FDA Responds to PO Box Petition

Industry News & Legislation19 Comments

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.

 

 


19 Comments on “FDA Responds to PO Box Petition”

  1. Thank you for the update. I work full time in a county library and we do not even allow you to use a PO Box for getting a card. You must prove that you live in the county physically. So, I can see where they are going with this. I am still not in support of handing out my home address but at least I can prove to them I make my products where I do. Thanks again for fighting the good fight!

  2. Ok. I went to the yellow pages online and saw that several businesses did not list a street address, but did put a city and telephone number. Are you saying this is okay for us?

  3. Not 100% great news, but we will take what we can get. Thank-you for the petition and fighting for our rights!

  4. What a great thing it is to be able to take my home address off of my labels. I make soap at home and it was always uncomfortable to have my address on my labels. I just did a free listing with yellowpages.com.
    It took all of 5 minutes for them to verify my business as legitimate and grant the business listing. They will show my home address, and that’s fine with me, at least its not on every single label!
    Thank you so much for all of your hard work on behalf off all of us. Sad they wouldn’t let PO boxes be used, but thank you for a second option.
    Alicia

  5. Thanks for fighting the good fight to get us at least this much of an accommodation. It will be nice not to have our home address on every label.

  6. I really want to start a small home-based soap making business, but I don’t want to put my home address on the label. There is no way I can afford to rent or buy a separate building in the beginning but I don’t want to take the chance of people just showing up to my home. Thanks for taking up for the small people such as myself.

  7. Barbara,

    The letter we received from the FDA states “Telephone directories are published both in print and online, and a listing in either would satisfy the option under 21 CFR 701.12 (d) to list a street address in a current city directory or telephone directory if the street address in not included on the product label.” Therefore, we interpret this to mean that the street address is required in the online and/or print listing.

  8. So glad to hear this!

    I need a bit of assistance with my FREE Yellow Pages listing.

    What category are Soapmakers using?

    Someone said the YP verified her business. Does anyone know how they do that? I don’t yet have an LLC or DBA for mine.

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  10. I have been in the on-line Yellow pages for a while now so great news! So my question is, once you have the public listing woith your street address, on the labels themselves, do we still need to have our company name , AND our town and state printed on it, just omitting the street address? And thnak you for all of your hard work!

  11. Thank you so much for this information! I am in the middle of getting my ducks in order for launching my skincare business and this was always such an uncomfortable area for me. Gratitude to those involved with making other options available!

  12. Theresa,

    This is from the FDA and applies to cosmetics and cosmetic labels. That being said, soap can either be classified as a cosmetic or as a consumer commodity depending on how it is formulated and marketed. When soap is made with it’s non-volatile portion being from the alkali salts of fatty acids and there are no cosmetic claims being made on the label, brochures, website etc, about the product (i.e.. moisturizing, deodorizing) is considered true soap and is regulated by the FTC as a consumer commodity not the FDA as a cosmetic. Therefore, the regulation mentioned in the FDA letter 21 CFR 701.12 (d) would not apply.

    Soap that is classified as a non-cosmetic consumer commodity and regulated by the FTC falls under the regulation 16 CFR 500.5 (c) “statement of the place of business shall include the street address, city, state and ZIP code; however, the street address may be omitted if it shown in a current city directory or telephone directory”.

    We have nothing that says this interpretation is being accepted by any other entity than the FDA at this time, nor do we have any information that it is not.

  13. Lisa,

    21 CFR 701.12 (d) states: “statement of the place of business shall include the street address, city, state and ZIP code; however, the street address may be omitted if it shown in a current city directory or telephone directory”. The FDA is now accepting ONLINE directories as well as print, however, only the street address may be omitted on the label, all of the other information must remain.

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