FDA Issues Warning Letter to Everymarket for Drug Claims

The US Food and Drug Administration (FDA) issued a Warning Letter to Everymarket Inc., O’Fallon, MO, for making drug claims. Specifically, FDA reviewed the company’s website and charged Everymarket’s “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 Vail-Bon Jie Yang Wan contains undeclared dexamethasone and chlorpheniramine. Dexamethasone is a corticosteroid commonly used to treat inflammation. FDA notes that 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, according to FDA.

Chlorpheniramine is an over-the-counter (OTC) antihistamine used for allergies. Antihistamines may cause drowsiness and affect mental alertness.

Unapproved New Drugs

According to FDA, 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:
• “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)

According to FDA, 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).

FDA said Vail-Bon Jie Yang Wan 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.