FDA Warns New Mexico Drugmaker, Orders Halt to Fertility Center's Work
The US Food and Drug Administration (FDA) sent a warning letter last week to New Mexico-based EPH Technologies for taking orders on its website for various unapproved new drugs.The unapproved drugs are meant to help migraines, nasal allergies and opioid withdrawal, but FDA said that the introduction of such products into interstate commerce violates the Federal Food, Drug, and Cosmetic Act.
The agency expressed particular concerns with “Detoxoplex,” which is marketed as a treatment or cure for 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,” the warning letter says.
While the three drugs mentioned by FDA and others are no longer available for purchase on the company’s website, they are still available for sale on Amazon.
The company says on its website that all of its products are based upon, or are derivatives of, “Xtremoplex,” which is available for $159.99, and which the company says is “created in, and extracted from, EPH Bioreactors saturated with our proprietary combination of naturally-occurring microbes,” such as “amino acids, proteins and enzymes.”
All of the applications of Xtremoplex, which the company listed as including psoriasis, eczema, acne and others, “represent sample sizes of > or equal to 10 users reporting similar efficacy,” the company said.
FDA says in its warning letter that the drugs “are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling.”
Warning Letter
Order to Cease HCT/Ps
In addition to the warning letter, FDA earlier this week also sent an order to cease manufacturing at a Puerto Rico-based fertility center. The facility works on donor screening, testing and determines the eligibility of donors of oocytes and semen, the letter explains.
The order says that the Gynecology, Reproductive Endocrinology and Fertility Institute failed to use “appropriate FDA-licensed, approved, or cleared donor screening tests to test a specimen from an anonymous or directed reproductive donor for evidence of infection due to relevant communicable disease agents, including human immunodeficiency virus, types 1 and 2 (HIV-1/2), hepatitis B virus (HBV), hepatitis C virus (HCV), and Treponema pallidum.”
FDA notes examples of donors deemed eligible despite not having the appropriate test results completed. The agency also takes issue with the acceptance of an anonymous oocyte donor who said she resided in Puerto Rico, which FDA considers a risk factor because it’s an area considered to be at an increased risk for Zika virus.
Order
Earlier this Week
FDA also recently sent 15 warning letters to companies illegally selling products containing cannabidiol (CBD).
“Many unanswered questions and data gaps about CBD toxicity exist, and some of the available data raise serious concerns about potential harm from CBD. The revised Consumer Update outlines specific safety concerns related to CBD products, including potential liver injury, interactions with other drugs, drowsiness, diarrhea, and changes in mood,” the agency said.