Update on MA H2361

ICMAD Testifies  Against MA  H2361 on Sept. 13, 2011 in Boston        

ICMAD Board Member David Steinberg testified against MA H2361 this past Tuesday in Boston before the Joint Committee on Public Heatlh.  He was joined on a panel by Mike Thompson from the PCPC, the VP of Government Affairs from Mary Kay, and a representative from ICMAD Member Iredale Cosmetics. Also ICMAD member Jim Akerson attended the hearing and was at the ready if his regulatory expertise was needed.

Prior to the public hearing, all members of the committee were sent a letter from Pam Busiek, ICMAD’s President and CEO.  We are posting this letter below.

Another panel testifying was made up of 4 small women-owned companies including  ICMAD member Doris Crary from Prostrong, Inc.  This panel too testified against the bill.  In fact, Doris Crary said the bill would make it impossible to sell her products in the state.

Mia Davis was the last panelist  and represented the Campaign for Safe Cosmetics who demanded full disclosure of all trace ingredients. She was the only one questioned and it concerned her tattoo.  She said it was her choice.  One of the committee members then said it was his choice to use cosmetics and they label their ingredients while tattoos do not.  Before Miss Davis could respond she was dismissed.

The bill sponsor agreed to drop the bill and the hearing ended.

Text of Letter sent to all members of Public Health Committee:

September 10, 2011

Commonwealth of Massachusetts House Bill 2361

I am writing on behalf of the Independent Cosmetic Manufacturers and Distributors (ICMAD) Association. ICMAD is recognized as the trade association for cosmetic entrepreneurs and innovators. Through innovation and entrepreneurial efforts, our members have been a strong part of the small business effort to create new products and jobs even in these difficult economic times. Our 650 member companies, which range in size from the small entrepreneur to mid-tier and large companies, are located throughout the United States, including Massachusetts. We are submitting this letter in support of our Massachusetts members who are deeply concerned about the effect the proposed legislation will have on their businesses, their ability to continue to grow, and ability to contribute to the Massachusetts economy.

From our review, the bill proposes to create a separate Massachusetts program for the evaluation and regulation of cosmetic safety where determinations are made on the mere presence of an ingredient without regard to the ingredient's concentration and, most importantly, the concentration at which the ingredient presents a risk. The bill requires all product ingredients, such as unintentional ingredients at the parts per billion range and lower, if technically possible, be considered and reviewed as ingredients.

This onerous standard would render most cosmetics unsafe by the mere presence of water, for example. Water, a common ingredient in most cosmetic products, generally is sourced from local drinking water that is deionized. Most drinking water contains very minute quantities of heavy metals and other unintended ingredients. Under Federal law, minute quantities of heavy metals and other unintended ingredients in drinking water are permissible, provided they are present at concentrations below established risk levels. Under the regulatory scheme proposed by this legislation, drinking water as well as any level of heavy metals would be unsafe.

Under the regulatory scheme contemplated by the bill, once a product is determined to contain even minute amounts of an ingredient that have been found to be a possible carcinogen or reproductive toxicant, the product will be deemed unsafe and will have to be listed with the authorities. Certain information regarding concentration of the ingredient and other health and safety testing data and this information also will have to be supplied by the marketer of the product. The product would also be required to bear warning labels and could be subjected to reformulation through "green chemistry." Again this will all be required for even the most minute quantities of ingredients, even if the amount present is far below the concentration at which the ingredient presents a risk.

The threshold for determination of the presence of ingredients is parts per billion, as trace ingredients can vary by batch of manufactured products. The proposed legislation would require a detailed analysis be conducted on each batch of product sold in Massachusetts. Based upon this, reporting would have to be on a batch-by-batch basis, as opposed to a product basis. This could result in some batches of the same product requiring warning labels, while others would not. This could create a serious logistical burden for marketers, consumer confusion from inconsistent labeling and an undue burden on the governmental oversight authorities. The mere presence of minute quantities of an ingredient, which in fact presents no risk because it is present at concentrations found to present no risk, could well result in market turmoil.

