WARNING LETTER
MKS Enterprise, LLC
MARCS-CMS 624478 —
July 01, 2022
Delivery Method:
Via Overnight Delivery
Product:
Drugs
Food & Beverages
Recipient:
Recipient Name
Satish Bhatia
MKS Enterprise, LLC
59 Paulison Ave. #13
Passaic
,
NJ
07055
United States
mks@wholesaleonline1.com
sam77usa@gmail.com
Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)
United States
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, which is 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 has been added a drug approved under section 505 of the FD&C Act [21 U.S.C. 355] or for which substantial clinical investigations have been instituted and for which the existence of such investigations has been 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 of which the 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. As explained further below, introducing or delivering this product for introduction into interstate commerce for such uses violates the FD&C Act.
Examples of some of the website claims that provide evidence that your product is intended for use 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 [sic] 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 approval from FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. 331(d), 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.
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. Therefore, 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, therefore, the product 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 CFSANResponse@fda.hhs.gov. If you have any questions, you may also email at CFSANResponse@fda.hhs.gov.
Sincerely,
/S/
Ann M. Oxenham
Director
Office of Compliance
Center for Food Safety and Applied Nutrition
Food and Drug Administration
___________________________
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 the 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.
Content current as of:
07/12/2022
Regulated Product(s)
Drugs
Food & Beverages