
Undeclared prescription drugs in over‑the‑counter supplements pose serious health risks and undermine consumer trust in the dietary‑supplement market. The alert highlights regulatory gaps that could affect public safety and industry credibility.
The surge of so‑called "natural" sexual‑enhancement products has outpaced regulatory oversight, prompting the FDA to intensify testing of suspect items. Products like Boner Bears Chocolate are marketed on niche e‑commerce sites and sometimes appear in brick‑and‑mortar stores, blurring the line between dietary supplements and prescription medicines. This environment creates opportunities for manufacturers to embed pharmaceutical actives, exploiting consumer demand for quick results while evading the rigorous approval process required for drugs such as sildenafil.
Hidden sildenafil presents acute medical dangers, especially for individuals taking nitrate‑based heart medications. The drug can precipitate a sudden drop in blood pressure, leading to dizziness, fainting, or even life‑threatening cardiovascular events. Because the ingredient is not disclosed, users cannot assess contraindications, and health‑care providers may be unaware of the source of adverse symptoms. The FDA’s warning underscores the importance of transparent labeling and the need for clinicians to inquire about over‑the‑counter supplements during patient evaluations.
For consumers, vigilance is essential. Checking product claims against FDA databases, reading ingredient lists carefully, and reporting unexpected side effects through MedWatch can help curb the spread of adulterated supplements. The broader industry implication is a call for stricter enforcement of the Dietary Supplement Health and Education Act, coupled with increased public education about the risks of unverified enhancement products. Strengthening oversight will protect public health and restore confidence in legitimate supplement offerings.
[2‑13‑2026]
The Food and Drug Administration is advising consumers not to purchase or use Boner Bears Chocolate, a product promoted and sold for sexual enhancement on various websites, including lockoutsupplements.com, and possibly in some retail stores.

FDA laboratory analysis confirmed that Boner Bears Chocolate contains sildenafil not listed on the product label.
Sildenafil is the active ingredient in the FDA‑approved prescription drug Viagra, used to treat erectile dysfunction. FDA approval of Viagra is restricted to use under the supervision of a licensed health‑care professional. This undeclared ingredient 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.
Health‑care professionals and consumers should report adverse events or side effects related to the use of this product to FDA’s MedWatch Safety Information and Adverse Event Reporting Program:
Complete and submit the report online at the MedWatch Online Voluntary Reporting Form, or
Download and complete the form, then submit it via fax at 1‑800‑FDA‑0178.
This notification is to inform the public of products potentially marketed as dietary supplements or conventional foods with hidden drug ingredients and chemicals. These products are typically promoted for sexual enhancement, weight loss, pain relief and body building and are often represented as being all natural. Consumers should exercise caution before purchasing these products.
FDA is unable to test and identify all products marketed as dietary supplements that have potentially harmful hidden ingredients.
For more information, see:
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