In response to growing concerns over sesame allergies, the U.S. Food & Drug Administration (“FDA”) is reportedly considering adding sesame to the list of major food allergens. Since the enactment of the Food Allergen Labeling and Consumer Protection Act of …
FDA to Review Standard of Identity for Dairy Products
On July 26, 2018, the U.S. Food & Drug Administration (“FDA”) announced that the Agency will be reviewing and modernizing established standards of identity for dairy products. A contentious issue among the dairy industry, dairy-alternative producers and consumers, FDA has …
No Quiero Taco Bell: Recall Issued for Taco Bell Cheese Sauce
On July 24, 2016, Kraft Heinz Co. announced its issuance of a recall of Taco Bell cheese sauce, indicating that the products present a botulism risk. The recall notice, found here, indicates that this a voluntary recall, which is undertaken …
FDA Warning Issued to Fraudulent and Unapproved Flu Products
On March 2, 2018, the U.S. Food & Drug Administration (“FDA”) published a warning to the public entitled “FDA warns of fraudulent and unapproved flu products (“FDA Warning”). Found here, the FDA Warning is aimed at notifying the public of …
Guidance Issued on Proper FDA Labeling of Honey and Honey Products
In February 2018, the U.S. Food & Drug Administration (“FDA”) published a guidance document entitled “Proper Labeling of Honey and Honey Products: Guidance for Industry (“Guidance”). Found here, the Guidance is aimed at explaining to industry FDA labeling for honey …
FTC Issues Multi Level Marketing (MLM) Guidance
On January 4th of 2018, the Federal Trade Commission (FTC) issued a document, entitled “Business Guidance Concerning Mutli-Level Marketing.” This Guidance relates to Multi-Level Marketing (MLM) practices and addresses how these businesses can ensure their compliance with the FTC Act. …
Sample Response to FDA Tobacco Warning Letter
No One-Size-Fits-All Approach, No Sample Response to a FDA Tobacco Warning Letter Getting a FDA Warning Letter for your tobacco business can be confusing. Responding to a FDA Tobacco Warning Letter can be even more confusing and time-consuming for a …
FDA Untitled Letters: FDA Warnings with a Twist
The U.S. Food and Drug Administration (“FDA”) has recently been issuing letters to companies that are distinct from traditional FDA Warning Letters. Referred to as FDA Untitled Letters, these letters must be taken seriously, as the terms of FDA Untitled …
District Court sides with Industry on Dietary Supplement Substantiation
A U.S. District judge New Jersey has ruled in United States v. Bayer Corporation that Bayer will not be held in contempt for alleged violations of a 2007 consent decree regarding the marketing of its Phillip’s Colon Health (PCH) product. …
FDA Issues Tobacco Warning Letters for Tobacco Retailer Inspection Violations
The U.S. Food and Drug Administration (FDA) has been ramping up their enforcement efforts against tobacco retailers in recent months for compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act) by issuing countless tobacco warning letters in connection …