Health News: Alarming New ‘Superbug’ Gene found in animals and people ♦ DOJ: Consumers must remain on guard about supplement risks ♦ Electronic cigarettes need restrictions

Alarming New ‘Superbug’ Gene found in animals and people in China A new gene that makes bacteria highly resistant to a last-resort class of antibiotics has been found in people and pigs in China - including in samples of bacteria with epidemic potential, researchers said on Wednesday.The discovery was described as "alarming" by scientists, who called for urgent restrictions on the use of polymyxins - a class of antibiotics

DOJ: Consumers must remain on guard about supplement risks Putting out too much information is rarely a problem for the government, but most reports about Tuesday’s announcement by federal agencies of their new and ongoing “sweep” against unlawful dietary supplements overlooked some important consumer information. In addition to the criminal and civil actions made public Nov. 17, 2015, by the U.S. Department of Justice

New microscopy technology may help surgeons save more lives Biomedical engineers and neurosurgeons have developed an augmented microscopy technology to help surgeons operate with greater precision and reduced risk of harming patients.

Teens and parents agree: Electronic cigarettes need restrictions More than three fourths of both teens and adults say e-cigarettes should be restricted in public spaces, come with health warnings and be taxed like conventional cigarettes.

13 Dietary Supplements Recalled Due to Undeclared Salicylic Acid

Novacare, LLC of Murray, Utah is voluntarily recalling all lots of the following dietary supplements to the consumer level:

Name*	Brand Name	Quantity	UPC	Dates of Manufacture
Thin & Slim	Fataway Ultimate Stack	120 capsules	853002003025	2/21/2011- 3/16/2011
ThermoFX	ThermoFX<	90 capsules	793573902665	4/5/2011
Thin and Slim	MaxOut Body	60 capsules	N/A	10/24/2011- 2/11/2014
Metabolic Accelerator	Metabolic Accelerator	120 capsules	637687114593	2/23/2011- 3/18/2013
Thin and Slim	Burn Fat Now>	90 capsules	N/A	10/29/2011- 10/29/2014
Thin and Slim	Thermogenic Fat Burner	90 capsules	020025500095	10/29/2011- 10/29/2014
TruTrim		Bulk		11/30/2011
Thin and Slim Naturally AM	Thin and Slim Naturally	90 capsules	637687019003	10/29/2011- 10/29/2014
Thin and Slim	Extreme Stack	90 capsules	637687019133	1/30/2012, 3/20/2012
Xcellerator		Bulk		10/27/2011- 3/26/2012
Asia Black	Asia Black	100 capsules	859613274229	5/19/2011- 5/13/2014
Black Widow	Black Widow 25	100 capsules	859613252258	1/25/2011- 8/10/2014
Methyldrene	Methyldrene Original 25	100 capsules	859613638496	1/19/2011- 6/28/2013

* - Pictures of the product labels are included herewith for easier identification.

Sample analysis by the FDA has revealed that these products contain the undeclared drug ingredient salicylic acid making these unapproved new drugs.

Salicylic acid is acutely toxic, not recommended for oral use and is harmful if swallowed. Nausea, vomiting, gastrointestinal irritation, loss of hearing, sweating to severe reactions of blurred vision, mental confusion, cerebral edema and cardiorespiratory arrest which could be life-threatening may occur. Since the labeling does not state salicylic acid is contained it the product, individuals who are allergic, elderly, have a history of stomach ulcers or bleeding problems, consume ≥ 3 alcoholic drinks per day, or take concomitant medications containing salicylates are at higher risk for toxicity. No illnesses from these products have been reported to date.

These products are marketed as dietary supplements aiding in weight loss, produced in capsule form, and were sold in bottles. These products were distributed nationwide to distributors.

