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2023 Warning Letters - Health Fraud
… /consumers/health-fraud-scams/2023-warning-letters-health-fraud … Examples of FDA Warning Letters that cite unapproved or unsubstantiated …
Warning & Untitled Letters to Industry Citing Color Additive Violations
… /industry/color-additive-enforcement-news/warning-untitled-letters-industry-citing-color-additive-violations … Warning Letters Citing Color Additive Violations Matters described in FDA Warning Letters may have been subject to subsequent …
FDA Sends Warning Letters to Seven Companies Illegally Selling Hangover Products
… /food/cfsan-constituent-updates/fda-sends-warning-letters-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, …
FDA Issues Warning Letters to Three Infant Formula Manufacturers
… /news-events/press-announcements/fda-issues-warning-letters-three-infant-formula-manufacturers … Español Today, the U.S. Food and Drug Administration issued warning letters to three infant formula manufacturers as part …
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
… /food/compliance-enforcement-food/warning-letters-related-food-beverages-and-dietary-supplements … When … manufacturer. This notification is often in the form of a Warning Letter. Search for Warning Letters: Recently posted Warning Letters and an archive …
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 …
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 …
Untitled Letters Issued by CFSAN
… /food/compliance-enforcement-food/untitled-letters-issued-cfsan … Under the 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 …
Untitled Letters (CBER)
… /vaccines-blood-biologics/enforcement-actions-cber/untitled-letters-cber … An Untitled Letter is an initial … do not meet the threshold of regulatory significance for a Warning Letter. Examples when CBER has issued an Untitled … do not meet the threshold of regulatory significance for a Warning Letter. … Biologics … Untitled Letters (CBER) …
Enforcement Actions (CBER)
… (CBER) may issue several types of regulatory action letters. These letters are ordinarily issued to biological … of regulatory action letters issued by CBER include: Warning Letters Notice of Initiation of Disqualification … Tissue, and Cellular and Tissue-Based Products (HCT/Ps) Warning Letters A Warning Letter is an informal, advisory …
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 …
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 …
FDA Raises Concerns About Probiotic Products Sold for Use in Hospitalized Preterm Infants
… The agency recently sent a letter to healthcare providers warning them about this topic and has issued two warning letters to companies for illegally selling their products for …
Federal court issues decision holding that US Stem Cell clinics and owner adulterated and misbranded stem cell products in violation of the law
… time, the FDA will continue to take action—such as issuing warning letters or initiating court cases—against clinics that abuse … The FDA initially raised concerns about US Stem Cell in a warning letter issued in 2017 for marketing stem cell …
5 Things to Know about Delta-8 Tetrahydrocannabinol – Delta-8 THC
… 1932a found at: www.fda.gov/ReportAnimalAE . FDA Issues Warning Letters: FDA Issues Warning Letters to Companies Illegally Selling CBD and …
Health Fraud Scams
… or even fatal injuries. Health Fraud News FDA Issues Warning About Certain Supplements Substituted with Toxic … Honey-based Products with Hidden Active Drug Ingredients . Warning Letters and Test Results for Cannabidiol-Related Products …
Innovative Regenerative Medicine Therapies – Patient Safety Comes First
… was announced. During this period, the agency issued 14 Warning Letters and 24 Untitled Letters involving violative HCT/Ps regulated under Section …