What are the dangers of tainted honey-based sexual enhancement products. How do undisclosed prescription medications in supplements pose health risks. Why is the FDA cracking down on companies selling adulterated honey products for sexual enhancement.

FDA Issues Warning Letters to Companies Selling Adulterated Honey Products

The U.S. Food and Drug Administration (FDA) has taken action against four companies selling honey-based products marketed for sexual enhancement. Laboratory testing revealed these products contain undisclosed active drug ingredients used to treat erectile dysfunction, namely tadalafil (Cialis) and sildenafil (Viagra).

The FDA sent warning letters to the following companies:

• Thirstyrun LLC (also known as U.S. Royal Honey LLC)
• MKS Enterprise LLC
• Shopaax.com
• 1am USA Incorporated dba Pleasure Products USA

These companies are accused of violating federal law by selling products containing active drug ingredients while marketing them as foods. They also made unauthorized claims about treating disease and improving health.

Hidden Drug Ingredients Pose Serious Health Risks

The presence of undisclosed prescription medications in these honey-based products raises significant health concerns. Tadalafil and sildenafil are prescription drugs that should only be used under medical supervision due to potential interactions with other medications.

Do these hidden ingredients interact dangerously with common medications? Yes, tadalafil and sildenafil can interact with nitrates, which are often prescribed for conditions like:

• Diabetes
• High blood pressure
• High cholesterol
• Heart disease

Both nitrates and erectile dysfunction drugs cause blood vessels to dilate. When taken together, they can lead to a dangerous drop in blood pressure. This severely low blood pressure can be life-threatening, potentially causing:

• Inadequate blood flow to vital organs
• Shock
• Irreversible organ damage
• Death

Products Flagged by the FDA

The FDA specifically called out several products in their warning, including:

• Etumax VIP Royal Honey for Him
• Dose Vital Honey for Men
• Secret Miracle Royal Honey for Her
• X-Rated Honey for Men

These products were marketed as sexual enhancement supplements, but contained undisclosed prescription drug ingredients.

FDA’s Response and Consumer Advice

The FDA has requested that the companies respond within 15 working days, outlining how they will address these violations. Failure to comply may result in legal action, including product seizure and/or injunction.

What should consumers do if they’ve purchased these products? The FDA advises:

• Speak with a healthcare provider before trying any over-the-counter product marketed for sexual enhancement
• Check the FDA’s health fraud products database to see if a product has been flagged as potentially hazardous
• Report any adverse reactions through the FDA’s MedWatch program or Safety Reporting Portal

The Dangers of Tainted Supplements

The case of adulterated honey products highlights a broader issue in the supplement industry. Tainted supplements pose significant risks to consumers who may be unaware of hidden ingredients and their potential interactions with other medications or health conditions.

Why are tainted supplements so dangerous?

1. Consumers are unaware of hidden ingredients
2. Undisclosed drugs may interact with other medications
3. Underlying health conditions may be affected
4. Dosages are not controlled or standardized
5. Quality control and safety measures may be lacking

The FDA’s action against these companies underscores the importance of regulatory oversight in the supplement industry to protect public health.

The Appeal and Risks of “Natural” Sexual Enhancement Products

Many consumers are drawn to products marketed as “natural” alternatives to prescription medications for erectile dysfunction. However, this case demonstrates that not all “natural” products are as harmless or unadulterated as they may seem.

Why do some consumers prefer “natural” sexual enhancement products?

• Perception of fewer side effects
• Availability without a prescription
• Desire to avoid discussing sexual health with a doctor
• Lower cost compared to prescription medications
• Belief in traditional or alternative remedies

Despite these perceived benefits, the risks of using unregulated products far outweigh any potential advantages. The presence of hidden drug ingredients negates any claims of being a natural alternative.

The Role of Regulatory Bodies in Protecting Consumers

This incident highlights the crucial role that regulatory agencies like the FDA play in protecting public health. By identifying and taking action against companies selling adulterated products, the FDA helps safeguard consumers from potentially dangerous hidden ingredients.

How does the FDA protect consumers from tainted supplements?

• Conducting laboratory tests on suspicious products
• Issuing public warnings about dangerous products
• Sending warning letters to non-compliant companies
• Maintaining databases of tainted products
• Educating the public about supplement safety
• Enforcing regulations on supplement labeling and marketing claims

While the FDA’s efforts are crucial, consumers must also remain vigilant and informed about the products they purchase and consume.

The Importance of Consulting Healthcare Professionals

The FDA’s warning serves as a reminder of the importance of consulting healthcare professionals before using any sexual enhancement products or supplements. Healthcare providers can offer valuable guidance on safe and effective treatments for erectile dysfunction and other sexual health concerns.

Why is it crucial to consult a healthcare professional about sexual health issues?

