW Jetta TDI (model years 2009 – 2015)
  • VW Jetta SportWagen TDI (model years 2009-2014)
  • VW Golf TDI (model years 2010-2015)
  • VW Golf SportWagen TDI (model year 2015)
  • VW Beetle TDI and VW Beetle Convertible TDI (model years 2012-2015)
  • VW Passat TDI (model years 2012-2015)
  • Audi A3 TDI models using the 2.0L 4-cylinder TDI engine (model years 2010-2013)

    VW Diesel Owners -Florida Law Protects You

    The only way affected customers can help ensure they will be fully compensated for their losses is to sue Volkswagen.  What can one person claim - outside of a class action?
    • Overpayment of up to $6,000 for their vehicles.
    • Substantial loss of value in their vehicles.
    • Great difficulty in reselling their vehicles.
    • Potential loss of fuel efficiency and/or performance as the result of “fixing ” their vehicles.
  • contact us at 813-513-1381

Dietary Supplements Send 23,000 to ER Yearly

From Study: 

On the basis of 3667 cases, we estimated that 23,005 (95% confidence interval [CI], 18,611 to 27,398) emergency department visits per year were attributed to adverse events related to dietary supplements. These visits resulted in an estimated 2154 hospitalizations (95% CI, 1342 to 2967) annually. Such visits frequently involved young adults between the ages of 20 and 34 years (28.0% of visits; 95% CI, 25.1 to 30.8) and unsupervised children (21.2% of visits; 95% CI, 18.4 to 24.0). After the exclusion of unsupervised ingestion of dietary supplements by children, 65.9% (95% CI, 63.2 to 68.5) of emergency department visits for single-supplement–related adverse events involved herbal or complementary nutritional products; 31.8% (95% CI, 29.2 to 34.3) involved micronutrients. Herbal or complementary nutritional products for weight loss (25.5%; 95% CI, 23.1 to 27.9) and increased energy (10.0%; 95% CI, 8.0 to 11.9) were commonly implicated. Weight-loss or energy products caused 71.8% (95% CI, 67.6 to 76.1) of supplement-related adverse events involving palpitations, chest pain, or tachycardia, and 58.0% (95% CI, 52.2 to 63.7) involved persons 20 to 34 years of age. Among adults 65 years of age or older, choking or pill-induced dysphagia or globus caused 37.6% (95% CI, 29.1 to 46.2) of all emergency department visits for supplement-related adverse events; micronutrients were implicated in 83.1% (95% CI, 73.3 to 92.9) of these visits.

http://www.nejm.org/doi/full/10.1056/NEJMsa1504267

More than a quarter of the ER visits documented in the study involved young adults between the age of 20 and 34 years.

Sunday, October 04, 2015

Sunset Natural Products ordered to stop making or selling dietary supplement products

A Florida judge has barred a Florida dietary supplements maker from doing business until it cleans up its act.

The consent decree of permanent injunction was issued against Sunset Natural Products Inc. and its two owners, Teresa Martinez (a.k.a. Teresa Martinez-Arroyo) and Elsy Cruz, for manufacturing and distributing adulterated dietary supplements at its facility located in Miami, Florida.

The decree was entered by U.S. Magistrate Judge Edwin G. Torres for the U.S. District Court for the Southern District of Florida on the strength of a complaint filed by the U.S. Department of Justice, which alleged the company operates under conditions that do not meet the U.S. Food and Drug Administration’s current Good Manufacturing Practice (cGMP) requirements.

Under the terms of the consent decree, the company will not be allowed to manufacture or sell dietary supplement products until the FDA has determined that the business is in compliance with the Federal Food, Drug, and Cosmetic Act.

Novartis issues voluntary recall of ADHD drug manufactured in Georgia

Novartis  has issued a voluntary recall of more than 10,000 bottles of a drug used to treat attention deficit hyperactivity disorder (ADHD) that were manufactured at a plant in Georgia.
According to a FDA enforcement report, the Class III recall was for 10,767 bottles of prescription-only 10-milligram dexmethylphenidate HCI extended-release capsules that were manufactured by Alkermes Gainesville in Gainesville, GA. 

The reason cited for the recall was an "out of specification (above specification) result obtained at 6-hour dissolution time point during the 12-month stability testing."

http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=D-1430-2015&w=09232015&lang=eng

VW Recall Information

Trying to get to the full understanding of the VW scandal. VW's problems have continued to escalate in recent days, and even as prosecutors in both the U.S. and Germany look into the scandal, the automaker's top U.S. executive has been summoned to Capitol Hill, where he will testify before a congressional oversight panel on Oct. 8.

"The American people want to know why these devices were in place, how the decision was made to install them, and how they went undetected for so long. We will get them those answers," said Rep. Tim Murphy, the Pennsylvania Republican who serves as chairman of the Energy and Commerce Subcommittee on Oversight and Investigations.

