FDA Policy Change on Hand Sanitizers

On October 12th, 2021, the FDA announced they are withdrawing their temporary policies allowing manufacturers who were not drug manufacturers to produce certain alcohol-based hand sanitizers. Background In the US (and elsewhere) hand sanitizers are drugs, usually over-the-counter drugs. They must be manufactured by approved drug manufacturers, in registered, inspected and approved facilities. The product must follow one of several … Read More

FDA Warning Letters 2021

I’ve been receiving a lot notices of FDA warning letters, so I reviewed the last 106 warning letters (60 days) to see what sort of warnings they have been sending out lately. Here’s the breakdown of the types of products cited (in descending order). Family Smoking Prevention & Tobacco Control – 46 Unapproved new drug – 19 Corona Virus 2019 … Read More

Ingredient Declarations for Soap (US Only)

There has been a lot of discussion over the years about whether an ingredient declaration is required on soap products. Let’s take another look. Applicable Laws There are several acts and laws that apply to the labeling of soap and cosmetics, including the requirements of an ingredient declaration on the product label. Fair Packaging and Labeling Act The Fair Packaging … Read More

Making Cosmetics in Alabama

Alabama Code AL Code § 20-1-50 to 57 (2019) covers cosmetics. It’s pretty brief. The definition of a cosmetic is the same as the federal law and regulations, as are the definitions of adulterated and misbranded. The State Board of Agriculture and Industries is responsible for setting standards of “purity and quality.”  Essentially, it is a violation to have or sell adulterated or misbranded cosmetics (unless you have them … Read More

Florida – 2021-Changes to Cosmetic Manufacturers Law

Yesterday Florida Governor Ron DeSantis signed a SB 1966 into law, making it possible for small businesses to manufacture cosmetics! This is such GOOD NEWS! Overview It’s a big act, and one small bit  …(drum roll, please) …  exempts certain persons from being required to have a cosmetic manufacturer’s license! Before this bill Before this bill and the changes it … Read More

Making Cosmetics in Pennsylvania

Pennsylvania is apparently another state that has specific requirements for cosmetic manufacturers. They’ve been on the books for a number of years (at least partially) but apparently haven’t been enforced much until just recently. The information available online is somewhat contradictory, but it does look like they do expect all cosmetic manufacturers to register. Registrations are under the Pennsylvania Department … Read More

Finally My Labeling eClass is Available!

For all the people who have asked me to put together an actual eClass, I am so excited announce that my eClass is now – finally – available to one and all at The Nova Studio!!!  It’s been months in the making and I’m extremely proud of the finished product. Rather than do one long lecture-type video, we decided to … Read More