• Proper diagnosis of underlying conditions
• Personalized treatment recommendations
• Assessment of potential drug interactions
• Monitoring for side effects and complications
• Access to regulated, safe medications when appropriate
• Addressing overall sexual health and well-being

By seeking professional medical advice, consumers can avoid the risks associated with unregulated and potentially dangerous products.

The Broader Implications for the Supplement Industry

The discovery of hidden drug ingredients in honey-based sexual enhancement products raises questions about the broader supplement industry. While many supplements are safe and beneficial when used appropriately, this incident underscores the need for stricter regulations and oversight.

What are the challenges facing the supplement industry?

• Limited pre-market testing requirements
• Difficulty in monitoring all products on the market
• Prevalence of misleading marketing claims
• Consumer misconceptions about supplement safety and efficacy
• Globalization of the supplement supply chain

As consumers become more aware of these issues, there may be increased pressure for reform and greater transparency in the supplement industry.

The Science Behind Erectile Dysfunction Medications

To understand the risks associated with hidden erectile dysfunction drugs in supplements, it’s helpful to examine how these medications work. Tadalafil (Cialis) and sildenafil (Viagra) belong to a class of drugs called phosphodiesterase type 5 (PDE5) inhibitors.

How do PDE5 inhibitors treat erectile dysfunction?

1. They inhibit the PDE5 enzyme, which breaks down cyclic guanosine monophosphate (cGMP)
2. Increased cGMP levels lead to smooth muscle relaxation in blood vessels
3. This relaxation improves blood flow to the penis
4. Enhanced blood flow facilitates and maintains erections

While effective for many men, these medications can have side effects and interactions, which is why they require a prescription and medical supervision.

The Global Impact of Tainted Supplements

The issue of adulterated sexual enhancement products extends beyond the United States. The global nature of the supplement industry means that tainted products can easily cross borders, posing risks to consumers worldwide.

What challenges does the international supplement market face?

• Varying regulatory standards between countries
• Difficulties in tracking products across borders
• Language barriers in product labeling and warnings
• Cultural differences in attitudes toward supplements and traditional remedies
• Economic incentives for producing and selling adulterated products

International cooperation and harmonization of regulations are crucial to addressing this global health concern.

The Future of Sexual Enhancement Products

As awareness of the risks associated with tainted supplements grows, the market for sexual enhancement products may evolve. There may be increased demand for transparently produced, clinically tested products that offer natural alternatives to prescription medications.

What might the future hold for sexual enhancement products?

• Greater emphasis on clinical studies and evidence-based formulations
• Improved regulatory oversight and enforcement
• Increased consumer education about supplement safety
• Development of new, safer alternatives to current medications
• Integration of sexual health products with overall wellness approaches

As the industry adapts to these challenges, consumers may benefit from safer and more effective options for addressing sexual health concerns.

The Role of Consumer Education in Supplement Safety

Educating consumers about the potential risks of dietary supplements, particularly those marketed for sexual enhancement, is crucial for public health. Informed consumers are better equipped to make safe choices and avoid potentially dangerous products.

How can consumer education about supplement safety be improved?

• Enhancing health literacy in schools and communities
• Providing clear, accessible information about supplement regulations
• Encouraging open discussions about sexual health with healthcare providers
• Promoting awareness of reliable sources for supplement information
• Teaching critical evaluation of marketing claims and product labels

By empowering consumers with knowledge, we can reduce the risks associated with tainted supplements and promote overall health and well-being.

The Intersection of Traditional Remedies and Modern Medicine

The case of adulterated honey products highlights the complex relationship between traditional remedies and modern pharmaceuticals. Many consumers are drawn to products that claim to harness the power of natural ingredients, but the addition of hidden drugs complicates this narrative.

How can we navigate the intersection of traditional and modern approaches to sexual health?

• Encouraging research into the efficacy of traditional remedies
• Promoting transparency in product formulations
• Integrating traditional knowledge with modern scientific understanding
• Developing regulations that respect cultural practices while ensuring safety
• Fostering dialogue between practitioners of traditional and modern medicine

By finding a balance between honoring traditional practices and ensuring product safety, we can create a more holistic approach to sexual health and wellness.

The Economic Impact of Tainted Supplements

The presence of hidden drug ingredients in supplements not only poses health risks but also has significant economic implications. The supplement industry is a multi-billion dollar market, and the discovery of tainted products can have far-reaching consequences.

What are the economic impacts of tainted supplements?

• Loss of consumer trust in the supplement industry
• Increased costs for regulatory compliance and testing
• Potential legal liabilities for companies selling adulterated products
• Market shifts towards more reputable brands and products
• Investment in new technologies for detecting hidden ingredients

Addressing the issue of tainted supplements is not only a matter of public health but also crucial for the long-term sustainability and credibility of the supplement industry.

