FDA Issues Warning Letters to Companies Selling Honey-Based Food Products That Contain Illegal Ingredients

On July 12, 2022, the U.S. Food and Drug Administration (FDA) issued warning letters to four companies selling honey-based products that were tainted with hidden active drug ingredients. These products were marketed as food, but laboratory testing conducted on samples detected the presence of ingredients that meet FDA’s drug definition. These ingredients include the active drug ingredients found in Cialis (tadalafil) and Viagra (sildenafil), which are drugs that FDA has approved for use in the treatment of erectile dysfunction.

Based on FDA’s review of the companies’ marketing materials as well as results from laboratory analysis, the products cited in the warning letters are in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

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Read on to learn about the affected products’ claims, the dangers of hidden ingredients, and FDA’s response to companies.

Undeclared Drug Ingredients

Companies that received the warning letters have been distributing food products, such as honey, that contain undeclared drug ingredients. FDA states: “Subject to a limited exception, it is a prohibited act under section 301(ll) of the FD&C Act [21 U.S.C. 331(II)] to introduce or deliver for introduction into interstate commerce any food to which has been added a drug approved under section 505 of the FD&C Act [21 U.S.C. 355]”.

FDA issued warning letters to the following companies:

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

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, but do not have FDA approval. If a company markets a product as one that is intended to diagnose, cure, mitigate, treat or prevent a disease, FDA regulates it as a drug, even if the product is marketed as a food.

Some of the cited products reference diseases that require a professional medical diagnosis or treatment. Additionally, some products containing tadalafil and sildenafil are being marketed as dietary supplements, but FDA solely regulates products containing these ingredients as drugs.

Potential Dangers of Hidden Active Drug Ingredients

Sildenafil and tadalafil can only be used under the supervision of a licensed health care professional. If a consumer is taking prescription drugs containing nitrates, consuming sildenafil or tadalafil may cause a dangerous drop in blood pressure, as these ingredients may interact with nitrates. People with diabetes, high blood pressure, high cholesterol, or heart disease often consume nitrates.

FDA has requested that the companies that received the warning letters respond 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.” If companies do not rectify the cited violations, their products may be subject to seizure or injunction.

Get assistance with FDA compliance.

Registrar Corp’s Regulatory Specialists help companies comply with FDA requirements.

For assistance with FDA regulatory requirements, call: +1-757-224-0177, email: info@registrarcorp.com, or chat with a Regulatory Advisor 24-hours a day: www.registrarcorp.com/livechat.

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