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WARNING LETTER

November 18, 2019

RE: 590707

Dear Ms. Saunders:

This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your websites at the Internet addresses www.xtremoplex.com and www.detoxoplex.com both of which redirect to www.ephbiotech.com in August 2019 and has determined that you take orders there for various products, including but not limited to, “Detoxoplex,” “Sinoplex” and “Migrenza.” FDA has determined that these products are unapproved new drugs sold 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, your “Detoxoplex” product is a misbranded drug under section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1). As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the FD&C Act. You can find the FD&C Act and FDA regulations through links on FDA’s home page at www.fda.gov.

On October 26, 2017, the Acting Secretary of the Department of Health and Human Services, under section 319 of the Public Health Service Act, 42 U.S.C. 274d, determined that a public health emergency exists nationwide involving the opioid crisis. As described in more detail below, you market “Detoxoplex” for the treatment or cure of opioid withdrawal symptoms. However, this product has not been determined by FDA to be safe and effective for these uses. Further, this unproven treatment could cause patients to forgo or delay FDA-approved treatments for opioid addiction and withdrawal. The marketing and sale of unapproved opioid addiction treatment products is a potentially significant threat to the public health. Therefore, FDA is taking measures to protect consumers from products that, without approval by FDA, claim to diagnose, mitigate, prevent, treat or cure opioid addiction.

Unapproved New Drugs and Misbranded Drugs

Claims on your website and/or product labels establish that your “Detoxoplex,” “Sinoplex” and “Migrenza” 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, including opiate withdrawal, and/or because they are intended to affect the structure or function of the body. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the FD&C Act.

Examples of claims observed on the website where you take orders, www.ephbiotech.com, that establish the intended use of your products include, but may not be limited to the following:

On the webpage titled “Detoxoplex”:

    • “Detoxoplex Withdrawal Relief”
    • “[R]educing: symptoms typically associated with withdrawal from opioid use.”

On the webpage titled “Sinoplex”:

    • “[R]educing: symptoms commonly associated with allergies, congestion, nausea, migraines, headache, hangover, colds, dizziness”

On the webpage titled “Migrenza”:

    • “Migrenza Migraine”
    • “[A]ssist in reducing…headache, migraines, congestion, hangover”

Your products are also “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 conditions prescribed, recommended, or suggested in their labeling. Under section 505(a) of the FD&C Act, 21 U.S.C. 355(a), new drugs may not be introduced or delivered for introduction into interstate commerce without prior approval from FDA. No 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 violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).

In addition, your “Detoxoplex” product is misbranded within the meaning of section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1), in that its labeling fails to bear adequate directions for use. “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended. (See 21 CFR 201.5.) As previously noted, your “Detoxoplex” product is intended for the treatment or cure of opioid withdrawal symptoms that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Therefore, adequate directions for use cannot be written so that a layperson can use your product safely for its intended purpose. Moreover, your “Detoxoplex” product is not exempt, under 21 CFR 201.100(c)(2) or 201.115, from the requirements that its labeling bears adequate directions for use because no FDA-approved application is in effect for your product. The introduction or delivery for introduction into interstate commerce of a misbranded drug is prohibited 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 exist in connection with your marketed products. You are responsible for investigating and determining the causes of the violations identified above 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 and FDA regulations.

You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction.

Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to correct 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 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, 10903 New Hampshire Avenue, WO51, Silver Spring, MD 20993-0002 or by email to [email protected].

Sincerely,
/S/
Carolyn E. Becker
Director
Office of Unapproved Drugs and Labeling Compliance
Center for Drug Evaluation and Research
Food and Drug Administration