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ICMAD Regulatory Update

By: Jeff Falk
Posted: March 7, 2007

Don Havery, cosmetics technology team, FDA, told attendees that FDA’s “mission hasn’t changed, but (its) structure is definitely changing.” Budget cuts have effected FDA staffing at the office of cosmetics and colors while government and special-interest groups continue to push for more regulations. Havery stressed the advantages of the participating in the online Voluntary Cosmetic Registration Program (VCRP) in the face of increased regulatory scrutiny. Havery stated that the agency is working on unresolved botanical ingredients issues within VCRP (largely due to inconsistencies in the INCI dictionary) and that color nomenclature “is definitely confusing.” U.S. color names plus CI numbers are not recognized by the current system.

Robert Eshelman, OTC drug team, FDA, highlighted labeling regulations. He noted that the final rile for sunscreens was published on May 21, 1999 with an original effective date of May 21, 2001. However, there was almost immediate stay, and Eshelman noted that sunscreen labeling regulations are still “a work in progress.”

David Steinberg, Steinberg & Associates, spoke about REACH. The scope of its coverage and the cost of registration seemed to scare the devil out of the crowd. Steinberg presented numbers of €25,000 for registration of an ingredient and upwards of $2.5 million for testing of an ingredient. Nothing is exempt—packaging, for example, can be hit. The ink and adhesive used on the label… “the cosmetic industry is not very high on the totem pole in REACH.”

Carl Geffken, president of Carl Geffken Consultants and a GCI columnist, reviewed the status of international regulations. Geffken began his presentation by stating, “Most companies, if not already in international markets, want to be international.” The remainder of his presentation illustrated the complexity of regulations, and the similarities and contrasts in regulations worldwide. Going international means doing your homework.

Jack Bierig, a partner at Sidley Austin LLP and ICMAD legal counsel, spoke about advertising claims, warning marketers to watch the claims they make. Claims are an opening for both regulatory scrutiny and lawsuits. “Hypoallergenic,” for example, is an ideal opening. Inevitably, one consumer is going to have a negative reaction to the product. As the trend for naturals and organics grow, “organic” is one of the most scrutinized claims.