Marie Gale Answers Your Questions

Hi Marie - Can you point me to the Florida statute that states that home based businesses cant make any product other than soap? For example - no lotions, scrubs, etc. Thanks. Joan King  -- J.K.

It's Florida Statutes (here: http://www.flsenate.gov/Laws/Statutes/2013/Chapter499/All):

499.01 Permits:  Says "Prior to operating, a permit is required for each person and establishment that intends to operate as: .... a cosmetic manufacturer"

499.012(1)(a) which says "An establishment that is a place of residence may not receive a permit and may not operate under this part."

Cosmetic is defined in 499.003(13)(a): "an article, with the exception of soap, that is intended to be rubbed, poured, sprinkled, or sprayed on; introduced into; or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance."

The cosmetic manufacturing laws apply to making any type of cosmetics, which includes lotions, scrubs, fizzies, lip balm, lotion bars, cream, etc.  It also includes soap that is marketed as a cosmetic (that is, it claims to do more than just clean, such as moisturize, etc.).

If you are manufacturing soap that is exempt from the definition of a cosmetic (which means that it is the alkali salt of fatty acids and is labeled and marketed only as "soap"), then the cosmetic manufacturing laws don't apply. 

 


I recently started to use lake colors in my bath bombs, and I am having trouble finding a correct answer on how to properly label them. Can I simply use "RED 40" or do I need to label "FD&C Red 40 Aluminum Lake" or someone had even recently told me I needed to put "FD&C RED 40 LAKE BATCH #12345678. It's safe to say I am more than confused. Any insight you have will be GREATLY appreciated!  -- K.K.

You can just use Red 40.  You don' tneed to specify the batch number (that is only necessary for manufacturers who are providing the ingredient, not for consumer products).

I am surprised that you are using lakes in your bath bombs since lakes, by definition, are not water soluable.  


Marie, Enjoyed your class. Trying to implement GMP and can't find recommendations re: how long to retain samples of soap, lip balm, bath bombs, lotion, and salts. The only thing I found was a European recommendation that said 1 year after expiration, which makes soap and salts problematic, and we don't usually put expiration dates on the other products. What is your best recommendation? Thank you. Anne  -- A.R.

General rule is that retain samples should be kept for 1 year past the end of the shelf life.

For soaps that can last a pretty long time, I'd say keeping 1 year past the reasonable time that a person would hold on to them or use them should be okay.

Nearly all other cosmetic products - particularly those that could be affected by environment/humidity (bath bombs, bath salts), that contain preservatives (lotions, creams), or that have other potential degradation over time (scent dissipation) SHOULD have an expiration date.  Even if you don't put it on the package (which I would recommend doing), you should have a standard within your GMP. Kep the retain samples 1 year past that date.


What's the best way to incorporate batch numbers on products? A separate label or should it be on the product label itself. Is it okay if it is handwritten? Sheri  -- S.V.

In big companies, the batch number is included on the label or stamped onto the container when it is filled.  For handcrafters, you have several options...

If you make the labels yourself and only print enough for each batch when it is done, then including the batch number when you print should be relatively easy.  That looks the cleanest.

If you have labels printed in advance and you have room, you can leave a space for the batch number and then either stick on a label with the batch number or write in the batch number.  Keep in mind that if the labels are printed professionally and are on glossy paper or have a UV coating, you won't be able to easily write on the label.

In either case, another option would be to print little stand-alone labels that say "batch number 12345" and stick those on the container/package somewhere.  

Handwriting the batch number is fine, so long as it is readable.  If you are thinking about taking that option, take into consideration whether a handwritten addition to the label would be appropriate for your brand and your selected target customer base.


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