GEC Laxoplex Muscle-Building Supplement Recalled for Containing Steroids

Genetic Edge Compounds recalled all lot codes of GEC Laxoplex dietary supplement capsules distributed between February 2, 2015-May 2, 2017 to the retail level and consumer level. FDA analysis found GEC Laxoplex to be tainted with anabolic steroids and steroid-like substances.

The presence of these anabolic steroids and steroid-like substances in GEC Laxoplex renders it an unapproved drug for which safety and efficacy have not been established and therefore subject to recall.

Use or consumption of products containing anabolic steroids may cause acute liver injury, which is known to be a possible harmful effect of using steroid-containing products. In addition, abuse of anabolic steroids may cause other serious long-term adverse health consequences in men, women, and children. These include shrinkage of the testes and male infertility, masculinization of women, breast enlargement in males, short stature in children, a higher predilection to misuse other drugs and alcohol, adverse effects on blood lipid levels, and increased risk of heart attack, stroke, and death.

GEC Laxoplex is marketed as a dietary supplement and sold as a muscle-enhancing agent. The product is packaged in a white plastic bottle containing 60 capsules with UPC code 0058049984 and can be identified by GEC Laxoplex. The recall affects all lots of GEC Laxoplex. GEC Laxoplex was distributed Nationwide in the USA through various nutritional supplement retail outlets.

Genetic Edge Compounds is notifying its retailers and customers by a formal recall notification and is arranging for a return of all recalled products. Consumers and retailers that have GEC Laxoplex dietary supplement capsules which are being recalled should stop using them and return to place of purchase.

 

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Charging that Vitamin E is Bad for Your Heart, Class Action is Revived Against CVS

vitaminThe First US Circuit Court of Appeals ruled that a class action lawsuit against CVS Caremark pharmacies may proceed in light of misleading labels for Vitamin E it sold that say it promotes “heart health” — when studies show the opposite is true.

Plaintiff Ronda Kaufman alleges that one study reflects “that those taking vitamin E had higher rates of heart failure and were more likely to be hospitalized for heart failure,” while another study found “an increase in mortality that progressively increased as daily dosage exceeds 150 IU.” The complaint further states that “[a]ll variations of [CVS’s] pill type vitamin E products exceed the 150 IU level shown to increase mortality in this study.”

No Preemption

The court ruled that the Federal Food Drug and Cosmetic Act (FDCA), 21 U.S.C. § 343-1(a)(5), does not preempt the lawsuit, brought under New York’s consumer protection law. The case is Kaufman v CVS Caremark Corp. (PDF), 1st U.S. Circuit Court of Appeals, No. 16-1199 (Sept. 6, 2016).

Kaufman purchased CVS-brand Vitamin E 400 International Unites (iu) with a label making four statements that are subject to the requirements of FDCA section 343(r)(6): that Vitamin E “supports antioxidant health”; that Vitamin E helps “maintain healthy blood vessels”; that Vitamin E “supports heart health”; and that Vitamin E “supports the immune system.”

Kaufman claims that there exist no scientifically valid studies establishing that CVS’s heart health statements are truthful and not misleading. Most studies about Vitamin E simply presume that it promotes heart health.

In fact, Kaufman cited 7 studies indicating that Vitamin E can even damage the heart. One study found that increasing Vitamin E intake may increase the risk for heart failure. Another found that “high-dosage” Vitamin E supplements of 400 IU or more–the very dosage that Kaufman purchased–may increase all-cause mortality. “This indication, which the studies at least render plausible, would seem to mean that Vitamin E can play a role in harming heart health,” the court says.

Accordingly, the label can plausibly be viewed as misleading within the meaning of the FDCA. “Federal law does not, therefore, preempt application of New York state law for the purpose of holding CVS accountable for misleading consumers by failing to satisfy those requirements,” the court ruled.

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FDA Updates Draft Guidance for Dangerous Dietary Supplements

Consumer Reports Supplements
See below for 15 supplements to always avoid.

The U.S. Food and Drug Administration issued a revised draft guidance to improve dietary supplement companies’ new dietary ingredient premarket safety notifications to the agency. These notifications help the agency identify safety concerns before products reach consumers.

Under the Dietary Supplement Health and Education Act (DSHEA), the manufacturer or distributor must notify the FDA at least 75 days before beginning to market a dietary supplement that contains a new dietary ingredient, unless the new ingredient is used in the food supply without chemical alteration.

Dietary supplements are considered adulterated if they contain a new ingredient not used in the food supply and the required notification has not been submitted to the FDA 75 days before marketing.

The FDA encourages public comments on the revised draft guidance during the 60-day comment period.

55,000+ dietary supplements

The FDA estimates that:

  • There are more than 55,600 dietary supplements on the market.
  • 5,560 new dietary supplement products come on the market each year.
  • Fewer than 1,000 NDI notifications have been sent to the FDA since DSHEA was passed in 1994.

“This revised draft guidance is an important step forward in the agency’s work to protect public health from potentially dangerous new dietary ingredients,” said Steven Tave, acting director of the FDA’s Office of Dietary Supplement Programs. “Notification of new dietary ingredients is the only pre-market opportunity the agency has to identify unsafe supplements before they are available to consumers. The revised draft guidance is intended to improve the quality of industry’s new dietary ingredient reporting so the FDA can more effectively monitor the safety of dietary supplements.”

