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Warning Letters


NPA, CRN Respond to Research Showing Supplements With Banned Ingredients are Still on the Market

by Angela Sabarese | August 2, 2022

A study recently published in JAMA by Pieter A. Cohen, MD; Bharathi Avula, PhD; and Kumar Katragunta, PhD, et al, has found that supplements with banned ingredients are still on the market despite the companies having received warning letters from the U.S. Food and Drug Administration (FDA). The study stated that “Some dietary supplements are adulterated […]

FDA Warns Marketers of Products Labeled as Dietary Supplements That Contain Tianeptine

by Nicholas Saraceno | November 26, 2018

The U.S. Food and Drug Administration (FDA) on Nov. 20 posted warning letters issued to two companies for the illegal marketing of products labeled as dietary supplements that contain tianeptine, a chemical compound that companies are illegally claiming treats opioid use disorder (OUD), pain and anxiety, and other unlawful and unproven claims. These actions follow reports to […]

FDA Takes Action Against 14 Companies For Selling Illegal Cancer Treatments

by Nicholas Saraceno | May 2, 2017

On April 25, the U.S. Food and Drug Administration (FDA) posted warning letters addressed to 14 U.S.-based companies illegally selling more than 65 products that fraudulently claim to prevent, diagnose, treat or cure cancer. The products are marketed and sold without FDA approval, most commonly on websites and social media platforms. “Consumers should not use […]

FDA Issues More Warning Letters

by Corinne Anderson | February 23, 2016

The U.S. Food and Drug Administration (FDA) has sent out more warning letters to dietary supplement companies who are not following cGMP (good manufacturing practices) and label claims. ATS Labs, in Spring, TX, was sent a warning letter citing cGMP violations earlier in February. These violations cause the company’s products: Support, Liver Food, Test PSI, […]

FDA Issues Warning Letters About CBD

by Corinne Anderson | February 16, 2016

The Food and Drug Administration (FDA) posted warning letters issued to marketers of products containing cannabidiol (CBD). Marketers included: ABC Productions, Dose of Nature, Green Garden Gold, HealthyHempOil.com, Michigan Herbal Remedies, MorgueJuice.com, PainBomb and Sana Te Oils, according to New Cannabis Ventures. Two of the companies faced criticism for claims made about products manufactured by CV Sciences, […]

CRN Launches Tool to Help Industry Monitor and Learn From Violations

by Angela Santoriello | November 17, 2014

The Council for Responsible Nutrition (CRN) announced a free online tool that compiles FDA Warning Letters sent to dietary supplement companies into a searchable database to help the industry achieve better regulatory compliance. The database can be used to evaluate FDA’s warning letter allegations of good manufacturing practices (GMPs) violations, products making impermissible claims, and products […]

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