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    • Will Modernization of Cosmetic Regulation Finally Happen?July 7th, 2022

      On June 14, 2022, the Senate Health, Education, Labor and Pensions Committee voted to pass the FDA Safety and Landmark Advancements (FDASLA) Act (S.4348).   While FDASLA focuses on user fees and includes several other provisions regarding drugs and devices, it also includes provisions related to …

    • Are You Recall Ready? FDA Expects You to BeMarch 21st, 2022

      All companies dread the logistics, cost, and reputational harm associated with conducting a recall when necessary to remove or correct products in the field.  But the more prepared a company is for a potential recall, the less pressure it will feel when a situation necessitates …

    • Grandma, What White Teeth You Have! But it’s Still Such a Gray AreaMarch 30th, 2021

      Tooth whiteners – drugs or cosmetics or both?  In the case of certain tooth whiteners, the regulatory status remains gray, apparently with no prospect of illumination from the Agency. As we reported back in 2014, FDA’s interest in the regulation of peroxide-containing tooth whiteners began in …

    • New California Requirement for Some CosmeticsOctober 14th, 2019

      On September 20, 2019, the governor of California approved AB 647 which expands the obligations of manufacturers and importers of cosmetics (and disinfectants) containing hazardous substances.  Beginning on July 1, 2020, these manufacturers and importers are required to not only provide safety data sheets (“SDSs”) …

    • FDA Requests Input on Consumer Survey Regarding Allergens in CosmeticsNovember 30th, 2018

      On November 7, the FDA announced that it is seeking approval for a web-based pilot survey about allergens in cosmetics, including fragrances, hair products, makeup, nail products and skin care products.  The federal register notice was published on Nov. 8, 2018. The survey is part of …

    • DC District Court Sets the Record Straight on Standing to Sue FDAMarch 29th, 2018

      Last week, the U.S. District Court for the District of Columbia dismissed a lawsuit filed by the Environmental Working Group (EWG) and Women’s Voices for Earth (WVE) against the Food and Drug Administration (FDA) and the Commissioner of the FDA. The facts of this case …

    • Just in time for Halloween, California Retailers Charged with Illegal Sale of Cosmetic Contact LensesNovember 9th, 2017

      Back in the day, there were some freaky-looking cosmetic contact lenses that could make people look like they had the eyes of a wolf, a fish, or an insomniac vampire (excuse the redundancy, please). The costume accessories were especially popular with the frightener, if not …

    • ACI’s 4th Annual Legal, Regulatory, and Compliance Forum on Cosmetics & Personal Care ProductsFebruary 8th, 2017

      The American Conference Institute (“ACI”), in collaboration with the Independent Cosmetic Manufacturers and Distributors (“ICMAD”), is holding the 4th Annual Legal, Regulatory, and Compliance Forum on Cosmetics & Personal Care Products on March 6-8, 2017 at the Millennium Broadway Hotel in New York City.  Join …

    • Winter Freeze Descends on Nation’s CapitalJanuary 23rd, 2017

      On January 20, 2017, the Trump administration took a first step toward delaying, reconsidering, and potentially undoing numerous regulations and policies issued by the Obama administration. In order to ensure that “the President’s appointees or designees have the opportunity to review any new or pending …

    • In Time for the Holidays, FDA Grants PCPC’s Petition for Lead Levels in Lipstick and Externally Applied CosmeticsJanuary 3rd, 2017

      On December 21, FDA announced the availability of a draft guidance for lead levels in cosmetics. As further described in that draft guidance, FDA has concluded that use of lipstick and externally applied cosmetics that meet the recommended maximum lead level of 10 ppm would …

    • The FTC Grants Summary Decision in Proceeding Regarding All Natural SunscreenDecember 13th, 2016

      As we previously reported, in April 2016, the FTC announced several settlements regarding all natural claims for cosmetic products.  In addition, the FTC filed an administrative complaint against California Naturel, Inc., (the Company) for falsely advertising its sunscreen product as “all natural” in violation of …

    • FDA Makes Publicly Available Data on Adverse Events Associated with Food and CosmeticsDecember 8th, 2016

      This week, FDA announced (here and here) that it is making available adverse event information for foods (including dietary supplements, food additives, and color additives) and cosmetics the Agency has received through its Center for Food Safety and Nutrition (CFSAN) Adverse Event Reporting System (CAERS). CAERS …

    • ACI’s Legal, Regulatory, and Compliance Forum on Cosmetics & Personal Care ProductsMarch 1st, 2016

      ACI is holding its 3rd Annual Legal, Regulatory, and Compliance Forum on Cosmetics & Personal Care Products on March 7-9, 2016 at the Carlton Hotel in New York City. This is the first year ACI is partnering with the Independent Cosmetic Manufacturers and Distributors and the …

    • The Cosmetic Modernization Amendments of 2015 Seek a Facelift for the Cosmetics IndustryNovember 30th, 2015

      By Kurt R. Karst –        On November 18, 2015, Representative Peter Sessions (R-TX) introduced H.R. 4075, the Cosmetic Modernization Amendments of 2015, to little fanfare. The bill continues a recent trend among legislators (both federal and state) to attempt to legislate in the personal care products …

    • “Should I Stay or Should I Go” to FDA for an IND? FDA Issues a Stay for Certain Food Provisions of the Final IND GuidanceNovember 4th, 2015

      By Wes Siegner –  Effective October 30, 2015, FDA issued a stay on certain food provisions of the final guidance, “Investigational New Drug Applications—Determining Whether Human Research Studies Can Be Conducted Without an IND” (IND Guidance).  FDA announced the stay in the Federal Register notice, 80 …