Plastic Microbeads

Plastic microbeads are prohibited for use in rinse-off cosmetics. If a rinse-off cosmetic contains plastic microbeads, it is adulterated (and therefore illegal).1 21 USC 331(ddd) Definition: A plastic microbead is any solid plastic particle that is less than 5 millimeters in size and is intended to be used to exfoliate or cleanse the human body or any part thereof. For … Read More

Ethyl Alcohol (Ethanol)

In cosmetic ingredient naming, “alcohol” is the INCI name for ethyl alcohol (ethanol). Ethyl alcohol – also called grain alcohol – is the consumable kind of alcohol. It’s naturally produced by the fermentation of sugars, from which we get all sorts of alcoholic beverages; beers, wines and hard liquors. It can also be produced synthetically from petrochemicals. Many cosmetic products … 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

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

FDA Warning Letters: Products Containing CBD

The FDA sent out 15 warning letters last week to companies that are illegally marketing products containing CBD.  I thought it might be interesting to take a look at what the FDA is going after and why. The FDA’s Position First, let’s review the FDA’s position on the marketing of products containing CBD. The FDA has acknowledged what we all … Read More

Florida Regs – 2019 Recap

[Updated July 11, 2019 to include a section on Inspections and a link to the actual regulations for the requirements that must be met.] Of all the subjects I get asked about, making cosmetic products in Florida is close to the top of the list because they have the most stringent regulations for cosmetic manufacturers. That being the case, I … Read More

FDA & Social Media

NOTE: This post is not specifically about handcrafted soap and cosmetics, but more about FDA enforcement generally. The Food Drug and Cosmetic Act defines the “label” as the written printed or graphic matter on the immediate container of a product and “labeling” as all written, printed, or graphic matter accompanying an article at any time. The FDA has authority over … Read More

FDA Site Update

If you’ve gone to the FDA website in the past week or so, you probably noticed that they site has been updated and now looks completely different. According to their website, they are changing over to a new “more modern” WCMS (Website Content Management System), the biggest benefit of which is that it will be easy to view the site … Read More