FDA responds to PO Box Petition

[Moody Glenn]

Moody Glen, just so you know, your lawyer could be subject to disciplinary action for advising you to break the law.

JStar, that is incorrect. Federal law supercedes state law, states can be more stringent but not less so. You are correct that as long as you are just making and selling soap, that does not fall under FDA regs, but it DOES fall under the Consumer Protection Act and is subject to Fair Labeling, and that also requires you to list the physical address or be listed in a directory.

Look, folks, comply with the law or choose to take the risk and don't comply. I just think it is important to anyone that reads this thread to understand the law so they can make an informed decision for themselves, and the fact is that if you are selling soaps or cosmetics at all you must list the address of your place of manufacture or primary place of business on the label or in a directory. Period.

eta: anywhere within the US, that is!

Hello new12soap! Thank you for your comment and information - and I do mean this. My opinion and views of this particular post falls under Henry David Thoreau's attitude of civil disobedience. I will have to contact the lawyer to get his new assessment of the current FDA regulations. He was only looking after my concerns about home safety. If I definitely have to comply with this "law" - then I will shut my home business down and end it. I am not paranoid but it's not worth the potential troubles - legal or safety wise. I totally understand protecting the consumer - since I am one - but I also value protecting my family and home from certain types of consumers a whole lot more.

 

[new12soap]

Glen, I completely understand your position, and I am not disagreeing with you in principle. The whole point of the petition to the FDA was because so many homecrafters feel that this regulation puts them at risk.

My concern was someone else coming along later and saying, "well, I read on an internet forum that someone's lawyer said you don't have to..."

It is surprising to me how many people are actually selling product and either don't know about the regs or sincerely believe that this does not apply to them. Again, I don't work for the FDA or the Consumer Protection Agency, I am not the label police. If you or anyone else who knows the law and is aware of the potential penalties chooses not to comply, that is absolutely your decision. I just like to make sure the information is accurate!

 

[Moody Glenn]

New12soap - Thank you for the clarification. Well stated and I understand.

 

[Cindy2428]

Glen in my heart and my unwillingness to be a "sheep" I completely agree with you. But that being said, if I was to sell I would follow the law. Earthen Step what a wonderful idea! I have some of my supplies shipped to my husband's business anyway, so potentially I could use that. I have been struggling with this since the beginning and this item remains #2 on my Con List for starting a business. (#1 Con is going back to 12-14 hr work days to get a one-woman show up and running again).

 

[Moody Glenn]

Glen in my heart and my unwillingness to be a "sheep" I completely agree with you. But that being said, if I was to sell I would follow the law. Earthen Step what a wonderful idea! I have some of my supplies shipped to my husband's business anyway, so potentially I could use that. I have been struggling with this since the beginning and this item remains #2 on my Con List for starting a business. (#1 Con is going back to 12-14 hr work days to get a one-woman show up and running again).

Hi Cindy! Thanks for your support and advice. I get so worked-up about many issues. My heart always speaks louder than my brain most of the time. (Actually, my stomach has the loudest voice but that's a totally different thing). Most likely I will "bite the bullet" and sign-up for one of those websites just to satisfy "the Fed". I love what I do and I am old enough to realize that compromises have to be made - even if I am so darn frustrated over an issue.

Hey, life is too short. Go ahead and become the best 'one-woman-show' out there! :clap:

 

[Jstar]

JStar, that is incorrect. Federal law supercedes state law, states can be more stringent but not less so. You are correct that as long as you are just making and selling soap, that does not fall under FDA regs, but it DOES fall under the Consumer Protection Act and is subject to Fair Labeling, and that also requires you to list the physical address or be listed in a directory.

, and the fact is that if you are selling soaps or cosmetics at all you must list the address of your place of manufacture or primary place of business on the label or in a directory. Period.

eta: anywhere within the US, that is!

Im sorry, but I think you are mixing cosmetics with soap...Here is the law, and I have highlighted areas with >*< and >italics< etc



===============

[Code of Federal Regulations]
[Title 21, Volume 7]
[Revised as of April 1, 2014]
[CITE: 21CFR701.12]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER G--COSMETICS

PART 701 -- COSMETIC LABELING

Subpart B--Package Form
Sec. 701.12 Name and place of business of manufacturer, packer, or distributor.

(a) **The label of a cosmetic** in package form shall specify conspicuously the name and place of business of the manufacturer, packer, or distributor.

(b) The requirement for declaration of the name of the manufacturer, packer, or distributor shall be deemed to be satisfied in the case of a corporation only by the actual corporate name, which may be preceded or followed by the name of the particular division of the corporation. Abbreviations for "Company," "Incorporated," etc., may be used and "The" may be omitted. In the case of an individual, partnership, or association, the name under which the business is conducted shall be used.

(c) Where the cosmetic is not manufactured by the person whose name appears on the label, the name shall be qualified by a phrase that reveals the connection such person has with such cosmetic; such as, "Manufactured for _______", "Distributed by ________", or any other wording that expresses the facts.

(d) The 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 is shown in a current city directory or telephone directory. The requirement for inclusion of the ZIP Code shall apply only to consumer commodity labels developed or revised after the effective date of this section. In the case of nonconsumer packages, the ZIP Code shall appear either on the label or the labeling (including the invoice).

(e) If a person manufactures, packs, or distributes a cosmetic at a place other than his principal place of business, the label may state the principal place of business in lieu of the actual place where such cosmetic was manufactured or packed or is to be distributed, unless such statement would be misleading.
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==

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=701.20

[Code of Federal Regulations]
[Title 21, Volume 7]
[Revised as of April 1, 2014]
[CITE: 21CFR701.20]


TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER G--COSMETICS

PART 701 -- COSMETIC LABELING

Subpart C--Labeling of Specific Ingredients
Sec. 701.20 Detergent substances, **other than soap,** intended for use in cleansing the body.

(a)** In its definition of the term cosmetic, the Federal Food, Drug, and Cosmetic Act specifically excludes soap. The term soap is nowhere defined in the act.** In administering the act, the Food and Drug Administration interprets the term "soap" to apply only to articles that meet the following conditions:

(1) The bulk of the nonvolatile matter in the product consists of an alkali salt of fatty acids and the detergent properties of the article are due to the alkali-fatty acid compounds; and

(2) The product is labeled, sold, and represented only as soap.

**(b) Products intended for cleansing the human body and which are not "soap" as set out in paragraph (a) of this section are "cosmetics," and accordingly they are subject to the requirements of the act and the regulations thereunder.** [this I think is talking about shampoo's, body wash etc] For example, such a product in bar form is subject to the requirement, among others, that it shall bear a label containing an accurate statement of the weight of the bar in avoirdupois pounds and ounces, this statement to be prominently and conspicuously displayed so as to be likely to be read under the customary conditions of purchase and use.

To me, this is pretty clear of the differences of cosmetics and soap...however that being said, I always list my ingredients for my customers, and as far as address, that I do include on home made goods {cottage law is for anything baked or cooked, canned at home and sold that does not require temperature control to prevent spoilage}

 

[Jstar]

Also, this is from TxDHHS, which is in cahoots with the FDA so Im pretty sure I can safely follow these rules for home made goods.

http://www.dshs.state.tx.us/foodestablishments/cfpo/

During the 83rd Legislature, Regular Session 2013, the Texas Legislature enacted House Bill 970 that amends the Health and Safety Code (HSC), Chapter 437, by amending provisions for cottage food production operations. This law is effective September 1, 2013.
A cottage food production operation is exempt from the requirements of a food service establishment and does not have to comply with the Texas Food Establishment Rules. Health departments do not have regulatory authority to conduct inspections of a cottage food production operation. However, the Department or local health authority has authority to act to prevent an immediate and serious threat to human life or health through emergency order, recall orders and delegation of powers or duties. Health departments are required to maintain records of all complaints against a cottage food production operation.
A cottage food production operation is defined as an individual, operating out of the individual’s home, who:

• Produces a baked good, candy, coated and uncoated nuts, unroasted nut butters, fruit butters, a canned jam or jelly, a fruit pie, dehydrated fruit or vegetables, including dried beans, popcorn and popcorn snacks, cereal, including granola, dry mix, vinegar, pickles, mustard, roasted coffee or dry tea, or a dried herb or dried herb mix.
• Has an annual gross income of $50,000 or less from the sale of the described foods; and
• Sells the foods produced directly to consumers at the individual’s home, a farmers’ market, a farm stand, or a municipal, county, or nonprofit fair, festival or event.
• Delivers products to the consumer at the point of sale or another location designated by the consumer.

An individual who operates a cottage food production operation must successfully complete a basic food safety education or training program for food handlers accredited under Health and Safety Code, Chapter 438(D) by January 1, 2014.
A cottage food production may not sell to customers potentially hazardous foods. A potentially hazardous food (PHF) is a food that requires time and temperature control for safety (TCS) to limit pathogen growth or toxin production. In other words, a food must be held under proper temperature controls, such as refrigeration to prevent the growth of bacteria that may cause human illness. A PHF/TCS is a food that: contains protein, moisture (water activity greater than 0.85), and is neutral to slightly acidic (pH between 4.6 -7.5).
Foods sold by a cottage food production operation must be packaged and labeled. The food must be packaged in a manner that prevents product contamination, except for foods that are too large and or bulky for conventional packaging. The labeling information for foods that are not packaged must be provided to the consumer on an invoice or receipt. The label must include:

• The name and address of the cottage food production operation;
• The common or usual name of the product, if a food is made with a major food allergen, such as eggs, nuts, soy, peanuts, milk or wheat that ingredient must be listed on the label; and
• A statement: “This food is made in a home kitchen and is not inspected by the Department of State Health Services or a local health department."
• The labels must be legible.

Food produced by a cottage food production operation may not be sold via the Internet, by mail order or at wholesale.
The Department of State Health Services is in the process of amending the rule, Section 229.661, concerning cottage food production operations.

 

[Earthen_Step]

Right Jstar, that's how I understand it (soap and cosmetic are different). Soap has no requirements unless you use cosmetic wording turning your soap into a cosmetic. I use words such as "exfoliate" and "conditioning" and "moisturizing" which turns my product into a cosmetic. If you don't do this then you aren't required to label your address under cosmetic label laws. If you are selling it as soap only, you can omit any portion you desire. You can even sell it with no packaging at all, or wrap it in blank tissue paper. When you add a cosmetic word or phrase you need to comply with cosmetic laws.

Pretty silly stuff IMO

 

[Jstar]

Exactly

 

[Jstar]

Not to take this too far off the track, but in addition to the PO boxes being allowed, Id like to see the cottage laws to be able to extend to online...we're making progress tho because before we could only sell at our homes.

 

[girlishcharm2004]

...you have the potential to have weird people stopping by at all hours to sample products, sniff the soap, ask for samples, ask if you have kids, dogs, etc. I think you get the general idea. All it takes is one very determined person...

The first thought that went through my mind was a meth addict seeking ingredients (lye). I've had this happen before -- someone break into my home for drug money, ingredients, etc. It is very violating. I wouldn't wish it on anyone.

http://youtu.be/iv4L2wkisVI

 

[girlishcharm2004]

"But that'll cost more!" Well, too bad. Your customers deserve the ability to have a sure fire way to get hold of you in case they need to. Don't forget that some people might well ignore an email or phone calls from a customer seeking damages - so the solution is a physical location.

It sounds like the PO box offer from the FDA is a great compromise. It shows they are taking the soapers concerns on board but still protecting your customers.

The post office is acting as the medium with a P.O. Box. The government can still get a hold of you even if your customers don't know where you live. That's what we call "certified mail" (proof you received the message) and/or a "subpoena" (a policeman serving you to appear in court). The customer has no reason to know where you live.

The FDA isn't allowing the P.O. Box. I'm not sure where you got that information from. They are not taking any concerns. What they are saying is that if someone can search Google for "The Efficacious Gentleman's Soaps" and find your home address in, say, YellowPages.com, then you can omit your address from your packaging. Not really a compromise at all.

 

[new12soap]

Jstar, yes there is a difference between just plain soap and anything that qualifies as a cosmetic. True, soap is exempt from the regulations set forth by the FDA.

Soap does however fall under the Consumer Protection Agency and the Fair Packaging and Labeling Act http://www.ecfr.gov/cgi-bin/text-id...rgn=div5&view=text&node=16:1.0.1.5.62&idno=16

Soap must be labeled correctly, not as a cosmetic (unless, of course it IS a cosmetic) but as a consumer commodity, and that includes using the physical address or being listed in a directory, exactly like the FDA requirements.

From the regs:
§500.5 Name and place of business of manufacturer, packer or distributor.

(a) The label of a consumer commodity shall specify conspicuously the name and place of business of the manufacturer, packer, or distributor. Where the consumer commodity is not manufactured by the person whose name appears on the label, the name shall be qualified by a phrase that reveals the connection such person has with such commodity; such as “Manufactured for ___,” “Distributed by ___,” or any other wording that expresses the facts.

(b) The requirement for declaration of the manufacturer, packer, or distributor shall in the case of a corporation be deemed to be satisfied only by the actual corporate name, which may be preceded or followed by the name of the particular division of the corporation. In the case of an individual, partnership, or association, the name under which the business is conducted shall be used.

(c) The 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 is shown in a current city directory or telephone directory.

(d) If a person manufactures, packs, or distributes a consumer commodity at a place other than his principal place of business, the label may state the principal place of business in lieu of the actual place where such consumer commodity was manufactured or packed or is to be distributed, unless such statement would be misleading.

(e) Standard abbreviations may be used in complying with the requirements of this section.


I have not yet seen any clear indication of whether the Consumer Protection Agency has changed their terms to allow for listing in an online directory as the FDA has or not.