The Psychological Aspects of Sexual Enhancement Products

The popularity of sexual enhancement products, including those marketed as natural alternatives, reflects broader societal attitudes towards sexual performance and masculinity. Understanding the psychological factors that drive consumers to seek out these products is crucial for addressing the issue comprehensively.

What psychological factors influence the use of sexual enhancement products?

• Societal pressure to meet certain standards of sexual performance
• Anxiety about sexual inadequacy or dysfunction
• Desire to improve intimate relationships
• Cultural beliefs about virility and masculinity
• Impact of media and advertising on perceptions of sexual norms

Addressing these psychological aspects alongside physical health concerns can lead to more holistic approaches to sexual well-being and reduce reliance on potentially dangerous products.

Honey marketed for ‘sexual enhancement’ could be dangerous, FDA warns

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The FDA called out several companies for selling honey-based products that contained drug active ingredients.
(Image credit: Javier Zayas Photography via Getty Images)

Four companies selling honey-based products containing unlisted active drug ingredients have received warning letters from the U.S. Food and Drug Administration (FDA). The companies promoted these products as sexual enhancers, and laboratory testing revealed that they contained active ingredients found in drugs for erectile dysfunction — namely, tadalafil (Cialis) and sildenafil (Viagra), the FDA announced Tuesday (July 12).  

Tadalafil and sildenafil may be used only under the supervision of a licensed health care professional, in part because they interact with common prescription medications known as nitrates. Nitrates are commonly taken by people with diabetes, high blood pressure, high cholesterol and heart disease and work by causing blood vessels to dilate, thus increasing the flow of blood and oxygen to the heart, according to the medical database StatPearls.

Tadalafil and sildenafil also cause blood vessels to dilate, so if someone takes these drugs at the same time as nitrates, their blood pressure may plummet to dangerously low levels. Severely low blood pressure can be life-threatening because vital organs may not receive an adequate supply of blood and oxygen, and this deficit can lead to shock, irreversible organ damage and death, according to the Mayo Clinic.

“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,” Judy McMeekin, the FDA’s associate commissioner for regulatory affairs, said in the agency’s statement.  

Related: Men who took erectile-dysfunction drug had blue-tinted vision for days 

“Products marketed with unidentified ingredients may be dangerous and, in some cases, deadly to consumers,” she said. “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.”

The four companies that received warning letters include Thirstyrun LLC (also known as U.S. Royal Honey LLC), MKS Enterprise LLC, Shopaax.com, and 1am USA Incorporated dba Pleasure Products USA. The FDA said these companies violated federal law by allegedly selling active drug ingredients in products marketed as foods and by making unauthorized claims that their products treat disease or improve health.

RELATED STORIES

Specifically, the products — including Etumax VIP Royal Honey for Him, Dose Vital Honey for Men, Secret Miracle Royal Honey for Her and X-Rated Honey for Men — were promoted as sexual enhancement products.

“The FDA has requested responses from the companies within 15 working days stating how they will address these issues or providing their reasoning and supporting information as to why they think the products are not in violation of the law,” the FDA statement reads. “Failure to promptly address the violations may result in legal action, including product seizure and/or injunction.”

The FDA encourages consumers to speak with a health care provider before trying any over-the-counter product marketed for sexual enhancement. Consumers can also refer to the FDA’s health fraud products database to check if a product has been flagged as potentially hazardous. 

Consumers and health care providers can report adverse reactions related to specific products through the FDA’s MedWatch program or the Safety Reporting Portal. 

Originally published on Live Science. 

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Nicoletta Lanese is the health channel editor at Live Science and was previously a news editor and staff writer at the site. She holds a graduate certificate in science communication from UC Santa Cruz and degrees in neuroscience and dance from the University of Florida. Her work has appeared in The Scientist, Science News, the Mercury News, Mongabay and Stanford Medicine Magazine, among other outlets. Based in NYC, she also remains heavily involved in dance and performs in local choreographers’ work.

Royal Honey for Him, X Rated Honey for Men Tainted, Warns FDA

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

The Food and Drug Administration (FDA) 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.

In a press release on Tuesday, the FDA said 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.

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 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.

Erectile Dysfunction

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, to NBC News.

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

BETTER SEX

A Growing Danger

These warnings come as the FDA’s list of tainted sexual enhancement products grows. In April, the FDA warned of close to a dozen other honey-based sexual supplements with 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.

“It’s extremely important for men experiencing erectile dysfunction to talk to a doctor about their symptoms,” says Jack 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.”

Is low testosterone sabotaging your performance? Get answers with Hone’s comprehensive at-home hormone test. If you qualify, treatments for low T and ED are delivered right to your door. 

Etumax Royal Honey for him Etumax Royal Honey Vip 12X10 g

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