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FDA Releases Guidance on Evaluating Animal Drug Safety in Food-Producing Animals

Posted on June 14, 2018

FDA’s Center for Veterinary Medicine (CVM) has released a new guidance document (Guidance for Industry #3: General Principles for Evaluating the Human Food Safety of New Animal Drugs Used

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Bipartisan Bill Would Protect State Marijuana Laws

Posted on June 12, 2018

Several U.S. Senators introduced a bipartisan bill titled, Strengthening the Tenth Amendment Through Entrusting States Act (STATES Act), on June 7. The bill would allow states, U.S. territories,

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FDA and CDC Release Results of 2017 National Youth Tobacco Survey

Posted on June 8, 2018

On June 7, FDA and CDC released the results of the 2017 National Youth Tobacco Survey. Total number of high- and middle-school tobacco users of any tobacco product continued

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FDA and USDA Announce Collaborative Effort to Align Produce Safety Requirements

Posted on June 6, 2018

On June 5, 2018, FDA and USDA announced a new collaborative effort to streamline produce safety requirements for farmers by aligning the USDA Harmonized Good Agricultural Practices Audit Program (USDA

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Continuing Fallout from E. Coli Outbreak in Romaine

Posted on May 31, 2018

According to the Wall Street Journal (paywall), the impact of the recent E. coli outbreak in romaine lettuce continues to ripple through the market, causing a 44.5% drop

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FDA Issues Food Facility Registration Small Entity Compliance Guide

Posted on May 30, 2018

FDA has released a Small Entity Compliance Guide (SECG) to help food facilities comply with the registration requirements under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Section 415

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FDA Encourages Importer Preparation for Next VQIP Application Cycle

Posted on May 29, 2018

As previously discussed on this blog, the Food Safety Modernization Act (FSMA) established a voluntary, fee-based program for the review and importation of foods from importers who achieve and

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FDA Continues its Enforcement Efforts Aimed at Companies Marketing Kratom Products

Posted on May 25, 2018

On May 22, 2018 FDA announced that it had issued warning letters to three companies marketing kratom products with medical claims. FDA’s letter asserts that the claims that the products

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FDA Warns Companies Illegally Marketing Dietary Supplements as Sunscreen

Posted on May 23, 2018

On May 22, 2018, FDA sent warning letters to companies illegally marketing dietary supplements that make unproven drug claims about sun protection without meeting FDA’s standards for safety and effectiveness.

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FDA Extends Compliance Dates for Certain Uses of Partially Hydrogenated Oils in Food; Denies Petition for PHO Use

Posted on May 18, 2018

As previously discussed in this blog, in November 2013, FDA announced its tentative conclusion that partially hydrogenated oils (PHOs) are not generally recognized as safe (GRAS). In June 2015

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