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It has recently been reported that China is in discussions with the Organization for Economic Cooperation and Development (OECD) to become a provisional adherent to the Mutual Acceptance of Data (MAD) system. This would require China to accept data from safety testing of chemicals from participating countries generated under the MAD conditions and to establish a Good Laboratory Practice (GLP) compliance monitoring program. If China were to become a provisional adherent to the MAD system, this...

On June 26, 2014, the U.S. Food and Drug Administration (FDA) held a public meeting to discuss the proposed changes to the nutrition label and serving sizes. The meeting was attended by interested parties both in Washington, D.C. and via webcast. The Acting U.S. Surgeon General, Rear Admiral Boris D. Lushniak, M.D., M.P.H., gave the opening remarks stating the importance of these changes in relation to the Surgeon General's national prevention strategy started in June 2011. FDA has posted...

Bloomberg BNA Daily Environment Report reported on Lynn L. Bergeson’s comments regarding final nanotechnology guidances released by the Food and Drug Administration. “The guidances reaffirm the FDA’s position that it has sufficient statutory authorities and policies to oversee the safety of products it regulates, Bergeson said. She expanded on that perspective in a memo her law firm issued. The FDA also restated its view that nanotechnology isn’t inherently safe or harmful, but that...

On June 24, 2014, the U.S. Food and Drug Administration (FDA) issued three final guidances and one draft guidance that it intends to provide "greater regulatory clarity for industry on the use of nanotechnology in FDA-regulated products." One final guidance addresses FDA's overall approach for all products that it regulates, while the two additional final guidances and the new draft guidance provide specific guidance for the areas of foods, cosmetics, and food for animals, respectively. FDA...

On June 24, 2014, the U.S. Food and Drug Administration (FDA) issued three final guidances and one draft guidance that it intends to provide “greater regulatory clarity for industry on the use of nanotechnology in FDA-regulated products.” One final guidance addresses FDA’s overall approach for all products that it regulates, while the two additional final guidances and the new draft guidance provide specific guidance for the areas of foods, cosmetics, and food for animals,...

On June 24, 2014, the U.S. Food and Drug Administration (FDA) issued three final guidances and one draft guidance that it intends to provide "greater regulatory clarity for industry on the use of nanotechnology in FDA-regulated products." See http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm402499.htm. One final guidance addresses FDA's overall approach for all products that it regulates, while the two additional final guidances and the new draft guidance provide specific...

Bergeson & Campbell, P.C. (B&C®) and The Acta Group (Acta) are pleased to announce the addition of Brian Xu, Ph.D., to our firms. Dr. Xu, a board-certified toxicologist and medical doctor, will assist clients in developing and managing international projects involving U.S. Food and Drug Administration (FDA) and U.S. Environmental Protection Agency (EPA) regulated consumer products, pharmaceuticals, cosmetics, industrial and specialty chemicals, agrochemicals, and antimicrobials. Dr. Xu...

The U.S. Environmental Protection Agency (EPA) published a notice on April 4, 2014, announcing that it issued a testing consent order that incorporates an enforceable consent agreement (ECA) for octamethylcyclotetrasiloxane (D4), a chemical intermediate and component of personal care products. 79 Fed. Reg. 18822. There are two big take away messages here. First, that EPA issued a testing order at all under Toxic Substances Control Act (TSCA) Section 4 is big news as none has been issued in a...

On March 7, 2014, the Office of Environmental Health Hazard Assessment (OEHHA) released a pre-regulatory proposal for a potential draft regulation amending Proposition 65 regulations. Significantly -- and likely controversially -- the proposal seeks changes to the warning requirements to require more detailed information, including the names of the chemicals covered by individual warnings, the ways that individuals are exposed to these chemicals, and how individuals can avoid or reduce their...

Bergeson & Campbell, P.C. (B&C®) and The Acta Group (Acta) are pleased to announce the addition of Karin F. Baron to our firms. Ms. Baron is an expert regulatory consultant with more than 15 years of experience in developing, implementing, and managing complex chemical regulatory compliance matters for some of the largest industrial and specialty chemical companies in the world, including International Specialty Products, Ciba Specialty Chemicals, and most recently 3E. Her primary areas...