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The U.S. Food and Drug Administration (FDA) recently issued updated guidance that extends agency enforcement discretion over compliance with the requirement that domestic and foreign food facilities provide a unique facility identifier (UFI) when registering or renewing an existing food facility registration. Food facilities now have until 31 December 2022 to obtain and submit a UFI with their registration.
FDA UFI food facility registration requirement
The Federal Food, Drug, and Cosmetic Act (FFDCA) requires domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States to register with the FDA.
Monday, February 22, 2021
FDA will evaluate claims and other information on a dietary supplement’s website to establish the product’s “intended use.” In general, a dietary supplement is allowed to make claims about having an effect on the “structure” or a “function” of the human body. If FDA finds that the product is intended for use in the cure, mitigation, treatment, or prevention of disease, it will be deemed a “drug” under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (“FD&C Act”). FDA routinely takes enforcement action against such unapproved new drugs.
In a February 18, 2021 Constituent Update, FDA announced that it had issued warning letters to 10 companies for illegally selling dietary supplements, containing a variety of ingredients, that all claim on their websites, as well as their Amazon product pages in some cases, to cure, treat, mitigate, or prevent depression and other mental health disorders as follows:
On December 16, 2020, the U.S. Food and Drug Administration (“FDA”) issued a corporate Warning Letter to Whole Foods Market (“Whole Foods”) following 32 recalls Whole Foods conducted.
Following a series of Warning Letters issued throughout 2020 related to recalls due to allergen labelling errors, the U.S. Food and Drug Administration (FDA) recently issued a.