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IBN Members FDA Call: How To Manufacture, Label and Sell Your Cosmetics

Event Details

IBN Members FDA Call: How To Manufacture, Label and Sell Your Cosmetics

Time: February 22, 2012 from 1pm to 3pm
Location: online
Event Type: webinar
Organized By: dM, CEO
Join the Discussion: Mar 21, 2012

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Event Description

This Event Is Over!

All times are EST! This is an exclusive IBN Member event. To join IBN so you can benefit from this and other members only events, click here.

Get the answers to your questions about how your soaps, lotions, creams, mineral makeup, sugar scrub and more are regulated by the US Food & Drug Administration -- and get the answers from the horse's mouth!

Through an arrangement with FDA's Office of Cosmetics & Colors, IBN is pleased to present this overview of how FDA regulates cosmetics.

What you'll learn:

* What are the differences between a cosmetic and a drug * How to make informed decisions about using innovative marketing claims without turning your cosmetic into a product regulated like a drug
* What marketing claims come close to the drug line -- anti-aging, healing, aid, diminish, control, smoking cessation, insomnia, relaxation, etc.
*What the FDA looks at to determine whether drug claims are being made -- websites, blogs, Twitter, customer testimonials, etc.
* Whether and how the FDA regulate use of the term, "organic * How colors are certified and what color certification means
* How and whether to use INCI names on product labels?
* What print sizes and fonts are required for cosmetics labels?
* and more!!

Meet Our Expert Guest

Don Havery is the Leader of the Cosmetics Activities Team, Office of Cosmetics and Colors, in FDA’s Center for Food Safety and Applied Nutrition. Mr. Havery began working at the Food and Drug Administration in 1971 as an analytical chemist, primarily developing methods for the determination of N-nitrosamines in foods and other consumer products. In 1991 he took the position as Leader of the Cosmetic Technology Team in the Office of Cosmetics and Colors, where he was responsible for managing a laboratory team responsible for developing analytical methods for the determination of cosmetic ingredients and contaminants, and investigating causes of adverse reactions.

His current team has numerous functions including responding to Congressional, consumer and media inquiries, responding to FOI requests, addressing citizen petitions, developing guidance documents, maintaining the office web site, investigating and responding to consumer adverse reactions, investigating the toxicological profiles of cosmetic ingredients and contaminants, performing exposure and risk assessments, and providing cosmetic chemistry support to FDA laboratory projects.

Mr. Havery is also administrator of the Voluntary Cosmetic Registration Program, which program he played a large role in creating.

Mr. Havery received his BS degree in chemistry from the University of South Florida, Tampa, FL. He has published about 30 technical papers, many on the subject of the determination of N-nitroso compounds in foods and cosmetics.

How To Register

IBN members, log in to get the exclusive, members only call info here.

IMPORTANT NOTE: Do not use Internet Explorer at the private site. Use Chrome or Firefox. Internet Explorer does not display properly.

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Comment by dM, CEO on March 21, 2012 at 3:41pm

Important Update for members who attended this call!

During the call, Mr. Havery answered questions about what type of address (street, PO Box, etc.) was sufficient to comply with FDA regulations. In the call, he said that a PO Box was sufficient. After the call, Mr. Havery posed the question to an FDA lawyer to get another opinion. He is now updating his statement, via this email to IBN members, and I quote:

"While [the FDA lawyer] understood the reason why a small business wouldn’t want to include a street address that might be a personal residence, it was her opinion that the regulation at 21 CFR 701.12 was very clear. There are only two options: 1) put their business address in the local phone book so that it doesn’t have to be on the product label; or, 2) put the address on the product label. There is no provision for replacing the street address with either a P.O. box or a website address. I apologize for the error. It seems to me we will need to consider amending this regulation to bring it up to date with how businesses operate today, but until we do, those are the only options available."

Please update your notes to include this clarification.

To listen to the entire (amazing call), log in with your IBN member username and password here.

Comment by dM, CEO on March 9, 2012 at 11:56am

Diana, you are most welcome. Enjoy the call! It was amazingly useful!

Comment by Diana Hermann on February 28, 2012 at 4:58pm

I am so bummed I missed this call!  I broke out in shingles and was out of commission for a few days.  But I am on the mend and back to work now.  I will listen to the audio recording - thank you so very much for these kinds of informative tools!!

Comment by dM, CEO on February 22, 2012 at 6:53pm

IBN members! If you missed today's super FDA regulatory call, the audio is ready for you. Log in to get it now! http://ow.ly/9epIe

Comment by Lalli Meera on February 22, 2012 at 4:58pm

Today's event was SO informative - thank you!

Comment by Melissa Rivera on February 22, 2012 at 2:53pm

My notes say:

Certification Exempt - do not need certification ie. oxides, mica, ultramarines

Certified Colors - Synthetic man made and already approved by FDA ie. FD&C Blue1

Hope that helps.

Comment by carol on February 22, 2012 at 2:31pm

Still confused over colors.

he said certifiable and non certifiable -

but even if non certifiable do they still have to be approved?

Comment by Rae Keegan on February 22, 2012 at 2:24pm

Looking forward to a recording link for this one.  I had the same problem as Lalli--also using Chrome--but I registered too late to get the phone number.  My bad.

Comment by dM, CEO on February 22, 2012 at 2:07pm

I know, it's awesome! I hope I'm asking good questions. Excited to start the Q&A for members now!

Comment by Melissa Rivera on February 22, 2012 at 1:51pm

Incredible call!

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