Novacare, LLC is notifying its distributors and customers by certified mail and is arranging for return of all recalled product. Consumers/distributors/retailers that have the aforementioned products that are being recalled should stop using, distributing, or selling them and return them to:

Novacare, LLC

Returns Dept.: MS# 2000

913 West 2900 South

Salt Lake City, UT 84119

Consumers with questions regarding this recall can contact Novacare, LLC directly at (801) 261-2252, Monday through Friday from 10:00 am – 4:00 pm MST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking any of the aforementioned products.

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.

• Complete and submit the report Online:www.fda.gov/medwatch/report.htm

Health News: FDA:17 Dietary supplements contain illegal ingredient ♦ Noroviruses spread several meters by air: ♦ New cellular response to radiation exposure

FDA:17 Dietary supplements contain illegal ingredient   The U.S. Food and Drug Administration (FDA) has advised 14 dietary supplement companies in warning letters dated April 24, 2015, that their total of 17 products include an ingredient on the Supplement Facts panel which is not approved for such use under federal law

Noroviruses spread several meters by air: Noroviruses, a group of viruses responsible for over 50 percent of global gastroenteritis cases, can spread by air up to several meters from an infected person. The discovery suggests that measures applied in hospitals during gastroenteritis outbreaks may be insufficient..

Engineering new blood vessels in people is one step closer to reality  Scientists moved a step closer toward coaxing the body into producing its own replacement blood vessels after discovering that suppressing parts of the innate immune system may raise the chances of a tissue engineered vascular graft success.

New cellular response to radiation exposure: Must we reconsider the risks of low doses? Almost the entire human genome is transcribed into RNA, but only a fraction of this is actually used to produce protein. The function of the majority of the RNA, the so-called 'non-coding transcriptome' remains an enigma. Some non-coding RNA families have been recognized through their shared structural features.

Impaired sleep linked to lower pain tolerance People with insomnia and other sleep problems have increased sensitivity to pain. The effect on pain tolerance appears strongest in people who suffer from both insomnia and chronic pain, who may benefit from treatments targeting both conditions.

10/23/14 Health News: Food Justice for Babies ♦ Norovirus outbreak in Arizona school ♦ DIETARY SUPPLEMENTS CONTAINED BANNED DRUGS AFTER FDA RECALLS

Food Justice for Babies

There’s only one day a year that’s dedicated just to food. Every October 24 is Food Day, a nationwide celebration of healthy, affordable and sustainable food. While Food Day strives to inspire us to improve our diets and our food policies, the 2014 Food Day places a special emphasis on food access and food justice.Continue Reading

Arizona school’s norovirus outbreak linked to over 100 students

I was chatting with a couple of guys at a birthday party of one of Sam’s friends this past weekend and relayed that I do food safety stuff. One dude said “I hate this time of year: between the colds, pink eye and norovirus our kids pick up at school we’ll all be sick until Thanksgiving.”  Continue Reading

DIETARY SUPPLEMENTS CONTAINED BANNED DRUGS AFTER FDA RECALLS

A new study finds that a high percentage of dietary supplements still contained banned drugs at least six months after being recalled by the U.S. Food and Drug Administration (FDA). Approximately half of all FDA class-I drug recalls since 2004 have involved dietary supplements adulterated with banned pharmaceutical ingredients. Previous studies have found that dietary... Continue Reading

Recall: Dietary Supplement RezzRX Due to Undeclared Active Ingredients

Recall of “RezzRX” Due to Undeclared Active Ingredients

FOR IMMEDIATE RELEASE - November 18, 2013 - Fossil Fuel Products, LLC, is voluntarily recalling lots QL110714A102 (20-count bottles) and QL110408B046 (single blister packs) of “RezzRX” to the consumer level. Laboratory analysis conducted by the FDA determined the RezzRX lot QL110714A102 (20-count bottles) contains undeclared hydroxylthiohomosildenafil and aminotadalafil and RezzRX lot QL110408B046 (single blister packs) contains undeclared hydroxylthiohomosildenafil. The products have been found to contain hydroxylthiohomosildenafil and amionotadalafil which are active ingredients of FDA approved drugs used to treat erectile dysfunction (ED), making “RezzRX” an unapproved new drug.

