Your E-mail of 4/7/02 Re: 21 CFR 701.3 and Aubrey Organics

[Guest guest]

On April 7, 2002, I sent an email message to Mr. Curt Valva, General

Manager for Aubrey Organics. When I sent the email message to Mr.

Valva I also copies several people at the FDA.

This is the response that I received from the FDA. The original email

message, which can be found below, was also faxed and posted on the

Aubrey Organics discussion board.

-----------------------------------------------

Maurice O. Hevey

Convergent Cosmetics, Inc.

2393 Blaine Avenue

Orono, MN 55391

Dear Mr. Hevey:

We are in receipt of your April 7, 2002 E-mail note to Aubrey Organics

concerning the ingredient declarations that appear on various cosmetic

and cosmetic/drug products which that firm markets. You indicated that

although Aubrey Organics indicates on their message board that their

" ... labeling is in compliance with FDA regulations " , your review of

that firm's ingredient declarations reveal that none are fully

compliant with the 21 CFR 701.3.

We share your concern that products under our jurisdiction are properly

labeled (e.g., bear ingredient declarations that comply with 21 CFR

701.3) and otherwise meet the requirements of the laws and regulations

that we enforce. We will not offer specific comments on the products

referenced in your E-mail since it is our policy as a law enforcement

agency not to comment on the status of specific products to persons or

firms other than those responsible for the products and their labeling.

Additionally, we do not have actual labels for the products you

referenced or necessarily know all of the facts involved.

By way of general comment we can state that FDA established the

requirement for cosmetic ingredient declarations on product package

labeling under the authority of Section 5 of the Fair Packaging and

Labeling Act (FPLA) [c.f., Section 5©(3)(]. Specific requirements

for cosmetic ingredient nomenclature may be found at 21 CFR 701.3©.

Information relating to the international harmonization of cosmetic

ingredient labeling names may be found in correspondence between the

Food and Drug Administration (FDA) and The Cosmetic, Toiletry, and

Fragrance Association (CTFA) by visiting the FDA web site at

[www.fda.gov] and scrolling into " Cosmetics " . Once in the " cosmetics "

homepage, scroll into " International Activities " and then " Requests

Regarding the Harmonization of Ingredient Nomenclature " .

We thank you for bringing this matter to our attention. Alert industry

representatives such as yourself are often very helpful in identifying

violations of the laws that we enforce. In order to make our records as

complete as possible, to maximize the use of our limited resources and

to further evaluate the significance of the situation described in your

E-mail letter to Aubrey Organics, we would appreciate receiving labels

for some of the products you referenced as well as any specific

information you have developed with respect to the improper listing of

ingredients on Aubrey Organics products intended for domestic

distribution. You can be assured that we will conduct appropriate

follow-up as deemed necessary, commensurate with our obligation to

protect the public health and welfare.

Your interest in assuring that products under our jurisdiction are

properly labeled is appreciated.

Sincerely yours,

R. Halper

Office of Cosmetics and Colors

Division of Programs and Enforcement Policy, HFS-105

------------------------

The following email was sent to Mr. Valva:

>April 7, 2002

>

>Curt Valva

>General Manager

>Aubrey Organics

>4419 N. Manhattan Ave.

>Tampa, FL 33614

>

>Dear Mr. Valva,

>

>On February 20, 2002, you wrote the following on the Aubrey Organics

>Message Board:

>

> " Our legal department assures us that our labeling is in compliance

>with FDA regulations. To be sure we are current with the latest

>labeling legislation, we contacted the FDA last Thursday, February 14,

>2002, and were assured, once again, that we are in compliance. "

>

>I am having difficulty reconciling this statement and the ingredient

>declarations used on Aubrey Organics products with my interpretation of

>the FDA labeling regulations, specifically I am referring to Title 21

>of the Code of Federal Regulations Section 701.3(a).

>

>I have reviewed ingredient declarations on the following Aubrey

>Organics' products and found that none are fully compliant with the FDA

>cosmetic regulations as published in 21 CFR 701.3 as I understand them:

>

>Natural Baby and Kids Bath Soap

>Natural Baby and Kids Body Lotion

>Natural Baby and Kids Shampoo

>Blue Chamomile Bath Oil

>Blue Cypress Winter Bath

>Chamomile Bubbles Herbal Bath Oil

>Evening Primrose & Lavender Skin Care Bar

>G'Day Eucalyptus Bath Bar

>Herbal Liquid Body Soap

>Herbal Liquid Body Soap

>Honeysuckle Roser Vegetal Soap

>Meal & Herbs Exfoliation Skin Care Bar

>NSB (Natural Sports Bath) with Kava Kava

>Relax-R-Bath Herbal Bath Emulsion

>Relax-R-Bath Herbal Bath Emulsion

> Mosquetar Bath Jal‚a

> Mosquetar Moisturizing Cleansing Bar

> Mosquetar Rose Hip Complexion and Body Soap

>Sea Buckthorn Skin Care Bar with Sandalwood

>Sea Spa Bath Liquid

>Seasoap Face & Body Cleansing Cream

>White Camellia and Jasmine Emollient Soap

>Calaguala Skin Treatment Bar

>NSB (Natural Sports Bath) with Kava Kava

>100% Pure and Certified Organic Aloe Vera Gel

>After Sun Natural Tanning Maintenance

>Swimmers Conditioner

>Swimmers Shampoo

>

>I also found that labeling on the following OTC drugs are also non

>compliant with my interpretation the same FDA cosmetic labeling

>regulations as well as those that apply to OTC drugs:

>

>Titania Full Spectrum Sunblock SPF 25

>Green Tea Sunblock for Children SPF 25

> Mosquetar Sun Protection Herbal Butter SPF 12

>Swimmers Moisturizer SPF 15

>Sun Shade Ultra 8

>Sun Shade Ultra 4

>Sun Shade Ultra 15

>Sun Shade Ultra 12

>Saving Face SPF 10 Spray

>

>Surely the FDA is the final authority in the matter and I would like to

>resolve the obvious conflict that I see between your statements that

>Aubrey Organics labeling is in compliance with FDA regulations and that

>you current with the latest labeling regulations.

>

>As a cosmetic industry professional and small business person, I have

>been advising my clients to use International Nomenclature Cosmetic

>Ingredients (INCI) names when labeling their cosmetic products. If

>your statement cited above is true, then it appears that I may have

>advised my clients incorrectly.

>

>Perhaps you could be so kind as to let me know to whom your legal

>department spoke to at the FDA. Did you contact someone at the FDA

>district office? I would like to resolve this matter so that I can

>advise my clients that they no longer have to use INCI names.

>

>Thank you very much for your time.

>

>Sincerely,

>

>Maurice O. Hevey

>Convergent Cosmetics, Inc.

>2393 Blaine Avenue

>Orono, MN 55391