Made in the USA

[Updated Feb 14, 2022]  to include additional information about non-USA sourced packaging materials.] If you want to make the claim that a product is “Made in the USA” you must comply with the Federal Trade Commission’s “Made in the USA” policy. The FTC enforcement is based on its general authority to act against deceptive acts and practices and applies to … Read More

Ohio Regulations – 2021

In Ohio, cosmetic manufacturers must be inspected prior to start of operation. NOTE: This post supercedes our Cosmetic Regulations – Ohio post from 2015. The Ohio Department of Agriculture recently published (June 2021) a Cosmetics webpage containing the requirements for a cosmetic manufacturer to get their facility inspected. There is also downloadable pdf1The pdf linked to in this blog post … Read More

The Importance of Good Manufacturing Practices

Sometimes it’s easy to think that keeping in Good Manufacturing Practices when making cosmetics is just a good idea — a “suggestion” rather than a “rule”. I suppose that idea is reinforced by the fact that cosmetic GMP isn’t actually in the regulations, it’s a “guidance”. Events of the past several months have shown that GMP failures can have a … Read More

What is INCI?

Important Terms Nomenclature: The words and terminology specific to a particular subject or area of study. Botanical: Related to plants; a part of a plant. “INCI” stands for the International Nomenclature of Cosmetic Ingredients. It is a list of the standardized and internationally accepted names (called “INCI Names”) that should be used in the declaration of ingredients on cosmetic and … Read More

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