 

[new12soap]

Right Jstar, that's how I understand it (soap and cosmetic are different). Soap has no requirements unless you use cosmetic wording turning your soap into a cosmetic. I use words such as "exfoliate" and "conditioning" and "moisturizing" which turns my product into a cosmetic. If you don't do this then you aren't required to label your address under cosmetic label laws. If you are selling it as soap only, you can omit any portion you desire. You can even sell it with no packaging at all, or wrap it in blank tissue paper. When you add a cosmetic word or phrase you need to comply with cosmetic laws.

Pretty silly stuff IMO

Earthen Step, that is totally incorrect. There are very clear regulations regarding the labeling of soap, it just doesn't fall under the FDA unless it is also a cosmetic or a drug. Please see the link in my previous post.

 

[Jstar]

What do you make of this section?
=============
(c) The term consumer commodity or commodity means any article, product, or commodity of any kind or class which is customarily produced or distributed for sale through retail sales agencies or instrumentalities for consumption by individuals, or use by individuals for purposes of personal care or in the performance of services ordinarily rendered within the household, and which usually is consumed or expended in the course of such consumption or use. For purposes of the regulations in this part the term consumer commodity does not include any food, drug, device or cosmetic as defined by section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321); any meat or meat product, poultry or poultry product, or tobacco or tobacco product; any commodity subject to packaging or labeling requirements imposed by the Administrator of the Environmental Protection Agency pursuant to the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136 et seq.); any commodity subject to the provisions of the eighth paragraph under the heading “Bureau of Animal Industry” of the Virus-Serum-Toxin Act (21 U.S.C. 151-157); any beverage subject to or complying with packaging or labeling requirements imposed under the Federal Alcohol Administration Act (27 U.S.C. 201 et seq.); any commodity subject to the provisions of the Federal Seed Act (7 U.S.C. 1551-1610).

 

[The Efficacious Gentleman]

I read that as "if it is cosmetic (lotion etc, shaving soap or soap where you make cosmetic claims) then you need to use the FDA system. Otherwise, use ours"

My mistake on the PO box thing - I did mean the online listing.

Let's not forget, your home address is available to people who might well be weirdos. All of your suppliers who deliver to your house - do you know all of their employees aren't the sorts of people you are looking to avoid? Not forgetting - your house is physically there for any passerby to just walk up to.......

 

[Earthen_Step]

Earthen Step, that is totally incorrect. There are very clear regulations regarding the labeling of soap, it just doesn't fall under the FDA unless it is also a cosmetic or a drug. Please see the link in my previous post.

Thanks for the clarification.

(a) The label of a consumer commodity shall specify conspicuously the name and place of business of the manufacturer, packer, or distributor. Where the consumer commodity is not manufactured by the person whose name appears on the label, the name shall be qualified by a phrase that reveals the connection such person has with such commodity; such as “Manufactured for ___,” “Distributed by ___,” or any other wording that expresses the facts.

I still think this is our best option. Go pack your soap up at a place of business you trust that will let you do so.

 

[new12soap]

JStar, Craig is correct. Anything that is a food, drug, device, or cosmetic is covered by the FDA. Anything else (soap!)* is covered by the CPA.

Essentially the only difference in labeling requirements for soaps and cosmetics is the ingredients. For just soap you are not required to list the ingredients (however, if you do list any ingredients, you must list all ingredients and do so correctly), for cosmetics you are. That's it. Soap must still be labeled with what it is, how much of it there is (by weight), the name of the manufacturer, and where it was made.

Again, all I am doing is pointing out what the regulations are and where to find them. What you do with the info is up to you, I just want everyone to have the correct information on which to base their decision.

*everything else for purposes of our discussion in a soap and bath and body forum, the other exceptions as noted in the section JStar quoted still apply!

**this applies only to the USA, this is an international forum and each country has their own rules and regulations.

 

[Earthen_Step]

The post office is acting as the medium with a P.O. Box. The government can still get a hold of you even if your customers don't know where you live. That's what we call "certified mail" (proof you received the message) and/or a "subpoena" (a policeman serving you to appear in court). The customer has no reason to know where you live.

I agree completely girlishcharm -- I hope someday the laws are changed. I also applaud those who knowingly omit the information as an act of civil disobedience. I hope you are never harassed for it! I also appreciate your efforts as well New12Soap, it's good to be informed on the laws in whatever business you are into. Some good info has come up over the life of this thread, thanks for all your input.

 

[new12soap]

Thanks guys Like I said, I don't disagree with a little civil disobedience now and then, either. And I really have to say that I appreciate the level of discourse around here, that everyone can ask questions, share information, and be so receptive to one another!