FDA sends warning to company selling unapproved ‘opioid withdrawal’ drug.
The Food and Drug Administration (FDA) recently sent a warning letter to EPH Technologies, accusing the company of “marketing and selling unapproved drugs.” The products at the center of the claims are Detoxoplex, Sinoplex and Migrenza, which are being sold to treat opioid withdrawal and migraine headaches, among other ailments. According to EPH Technologies, Detoxoplex can reduce “symptoms typically associated with withdrawal from opioid use.”
In the warning letter, the FDA said the product has not been determined to be safe and effective for these uses. It specifically states, in part, “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)…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…[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.”
It continues, “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…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.”
These drugs are no longer for sale on the company’s website but, unfortunately, are still available for purchase online from third party companies.
Sources:
FDA issues warning for products marketed to treat opioid withdrawal
Warning Letter: EPH Technologies, Inc., MARCS-CMS 590707 — NOVEMBER 18, 2019
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