Quackery! Central to FDA’s mission is identifying and stopping quacks – medical products that lack adequate (usually any) proof that they work. The Agency now calls these health frauds, but quackery is a much better in my opinion. This April First, let’s take a look into the Tails from the Quack Files with the Orgone…
Characterizing Flavors: When to Qualify or Not?
The characterizing flavor regulation is back! This time we look at the foundational question – when does this regulation even apply? FDA’s answer, only in “relatively limited circumstances”. Alas if FDA could quote the 2000s film Hitch “I saw that going differently in my mind” because in practice this regulation is “so complex that it…
FDA FVSP Enforcement in 2023 (by the Numbers)
FDA continued to aggressively enforce the Foreign Supplier Verification Program (FSVP) in 2023 with a steady set of Warning Letters, import alert listings, and import refusals. When looking behind the numbers, there continues the same general pattern from the last few years: the importer failed two or three inspections and received a Form 483 each…
FDA’s 2024 To Do List: Food Labeling and Standards
A new year comes with resolutions and to-do lists. In that spirit, let’s see what FDA is working on for food labeling and food standard: Topic Additional Details Estimated Date Labeling of Plant-Based Alternatives to Animal-Derived Foods; Draft Guidance for Industry Presumably this will similar to the draft guidance for Plant-Based Milk Alternatives (issued February…
Characterizing Flavors & Lemon Pudding
The characterizing flavor regulation turned 50 this year (2023)! FDA originally believed that this regulation be simple to apply and used lemon pudding with natural flavors to explain the different qualifiers. Alas if FDA could quote the 2000s film Hitch “I saw that going differently in my mind” because in practice this regulation is “so…
FDA FVSP Enforcement in 2022 (by the Numbers)
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…
FDA Storytime 