We believe that the basis for this legislation is a concern that the U.S. Food and Drug Administration (FDA) does not have adequate authority to regulate cosmetic safety. These concerns are unfounded by the FDA and other federal agencies that are charged with the responsibility to study the safety of the chemicals used in cosmetics and other consumer products, diligently exercising their charge. The FDA has reviewed and studied the safety of many of the chemicals used by the cosmetic industry. Private self-regulatory bodies such as the Cosmetic Ingredient Review (CIR) and the Research Institute for Fragrance Materials also have studied the safety of a preponderance of the remaining ingredients that are used in cosmetic products.

The CIR is modeled after the review panels established by the FDA, and CIR members are world-renowned scientists and medical practitioners. The FDA and consumer groups also participate in CIR proceedings. The CIR proceedings are subject to peer-review and their findings are published in peer-reviewed journals. The CIR proceedings are transparent and public participation and comments are encouraged. We are aware of the ongoing campaign by activists to discredit the work of the CIR and to question the FDA's authority to address unsafe products. It is on the basis of this that the activists are now pressing for more rigorous state regulation of cosmetics. These concerns are unfounded. The FDA has broad authority to seize or enjoin the sale of unsafe cosmetics, and they have exercised this authority. The FDA also has responded to questions of safety by conducting extensive testing, such as was done when concerns were raised regarding the safety of lead in lipsticks.

The regulation of cosmetics contemplated by the proposed legislation is far more extensive and onerous than that which exists for over-the-counter (OTC) drugs and dietary supplements that contain many of the same ingredients used in cosmetics. This proposed rigorous regulation comes from the fact that supplements and OTC products create a far greater potential for risk than cosmetics based upon their route of administration. Cosmetics currently enjoy the lowest insurance experience rating of all FDA regulated products and have been the subject of far fewer FDA regulatory actions than supplements or OTC drugs. Based upon this and the existence of the CIR program, we question the need for the further regulation and programs contemplated by this proposed legislation.

While we support the Massachusetts legislature in its review of these issues, we encourage a careful scientific review of the actual risks presented by cosmetic ingredients that is based upon concentration levels and route of administration. We encourage the legislature to weigh these conjectural risks against the real risks presented by adoption of a regulatory scheme proposed by this legislation. If adopted, this legislation will require manufacturers and marketers to develop an extensive regulatory compliance program and possible separate product formulas strictly for products sold in Massachusetts. The proposed legislation will require detailed analytical studies on each product batch with an analysis of each ingredient, intended or unintended, present at the parts per billion or lower level. This level of testing will be both time consuming and extraordinarily expensive. This goes far beyond requirements imposed by any other state or the Federal government. This could well require separate manufacturing, packaging, labeling and testing for products sold in Massachusetts.

The dramatic increase in the cost of selling products in Massachusetts may result in marketers withdrawing their products from Massachusetts or dramatically raising the price of products sold in Massachusetts. Either of these consequences would result in consumers buying their cosmetic products in neighboring states or online. Not only will the Commonwealth lose money, but retailers at all levels of distribution will lose sales of one of their most profitable categories. This in turn will clearly lead to job losses at the retail level and other businesses that support the manufacture of these products and the retailers that sell these products.

Through the expertise of our members, we would be pleased to work with the legislature and provide further information on these issues and the impact if this legislation is adopted. As manufacturers and marketers, our members are keenly aware of the need to manufacture and market high-quality products that are safe. In fact our association's ethics policy requires that our members adhere to these principles.

Please note while I currently serve as the President and CEO of ICMAD, I served as founder and president of two entrepreneurial cosmetic businesses that I grew from small business start-ups to larger, mid-sized companies. In my role for both of these businesses, I understood the need to produce high-quality safe products and adhered consistently with industry practices and with the testing and analysis required to produce safe cosmetic products. Finally at a time when Congress and the Administration are discussing rolling back certain regulations, it seems counter intuitive to impose new regulations in an area properly and appropriately covered by federal regulations.

Thank you for your time and consideration of these matters.

Very truly yours,


Pamela Jo Busiek

President and CEO

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