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 (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.

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.

The FDA said that while testosterone products already carry a warning about the risk of clots related to a condition that sometimes occurs with testosterone treatment, the latest reports of clots were unrelated to that condition, called polycythemia.

 

In January, the FDA said it has been monitoring the stroke and heart risks posed by testosterone products but in light of two recent studies has "decided to reassess this safety issue," prompting an investigation.

 

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.

 

 

 

Read more: FDA moves for more warnings on testosterone products - FiercePharma http://www.fiercepharma.com/story/fda-moves-more-warnings-testosterone-products/2014-06-20#ixzz35Z6yNsJM
Subscribe at FiercePharma

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.

FDA: New advice on mercury levels in Seafood

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

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/

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

 (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

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:

Ftc national from mzamoralaw

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 . (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 Number	Packaging	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 Ant	All 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

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

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

Lansal Recalls Hummus and Dip Products

Prepared Foods manufacturer, Lansal, Inc.( d.b.a Hot Mama’s Foods) has announced it is recalling approximately 14,860 pounds of hummus and dip products.The products were sold at Trader Joes and Target, and the recall is based on worries about possible Listeria contamination.  

 

The potential for contamination was found during a routine test of Target Archer Farms Traditional Hummus (10 ounce) by the Texas Department of Health. No illness has been reported.

 

 Here are the UPC codes: 

  

UPC: 85239233405

Target Archer Farms Traditional Hummus 10oz.

JUN/11/2014

National

 

UPC: 8968630 01823

Target Archer Farms Traditional Hummus 2lb. 

(Non-retail item; Ingredient item used in SuperTarget store production of 2 items, Archer Farms Mediterranean Veggie Hummus Wrap and Archer Farms Hummus Veggie Snacker)

JUN/11/2014

National

 

UPC: 85239233498

Target Archer Farms Roasted Garlic with Roasted Garlic Tapenade 17 oz.

JUN/9/14 & JUN/12/14

National

 

UPC: 85239233481

Target Archer Farms Roasted Red Pepper with Roasted Red Pepper Topping 17 oz.

JUN/12/2014

National

 

UPC: 988582 Trader Joe’s Edamame Hummus 8oz.

APR/28/14 & APR/29/14 & MAY/9/24

Arizona, California, Colorado, Florida, Georgia, Idaho, Louisiana, North Carolina, Nevada, New Mexico, Oregon, South Carolina, Tennessee, Texas, Utah, Virginia (Southern), Washington.

Dietary Supplement "Lean Slow Motion" gets an FDA Warning Letter

In a key  first warning letter on issue since FDA liquid dietary supplements guidance was finalized in January, the FDA warned a manufacturer that the beverage drinks are adulterated under federal law because they contain melatonin, which is not approved for use in food

Marco Moran, President

Dewmar International BMC, Inc.

101 Convention Center Drive, Suite 700

Las Vegas, Nevada 89109

 

Dear Mr. Moran:

 

The Food and Drug Administration (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.

 

• Under 21 CFR 170.3(h), “[s]cientific procedures include those human, animal, analytical, and other scientific studies, whether published or unpublished, appropriate to establish the safety of a substance.”  Under 21 CFR 170.30(b), “[g]eneral recognition of safety based upon scientific procedures shall require the same quantity and quality of scientific evidence as is required to obtain approval of a food additive regulation for the ingredient.”  Section 170.30(b) further states that general recognition of safety through scientific procedures is ordinarily based upon published studies, which may be corroborated by unpublished studies and other data and information.
• Under 21 CFR 170.3(f), “[c]ommon use in food means a substantial history of consumption of a substance for food use by a significant number of consumers.”  Under 21 CFR 170.30(c)(1), “[g]eneral recognition of safety through experience based on common use in food prior to January 1, 1958, shall be based solely on food use of the substance prior to January 1, 1958, and shall ordinarily be based upon generally available data and information.”  Importantly, however, the fact a substance was added to food before 1958 does not, in itself, demonstrate such use is safe, unless the pre-1958 use is sufficient to demonstrate to qualified experts that the substance is safe when added to food [21 CFR 170.30(a)].
• Under 21 CFR 170.3(i), “[s]afe or safety means that there is a reasonable certainty in the minds of competent scientists that the substance is not harmful under the intended conditions of use.”  The regulation provides that, in determining safety, the following factors are to be considered:  (1) The probable consumption of the substance and of any substance formed in or on food because of its use; (2) the cumulative effect of the substance in the diet, taking into account any chemically or pharmacologically related substance or substances in such diet; and (3) safety factors which, in the opinion of qualified experts, are generally recognized as appropriate. Such safety factors ordinarily are established through extensive testing in animals to determine whether consumption of the ingredient produces adverse effects when consumed chronically (i.e., on a daily basis over the course of a lifetime).1

 

