FDA continued to aggressively enforce the Foreign Supplier Verification Program (FSVP) in 2022 with an increase in Warning Letters, Import Alerts, and import refusals. When looking behind the numbers, there continues the same general pattern: the importer failed two or three inspections and received a Form 483 each time, then they received a Warning Letter…
A Unifying Connection between M*A*S*H, FDA, and the Unified Agenda
There’s a CPSC and M*A*S*H connection too! The Links:
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FSVP: The Basics
The Foreign Supplier Verification Program (FSVP) is one of the foundational rules from the Food Safety Modernization Act (FSMA). FSVP requires a food importer to create a due diligence program to review and approve its foreign suppliers. Then the importer must take action to verify that the food was produced in a manner that provides…
A Regulatory Riddle
Baking soda! Also known as sodium bicarbonate, this ingredient is a wonder; a regulatory mythical creature! To my knowledge, no other product can be lawfully sold across so many regulatory classifications: Food: It helps to make your pancakes fluffy (in other words, it’s a leavening agent). Drug: It helps you when you ate too much…
Curious George, Dick Van Dyke, and FDA…
What do Curious George and Dick Van Dyke have in common? Spokesmen for the Food and Drug Administration (FDA), of course!* They educated the public about nutrition labeling as a tool for a healthy lifestyle. Although public education has always been a part of FDA’s mission, nutrition labeling has had some different looks over the…
When Santa was on FDA’s Naughty List
Santa must have a robust regulatory affairs and quality team to manage all of the requirements for his global operation. However, he once ran into an FDA problem when his candy canes contained an unlawful colorant: Red Number 2. This lead to a plant inspection, which discovered additional problems. Take a look: Source: FDA Consumer…
Every Plant can be a Weed and a Pest too … Federal Law Says So
I love to garden. But weeds, along with deer, cause me great pain and toil. I hate weeds, but what exactly is a weed? Let’s turn to the law (I am a lawyer after all). Pesticides are nationally regulated under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). This law, like any good law, contains…
BB Guns: An Ineffective Rat Control Program
FDA once seized food from a warehouse that had a rat infestation problem, which unsurprising violates the Food, Drug, and Cosmetic Act. A food is adulterated “if it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.”…
Love Potion # 9 Unlawful … Or Maybe Not?
Good thing that Madame Ruth on Thirty-Fourth and Vine never mass produced her famed Love Potion # 9 or she may have had an issue with the Food and Drug Administration (FDA). In 1989, FDA concluded that all aphrodisiacs are unapproved new drugs and thus are prohibited from being sold without first obtaining FDA premarket approval…
FDA Storytime 