Sunday, June 1, 2008

Food and Drug Administration Globalization Act of 2008

There has been a lot of talk lately about the Food and Drug Administration Globalization Act of 2008. It has come to my attention that Donna from the indie beauty network is going to write a letter on our behalf (as small business owners). She has asked for opinions about the Act so that she can better write the letter on our behalf. I urge you all to go to the forum she has (link below) and put in your opinon. I have attached the letter she wrote to IBN members.

Dear Indie Beauty Network Members,

I write to you with an update on a regulatory concern that threatens the Indie Beauty industry, and the action I would like to take.

First a bit of background.

Before 2000, the year I founded the Indie Beauty Network, I worked as an attorney for many years, mostly as an advocate for various companies before federal and state regulatory bodies. When I started making cosmetics of my own, and later selling them, I often pondered and appreciated the regulatory freedoms that participants in the cosmetics industry enjoyed.

Unlike other industries, cosmetics industry participants do not have to register their businesses or their manufacturing facilities with the federal government. Registration is voluntary, and estimates are that less than 1/3 of the operating cosmetics facilities in the US are registered under the FDA's voluntary registration program. While a few states require facility registration, the vast majority do not. In addition, companies do not have to obtain state or federal pre-approval before selling cosmetics.

One of the reasons I started IBN is because I have a passion for cosmetics and beauty products. I also have a passion for you -- the Indie beauty business owners -- who make and sell them. I have always felt strongly that, as the industry grew and flourished, increased regulatory oversight would follow.

Today, Congress is poised to give the Food & Drug Administration the ability to implement what I consider to be burdensome and costly regulations that go far beyond what is required for the agency to effectively perform its legislative mandate.

I formed IBN in part so that, when the time came, IBN members would have an advocate in the event this type of unfair regulation became a possibility.

It seems as though that time has come.

Food and Drug Administration Globalization Act of 2008

The draft of the Food and Drug Administration Globalization Act of 2008 was announced late last month. The legislation is aimed at giving the FDA authority to promulgate new regulations that are supposed to protect consumers and also provide the funding the agency needs to enforce existing laws in a global market.

Since its announcement, several industry participants have testified before the House Committee on Energy and Commerce, Subcommittee on Health about the draft, including Stephen F. Sundlof, DVM, PhD, Director of the Center for Food Safety and Applied Nutrition at the Food and Drug Administration (see:, and a representative of the Personal Care Products Council, formerly known as the Cosmetic, Toiletries & Fragrances Association. (See:

You can read the full text of the draft legislation here: As you can see, the proposed legislation would, among other things:

1. Require all cosmetics companies serving American consumers to register annually with the FDA, and pay a registration fee of $2,000 per facility per year, and to list in its registration the cosmetics is manufactures, processes, packs or holds, and also, for manufacturers, to list all ingredients in each product contained in the registration listing.
2. Require all cosmetics companies to report to the FDA "serious adverse events" resulting from the use of the products.
3. Require all cosmetics companies to comply with the FDA's Good Manufacturing Practices.
4. Require all cosmetics that import cosmetics to register annually with the FDA, and pay another registration fee to do so.
5. Give the FDA authority to levy substantial fines for violations of the new requirements.

The implications of passage of this draft legislation are obvious and far reaching, and should it become law, it will have a definitive and immediate effect. While I feel we must acknowledge the critical role of the FDA in protecting consumers from unsafe or misbranded cosmetics products, we also must ensure that they appreciate that imposition of registration fees, registration requirements and burdensome reporting requirements on small businesses will snuff out an entire segment of the cosmetics industry. It will also have the devastating effect of hampering the creativity and robust competition that consumers have come to expect and appreciate.

What I'd Like To Do On Your Behalf

I would like to prepare a position paper on behalf of the 700+ members of the Indie Beauty Network to will address the draft legislation and share IBN members' perspective. Of course, I first need to know what your perspective is, so I have set up a forum for you to post your opinions:

Please share your suggestions, opinions and questions here.

Please post your comments as soon as possible. Once they are reviewed, I will call a member-wide teleconference meeting to address our options so we can collectively decide what steps to take next.

I will also post updates here from time to time.

Please note that this forum is open to the public at this time, but any draft letters sent to any authority on this topic will be vetted only among IBN members in a private forum. Members of the public are invited to submit comments via the forum and join the discussion. Only IBN member opinions and input will be included in any filings made on this issue. Non-members will not be able to review draft letters, or the edits we make to them before filing.

Please feel free to post this email to your blogs, discussion groups, newsletters, etc. I know it's kind of long, but if you post it, please do so without making any changes.I look forward to hearing your thoughts and questions, and to working with you on these important matters.

Thank you,

Donna Maria Coles Johnson
Founder & President
The Indie Beauty Network

Resources & Links:

Committee on Energy & Commerce:
Discussion Draft Legislation:
Testimony of Janet Woodcock, M.D., Director, Center for Drug Evaluation and Research
Testimony of Center for Science in the Public Interest:
Donna Maria
Founder & President
Indie Beauty Network
Indie Business Media, LLC