We know of no basis for general recognition of safety for melatonin based either on scientific procedures or common use in food prior to January 1, 1958. Melatonin is a neurohormone that is used for medicinal purposes, primarily as a sleep aid in the treatment of sleep-related disorders.  In assessing the GRAS status of melatonin for use in a conventional food such as “Lean Slow Motion…Potion (Easta Pink, Purp, and Yella),” we considered the criteria described above. FDA is not aware of data to establish the safety of melatonin for use as an ingredient in conventional foods. On the contrary, reports in the scientific literature have raised safety concerns about the use of melatonin. Among these are concerns about effects on blood glucose homeostasis (References 1- 4), and effects on the reproductive/developmental (References 5- 11), cardiovascular (References 12- 18), ocular (References 19- 21) and neurological systems (References 22, 23). Therefore, the use of melatonin in your “Lean Slow Motion…Potion (Easta Pink, Purp, and Yella)” products does not satisfy the criteria for GRAS status under 21 CFR 170.30.

 

FDA is not aware of any other exemption from the food additive definition that would apply to melatonin for use as an ingredient in a conventional food, such as your beverage product. Therefore, melatonin added to a conventional food is a food additive under Section 201(s) of the Act [21 USC 321(s)] and is subject to the provisions of Section 409 of the Act [21 USC 348].  Under Section 409, a food additive is deemed unsafe unless it is approved by FDA for its intended use prior to marketing. Melatonin is not approved for use in any food, including beverages.  Therefore, your “Lean Slow Motion…Potion (Easta Pink, Purp, and Yella)” products are adulterated within the meaning of Section 402(a)(2)(C) of the Act [21 USC 342(a)(2)(C)].

 

Misbranded Food

 

Your Lean Slow Motion…Potion (Easta Pink, Purp, and Yella) products are misbranded within the meaning of Section 403(a)(1) of the Act [21 USC 343(a)(1)]. As discussed above, the products are represented for use as conventional foods, however, below the Nutrition Facts panel, the labels state:  “DIETARY SUPPLEMENT.”

 

Your Lean Slow Motion…Potion (Easta Pink, Purp, and Yella) products are misbranded within the meaning of Section 403 (i)(1) of the Act [21 USC 343(i)(1)] because they fail to bear a statement of identity in accordance with 21 CFR 101.3.

 

Your Lean Slow Motion…Potion (Easta Pink, Purp, and Yella) products are misbranded within the meaning of Section 403(q) of the Act [21 USC 343(q)] because the nutrition information is not in an appropriate format, as specified in 21 CFR 101.9. For example:

 

• A declaration of “Acai Berry Extract” is not allowed within the nutrition label (e.g., Nutrition Facts panel). According to 21 CFR 101.9(c), no nutrients or food components other than those listed in 21 CFR 101.9(c) as either mandatory or voluntary may be included within the nutrition label.
• The amounts of saturated fat and trans fat are not declared as provided for in either of the methods specified in 21 CFR 101.9(c)(2)(i) and 21 CFR 101.9(c)(2)(ii) or 21 CFR 101.9(f)(4).  Further, the amount of cholesterol is not declared as provided for in either of the methods specified in 21 CFR 101.9(c)(3) or 21 CFR 101.9(f)(4).
• The label uses the simplified Nutrition Facts labeling format under 21 CFR 101.9(f). When using this format, the declaration of voluntary nutrients triggers the requirement that the statement “Not a significant source of ___” be included at the bottom of the nutrition label. We note the labels fail to use this statement to declare trans fat, saturated fat, cholesterol, vitamins A and C, iron and calcium.

 

This letter is not intended to be an all-inclusive list of violations in your products. It is your responsibility to ensure all of your products comply with the Act and other applicable regulations. You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in FDA taking regulatory action without further notice, such as seizure or injunction.

 

(b)(4)

 

 

 

You should respond in writing within 15 working days from the date you receive this letter. Your response should include specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrective action you have taken. If your planned correction will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed. Your response should be comprehensive and address all violations included in this Warning Letter.

 

Your response should be sent to:  Ms. Kimberly Dutzek, Compliance Officer, at the address above.  If you have any questions about the content of this letter, please contact Ms. Dutzek at (615) 366-7826.

 

                                                                       

Sincerely,

/S/ 

Patricia K. Schafer

District Director

New Orleans District

 

May News - Morcellator Warning from the FDA

The FDA has discouraged the use of laparoscopic power morcellation for the removal of the uterus (hysterectomy) or uterine fibroids (myomectomy) in women because, based on an analysis of currently available data, it poses a risk of spreading unsuspected cancerous tissue, notably uterine sarcomas, beyond the uterus.

Laparoscopic power morcellation is one of several available treatments for fibroids. It is a procedure that uses a medical device to divide the uterine tissue into smaller pieces or fragments so it can be removed through a small incision in the abdomen, such as during laparoscopy.

