4 Companies Warned By FDA For Selling Sex Honey Products With Viagra In Them

The U.S. Food and Drug Administration (FDA) issued a warning to four companies after discovering they sold products with ingredients that may "pose a significant health risk to consumers." The companies sell honey-based products marketed to people as “sexual enhancement remedies”, but they were found to contain drug ingredients not listed on the product labels. Here's what you need to know.

Which companies received a warning letter?

The warning letter sent by the FDA went to four companies after the agency discovered each sells products that contain Viagra and Cialis, unlisted in the ingredients.

The companies that sell honey-based products with hidden ingredients include Thirstyrun LLC, also called US Royal Honey LLC, MKS Enterprise LLC, Shopaax.com, and 1 am USA Incorporated dba Pleasure Products USA.

Shopaax.com issued a voluntary recall posted on the FDA website and MKS Enterprise LLC told Fatherly they issued recalls of their affected products and posted an announcement on their website.

The products sold by the four companies are sold on various websites and possibly in some retail stores and online marketplaces. They are marketed as sexual enhancement remedies. The products are titled names such as “Dose Vital Honey For Men,” “Secret Miracle Royal Honey For Her,” “Kingdom Honey Royal VIP,” etc. The product descriptions do not include the mention of Viagra or Cialis in their ingredient list, only natural ingredients like “caviar powder” and “cinnamon,” per a Vice News investigation.

What did the FDA find in the products sold by the four companies?

According to the notice posted by the FDA, the agency's laboratory testing found samples of the products containing drug ingredients that are not listed on the product labels. More specifically, the four companies' products contain the active ingredient found in Viagra (sildenafil) and Cialis (tadalafil), which are approved drugs by the FDA to treat people with erectile dysfunction.

Since the medications are approved drugs for medical purposes only, the sale of products containing the active ingredients in Viagra or Cialis is restricted to being prescribed under the supervision of licensed health care professionals.

Fatherly reached out to the companies for comment, and MKS Enterprise LLC sent a press-release recall announcement as a statement via email, a statement they also published on their website. It has not yet been published on the FDA website. The Shopaax.com recall has been posted on the FDA website. If the other three companies respond, we will update this article with their statements.

Why the products containing undeclared active medications can be a severe issue.

The FDA explains in the warning letter that the honey-based products in question are marketed to people as sexual enhancement drugs — which would be fine if they didn't contain medical claims and restricted medications.

"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 FDA Associate Commissioner for Regulatory Affairs Judy McMeekin, Pharm.D.

The commissioner continued, "Products marketed with unidentified ingredients may be dangerous and, in some cases, deadly to consumers. We encourage consumers to remain vigilant when shopping online or in stores to avoid purchasing products that put their health at risk, and instead seek effective FDA-approved treatments."

According to IFL Science, the health risks posed by taking medication not explicitly prescribed to you — willingly or unwillingly, which would be the case with these supplements — can be dangerous.

"Viagra works by blocking the action of an enzyme called PDE5," the publication notes. "Stopping PDE5 from working causes the blood vessels to relax, increasing blood flow and lowering blood pressure. As a result, these kinds of drugs run the risk of lowering blood pressure to dangerously low levels."

Medications like Viagra and Cialis also "interact with nitrates, which people sometimes take with diabetes, high blood pressure, high cholesterol, or heart disease," IFL Science explains, which can lead to serious medical issues.

What this notice says about the regulation of supplements, food, and drugs in the U.S.

The FDA has a set of rules and guidelines that companies must follow when selling products to ensure safety to consumers. The issue is that these rules and guidelines differ depending on whether the product is categorized as a food, supplement, or drug.

The four companies in question categorized their honey-based sexual enhancement products as "food" instead of a "drug" despite containing tadalafil or sildenafil. In doing so, they've violated federal law.

Per the FDA, products containing active ingredients that would be classified as a drug need to be tested to prove the product is safe. However, that's not the same for dietary supplements — which are only monitored after a product hits the market.

"In general, FDA is limited to postmarket enforcement [for dietary supplements]," the agency explains. This is "because, unlike drugs that must be proven safe and effective for their intended use before marketing, there are no provisions in the law for FDA to approve dietary supplements for safety before they reach the consumer."

In terms of regulations for food, there are strict guidelines to follow for manufacturing and labeling, including ensuring the ingredients in the product are listed on the label — which the four products containing Viagra/Cialis did not.

What comes next after the FDA warning?

The FDA has given the four companies who were sent the warning letter 15 working days to respond and state "how they will address these issues" or to provide "their reasoning and supporting information as to why they think the products are not in violation of the law."

Should they fail to do so, they may face "legal action, including product seizure and/or injunction."

Shopaax.com issued a voluntary recall of its “Kingdom Honey Royal VIP” because of the undeclared presence of sildenafil, the active ingredient in Viagra. Shopaax.com has posted full recall instructions — including what to do if you have taken the product or need to return the product for a full refund.

MKS Enterprise LLC sent Fatherly via email a press statement that the company is recalling their “Vital Royal Honey VIP Honey” product due to the fact that FDA lab tests found it contained tadalafil, the active ingredient in Cialis. The company also states that they “do not have any stock left.” Whoever purchased the product can return it to their website, wholesealeonline1.com, for a refund.

The FDA asks consumers who use over-the-counter products marketed for sexual enhancement to speak to their doctors before starting any new product. "If a consumer thinks that a product might have caused a reaction or an illness, they should immediately stop using the product and contact their health care provider," the agency warns.