WARNING LETTER
Everymarket Inc.
MARCS-CMS 688348 —
August 27, 2024
Product:
Drugs
Recipient:
Recipient Name
Christopher Baton
Everymarket Inc.
2101 E. Terra Lane
O’Fallon
,
MO
63366
United States
cs@everymarket.com
Issuing Office:
Center for Drug Evaluation and Research (CDER)
United States
WARNING LETTER
August 27, 2024
RE: 688348
Dear Mr. Christopher Baton:
This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address https://www.everymarket.com/ in July 2024 and has observed that your website offers the products “Vail-Bon Jie Yang Wan” and “Ossos-Sans” for sale in the United States. In addition, FDA has obtained samples and labeling of your “Vail-Bon Jie Yang Wan” product. As described below, “Vail-Bon Jie Yang Wan” and “Ossos-Sans” are unapproved new drugs introduced or delivered for introduction into interstate commerce in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a) and 331(d). Furthermore, “Vail-Bon Jie Yang Wan” is a misbranded drug under section 502 of the FD&C Act, 21 U.S.C. 352, introduced or delivered for introduction into interstate commerce in violation of section 301(a) of the FD&C Act, 21 U.S.C. 331(a).
FDA confirmed through laboratory analysis that a sample of your “Vail-Bon Jie Yang Wan” contains undeclared dexamethasone and chlorpheniramine.
1
Dexamethasone is a corticosteroid commonly used to treat inflammatory conditions. Corticosteroid use can impair a person’s ability to fight infections and can cause high blood sugar levels, muscle injuries and psychiatric problems. When corticosteroids are taken for a prolonged period, or at high doses, they can suppress the adrenal gland. This hidden drug ingredient may also interact with other medications and significantly increase the risk of adverse events.
Chlorpheniramine is an over-the-counter (OTC) antihistamine used for allergies. Antihistamines may cause drowsiness and affect mental alertness.
Unapproved New Drugs
Your “Vail-Bon Jie Yang Wan” and “Ossos-Sans” products are drugs as defined by section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1) because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or any function of the body. Examples of claims from the labeling, including the outer packaging, that provide evidence of the intended use of these products as drugs include, but may not be limited to, the following:
“Vail-Bon Jie Yang Wan”:
• “Indications : [sic] Urticaria, tinea, itching due to skin diseases, including eczema, pruritus; and serum sickness; and reheumatic [sic] skin itching, itch caused by drug reaction, pruritus universalis, pruritus pregnancy.”
“Ossos-Sans”
2
:
• “Artritis” (English translation: Arthritis)
• “Osteoporosis” (English translation: Osteoporosis)
• “Osteoartritis” (English translation: Osteoarthritis)
• “Fracturas” (English translation: Fractures)
• “Inflamacion” (English translation: Inflammation)
• “Reumos” (English translation: Rheumatisms)
• “Golpes” (English translation: Bruises)
• “Calambres” (English translation: Cramps)
• “Regeneración de cartílago” (English translation: Cartilage Regeneration)
• “Dolores Musculares” (English translation: Muscle Pains)
“Vail-Bon Jie Yang Wan” and “Ossos-Sans” are not generally recognized as safe and effective for the above referenced uses and, therefore, are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p). Subject to certain exceptions not applicable here, a new drug may not be legally introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a). No FDA-approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355 are in effect for these products. Accordingly, the introduction or delivery for introduction into interstate commerce of these products violate sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).
Misbranded Drug
Your “Vail-Bon Jie Yang Wan” product is misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a). Under section 502(a) of the FD&C Act, 21 U.S.C. 352(a), a drug is misbranded if its labeling is false or misleading in any particular. Section 201(n) of the FD&C Act, 21 U.S.C. 321(n), provides that, in determining whether an article’s labeling or advertising “is misleading there shall be taken into account…not only representations made or suggested…but also the extent to which the labeling or advertising fails to reveal facts material in light of such representations.” The labeling for “Vail-Bon Jie Yang Wan” does not declare that the product contains the drug ingredients dexamethasone and chlorpheniramine. The failure to disclose the presence of dexamethasone and chlorpheniramine in the product’s labeling renders “Vail-Bon Jie Yang Wan” misbranded under section 502(a) of the FD&C Act.
The introduction or delivery for introduction into interstate commerce of this misbranded drug is a prohibited act under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).
A list of tainted products discovered by FDA can be found at https://www.fda.gov/consumers/health-fraud-scams/health-fraud-product-database.
Conclusion
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.
Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to correct 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 believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction. Your response should be sent to U.S. Food and Drug Administration, CDER/OC/Office of Unapproved Drugs and Labeling Compliance by email to FDAAdvisory@fda.hhs.gov.
Sincerely,
/S/
CAPT Tina Smith
Director
Office of Unapproved Drugs and Labeling Compliance
Center for Drug Evaluation and Research
Food and Drug Administration
_________________
1
U.S. Food & Drug Administration,
Public Notification: Vail-Bon Jie Yang Wan contains hidden drug ingredients
, (July 10, 2024), https://www.fda.gov/drugs/medication-health-fraud/vail-bon-jie-yang-wan-weianjieyangwan-contains-hidden-drug-ingredients.
2
Previous FDA laboratory analysis of “Ossos-Sans” revealed that it contains the undeclared ingredients diclofenac and methocarbamol. On April 17, 2024, FDA issued a public notification, found at https://www.fda.gov/drugs/medication-health-fraud/ossos-sans-contains-hidden-drug-ingredients, to consumers not to purchase or use “Ossos-Sans.” While the Agency has not sampled and tested this product from your inventory to date, be advised of our serious concern about the safety of this products and that it is your legal responsibility under federal law to ensure this product does not contain any undeclared and potentially harmful ingredients.
Content current as of:
09/03/2024
Regulated Product(s)
Drugs