FDA

Lynn L. Bergeson, "Is FDA Food Safety Revision in Our Future?," Chemical Processing, August 24, 2021.

Food safety comes in many forms. Years ago, Congress passed the Food Quality Protection Act, amending the nation’s pesticide law to ensure a safer, more reliable, food supply. Consumer groups have urged Congress for years to modernize the nation’s food chemical law, the Federal Food, Drug, and Cosmetic Act (FFDCA), to address often-stated concerns with chemicals in food. Thus far, those concerns remain largely unaddressed by any legislative effort. Things may be changing. On July 26, 2021, Representative Jan Schakowsky (D-IL), chair of the House Energy and Commerce Subcommittee on Consumer Protection and Commerce, introduced the Food Chemical Reassessment Act of 2021 (H.R. 4694), which would require the U.S. Food and Drug Administration (FDA) to study and reassess chemicals used in food. This article summarizes the measure, and speculates on its likelihood of passage.

Lynn L. Bergeson, "The importance of regulatory diligence in funding," Financier Worldwide, April 2021.

Lawyers counselling companies in the biotechnology, biopesticide and related crop protection and industrial biotechnology areas appreciate the critically important role federal agencies play in ensuring the success of start-up businesses.

Federal agencies, including the US Environmental Protection Agency (EPA) and the US Food and Drug Administration (FDA), among others, wield enormous power over businesses that require premarket product approval. While we product approval practitioners know this, it comes as a bit of a surprise when investors, poised to make multimillion-dollar investments in start-up businesses, neglect to focus on the regulatory integrity of the start-up. This lack of focus invites costly mistakes. This article explains why, and how to avoid making these mistakes.

Lynn L, Bergeson, "FDA Proposed Rule for OTC Sunscreen Drug Products Addresses Sunscreens Containing Nanomaterials," Nanotechnology Now, February 22, 2019.

The Food and Drug Administration (FDA) is scheduled to publish a proposed rule in the Federal Register on February 26, 2019, that would put into effect a final monograph for nonprescription, over-the-counter (OTC) sunscreen drug products.

J. Brian Xu, M.D., Ph.D., DABT® and Scott J. Burya, Ph.D., "FCM regulations in China and the US - a comparison," CW+ AsiaHub, July 18, 2018.

While the intention of food contact regulations in both China and the US is to protect public health, the approaches taken, the obligations for industry and other facets of the regulations differ in notable ways. This article overviews the two regulatory systems, highlighting key similarities and differences between the emerging regulatory regime in China and the established US Food and Drug Administration (FDA) food contact regulations. 

Lynn L. Bergeson, "Enlisting Modern Technologies to Ensure a Safe Food Supply," Natural Resources & Environment, Volume 31, Issue 3, Winter 2017.

Nanotechnology, biotechnology, and synthetic biology are the ploughs and tractors of the twenty-first century. These precision farming tools are ensuring a sustainable food supply otherwise threatened by climate change and population growth, among other global challenges. Genetically modified E. coli is being used to produce synthetically derived pheromones, substances beneficially used in agricultural applications to attract, capture, and eliminate harmful pests. Nanopesticides and nanofertilizers are being effectively used in drought-stricken regions, eliminating or minimizing the need for conventional agricultural chemicals. These and similar technologies are essential to enable today’s agricultural professionals to compete with an increasingly unforgiving Mother Nature and an ever-increasing demand for food.

 

These emerging technologies do not come without potential risks, however. How to regulate them is a  subject upon which stakeholders disagree.

 

Against this backdrop, this article considers emerging agricultural technologies, and discusses domestic agricultural oversight systems and their ability to keep pace with innovation. As discussed below, the domestic governance system is capable of addressing comprehensively the potential risks posed by these evolving technologies. The system, however, could be improved by better integration of measures  to educate policy makers and regulators on these technologies, and greater involvement by the private  sector in facilitating a predictable flow of information on these technologies to all stakeholders.

Lynn L. Bergeson, "FDA Issues Final Guidance on Use of Nanomaterials in Food for Animals," Nanotechnology Now, August 5, 2015.

On August 4, 2015, the U.S. Food and Drug Administration (FDA) announced the availability of a final guidance document entitled "Guidance for Industry: Use of Nanomaterials in Food for Animals." The Guidance is intended to assist industry and other stakeholders in identifying potential issues related to safety or regulatory status of food for animals containing nanomaterials or otherwise involving the application of nanotechnology.

Lynn L. Bergeson, Carla N. Hutton, "FDA’s Final and Draft Nanotechnology Guidance Documents: No Big Surprises," Nanotechnology Law & Business, Spring 2015.
On June 24, 2014, the U.S. Food and Drug Administration (FDA) issued three final guidance documents and one draft guidance document that FDA believes will provide greater regulatory clarity for industry and other stakeholders on the use of nanotechnology in FDA-regulated products. In this article, Lynn Bergeson and Carla N. Hutton review the recent guidance and highlight important considerations.
Lynn L. Bergeson, "FDA Issues Final and Draft Nanotechnology Guidances," Nanotechnology Now, June 24, 2014.

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 guidance for the areas of foods, cosmetics, and food for animals, respectively.

Lynn L. Bergeson, "FDA Finds Current Regulatory Review Processes Protect Public from Risks of Nanomaterials," Nanotechnology Now, October 29, 2013.

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.

Lynn L. Bergeson, "Edible Nanotechnology," Pollution Engineering, July 2012.

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

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