FDA Responds to PO Box Petition

In August of 2012, the HSCG wrote a Citizen Petition to the FDA – Department of Health & Human Services, regarding the use of a PO Box in the place of a street address on a cosmetic label.  We did this mainly for the safety of the small businesses that make up the handcrafted soap and cosmetic industry as many of them operate out of their primary residence.   In February of 2013, we received an interim response from FDA stating that they were still reviewing the request and had not reached a decision.  The original petition as well as the supporting documentation can be viewed online at regulations.gov.

In November of 2014, we decided to send in a supplement letter to the petition to update FDA with our new name (the association changed from The Handcrafted Soapmakers Guild to The Handcrafted Soap & Cosmetic Guild in February of 2013) and our significant increase in membership (182% since the first petition).  We again requested that a PO Box be allowed in the place of a street address on a cosmetic label.

We received a final response letter from FDA denying our request to change the current regulation.  You can read the full letter here.

Even though the request was denied and the regulation will not change, there was some clarification on what constitutes a “telephone or city directory”.  You need to pay close attention to this…

Under current regulation, the business name and address (full street address) of the person or business responsible for the product must be on every cosmetic label.  The business address must include the street address, city, state and the ZIP code unless the business is listed in a current city or telephone directory under the business name.  In the response letter from FDA dated November 14, 2014, they defined “city directory or current telephone directory” as both print AND online and that either would satisfy the option under the current regulation if the street address is not listed on a cosmetic label.  They further offer the following examples of acceptable online directories that are “no cost or nominal cost” annually:

What this means for a small handcrafted soap and cosmetic business is that in order to meet the requirement under the regulation, to omit your street address, you would only need to list your business in one of these directories annually.  It would be important to keep the listing up to date with current information.

On the one hand, we were disappointed that a PO Box was not accepted but it was nice to see that the FDA is taking advantage of the non-traditional directory options offered by the internet.  On the whole, this is great news for our industry.

 

 

Label on!

Last week, the Handcrafted Soapmakers Guild welcomed author, past HSMG President, and savvy labeler Marie Gale into our twitter chat room to share some of her vast experience labeling soaps and cosmetics for sale in the US. Read on for highlights of our discussion.

Soap and Cosmetic Labeling #HSMGchat

Last week, the Handcrafted Soapmakers Guild welcomed author, past President, and labeling expert Marie Gale into our twitter chat room to share some of her vast experience labeling soap for sale in the US. Read on for highlights of our discussion and check out our post on the HSMG blog.

