Posts in Guidance
FDA to modernize proposed rules defining the identify of foods.

The FDA announced today that they were withdrawing the “Food Standards; General Principles and Food Standards Modernization” rule, proposed in 2005 and were aiming to make FDA definitions and standards of identity for foods consistent with the Federal Food, Drug, and Cosmetic Act, and the standards used by the USDA Food Safety and Inspection Service (FSIS) to inspect meat and poultry products.

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White House announcement of the Bioeconomy Initiative includes support for cultured meat and a streamlined process for regulatory approval

Of particular relevance to Vireo Advisors, LLC and our clients is the intent to improve the clarity and efficiency of the regulatory process for biotechnology products.

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Washington State to Impose Restrictions or Mandate Reporting on Chemical Classes with Well-Established Toxicity

In June 2022, The Washington State Department of Ecology (Ecology) has proposed state-wide chemical restrictions on five classes of chemicals in eleven product categories, the largest number of chemical classes and products to ever be considered by a state at one time.

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Cultured Meat Regulation in Japan

According to a report in The Japan News, a team of experts will be established this fiscal year by the Japanese Health, Labor and Welfare Ministry to investigate whether there are risks in proposed meat cultivation processes that could adversely affect human health.

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FDA enforcement discretion and faster new product approval to increase infant formula supply in the U.S.

A voluntary recall and facility shutdown by Abbott Nutrition has created a supply disruption for certain types of infant formula. President Biden has announced a series of measures to address the resulting crisis for families around the country, including action by the FDA help make up the shortfall.

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Achieving the potential of the US bioeconomy

The US bioeconomy (biotechnology-based economic activity) currently contributes 5.1 percent or more of US GDP and has tremendous growth potential. Realizing that potential requires, among other efforts, investment by the government to advance innovation infrastructure including regulatory frameworks that are open to new technologies and don’t obstruct them.

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