New FDA Webpage for Handcrafters

December 4, 2015

The FDA has published a new webpage that is directed to cosmetic handcrafters. It’s the Small Businesses & Homemade Cosmetics: Fact Sheet, which can currently be found in the Cosmetics section of the FDA website, under “Resources for You” > “Industry“.

Just to clarify, nothing has changed; there are no new regulations. This is just a new page on their website that summarizes important points that small businesses and homemade cosmetic makers should know.

Questions & Answers

The new page is in a Q & A format, and provides answers to 15 commonly asked (and frequently misunderstood) questions that cosmetic handcrafters often ask. The answers are relatively easy to understand and contain links to other FDA web pages with additional information. The questions covered are:

Does FDA regulate cosmetics?
How do I know if my products are regulated as cosmetics, and not as drugs or some other product category?
Do I need to have my cosmetic products or ingredients approved by FDA?
What do I need to know about using color additives in cosmetics?
Do I need to register my cosmetic firm or product formulations with FDA?
Can I manufacture cosmetics in my home or salon?
Can I label my cosmetics “natural” or “organic?”
Must I test my products and ingredients?
Using available safety data.
Doing additional testing.
Can I use a Post Office (P.O.) box or website for the address on the label?
Where can I learn more about labeling requirements?
What local requirements are there for starting a cosmetics business?
Do I need to get a license from FDA to manufacture or market cosmetics?
Where can I find more information on FDA requirements I need to know about?

My Opinion

(Hey, it’s my blog, so I’m going to post my opinion here!)

Personally, I’m very pleased the FDA has taken the time to put up this page and answer these questions. I’ve been answering them over and over for years now, and there has never been a clear-cut place on the FDA website covering some of this information. (The question about Post Office boxes is a good example.)

Again, nothing has changed. There are no new regulations. It’s just what I’ve been saying all along.

Navigating the Rules and Regs book by Marie Gale

Shameless plug!

Besides labeling, there are many other laws and regulations that apply to handcrafters. To find out which ones apply to you and how to comply with them, buy my book and keep it handy!

Buy on Amazon

Comments

One response to “New FDA Webpage for Handcrafters”

Dawn Mason

April 15, 2016

Hi Marie,

Thanks for all of the information.

I was reading the GMP inspection checklist. Thanks to your book, I think I am really close to passing if I ever was inspected. One area concerns me, and that is the testing of raw materials and finished products for microorganisms.

I don’t make anything that contains water, only oils and waxes. I’ve been told by a few suppliers that I don’t need to do microbial testing. Is this true? If not, how is a home based manufacturer supposed to do this. Does the clause “to the extent necessary” in the checklist below excuse us from microbial testing of lip balms and such because it is, in fact, not necessary?

Here is the section from the FDAs checklist:
4. Raw Materials. Check whether:
(omitted material)
Materials are sampled and tested or examined in conformance with procedures assuring the absence of contamination with filth, microorganisms or other extraneous substances to the extent necessary to prevent adulteration of finished products. Pay particular attention to materials of animal or vegetable origin and those used in the manufacture of cosmetics by cold processing methods with respect to contamination with filth or microorganisms.

Thanks,
Dawn

Reply