What the FDA's warning about Miracle Power of King Kong Honey means for your brand

What exactly did the FDA say about Miracle Power of King Kong Honey?

On its website, the FDA posted a public notification dated September 25, 2026, advising consumers not to purchase or use Miracle Power of King Kong Honey. The product is promoted and sold for sexual enhancement on various websites, including usroyalhoney.com, and possibly in some retail stores.

The agency's laboratory analysis confirmed the product contains tadalafil, which is not listed on the product label. Tadalafil is the active ingredient in the FDA-approved prescription drug Cialis, used to treat erectile dysfunction.

The notification explains that tadalafil may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. The FDA notes this is especially concerning for people with diabetes, high blood pressure, high cholesterol, or heart disease, who commonly take nitrate-containing medications.

Is this a dietary supplement enforcement action?

The FDA classifies this as a medication health fraud notification. The agency states these notifications inform the public of products 'potentially marketed as dietary supplements or conventional foods with hidden ingredients' and typically promoted for sexual enhancement, weight loss, pain relief, and body building, often represented as being all natural.

The notification appears under both 'Dietary Supplements' and 'Drugs' regulated product categories. The source text does not make a legal determination that the product is an unapproved drug or that it is not a dietary supplement. It describes a product that was marketed a certain way and found to contain an undeclared pharmaceutical ingredient.

What does the notification NOT address?

The FDA does not state that it has taken regulatory action against the brand owner or manufacturer beyond this public advisory. The notification does not mention any recall, seizure, or injunction.

The text is silent on whether the agency has tested or flagged other honey products or products from the same source. It does not discuss whether usroyalhoney.com sells other items or whether those items are under investigation.

The alert also does not address how a retailer like Amazon might handle the product, what document reviewers will request from other supplement brands, or how this affects category-level enforcement patterns. The source is limited to a single product finding.

Does this change what a supplement brand needs to do?

The notification does not impose new regulatory requirements on other supplement brands. If your products do not contain undeclared pharmaceutical ingredients, the FDA's advisory does not directly change your obligations.

What the notice does reinforce is a pattern: the agency publicly flags products when its laboratory analysis finds a hidden drug ingredient not listed on the label. A sensible step is to confirm with your contract manufacturer that every ingredient in your product appears on the label, and that your identity testing and finished product testing cover what is supposed to be there and what is not.

If your brand sells products in categories the FDA calls out in these alerts—sexual enhancement, weight loss, pain relief, body building—it is especially important that your Certificates of Analysis align with your label claims. A buyer or platform reviewer who sees this category draw enforcement attention may scrutinize documentation for these product types more closely.

What should a brand that sells honey or sexual enhancement products consider?

First, review your label. The FDA's notification repeatedly emphasizes that the tadalafil was 'not listed on the product label.' If a product you sell makes sexual enhancement claims, a sensible step is to verify that every active ingredient appears on your Supplement Facts panel and that none are prescription drug ingredients.

Second, consider your supplier relationships. The product was sold on usroyalhoney.com and possibly in some retail stores. If you source private-label honey products or sexual enhancement formulas from unfamiliar suppliers, you may want to ask for a full list of ingredients used and confirm that your testing covers potential adulterants common in the category.

Third, the FDA encourages health care professionals and consumers to report adverse events to its MedWatch program. If your brand receives a consumer report of an unexpected reaction, the serious adverse event reporting requirements under 21 CFR Part 111 apply to the brand owner whether or not you manufactured the product.

What does the FDA want consumers to do?

The agency's advice is straightforward: do not purchase or use this product. For anyone who has used it and experienced a side effect, the FDA directs consumers and health care professionals to report adverse events through the MedWatch Safety Information and Adverse Event Reporting Program, either via the online form or by fax.

The notification also includes a broader caution: consumers should exercise caution before purchasing products typically promoted for sexual enhancement, weight loss, pain relief, and body building that are often represented as being all natural. The FDA notes it is unable to test and identify all products marketed as dietary supplements that have potentially harmful hidden ingredients.

How this fits into the larger enforcement picture

This notification is one of several categories the FDA maintains under medication health fraud: sexual enhancement and energy product notifications, weight loss product notifications, pain and arthritis product notifications, and sleep, skin, bodybuilding and other product notifications. Each follows a similar pattern—laboratory analysis finds an undeclared active pharmaceutical ingredient, and the agency advises the public not to use the product.

For a brand owner, the pattern is worth noting. The FDA appears to target products that make drug-like claims (sexual enhancement, weight loss) yet are marketed as supplements or conventional foods, especially those represented as 'all natural.' The agency's laboratory testing capacity is finite, as the notification acknowledges, but its public advisories signal clear areas of focus.

Frequently asked questions

Did the FDA say Miracle Power of King Kong Honey is illegal?

The FDA did not use the word illegal or make a legal determination in this notification. It is a public health advisory stating the product contains a hidden drug ingredient not on the label and advising consumers not to use it.

Does this notification apply to other honey-based sexual enhancement products?

No. The notification names only one product: Miracle Power of King Kong Honey. The FDA is silent on whether it has tested or flagged other honey products.

What should I do if my brand sells a product in the sexual enhancement category?

Confirm that every ingredient in your product appears on the label and that none are prescription drug ingredients. Review testing documentation to ensure it covers what should be there and what should not.

Does this change Amazon's documentation requirements for supplements?

The FDA notification does not mention Amazon or any retailer. Amazon's requirements are separate. If you sell in a category that draws FDA enforcement attention, your listing documentation may receive closer review, but that is not stated in this notification.

Where can I report a problem with a product like this?

The FDA directs reports to its MedWatch Safety Information and Adverse Event Reporting Program. You can complete and submit the online form at the FDA's MedWatch site or download the form and fax it to 1-800-FDA-0178.

Related guides

• What do FDA warning letters to supplement firms actually cite?
• Serious adverse event reporting: what a supplement brand is required to do
• What is the '100 percent' identity testing rule under 21 CFR Part 111?