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Psychiatry Advisor1d
FDA Sends Warning Letters to Companies Selling Illegal Opioid Compound
The US Food and Drug Administration has issued 7 warning letters to companies illegally marketing products containing 7-hydroxymitragynine (7-OH), which is found in trace amounts in kratom.
National Consumer Alert on 7-OH Products Posing Significant Dangers
FDA issues warning letters to distributors of food, dietary supplements and unapproved drugs that contain ...
MyChesCo on MSN3d
FDA Targets 7-OH Kratom Products in Crackdown on Unapproved Opioid-Like Supplements
The U.S. Food and Drug Administration (FDA) has issued warning letters to seven companies accused of unlawfully marketing products containing 7-hydroxymitragynine (7-OH), a potent opioid compound ...
MedTech Dive6d
Whoop’s FDA warning letter sparks debate over blood pressure as a wellness metric
Whoop pushed back on the warning letter, claiming its blood pressure feature for a wearable wristband is for “wellness” and ...
JD Supra2d
FDA Warning Letter Reminds Industry that Wellness Claims Only Go So Far, Other Features Can Establish Intended Use
U.S. Food & Drug Administration (FDA) warning letter to a prominent wellness product and services company offers a blunt reminder ...
Psychiatry Advisor3d
FDA Publishes Full Texts of Response Letters to Drug Applications
The US Food and Drug Administration has published more than 200 complete response letters, or decision letters, sent as replies to drug and biological product applications submitted to the agency from ...