Warning Letters
FDA Issues Warning Letters to Firms Marketing Products Containing 7-Hydroxymitragynine
On July 15, the U.S. Food and Drug Administration (FDA) announced seven recent warning letters sent to companies for illegally marketing products containing 7-hydroxymitragynine, also known as 7-OH. This action reflects the Agency’s growing concern around novel potent opioid products being marketed to U.S. consumers and sold online and in smoke shops, gas stations and ...
NJ Labs Underscores Importance of TOC Water Testing Analysis for Cosmetic, Nutraceutical and Pharmaceutical Products
A flood of warning letters from the FDA (U.S. Food and Drug Administration) on water system suitability could pull the plug on the production of food, beverage, cosmetic, nutraceutical, and over-the-counter (OTC) or pharmaceutical products if companies are not conducting total organic carbon (TOC) water testing analysis on a regular basis, reports NJ Labs (New Brunswick, NJ). ...
NPA, CRN Respond to Research Showing Supplements With Banned Ingredients are Still on the Market
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 Selling of Topical CBD Products Violates FD&C Act
On March 22, the U.S. Food and Drug Administration (FDA) stated that it has issued warning letters to two companies for selling topical pain relief products labeled as containing cannabidiol (CBD) in ways that violate the Federal Food, Drug and Cosmetic Act (FD&C Act). Specifically, the warning letters addressed the illegal marketing of unapproved drugs ...
Registrar Corp Introduces FDA Compliance Monitor
The U.S. Food and Drug Administration (FDA) recently finalized two new rules that require food facilities and importers of food and beverages to monitor and document the compliance status of each supplier, “including FDA warning letters or import alerts relating to the safety of food and other FDA compliance actions.” The two new rules, the Preventive ...
CRN Launches Tool to Help Industry Monitor GMP Violations
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 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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