Two federal agencies are warning the makers of a dozen unapproved opioid addiction treatments that their products are being illegally marketed and sold.
The US Food and Drug Administration (FDA) and the US Federal Trade Commission (FTC) made the warnings public on January 24. The warnings, which were issued to the sellers on January 11, required them to cease and desist by January 26. Failure to correct violations could result in seizures or injunctions, said the agencies.
The companies advertised the products — mostly through Facebook, YouTube, and other online platforms — with various claims, such as, “#1 Selling Opiate Withdrawal Brand” and “Safe and effective natural supplements that work to ease many physical symptoms of opiate withdrawal.”
“The FDA is increasingly concerned with the proliferation of products claiming to treat or cure serious diseases like opioid addiction and withdrawal,” said FDA Commissioner Scott Gottlieb, MD, in a statement.
“People who are addicted to opioids should have access to safe and effective treatments and not be victimized by unscrupulous vendors who are trying to capitalize on the opioid epidemic by taking advantage of consumers and selling products with baseless claims,” he said.
“Individuals and their loved ones who struggle with this disease need real help, not unproven treatments,” said Acting FTC Chairman Maureen K. Ohlhausen in a statement.
The two agencies issued joint warning letters to 11 companies for their products: Opiate Freedom Center (Opiate Freedom 5-Pack), U4Life, LLC (Mitadone), CalmSupport, LLC (CalmSupport), TaperAid (TaperAid and TaperAid Complete), Medicus Holistic Alternatives LLC (Natracet), NutraCore Health Products, LLC (Opiate Detox Pro), Healthy Healing, LLC (Withdrawal Support), Soothedrawal, Inc (Soothedrawal), Choice Detox Center, Inc (Nofeel), GUNA, Inc (GUNA-ADDICT 1), and King Bio, Inc (AddictaPlex).
The FDA notified each company that it was making unproven efficacy claims and marketing their products as drugs.
“New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from the FDA, as described in sections 301(d) and 505(a) of the Act [21 USC §§ 331(d), 355(a)),” said the agency in its letter to Opiate Freedom Center. “FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective,” the FDA added.
Similar language was in letters to every manufacturer.
None of the manufacturers or marketers have applied for FDA approval.
The FDA also noted in every letter that the manufacturers were violating FTC rules governing marketing and promotion.
The FTC sent four additional warning letters to other marketers of opioid cessation products.
The agency stated in its letters, “Competent and reliable scientific evidence for a product claiming to treat opiate withdrawal symptoms or opiate addiction consists of randomized, controlled, human clinical testing of that product.” It added, “If any of your claims are not supported by competent and reliable scientific evidence, you should delete or revise them immediately.”
An injunction or administrative order to stop distribution can be issued to companies found in violation of the US Federal Food, Drug, and Cosmetic Act. The agency can also require marketers to give consumers refunds for faulty products.
The FTC noted that it has already been successful in getting two companies to stop making deceptive claims about their opioid addiction treatment products: Sunrise Nutraceuticals, LLC (Elimidrol), and Catlin Enterprises, Inc (Withdrawal Ease and Recovery Ease). The companies also had to pay fines.
According to the Substance Abuse and Mental Health Services Administration (SAMHSA), more than 2 million persons in the United States have an opioid use disorder.
The FTC and SAMHSA recently issued a fact sheet that offers tips on how to find legitimate help for opioid addiction or withdrawal.
The FDA and FTC urge healthcare professionals and consumers to report adverse events related to these products to the FDA’s MedWatch Adverse Event Reporting program.
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