Only Diesel Vehicles are Subject to the Recall & Subject to Possible Compensation for Owners/Lessees:

  • 2010 - 2015 Audi A3
  • 2012 - 2015 Volkswagen Beetle
  • 2012 - 2015 Volkswagen Beetle Convertible
  • 2010 - 2015 Volkswagen Golf
  • 2009 - 2015 Volkswagen Jetta
  • 2009 - 2014 Volkswagen Jetta SportWagen
  • 2012 - 2015 Volkswagen Passat
http://www.cnbc.com/2015/10/02/vw-emissions-cheating-scandal-heading-to-congress.html

Friday, October 02, 2015

Some Brain & Workout Supplements Contain Unapproved Drugs

The Study is here: 
http://onlinelibrary.wiley.com/doi/10.1002/dta.1853/full
Conclusion:

The newly developed UHPLC-PDA method facilitated the detection of vinpocetine and picamilon. This method exhibited excellent performance in terms of sensitivity and is a suitable method for rapid analysis of vinpocetine and picamilon in dietary supplements. The developed method was validated for all the parameters tested and successfully applied to the identification of vinpocetine in authenticated plant samples and dietary supplements.
As expected, vinpocetine was not detected in 2 authenticated samples of Vinca minor. Of the 23 vinpocetine dietary supplements tested, 17 contained vinpocetine and the quantity of vinpocetine in these supplements ranged from 0.3 to 32 mg per recommended daily serving. No vinpocetine was detected in 26% (6/23) of the sampled supplements. Vinpocetine was sold as if it were a constituent of lesser periwinkle in 13% (3/23) of the supplements. In summary, 39% (9/23) of the vinpocetine supplements were misbranded, and 74% (17/23) of vinpocetine supplement labels did not provide any information on the quantity of vinpocetine.
Of the 31 picamilon supplements tested, 30 contained picamilon and the quantity of picamilon ranged from 2.7 to 721.5 mg per maximum recommended daily serving. In the supplements providing a specific quantity of picamilon on the label, actual quantity of picamilon ranged from 99.6 to 157.9% of labelled quantity.


New York Advisory Position Regarding Juror Research and Social Media

Definitely worth a read:

TOPIC: Jury Research and Social Media
DIGEST: Attorneys may use social media websites for juror research as long as no communication occurs between the lawyer and the juror as a result of the research. Attorneys may not research jurors if the result of the research is that the juror will receive a communication. If an attorney unknowingly or inadvertently causes a communication with a juror, such conduct may run afoul of the Rules of Professional Conduct. The attorney must not use deception to gain access to a juror’s website or to obtain information, and third parties working for the benefit of or on behalf of an attorney must comport with all the same restrictions as the attorney. Should a lawyer learn of juror misconduct through otherwise permissible research of a juror’s social media activities, the lawyer must reveal the improper conduct to the court.
RULES: 3.5(a)(4); 3.5(a)(5); 3.5(d); 8.4
Read more here:http://www.nycbar.org/ethics/ethics-opinions-local/2012opinions/1479-formal-opinion-2012-02

Imported Dietary Supplements Recalled for Elevated Lead and Mercury Levels

Butala Emporium Inc., of Jackson Heights, NY, is voluntarily recalling 11 Ayurvedic (dietary) supplements (listed below) because the products were found to contain elevated lead and mercury levels which, if consumed, may cause health problems to consumers, particularly infants, small children, pregnant women, and those with underlying kidney disorders.
The products were distributed in NY through retail stores and to consumers as single-unit purchases via the firm’s Internet site within CA, CT, FL, HI, MA, NJ, OH, PA, VT, Washington, D.C., and PR.
Butala EmporiumThe recall was initiated after it was discovered that the products contain high levels of lead and mercury based on testing by the New York City Department of Health laboratory and the U.S. Food and Drug Administration (FDA). No complaints or illnesses have been received to date.
The concentration of lead exceeds the recommended daily lead exposure for children younger than 6 years of age and women of childbearing age and would likely be injurious to health. If a child or a pregnant woman is exposed to lead for a protracted period of time (e.g., weeks to months), permanent damage to the central nervous system, learning disorders, developmental defects, and other long-term health problems can occur. The problems that might occur are dependent on the duration and degree of exposure.

http://www.foodsafetynews.com/2015/09/imported-dietary-supplements-recalled-for-elevated-lead-and-mercury-levels/#.Vg6icvlViko

Sunday, August 23, 2015

Iowa Dietary Supplement Firm Shuts Down Under Consent Decree

U.S. District Judge Edward J. McManus for the U.S. District Court for the Northern District of Iowa entered a consent decree of permanent injunction against Iowa Select Herbs LLC, a manufacturer and distributor of drugs and dietary supplements, and its two co-owners, Gordon L. Freeman and Lois A. Dotterweich. The complaint, filed by the U.S. Department of Justice, sought a permanent injunction against the company and its owners for unlawfully manufacturing and distributing unapproved new drugs, misbranded drugs, adulterated dietary supplements and misbranded dietary supplements.  
 
The company and its owners marketed their products online athttp://stores.iowaselectherbs.com/ and through online marketplace websites, such as eBay, Amazon and buy.com. They also sold their products through a retail location in Cedar Rapids, Iowa. 
“The FDA works with companies to ensure their processes comply with the public health requirements in our laws and regulations,” said Melinda Plaisier, FDA associate commissioner for regulatory affairs. “But when a company refuses to comply, we will take aggressive enforcement action.”

