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The Cosmetic Ingredient Review’s newly figured margins of safety for single- and multi-paraben use in cosmetic products are dramatically lower than previous MOSs that informed the Expert Panel’s 2008 “safe as used” conclusions. Whether the panel still deems the MOSs sufficiently protective is the question going into the group’s Sept. 24-25 meeting.
Marketers' websites and product labels stated other noncompliant claims that render their products unapproved new drugs, but references to opioid withdrawal treatment got FDA Commissioner Scott Gottlieb's attention. "Despite our warnings and previous regulatory and enforcement actions, we continue to find marketers actively selling kratom with unsubstantiated claims," Gottlieb says.
Latest From Cosmetic Ingredients
The Cosmetic Ingredient Review’s draft report on brown algae-derived ingredients is up for Expert Panel consideration Sept. 24-25, and five Ginkgo biloba ingredients could receive final safe-as-used sign-off. CIR also seeks the panel’s help in preparing a re-review document for the MI/MCI preservative combination, which is overdue for an updated assessment with usage up significantly since 1992.
Beginning with its newly relaunched washes, lotions and hair products, Johnson’s is providing product-specific detail on fragrance components in a transparency move that other J&J skin-care brands will be following, according to a company rep.
The ingredients at issue already must be labeled on cosmetic products in the EU due to their recognized sensitization and allergy potential. FDA expects to award the contract by the end of September, and finished work will be due to the agency within 18 months thereafter.
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