MKS Enterprise, LLC - 624478 - 07/01/2022

Why It Matters

Undeclared pharmaceuticals in dietary supplements pose serious health risks and expose companies to significant legal liability, prompting tighter regulatory scrutiny across the supplement market.

Key Takeaways

• FDA found undeclared tadalafil in Vital Honey
• Product marketed as food but makes drug claims
• Violates FD&C Act sections 301(ll) and 502(f)(1)
• Misbranding due to lack of usage directions
• Company must respond within 15 working days

Pulse Analysis

The discovery of tadalafil—a prescription erectile‑dysfunction drug—in a honey‑based supplement underscores a growing trend of adulterated nutraceuticals. Consumers seeking natural remedies are increasingly exposed to hidden pharmaceuticals that can interact dangerously with existing medications, especially cardiovascular drugs. FDA’s laboratory testing of Vital Honey illustrates how routine surveillance can uncover such violations, reinforcing the agency’s commitment to protecting public health amid a booming online supplement market.

Under the Federal Food, Drug, and Cosmetic Act, adding a regulated drug to a food product without approval constitutes a prohibited act under section 301(ll). The agency also deemed Vital Honey a "new drug" because the company’s website touted unsubstantiated health benefits, ranging from arthritis prevention to cholesterol reduction. These claims trigger misbranding provisions, as the product lacks adequate directions for safe self‑administration. For e‑commerce sellers, the case highlights the legal peril of blending dietary‑supplement marketing with therapeutic language without FDA clearance.

The broader industry impact is clear: manufacturers must implement rigorous ingredient verification and label compliance programs. Failure to do so can result in costly warning letters, product seizures, and lasting damage to brand reputation. As regulators intensify scrutiny of online supplement sales, companies that proactively audit their supply chains and adhere to FDA guidance will better safeguard consumers and maintain market credibility. Continued vigilance will likely drive stricter enforcement actions, prompting a shift toward greater transparency and scientific substantiation in product claims.

MKS Enterprise, LLC - 624478 - 07/01/2022

MKS Enterprise, LLC · MARCS‑CMS 624478 · July 1, 2022

Delivery Method: Overnight Delivery

Product: Drugs – Food & Beverages

Issuing Office: Center for Food Safety and Applied Nutrition (CFSAN), United States

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WARNING LETTER

July 1, 2022

RE: 624478

Dear Mr. Bhatia,

This letter is to advise you that the U.S. Food and Drug Administration (FDA) obtained a sample of your product Dose Vital Royal Honey VIP Honey (Vital Honey) purchased directly from your website at www.wholesaleonline1.com. FDA also reviewed your website in June 2022. Based on our review of your website and laboratory analysis of your product, FDA has identified serious violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Prohibited Act under Section 301(ll)

FDA confirmed through laboratory analysis that a sample of your Vital Honey contains the undeclared active pharmaceutical ingredient tadalafil, a phosphodiesterase type‑5 (PDE‑5) inhibitor. Tadalafil is the active ingredient in the FDA‑approved prescription drug Cialis, used to treat erectile dysfunction (ED). This undeclared ingredient may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Men with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.

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 a drug approved under section 505 of the FD&C Act [21 U.S.C. 355] has been added, or for which substantial clinical investigations have been instituted and made public. Based on available evidence, FDA has concluded that the prohibition in section 301(ll) applies to tadalafil.¹ FDA is not aware of any evidence that would call into question its conclusion that section 301(ll) of the FD&C Act prohibits the introduction into interstate commerce of any food to which tadalafil has been added.

Your Vital Honey product is a food to which tadalafil has been added. Therefore, the introduction or delivery for introduction into interstate commerce of this product is a prohibited act under section 301(II) of the FD&C Act.

Unapproved New Drug

FDA reviewed your website at www.wholesaleonline1.com in June 2022 and determined you take orders there for the product Vital Honey. In addition to being a food whose introduction or delivery for introduction into interstate commerce is prohibited under section 301(ll) of the FD&C Act, this product is a drug under section 201(g)(1)(B) of the FD&C Act [21 U.S.C. 321(g)(1)(B)], as established by the claims on your website, because it is intended for use in the cure, mitigation, treatment, or prevention of disease. Introducing or delivering this product for such uses violates the FD&C Act.

Examples of website claims that provide evidence that your product is intended as a drug include:

• “Prevent arthritis and multiple sclerosis”

• “Accelerating the healing and consolidation of fractured bones”

• “Lower cholesterol”

• “Alleviate cardiovascular ailments”

• “Remedy liver disease, pancreatic, insomnia, fatigue, ulcers, and digestive and skin disorders”

• “Reduce … anxiety states, insomnia and anorexia”

• “Decreases prostate issues and illnesses in the man’s productive system.”

Your Vital Honey is not generally recognized as safe and effective for the above‑referenced uses and, therefore, the product is a “new drug” under section 201(p) of the FD&C Act [21 U.S.C. § 321(p)]. With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior FDA approval, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. 331(d), 355(a)].

Misbranded Drug

Your product Vital Honey is intended for treatment of one or more diseases that are not amenable to self‑diagnosis or treatment without the supervision of a licensed practitioner. Consequently, it is impossible to write adequate directions for a layperson to use your product safely for its intended purposes. Accordingly, Vital Honey fails to bear adequate directions for its intended use and is misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of this misbranded drug violates section 301(a) of the Act [21 U.S.C. 331(a)].

This letter is not intended to be an all‑inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.

This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action, including, without limitation, seizure and injunction.

Additionally, we have the following comment:

FDA has not conducted a complete review of your inventory. It is your responsibility under the FD&C Act to ensure that products marketed by your firm do not contain undeclared ingredients and comply with all requirements of federal law. A full list of all tainted products discovered by FDA can be found at http://www.accessdata.fda.gov/scripts/sda/sdNavigation.cfm?sd=tainted_supplements_cder. We recommend that you subscribe to our email service at https://public.govdelivery.com/accounts/USFDA/subscriber/new to receive regular notices about tainted products discovered by FDA.

Please notify FDA in writing, within fifteen (15) working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within fifteen (15) working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration.

Your written reply to the above violations should be directed to Kimberly Dutzek with the FDA via email at [email protected]. If you have any questions, you may also email at the same address.

Sincerely,

/S/

Ann M. Oxenham

Director, Office of Compliance

Center for Food Safety and Applied Nutrition

Food and Drug Administration

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¹ FDA approved Cialis™ (containing tadalafil as the active ingredient) as a new drug on November 21, 2003. There is an exception if the substance was marketed in food before the drug was approved or before substantial clinical investigations involving the drug had been instituted. However, based on available evidence, FDA has concluded that this is not the case for tadalafil.