Warning Letters Related to Food, Beverages, and Dietary Supplements

… manufacturer. This notification is often in the form of a Warning Letter. Search for Warning Letters: Recently posted Warning Letters and an archive …

Letters to Industry

… (CDRH) for a variety of purposes. These primarily include Warning Letters, Untitled Letters, "It Has Come To Our Attention" … Manual (RPM) contains Agency guidance and procedures for Warning Letters and Untitled Letters. Warning Letters Chapter …

2018 Warning Letters

… Office of Regulatory Affairs … 2018 Warning Letters …

Sunscreen Warning Letters

… 2015 … Center for Drug Evaluation and Research … Sunscreen Warning Letters …

FDA Warns Firms to Remove Unauthorized E-liquid Products from Market in First Letters Issued to Manufacturers that Did Not Submit Premarket Applications by Deadline

… Today, the U.S. Food and Drug Administration issued warning letters to 10 firms who manufacture and operate websites … by the Sept. 9, 2020 deadline. This is the first set of warning letters being issued to firms who have not submitted …

FDA sends warning to company for marketing dangerous unapproved stem cell products that put patients at risk and puts other stem cell firms, providers on notice

… and effective products for patients, the agency is sending letters to reiterate the FDA’s compliance and enforcement … issuance, that details how the deviations noted in the warning letter will be corrected. Deviations not corrected by … tobacco products. … Office of the Commissioner … FDA sends warning letter to Genetech, Inc. and letters to other …

FDA issues warning about body-building products labeled to contain steroid and steroid-like substances

… The U.S. Food and Drug Administration today posted warning letters to  Flex Fitness/Big Dan’s Fitness ,  AndroPharm , … Although the products that are the subject of these warning letters are marketed as dietary supplements, they are …

FDA issues warnings to companies selling illegal, unapproved kratom drug products marketed for opioid cessation, pain treatment and other medical uses

… The U.S. Food and Drug Administration issued warning letters to two marketers and distributors of kratom products … kratom combined with other drugs. The companies receiving warning letters use websites and social media to illegally …

FDA Warns Online Retailers for Sale of Unauthorized E-Cigarettes Resembling Alcohol Bottles

… December 20, 2023 On Dec. 20, 2023, FDA issued warning letters to three online retailers for selling and/or … emerging products of concern.” The retailers receiving the warning letters sold or distributed e-cigarette products in …

FDA Warns Companies Illegally Selling CBD Products

… Today, the U.S. Food and Drug Administration issued five warning letters to companies for selling products containing … Federal Food, Drug, and Cosmetic Act (FD&C Act). All five warning letters address the illegal marketing of unapproved …

FDA Warns Five More Online Retailers for Selling Unauthorized E-Cigarettes Popular with Youth

… February 28, 2024 On Feb. 28, FDA announced the issuance of warning letters  to five online retailers for selling unauthorized e-cigarette products. These warning letters cite the sale of disposable e-cigarette …

FDA and DEA warn website operators illegally selling opioids

… the U.S. Drug Enforcement Administration have issued joint warning letters to four online networks, operating a total of 10 … including tramadol, that are potentially dangerous. The warning letters issued to each of the networks state that …

FDA Warns Companies for Illegally Selling Food and Beverage Products that Contain CBD

… Today, the U.S. Food and Drug Administration (FDA) posted warning letters to five companies for illegally selling products containing cannabidiol (CBD).  Warning letters were sent to the following companies: …

Questions and Answers: FDA alerts companies to stop the illegal sale of products claiming to treat Alzheimer’s disease

… The FDA has issued warning letters and online advisory letters to a number of domestic … written responses to address the violations covered in the warning letters and online advisory letters. Companies that …

FDA Acts on Dietary Supplements Containing DMHA and Phenibut

… Update April 16, 2019 On April 10, 2019, the FDA issued 12 warning letters to companies whose dietary supplement products are in violation of the law. The FDA issued 9 warning letters to companies whose products are marketed as …

FDA In Brief: FDA warns against using SARMs in body-building products

… The U.S. Food and Drug Administration recently issued warning letters to Infantry Labs, LLC , IronMagLabs and Panther … contain SARMs. Although the products identified in the warning letters are marketed and labeled as dietary …

Recent FDA Action on Dietary Supplements Labeled as Containing DMBA

… Update April 28, 2015 On April 28, 2015, the FDA issued warning letters to 14 companies regarding a total of 17 products for … to bring their products into compliance with the law. The warning letters also caution the companies that the FDA may …

Coronavirus Update: FDA and FTC Warn Seven Companies Selling Fraudulent Products that Claim to Treat or Prevent COVID-19

… (FDA) and the Federal Trade Commission (FTC) issued warning letters to seven companies for selling fraudulent COVID-19 … Americans during the global COVID-19 outbreak. The warning letters are the first to be issued by the FDA for …

FDA Continues to Implement Law Regarding Non-Tobacco Nicotine Products

… review. In total, FDA has issued refuse-to-accept (RTA) letters for more than 800,000 NTN products in applications … proceed with further review. In total, FDA has issued 44 warning letters to manufacturers and over 300 warning letters to retailers for violations in relation to …

FDA, FTC Continue Joint Effort to Protect Consumers Against Companies Illegally Selling Copycat Delta-8 THC Food Products

… and the Federal Trade Commission (FTC) issued warning letters to five companies for illegally selling copycat food … the Federal Food, Drug, and Cosmetic Act (FD&C Act). The warning letters were issued to: Hippy Mood , Earthly Hemps , …

FDA takes new enforcement actions as part of the agency’s ongoing effort to combat the illegal online sales of opioids

… Food and Drug Administration announced the issuance of two warning letters to operators of websites that illegally market … and misbranded opioid medications, including tramadol. The warning letters issued to azmedicinalshop.com and …

FDA In Brief: FDA Warns Firms for Continuing to Market E-cigarette Products After Agency Denied Authorizations

… Today, the U.S. Food and Drug Administration issued warning letters to 20 companies for continuing to unlawfully market … of Marketing Denial Orders (MDOs). These are the first warning letters issued for products subject to MDO …

FDA Puts Firms Responsible for Esco Bars and Breeze — Two Popular Disposable E-Cigarette Brands — on Notice

… May 25, 2023 On May 25, FDA issued warning letters to firms responsible for two popular flavored, … enforcement action.” The e-cigarette firms that received warning letters today make, distribute, or import tobacco …

FDA Warns Retailers to Stop Selling Illegal Youth-Appealing E-Cigarettes Disguised as Everyday Items

… November 16, 2023 On Nov. 16, FDA issued warning letters to seven online retailers for selling and/or … addiction. The unauthorized products described in the warning letters issued today include e-cigarettes that: …

Recent FDA Action on Dietary Supplements Labeled as Containing Picamilon

… November 30, 2015 On November 30, 2015, the FDA issued warning letters to five companies whose products marketed as dietary … event additional actions are taken related to picamilon. Warning Letters DBM Nutrition for DBM Endurance World …