Storified by HandcraftedSoapGuild · Mon, Aug 27 2012 18:59:32

We started with the obvious….
Q1: Correct labeling…why should a biz owner care? #HSMGchatHandcraftedSoapGuild
and Heather from Honestly Simple Soaps jumped in with a great answer!
@TheSoapGuild Its important to people who have allergies and other sensitivities. #hsmgchatHeather Albrecht
Then, we established that although there are soap exemptions, most soap here in the US falls under cosmetic regulations.  Forewarned is forearmed!
Q2: Based on how US soapmakers market their products, how often do you think soap is considered soap and not a cosmetic? #HSMGchatHandcraftedSoapGuild
A2: likely not very often. Labeling includes your marketing info, which almost always turns your soap into a cosmetic! #HSMGchatHandcraftedSoapGuild
Oh! I just re-read that, I meant its probably a considered a cosmetic most of the time – moisturizing/ exfoliating, etc. yes? #hsmgchatHeather Albrecht
The way you package your products definitely impacts your labeling:
I don’t use boxes, that’s a question I had about packaging. I see soaps in stores not enclosed in a package. Is it okay to be open #hsmgchatHeather Albrecht
@HonestVTSoaps yup, it’s okay to be open, but full labeling information has to be available to consumer (even if separate) #HSMGchatHandcraftedSoapGuild
Okay, so just where does that pesky net weight statement go? 
Does it matter where the net weight is stated on the packaging? I’ve seen some indicate it on the front, and some on the back. #HSMGchatNoir Naturals
@NoirNaturals good one! Net weight has to be on the front…this is one of the non-negotiable labeling guidelines #HSMGchatHandcraftedSoapGuild
Marie clarified that different levels of government have a different focus when it comes to labeling enforcement:
Q7: Any speculation as to which guidelines the FDA most rigorously enforces? #HSMGchatHandcraftedSoapGuild
A7 – FDA concentrates heavily on drug claims on cosmetics. If they find that, then they are likely to look further. #HSMGchatMarieGale
A7 – LOCAL and STATE agencies are more likely to pick up on incorrect or missing weight or name/address. #HSMGchatMarieGale
Speaking of drug claims….
what counts as a ‘drug claim’ #hsmgchatHeather Albrecht
@HonestVTSoaps Drug claim is that the product will "heal, cure, mitigate or prevent" something physical. #HSMGchatMarieGale
@HonestVTSoaps Cosmetics "cleanse, beautify or promote attractiveness". There’s a big gray area in the middle. #HSMGchatMarieGale
@HonestVTSoaps The bottom line is what the consumer thinks the product will do (or what the FDA thinks the consumer thinks) #HSMGchatMarieGale
so when talking about tea tree oil in your product, for instance, is it okay to mention that it has antibacterial properties? #hsmgchatHeather Albrecht
@HonestVTSoaps Technically, saying an ingredient can cure, mitigate or prevent disease is making a drug claim for the product. #HSMGchatMarieGale
"Antibacterial" is a drug claim, for sure. #HSMGchatMarieGale
Anything WITH or ON the product counts as labeling, so website, signage, the label itself, books displayed with the product … #HSMGchatMarieGale
Best is to say what’s in the product and then let the consumer research it separately. Savvy consumers know what to look for. #HSMGchatMarieGale
At craft shows I’d say, "I can’t legally say that tea tree oil is antibacterial – or that it does anything, but it IS in my soap!" #HSMGchatMarieGale
You can also say things like "we choose our ingredients because of they are known to be healthy and beneficial" – but no specifics #HSMGchatMarieGale
@MarieGale yes, if customers seek you out, they probably know the properties of your ingredients. #HsmgchatTygerheart Fine Soap
@tygerheartsoap great point – consumers are a smart bunch #HSMGchatHandcraftedSoapGuild
Any surprises in the labeling regulation world?  Of course!!
So @MarieGale, is there anything that surprises you the most about soap and cosmetic labeling regulations? #HSMGchatHandcraftedSoapGuild
I’m most surprised by the fact that they are so understaffed that they have to concentrate on the most flagrant violations. #HSMGchatMarieGale
FDA seems to concentrate on imports – it’s a "homeland security" thing. #HSMGchatMarieGale
Local and state agencies have been more active over the last few years – possible as a revenue stream. #HSMGchatMarieGale
From enforcement, we move right into another hot topic – soap weight!
Here is a totally off the topic question: how is the weight of a recipe calculated? It will say 58 oz ie. and yield 89 oz of soap? #hsmgchatHeather Albrecht
@HonestVTSoaps Weight of recipe is ALL of the ingredients you put in the pot – oils, water, lye, eo/fo, color, herbs, etc. #HSMGchatMarieGale
@HonestVTSoaps Water percent is the amount of water divided by the total of all ingredients. (Gives a decimal, x by 100 for %) #HSMGchatMarieGale
Member Carol from Tygerheart Fine Soaps shares how she determines the net weight of her soaps:
@MarieGale I figured my soaps are always 17% water so I subtract that. They can’t go below it. #HsmgchatTygerheart Fine Soap
@tygerheartsoap That’s an excellent way to do it. If soap is 17% water, it won’t ever go below that, no matter how dry it gets. #HSMGchatMarieGale
And Heather clarifies differences in procedure for hot processed soap:
yes, how do you calculate the net weight and water evap? I make HP soap, does it make a difference? #hsmgchatHeather Albrecht
@HonestVTSoaps For hot process, you’d need to weigh the batch once made, deduct the weight of all non-water ingredients & then … #HSMGchatMarieGale
@HonestVTSoaps .. that will tell you how much water is left in the soap that could evaporate. Calculate the percentage & use that #HSMGchatMarieGale
From what I’ve seen, water is usually 15 – 20% in CP. In HP, it’s probably less. #HSMGchatMarieGale
If you’re going to sell your soap in a few weeks or months, you can weigh the soap when it comes out of the mold, and then each wk #HSMGchatMarieGale
That will tell you how much it loses over time. That will give you some numbers to work with if you are selling soon. #HSMGchatMarieGale
The net weight needs to be correct when on display and when sold … if it gets less after the customer buys, not your problem. #HSMGchatMarieGale
Also check out Marie’s blog for two methods (part 1 and part 2) to help you calculate net weight.

