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On June 24, 2014, the U.S. Food and Drug Administration (FDA) issued three final guidances and one draft guidance that it intends to provide "greater regulatory clarity for industry on the use of nanotechnology in FDA-regulated products."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FDA's overall approach for all products that it regulates, while the two additional final guidances and the new draft guidance provide specific guidance for the areas of foods, cosmetics, and food for animals, respectively.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On June 24, 2014, the U.S. Food and Drug Administration (FDA) issued three final guidances and one draft guidance that it intends to provide “greater regulatory clarity for industry on the use of nanotechnology in FDA-regulated products.”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FDA’s overall approach for all products that it regulates, while the two additional final guidances and the new draft guidance provide specific guidance for the areas of foods, cosmetics, and food for animals,...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

The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) posted a blog item on October 24, 2013, concerning the use of nanotechnology to develop new drugs. According to the item, “[t]here are already many products made using materials at the nanoscale, including new kinds of clothing, packaging materials, and light-weight, but strong, building materials.” CDER conducted a series of risk assessment and risk management exercises concerning...

The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) posted a blog item on October 24, 2013, concerning the use of nanotechnology to develop new drugs.

Bergeson & Campbell, P.C. (B&C) is pleased to announce that Lara A. Hall, a Registered Quality Assurance Professional in Good Laboratory Practice with a Masters degree in Biology, has joined our staff of scientists at B&C, The Acta Group (Acta), and B&C Consortia Management, L.L.C. (BCCM). With over a decade of experience in environmental research, study monitoring, and international regulatory support, Ms. Hall will assist our clients in placing and monitoring studies to assist...

This is the first in a series of updates concerning compliance initiatives underway by the U.S. Food and Drug Administration (FDA) that affect various segments of the regulated industry. This issue focuses on court actions, Warning Letters, recalls, and other matters pertaining to dietary supplements. We will periodically outline actions and issues affecting prescription and over-the-counter (OTC) drugs, medical device and diagnostic products, food, cosmetics, animal drugs, and biologics....

On July 9, 2012, President Barack Obama signed the Food and Drug Administration Safety and Innovation Act (P.L. 112-144). The Act authorizes the U.S. Food and Drug Administration (FDA) to collect user fees from industry to fund reviews of innovator drugs, medical devices, generic drugs, and biosimilar biologics. It also includes a section concerning nanotechnology, directing the Secretary of Health and Human Services to “intensify and expand activities related to enhancing scientific...

The FDA issues two new draft guidance documents on nanotechnology in food substances and cosmetics.

On April 20, 2012, the U.S. Food and Drug Administration (FDA) issued two new draft guidance documents on the use of nanotechnology in food and cosmetic products -- "Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes, Including Emerging Technologies, on the Safety and Regulatory Status of Food Ingredients and Food Contact Substances, including Food Ingredients that are Color Additives," which is available online, and "Guidance for Industry: Safety of...

On April 20, 2012, the U.S. Food and Drug Administration (FDA) announced the availability of two draft guidance documents addressing the use of nanotechnology, “Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes, including Emerging Technologies, on the Safety and Regulatory Status of Food Ingredients and Food Contact Substances, Including Food Ingredients that are Color Additives,” and “Guidance for Industry: Safety of Nanomaterials in...

The April 6, 2012, issue of Bloomberg BNA Daily Environment Report quotes Lynn L. Bergeson regarding the Food and Drug Administration’s (FDA) recent decision to reject the Natural Resources Defense Council’s petition to ban the use of bisphenol A in food packaging.

Bergeson & Campbell, P.C. (B&C) and its consulting affiliates, B&C Consortia Management, L.L.C. (BCCM) and The Acta Group, L.L.C. (Acta), are pleased to announce the expansion of their capabilities in Asia. The Acta Group China, L.L.C. has formed a joint venture with Pacific Life Sciences Co. Ltd. (PLS), a leading Chinese firm serving the chemical industry with offices in Beijing, Shanghai, and Tanjin, China. This partnership broadens the firms' global capabilities in product...