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm458752.htm

FDA: CBD oil not a dietary supplement

A warning letter went to a seller of CBD Oil: 


This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address https://www.hempoilcare.com[1] in November 2014 and has determined that you take orders for several products that you claim contain cannabidiol (CBD), including but not limited to “Cibdex Hemp CBD Complex Drops,” “Cibaderm Hemp Salve,” “Dixie Botanicals Dew Drops Hemp Oil Supplement,” “Hemp Honey 21% Cannabidiol Oil,” “Hemp Honey CBD Vape Oil,” and “Hemp Pure Vape E-Drops,” which the website promotes for conditions that cause the products to be drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)], because the products are intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act. 
 
Examples of claims observed on your website https://www.hempoilcare.com that establish the intended use of your products include, but may not be limited to: 
 
On the “CBD oil – Pure Vape E-Drops 50mG” product webpage, https://www.hempoilcare.com/product/cbd-oil-pure-vape-drops/:
 
• “A literature review from 2009 recapped CBD’s documented capabilities as an . . . antipsychotic . . . vasorelaxant (lower blood pressure), antispasmodic, anti-ischemic, anti-cancer agent . . . antibacterial agent, anti-diabetic . . .”
 
On the “Hemp oil – Dixie Botanicals Dew Drops” product webpage, https://www.hempoilcare.com/product/hemp-oil-dixie-botanicals-dew-drops-100mg/:
 
• “EXPLORING SEVEN HEALTH BENEFITS OF CANNABIDIOL (CBD) . . . antipsychotic, anti-depressant . . . analgesic for rheumatoid arthritis . . . stimulating new bone growth and strengthening bones affected by osteoporosis . . . vasorelaxant for glaucoma . . . atheroscloerosis [sic], anti-ischemic (prevents plaque buildup in arteries)”
 
On the “CBD Oil” webpage, https://www.hempoilcare.com/cbd-oil/:
 
Under the heading, “Study: Cannabinoids Could Play A Role In Pancreatic Cancer Treatment”:
 
 “[A study] suggests that cannabinoids could help treat pancreatic adenocarcinoma – one of the most aggressive forms of cancer.”
 “[T]he administration of cannabinoids seemed to induce cancer cell apoptosis . . ..”
 
Under the heading, “CBD May Help Reduce Psychotic Symptoms of Schizophrenia”:
 
 “CBD has shown promise in preventing cancer from cigarette smoke, reducing heart damage from chemotherapy . . ..”
 “[Researchers] compared benefits of CBD and amisulpride, a potent antipsychotic, in 42 acute schizophrenia patients . . . . The researchers found that cannabidiol and amisulpride were both ‘safe and effective’ but they declared CBD superior . . . .”
 
It is clear from the claims above that your marketed products “Cibdex Hemp CBD Complex Drops,” “Cibaderm Hemp Salve,” “Dixie Botanicals Dew Drops Hemp Oil Supplement,” “Hemp Honey 21% Cannabidiol Oil,” “Hemp Honey CBD Vape Oil,” and “Hemp Pure Vape E-Drops” are drugs under section 201(g)(1)(B) of the Act because they are articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.
 
Your marketed products  “Cibdex Hemp CBD Complex Drops,” “Cibaderm Hemp Salve,” “Dixie Botanicals Dew Drops Hemp Oil Supplement,” “Hemp Honey 21% Cannabidiol Oil,” “Hemp Honey CBD Vape Oil,” and “Hemp Pure Vape E-Drops” are also “new drugs” under section 201(p) of the Act [21 U.S.C. § 321(p)] because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from the FDA, as described in section 505(a) of the Act [21 U.S.C. § 355(a)]; see also section 301(d) of the Act [21 U.S.C. § 331(d)].  FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective. 
 
Additionally, your marketed products  “Cibdex Hemp CBD Complex Drops,” “Cibaderm Hemp Salve,” “Dixie Botanicals Dew Drops Hemp Oil Supplement,” “Hemp Honey 21% Cannabidiol Oil,” “Hemp Honey CBD Vape Oil,” and “Hemp Pure Vape E-Drops” are misbranded within the meaning of section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)], because the labeling for these products fails to bear adequate directions for use. “Adequate directions for use” means directions under which a layman can use a drug safely and for the purposes for which it is intended [21 CFR § 201.5]. Your marketed products are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use this drug safely for its intended purposes. FDA-approved drugs which bear their FDA-approved labeling are exempt from the requirements that they bear adequate directions for use by a layperson [21 CFR §§ 201.100(c)(2) and 201.115].  Because the above-mentioned products lack FDA-approved applications, they are not exempt under 21 CFR §§ 201.100(c)(2) and 201.115.  For these reasons, these products are misbranded under section 502(f)(1) of the Act. The introduction or delivery for introduction of a misbranded drug into interstate commerce is a violation of section 301(a) of the Act [21 U.S.C. § 331(a)].
 
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your marketed products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law and FDA regulations.
 
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction. 
 
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction. Your response should be sent to: