In November of 2012, I blogged about the Citizen Petition filed with the FDA by the Handcrafted Soapmakers Guild (now known as the Handcrafted Soap & Cosmetic Guild). The blog was about the current regulation of requiring a home address on the label of cosmetic products. The petition requested that the FDA allow a PO Box address on the label, in place of a physical home address. Many small business owners run their business in their home and some are concerned that placing a home address on the label of a product introduces personal risk. Replacing the business address with a PO Box would eliminate this risk.
UPDATE 9/19/2017: The FTC has updated regulations concerning business name and address. The NEW regulation says the street address may be omitted if it is listed in a readily accessible, widely published, and publicly available resource. Read more here.
Since November of 2012, the HSMG filed an Amendment of Citizen Petition with the FDA on November 6, 2014. You can find the amendment here. This document briefly recaps the past events, including the response on February 1st, in which the Acting Director of the Office of Cosmetics and Colors stated they were unable to reach a decision. The amendment also presents new information, including the decision to change the name of the Handcrafted Soapmakers Guild, to the Handcrafted Soap & Cosmetic Guild.
Two years later, the Handcrafted Soap & Cosmetic Guild received a final response to the petition. The FDA denied the petition. You can read the final response from the FDA here. Bottom line, the FDA did not agree that a PO Box address would be a suitable alternative to a street address. The response reads:
“We disagree that allowing the listing of a PO Box on labeling in lieu of street address would be an acceptable amendment to 21 CFR § 701.12(d). In considering whether listing a PO Box is a suitable alternative to listing a street address, we must consider the definition of “principal place of business,” and its applicability to the use of a PO Box in lieu of a street address in this instance. “Principle place of business” commonly refers to a location where the corporation’s chief executives, head office or headquarters of a business can be found.”
While it is disappointing that the petition was denied, there is good news. In the response, the FDA states the street address may be omitted from the label if the business name is listed in a current telephone or city directory, including online directories. In the response, the FDA goes into detail regarding the various types of appropriate directory listings of phone numbers which include yellowpages.com and localpages.com. The response reads:
“Telephone directories are published both in print and online, and a listing in either would satisfy the option under 21 CFT 701.12(d) to list a street address in a current city directory or telephone directory, if the street address is not included on the product label.”
What does this mean for your labeling? You may omit the street address from your label if your phone number is listed in an appropriate directory (including online directories). For many small business owners, this is a simple way to meet the FDA’s new requirements. You can find the Handcrafted Soap and Cosmetic Guild’s summary of the events here.
Q & A via the Handcrafted Soap & Cosmetic Guild:
- Do I have to list my street address in the online listing?
Answer: 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.
- Does this cover soap too or just cosmetics?
Answer: 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.
What do you think of the new developments in this matter? Personally, I feel it’s a step in the right direction. I’m glad there is now an easy alternative to placing a home address on the product label.