Supplements Recalled Because of Undeclared Drug Ingredients

Detox Transforms Health and Nutrition, Garner, NC announced it is conducting a voluntary recall of the following dietary supplements, to the consumer level, because they contain undeclared drug ingredients making them unapproved drugs.suppliments

Product Name	Bottle Color	Label	# Capsules	UPC	Lot	Expiration
EDGE Amplified Weight Release	White	Purple label	60	852175004174	ALL
iNDiGO	White	Dark blue label	60	852175004044	000034	4/10/2017
AMPD Gold Bee Pollen	White	Black label	60	852175004181	ALL
BtRim Max	White	Dark Red label	60	852175004068	00002	4/27/2017
iNSANE Bee Pollen	White	Bright Red label	60	852175004082	0000:02	6/20/2017

FDA analysis found iNDiGO and BtRim Max to contain undeclared phenolphthalein. The health risks of phenolphthalein could include potentially serious gastrointestinal disturbances, irregular heartbeat, and cancer with long-term use. FDA analysis found EDGE Amplified Weight Release and iNSANE Bee Pollen to contain undeclared phenolphthalein and fluoxetine. In addition to the potential adverse health consequences for phenolphthalein, the concomitant use of fluoxetine with other medications such as MAO-Inhibitors and serotonin precursors (such as tryptophans) is either contraindicated or is not recommended.

Fluoxetine is an SSRI with potentially life threatening side effects that is given to patients to treat depression, anxiety, panic attacks, obsessive-compulsive disorder, or bulimia. Even when taken as prescribed, fluoxetine has been associated with serious side effects including suicidal thinking, abnormal bleeding, and seizures. Thus, any adverse reaction that is possible with fluoxetine is possible with the fluoxetine containing dietary supplement product.

In patients on other medications for common conditions (aspirin, ibuprofen, or other drugs for depression, anxiety, bipolar illness, blood clots, chemotherapy, heart conditions, and psychosis), ventricular arrhythmia or sudden death can occur with concomitant use of fluoxetine. FDA analysis found AMPD Gold Bee Pollen to contain undeclared sildenafil which has the potential to interact with medications. Males taking nitrates are at risk for life threatening hypotensive events. Certain medications such as ritonavir, ketoconazole, and itraconazole as well as consuming substantial amounts of alcohol can increase the effects of sildenafil.

The products were distributed nationwide via the internet and retail stores.

Detox Transforms has ceased distribution of the products as the company is working in close cooperation with the U.S. Food and Drug Administration (FDA) to fully resolve this issue. Detox Transforms is notifying its distributors and customers by email, telephone, and mail and is arranging for return of all recalled products. Consumers/distributors/retailers that have these products which are being recalled should stop use and return to place of purchase for a full refund.

Consumers with questions regarding this recall may contact Detox Transforms at 877-404-7873 or 919-341-9050 between the hours of 10am – 6pm (EST), Monday through Friday. 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 these 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
• Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

Two Weight Loss Supplements Recalled

REFA Enterprises, LLC is voluntarily recalling one lot of each: Forever Beautiful Bee Pollen (UPC # 6333090804632), Forever Beautiful Infinity UPC # 633090804649), to the consumer level. The products have been found to contain undeclared Sibutramine or a combination of both Sibutramine and Phenolphthalein through FDA laboratory analyses. Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010 (due to increased risk of seizures, heart attacks, arrhythmia and strokes). Phenolphthalein is an ingredient previously used in over-the-counter laxatives, but because of concerns of carcinogenicity, it is not currently approved for marketing in the United States. These undeclared ingredients make these products unapproved new drugs for which safety and efficacy have not been established.

Products containing sibutramine pose a threat to consumers because Sibutramine can increase blood pressure and/or pulse rate in some patients and may present a risk for those with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke. These products may also interact in life threatening ways with other medications a consumer may be taking. Health risks associated with phenolphthalein could include potentially serious gastrointestinal disturbances, irregular heartbeat, and cancer with long-term use.

All affected products are marketed as dietary supplements for weight loss and were packaged and distributed as follows:

Forever Beautiful Bee Pollen is packaged in bottles of 60 capsules, Forever Beautiful Bee pollen was distributed via internet to consumers nationwide from July 7, 2014 – November 3, 2014.

Forever Beautiful Infinity is packaged in bottles of 60 capsules. Forever Beautiful Infinity was distributed via internet to consumers nationwide from July 7, 2014 – November 3, 2014.

REFA Enterprises, LLC is notifying its customers by email and is arranging for return of all recalled products. Consumers that have product which is being recalled should stop using and return products to REFA Enterprises, LLC.

Consumers with questions regarding this recall can contact REFA Enterprises, LLC at (757) 420-1122 Monday – Friday 12:00 p.m. – 6:00 p.m. EST or email support@fbbpshop.com.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.

Adverse reactions 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
• Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

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

Some Bee Pollen Weight Loss Products Are a Dangerous Scam

Products labeled to contain bee pollen that promise to help you lose weight or reshape your body could actually harm you, warns the Food and Drug Administration (FDA).

