Essential Wholesale & Kayla Fioravanti Taking a Stand Against The FDA Globalization Act 2008

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Four Industries. One Bad Law. In today's cosmetic industry, there is no more pressing issue than the FDA Globalization Act of 2008. For this industry, it's the wrong policy and the wrong law during this challenging economic time. Industry leaders, Mrs. Fioravanti and Essential Wholesale are taking a stand against the Discussion Draft of the Food and Drug Administration Globalization Act of 2008 in hopes that it does not pass.

Kayla Fioravanti is the Vice President, Chief Formulator, ARC Registered & Certified Aromatherapist for Essential Wholesale and its lab division Essential Labs. Wife and mother of three, Kayla runs her company along with her husband Dennis. In 1998, Kayla started creating products in her kitchen using essential oils. Her first glimpse into the world of essential and botanical oils was by means of a personal trial; one of her children had a case of ringworm that would not go away. After trying every over-the-counter ointment and even some prescriptions, she looked into the natural way of healing and discovered essential oils. The ringworm was gone in three days and Kayla was hooked on aromatherapy. She was unable to find any companies that would work with a start up business or that formulated truly natural bases which could add to the essential oils. So, she and her husband decided to fill the missing niche by creating Essential Wholesale - today's leading supplier of raw ingredients, bulk personal care products, mineral makeup and aromatherapy at wholesale prices.

Kayla believes that natural living should be readily available to everyone interested in a healthier lifestyle; she is the go-to-specialist for formulating and supplying information on natural, organic and pure cosmetics and personal care items. She formulates thousands of private label products including: mineral makeup, skin care, body care, hair care and so much more for customers big to small from around the world.

Four Industries. One Bad Law.
In today's cosmetic industry, there is no more pressing issue than the FDA Globalization Act of 2008. For this industry, it's the wrong policy and the wrong law during this challenging economic time. Industry leaders, Mrs. Fioravanti and Essential Wholesale are taking a stand against the Discussion Draft of the Food and Drug Administration Globalization Act of 2008 in hopes that it does not pass.

Important in understanding why Kayla and so many other cosmetic companies are protesting this act, one must take into consideration that the cosmetic industry falls under the same administrative umbrella as food, drugs and drug devices. Basically, if one party falls under scrutiny, it negatively affects the other 'sibling' branches. The FDA Globalization Act of 2008 was triggered by the food crisis' that occurred that year which brought the food industry under examination when this "sibling" fell under hardship. While the cosmetic industry could use some discipline, the provisions of the FDA Globalization Act do not address the issues most important to remedy the problems in the cosmetic industry: the loop holes that allow fragrance chemicals and "processing aids" to go unlisted on the ingredient lists. According to the rules set in place by the FDA, all ingredients must be listed in order of predominance on a cosmetic ingredient list EXCEPT ingredients that give a product an odor. Because of this loop hole, the word 'fragrance' may represent many hundreds of ingredients in one product. Therefore, a product that contains fragrance chemicals can be labeled 'unscented' or 'fragrance-free'.

At the end of the day, the provisions listed by the FDA Globalization Act add fees and increased administrative work to the cosmetic industry which goes toward fixing the problems of its "siblings" in the food industry, but bring no benefit or reform to the cosmetic industry. The fact is the conditions contained in the draft of the FDA Globalization Act do not address any of the challenges faced by the cosmetics industry today. Instead, they focus on adding burdensome and unreasonable fees and incredibly labor intensive paperwork that are really designed to send a "tsk-tsk" to our siblings. They do nothing to protect consumers, which is the stated intent of the cosmetics laws.

In a nutshell the FDA Globalization Act of 2008 in current form will require:
**$2000 yearly registration fee for all companies engaged in manufacturing, processing, packing or holding cosmetics in the United States
**$10,000 yearly registration fee for all companies that import ingredients or finished cosmetics
**$12,000 yearly registration fee for all companies that import ingredients, manufacture, process or hold cosmetics
**The administration of the requirements of the FDA will require companies to have at least one person working full time on staying compliant. This will cause many one person operations to go out of business and raise the price of cosmetics industry wide to pay for the new person or entire department depending on the size of the company
**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. In reality if a company anticipates adverse events they would not put out the product and how can they plan for an unanticipated event
**Included hidden fees not yet discussed including; re-registration fees, re-inspection fees, certification fees, certifying agent accreditation, laboratory accreditation, export certification and importer registration
**It will create a system that makes cosmetics as expensive as drugs and you know what that means…consumers pay the price

FDA Globalization Act of 2008 in the current form will:
**Shut down free trade with countries now dependent on the cosmetic industry. Natural ingredients are sourced from countries around the world because they grow only in those regions. A great example of an ingredient that is enjoyed by millions of Americans is Shea Butter. It grows abundantly in Africa and small villages around Africa sell their Shea Butter directly to small businesses all over America. With this legislation the livelihood of the American company and the African village will be shut down
**Shut down existing small and medium sized cosmetic companies that cannot afford the YEARLY registration fee. Many companies will be shut down over night by the fees and others will not last through the year once they pay the fee and now must hire additional employees to process the additional administrative work
**Shut down the stream of new companies started with a dream, a passion, and a shoe string budget started around the kitchen table. How many success stories started right there? Thousands of them started just there. Even many of the giant corporations today started with one or two people who had a vision to make a difference in their industry

FDA Globalization Act of 2008 will NOT:
**Make cosmetics safer. There is nothing in the language of the FDA Globalization Act of 2008 that will make cosmetics safer to the American people. It will not change labeling laws or disclose loop holes that currently allow fragrance chemicals to be undisclosed

Granted this is just a 'draft' at the moment, not a formal bill, nevertheless it is moving in that direction. Petitioning and making trips to Washington DC to advocate against the passage of the FDA Globalization Act, Kayla Fioravanti is excited to be a part of the effort to impact it on behalf of her customers.

At the 2009 Handcrafted Soap Makers Guild Conference Kayla is scheduled to speak on the topic of GMP, the FDA Globalization Act and surviving in business during tough economic times. She recently earned a spot as a finalist for "Innovation of the Year" by the International Cosmetic Manufactures and Distributors Association. Essential Wholesale was also recognized by the INC 5000 as one of the fastest growing companies in America for the past two years. Kayla writes articles for Dermascope Magazine, Handmade Beauty Business Magazine, HK Magazine Online, Indie Magazine and Total Mom. Kayla has been a guest on Organic Beauty Radio, Indie Radio, KPDQ Northwest Showcase, Good Day Oregon, 104.1 The Fish and Podcast from the Heart. She has been a speaker for Handmade Beauty Network and the 2006 and 2008 Handcrafted Soap Makers Guild Conference. She also writes Essential U News for Essential Wholesale and for the Essential U blog that launched in 2007. Kayla is the driving force behind the Essential U online University, an educational center for aromatherapy, cosmetics, industry standards and business ownership. What matters most to Kayla Fioravanti is teaching others about the wonders of natural and holistic living.

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For more information on Kayla Fioravanti and The FDA Globalization Act of 2008, please contact Meredith Morville-Reilly of Bella Public Relations, Inc. 212.868.8183


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