As member Noir Naturals discovers, calculating the amount of water for soaps made with alternative liquids can get tricky:

How much different is it with goat milk soap that contain no water? #HSMGchatNoir Naturals
@NoirNaturals You’d need to know how much fat and other non-water stuff was in the goat’s milk and add that to the non-water amt #HSMGchatMarieGale
And finally, Carol closes out the evening with a great question for Marie:
@mariegale, your labeling book had been very helpful. What gave u the idea to write it? #HsmgchatTygerheart Fine Soap
@tygerheartsoap The confusion I encountered when trying to label my soap was the first thing. #HSMGchatMarieGale
@tygerheartsoap Then it was the amazing amount of WRONG information I found on the web. #HSMGchatMarieGale
@tygerheartsoap Since I actually LIKE reading regulations (I know, strange), and I like writing, it seemed a natural fit. #HSMGchatMarieGale

Find the full text by searching for #HSMGchat on twitter.  Thanks to Marie for sharing her expertise with us and thanks to everybody who joined us and followed along in the chat room.

What would you like to see in a future twitter chat?

Come Chat with Us!

We’re having a tweet party and you’re invited!  Come to HSMG’s twitter chat debut on Wednesday, August 22 at 5pm Pacific/8pm Eastern.  Resident labeling expert Marie Gale, author of Soap and Cosmetic Labeling: How to Follow the Rules and Regs Explained in Plain English, will be on hand to answer your most pressing questions about labeling.Labels, why do you confound us so?

How does it work?

When the chat starts, we will tag all tweets with #HSMGchat. The HSMG twitter account will moderate the proceedings, starting by introducing our expert guest, Marie Gale, asking Marie a few questions and then inviting you to jump in with questions.

Make sure to tag your question with #HSMGchat so that everyone participating can see it.  In fact, feel free to send a tweet to @TheSoapGuild before the chat with your questions.

You can search for tweets tagged with #HSMGchat directly from twitter, but even better, you can join the party by using TweetChat.

Never used TweetChat before?  No worries.  You’ll get the hang of it in no time.  Here’s how to do it:

  1. Go to the tweetchat website for our chat
  2. Click “Sign In” to sign in with your twitter account and boom, you’re ready to party!

TweetChat will automatically add the #HSMGchat hash tag to your tweets so that everyone can follow the discussion.  TweetChat will also show you all the tweets being tagged with #HSMGchat.

Start asking your questions now…tweet them to @TheSoapGuild.

Mark Your Calendars!
what: HSMG’s first-ever twitter chat
when:  5:00pm PDT (6:00 pm Mountain, 7:00 pm Central, 8:00 pm Eastern) Convert to your time zone here.
where: http://tweetchat.com/room/HSMGchat
why: to discuss labeling: the good, the bad, and the ugly with expert Marie Gale

Hope to see you all there!

It’s your turn.  Have you ever attended a twitter chat?  Have any labeling triumphs (or tragedies) to share?