Category: Legislation & Regulation
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California Legislation – Microplastics
In February 2022, California Assemblymember Bill Quirk introduced Assembly Bill (A.B.) 2787 “Microplastics in Products.” It covers both rinse-off and leave-on cosmetic products.
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Cosmetic Regulation Update
On May 17, the Senate HELP (Health, Education, Labor, and Pensions) Committee introduced a draft bill which includes changes to the Food Drug and Cosmetic Act regarding cosmetics.
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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…
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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…
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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…
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Making Cosmetics in Pennsylvania
Pennsylvania has requirements for cosmetic manufacturers, including registration.
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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…
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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, and defines “labeling” as all written, printed, or graphic matter accompanying an article at…
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FDA Site Update
If you’ve gone to the FDA website in the past week or so, you probably noticed that their website 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…
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FDA Warning Letters Over CBD
Three of the FDA warning letters in the past week have been concerning products containing CBD. Looks like they are starting enforcement activities in this area. All three of the warning letters (to PotNetwork Holdings, Advanced Spine and Pain, and Nutra Pure) cited similar violations. Drug Claims Claims that the product would treat or mitigate…
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What about CBD Oil?
CBD is short for cannabidiol, one of the many compounds found in the cannibis plant. It is non-intoxicating, but many claim it has significant physical benefits. “Hemp” and “marijuana” have been lumped into the same category since the 1937 Marijuana Tax Act and the 1970 Controlled Substances act. However, last December the 2018 Farm Bill…
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Certificate of Free Sale
A Certificate of Free Sale is a document that provides proof that a product is being freely and legally sold without restriction. It is sometimes also called a “Certificate for Export” or “Certificate to Foreign Governments.” When is a Certificate of Free Sale needed? A Certificate of Free Sale is needed if you are exporting…
