FDA: Bee Pollen Products Can Have Dangerous Ingredients

By Jane Farrell

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 health care 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.

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.

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.  The system includes a 16-digit code on the package that consumers can use to go online and “validate” whether the product is “genuine” or counterfeit.

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 health care professionals should report any adverse events related to bee pollen products to the FDA’s MedWatch program by:

Completing and submitting the report online at www.fda.gov/medwatch/report.htm or 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.”

Reprinted with permission from FDA Consumer Health Information. This article appears on FDA’s Consumer Updates page, which features the latest on all FDA-regulated products. For more information, click here.