Honey-Based Dietary Supplements Recalled

FDA Recall of Adulterated Supplements Raises Questions About DSHEA Oversight

Lessons from the “Boner Bear” Recall

The FDA’s recent recall of several honey-based “sexual enhancement” supplements illustrates a recurring problem in the dietary supplement marketplace: products marketed as natural remedies that contain undeclared pharmaceutical ingredients.

Pure Vitamins and Natural Supplements, LLC announced a nationwide recall of Boner Bear Honey, Red Bull Extreme, and Blue Bull Extreme after FDA laboratory analysis confirmed the presence of sildenafil and tadalafil, the active pharmaceutical ingredients used in the prescription drugs Viagra® and Cialis®. The ingredients were not listed on the product labels.

Both drugs are approved by FDA only for use under the supervision of a licensed healthcare professional for the treatment of erectile dysfunction. When used improperly or unknowingly, these medications can pose significant health risks, particularly for individuals who take nitrate medications such as nitroglycerin. Combining these drugs with nitrates can cause dangerous drops in blood pressure, which may lead to serious cardiovascular complications.

The products were marketed as single-serve honey supplements intended to enhance sexual performance, packaged in small plastic tubes. No adverse events have been reported to date, but the recall highlights a broader safety concern: consumers may unknowingly ingest prescription drug ingredients when purchasing products labeled as dietary supplements.

A Familiar Enforcement Pattern

FDA has repeatedly warned that adulterated supplements most often appear in three product categories – sexual enhancement products, weight loss supplements, and bodybuilding and performance products.

In many cases, the products contain pharmaceutical ingredients intended to produce noticeable physiological effects. These substances may be undeclared versions of approved drugs or chemically modified analogues designed to avoid detection.

The recall of the honey-based supplements fits squarely within this pattern. While the branding of the product may have drawn attention to its intended use, the underlying regulatory concern is not unusual: supplements that appear to function like drugs may in fact contain undisclosed drug ingredients.

The Regulatory Framework Behind the Problem

One reason these cases continue to appear is the structure of the U.S. dietary supplement regulatory system.

Under the Dietary Supplement Health and Education Act (DSHEA) of 1994, dietary supplements generally do not require FDA premarket approval before entering the market. Manufacturers are responsible for ensuring their products are safe and properly labeled, and FDA typically becomes involved only after a product is already being sold.

As a result, regulators rely heavily on post-market oversight tools, including inspections, laboratory testing, import surveillance, and adverse event reports, to identify adulterated products.

This system allows legitimate manufacturers to bring products to market efficiently, but it also creates opportunities for companies willing to operate outside regulatory boundaries.

Hidden Drug Ingredients and Consumer Risk

The public health concern in these cases extends beyond simple labeling violations.

Consumers purchasing dietary supplements may assume they are ingesting herbal or nutritional ingredients. When pharmaceutical compounds are added without disclosure, individuals may unknowingly expose themselves to medications that interact with prescription drugs, affect cardiovascular function, or produce other unintended physiological effects.

Because sildenafil and tadalafil affect blood pressure, individuals with heart disease, diabetes, hypertension, or other chronic conditions may be particularly vulnerable.

The risk is compounded by the fact that these ingredients are being consumed outside the context of medical supervision.

The Broader Policy Question

Cases like this raise a recurring policy question: how should regulators oversee a marketplace where thousands of new supplement products appear each year, but premarket regulatory review is limited?

FDA enforcement actions and recalls demonstrate that post-market surveillance can identify problematic products. However, the repeated discovery of supplements adulterated with drug ingredients suggests that the underlying regulatory structure may not always prevent such products from reaching consumers in the first place.

For that reason, some policymakers and public health experts have begun to revisit the framework established by DSHEA, particularly as the supplement market has grown dramatically over the past three decades.

Whether future reforms will focus on stronger product listing requirements, expanded testing authority, or other oversight tools remains an open question. But cases like the recent honey supplement recall continue to fuel discussion about whether the current regulatory model remains adequate for today’s marketplace.

For a deeper look at the evolving policy debate, see our recent analysis of proposals for potential DSHEA reform.