What Is Royal Honey and Why Did the FDA Recall It? (2024)

Popular honey-based sexual supplements may not be as natural as you think.

The Food and Drug Administration (FDA) has issued warning letters to four companies that sell honey-based sexual enhancement supplements. The agency found the active ingredients in Cialis and Viagra—prescription meds used to treat erectile dysfunction—in the supplements.

The FDA has spoken out through several press releases over a number of years, finding that internal lab testing found tadalafil (Cialis) and sildenafil (Viagra) in products with names including “Royal Honey for Him” and “X Rated Honey for Men.” The FDA said these drugs pose a serious risk to consumers taking other prescription drugs with nitrates (like nitroglycerin), medications used to treat diabetes, high cholesterol, and heart disease. Interaction could lead to dangerously low blood pressure levels.

“Tainted honey-based products like these are dangerous because consumers are likely unaware of the risks associated with the hidden prescription drug ingredients in these products and how they may interact with other drugs and supplements they may take,” said Judy McMeekin, Pharm.D., FDA Associate Commissioner for Regulatory Affairs, via the FDA’s release.

There’s also the reality that some people may experience allergic reactions to these drugs, a risk heightened by taking them without knowing it.

The four companies mentioned by the FDA include Thirstyrun LLC (also known as US Royal Honey LLC), MKS Enterprise LLC, Shopaax.com, and 1am USA Incorporated dba Pleasure Products USA. The honey-based sexual supplements were sold online—the agency named Amazon and Etsy in various press releases—and maybe even in select retail stores, according to the FDA.

The companies issued warnings have 15 days to either address the issues of their products or provide information on why their products don’t violate the law. Failure to do so will result in legal action, like product seizure, according to the press release.

On July 13, Shopaax.com recalled all lots of its Kingdom Honey Royal Honey VIP because it contains sildenafil. Consumers should immediately are advised to stop using the product and may return it for a full refund.

An Unregulated Industry

Supplements live in an unregulated market and aren’t vetted by the FDA.

The supplement “Royal Honey for Men” claims to deliver ultimate power and is “the most potent and natural source of sexual power and testosterone,” according to their marketing. Listed ingredients include tribulus terrestris (a fruit-producing plant), tongkat ali (a shrubby tree), and ginseng (a root), all popular ingredients in testosterone boosters and sexual supplements.

“People should be very leery taking many of the products and supplements, because they’re unregulated, and most people don’t know what’s actually in them,” said Franklin Lowe, M.D., vice chairman of the Department of Urology at Montefiore Medical Center and a professor at Albert Einstein School of Medicine, toNBC News.

“What is on the label doesn’t necessarily correlate to what’s actually in the bottle or pill. And this is a perfect example of that,” Lowe added.

A Growing Danger

These warnings come as theFDA’s list of tainted sexual enhancement productsgrows. In April, theFDA warned of 18 other honey-based sexual supplementswith hidden drugs. And in 2019, the FDA warned that sexual enhancement pills sold online could contain hidden ingredients like sildenafil, the active ingredient of Viagra. Again, FDA approvals of Cialis and Viagra are restricted to use under the supervision of a licensed health care professional.

“It’s extremely important for men experiencing erectile dysfunction to talk to a doctor about their symptoms,” saysJack Jeng, M.D., Chief Medical Officer at Hone Health. “Erectile dysfunction is a risk marker for cardiovascular disease and may be caused by underlying problems like low testosterone. A doctor can review your medical history and order lab tests to determine the best course of action. If medication is appropriate, your doctor will provide a prescription and monitor for side effects and efficacy.”

Reporting Side Effects

If you feel you’ve taken a supplement like the ones described in this article and felt negative or unintended side effects, you can report them to the FDA’sMedWatch Safety Information and Adverse Event Reporting Programonline.

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