By Riëtte van Laack – On Monday April 20, 2015, Senators Dianne Feinstein (D-Calif.) and Susan Collins (R-Maine) introduced the Personal Care Products Safety Act (S. 1014). The almost 100-page bill would significantly expand FDA's authority over cosmetic products sold in the United States. The bill …
By Ricardo Carvajal – FDA finalized three guidance documents that address various aspects of the use of nanotechnology in products regulated by the agency: Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology, Safety of Nanomaterials in Cosmetic Products, and Assessing the Effects of Significant …
By Kurt R. Karst – On May 29th, the U.S. House of Representatives Committee on Appropriations voted 31-18 during a mark-up session to send to the House floor its version of the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2015, along …
By Kurt R. Karst – FDA’s recent denial of a November 2009 Citizen Petition (Docket No. FDA-2009-P-0566) submitted by the American Dental Association (“ADA”) requesting that the Agency “review and establish an appropriate regulatory classification” for the safe use of peroxide-containing tooth whiteners that lighten tooth …
By Jennifer M. Thomas & James P. Ellison – Hyman, Phelps & McNamara, P.C. (HP&M) filed comments on April 7 concerning FDA’s Guidance document, Investigational New Drug Applications (INDs) — Determining Whether Human Research Studies Can Be Conducted Without an IND (the “Guidance”). HP&M has previously blogged …
By Kurt R. Karst – Last week, in an unusual move, the U.S. Court of Appeals for the Federal Circuit waded into non-patent territory when the Court issued its decision in Allergan, Inc. v. Athena Cosmetics, Inc. (Case No. 2013-1286), a consolidated appeal of several decisions …
By Ricardo Carvajal & Kurt R. Karst – According to contingency plans drawn up by the Department of Health and Human Services, 45% of FDA’s nearly 15,000 staff were to be furloughed in the absence of enacted annual appropriations – popularly referred to as a …
By Etan J. Yeshua – Three months after announcing a strategic research plan to support its regulatory agenda, FDA's Center for Food Safety and Applied Nutrition ("CFSAN") this week announced its regulatory priorities for 2013 and 2014, giving those in the food, dietary supplement, and cosmetic …
By Kurt R. Karst – It was 75 years ago today, on June 25, 1938, that President Franklin Delano Roosevelt signed into law the Federal Food, Drug, and Cosmetic Act (“FDC Act”), which replaced the Pure Food and Drug Act of 1906, 34 Stat. 768, …
By Kurt R. Karst – A Draft Committee Report made available by the U.S. House of Representatives Committee on Appropriations that would, once finalized, accompany the Fiscal Year 2014 Agriculture/FDA Apprropriations bill (currently available as a Full Committee Draft), lays out a laundry list of …
By Etan Yeshua – Manufacturers of foods, drugs and cosmetics might possibly be able to label their products as “Carcinogen-Free” with federal approval. In November, Rep. Theodore Deutch (D-FL) and Rep. Sue Myrick (R-NC) introduced the "Carcinogen-Free Label Act of 2012" (H.R. 6601), which would …
By Riëtte van Laack – The Organic Food Products Act of 1990 (“OFPA”) established national standards for the marketing of certain agricultural products marketed as organically produced. It directed USDA to issue regulations specifying the requirements for certification and labeling of organic agricultural products. In promulgating …
By Ricardo Carvajal – April was a busy month for nanotechnology at FDA. The agency issued two draft guidance documents worthy of close examination for those with an interest in the use of emerging technologies, including nanotechnology, in the cosmetic and food industries. Further, FDA denied …
By Riëtte van Laack— On April 18, 2012, Rep. Leonard Lance introduced the Cosmetic Safety Amendments Act of 2012, a bill (H.R.4395) “to establish new procedures and requirements for the registration of the cosmetic product manufacturing establishments, the submission of cosmetic product and ingredient statements, and …
By Cassandra A Soltis – In a decision that could have implications in the United States, the U.K.’s Advertising Standards Authority (“ASA”), which describes itself as “the UK’s independent watchdog” that regulates advertising, found both a Lancôme and a Maybelline advertisement misleading because the images of …