Bee pollen is the pollen that bees collect from flowers; it is the food that nourishes bee larvae. But it’s not a miracle ingredient, says Gary Coody, R.Ph., FDA’s national health fraud coordinator.

Some bee pollen products marketed for weight loss have been found to contain hidden and potentially dangerous ingredients that may be harmful for people who have conditions such as irregular heartbeat, high blood pressure and bipolar disorders (a brain disorder that causes unusual shifts in mood), says Coody.

FDA recently warned consumers to immediately stop using one of these products—Zi Xiu Tang Bee Pollen—because it contains at least one potentially harmful ingredient that is not listed on the product’s label.

Zi Xiu Tang is just one of several bee pollen products that the FDA has found to contain undeclared sibutramine and/or phenolphthalein. Others include Ultimate Formula, Fat Zero, Bella Vi Amp’d Up, Insane Amp’d Up, Slim Trim U, Infinity, Perfect Body Solution, Asset Extreme, Asset Extreme Plus, Asset Bold and Asset Bee Pollen. All these products marketed for weight loss included bee pollen in the list of ingredients.

The agency has received from consumers and healthcare professionals more than 50 adverse event reports associated with the use of tainted bee pollen weight loss products. The reports include at least one death, serious cardiac issues, chest pain, heart palpitations, tachycardia (increased heart rate), increased blood pressure, seizures, suicidal thoughts, anxiety, insomnia and diarrhea.

In addition, many bee pollen weight loss products are marketed as dietary supplements with claims to treat or prevent a variety of diseases and signs or symptoms of disease, including obesity, allergies, high blood pressure and high cholesterol. By law, dietary supplements may not claim to treat or prevent a disease.

“When people buy these tainted bee pollen weight loss products, they are unknowingly taking one or more hidden drugs that have been banned from the market,” Coody warns.

The case of Zi Xiu Tang Bee Pollen illustrates the potential dangers posed by unscrupulous promoters of quick health fixes.

A Dangerous Concoction

FDA labs have analyzed 15 different Zi Xiu Tang Bee Pollen samples from various distributors with a variety of expiration dates and lot numbers. All products tested, including those that claim to be “genuine” and “anti-counterfeit,” had undeclared drug ingredients: sibutramine and/or phenolphthalein.

Sibutramine is a controlled substance that was removed from the market in October 2010 after clinical data indicated that it posed an increased risk of heart attack and stroke. Sibutramine substantially increases the blood pressure and/or pulse in some people and can be risky for patients with a history of coronary artery disease, congestive heart failure, heart arrhythmias or stroke, says Jason Humbert, a senior regulatory manager with FDA’s Office of Regulatory Affairs.

Phenolphthalein, a laxative and a suspected cancer-causing agent, isn’t approved in the United States. FDA has classified phenolphthalein as not generally recognized as safe and effective.

“They will tell you you’re going to get thirsty and need to drink more water. They won’t tell you that’s a side effect of sibutramine,” Coody says of the vendors of tainted supplements. “They’ll tell you that you may not feel well because you’re detoxifying your body. Well, you’re not feeling well because of the side effects of sibutramine.”

The product conveys an image of authenticity, fitness and health, Coody says. “These folks are very savvy in how they market the product. They are going to make you think that it’s not only exotic but also all natural,” he adds.

FDA is also investigating other bee pollen weight loss products suspected to contain hidden drugs. “But we cannot test every product,” Coody says.

An Elaborate Marketing Scheme

Zi Xiu Tang Bee Pollen is sold in health stores, fitness centers and spas. It’s even touted by some health care practitioners.

Manufacturers and distributors of Zi Xiu Tang have created an anti-counterfeit system to persuade consumers that their product is “authentic” and that not all bee pollen products are the same (“That theirs is the real thing – the good stuff,” Humbert says). The ruse includes a 16-digit code on the package that consumers can use to go online and “validate” whether the product is “genuine” or counterfeit.

There are also legitimate-looking web sites and a huge social media presence, especially on Facebook and YouTube, to market the product. “It’s a very elaborate and sophisticated scheme,” says Humbert. “It preys on people’s weaknesses. They want the product to work.”

Zi Xiu Tang Bee Pollen was placed on Import Alert to prevent it from being shipped into the United States. But the product is still entering the country illegally, Coody says. FDA is investigating and may issue additional warning letters or take enforcement action, such as issuing an administrative detention order against products with undeclared drugs, bringing a seizure action in federal court, or seeking an injunction or criminal prosecution against the firm or responsible individuals.

Consumers can also check FDA’s website for a list of products previously tested and found to contain undeclared drug ingredients.

Consumers and healthcare professionals should report any adverse events related to Zi Xiu Tang Bee Pollen or other bee pollen products to the FDA’s MedWatch program by:

• Completing and submitting the report online at www.fda.gov/medwatch/report.htm.
• Downloading the form, completing it and then faxing it to 1-800-FDA-0178.

“It is tempting to believe that a quick and effortless weight loss supplement is safe for use,” Humbert says. “But given the fact that these products contain a hidden dangerous ingredient, consumers should avoid taking them.”