Search
Warning Letters Related to Cosmetics
… FDA issues Warning Letters to let companies know that they have violated the … action they need to take. For more information on Warning Letters in general, please see: General FDA Warning …
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 …
Warning Letters Cite Cosmetics as Adulterated Due to Microbial Contamination
… substance" may include microbial contamination. FDA issued Warning Letters to the following firms, citing cosmetic products as … do not meet the threshold of regulatory significance for a warning letter and to request correction of these violations. …
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 Address Drug Claims Made for Products Marketed as Cosmetics
… The Warning Letters appearing below illustrate an important legal … the United States (FD&C Act, Section 505(a)). FDA issued Warning Letters to the following firms, citing drug claims associated …
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 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 …
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 …
Untitled Letter to Juice Beauty Inc. 4/16/15
… FDA uses untitled letters for violations that do not meet the threshold of regulatory significance for a warning letter and to request correction of these violations. Unlike a warning letter, an untitled letter does not include a …
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 …
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 …
Hair Smoothing Products That Release Formaldehyde When Heated
… required to have directions for safe use and any necessary warning statements. In addition, the Occupational Safety and … . FDA Actions As part of its authority, the FDA issues warning letters to notify firms or individuals that they have been …