MD, PhD, MAE, FMedSci, FRSB, FRCP, FRCPEd.

The interest in the medicinal properties of honey is lively. A recent review, for instance, concluded that honey is a safe natural substance, effective in the inhibition of bacterial growth and the treatment of a broad range of wound types, including burns, scratches, diabetic boils (Skin abscesses associated with diabetic), malignancies, leprosy, fistulas, leg ulcers, traumatic boils, cervical and varicose ulcers, amputation, burst abdominal wounds, septic and surgical wounds, cracked nipples, and wounds in the abdominal wall. Honey comprises a wide variety of active compounds, including flavonoids, phenolic acid, organic acids, enzymes, and vitamins, that may act to improve the wound healing process. Tissue-engineered scaffolds have recently attracted a great deal of attention, and various scaffold fabrication techniques are being researched.

But there is also reason to be cautious. The U.S. Food and Drug Administration (FDA) posted warning letters to four companies for illegally selling honey-based products that may pose a significant health risk to consumers. The FDA’s laboratory testing found that product samples contained active drug ingredients not listed on the product labels, including the active drug ingredients found in Cialis (tadalafil) and Viagra (sildenafil), which are FDA approved drugs used to treat men with erectile dysfunction. Sildenafil and tadalafil are restricted to use under the supervision of a licensed health care professional. These undeclared ingredients may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels. People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.

“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., “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.”

Today’s warning letters outline how companies violated federal law by selling active drug ingredients in products marketed as foods, like honey, and by making unauthorized claims that their products treat disease or improve health. These products are promoted and sold for sexual enhancement on various websites and online marketplaces, and possibly in some retail stores.

The warning letters were issued to:

Companies marketing food products containing tadalafil and/or sildenafil violate federal law. Some of the products cited in the warning letters are also unapproved new drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease and they lack FDA approval. In some cases, product claims reference diseases that can only be diagnosed or treated under medical supervision. Additionally, some products cited in the warning letters are represented as dietary supplements even though tadalafil and sildenafil products are excluded from the dietary supplement definition.
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. Failure to promptly address the violations may result in legal action, including product seizure and/or injunction.

Consumers using or considering using any over-the-counter product marketed for sexual enhancement should talk to a health care professional first, as some ingredients may interact with medications or dietary supplements. The FDA’s health fraud products database can help consumers identify nearly 1,000 of these potentially dangerous products.

The FDA previously warned consumers about more than 10 honey-based products containing hidden drug ingredients. The FDA’s laboratory testing found that product samples contained undeclared active ingredients, including sildenafil and tadalafil. The agency also previously warned consumers to avoid products with hidden drug ingredients sold through Amazon, eBay, Walmart and other retailers. The FDA is committed to protecting consumers by identifying and removing these potentially dangerous products from the market and urges stores, websites, and online marketplaces to stop selling these products.

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 FDA also encourages health care providers and consumers to report adverse reactions associated with FDA-regulated products to the agency using MedWatch or the Safety Reporting Portal.

9 Responses to Honey-based products that pose a significant health risk

  • Typical, now honey is “not safe and effective(TM)”

    • you seem to be the only one making this claim, OB!

    • Even naturally occuring honey can be toxic if bees consume pollen fron certain flowers, for example;

      https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2720281/
      https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9080652/
      https://www.researchgate.net/publication/309693828_The_Effect_of_Rhododendron_Honey_on_Mice_Liver_Tissue

      While most honey is likely to be fine (although some cheap honeys are blended with cheap sugr syrups) producers should take care with regard to the flowers in their area that the bees may visit.

      The very mildly hallucinogenic honey created by bees visiting certain species of rhododendrons is sold online and in various territories as an aphrodisiac and health tonic (Mad Honey) however it is toxic and, rarely, potentially lethal if too much is consumed.

      https://pubs.rsc.org/en/content/articlehtml/2018/ra/c8ra01924j

      Just because something is natural does not mean it is not toxic. Nature is full of poisonous plants and animals and “natural goodness” has to be one of the most over-used, misleading tems ever used in food marketing.

      • louise on Saturday 30 July 2022 at 14:31 said:
        “Even naturally occurring honey can be toxic if bees consume pollen from certain flowers, for example… ”

        Likewise all existing things, from water to space rockets: all have risk and by delimiting the context aply/inaply, can be *proved* to be “safe” or “deadly” e.g. “the poison is/ain’t the dose” for wide-enough-range / too-narrow-range.

        The FDA “calls for xyz, because of abc…”, for control, not for public benefit, but for its own increase in power, in the name of “safe and effective(™).” the protection racket of for-you-own-good (we control you more).

        • “The FDA “calls for xyz, because of abc…”, for control, not for public benefit, but for its own increase in power, in the name of “safe and effective(™).” the protection racket of for-you-own-good (we control you more).”
          Oh, yeah?
          Or perhaps you are just a trifle paranoid?

      • There’s also a small risk of botulism.

        I do wonder where these Clostridium spores come from – they’re anaerobic bacteria, so it seems unlikely that they come from the original plant nectar. Maybe they can survive in the bees’ gut?

        • Richard Rasker wrote “I do wonder where these Clostridium spores come from…”

          QUOTE
          The contamination level of C. botulinum spores could be dependent on the harvesting region of the honey samples and on hygienic aspects of the entire honey harvest process. According to Nevas et al. [19], the most influential factors on the presence of C. botulinum spores are: extractor size, wearing the same footwear outdoors and in the extraction room, the availability of hand-washing facilities in the extraction room, and the presence of C. botulinum in soil samples. The variability in phenotypic features among the strains of this pathogen, the silent bont genes, and the high probability of toxin gene loss in culture process (through the subsequent culture passages) beset C. botulinum detection with difficulties.

          Grenda, T., Grabczak, M., Sieradzki, Z., Kwiatek, K., Pohorecka, K., Skubida, M., & Bober, A. (2018). Clostridium botulinum spores in Polish honey samples.
          Journal of veterinary science, 19(5), 635–642.
          https://doi.org/10.4142/jvs.2018.19.5.635
          END OF QUOTE

  • Maybe the bees just hate us. After all they do show evidence of intelligence.

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