2023 Warning Letters - Health Fraud

… Examples of FDA Warning Letters that cite unapproved or unsubstantiated claims, … or other health fraud* - related violations. For all FDA Warning Letters, click here . Letter Issue Date Firm Name …

FDA Issues Two Warning Letters to Leading Manufacturer of Endoscopes

… Devices and Radiological Health (CDRH) recently issued two warning letters to a leading manufacturer of endoscopes, Olympus … Olympus Co, Ltd ., following facility inspections. The warning letters concern violations related to medical device …

FDA Sends Warning Letters to Seven Companies Illegally Selling Hangover Products

… 2020, the U.S. Food and Drug Administration (FDA) issued warning letters to seven companies whose products claim to cure, … limiting their consumption of alcoholic beverages. Warning letters were sent to the following companies: Double …

Warning Letters Highlight Differences Between Cosmetics and Medical Devices

… FDA warning letters issued to manufacturers and/or distributors of … and medical devices. Although the devices cited in these warning letters are intended to affect a person's appearance, the …

FDA Issues Warning Letters to Three Infant Formula Manufacturers

… Español Today, the U.S. Food and Drug Administration issued warning letters to three infant formula manufacturers as part of the … formula under the safest conditions possible.   These warning letters for violations of the Federal Food, Drug, and …

FDA Provides Update on Plastic Syringes Made in China, Issues Warning Letters Related to Violative Products

… known. As such, on March 18, 2024, the FDA issued a warning letter to Jiangsu Shenli Medical Production Co. Ltd, a China-based manufacturer of plastic syringes, and warning letters to Medline Industries, LP and Sol-Millennium Medical, …

FDA and FTC Send Warning Letters to 10 Companies for Illegally Selling Dietary Supplements Claiming to Treat Diabetes

… (FDA) and the Federal Trade Commission (FTC) issued warning letters to 10 companies for illegally selling dietary … suffer harm and may not receive appropriate treatment. Warning letters were sent to the following companies: Live …

FDA In Brief: FDA Issues Warning Letters to Jimmy John’s and a Sprout Distributor for Food Safety Violations

… Today the U.S. Food and Drug Administration posted a warning letter issued to Jimmy John’s Franchise LLC for … clover sprouts and cucumbers. The FDA also posted a warning letter to Sprouts Unlimited Wholesale Foods for …   … Office of the Commissioner … FDA issues warning letters to Jimmy John’s and a sprout distributor for food …

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 …

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 …

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, 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 , …

Recent FDA Action on Dietary Supplements Containing Cesium Chloride

… 2020, the U.S. Food and Drug Administration (FDA) issued warning letters to five dietary supplement companies whose product … containing cesium salts, primarily cesium chloride. Warning letters were sent to the following companies: …

FDA, FTC Warn Six Companies for Illegally Selling Copycat Food Products Containing Delta-8 THC

… Administration and the Federal Trade Commission issued warning letters to six companies for illegally selling copycat food … children, or taken in higher doses than intended. The warning letters were issued to: Delta Munchies , Dr. Smoke …

FDA Takes Action on Products Marketed as Dietary Supplements Containing Tianeptine and Warns Consumers

… 2018, the U.S. Food and Drug Administration (FDA) issued Warning Letters to two companies whose products marketed as dietary … In addition, the products that were the subject of these Warning Letters are considered to be drugs under the Act …

FDA Alerts Public about Improper Use of Thermal Imaging Devices; Warns Firms for Illegally Offering Thermal Imaging Systems for Sale

… a variety of factors. Additionally, the FDA issued several Warning Letters to certain firms offering unapproved, uncleared, and … to users about the correct use of these devices and is warning certain firms that the FDA will not tolerate their …

Coronavirus (COVID-19) Update: April 9, 2021

… effort to protect consumers and animals, the agency issued warning letters jointly with the Federal Trade Commission (FTC) to … use of decontaminated disposable respirators, and issues warning letters to two companies for selling unapproved …

Untitled Letters Issued by CFSAN

… FDA transparency initiative, FDA began posting untitled letters issued by Center for Food Safety and Applied … do not meet the threshold of regulatory significance for a Warning Letter, or that are issued to Internet websites (cyber letters).  2018 Seafood Facility - SIA Piejura 03/23/2018 …

FDA Warns Whole Foods Market After Repeated Food Recalls for Undeclared Allergens

… Today the U.S. Food and Drug Administration (FDA) posted a warning letter issued to Whole Foods Market for a pattern of … manufacturing processes. In 2020, the FDA sent eight warning letters to companies that have manufactured and distributed …

Compliance & Enforcement of Color Additives

… Examination Of Cosmetics Containing Illegal Colors Warning Letters Citing Color Additive Violations  The FDA issues Warning Letters to let companies know that they have violated …

Firm/Supplier Evaluation Resources for FSMA Rules

… including whether the supplier is the subject of an FDA warning letter, import alert, or other FDA compliance action … in these regulations as well as information on their use: Warning Letters Warning letters are considered advisory actions and …

Coronavirus (COVID-19) Update: March 5, 2021

… response effort to the COVID-19 pandemic: The FDA sent letters to 25 firms that produce and issue “FDA registration … a variety of factors. Additionally, the FDA issued several warning letters to certain firms offering unapproved, … and unauthorized thermal imaging systems for sale. Warning Letters that have been issued by the FDA are …

Compliance & Enforcement (Food)

… Criminal prosecution This section provides access to FDA's warning and untitled letters, information about inspection and compliance … do not meet the threshold of regulatory significance for a Warning Letter. Untitled letters can also be issued to …