Re: Re: Private Label Update

[Guest guest]

Hi Alice,

The information on the FDA website can be a little overwhelming. May I suggest

that when you have questions concerning compliance with FDA regulations and

conflicting information from various sources (like me and others), you also

consider contacting your Regional FDA office and speaking to a Compliance

Officer. Here is the phone number for the Regional Office in the Pacific

Northwest:

Seattle District (SEA-DO), 2201 23rd Drive SE, Bothell, WA 98021-4421

Main Number and Emergency (after hours) Answering Service

In an earlier Pam stated: Even a private label needs to contain information

about whom the manufacturer is. You need to insist that your company name,

contact info, and website be included somewhere on the label preceded by a

statement saying something like, " Manufactured exclusively for [Client Name] by

.... " Just tell them the FDA requires that the city of manufacture be included on

the label. Seems silly to include the city without indicating the company, too

.... but I suppose I'm not a neutral opinion on this.

As I mentioned before, these statements are not correct. It is the name and

address of the marketer that must be on the label. A marketer may be a

manufacturer, a packer, or a distributor (the FDA doesn't care). But in the case

of Private Label, if a company has contracted with a manufacturer to create a

private label product for them to market, the manufacture's name or city/state

does not need to be on the label in addition to the marketer's. That is not to

say that both cannot be on the label if you and your customer want both on

there, but to say that both must be on there or that the manufacturer's must be

on there is incorrect.

We have been referring to an excerpt of the CFR that is quoted on this page:

http://www.cfsan.fda.gov/~dms/cos-lab1.html

This is an excerpt from Title 21, Code of Federal Regulations (21 CFR) Part 701

covering Cosmetic Labeling. The full text of the actual regulations can be

found here (and might make things a little clearer):

http://frwebgate.access.gpo.gov/cgi-bin/get-cfr.cgi?TITLE=21 & PART=701 & SECTION=12\

& YEAR=2000 & TYPE=TEXT

Please note below in Sec 701.12 (a), ( it clearly states: " The requirement for

declaration of the name of the manufacturer, packer, OR distributor, " not AND

distributor.

TITLE 21--FOOD AND DRUGS

DEPARTMENT OF HEALTH AND HUMAN SERVICES--(Continued)

PART 701--COSMETIC LABELING--Table of Contents

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.

( 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.

© 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.

I called today and spoke at length with a Compliance Officer at the Seattle

office of the FDA regarding the above Private Label issues. She confirmed my

understanding of the regulations. There are hundreds of companies in this

country doing private label contracting for distributors large and small. In

most cases, the actual manufacturer of the goods will NOT be known by the

consumer, unless by agreement of the parties they want it known to promote the

marketer's " exclusive " arrangement with the manufacturer of a well known

product. If you are doing Private Label for a customer, it is perfectly correct

NOT to have the manufacturer's name or city/state on the label. However, your

customer's name and address must be on the label and must be preceded by:

" Distributed BY " or " Manufactured FOR, " or words to that effect, to make it very

clear the relationship the distributor/marketer (your customer) has with the

product (in other words, they didn't manufacturer it, somebody else manufactured

it for them).

Regards,

Lotioncrafter

www.lotioncrafter.com

Re: Private Label Update

| Well, I am so grateful for all the response and thoughts on the private

| label questions I posed. I did go into the FDA site and read till I was

| crosseyed and what I gleaned from it was exactly what Pam said " the name of

| the manufacturer, distributor or packager " is what the FDA said has to be on

| the label. And I already put " Made in Gold Beach, Oregon especially for XXX

| Gifts " followed by her addy and such.

|

[Guest guest]

I felt the need to add that Pam and Pamela are two different people in this

discussion. , you refer to Pamela as Pam and it may cause confusion on

the conversation topic when reading back through all the info in this

thread. She and I are both responding to this issue and it may be a tad

confusing.

I've enjoyed the thread and have taken much away for my records. Thanks

and to all who have responded.

Pamela is more seasoned than I and I just felt the need to clarify that. I'm

the Pam thinking outloud and asking questions.

<*S>

the other Pam

[Guest guest]

LOL ... " more seasoned " ... that cracked me up.

I think it's very interesting that several of us have very different

interpretations of these guidelines. I think this is definitely an area worthy

of calling our FDA reps and seeing what they say.

Heck ... I lead seminars on FDA labeling and I'm even confused about this

now!!!!!!!!!!!! I hate that!!!! LOL

Pamela Reilly

Pleasing Odors Creations

www.pleasingodors.com

Re: Re: Private Label Update

I felt the need to add that Pam and Pamela are two different people in this

discussion. , you refer to Pamela as Pam and it may cause confusion on

the conversation topic when reading back through all the info in this

thread. She and I are both responding to this issue and it may be a tad

confusing.

I've enjoyed the thread and have taken much away for my records. Thanks

and to all who have responded.

Pamela is more seasoned than I and I just felt the need to clarify that. I'm

the Pam thinking outloud and asking questions.

<*S>

the other Pam

[Guest guest]

I'm sorry, Pam E. I do know there are both a Pamela and a Pam E. here. The

problem was that I was responding to a message from Alice at Moose Creek. Alice

referred to Pam, not Pamela as follows:

>>From: " Moose Creek " <moosecreekcreations@...

>>< >

>>Sent: Tuesday, July 20, 2004 10:15 PM

>>Subject: Re: Private Label Update

>> " I did go into the FDA site and read till I was

>>crosseyed and what I gleaned from it was exactly what Pam said " the name of

>>the manufacturer, distributor or packager " is what the FDA said has to be on

>>the label. And I already put " Made in Gold Beach, Oregon especially for XXX

>>Gifts " followed by her addy and such.

I looked at your response on the earlier thread and knew that you were not the

Pam that Alice was referring to above. The snippet from the thread above was

from Pamela/Pleasing Odors and I was reiterating Pamela's full statement again

to clarify, based on my conversation with the FDA, that labeling in the manner

Pamela was suggesting was not necessary.

LOL I'll say no more (and get out of the hole I'm digging myself into <g>).

Lotioncrafter

www.lotioncrafter.com

Re: Re: Private Label Update

I felt the need to add that Pam and Pamela are two different people in this

discussion. , you refer to Pamela as Pam and it may cause confusion on

the conversation topic when reading back through all the info in this

thread. She and I are both responding to this issue and it may be a tad

confusing.

I've enjoyed the thread and have taken much away for my records. Thanks

and to all who have responded.

Pamela is more seasoned than I and I just felt the need to clarify that. I'm

the Pam thinking outloud and asking questions.

<*S>

the other Pam

[Guest guest]

( said)...I'll say no more (and get out of the hole I'm digging myself

into <g>).

no no don't you duck and run! You're a valuable player here! I always

appreciate your input, no matter the subject.

Pam