Uterine fibroids are non-cancerous growths that originate from the smooth muscle tissue in the wall of the uterus. According to the National Institutes of Health, most women will develop uterine fibroids at some point in their lives. While most uterine fibroids do not cause problems, they can cause symptoms, such as heavy or prolonged menstrual bleeding, pelvic pressure or pain, and frequent urination, sometimes requiring medical or surgical therapy.

Based on an analysis of currently available data, the FDA has determined that approximately 1 in 350 women who are undergoing hysterectomy or myomectomy for fibroids have an unsuspected type of uterine cancer called uterine sarcoma. If laparoscopic power morcellation is performed in these women, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s likelihood of long-term survival.

“The FDA’s primary concern as we consider the continued use of these devices is the safety and well-being of patients,” said William Maisel, M.D., M.P.H., deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health. “There is no reliable way to determine if a uterine fibroid is cancerous prior to removal. Patients should know that the FDA is discouraging the use of laparoscopic power morcellation for hysterectomy or myomectomy, and they should discuss the risks and benefits of the available treatment options with their health care professionals.”

A number of additional treatment options are available for women with symptomatic uterine fibroids, including traditional surgical hysterectomy (performed either vaginally or abdominally) and myomectomy, and laparoscopic hysterectomy and myomectomy without morcellation, as well as other non-surgical options.

The FDA will convene a public meeting of the Obstetrics and Gynecological Medical Devices Panel to discuss information related to laparoscopic power morcellation.

“Input from clinical and scientific experts will help provide valuable information and perspectives to clarify the proper clinical role for these devices,” said Maisel. “We anticipate the discussion will include whether a boxed warning related to the risk of cancer spread should be added to the product labeling for laparoscopic power morcellators to ensure patients and health care professionals are adequately informed of the risks.” 

http://www.fda.gov/newsEvents/Newsroom/PressAnnouncements/ucm393689.htm

From FDA Safety communication:

Summary of Problem and Scope:

Uterine fibroids are noncancerous growths that develop from the muscular tissue of the uterus. Most women will develop uterine fibroids (also called leiomyomas) at some point in their lives, although most cause no symptoms1. In some cases, however, fibroids can cause symptoms, including heavy or prolonged menstrual bleeding, pelvic pressure or pain, and/or frequent urination, requiring medical or surgical therapy.

Many women choose to undergo laparoscopic hysterectomy or myomectomy because these procedures are associated with benefits such as a shorter post-operative recovery time and a reduced risk of infection compared to abdominal hysterectomy and myomectomy2. Many of these laparoscopic procedures are performed using a power morcellator.

A number of additional treatment options are available for women with symptomatic uterine fibroids including traditional surgical hysterectomy (performed either vaginally or abdominally) and myomectomy, laparoscopic hysterectomy and myomectomy without morcellation, laparotomy using a smaller incision (minilaparotomy), deliberate blocking of the uterine artery (catheter-based uterine artery embolization), high-intensity focused ultrasound, and drug therapy. Evidence demonstrates that, when feasible, vaginal hysterectomy is associated with comparable or better results and fewer complications than laparoscopic or abdominal hysterectomy3.

From  the American Cancer Society:

Sarcomas are cancers that start from tissues such as muscle, fat, bone, and fibrous tissue (the material that forms tendons and ligaments). Cancers that start in epithelial cells, the cells that line or cover most organs, are calledcarcinomas.

More than 95% of cancers of the uterus are carcinomas. If a carcinoma starts in the cervix, it is called a cervical carcinoma. Carcinomas starting in the endometrium, the lining of the uterus, are called endometrial carcinomas. These cancers are discussed in our other documents Cervical Cancer and Endometrial (Uterine) Cancer. This document is only about uterine sarcomas.

Most uterine sarcomas are put into categories, based on the type of cell they developed from:

• Endometrial stromal sarcomas develop in the supporting connective tissue (stroma) of the endometrium. These cancers are rare, representing less than 1% (1 in 100) of all uterine cancers. These tumors are low grade -- the cancer cells do not look very abnormal and they tend to grow slowly. Patients with these tumors have a better outlook than those with other uterine sarcomas .
• Undifferentiated sarcomas used to be considered a type of endometrial stromal sarcoma, but since they are more aggressive and are treated differently from low-grade tumors, they are now considered separately. These cancers make up less than 1% of all uterine cancers and tend to have a poor outlook.
• Uterine leiomyosarcomas start in the muscular wall of the uterus known as the myometrium. These tumors make up about 2% of cancers that start in the uterus.

Another type of cancer that starts in the uterus is called carcinosarcoma. These cancers start in the endometrium and have features of both sarcomas and carcinomas. They can be classified with uterine sarcomas, but many doctors now believe they are more closely related to carcinomas. These cancers are also known as malignant mixed mesodermal tumors or malignant mixed mullerian tumors. Uterine carcinosarcomas are discussed in detail in the American Cancer Society document Endometrial (Uterine) Cancer.

http://www.cancer.org/cancer/uterinesarcoma/detailedguide/uterine-sarcoma-what-is-uterine-sarcoma