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 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 …

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 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 …

Untitled Letters (CBER)

… do not meet the threshold of regulatory significance for a Warning Letter. Examples when CBER has issued an Untitled … BIMO/Team Biologics/Internet Surveillance/Other Untitled Letters Regarding Advertising & Promotional Labeling for … 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 …

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 …

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 …

Health Fraud Scams

… Chocolate Bars, Cones, & Gummies (June 2024) FDA Issues Warning About Certain Supplements Substituted with Toxic … What You Need to Know About Skin Lightening Products Warning Letters and Test Results for Cannabis-Derived Products Health …

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 …