These undeclared active ingredients pose a threat to consumers because use of these products have the potential to interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to unsafe levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Additionally, may cause side effects, such as headaches and flushing. Fossil Fuel Products, LLC, has not received any reports of adverse events related to this recall.

The product is marketed as a natural supplement for sexual enhancement and is packaged in single blister retail cards containing 1 yellow capsule and 20-count white bottles containing 20 yellow capsules. The affected RezzRX lots include the following lot numbers and expiration dates [QL110714A102 Exp 11/2013 and QL110408B046 Exp 06/2015]. RezzRX was distributed nationwide through various websites and retail stores in Georgia.

Fossil Fuel Products, LLC, is notifying its distributors and customers by direct mail and email and is arranging for return of all recalled products. Consumers/distributors/retailers that have product which is being recalled should stop using/return to place of purchase/discard/contact their doctor, etc.

Consumers with questions regarding this recall can contact Fossil Fuel Products, LLC, by 1-877-773-9979 orinfo@rezzrx.com, Monday-Friday, 9:00 am- 5:00 pm, EST. 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.

• Online:www.fda.gov/medwatch/report.htm1
• Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm2. Mail to address on the pre-addressed form.
• Fax: 1-800-FDA-0178

    

Recall of Dietary Supplement Rhino 5 Plus, Maxtremezen and Extenzone

Paramount, CA, Jobbers Wholesale is voluntarily recalling Lot No. KWAKPMC030505175957019 of Rhino 5 Plus, Lot No. JBP-L-1270-70 of Maxtremezen and Lot No. KWAKPMC03050517 of Extenzone. FDA analysis found these products to contain undeclared desmethylcarbondenafil and dapoxetine. Desmethylcarbondenafil is a phosphodiesterase PDE-5 inhibitor which is a class of drugs used to treat male erectile dysfunction, making these products unapproved new drugs. Dapoxetine is an active ingredient not approved by the U.S. Food and Drug Administration (FDA).

Desmethylcarbondenafil may pose a threat to consumers because this PDE-5 inhibitor may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels that can be life threatening. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Dapoxetine has not been approved by the FDA and therefore its safety or efficacy has not been established. Chemically, dapoxetine belongs to a class of drugs known as selective serotonin reuptake inhibitors (SSRIs) used to treat depression. Studies have shown that antidepressants increased the risk of suicidal thinking and behavior in children, adolescents, and young adults when compared to placebo. Therefore, consuming these products presents a health risk which could be life threatening. Jobbers Wholesale has not received any reports of adverse events related to this recall.

These 3 products are labeled and intended to be used as dietary supplements for sexual enhancement. The products are packaged in 1 capsule blister packs. All three products were distributed to selected retail customers in California by Jobbers Wholesale from June 1, 2013 to November 7, 2013.

Jobbers Wholesale is notifying its retailers and customers by telephone and recall letter and is arranging for return of all recalled products. Consumers and retailers that have these products which are being recalled should stop consumption or further distribution and return to place of purchase or directly to Jobbers Wholesale, 16101 Garfield Avenue, Paramount, CA 90723.

Consumers are requested to have order number or proof of purchase.

Consumers with questions regarding this recall can contact Jobbers Wholesale by phone (562-331-0700), from Monday to Friday, 09:00-17:00. 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.

• This recall is beOnline: www.fda.gov/medwatch/report.htm
• Regular Mail: use postage-paid, pre-addressed form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form.
• Fax: 1-800-FDA-0178

FDA Seeks Injunction for Unapproved Drugs & Adulterated Dietary Supplements

The U.S. Food and Drug Administration, in a complaint filed by the U.S. Department of Justice, is seeking a permanent injunction against the dietary supplement manufacturer James G. Cole, Inc., its president, James G. Cole, and its general manager, Julie D. Graves, following the company’s repeated distribution of unapproved drugs and adulterated dietary supplements in violation of the Federal Food, Drug, and Cosmetic Act

If granted, the injunction would stop the company, based in Hood River, Ore., from promoting and distributing its products until it complies with current good manufacturing practice (cGMP) requirements for dietary supplements and all disease claims are removed from its websites, product labels, and all other products and websites under Cole’s custody and control.

