Food and Drug Administration Globalization Act of 2008

he Environmental Working Group applauds the Food and Drug Administration Globalization Act of 2008, which will harm small businesses and create more government regulation. Under Title III, Cosmetic Safety the bill will require that “any facility engaged in manufacturing, processing, packing, or holding cosmetics in the United States or for import to the United States be registered with the “Secretary” with a $2000 to $10,000 minimum fee effective 6 months after the Act passes.

      

In addition the Adverse Event Registry will require that “a facility that manufactures cosmetics to report to the Secretary all anticipated and unanticipated serious adverse events relating to the use of cosmetics it has manufactured” within 18 months of the enactment of this legislation. I wonder if they will be handing out psychic licenses so that we can determine what the unanticipated events will be.

Jane Houlihan of the Environmental Working Group (a.k.a. EWG, Skin Deep and Campaign for Safe Cosmetics) believes that the FDA should be the final authority for assessing cosmetic ingredients. She does not support the independent Cosmetic Ingredient Review (CIR) Panel which is made up of independent physicians and scientists established by the cosmetic industry trade to provide monitoring of cosmetic ingredients. She also favors requiring pre-market safety testing of cosmetic products that is reviewed and passed by the FDA before they reach the market.

Last time I had a conversation with someone at the FDA the word was that they were seriously underfunded and lacked the manpower to do what they were charge to do now. A $2,000 fee to register will not come close to funding all that this bill will require. Currently, the FDA cosmetic program has 18 employees for the entire country and thousands of cosmetic companies and a budget of $4.5 million, which barely keeps them afloat. Cosmetics have a very low risks compared to the other duties of the FDA in watching out for safety issues with drugs and foods.  No one has ever died from putting on lotion, but there is barely a day that goes by where there is not a serious injury or death cause by bad drugs or tainted foods. And since the FDA seems to be in the pockets of the drug companies these days, I guess they have tapped out that sector as a funding resource and now it is our turn.

The Cosmetic Ingredient Review (CIR) program was established in 1976 to evaluate the safety data for the most commonly used cosmetic ingredients.  The CIR process allows manufacturers to insure the safety of each ingredient before they are used in cosmetics.  The seven leading academic scientists and physicians are required to meet the same standards as advisory panels to the FDA.  The panel is made up of experts from the fields of dermatology, pharmacology, chemistry, toxicology and oncology. The panel also includes a non-voting position for an industry representative, an FDA liaison for the Office of Cosmetics and Colors, as well as a consumer representative from the Consumer Federation of America. 

Houlihan said, “One shortcoming of the CIR process is that it is dominated by dermatologists who are primarily interested in allergic reactions and irritations in the ingredients.”  Yet that is totally incorrect as the panel is a very diverse group who are required to have absolutely no conflicts of interest.  The panel is non-profit and independent.  And it was established by a cosmetic industry trade organization with over a hundred years of support for our industry.  The FDA has a very small segment devoted to the cosmetic industry and if this passes then where do you think the FDA will turn for their experts to enforce the “new standards”?  Our guess is the already existing and FREE experts found in the cosmetic industry similar if not specifically the CIR Expert Panel.  Only we will have the privilege of paying for it. 

I agree with Rep. Michael C. Burgess, D-Texas, who said that he had attended “hearing after hearing with regard to the resources, or lack thereof, of the FDA. I am sure that there are some reforms that need to be made in the office of Cosmetics and Colors, but I would urge this committee to move methodically and deliberately; we shouldn’t just be passing legislation because we happened to be here.” This is not legislation that is being supported or pushed forward by big cosmetic companies.  It is supported by those in favor of bigger government and more regulations. 

The translation of all this information is that you will most likely be paying more taxes in the near future in addition to a $2000 to $10,000 registration fee in order to continue manufacturing.  The Energy and Commerce Committee’s Subcommittee on Health, which has the full support of the Environmental Working Group will wipe out small home crafters and start ups that are unprepared to switch to a private label manufacturer with their proposed legislation. The FDA Law Blog points out that there will be more hidden fees including; registration fees, re-registration fees, re-inspection fees, certification fees, certifying agent accreditation, laboratory accreditation, export certification and importer registration. The implications of this bill are far reaching. If your small business or hobby is of continued interest to you, they you need to take action NOW. Call your congressman and voice your concerns or send a letter via email to their office, but whatever you do, do something.

As for Essential Wholesale/Labs, we are already adhere to Good Manufacturing Practices, OTC regulations, are FDA & EPA Registered and Organic Certified. All of which is to say we already deal with more paperwork, regulations and fees than this new legislation will bring.  But we do mind paying more taxes and fees for something that is already working well only to see most home based cosmetic and soap businesses shut down.  The Globalization Act of 2008 could actually help our private label division, Essential Labs, but I’m not interested in that kind of help. I’d rather be the company that is there for you when you are growing too fast to keep up, than the company that takes over your production because big government shut you down. We remember the early days and how hard it was to follow the rules. This is just another expense for small business created by government that is hostile to the backbone of our economy, the small business owner.

Let’s all remember, it is already illegal to market unsafe cosmetics. Criminal even and cosmetic companies are already required to substantiate the safety of their products and the individual ingredients before going to market.  It is illegal to sell cosmetics that are adulterated, which includes microbial contamination. Products have not been substantiated for safety must bear the, “Warning—the safety of this product has not been determined.” Why exactly do we need new fees, new legislation and more regulations to follow that simple law? What do you think?

Comments

[Cecelia Aldrich]

I think it is very ironic that the FDA will be additionally charged with scrutinizing the small cosmetic and body products businesses (who are likely in this business because they couldn't find natural, chemical free products to their liking currently on the market)when they have not been able to keep the cancer-causing ingredients out of products on the shelves in stores across this country. Thank you so much for going to bat for us small businesses - I'm not even small, I'm just tiny or micro in the big picture. But, I care about people and the planet and would like to be able to continue to make healthy, as close to natural and organic products as I can.

[Sonsa Rae]

Just as the bailout was passed by Congress just recently, much to the surprise and chagrin of many of us, with a flick of the wrist the FDA Globalization Act of 2008 will probably be passed as well. The government does not care about the average person, other than collecting their hard earned tax dollars. They actually refer to us as "feeders and breeders".

[Stephanie Halpin]

The Government has it hands in everything. The FDA needs to stay out of the personal care industry and focus on taking care of Pharmaceutical regulations, not charging small businesses more taxes fees and more headaches. Many of us will not survive this kind of regulation. Knock on Wood!

[Amelia Quinn]

Thank You! I am in agreement and will stand with you by signing the petition and calling my state representative.

[Galan Merrill]

Government regulation is already overpowering and under funded. FDA needs to regulate properly the areas that they now have responsibility for, before moving into areas that are of very low risk.