At ICMAD's breakfast presentation (held at Cosmoprof North America), ICMAD vice president and technical/regulatory/legislative committee chair Carl Geffken shared that the Energy and Commerce Committee's Subcommittee on Health is working on draft legislation known as the "Food and Drug Administration (FDA) Globalization Act of 2008." The legislation is being sheparded by Committee Chairman John Dingell (D-MI). The draft bill addresses FDA oversight and regulation of food products, drugs and medical devices, and cosmetics.
In its current draft, the legislation includes mandatory registration of "any facility engaged in manufacturing, processing, packaging or holding cosmetics in the United States or for import" into the United States. Registration is required on an annual basis, and facilities will be subject to a $2,000 registration fee.
ICMAD, while supporting a strong FDA, is of the opinion that the legislation, as currently proposed, creates an undue hardship on small business entities. Additionally, the language of certain provisions within the legislation appears to be somewhat broad and ambiguous.
ICMAD strongly encourages participation in the FDA's Voluntary Cosmetic Registration Program (VCRP) for cosmetic establishments and formulations. Under this program, the FDA collects information on manufacturers, packers and distributors of products in commercial distribution in the U.S.
If the Globalization Act goes into effect, each facility used in the manufacture of cosmetics will be required to list the products it manufactures, processes, packs or holds and, in the case of a manufacturing facility, a list of the individual ingredients for each product that it manufactures. Another provision would require the Health & Human Services (HHS) Secretary to establish a mandatory adverse event registry for facilities to report "all anticipated and unanticipated serious adverse events" related to manufactured cosmetics.
The draft legislation would also require importers of cosmetics to register with the HHS Secretary and pay an annual registration fee of $10,000. Moreover, the FDA would be required to create a corps of inspectors to conduct inspections of foreign cosmetics facilities "at least equivalent to the inspection rate of domestic" cosmetic facilities and establishments.
Additional information is available at www.icmad.org; a full report on the ICMAD breakfast and Cosmoprof NA will be available in the September issue of GCI magazine and online.