The FDA issued warnings to companies found illegally selling honey-based products that could endanger general consumers in July 2022. These products pose significant health risks because they are linked to active drug ingredients such as sildenafil (Viagra) and tadalafil (Cialis). Both of these medications are FDA-approved for erectile dysfunction in men. While these drugs are commercially available and can be compounded into other dosage forms, patients’ use of these medications is determined by healthcare professionals; thus, honey products containing these undeclared ingredients are illegal.
Four existing companies were issued warning letters, each of which produced food containing tadalafil or sildenafil (with the possibility of both). Citations were issued for the presence of unapproved new drugs because their use was intended to cure, treat, or prevent a disease without proper FDA approval. Some of the products were identified as dietary supplements, despite the fact that the two active ingredients did not fit that description. Over 10 honey-based products were discovered to contain these hidden active pharmaceutical ingredients (APIs)—a medication component that is used to achieve desired health effects.
Both sildenafil citrate and tadalafil belong to a class of drugs known as phosphodiesterase-5 inhibitors. While sildenafil citrate is primarily used to treat erectile dysfunction in men, tadalafil can also be used to treat benign prostatic hyperplasia. Common side effects include headache, flushing, dyspepsia, and back and limb pain. While both of these medications are commercially available in solid dosage forms, combining them with other products without proper testing increases the risk of drug interactions and other health risks. These ingredients, in particular, can interact with other prescription medications such as nitrates, resulting in a rapid drop in blood pressure levels. Patients with diabetes, high cholesterol, high blood pressure, or heart disease are common users of nitrates or nitrate-containing medications.
Both sildenafil and tadalafil are currently available commercially as tablets with doses ranging from 25 mg to 100 mg and 2.5 mg to 20 mg, respectively. Patients, however, may be unable to use this type of solid dosage form, entailing for the need of medication modification.
Extemporaneous compounding can be used to create other viable dosage forms, such as rapid-dissolving tablets or medical lozenges. Extemporaneous compounding is the act of preparing a medication that is specifically tailored to the needs of a patient. Individual patient needs can be met by using approved amounts of the active ingredient to make other dosage forms. However, if some companies mixed these APIs into their honey-based products, this would not be considered extemporaneous compounding.
These warnings request that the companies address the concerns and provide additional evidence to demonstrate that the products do not violate the law. To assist consumers in identifying potentially dangerous products, the FDA continues to monitor and update its health fraud products database. These products can be identified and removed from sources to prevent them from being sold. All consumers are strongly advised to discontinue use of a product immediately if a direct causative reaction or illness is suspected.
The content contained in this article is for informational purposes only. The content is not intended to be a substitute for professional advice. Reliance on any information provided in this article is solely at your own risk.
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