Over the past three years, the FDA has taken numerous actions on dietary supplements, including action on several products containing new dietary ingredients that pose safety concerns and should have been the subject of an NDI notification but were not, such as Acacia rigidula.

The agency reaffirmed its commitment to remove from the market products that contain potentially harmful pharmaceutical agents, are otherwise dangerous to consumers, or are falsely labeled as dietary supplements; enforce the dietary supplement good manufacturing practices regulation; and take action against claims that present a risk of harm to consumers (such as egregious claims of benefit in treating serious diseases) or economic fraud.

 

 

Avoid 15 Dangerous Supplements

Consumer Reports identified 15 supplements that cause death or damage to the kidneys, liver and heart.

 

Ingredient Claimed Benefits Risks 
Aconite
Also called: Aconiti tuber, aconitum, angustifolium, monkshood, radix aconti, wolfsbane
Reduces inflammation, joint pain, gout Nausea, vomiting, weakness, paralysis, breathing and heart problems, possibly death
Caffeine Powder
Also called: 1,3,7-trimethylxanthine
Improves attention, enhances athletic performance, weight loss Seizures, heart arrhythmia, cardiac arrest, possibly death; particularly dangerous when combined with other stimulants
Chaparral
Also called: Creosote bush, greasewood, larrea divaricata, larrea tridentata, larreastat
Weight loss; improves inflammation; treats colds, infections, skin rashes, cancer Kidney problems, liver damage, possibly death
Coltsfoot
Also called: Coughwort, farfarae folium leaf, foalswort, tussilago farfara
Relieves cough, sore throat, laryngitis, bronchitis, asthma Liver damage, possible carcinogen
Comfrey
Also called: Blackwort, bruisewort, slippery root, symphytum officinale
Relieves cough, heavy menstrual periods, stomach problems, chest pain; treats cancer Liver damage, cancer, possibly death
Germander
Also called: Teucrium chamaedrys, viscidum
Weight loss; alleviates fever, arthritis, gout, stomach problems Liver damage, hepatitis, possibly death
Greater Celandine
Also called: Celandine, chelidonium majus, chelidonii herba
Alleviates stomachache Liver damage
Green Tea Extract Powder
Also called: Camellia sinensis
Weight loss Dizziness, ringing in the ears, reduced absorption of iron; exacerbates anemia and glaucoma; elevates blood pressure and heart rate; liver damage; possibly death
Kava
Also called: Ava pepper, kava kava, piper methysticum
Reduces anxiety, improves insomnia Liver damage,exacerbates Parkinson’s and depression, impairs driving, possibly death
Lobelia
Also called: Asthma weed, lobelia inflata, vomit wort, wild tobacco
Improves respiratory problems, aids smoking cessation Nausea, vomiting, diarrhea, tremors, rapid heartbeat, confusion, seizures, hypothermia, coma, possibly death
Methylsynephrine
Also called: Oxilofrine, p-hydroxyephedrine, oxyephedrine, 4-HMP
Weight loss, increases energy, improves athletic performance Causes heart rate and rhythm abnormalities, cardiac arrest; particularly risky when taken with other stimulants
Pennyroyal Oil
Also called: Hedeoma pulegioides, mentha pulegium
Improves breathing problems, digestive disorders Liver and kidney failure, nerve damage, convulsions, possibly death
Red Yeast Rice
Also called: Monascus purpureus
Lowers LDL (“bad”) cholesterol, prevents heart disease Kidney and muscle problems, liver problems, hair loss; can magnify effect of cholesterol-lowering statin drugs, increasing the risk of side effects
Usnic Acid
Also called: Beard moss, tree moss, usnea
Weight loss, pain relief Liver injury
Yohimbe
Also called: Johimbi, pausinystalia yohimbe, yohimbine, corynanthe johimbi
Treats low libido and erectile dysfunction, depression, obesity Raises blood pressure; causes rapid heart rate, headaches, seizures, liver and kidney problems, heart problems, panic attacks, possibly death

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Weight Loss Products by Bee Extremely Amazed Recalled Because of Undeclared Drug Ingredients

Bee amazedBee Extremely Amazed LLC, Jewett, OH is voluntarily recalling various products marketed for weight loss to the consumer level due to findings of undeclared drug ingredients including sibutramine and/or phenolphthalein, according to an FDA report.

  • Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010. 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.
  • 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.
  • These undeclared ingredients make these products unapproved new drugs for which safety and efficacy have not been established. These products may also interact in life-threatening ways with other medications a consumer may be taking.

To date, Bee Extremely Amazed is not aware of any adverse event reports related to these products. See the Firm Press Release for a complete list of the recalled products.

The affected products were sold nationwide between 4/29/2014 – 12/17/2015 via distribution/resale via the U.S. Postal service with the return addressee referenced as Bee Extremely Amazed, LLC or through any association with the email address sales@beeextremelyamazed.com and websiteswww.beeextremelyamazed.com, www.beefitamy.com, www.slimtrim.diet, www.Storeenvy.com.

Bee Extremely Amazed LLC is notifying its customers to stop using these products immediately and dispose of or return all recalled products to Bee Extremely Amazed 85205 Sportsmans Club Road Jewett Ohio 43986. Consumers with questions regarding this recall can contact Bee Extremely Amazed by email to sales@beeextremelyamazed.com or 1-844-427-6553MondayFriday 8:00 am – 4: 00 pm EST. Consumers should contact their physician or healthcare provider if they have any health questions or have experienced any problems that may be related to taking or using this product.

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