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 …
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”) …
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 …
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 …
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 …
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 …
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 …
On December 21, FDA announced the availability of a draft guidance for lead levels in cosmetics. As further described in that draft guidance, FDA has concluded that use of lipstick and externally applied cosmetics that meet the recommended maximum lead level of 10 ppm would …
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 …
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 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 …
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 …
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 …
By Kurt R. Karst – Earlier this month, legislation was introduced in both the U.S. Senate and U.S. House of Representatives to fund FDA for the next fiscal year: Fiscal Year 2016. Both the Senate bill and the House bill, titled “Agriculture, Rural Development, Food and …
By Riëtte van Laack – The California Organic Products Act (COPA) allows the use of the term “organic” on cosmetics only if they contain at least 70% organic ingredients. In a consumer class action, plaintiffs alleged that Hain Celestial Group Inc. (Hain) misleadingly labeled two of …
