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FDA Addresses Use of Nanotechnology

June 4, 2012

FDA Addresses Use of Nanotechnology

FDA Addresses Use of Nanotechnology

• The Food and Drug Administration (FDA) issued two draft guidances on April 20 regarding its assessment of the effects of nanotechnology on food and cosmetics safety. The draft guidance to the cosmetics industry describes FDA’s current thinking on the safety of nanomaterials in cosmetics. It cautions that standard safety tests may need to be modified, or new test methods may need to be developed.

Public comment is invited, although official publication of the drafts has not yet been scheduled. For comments to be considered by FDA in developing the final guidances, the comments should be submitted within 90 days of publication of the notices of availability in the Federal Register.

The document on cosmetics is titled “Draft Guidance for Industry: Safety of Nanomaterials in Cosmetic Products.” It recommends that safety assessments for cosmetic products using nanomaterials address such factors as physico-chemical characteristics, testing conditions that correspond to the distribution of nanomaterials in the final product, impurities, potential exposure levels, toxicological data and clinical studies.

“FDA expects that the science surrounding nanomaterials will continue to evolve and be used in the development of new testing methods,” the draft said.

The draft encourages manufacturers to meet with FDA personnel to discuss the testing methods and data needed to substantiate a product’s safety.

Cosmetics are not subject to premarket approval, as the draft notes. But the Obama administration, members of Congress and industry have been concerned about how proper regulation of cosmetics can be achieved. Such steps as a mandatory registration program have been advocated (36 CRR 386, 4/2/12).

The draft guidance on food safety describes factors manufacturers should consider when determining whether emerging technologies such as nanotechnology may affect the nature and the regulatory status of a food or a substance such as packaging that comes into contact with food.

HR 4395 To Advance Federal Oversight, Modernize Regulations
• The US cosmetic industry announced its support for groundbreaking legislation to strengthen and modernize regulatory oversight of the industry and to create a greater role for the US Food and Drug Administration (FDA) in assessing the safety of personal care products.

Introduced by Rep. Leonard Lance (R-NJ), the “Cosmetic Safety Amendments Act of 2012,” HR 4395, will modernize federal oversight of cosmetics and personal care products, currently one of the safest product categories regulated by the FDA.HR 4395 builds on that strong record.

The proposal has the full support of the Personal Care Products Council and the Safe Cosmetics Alliance, which have consistently advocated for an updated, enhanced and transparent regulatory framework for FDA.

“FDA regulation of cosmetics has protected the public for decades, and this landmark legislation will enhance protections for millions of American consumers,” said Lezlee Westine, the Council’s president and chief executive officer. “Cosmetics companies recognize the need for a modern regulatory process that keeps pace with product innovation, as well as the demand for transparency.The Council applauds Congressman Lance for introducing this bill and will work to help gain bipartisan support for its passage.”

“Everyone agrees that we need to update the regulation of personal care products,” said Rep. Lance.
“This bill will continue to advance consumer safety and provide a regulatory framework that furthers growth and innovation for American cosmetics manufacturers and small businesses.”

HR 4395 calls for increased reporting and transparency by the industry and enhanced regulatory oversight without further straining taxpayer resources and damaging small and medium-sized businesses’ ability to compete globally and create new manufacturing jobs in the US.

The legislation aims to create formal processes for the FDA to review ingredients for safety, set safety levels for trace impurities, create national uniformity for cosmetics regulations, review all safety determinations made by the Cosmetic Ingredient Review (CIR) Expert Panel and establish industry-wide “Good Manufacturing Practices.”

In addition, under the new legislation, the voluntary registration programs for facilities and products would become mandatory, as would the reporting of any serious and unexpected adverse events.

HR 4395 builds upon portions of legislation originally introduced by Congressman John Dingell (D-MI) known as “The FDA Globalization Act of 2008.” Congressman Frank Pallone (D-NJ) along with Congressman Dingell recently introduced legislation that has similar provisions to HR 4395.

“Our industry is built on the trusted relationships we have established with consumers.We have always believed in going above and beyond the requirements of the current law,” said Westine.

“This critical legislation provides a roadmap for a contemporary approach that includes a more engaged and transparent federal regulatory role,”she added.

More info:,

Antimicrobial Workshop Slated For June 12-13 in Arlington, VA
• The Tenth Antimicrobial Workshop, set for June 12-13 in Arlington, VA, is an opportunity to obtain all the latest policy and procedural information critical to the manufacture, marketing and sale of antimicrobial pesticides in the US, according to event organizers. Antimicrobial products (such as disinfectants, sanitizers and wood preservatives) are a highly regulated product category making it imperative for companies to be aware of the regulatory environment in which they operate to enhance their ability to succeed in the marketplace.

The Tenth Antimicrobial Workshop—sponsored by the American Chemistry Council Biocides Panel, the Consumer Specialty Products Association and ISSA in coordination with the EPA Antimicrobials Division—is the only program of its nature that speaks directly to the unique needs of antimicrobial registrants.

Following the conclusion of the workshop on Wednesday, June 13, Steptoe & Johnson LLP will host additional complimentary sessions on the Regulation of Antimicrobials in China and the EU Biocidal Products Regulation.

This program is open to all workshop attendees, and will run from June 13, 4:30pm-6pm with a reception to follow, to June 14, 8am to 1pm with a networking lunch to follow.

More info:,

SOCMA Welcomes New Members in First Quarter
• The Society of Chemical Manu-facturers and Affiliates (SOCMA) welcomed one of its largest groups of new members in more than two years. Ten companies—representing chemical manufacturers, industry service providers and distributors/suppliers—were approved by SOCMA’s board of governors at a meeting recently held in Washington, D.C.

“This is a great time to join SOCMA because we have so many exciting things going on,” said Dave Hurder, chairman of SOCMA’s board of governors.

“Our recently launched Chemical Services Directoryand the ChemStewards Integrated Management System are just some of the new tools we’re offering to help members enhance their businesses.”

For a full list of SOCMA members, see the group’s website,
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