IBSPOT.com Inc.

This letter concerns your firm’s distribution of “Taoscare Motion Sickness Patch” and “Navabelle Motion Sickness Patches” products that violate the Federal Food, Drug, and Cosmetic Act (the “FD&C Act”). As discussed further below, your firm is responsible for introducing or delivering for introduction into interstate commerce these products, which are unapproved new drugs under section 505(a) of the FD&C Act, 21 U.S.C. 355(a). Furthermore, these products are misbranded drugs under section 502(a) of the FD&C Act, 21 U.S.C. 352(a). As explained further below, introducing or delivering these products for introduction into interstate commerce is prohibited under sections 301(a), 301(d), and 505(a) of the FD&C Act, 21 U.S.C. 331(a), 331(d), and 355(a).

FDA purchased “Taoscare Motion Sickness Patch” and “Navabelle Motion Sickness Patches” products through your website, www.ibspot.com. These products were introduced or delivered for introduction into interstate commerce by IBSPOT.com.1 FDA confirmed through laboratory analyses that “Taoscare Motion Sickness Patch” and “Navabelle Motion Sickness Patches” purchased on www.ibspot.com contained the ingredients diphenhydramine, diphenhydramine N-oxide, and diclofenac, which are not listed on the product labels.

“Taoscare Motion Sickness Patch” and “Navabelle Motion Sickness Patches” 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 from your product labeling that provide evidence of the intended use (as defined in 21 CFR 201.128) of the products as drugs include, but may not be limited to, the following:

Images of a plane, boat/ship, train, and bus

“Motion Sickness Patch”

“Fast Acting”

“Anti-Nausea Fast”

“Non-Drowsy”

“72h LONG EFFECT”

“The patch can be used behind the ears and on the navel at the same time if motion sickness is serious.”

Images of a plane, boat/ship, train, and car

“MOTION SICKNESS PATCHES”

“Anti-Nause Fast” [sic]

“Non-Drwsy” [sic]

“INDICATIONS:Relieve the vomiting, nausea, dizziness, anorexia, and other sickness symptoms caused by taking cars, ships, planes, trains, and other means of transport.”

“Anti-Nausea Relief Patches”

“Taoscare Motion Sickness Patch” and “Navabelle Motion Sickness Patches” are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the above-described conditions prescribed, recommended, or suggested in their labeling. With certain exceptions not applicable here, new drugs may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in section 505(a) of the FD&C Act, 21 U.S.C. 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, these products are unapproved new drugs and the introduction or delivery for introduction into interstate commerce of these products violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).

In addition, “Taoscare Motion Sickness Patch” and “Navabelle Motion Sickness Patches” are 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 respective labeling for “Taoscare Motion Sickness Patch” and “Navabelle Motion Sickness Patches” does not declare that the products contain the ingredients diphenhydramine, diphenhydramine N-oxide, or diclofenac. With the omission of these ingredients on the label, consumers may not be able to determine whether the products are appropriate for them to use due to, for example, potential drug allergies or interactions. The failure to disclose these ingredients in the products’ labeling renders “Taoscare Motion Sickness Patch” and “Navabelle Motion Sickness Patches” misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a).

The introduction or delivery for introduction into interstate commerce of these misbranded drugs is a prohibited act under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).

The violations cited in this letter are 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 lead to regulatory or 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. Please include your firm name and the unique identifier “715657” in the subject line of the email.