“This company has ignored the multiple warnings they have been issued by the FDA by continuing to make unsubstantiated drug claims about the products it sells and by failing to conform to the cGMP requirements for dietary supplements,” said Melinda K. Plaisier, the FDA’s associate commissioner for regulatory affairs. “We are taking this action to protect the public health.”

James G. Cole, Inc. has marketed products online, with some sites linking to the company’s Facebook page. Cole has claimed that the dietary supplement products treat serious medical conditions, such as cancer, heart disease, rheumatoid arthritis, autism, Alzheimer’s, fibromyalgia, and high cholesterol. Under federal law, products offered for such uses are considered to be drugs, in that they are intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease.

The company’s dietary supplement products have been unlawfully marketed as drugs that have not been approved by the FDA for their claimed uses. The products include PCA, PCA-Rx, C-60, ACAI Resveratrol, Cytomune, Anavone, Liver Rescue, Probiotics, and several other products, which are marketed under the brand names Maxam Labs, Advanced Sports Nutrition, and Maxam Nutraceutics.

Additionally, during inspections of James G. Cole’s facility in 2012 and 2013, the FDA found that the company distributed dietary supplements that were not manufactured in accordance with the cGMP requirements for dietary supplements. For example, the company did not establish an identity specification for each component and did not conduct at least one appropriate test to verify the identity of a dietary ingredient.

A Sexual Supplement and a Dietary Supplement Recalled.

Upon request of the FDA, Hardmenstore.com is voluntarily recalling 1000 lots of 72HP, Evil Root and Pro Power Max at the consumer level. According to representatives of the FDA, 72HP, Evil Root and Pro Power Max have reportedly been found to contain amounts of the PDE-5 Inhibitor, sildenafil, which is the active ingredient in an FDA-approved drug for erectile dysfunction (ED).

Sildenafil is not listed on the product labels. Sildenafil may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Additionally, the product may cause side effects, such as headaches and flushing.

These products are intended to be used as a dietary supplement and sexual supplement. 72HP is packaged in a single blister pack containing 1 dose. Evil Root is packaged in box containing a bottle of 6 pills. Pro Power Max is packaged in a single blister pack containing 1 dose.

All lots of 72HP, Evil Root and Pro Power Max are included in this recall. 72HP can be identified by the yellow packaging with a black horse insignia. Evil Root can be identified by its orange box with blue Chinese characters. Pro Power Max can be identified by the black and red packaging with flames on the bottom of the packaging. These sealed and packaged products were delivered to Hardmenstore.com as having contained only legitimate and lawful ingredients.

Aided with the information provided by the FDA, Hardmenstore.com is now notifying its distributors and customers by an email and online notice on the homepage of our site. It is arranging for a return of all recalled products. Consumers and retailers that have the 72HP, Evil Root or Pro Power Max supplements should stop using this product immediately, and contact a doctor if any of the side effects have been felt.

Consumers with questions regarding this voluntary recall can contact Howard Andrew by email at info@hardmenstore.com from Monday to Friday, 11am to 5pm, EST.

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.

• Online: www.fda.gov/medwatch/report.htm
• Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form.
• Fax: 1-800-FDA-0178

This recall is being conducted with the knowledge of and at the request of the U.S. Food and Drug Administration.

“As hardmenstore.com receives this product from overseas in a sealed package, representing that it contains only lawful and legitimate ingredients, we are relying on the representations of the Food and Drug Administration that the public interest would best be served by voluntarily complying with their request to get the product off the shelves. Our goal is to protect the safety of the consumer,” stated Howard Andrew, on behalf of Hardmenstore.com.